Journal articles
Britten N, Garside R, Pope C, Frost J, Cooper C (In Press). Asking more of qualitative synthesis: a response to Sally Thorne. Qualitative Health Research
Ohly H, White MP, Wheeler BW, Bethel A, Ukomunne O, Nikolaou V, Garside R (In Press). Attention restoration theory: a systematic review of the attention restoration potential of exposure to natural environments. Journal of Toxicology and Environmental Health, Part B, In Press
Britten N, France E, Cunningham M, Ring N, Uny I, Duncan E, Ruth J, Maxwell M, Roberts R, Turley R, et al (In Press). Improving reporting of Meta-Ethnography: the eMERGe Reporting Guidance. Journal of Advanced Nursing
Moore D, Nunns M, Shaw L, Rogers M, Walker E, Ford T, Garside R, Ukoumunne O, Titman P, Shafran R, et al (In Press). Interventions to improve the mental health of children and young people with long-term physical conditions: Linked evidence syntheses. Health Technology Assessment
Briscoe S, Thompson Coon J, Melendez-Torres GJ, Abbott R, Shaw E, Nunns M, Garside R (In Press). Primary care clinicians’ perspectives on interacting with patients with gynaecological conditions or symptoms suggestive of gynaecological conditions: a scoping review of qualitative studies.
NIHR web reportAbstract:
Primary care clinicians’ perspectives on interacting with patients with gynaecological conditions or symptoms suggestive of gynaecological conditions: a scoping review of qualitative studies
Background: in recent years several reports have found that women do not feel listened to either by clinicians or at the system level when discussing health care concerns. In particular, women perceive that they are treated dismissively and that their symptoms are not taken seriously. This finding is reflected both in reports on health care conditions which specifically affect women, such as endometriosis, heavy menstrual bleeding and menopause, and in reports which explore failures of the health care system to listen and intervene when patients feel they are experiencing harm. A particular issue has been highlighted around women not feeling listened to by primary care clinicians, who are seen as the ‘gatekeepers’ to the more specialist care available in secondary care services. This can lead to patients feeling that their health concerns are being dismissed without due consideration. What is less well-known is why this occurs and in what circumstances, or indeed to what extent primary care clinicians perceive that there are problems around listening to women patients.
In order to better understand this issue from the perspective of primary care clinicians, we were asked to carry out a scoping review of evidence on primary care clinicians’ views on listening to and, more broadly, interacting with women patients, including with specific groups of women patients such as ethnic minority women, LGBTQ+, older/younger and disabled women. Following initial exploratory work, we developed a protocol for a scoping review of the qualitative research evidence with the following aim and research questions.
Aim: to identify and summarise qualitative evidence on primary care clinicians’ perspectives on interacting with patients with gynaecological conditions or symptoms suggestive of gynaecological conditions.
Research questions:
1. What evidence is there about primary care clinicians’ perspectives on interacting with patients with gynaecological conditions or symptoms suggestive of gynaecological conditions?
2. What key themes have been raised about challenges of interacting with patients with gynaecological conditions or symptoms suggestive of gynaecological conditions?
Findings: Twenty-three papers, from 18 unique studies, were included in the qualitative scoping review. Most papers (n=8) were about clinicians’ experiences with diagnosing and managing endometriosis, with smaller numbers of papers discussing menopause (n=4), menorrhagia (n=3), polycystic ovary syndrome (n=3) and chronic pelvic pain (n=2). Infertility disease, menstrual disorders and premenstrual symptoms each were discussed in one paper. The papers reported data collected in the UK (n=8), Australia (n=7), US (n=3), Netherlands (n=2), Sweden (n=2) and Norway (n=1). Primary care clinicians who participated in the studies included GPs, nurse practitioners, internists/family practitioners, pharmacists and a community gynaecologist. GPs were included in the majority of papers (n=20).
We also identified a selection of themes and subthemes on or related to the challenge of interacting with patients with gynaecological conditions or symptoms suggestive of gynaecological conditions. Subthemes were organised within four thematic ‘levels’: the individual clinician; structural and organisational factors; community and external factors; and factors specific to gynaecological conditions and symptoms.
Abstract.
Haynes E, Garside R, Green J, Kelly MP, Thomas J, Guell C (In Press). Semi-automated text analytics for qualitative data synthesis. Research Synthesis Methods
Newlove-Delgado TV, Ford TJ, Stein K, Garside R (In Press). “You’re 18 now, goodbye”: the experiences of young people with Attention Deficit Hyperactivity Disorder of the transition from child to adult services. Emotional and Behavioural Difficulties
Shaw L, Nunns M, Briscoe S, Garside R, Turner M, Melendez-Torres GJ, Lawal HM, Coon JT (2023). Optimising the prescribing of drugs that may cause dependency: an evidence and gap map of systematic reviews.
J Health Serv Res Policy,
28(4), 271-281.
Abstract:
Optimising the prescribing of drugs that may cause dependency: an evidence and gap map of systematic reviews.
OBJECTIVES: We set out to map the quantitative and qualitative systematic review evidence available to inform the optimal prescribing of drugs that can cause dependency (benzodiazepines, opioids, non-benzodiazepine hypnotics, gabapentinoids and antidepressants). We also consider how this evidence can be used to inform decision-making in the patient care pathway for each type of medication. METHODS: Eight bibliographic databases were searched for the period 2010 to 2020. All included reviews were initially appraised using four items from the Collaboration for Environmental Evidence Synthesis Assessment Tool, with reviews that scored well on all items proceeding to full quality appraisal. Key characteristics of the reviews were tabulated, and each review was incorporated into an evidence and gap map based on a patient care pathway. The care pathway was based upon an amalgamation of existing NICE guidelines and feedback from clinical and patient stakeholders. RESULTS: We identified 80 relevant reviews and displayed them in an evidence and gap map. The evidence included in these reviews was predominantly of low overall quality. Areas where systematic reviews have been conducted include barriers and facilitators to the deprescribing of drugs that may cause dependency, although we identified little evidence exploring the experiences or evaluations of specific interventions to promote deprescribing. All medications of interest, apart from gabapentinoids, were included in at least one review. CONCLUSIONS: the evidence and gap map provides an interactive resource to support (i) policy developers and service commissioners to use evidence in the development and delivery of services for people receiving a prescription of drugs that may cause dependency, where withdrawal of medication may be appropriate, (ii) the clinical decision-making of prescribers and (iii) the commissioning of further research. The map can also be used to inform the commissioning of further systematic reviews. To address the concerns regarding the quality of the existing evidence based raised in this report, future reviews should be conducted according to best-practice guidelines. Systematic reviews focusing on evaluating interventions to promote deprescribing would be particularly beneficial, as would reviews focusing on addressing the paucity of evidence regarding the deprescription of gabapentinoids.
Abstract.
Author URL.
Abbott R, Thompson Coon J, Bethel A, Rogers M, Whear R, Orr N, Garside R, Goodwin V, Mahmoud A, Lourida I, et al (2023). PROTOCOL: Health and social care interventions in the 80 years old and over population: an evidence and gap map.
Campbell Systematic Reviews,
19(2).
Abstract:
PROTOCOL: Health and social care interventions in the 80 years old and over population: an evidence and gap map
AbstractThis is the protocol for a Campbell systematic review. The objectives are as follows: identify available systematic reviews and randomised controlled trials on interventions targeting health or social needs of the people aged over 80; identify qualitative studies relating to the experiences of people aged over 80 of interventions that target their health or social needs; identify areas where systematic reviews are needed; identify gaps in evidence where further primary research is needed; assess equity considerations (using the PROGRESS plus criteria) in available systematic reviews, randomised trials and qualitative studies of identified interventions; assess gaps and evidence related to health equity.
Abstract.
Whear R, Campbell F, Rogers M, Sutton A, Robinson‐Carter E, Sharpe R, Cohen S, Fergy R, Garside R, Kneale D, et al (2023). PROTOCOL: What is the effect of intergenerational activities on the wellbeing and mental health of older people?. Campbell Systematic Reviews, 19(2).
Alvarado M, Lovell R, Guell C, Taylor T, Fullam J, Garside R, Zandersen M, Wheeler B (2023). Street trees and mental health: developing systems thinking-informed hypotheses using causal loop diagraming. Ecology and Society, 28(2).
Orr N, Abbott R, Bethel A, Paviour S, Whear R, Garside R, Coon JT (2023). What are the effects of animals on the health and wellbeing of residents in care homes? a systematic review of the qualitative and quantitative evidence.
BMC Geriatrics,
23(1).
Abstract:
What are the effects of animals on the health and wellbeing of residents in care homes? a systematic review of the qualitative and quantitative evidence
Abstract
. Background
. There is some evidence to suggest that animal-assisted interventions can have beneficial impact for residents in long-term care, but the focus of the evidence has largely been on behavioural and psychosocial measured outcomes. Animals, either as companion animals or in the form of pet/animal-assisted therapy, may provide benefits in the form of social contact, as well as opportunities for sensory experiences and meaningful engagement not picked up by outcome tools. This review aimed to create a state-of-knowledge synthesis, bringing together qualitative and quantitative findings, on the impact of animal-human interaction on care home residents and care home staff.
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. Methods
. Fourteen databases were searched from inception to July 2020. Forward and backward citation chasing of included articles was conducted. Screening was undertaken independently by a team of reviewers. Thematic synthesis and meta-analysis were used to synthesise the qualitative and quantitative data.
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. Results
. Thirty-four studies, published in 40 articles (20 qualitative and 20 quantitative) were included. Five themes relating to resident wellbeing were identified in the qualitative evidence synthesis. These were animals as ‘living beings’, reminiscence and storytelling, caring (as ‘doing’ and ‘feeling’), respite (from loneliness, institutionalisation, and illness), and sensory engagement. A sixth theme related to staff perceptions and wellbeing, and a seventh to animal health and wellbeing. Maintaining identity was identified as an overarching theme. The majority of randomised trials had small sample sizes and were rated as low quality, mostly showing no evidence of beneficial effect. There was, however, limited evidence of a positive effect of pet/animal interaction on outcomes of loneliness, anxiety and depression, supporting the themes of respite and sensory engagement.
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. Conclusions
. The presence of animals can significantly impact the health and wellbeing of some care home residents. Residents had meaningful relationships with animals and derived pleasure and comfort from them. Interacting with animals offered residents a way to maintain a sense of self in the care homes, and with support, residents with dementia could also express their identities. Facilitating residents to interact with animals as part of person-centred care may also help residents to feel ‘at home’ in the care home.
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. Trial registration
. PROSPERO registration no: CRD42017058201.
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Abstract.
Cooper C, Booth A, Husk K, Lovell R, Frost J, Schauberger U, Britten N, Garside R (2022). A Tailored Approach: a model for literature searching in complex systematic reviews.
JOURNAL OF INFORMATION SCIENCE Author URL.
Coon JT, Orr N, Shaw L, Hunt H, Garside R, Nunns M, Gröppel-Wegener A, Whear B (2022). Bursting out of our bubble: using creative techniques to communicate within the systematic review process and beyond.
Systematic Reviews,
11(1).
Abstract:
Bursting out of our bubble: using creative techniques to communicate within the systematic review process and beyond
Abstract
. Background
. Increasing pressure to publicise research findings and generate impact, alongside an expectation from funding bodies to go beyond publication within academic journals, has generated interest in alternative methods of science communication.
. Our aim is to describe our experience of using a variety of creative communication tools, reflect on their use in different situations, enhance learning and generate discussion within the systematic review community.
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. Methods
. Over the last 5 years, we have explored several creative communication tools within the systematic review process and beyond to extend dissemination beyond traditional academic mechanisms.
. Central to our approach is the co-production of a communication plan with potential evidence users which facilitates (i) the identification of key messages for different audiences, (ii) discussion of appropriate tools to communicate key messages and (iii) exploration of avenues to share them. We aim to involve evidence users in the production of a variety of outputs for each research project cognisant of the many ways in which individuals engage with information.
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. Results
. Our experience has allowed us to develop an understanding of the benefits and challenges of a wide range of creative communication tools. For example, board games can be a fun way of learning, may flatten power hierarchies between researchers and research users and enable sharing of large amounts of complex information in a thought provoking way, but they are time and resource intensive both to produce and to engage with. Conversely, social media shareable content can be quick and easy to produce and to engage with but limited in the depth and complexity of shareable information.
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. Discussion
. It is widely recognised that most stakeholders do not have time to invest in reading large, complex documents; creative communication tools can be a used to improve accessibility of key messages. Furthermore, our experience has highlighted a range of additional benefits of embedding these techniques within our project processes e.g. opening up two-way conversations with end-users of research to discuss the implications of findings.
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Abstract.
Stanton IC, Bethel A, Leonard AFC, Gaze WH, Garside R (2022). Existing evidence on antibiotic resistance exposure and transmission to humans from the environment: a systematic map.
Environmental Evidence,
11(1).
Abstract:
Existing evidence on antibiotic resistance exposure and transmission to humans from the environment: a systematic map
Abstract
. Background
. Antimicrobial resistance (AMR) is predicted to become the leading cause of death by 2050 with antibiotic resistance being an important component. Anthropogenic pollution introduces antibiotic resistant bacteria (ARB) and antibiotic resistance genes (ARGs) to the natural environment. Currently, there is limited empirical evidence demonstrating whether humans are exposed to environmental AMR and whether this exposure can result in measurable human health outcomes. In recent years there has been increasing interest in the role of the environment and disparate evidence on transmission of AMR to humans has been generated but there has been no systematic attempt to summarise this. We aim to create two systematic maps that will collate the evidence for (1) the transmission of antibiotic resistance from the natural environment to humans on a global scale and (2) the state of antibiotic resistance in the environment in the United Kingdom.
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. Methods
. Search strategies were developed for each map. Searches were undertaken in 13 bibliographic databases. Key websites were searched and experts consulted for grey literature. Search results were managed using EndNote X8. Titles and abstracts were screened, followed by the full texts. Articles were double screened at a minimum of 10% at both stages with consistency checking and discussion when disagreements arose. Data extraction occurred in Excel with bespoke forms designed. Data extracted from each selected study included: bibliographic information; study site location; exposure source; exposure route; human health outcome (Map 1); prevalence/percentage/abundance of ARB/antibiotic resistance elements (Map 2) and study design. EviAtlas was used to visualise outputs.
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. Results
. For Map 1, 40 articles were included, from 11,016 unique articles identified in searches, which investigated transmission of AMR from the environment to humans. Results from Map 1 showed that consumption/ingestion was the most studied transmission route. Exposure (n = 17), infection (n = 16) and colonisation (n = 11) being studied as an outcome a similar number of times, with mortality studied infrequently (n = 2). In addition, E. coli was the most highly studied bacterium (n = 16). For Map 2, we included 62 studies quantifying ARB or resistance elements in the environment in the UK, from 6874 unique articles were identified in the searches. The most highly researched species was mixed communities (n = 32). The most common methodology employed in this research question was phenotypic testing (n = 37). The most commonly reported outcome was the characterisation of ARBs (n = 40), followed by characterisation of ARGs (n = 35). Other genetic elements, such as screening for intI1 (n = 15) (which encodes a Class 1 integron which is used as a proxy for environmental ARGs) and point mutations (n = 1) were less frequently reported. Both maps showed that research was focused towards aquatic environments.
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. Conclusions
. Both maps can be used by policy makers to show the global (Map 1) and UK (Map 2) research landscapes and provide an overview of the state of AMR in the environment and human health impacts of interacting with the environment. We have also identified (1) clusters of research which may be used to perform meta-analyses and (2) gaps in the evidence base where future primary research should focus.
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Abstract.
Eales J, Bethel A, Galloway T, Hopkinson P, Morrissey K, Short RE, Garside R (2022). Human health impacts of exposure to phthalate plasticizers: an overview of reviews.
Environ Int,
158Abstract:
Human health impacts of exposure to phthalate plasticizers: an overview of reviews.
In this review of reviews, we overview the current global body of available evidence from structured reviews of epidemiological studies that explore human health outcomes associated with exposure to phthalates (chemical plasticisers commonly found in plastics). We found robust evidence for an association with lower semen quality, neurodevelopment and risk of childhood asthma, and moderate to robust evidence for impact on anogenital distance in boys. We identified moderate evidence for an association between phthalates/metabolites and low birthweight, endometriosis, decreased testosterone, ADHD, Type 2 diabetes and breast/uterine cancer. There was some evidence for other outcomes including anofourchette distance, fetal sex hormones, pre-term birth, lower antral follicle count, reduced oestrodiol, autism, obesity, thyroid function and hearing disorders. We found no reviews of epidemiological human studies on the impact of phthalates from recycled plastics on human health. We recommend that future research should use urine samples as exposure measures, consider confounders in analyses and measure impacts on female reproductive systems. Our findings align with emerging research indicating that health risks can occur at exposure levels below the "safe dose" levels set out by regulators, and are of particular concern given potential additive or synergistic "cocktail effects" of chemicals. This raises important policy and regulatory issues for identifying and controlling plastics and health related impacts and highlights a need for more research into substances of concern entering plastics waste streams via recycling.
Abstract.
Author URL.
Whear R, Abbott RA, Bethel A, Richards DA, Garside R, Cockcroft E, Iles-Smith H, Logan PA, Rafferty AM, Shepherd M, et al (2022). Impact of COVID-19 and other infectious conditions requiring isolation on the provision of and adaptations to fundamental nursing care in hospital in terms of overall patient experience, care quality, functional ability, and treatment outcomes: systematic review.
Journal of Advanced Nursing,
78(1), 78-108.
Abstract:
Impact of COVID-19 and other infectious conditions requiring isolation on the provision of and adaptations to fundamental nursing care in hospital in terms of overall patient experience, care quality, functional ability, and treatment outcomes: systematic review
Aim: This systematic review identifies, appraises and synthesizes the evidence on the provision of fundamental nursing care to hospitalized patients with a highly infectious virus and the effectiveness of adaptations to overcome barriers to care. Design: Systematic review. Data Sources: in July 2020, we searched Medline, PsycINFO (OvidSP), CINAHL (EBSCOhost), BNI (ProQuest), WHO COVID-19 Database (https://search.bvsalud.org/) MedRxiv (https://www.medrxiv.org/), bioRxiv (https://www.biorxiv.org/) and also Google Scholar, TRIP database and NICE Evidence, forwards citation searching and reference checking of included papers, from 2016 onwards. Review Methods: We included quantitative and qualitative research reporting (i) the views, perceptions and experiences of patients who have received fundamental nursing care whilst in hospital with COVID-19, MERS, SARS, H1N1 or EVD or (ii) the views, perceptions and experiences of professional nurses and non-professionally registered care workers who have provided that care. We included review articles, commentaries, protocols and guidance documents. One reviewer performed data extraction and quality appraisal and was checked by another person. Results: of 3086 references, we included 64 articles; 19 empirical research and 45 review articles, commentaries, protocols and guidance documents spanning five pandemics. Four main themes (and 11 sub-themes) were identified. Barriers to delivering fundamental care were wearing personal protective equipment, adequate staffing, infection control procedures and emotional challenges of care. These barriers were addressed by multiple adaptations to communication, organization of care, staff support and leadership. Conclusion: to prepare for continuation of the COVID-19 pandemic and future pandemics, evaluative studies of adaptations to fundamental healthcare delivery must be prioritized to enable evidence-based care to be provided in future. Impact: Our review identifies the barriers nurses experience in providing fundamental care during a pandemic, highlights potential adaptations that address barriers and ensure positive healthcare experiences and draws attention to the need for evaluative research on fundamental care practices during pandemics.
Abstract.
Zain MA, Suhaimi J, Dahlui M, Goh HC, Then AY-H, Yakub NA, Noor MIM, Garside R, Eales J, Jose E, et al (2022). What are the outcomes of marine site protection on poverty of coastal communities in Southeast Asia? a systematic review protocol.
ENVIRONMENTAL EVIDENCE,
11(1).
Author URL.
Orr N, Yeo NL, Dean SG, White MP, Garside R (2021). "It Makes you Feel That you Are There": Exploring the Acceptability of Virtual Reality Nature Environments for People with Memory Loss.
Geriatrics (Basel),
6(1).
Abstract:
"It Makes you Feel That you Are There": Exploring the Acceptability of Virtual Reality Nature Environments for People with Memory Loss.
Aim: to report on the acceptability of virtual reality (VR) nature environments for people with memory loss at memory cafes, and explore the experiences and perceptions of carers and staff. Methods: a qualitative study was conducted between January and March 2019. Ten adults with memory loss, eight carers and six volunteer staff were recruited from two memory cafes, located in Cornwall, UK. There were 19 VR sessions which were audio recorded and all participants were interviewed at the end of the sessions. Framework analysis was used to identify patterns and themes in the data. Results: During the VR experience, participants were engaged to varying degrees, with engagement facilitated by the researcher, and in some cases, with the help of a carer. Participants responded positively to the nature scenes, finding them soothing and evoking memories. The VR experience was positive; many felt immersed in nature and saw it as an opportunity to 'go somewhere'. However, it was not always positive and for a few, it could be 'strange'. Participants reflected on their experience of the VR equipment, and volunteer staff and carers also shared their perceptions of VR for people with dementia in long-term care settings. Conclusions: the VR nature experience was an opportunity for people with memory loss to be immersed in nature and offered the potential to enhance their quality of life. Future work should build on lessons learned and continue to work with people with dementia in developing and implementing VR technology in long-term care settings.
Abstract.
Author URL.
Germeni E, Garside R, Frost J, Rogers M, Britten N (2021). Can a Meta-ethnography be Updated by Different Reviewers? Reflections from a Recent Update.
International Journal of Qualitative Methods,
20Abstract:
Can a Meta-ethnography be Updated by Different Reviewers? Reflections from a Recent Update
Over the last decade, there has been a proliferation of published meta-ethnographies. Yet, strategies and techniques for updating have not received the same attention, rendering answers to important methodological questions still elusive. One such question has to do with who can perform an update. Although it is not uncommon for quantitative systematic reviews and statistical meta-analyses to be updated by different reviewers, qualitative synthesists might find themselves caught between a rock and a hard place. On the one hand, as meta-ethnography constitutes an interpretation three times removed from the lived experience of the participants in the original studies, it could be argued that an update by different reviewers might add an extra layer of interpretation. By comparison, updating by the same reviewers could give rise to concerns about the robustness of updated findings, as an implicit drive for making new data fit the original work might be difficult to control for. We recently reported the findings of our attempt to update an earlier meta-ethnography of primary care antibiotic prescribing, conducted by a different team of reviewers. In this article, we wish to contribute to the emerging debate on the necessity of promoting a culture of updating in qualitative evidence synthesis, by discussing some of the practical and methodological issues we considered at each stage of the process and offering lessons learnt from our experience.
Abstract.
Aloe AM, Garside R (2021). Editorial: Types of methods research papers in the journal Campbell Systematic Reviews. Campbell Systematic Reviews, 17(2).
Strick K, Abbott R, Thompson Coon J, Garside R (2021). Meta-ethnography of the purpose of meaningful occupation for people living with dementia.
Int J Older People Nurs,
16(5).
Abstract:
Meta-ethnography of the purpose of meaningful occupation for people living with dementia.
BACKGROUND: Guidance on provision of care for people with dementia states that occupation people find meaningful is essential for well-being; however, definitions of 'meaningful occupation' are often broad, with intrinsic meaning coming from within the person rather than the activity, leading to an inconsistent understanding of its purpose. OBJECTIVES: This study aimed to create a conceptual framework depicting the types of meaning that are seen as stemming from occupation. METHOD: Six electronic databases were searched (CINAHL, PubMed Central, PsycINFO, Embase, AMED, ASSIA) using a pre-specified search strategy to identify qualitative studies relating to meaningful occupation for people living with dementia. From 114 eligible full-text articles, six qualitative studies were identified as sufficiently rich, topically relevant and explicit in their definition of meaningful activity. A further 14 were purposefully sampled for their ability to refute or advance the emerging conceptual framework. The synthesis is based on meta-ethnography and is reported following eMERGe guidance. RESULTS: We found the fundamental purpose of occupation is to support the person living with dementia to feel they are living a meaningful and fulfilling life. Three overlapping concepts were identified: (i) catalytic environment, (ii) meaningful life and (iii) occupation as a tool. CONCLUSION: the framework proposes how occupation could support meaning in multiple ways and considers how these forms of meaning were influenced by the worldviews and values of the individual, and context in which they were experienced. IMPLICATIONS FOR PRACTICE: the conceptual framework offers a consistent theoretical grounding with which to measure effectiveness of meaningful occupation for people living with dementia.
Abstract.
Author URL.
Short RE, Cox DTC, Ling Tan Y, Bethel A, Eales JF, Garside R (2021). Review of the evidence for oceans and human health relationships in Europe: a systematic map.
Environ Int,
146Abstract:
Review of the evidence for oceans and human health relationships in Europe: a systematic map.
BACKGROUND: Globally, there is increasing scientific evidence of critical links between the oceans and human health, with research into issues such as pollution, harmful algal blooms and nutritional contributions. However, Oceans and Human Health (OHH) remains an emerging discipline. As such these links are poorly recognized in policy efforts such as the Sustainable Development Goals, with OHH not included in either marine (SDG14) or health (SDG3) goals. This is arguably short-sighted given recent development strategies such as the EU Blue Growth Agenda. OBJECTIVES: in this systematic map we aim to build on recent efforts to enhance OHH in Europe by setting a baseline of existing evidence, asking: What links have been researched between marine environments and the positive and negative impacts to human health and wellbeing? METHODS: We searched eight bibliographic databases and queried 57 organizations identified through stakeholder consultation. Results include primary research and systematic reviews which were screened double blind against pre-defined inclusion criteria as per a published protocol. Studies were limited to Europe, US, Australia, New Zealand and Canada. Data was extracted according to a stakeholder-defined code book. A narrative synthesis explores the current evidence for relationships between marine exposures and human health outcomes, trends in knowledge gaps and change over time in the OHH research landscape. The resulting database is available on the website of the Seas, Oceans and Public Health in Europe website (https://sophie2020.eu/). RESULTS: a total of 1,542 unique articles were included in the database, including those examined within 56 systematic reviews. Research was dominated by a US focus representing 50.1% of articles. A high number of articles were found to link: marine biotechnology and cardiovascular or immune conditions, consumption of seafood and cardiovascular health, chemical pollution and neurological conditions, microbial pollution and gastrointestinal or respiratory health, and oil industry occupations with mental health. A lack of evidence relates to direct impacts of plastic pollution and work within a number of industries identified as relevant by stakeholders. Research over time is dominated by marine biotechnology, though this is narrow in focus. Pollution, food and disease/injury research follow similar trajectories. Wellbeing and climate change have emerged more recently as key topics but lag behind other categories in volume of evidence. CONCLUSIONS: the evidence base for OHH of relevance to European policy is growing but remains patchy and poorly co-ordinated. Considerable scope for future evidence synthesis exists to better inform policy-makers, though reviews need to better incorporate complex exposures. Priorities for future research include: proactive assessments of chemical pollutants, measurable impacts arising from climate change, effects of emerging marine industries, and regional and global assessments for OHH interactions. Understanding of synergistic effects across multiple exposures and outcomes using systems approaches is recommended to guide policies within the Blue Growth Strategy. Co-ordination of research across Europe and dedicated centres of research would be effective first steps.
Abstract.
Author URL.
Fleming LE, Depledge M, Bouley T, Britton E, Dupont S, Eatock C, Garside R, Heymans JJ, Kellett P, Lloret J, et al (2021). The Ocean Decade-Opportunities for Oceans and Human Health Programs to Contribute to Public Health.
Am J Public Health,
111(5), 808-811.
Author URL.
Downey H, Amano T, Cadotte M, Cook CN, Cooke SJ, Haddaway NR, Jones JPG, Littlewood N, Walsh JC, Abrahams MI, et al (2021). Training future generations to deliver evidence‐based conservation and ecosystem management. Ecological Solutions and Evidence, 2(1).
Eales J, Bethel A, Fullam J, Olmesdahl S, Wulandari P, Garside R (2021). What is the evidence documenting the effects of marine or coastal nature conservation or natural resource management activities on human well-being in South East Asia? a systematic map. Environment International, 151, 106397-106397.
Cooper C, Garside R, Varley-Campbell J, Talens-Bou J, Booth A, Britten N (2020). "It has no meaning to me." How do researchers understand the effectiveness of literature searches? a qualitative analysis and preliminary typology of understandings.
Res Synth Methods,
11(5), 627-640.
Abstract:
"It has no meaning to me." How do researchers understand the effectiveness of literature searches? a qualitative analysis and preliminary typology of understandings.
This study aimed to address the question: what does "effectiveness" mean to researchers in the context of literature searching for systematic reviews? We conducted a thematic analysis of responses to an e-mail survey. Eighty-nine study authors, whose studies met inclusion in a recent review (2018), were contacted via e-mail and asked three questions; one directly asking the question: in literature searching, what does effective (or effectiveness in) literature searching mean to you? Thirty-eight (46%) responses were received from diverse professional groups, including: literature searchers, systematic reviewers, clinicians and researchers. A shared understanding of what effectiveness means was not identified. Instead, five themes were developed from data: (a) effectiveness is described as a metric; (b) effectiveness is a balance between metrics; (c) effectiveness can be categorized by search purpose; (d) effectiveness is an outcome; and, (e) effectiveness is an experimental concept. We propose that these themes constitute a preliminary typology of understandings. No single definition of effectiveness was identified. The proposed typology suggests that different researchers have differing understandings of effectiveness. This could lead to uncertainty as to the aim and the purpose of literature searches and confusion about the outcomes. The typology offers a potential route for further exploration.
Abstract.
Author URL.
Leonard AFC, Garside R, Ukoumunne OC, Gaze WH (2020). A cross-sectional study on the prevalence of illness in coastal bathers compared to non-bathers in England and Wales: Findings from the Beach User Health Survey. Water Research, 176, 115700-115700.
Strick KE, Garside R, Thompson‐Coon J, Abbott RA (2020). Conceptual model of the purpose of meaningful occupation for people living with dementia developed through qualitative evidence synthesis. Alzheimer's & Dementia, 16(S7).
Berrang-Ford L, Döbbe F, Garside R, Haddaway N, Lamb WF, Minx JC, Viechtbauer W, Welch V, White H (2020). Editorial: Evidence synthesis for accelerated learning on climate solutions. Campbell Systematic Reviews, 16(4).
Aloe A, Barends E, Besharov D, Bhutta Z, Cai X, Gaarder M, Garside R, Haddaway N, Kristjansson E, Maynard B, et al (2020). Editorial: Fifty Campbell systematic reviews relevant to the policy response to COVID-19. Campbell Systematic Reviews, 16(3).
Yeo NL, Elliott LR, Bethel A, White MP, Dean SG, Garside R (2020). Indoor Nature Interventions for Health and Wellbeing of Older Adults in Residential Settings: a Systematic Review.
Gerontologist,
60(3), e184-e199.
Abstract:
Indoor Nature Interventions for Health and Wellbeing of Older Adults in Residential Settings: a Systematic Review.
BACKGROUND AND OBJECTIVES: Having contact with nature can be beneficial for health and wellbeing, but many older adults face barriers with getting outdoors. We conducted a systematic review of quantitative studies on health and wellbeing impacts of indoor forms of nature (both real and simulated/artificial), for older adults in residential settings. RESEARCH DESIGN AND METHODS: Search terms relating to older adults and indoor nature were run in 13 scientific databases (MEDLINE, CINAHL, AgeLine, Environment Complete, AMED, PsychINFO, EMBASE, HMIC, PsychARTICLES, Global Health, Web of Knowledge, Dissertations and Theses Global, and ASSIA). We also pursued grey literature, global clinical trials registries, and a range of supplementary methods. RESULTS: of 6,131 articles screened against eligibility criteria, 26 studies were accepted into the review, and were quality-appraised using the Effective Public Health Practice Project (EPHPP) tool. The participants were 930 adults aged over 60. Nature interventions and health/wellbeing outcomes were heterogeneous, which necessitated a narrative synthesis. The evidence base was generally weak, with 18 of 26 studies having a high risk of bias. However, several higher-quality studies found indoor gardening and horticulture programs were effective for cognition, psychological wellbeing, social outcomes, and life satisfaction. DISCUSSION AND IMPLICATIONS: There is inconsistent evidence that indoor nature exposures are beneficial for older care residents. We expect that successful interventions were, at least partly, facilitating social interaction, supporting feelings of autonomy/control, and promoting skill development, that is, factors not necessarily associated with nature per se. Higher-quality studies with improved reporting standards are needed to further elucidate these mechanisms.
Abstract.
Author URL.
Booth A, Cooper C, Garside R, Britten N (2020). Response to: Goldberg et al "Who are the researchers? Where are the librarians?".
Res Synth Methods,
11(6), 723-724.
Author URL.
Cheng SH, McKinnon MC, Masuda YJ, Garside R, Jones KW, Miller DC, Pullin AS, Sutherland WJ, Augustin C, Gill DA, et al (2020). Strengthen causal models for better conservation outcomes for human well-being.
PLoS ONE,
15(3).
Abstract:
Strengthen causal models for better conservation outcomes for human well-being
Background Understanding how the conservation of nature can lead to improvement in human conditions is a research area with significant growth and attention. Progress towards effective conservation requires understanding mechanisms for achieving impact within complex social-ecological systems. Causal models are useful tools for defining plausible pathways from conservation actions to impacts on nature and people. Evaluating the potential of different strategies for delivering co-benefits for nature and people will require the use and testing of clear causal models that explicitly define the logic and assumptions behind cause and effect relationships. Objectives and methods in this study, we outline criteria for credible causal models and systematically evaluated their use in a broad base of literature (~1,000 peer-reviewed and grey literature articles from a published systematic evidence map) on links between nature-based conservation actions and human well-being impacts. Results Out of 1,027 publications identified, only ~20% of articles used any type of causal models to guide their work, and only 14 total articles fulfilled all criteria for credibility. Articles rarely tested the validity of models with empirical data. Implications Not using causal models risks poorly defined strategies, misunderstanding of potential mechanisms for affecting change, inefficient use of resources, and focusing on implausible efforts for achieving sustainability.
Abstract.
Husk K, Blockley K, Lovell R, Bethel A, Lang I, Byng R, Garside R (2020). What approaches to social prescribing work, for whom, and in what circumstances? a realist review.
Health and Social Care in the Community,
28(2), 309-324.
Abstract:
What approaches to social prescribing work, for whom, and in what circumstances? a realist review
The use of non-medical referral, community referral or social prescribing interventions has been proposed as a cost-effective alternative to help those with long-term conditions manage their illness and improve health and well-being. However, the evidence base for social prescribing currently lags considerably behind practice. In this paper, we explore what is known about whether different methods of social prescribing referral and supported uptake do (or do not) work. Supported by an Expert Advisory Group, we conducted a realist review in two phases. The first identified evidence specifically relating to social prescribing in order to develop programme theories in the form of ‘if-then’ statements, articulating how social prescribing models are expected to work. In the second phase, we aimed to clarify these processes and include broader evidence to better explain the proposed mechanisms. The first phase resulted in 109 studies contributing to the synthesis, and the second phase 34. We generated 40 statements relating to organising principles of how the referral takes place (Enrolment), is accepted (Engagement), and completing an activity (Adherence). Six of these statements were prioritised using web-based nominal group technique by our Expert Group. Studies indicate that patients are more likely to enrol if they believe the social prescription will be of benefit, the referral is presented in an acceptable way that matches their needs and expectations, and concerns elicited and addressed appropriately by the referrer. Patients are more likely to engage if the activity is both accessible and transit to the first session supported. Adherence to activity programmes can be impacted through having an activity leader who is skilled and knowledgeable or through changes in the patient's conditions or symptoms. However, the evidence base is not sufficiently developed methodologically for us to make any general inferences about effectiveness of particular models or approaches.
Abstract.
Yeo NL, White MP, Alcock I, Garside R, Dean SG, Smalley AJ, Gatersleben B (2020). What is the best way of delivering virtual nature for improving mood? an experimental comparison of high definition TV, 360° video, and computer generated virtual reality. Journal of Environmental Psychology, 72, 101500-101500.
Stanton IC, Bethel A, Leonard AFC, Gaze WH, Garside R (2020). What is the research evidence for antibiotic resistance exposure and transmission to humans from the environment? a systematic map protocol.
Environmental Evidence,
9(1).
Abstract:
What is the research evidence for antibiotic resistance exposure and transmission to humans from the environment? a systematic map protocol
Abstract
Background
Antimicrobial resistance (AMR) is a public health crisis that is predicted to cause 10 million deaths per year by 2050. The environment has been implicated as a reservoir of AMR and is suggested to play a role in the dissemination of antibiotic resistance genes (ARGs). Currently, most research has focused on measuring concentrations of antibiotics and characterising the abundance and diversity of ARGs and antibiotic resistant bacteria (ARB) in the environment. To date, there has been limited empirical research on whether humans are exposed to this, and whether exposure can lead to measureable impacts on human health. Therefore, the objective of this work is to produce two linked systematic maps to investigate previous research on exposure and transmission of AMR to humans from the environment. The first map will investigate the available research relating to exposure and transmission of ARB/ARGs from the environment to humans on a global scale and the second will investigate the prevalence of ARB/ARGs in various environments in the UK. These two maps will be useful for policy makers and research funders to identify where there are significant gluts and gaps in the current research, and where more primary and synthesis research needs to be undertaken.
Methods
Separate search strategies will be developed for the two maps. Searches will be run in 13 databases, and grey literature will be sought from key websites and engagement with experts. Hits will be managed in EndNote and screened in two stages (title/abstract then full text) against predefined inclusion criteria. A minimum of 10% will be double screened with ongoing consistency checking. All included studies will have data extracted into a bespoke form designed and piloted for each map. Data to be extracted will include bibliographic details, study design, location, exposure source, exposure route, health outcome (Map 1); and prevalence/percentage of ARB/ARG (Map 2). No validity appraisal will be undertaken. Results will be tabulated and presented narratively, together with graphics showing the types and areas of research that has been undertaken and heatmaps for key exposure-health outcomes (Map 1) and exposure-prevalence (Map 2).
Abstract.
Cheng SH, MacLeod K, Ahlroth S, Onder S, Perge E, Shyamsundar P, Rana P, Garside R, Kristjanson P, McKinnon MC, et al (2019). A systematic map of evidence on the contribution of forests to poverty alleviation.
Environmental Evidence,
8(1).
Abstract:
A systematic map of evidence on the contribution of forests to poverty alleviation
Background: Forests provide an essential resource to the livelihoods of an estimated 20% of the global population. The contribution of forest ecosystems and forest-based resources to poverty reduction is increasingly emphasized in international policy discourse and conservation and development investments. However, evidence measuring the effect of forest-based activities on poverty outcomes remains scattered and unclear. Lack of systematic understanding of forest-poverty relationships, in turn, inhibits research, policymaking, and efficient financial resource allocation. Methods: to identify relevant studies for inclusion in this systematic map we searched six bibliographic databases, 15 organizational websites, eight systematic evidence syntheses (reviews and maps), and solicited information from key informants. Search results were screened for relevance against predefined inclusion criteria at title, abstract, and full text levels, according to a published protocol. Included articles were coded using a predefined framework. Trends in the evidence, knowledge gaps and relatively well-researched sub-topics are reported in a narrative synthesis. Occurrence and extent of existing evidence about links between interventions and outcomes are presented in a visual heatmap. Data are available through the open access Evidence for Nature and People Data Portal (http://www.natureandpeopleevidence.org). Results: a total of 242 articles were included in the systematic map database. Included articles measured effects of 14 forest-based intervention types on 11 poverty dimensions. The majority of the evidence base (72%) examined links between productivity-enhancement strategies (e.g. forest management, agroforestry, and habitat management) and monetary income and/or social capital outcomes. Other areas with high occurrence of articles include linkages between interventions involving governance, individual rights/empowerment or linked enterprises/livelihood alternatives with impacts on monetary income from direct sale of goods. A key knowledge gap was on the impacts of investment-based interventions (i.e. enhancing produced, human, and social capitals). Another was the impacts of forest-based interventions on financial capital (savings, debt), non-monetary benefits, and health. Conclusions: the evidence base on forest-based productive activities and poverty alleviation is growing but displays a number of biases in the distribution of articles on key linkages. Priorities for future systematic reviews and evaluations include in-depth examinations into the impacts of rights-based activities (e.g. governance, empowerment) on poverty dimensions; and productivity-enhancing activities on social capital. More comprehensive and robust evidence is needed to better understand the synergies and trade-offs among the different objectives of forest conservation and management and variation in outcomes for different social groups in different social-ecological contexts.
Abstract.
Thompson Coon J, Gwernan‐Jones R, Garside R, Nunns M, Shaw L, Melendez‐Torres GJ, Moore D (2019). Developing methods for the overarching synthesis of quantitative and qualitative evidence: the interweave synthesis approach.
Research Synthesis Methods,
11(4), 507-521.
Abstract:
Developing methods for the overarching synthesis of quantitative and qualitative evidence: the interweave synthesis approach
The incorporation of evidence derived from multiple research designs into one single synthesis can enhance the utility of systematic reviews making them more worthwhile, useful, and insightful. Methodological guidance for mixed‐methods synthesis continues to emerge and evolve but broadly involves a sequential, parallel, or convergent approach according to the degree of independence between individual syntheses before they are combined.We present two case studies in which we used novel and innovative methods to draw together the findings from individual but related quantitative and qualitative syntheses to aid interpretation of the overall evidence base. Our approach moved beyond making a choice between parallel, sequential, or convergent methods to interweave the findings of individual reviews and offers three key innovations to mixed‐methods synthesis methods:
The use of intersubjective questions to understand the findings of the individual reviews through different lenses,
Immersion of key reviewers in the entirety of the evidence base, and
Commencing the process during the final stages of the synthesis of individual reviews, at a point where reviewers are developing an understanding of initial findings.
Underlying our approach is the process of exploration and identification of links between and across review findings, an approach that is fundamental to all evidence syntheses but usually occurs at the level of the study. Adapting existing methods for exploring and identifying patterns and links between and across studies to interweave the findings between and across reviews may prove valuable.
Abstract.
Shaw L, Moore D, Nunns M, Thompson Coon J, Ford T, Berry V, Walker E, Heyman I, Dickens C, Bennett S, et al (2019). Experiences of interventions aiming to improve the mental health and well-being of children and young people with a long-term physical condition: a systematic review and meta-ethnography.
Child Care Health Dev,
45(6), 832-849.
Abstract:
Experiences of interventions aiming to improve the mental health and well-being of children and young people with a long-term physical condition: a systematic review and meta-ethnography.
BACKGROUND: Children and young people with long-term physical health conditions are at increased risk of experiencing mental health and well-being difficulties. However, there is a lack of research that explores the experiences of and attitudes towards interventions aiming to improve their mental health and well-being. This systematic review seeks to address this gap in the literature by exploring what children and young people with long-term conditions, their caregivers, and health practitioners perceive to be important aspects of interventions aiming to improve their mental health and well-being. METHODS: an information specialist searched five academic databases using predefined criteria for qualitative evaluations of interventions aiming to improve the mental health or well-being of children with long-term physical conditions. Reviewers also performed supplementary citation and grey literature searches. Two reviewers independently screened titles, abstracts, and full texts that met the inclusion criteria and conducted data extraction and quality assessment. Meta-ethnography was used to synthesize the findings. RESULTS: Screening identified 60 relevant articles. We identified five overarching constructs through the synthesis: (a) Getting in and Staying In, (b) Therapeutic Foundation, (c) Social Support, (d) a Hopeful Alternative, and (e) Empowerment. The line of argument that links these constructs together indicates that when interventions can provide an environment that allows young people to share their experiences and build empathetic relationships, it can enable participants to access social support and increase feelings of hope and empowerment. CONCLUSION: These findings may provide a framework to inform the development of mental health interventions for this population and evaluate existing interventions that already include some of the components or processes identified by this research. Further research is needed to establish which of the constructs identified by the line of argument are most effective in improving the mental well-being of young people living with long-term conditions.
Abstract.
Author URL.
Haynes E, Green J, Garside R, Kelly MP, Guell C (2019). Gender and active travel: a qualitative data synthesis informed by machine learning.
Int J Behav Nutr Phys Act,
16(1).
Abstract:
Gender and active travel: a qualitative data synthesis informed by machine learning.
BACKGROUND: Innovative approaches are required to move beyond individual approaches to behaviour change and develop more appropriate insights for the complex challenge of increasing population levels of activity. Recent research has drawn on social practice theory to describe the recursive and relational character of active living but to date most evidence is limited to small-scale qualitative research studies. To 'upscale' insights from individual contexts, we pooled data from five qualitative studies and used machine learning software to explore gendered patterns in the context of active travel. METHODS: We drew on 280 transcripts from five research projects conducted in the UK, including studies of a range of populations, travel modes and settings, to conduct unsupervised 'topic modelling analysis'. Text analytics software, Leximancer, was used in the first phase of the analysis to produce inter-topic distance maps to illustrate inter-related 'concepts'. The outputs from this first phase guided a second researcher-led interpretive analysis of text excerpts to infer meaning from the computer-generated outputs. RESULTS: Guided by social practice theory, we identified 'interrelated' and 'relating' practices across the pooled datasets. For this study we particularly focused on respondents' commutes, travelling to and from work, and on differentiated experiences by gender. Women largely described their commute as multifunctional journeys that included the school run or shopping, whereas men described relatively linear journeys from a to B but highlighted 'relating' practices resulting from or due to their choice of commute mode or journey such as showering or relaxing. Secondly, we identify a difference in discourses about practices across the included datasets. Women spoke more about 'subjective', internal feelings of safety ('I feel unsafe'), whereas men spoke more about external conditions ('it is a dangerous road'). CONCLUSION: This rare application of machine learning to qualitative social science research has helped to identify potentially important differences in co-occurrence of practices and discourses about practice between men's and women's accounts of travel across diverse contexts. These findings can inform future research and policy decisions for promoting travel-related social practices associated with increased physical activity that are appropriate across genders.
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Author URL.
Abbott R, Orr N, McGill P, Whear R, Bethel A, Garside R, Stein K, Thompson-Coon J (2019). How do "robopets" impact the health and well-being of residents in care homes? a systematic review of qualitative and quantitative evidence.
Int J Older People Nurs,
14(3).
Abstract:
How do "robopets" impact the health and well-being of residents in care homes? a systematic review of qualitative and quantitative evidence.
BACKGROUND: Robopets are small animal-like robots which have the appearance and behavioural characteristics of pets. OBJECTIVE: to bring together the evidence of the experiences of staff, residents and family members of interacting with robopets and the effects of robopets on the health and well-being of older people living in care homes. DESIGN: Systematic review of qualitative and quantitative research. DATA SOURCES: We searched 13 electronic databases from inception to July 2018 and undertook forward and backward citation chasing. METHODS: Eligible studies reported the views and experiences of robopets from residents, family members and staff (qualitative studies using recognised methods of qualitative data collection and analysis) and the effects of robopets on the health and well-being of care home residents (randomised controlled trials, randomised crossover trials and cluster randomised trials). Study selection was undertaken independently by two reviewers. We used the Wallace criteria and the Cochrane Risk of Bias tool to assess the quality of the evidence. We developed a logic model with stakeholders and used this as a framework to guide data extraction and synthesis. Where appropriate, we used meta-analysis to combine effect estimates from quantitative studies. RESULTS: Nineteen studies (10 qualitative, 2 mixed methods and 7 randomised trials) met the inclusion criteria. Interactions with robopets were described as having a positive impact on aspects of well-being including loneliness, depression and quality of life by residents and staff, although there was no corresponding statistically significant evidence from meta-analysis for these outcomes. Meta-analysis showed evidence of a reduction in agitation with the robopet "Paro" compared to control (-0.32 [95% CI -0.61 to -0.04, p = 0.03]). Not everyone had a positive experience of robopets. CONCLUSIONS: Engagement with robopets appears to have beneficial effects on the health and well-being of older adults living in care homes, but not all chose to engage. Whether the benefits can be sustained are yet to be investigated. IMPLICATIONS FOR PRACTICE: Robopets have the potential to benefit people living in care homes, through increasing engagement and interaction. With the robopet acting as a catalyst, this engagement and interaction may afford comfort and help reduce agitation and loneliness.
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Author URL.
France EF, Cunningham M, Ring N, Uny I, Duncan EAS, Jepson RG, Maxwell M, Roberts RJ, Turley RL, Booth A, et al (2019). Improving reporting of meta-ethnography: the eMERGe reporting guidance.
Psycho-Oncology,
28(3), 447-458.
Abstract:
Improving reporting of meta-ethnography: the eMERGe reporting guidance
Aims: the aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. Background: Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality. Design: the eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes. Methods: the study, conducted from 2015 to 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes. Findings: Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance. Conclusion: the bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology.
Abstract.
France EF, Cunningham M, Ring N, Uny I, Duncan EAS, Jepson RG, Maxwell M, Roberts RJ, Turley RL, Booth A, et al (2019). Improving reporting of meta-ethnography: the eMERGe reporting guidance.
BMC Medical Research Methodology,
19(1).
Abstract:
Improving reporting of meta-ethnography: the eMERGe reporting guidance
Aims: the aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. Background: Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality. Design: the eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes. Methods: the study, conducted from 2015 to 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes. Findings: Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance. Conclusion: the bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology.
Abstract.
France EF, Cunningham M, Ring N, Uny I, Duncan EAS, Jepson RG, Maxwell M, Roberts RJ, Turley RL, Booth A, et al (2019). Improving reporting of meta‐ethnography: the eMERGe reporting guidance. Review of Education, 7(2), 430-451.
Maguire K, Garside R, Poland J, Fleming LE, Alcock I, Taylor T, Macintyre H, Lo Iacono G, Green A, Wheeler BW, et al (2019). Public involvement in research about environmental change and health: a case study.
Health,
23(2), 215-233.
Abstract:
Public involvement in research about environmental change and health: a case study.
Involving and engaging the public are crucial for effective prioritisation, dissemination and implementation of research about the complex interactions between environments and health. Involvement is also important to funders and policy makers who often see it as vital for building trust and justifying the investment of public money. In public health research, ‘the public’ can seem an amorphous target for researchers to engage with, and the short-term nature of research projects can be a challenge. Technocratic and pedagogical approaches have frequently met with resistance, so public involvement needs to be seen in the context of a history which includes contested truths, power inequalities and political activism. It is therefore vital for researchers and policy makers, as well as public contributors, to share best practice and to explore the challenges encountered in public involvement and engagement. This article presents a theoretically informed case study of the contributions made by the Health and Environment Public Engagement Group to the work of the National Institute for Health Research (NIHR) Health Protection Research Unit in Environmental Change and Health (HPRU-ECH). We describe how Health and Environment Public Engagement Group has provided researchers in the HPRU-ECH with a vehicle to support access to public views on multiple aspects of the research work across three workshops, discussion of ongoing research issues at meetings and supporting dissemination to local government partners, as well as public representation on the HPRU-ECH Advisory Board. We conclude that institutional support for standing public involvement groups can provide conduits for connecting public with policy makers and academic institutions. This can enable public involvement and engagement, which would be difficult, if not impossible, to achieve in individual short-term and unconnected research projects.
Abstract.
Flemming K, Booth A, Garside R, Tunçalp Ö, Noyes J (2019). Qualitative evidence synthesis for complex interventions and guideline development: clarification of the purpose, designs and relevant methods.
BMJ Glob Health,
4(Suppl 1).
Abstract:
Qualitative evidence synthesis for complex interventions and guideline development: clarification of the purpose, designs and relevant methods.
This paper is one of a series exploring the implications of complexity for systematic reviews and guideline development, commissioned by the WHO. The paper specifically explores the role of qualitative evidence synthesis. Qualitative evidence synthesis is the broad term for the group of methods used to undertake systematic reviews of qualitative research evidence. As an approach, qualitative evidence synthesis is increasingly recognised as having a key role to play in addressing questions relating to intervention or system complexity, and guideline development processes. This is due to the unique role qualitative research can play in establishing the relative importance of outcomes, the acceptability, fidelity and reach of interventions, their feasibility in different settings and potential consequences on equity across populations. This paper outlines the purpose of qualitative evidence synthesis, provides detail of how qualitative evidence syntheses can help establish understanding and explanation of the complexity that can occur in relation to both interventions and systems, and how qualitative evidence syntheses can contribute to evidence to decision frameworks. It provides guidance for the choice of qualitative evidence synthesis methods in the context of guideline development for complex interventions, giving 'real life' examples of where this has occurred. Information to support decision-making around choice qualitative evidence synthesis methods in the context of guideline development is provided. Approaches for reporting qualitative evidence syntheses are discussed alongside mechanisms for assessing confidence in the findings of a review.
Abstract.
Author URL.
Macura B, Suškevičs M, Garside R, Hannes K, Rees R, Rodela R (2019). Systematic reviews of qualitative evidence for environmental policy and management: an overview of different methodological options.
Environmental Evidence,
8(1).
Abstract:
Systematic reviews of qualitative evidence for environmental policy and management: an overview of different methodological options
Qualitative research related to the human dimensions of conservation and environment is growing in quantity. Rigorous syntheses of such studies can help develop understanding and inform decision-making. They can combine findings from studies in varied or similar contexts to address questions relating to, for example, the lived experience of those affected by environmental phenomena or interventions, or to intervention implementation. Researchers in environmental management have adapted methodology for systematic reviews of quantitative research so as to address questions about the magnitude of intervention effects or the impacts of human activities or exposure. However, guidance for the synthesis of qualitative evidence in this field does not yet exist. The objective of this paper is to present a brief overview of different methods for the synthesis of qualitative research and to explore why and how reviewers might select between these. The paper discusses synthesis methods developed in other fields but applicable to environmental management and policy. These methods include thematic synthesis, framework synthesis, realist synthesis, critical interpretive synthesis and meta-ethnography. We briefly describe each of these approaches, give recommendations for the selection between them, and provide a selection of sources for further reading.
Abstract.
Booth A, Moore G, Flemming K, Garside R, Rollins N, Tunçalp Ö, Noyes J (2019). Taking account of context in systematic reviews and guidelines considering a complexity perspective.
BMJ Glob Health,
4(Suppl 1).
Abstract:
Taking account of context in systematic reviews and guidelines considering a complexity perspective.
Systematic review teams and guideline development groups face considerable challenges when considering context within the evidence production process. Many complex interventions are context-dependent and are frequently evaluated within considerable contextual variation and change. This paper considers the extent to which current tools used within systematic reviews and guideline development are suitable in meeting these challenges. The paper briefly reviews strengths and weaknesses of existing approaches to specifying context. Illustrative tools are mapped to corresponding stages of the systematic review process. Collectively, systematic review and guideline production reveals a rich diversity of frameworks and tools for handling context. However, current approaches address only specific elements of context, are derived from primary studies which lack information or have not been tested within systematic reviews. A hypothetical example is used to illustrate how context could be integrated throughout the guideline development process. Guideline developers and evidence synthesis organisations should select an appropriate level of contextual detail for their specific guideline that is parsimonious and yet sensitive to health systems contexts and the values, preferences and needs of their target populations.
Abstract.
Author URL.
Germeni E, Frost J, Garside R, Rogers M, Valderas JM, Britten N (2018). Antibiotic prescribing for acute respiratory tract infections in primary care: an updated and expanded meta-ethnography.
British Journal of General Practice,
68(674), e633-e645.
Abstract:
Antibiotic prescribing for acute respiratory tract infections in primary care: an updated and expanded meta-ethnography
BackgroundReducing unnecessary prescribing remains a key priority for tackling the global rise of antibiotic-resistant infections.AimThe authors sought to update a 2011 qualitative synthesis of GPs’ experiences of antibiotic prescribing for acute respiratory tract infections (ARTIs), including their views of interventions aimed at more prudent prescribing. They expanded the original scope to encompass all primary care professionals (PCPs) who can prescribe or dispense antibiotics for ARTIs (for example, nurses and pharmacists).Design and settingSystematic review and meta-ethnography of qualitative studies.MethodA systematic search was conducted on MEDLINE, EMBASE, PsycINFO, CINAHL, ASSIA, and Web of Science. No date or language restrictions were used. Identified studies were grouped according to their thematic focus (usual care versus intervention), and two separate syntheses were performed.ResultsIn all, 53 articles reporting the experiences of >1200 PCPs were included. Analysis of usual-care studies showed that PCPs tend to assume multiple roles in the context of ARTI consultations (the expert self, the benevolent self, the practical self), depending on the range of intrapersonal, interpersonal, and contextual situations in which they find themselves. Analysis of intervention studies identified four possible ways in which PCPs may experience quality improvement interventions (compromise, ‘supportive aids’, source of distress, and unnecessary).ConclusionContrary to the original review, these results suggest that the use of the same intervention is experienced in a totally different way by different PCPs, and that the same elements that are perceived as benefits by some could be viewed as drawbacks by others. Acceptability of interventions is likely to increase if these are context sensitive and take into account PCPs’ varying roles and changing priorities.
Abstract.
Lewin S, Bohren M, Rashidian A, Munthe-Kaas H, Glenton C, Colvin CJ, Garside R, Noyes J, Booth A, Tunçalp Ö, et al (2018). Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 2: how to make an overall CERQual assessment of confidence and create a Summary of Qualitative Findings table.
Implement Sci,
13(Suppl 1).
Abstract:
Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 2: how to make an overall CERQual assessment of confidence and create a Summary of Qualitative Findings table.
BACKGROUND: the GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on making an overall assessment of confidence in a review finding and creating a CERQual Evidence Profile and a CERQual Summary of Qualitative Findings table. METHODS: We developed this guidance by examining the methods used by other GRADE approaches, gathering feedback from relevant research communities and developing consensus through project group meetings. We then piloted the guidance on several qualitative evidence syntheses before agreeing on the approach. RESULTS: Confidence in the evidence is an assessment of the extent to which a review finding is a reasonable representation of the phenomenon of interest. Creating a summary of each review finding and deciding whether or not CERQual should be used are important steps prior to assessing confidence. Confidence should be assessed for each review finding individually, based on the judgements made for each of the four CERQual components. Four levels are used to describe the overall assessment of confidence: high, moderate, low or very low. The overall CERQual assessment for each review finding should be explained in a CERQual Evidence Profile and Summary of Qualitative Findings table. CONCLUSIONS: Structuring and summarising review findings, assessing confidence in those findings using CERQual and creating a CERQual Evidence Profile and Summary of Qualitative Findings table should be essential components of undertaking qualitative evidence syntheses. This paper describes the end point of a CERQual assessment and should be read in conjunction with the other papers in the series that provide information on assessing individual CERQual components.
Abstract.
Author URL.
Munthe-Kaas H, Bohren MA, Glenton C, Lewin S, Noyes J, Tunçalp Ö, Booth A, Garside R, Colvin CJ, Wainwright M, et al (2018). Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 3: how to assess methodological limitations.
Implement Sci,
13(Suppl 1).
Abstract:
Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 3: how to assess methodological limitations.
BACKGROUND: the GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's methodological limitations component. METHODS: We developed the methodological limitations component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual methodological limitations component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. RESULTS: When applying CERQual, we define methodological limitations as the extent to which there are concerns about the design or conduct of the primary studies that contributed evidence to an individual review finding. In this paper, we describe the methodological limitations component and its rationale and offer guidance on how to assess methodological limitations of a review finding as part of the CERQual approach. This guidance outlines the information required to assess methodological limitations component, the steps that need to be taken to assess methodological limitations of data contributing to a review finding and examples of methodological limitation assessments. CONCLUSIONS: This paper provides guidance for review authors and others on undertaking an assessment of methodological limitations in the context of the CERQual approach. More work is needed to determine which criteria critical appraisal tools should include when assessing methodological limitations. We currently recommend that whichever tool is used, review authors provide a transparent description of their assessments of methodological limitations in a review finding. We expect the CERQual approach and its individual components to develop further as our experiences with the practical implementation of the approach increase.
Abstract.
Author URL.
Colvin CJ, Garside R, Wainwright M, Munthe-Kaas H, Glenton C, Bohren MA, Carlsen B, Tunçalp Ö, Noyes J, Booth A, et al (2018). Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 4: how to assess coherence.
Implement Sci,
13(Suppl 1).
Abstract:
Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 4: how to assess coherence.
BACKGROUND: the GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) relevance, (3) coherence and (4) adequacy of data. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's coherence component. METHODS: We developed the coherence component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual coherence component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. RESULTS: When applying CERQual, we define coherence as how clear and cogent the fit is between the data from the primary studies and a review finding that synthesises that data. In this paper, we describe the coherence component and its rationale and offer guidance on how to assess coherence in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess coherence, the steps that need to be taken to assess coherence and examples of coherence assessments. CONCLUSIONS: This paper provides guidance for review authors and others on undertaking an assessment of coherence in the context of the CERQual approach. We suggest that threats to coherence may arise when the data supporting a review finding are contradictory, ambiguous or incomplete or where competing theories exist that could be used to synthesise the data. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.
Abstract.
Author URL.
Glenton C, Carlsen B, Lewin S, Munthe-Kaas H, Colvin CJ, Tunçalp Ö, Bohren MA, Noyes J, Booth A, Garside R, et al (2018). Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 5: how to assess adequacy of data.
Implement Sci,
13(Suppl 1).
Abstract:
Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 5: how to assess adequacy of data.
BACKGROUND: the GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations; (2) coherence; (3) adequacy of data; and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's adequacy of data component. METHODS: We developed the adequacy of data component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual adequacy of data component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. RESULTS: When applying CERQual, we define adequacy of data as an overall determination of the degree of richness and the quantity of data supporting a review finding. In this paper, we describe the adequacy component and its rationale and offer guidance on how to assess data adequacy in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess data adequacy, the steps that need to be taken to assess data adequacy, and examples of adequacy assessments. CONCLUSIONS: This paper provides guidance for review authors and others on undertaking an assessment of adequacy in the context of the CERQual approach. We approach assessments of data adequacy in terms of the richness and quantity of the data supporting each review finding, but do not offer fixed rules regarding what constitutes sufficiently rich data or an adequate quantity of data. Instead, we recommend that this assessment is made in relation to the nature of the finding. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.
Abstract.
Author URL.
Noyes J, Booth A, Lewin S, Carlsen B, Glenton C, Colvin CJ, Garside R, Bohren MA, Rashidian A, Wainwright M, et al (2018). Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 6: how to assess relevance of the data.
Implement Sci,
13(Suppl 1).
Abstract:
Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 6: how to assess relevance of the data.
BACKGROUND: the GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's relevance component. METHODS: We developed the relevance component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual relevance component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. RESULTS: When applying CERQual, we define relevance as the extent to which the body of data from the primary studies supporting a review finding is applicable to the context (perspective or population, phenomenon of interest, setting) specified in the review question. In this paper, we describe the relevance component and its rationale and offer guidance on how to assess relevance in the context of a review finding. This guidance outlines the information required to assess relevance, the steps that need to be taken to assess relevance and examples of relevance assessments. CONCLUSIONS: This paper provides guidance for review authors and others on undertaking an assessment of relevance in the context of the CERQual approach. Assessing the relevance component requires consideration of potentially important contextual factors at an early stage in the review process. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.
Abstract.
Author URL.
Booth A, Lewin S, Glenton C, Munthe-Kaas H, Toews I, Noyes J, Rashidian A, Berg RC, Nyakang'o B, Meerpohl JJ, et al (2018). Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 7: Understanding the potential impacts of dissemination bias.
Implementation Science,
13Abstract:
Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 7: Understanding the potential impacts of dissemination bias
Background: the GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on a probable fifth component, dissemination bias. Given its exploratory nature, we are not yet able to provide guidance on applying this potential component of the CERQual approach. Instead, we focus on how dissemination bias might be conceptualised in the context of qualitative research and the potential impact dissemination bias might have on an overall assessment of confidence in a review finding. We also set out a proposed research agenda in this area. Methods: We developed this paper by gathering feedback from relevant research communities, searching MEDLINE and Web of Science to identify and characterise the existing literature discussing or assessing dissemination bias in qualitative research and its wider implications, developing consensus through project group meetings, and conducting an online survey of the extent, awareness and perceptions of dissemination bias in qualitative research. Results: We have defined dissemination bias in qualitative research as a systematic distortion of the phenomenon of interest due to selective dissemination of studies or individual study findings. Dissemination bias is important for qualitative evidence syntheses as the selective dissemination of qualitative studies and/or study findings may distort our understanding of the phenomena that these syntheses aim to explore and thereby undermine our confidence in these findings. Dissemination bias has been extensively examined in the context of randomised controlled trials and systematic reviews of such studies. The effects of potential dissemination bias are formally considered, as publication bias, within the GRADE approach. However, the issue has received almost no attention in the context of qualitative research. Because of very limited understanding of dissemination bias and its potential impact on review findings in the context of qualitative evidence syntheses, this component is currently not included in the GRADE-CERQual approach. Conclusions: Further research is needed to establish the extent and impacts of dissemination bias in qualitative research and the extent to which dissemination bias needs to be taken into account when we assess how much confidence we have in findings from qualitative evidence syntheses.
Abstract.
Lewin S, Booth A, Glenton C, Munthe-Kaas H, Rashidian A, Wainwright M, Bohren MA, Tunçalp Ö, Colvin CJ, Garside R, et al (2018). Applying GRADE-CERQual to qualitative evidence synthesis findings: introduction to the series.
Implement Sci,
13(Suppl 1).
Abstract:
Applying GRADE-CERQual to qualitative evidence synthesis findings: introduction to the series.
The GRADE-CERQual ('Confidence in the Evidence from Reviews of Qualitative research') approach provides guidance for assessing how much confidence to place in findings from systematic reviews of qualitative research (or qualitative evidence syntheses). The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. Confidence in the evidence from qualitative evidence syntheses is an assessment of the extent to which a review finding is a reasonable representation of the phenomenon of interest. CERQual provides a systematic and transparent framework for assessing confidence in individual review findings, based on consideration of four components: (1) methodological limitations, (2) coherence, (3) adequacy of data, and (4) relevance. A fifth component, dissemination (or publication) bias, may also be important and is being explored. As with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach for effectiveness evidence, CERQual suggests summarising evidence in succinct, transparent, and informative Summary of Qualitative Findings tables. These tables are designed to communicate the review findings and the CERQual assessment of confidence in each finding. This article is the first of a seven-part series providing guidance on how to apply the CERQual approach. In this paper, we describe the rationale and conceptual basis for CERQual, the aims of the approach, how the approach was developed, and its main components. We also outline the purpose and structure of this series and discuss the growing role for qualitative evidence in decision-making. Papers 3, 4, 5, 6, and 7 in this series discuss each CERQual component, including the rationale for including the component in the approach, how the component is conceptualised, and how it should be assessed. Paper 2 discusses how to make an overall assessment of confidence in a review finding and how to create a Summary of Qualitative Findings table. The series is intended primarily for those undertaking qualitative evidence syntheses or using their findings in decision-making processes but is also relevant to guideline development agencies, primary qualitative researchers, and implementation scientists and practitioners.
Abstract.
Author URL.
Noyes J, Booth A, Cargo M, Flemming K, Garside R, Hannes K, Harden A, Harris J, Lewin S, Pantoja T, et al (2018). Cochrane Qualitative and Implementation Methods Group guidance series-paper 1: introduction.
J Clin Epidemiol,
97, 35-38.
Author URL.
Harris JL, Booth A, Cargo M, Hannes K, Harden A, Flemming K, Garside R, Pantoja T, Thomas J, Noyes J, et al (2018). Cochrane Qualitative and Implementation Methods Group guidance series-paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis.
J Clin Epidemiol,
97, 39-48.
Abstract:
Cochrane Qualitative and Implementation Methods Group guidance series-paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis.
This paper updates previous Cochrane guidance on question formulation, searching, and protocol development, reflecting recent developments in methods for conducting qualitative evidence syntheses to inform Cochrane intervention reviews. Examples are used to illustrate how decisions about boundaries for a review are formed via an iterative process of constructing lines of inquiry and mapping the available information to ascertain whether evidence exists to answer questions related to effectiveness, implementation, feasibility, appropriateness, economic evidence, and equity. The process of question formulation allows reviewers to situate the topic in relation to how it informs and explains effectiveness, using the criterion of meaningfulness, appropriateness, feasibility, and implementation. Questions related to complex questions and interventions can be structured by drawing on an increasingly wide range of question frameworks. Logic models and theoretical frameworks are useful tools for conceptually mapping the literature to illustrate the complexity of the phenomenon of interest. Furthermore, protocol development may require iterative question formulation and searching. Consequently, the final protocol may function as a guide rather than a prescriptive route map, particularly in qualitative reviews that ask more exploratory and open-ended questions.
Abstract.
Author URL.
Cargo M, Harris J, Pantoja T, Booth A, Harden A, Hannes K, Thomas J, Flemming K, Garside R, Noyes J, et al (2018). Cochrane Qualitative and Implementation Methods Group guidance series-paper 4: methods for assessing evidence on intervention implementation.
J Clin Epidemiol,
97, 59-69.
Abstract:
Cochrane Qualitative and Implementation Methods Group guidance series-paper 4: methods for assessing evidence on intervention implementation.
OBJECTIVES: This article provides reviewers with guidance on methods for identifying and processing evidence to understand intervention implementation. STUDY DESIGN AND SETTING: Strategies, tools, and methods are applied to the systematic review process to illustrate how process and implementation can be addressed using quantitative, qualitative, and other sources of evidence (i.e. descriptive textual and nonempirical). RESULTS: Reviewers can take steps to navigate the heterogeneity and level of uncertainty present in the concepts, measures, and methods used to assess implementation. Activities can be undertaken in advance of a Cochrane quantitative review to develop program theory and logic models that situate implementation in the causal chain. Four search strategies are offered to retrieve process and implementation evidence. Recommendations are made for addressing rigor or risk of bias in process evaluation or implementation evidence. Strategies are recommended for locating and extracting data from primary studies. The basic logic is presented to assist reviewers to make initial review-level judgments about implementation failure and theory failure. CONCLUSION: Although strategies, tools, and methods can assist reviewers to address process and implementation using quantitative, qualitative, and other forms of evidence, few exemplar reviews exist. There is a need for further methodological development and trialing of proposed approaches.
Abstract.
Author URL.
Harden A, Thomas J, Cargo M, Harris J, Pantoja T, Flemming K, Booth A, Garside R, Hannes K, Noyes J, et al (2018). Cochrane Qualitative and Implementation Methods Group guidance series-paper 5: methods for integrating qualitative and implementation evidence within intervention effectiveness reviews.
J Clin Epidemiol,
97, 70-78.
Abstract:
Cochrane Qualitative and Implementation Methods Group guidance series-paper 5: methods for integrating qualitative and implementation evidence within intervention effectiveness reviews.
The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method evidence from process evaluations. Despite a proliferation of methods for the synthesis of qualitative research, less attention has focused on how to integrate these syntheses within intervention effectiveness reviews. In this article, we report updated guidance from the group on approaches, methods, and tools, which can be used to integrate the findings from quantitative studies evaluating intervention effectiveness with those from qualitative studies and process evaluations. We draw on conceptual analyses of mixed methods systematic review designs and the range of methods and tools that have been used in published reviews that have successfully integrated different types of evidence. We outline five key methods and tools as devices for integration which vary in terms of the levels at which integration takes place; the specialist skills and expertise required within the review team; and their appropriateness in the context of limited evidence. In situations where the requirement is the integration of qualitative and process evidence within intervention effectiveness reviews, we recommend the use of a sequential approach. Here, evidence from each tradition is synthesized separately using methods consistent with each tradition before integration takes place using a common framework. Reviews which integrate qualitative and process evaluation evidence alongside quantitative evidence on intervention effectiveness in a systematic way are rare. This guidance aims to support review teams to achieve integration and we encourage further development through reflection and formal testing.
Abstract.
Author URL.
Noyes J, Booth A, Flemming K, Garside R, Harden A, Lewin S, Pantoja T, Hannes K, Cargo M, Thomas J, et al (2018). Cochrane Qualitative and Implementation Methods Group guidance series-paper 3: methods for assessing methodological limitations, data extraction and synthesis, and confidence in synthesized qualitative findings.
J Clin Epidemiol,
97, 49-58.
Abstract:
Cochrane Qualitative and Implementation Methods Group guidance series-paper 3: methods for assessing methodological limitations, data extraction and synthesis, and confidence in synthesized qualitative findings.
The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method implementation evidence. Choice of appropriate methodologies, methods, and tools is essential when developing a rigorous protocol and conducting the synthesis. Cochrane authors who conduct qualitative evidence syntheses have thus far used a small number of relatively simple methods to address similarly written questions. Cochrane has invested in methodological work to develop new tools and to encourage the production of exemplar reviews to show the value of more innovative methods that address a wider range of questions. In this paper, in the series, we report updated guidance on the selection of tools to assess methodological limitations in qualitative studies and methods to extract and synthesize qualitative evidence. We recommend application of Grades of Recommendation, Assessment, Development, and Evaluation-Confidence in the Evidence from Qualitative Reviews to assess confidence in qualitative synthesized findings. This guidance aims to support review authors to undertake a qualitative evidence synthesis that is intended to be integrated subsequently with the findings of one or more Cochrane reviews of the effects of similar interventions. The review of intervention effects may be undertaken concurrently with or separate to the qualitative evidence synthesis. We encourage further development through reflection and formal testing.
Abstract.
Author URL.
Cooper C, Booth A, Varley-Campbell J, Britten N, Garside R (2018). Defining the process to literature searching in systematic reviews: a literature review of guidance and supporting studies.
BMC Medical Research Methodology,
18(1).
Abstract:
Defining the process to literature searching in systematic reviews: a literature review of guidance and supporting studies
Background: Systematic literature searching is recognised as a critical component of the systematic review process. It involves a systematic search for studies and aims for a transparent report of study identification, leaving readers clear about what was done to identify studies, and how the findings of the review are situated in the relevant evidence. Information specialists and review teams appear to work from a shared and tacit model of the literature search process. How this tacit model has developed and evolved is unclear, and it has not been explicitly examined before. The purpose of this review is to determine if a shared model of the literature searching process can be detected across systematic review guidance documents and, if so, how this process is reported in the guidance and supported by published studies. Method: a literature review. Two types of literature were reviewed: guidance and published studies. Nine guidance documents were identified, including: the Cochrane and Campbell Handbooks. Published studies were identified through 'pearl growing', citation chasing, a search of PubMed using the systematic review methods filter, and the authors' topic knowledge. The relevant sections within each guidance document were then read and re-read, with the aim of determining key methodological stages. Methodological stages were identified and defined. This data was reviewed to identify agreements and areas of unique guidance between guidance documents. Consensus across multiple guidance documents was used to inform selection of 'key stages' in the process of literature searching. Results: Eight key stages were determined relating specifically to literature searching in systematic reviews. They were: who should literature search, aims and purpose of literature searching, preparation, the search strategy, searching databases, supplementary searching, managing references and reporting the search process. Conclusions: Eight key stages to the process of literature searching in systematic reviews were identified. These key stages are consistently reported in the nine guidance documents, suggesting consensus on the key stages of literature searching, and therefore the process of literature searching as a whole, in systematic reviews. Further research to determine the suitability of using the same process of literature searching for all types of systematic review is indicated.
Abstract.
McCabe R, Garside R, Backhouse A, Xanthopoulou DP (2018). Effectiveness of brief psychological interventions for suicidal presentations: a systematic review. BMC Psychiatry, 18
Leonard AFC, Zhang L, Balfour AJ, Garside R, Hawkey PM, Murray AK, Ukoumunne OC, Gaze WH (2018). Exposure to and colonisation by antibiotic-resistant E. coli in UK coastal water users: Environmental surveillance, exposure assessment, and epidemiological study (Beach Bum Survey).
Environ Int,
114, 326-333.
Abstract:
Exposure to and colonisation by antibiotic-resistant E. coli in UK coastal water users: Environmental surveillance, exposure assessment, and epidemiological study (Beach Bum Survey).
BACKGROUND: Antibiotic-resistant bacteria (ARB) present a global public health problem. With numbers of community-acquired resistant infections increasing, understanding the mechanisms by which people are exposed to and colonised by ARB can help inform effective strategies to prevent their spread. The role natural environments play in this is poorly understood. This is the first study to combine surveillance of ARB in bathing waters, human exposure estimates and association between exposure and colonisation by ARB in water users. METHODS: 97 bathing water samples from England and Wales were analysed for the proportion of E. coli harbouring blaCTX-M. These data were used to estimate the likelihood of water users ingesting blaCTX-M-bearing E. coli. Having identified surfers as being at risk of exposure to ARB, a cross-sectional study was conducted. Regular surfers and non-surfers were recruited to assess whether there is an association between surfing and gut colonisation by blaCTX-M-bearing E. coli. RESULTS: 11 of 97 bathing waters sampled were found to contain blaCTX-M-bearing E. coli. While the percentage of blaCTX-M-bearing E. coli in bathing waters was low (0.07%), water users are at risk of ingesting these ARB. It is estimated that over 2.5 million water sports sessions occurred in 2015 resulting in the ingestion of at least one blaCTX-M-bearing E. coli. In the epidemiological survey, 9/143 (6.3%) surfers were colonised by blaCTX-M-bearing E. coli, as compared to 2/130 (1.5%) of non-surfers (risk ratio=4.09, 95% CI 1.02 to 16.4, p=0.046). CONCLUSIONS: Surfers are at risk of exposure to and colonisation by clinically important antibiotic-resistant E. coli in coastal waters. Further research must be done on the role natural environments play in the transmission of ARB.
Abstract.
Author URL.
Leonard AFC, Singer A, Ukoumunne OC, Gaze WH, Garside R (2018). Is it safe to go back into the water? a systematic review and meta-analysis of the risk of acquiring infections from recreational exposure to seawater.
Int J Epidemiol,
47(2), 572-586.
Abstract:
Is it safe to go back into the water? a systematic review and meta-analysis of the risk of acquiring infections from recreational exposure to seawater.
BACKGROUND: Numerous illnesses are associated with bathing in natural waters, although it is assumed that the risk of illness among bathers exposed to relatively clean waters found in high-income countries is negligible. A systematic review was carried out to quantify the increased risk of experiencing a range of adverse health outcomes among bathers exposed to coastal water compared with non-bathers. METHODS: in all 6919 potentially relevant titles and abstracts were screened, and from these 40 studies were eligible for inclusion in the review. Odds ratios (OR) were extracted from 19 of these reports and combined in random-effect meta-analyses for the following adverse health outcomes: incident cases of any illness, ear infections, gastrointestinal illness and infections caused by specific microorganisms. RESULTS: There is an increased risk of experiencing symptoms of any illness [OR = 1.86, 95% confidence interval (CI): 1.31 to 2.64, P = 0.001] and ear ailments (OR = 2.05, 95% CI: 1.49 to 2.82, P < 0.001) in bathers compared with non-bathers. There is also an increased risk of experiencing gastrointestinal ailments (OR = 1.29, 95% CI: 1.12 to 1.49, P < 0.001). CONCLUSIONS: This is the first systematic review to evaluate evidence on the increased risk of acquiring illnesses from bathing in seawater compared with non-bathers. Our results support the notion that infections are acquired from bathing in coastal waters, and that bathers have a greater risk of experiencing a variety of illnesses compared with non-bathers.
Abstract.
Author URL.
Husk K, Lovell R, Garside R (2018). Prescribing gardening and conservation activities for health and wellbeing in older people.
Maturitas,
110, A1-A2.
Author URL.
Cooper C, Lovell R, Husk K, Booth A, Garside R (2018). Supplementary search methods were more effective and offered better value than bibliographic database searching: a case study from public health and environmental enhancement.
Res Synth Methods,
9(2), 195-223.
Abstract:
Supplementary search methods were more effective and offered better value than bibliographic database searching: a case study from public health and environmental enhancement.
BACKGROUND: We undertook a systematic review to evaluate the health benefits of environmental enhancement and conservation activities. We were concerned that a conventional process of study identification, focusing on exhaustive searches of bibliographic databases as the primary search method, would be ineffective, offering limited value. The focus of this study is comparing study identification methods. We compare (1) an approach led by searches of bibliographic databases with (2) an approach led by supplementary search methods. We retrospectively assessed the effectiveness and value of both approaches. METHODS: Effectiveness was determined by comparing (1) the total number of studies identified and screened and (2) the number of includable studies uniquely identified by each approach. Value was determined by comparing included study quality and by using qualitative sensitivity analysis to explore the contribution of studies to the synthesis. RESULTS: the bibliographic databases approach identified 21 409 studies to screen and 2 included qualitative studies were uniquely identified. Study quality was moderate, and contribution to the synthesis was minimal. The supplementary search approach identified 453 studies to screen and 9 included studies were uniquely identified. Four quantitative studies were poor quality but made a substantive contribution to the synthesis; 5 studies were qualitative: 3 studies were good quality, one was moderate quality, and 1 study was excluded from the synthesis due to poor quality. All 4 included qualitative studies made significant contributions to the synthesis. CONCLUSIONS: This case study found value in aligning primary methods of study identification to maximise location of relevant evidence.
Abstract.
Author URL.
Cooper C, Varley-Campbell J, Booth A, Britten N, Garside R (2018). Systematic review identifies six metrics and one method for assessing literature search effectiveness but no consensus on appropriate use.
J Clin Epidemiol,
99, 53-63.
Abstract:
Systematic review identifies six metrics and one method for assessing literature search effectiveness but no consensus on appropriate use.
OBJECTIVES: to identify the metrics or methods used by researchers to determine the effectiveness of literature searching where supplementary search methods are compared to bibliographic database searching. We also aimed to determine which metrics or methods are summative or formative and how researchers defined effectiveness in their studies. STUDY DESIGN AND SETTING: Systematic review. We searched MEDLINE and Embase to identify published studies evaluating literature search effectiveness in health or allied topics. RESULTS: Fifty studies met full-text inclusion criteria. Six metrics (sensitivity, specificity, precision, accuracy, number needed to read, and yield) and one method (capture recapture) were identified. CONCLUSION: Studies evaluating effectiveness need to identify clearly the threshold at which they will define effectiveness and how the evaluation they report relates to this threshold. Studies that attempt to investigate literature search effectiveness should be informed by the reporting of confidence intervals, which aids interpretation of uncertainty around the result, and the search methods used to derive effectiveness estimates should be clearly reported and validated in studies.
Abstract.
Author URL.
Cheng SH, Augustin C, Bethel A, Gill D, Anzaroot S, Brun J, DeWilde B, Minnich RC, Garside R, Masuda YJ, et al (2018). Using machine learning to advance synthesis and use of conservation and environmental evidence.
Conserv Biol,
32(4), 762-764.
Author URL.
Cooper C, Booth A, Britten N, Garside R (2017). A comparison of results of empirical studies of supplementary search techniques and recommendations in review methodology handbooks: a methodological review.
Syst Rev,
6(1).
Abstract:
A comparison of results of empirical studies of supplementary search techniques and recommendations in review methodology handbooks: a methodological review.
BACKGROUND: the purpose and contribution of supplementary search methods in systematic reviews is increasingly acknowledged. Numerous studies have demonstrated their potential in identifying studies or study data that would have been missed by bibliographic database searching alone. What is less certain is how supplementary search methods actually work, how they are applied, and the consequent advantages, disadvantages and resource implications of each search method. The aim of this study is to compare current practice in using supplementary search methods with methodological guidance. METHODS: Four methodological handbooks in informing systematic review practice in the UK were read and audited to establish current methodological guidance. Studies evaluating the use of supplementary search methods were identified by searching five bibliographic databases. Studies were included if they (1) reported practical application of a supplementary search method (descriptive) or (2) examined the utility of a supplementary search method (analytical) or (3) identified/explored factors that impact on the utility of a supplementary method, when applied in practice. RESULTS: Thirty-five studies were included in this review in addition to the four methodological handbooks. Studies were published between 1989 and 2016, and dates of publication of the handbooks ranged from 1994 to 2014. Five supplementary search methods were reviewed: contacting study authors, citation chasing, handsearching, searching trial registers and web searching. CONCLUSIONS: There is reasonable consistency between recommended best practice (handbooks) and current practice (methodological studies) as it relates to the application of supplementary search methods. The methodological studies provide useful information on the effectiveness of the supplementary search methods, often seeking to evaluate aspects of the method to improve effectiveness or efficiency. In this way, the studies advance the understanding of the supplementary search methods. Further research is required, however, so that a rational choice can be made about which supplementary search strategies should be used, and when.
Abstract.
Author URL.
Lovell R, Husk K, Blockley KV, Bethel A, Bloomfield D, Sara W, Pearson MGN, Lang IA, Byng R, Garside R, et al (2017). A realist review and collaborative development of what works in the social prescribing process. Lancet, 390, s62-s62.
Goodwin V, Orr N, Sharpe R, Smith J, Phoenix C, Lang I, Garside R (2017). Physical activity: how well does systematic review evidence on physical activity interventions reflect the expressed views of older people?. Physiotherapy, 103, e22-e23.
Oliver S, Garner P, Heywood P, Jull J, Dickson K, Bangpan M, Ang L, Fourman M, Garside R (2017). Transdisciplinary working to shape systematic reviews and interpret the findings: Commentary.
Environmental Evidence,
6(1).
Abstract:
Transdisciplinary working to shape systematic reviews and interpret the findings: Commentary
Important policy questions tend to span a range of academic disciplines, and the relevant research is often carried out in a variety of social, economic and geographic contexts. In efforts to synthesise research to help inform decisions arising from the policy questions, systematic reviews need conceptual frameworks and ways of thinking that combine knowledge drawn from different academic traditions and contexts; in other words, transdisciplinary research. This paper considers how transdisciplinary working can be achieved with: conceptual frameworks that span traditional academic boundaries; methods for shaping review questions and conceptual frameworks; and methods for interpreting the relevance of findings to different contexts. It also discusses the practical challenges and ultimate benefits of transdisciplinary working for systematic reviews.
Abstract.
Greaves C, Poltawski L, Garside R, Briscoe S (2017). Understanding the challenge of weight loss maintenance: a systematic review and synthesis of qualitative research on weight loss maintenance.
Health Psychol Rev,
11(2), 145-163.
Abstract:
Understanding the challenge of weight loss maintenance: a systematic review and synthesis of qualitative research on weight loss maintenance.
Behaviour change interventions can be effective in helping people to lose weight, but weight is often regained. Effective interventions are required to prevent this. We conducted a systematic review and synthesis of qualitative research on people's experiences of weight loss maintenance. We searched bibliographic databases for qualitative studies about the experience of currently or previously overweight adults trying to maintain weight loss. We thematically synthesised study findings to develop a model of weight loss maintenance. Twenty six studies from five countries with 710 participants were included. The model developed through our synthesis proposes that making the behaviour changes required for weight loss maintenance generates psychological 'tension' due to the need to override existing habits, and incompatibility of the new behaviours with the fulfilment of psychological needs. Successful maintenance involves management or resolution of this tension. Management of tension can be achieved through self-regulation, renewing of motivation and managing external influences, although this can require constant effort. Resolution may be achieved through changing habits, finding non-obesogenic methods for addressing needs, and potentially through change in self-concept. Implications for the development of weight loss maintenance interventions are explored.
Abstract.
Author URL.
Cheng SH, Ahlroth S, Onder S, Shyamsundar P, Garside R, Kristjanson P, McKinnon MC, Miller DC (2017). What is the evidence for the contribution of forests to poverty alleviation? a systematic map protocol.
Environmental Evidence,
6(1).
Abstract:
What is the evidence for the contribution of forests to poverty alleviation? a systematic map protocol
Background: Forests provide an essential resource that support the livelihoods of an estimated 20% of the global population. Forests are thought to serve in three primary roles to support livelihoods: subsistence, safety nets, and pathways to prosperity. While we have a working understanding of how poor people depend on forests in individual sites and countries, much of this evidence is dispersed and not easily accessible. Thus, while the importance of forest ecosystems and resources to contribute to poverty alleviation has been increasingly emphasized in international policies, conservation and development initiatives and investments- the strength of evidence to support how forests can affect poverty outcomes is still unclear. This study takes a systematic mapping approach to scope, identify and describe studies that measure the effect of forest-based activities on poverty outcomes at local and regional scales. This effort builds upon an existing systematic map on linkages between conservation and human well-being in order to make this process more efficient. We will conduct a refined and updated search strategy pertinent to forests-poverty linkages to glean additional evidence from studies outside the scope of the original map. Results of this study can be used for informing conservation and development policy and practices in global forest ecosystems and highlight evidence gaps where future primary studies and systematic reviews can add value. Methods: We build upon the search strategy outlined in McKinnon et al. (Environ Evid 1-25, 2016) and expand our search to cover a total of 7 bibliographic databases, 15 organizational websites, 8 existing systematic reviews and maps, and evidence gap maps, and solicit key informants. All searches will be conducted in English and encompass all nations. Search results will be screened at title, abstract, and full text levels, recording both the number of excluded articles and reasons for exclusion. Full text assessment will be conducted on all included article and extracted data will be reported in a narrative review that will summarize trends in the evidence, report any knowledge gaps and gluts, and provide insight for policy, practice and future research. The data from this systematic map will be made available as well, through an open access, searchable data portal and visualization tool.
Abstract.
Gwernan-Jones RC, Moore DA, Cooper P, Russell AE, Richardson M, Rogers M, Thompson Coon J, Stein K, Ford T, Garside R, et al (2016). A Systematic Review and Synthesis of Qualitative Research: the Influence of School Context on Symptoms of Attention Deficit Hyperactivity Disorder.
Emotional and Behavioural Difficulties,
21(1), 83-100.
Abstract:
A Systematic Review and Synthesis of Qualitative Research: the Influence of School Context on Symptoms of Attention Deficit Hyperactivity Disorder
This systematic review and synthesis of qualitative research explored contextual factors relevant to non-pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) in schools. We conducted meta-ethnography to synthesise 34 studies, using theories of stigma to further develop the synthesis. Studies suggested that the classroom context requiring pupils to sit still, be quiet and concentrate could trigger symptoms of ADHD, and that symptoms could then be exacerbated through informal/formal labelling and stigma, damaged self-perceptions and resulting poor relationships with staff and pupils. Influences of the school context on symptoms of ADHD were often invisible to teachers and pupils, with most attributions made to the individual pupil and/or the pupil's family. We theorise that this ‘invisibility’ is at least partly an artefact of stigma, and that the potential for stigma for ADHD to seem ‘natural and right’ in the context of schools needs to be taken into account when planning any intervention.
Abstract.
Ohly H, Gentry S, Wigglesworth R, Bethel A, Lovell R, Garside R (2016). A systematic review of the health and well-being impacts of school gardening: synthesis of quantitative and qualitative evidence.
BMC Public Health,
16Abstract:
A systematic review of the health and well-being impacts of school gardening: synthesis of quantitative and qualitative evidence.
BACKGROUND: School gardening programmes are increasingly popular, with suggested benefits including healthier eating and increased physical activity. Our objectives were to understand the health and well-being impacts of school gardens and the factors that help or hinder their success. METHODS: We conducted a systematic review of quantitative and qualitative evidence (PROSPERO CRD42014007181). We searched multiple databases and used a range of supplementary approaches. Studies about school gardens were included if they reported on physical or mental health or well-being. Quantitative studies had to include a comparison group. Studies were quality appraised using appropriate tools. Findings were narratively synthesised and the qualitative evidence used to produce a conceptual framework to illustrate how benefits might be accrued. RESULTS: Evidence from 40 articles (21 quantitative studies; 16 qualitative studies; 3 mixed methods studies) was included. Generally the quantitative research was poor. Evidence for changes in fruit and vegetable intake was limited and based on self-report. The qualitative research was better quality and ascribed a range of health and well-being impacts to school gardens, with some idealistic expectations for their impact in the long term. Groups of pupils who do not excel in classroom activities were thought to particularly benefit. Lack of funding and over reliance on volunteers were thought to threaten success, while involvement with local communities and integration of gardening activities into the school curriculum were thought to support success. CONCLUSION: More robust quantitative research is needed to convincingly support the qualitative evidence suggesting wide ranging benefits from school gardens.
Abstract.
Author URL.
Greenhalgh T, Annandale E, Ashcroft R, Barlow J, Black N, Bleakley A, Boaden R, Braithwaite J, Britten N, Carnevale F, et al (2016). An open letter to the BMJ editors on qualitative research.
BMJ-BRITISH MEDICAL JOURNAL,
352 Author URL.
Noyes J, Hendry M, Booth A, Chandler J, Lewin S, Glenton C, Garside R (2016). Current use was established and Cochrane guidance on selection of social theories for systematic reviews of complex interventions was developed.
J Clin Epidemiol,
75, 78-92.
Abstract:
Current use was established and Cochrane guidance on selection of social theories for systematic reviews of complex interventions was developed.
OBJECTIVE: to identify examples of how social theories are used in systematic reviews of complex interventions to inform production of Cochrane guidance. STUDY DESIGN AND SETTING: Secondary analysis of published/unpublished examples of theories of social phenomena for use in reviews of complex interventions identified through scoping searches, engagement with key authors and methodologists supplemented by snowballing and reference searching. Theories were classified (low-level, mid-range, grand). RESULTS: over 100 theories were identified with evidence of proliferation over the last 5 years. New low-level theories (tools, taxonomies, etc) have been developed for classifying and reporting complex interventions. Numerous mid-range theories are used; one example demonstrated how control theory had changed the review's findings. Review-specific logic models are increasingly used, but these can be challenging to develop. New low-level and mid-range psychological theories of behavior change are evolving. No reviews using grand theory (e.g. feminist theory) were identified. We produced a searchable Wiki, Mendeley Inventory, and Cochrane guidance. CONCLUSIONS: Use of low-level theory is common and evolving; incorporation of mid-range theory is still the exception rather than the norm. Methodological work is needed to evaluate the contribution of theory. Choice of theory reflects personal preference; application of theory is a skilled endeavor.
Abstract.
Author URL.
McCabe R, Garside R, Backhouse A, Xanthopoulou P (2016). Effective communication in eliciting and responding to suicidal thoughts: a systematic review protocol.
Systematic Reviews,
5(1).
Abstract:
Effective communication in eliciting and responding to suicidal thoughts: a systematic review protocol
Background: in the UK, over 6500 people die by suicide each year. In England alone, this is one person every 2 h. Professionals assess risk of suicide in face-to-face contacts with people potentially at risk. The National Confidential Inquiry into Suicide found that most people who took their life were classified as 'low risk' in their final contact with mental health services. Training for front-line staff in reducing suicide is a NHS priority. While there is considerable evidence on what to assess when exploring suicidal ideation, there is little evidence on how to ask sensitive questions to effectively identify suicide risk and how to respond in the treatment encounter to reduce patient distress and suicidal ideation. This is critical for identifying risk and putting appropriate care in place. Methods: an electronic search will be conducted using MEDLINE, CINAHL, Cochrane Library, EMBASE and PsycINFO databases. Controlled studies of effectiveness will be identified using a predefined search strategy. The focus will be on suicidal thoughts/feelings rather than self-harm without intent to die. Two authors will independently screen articles using predefined inclusion and exclusion criteria and relevant data will be extracted using the Cochrane Collaboration data extraction form for randomised controlled trials (RCTs). Discrepancies between the two authors will be resolved by consensus or by consulting a third author at all levels of screening. We will assess the quality of evidence as well as risk of bias. A meta-analysis will be conducted if participants, interventions and comparisons are sufficiently similar, and we will perform the meta-analysis using Stata data analysis and statistical software. Discussion: the results of this systematic review will be used to guide training and practice for health care professionals. Systematic review registration: PROSPERO CRD42015025867.
Abstract.
Ohly H, Gentry S, Wigglesworth R, Bethel A, Lovell R, Garside R (2016). Erratum to: a systematic review of the health and well-being impacts of school gardening: synthesis of quantitative and qualitative evidence.
BMC Public Health,
16(1).
Author URL.
Orr N, Wagstaffe A, Briscoe S, Garside R (2016). How do older people describe their sensory experiences of the natural world? a systematic review of the qualitative evidence.
BMC Geriatr,
16Abstract:
How do older people describe their sensory experiences of the natural world? a systematic review of the qualitative evidence.
BACKGROUND: Despite the increased scholarly interest in the senses and sensory experiences, the topic of older people's sensory engagement with nature is currently under researched. This paper reviews and synthesises qualitative research evidence about how older people, including those living with dementia, describe their sensory engagement with the natural world. METHODS: Ten databases were searched from 1990 to September 2014: MEDLINE (Ovid), MEDLINE-in-Process (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), GreenFILE (EBSCO), ProQuest Sociology, ASSIA (ProQuest), International Bibliography of the Social Sciences (ProQuest); HMIC (Ovid); Social Policy and Practice (Ovid). Forward and backward citation chasing of included articles was conducted; 20 organizations were contacted to identify unpublished reports. Screening was undertaken independently by two reviewers. RESULTS: Twenty seven studies were included. Thematic analysis revealed that descriptions of sensory experiences are encompassed within six themes: descriptions from 'the window'; sensory descriptions that emphasise vision; descriptions of 'being in nature'; descriptions of 'doing in nature'; barriers to sensory engagement; and meanings of being and doing in nature. CONCLUSIONS: Older people derive considerable pleasure and enjoyment from viewing nature, being and doing in nature which, in turn has a positive impact on their wellbeing and quality of life. Future research could usefully explore how sensory engagement with nature could be used to stimulate reminiscences of places and people, and evoke past sensory experiences to enrich everyday life and maintain a sense of self. The protocol was registered with PROSPERO ( CRD42015020736 ).
Abstract.
Author URL.
Husk K, Lovell R, Cooper C, Stahl-Timmins W, Garside R (2016). Participation in environmental enhancement and conservation activities for health and well-being in adults: a review of quantitative and qualitative evidence.
Cochrane Database of Systematic Reviews,
2016(5).
Abstract:
Participation in environmental enhancement and conservation activities for health and well-being in adults: a review of quantitative and qualitative evidence
There is growing research and policy interest in the potential for using the natural environment to enhance human health and well-being. This resource may be underused as a health promotion tool to address the increasing burden of common health problems such as increased chronic diseases and mental health concerns. Outdoor environmental enhancement and conservation activities (EECA) (for instance unpaid litter picking, tree planting or path maintenance) offer opportunities for physical activity alongside greater connectedness with local environments, enhanced social connections within communities and improved self-esteem through activities that improve the locality which may, in turn, further improve well-being. Objectives: to assess the health and well-being impacts on adults following participation in environmental enhancement and conservation activities. Search methods: We contacted or searched the websites of more than 250 EECA organisations to identify grey literature. Resource limitations meant the majority of the websites were from UK, USA, Canada and Australia. We searched the following databases (initially in October 2012, updated October 2014, except CAB Direct, OpenGrey, SPORTDiscus, and TRIP Database), using a search strategy developed with our project advisory groups (predominantly leaders of EECA-type activities and methodological experts): ASSIA; BIOSIS; British Education Index; British Nursing Index; CAB Abstracts; Campbell Collaboration; Cochrane Public Health Specialized Register; DOPHER; EMBASE; ERIC; Global Health; GreenFILE; HMIC; MEDLINE-in-Process; MEDLINE; OpenGrey; PsychINFO; Social Policy and Practice; SPORTDiscus; TRoPHI; Social Services Abstracts; Sociological Abstracts; the Cochrane Library; TRIP database; and Web of Science. Citation and related article chasing was used. Searches were limited to studies in English published after 1990. Selection criteria: Two review authors independently screened studies. Included studies examined the impact of EECA on adult health and well-being. Eligible interventions needed to include each of the following: intended to improve the outdoor natural or built environment at either a local or wider level; took place in urban or rural locations in any country; involved active participation; and were NOT experienced through paid employment. We included quantitative and qualitative research. Includable quantitative study designs were: randomised controlled trials (RCTs), cluster RCTs, quasi-RCTs, cluster quasi-RCTs, controlled before-and-after studies, interrupted-time-series, cohort studies (prospective or retrospective), case-control studies and uncontrolled before-and-after studies (uBA). We included qualitative research if it used recognised qualitative methods of data collection and analysis. Data collection and analysis: One reviewer extracted data, and another reviewer checked the data. Two review authors independently appraised study quality using the Effective Public Health Practice Project tool (for quantitative studies) or Wallace criteria (for qualitative studies). Heterogeneity of outcome measures and poor reporting of intervention specifics prevented meta-analysis so we synthesised the results narratively. We synthesised qualitative research findings using thematic analysis. Main results: Database searches identified 21,420 records, with 21,304 excluded at title/abstract. Grey literature searches identified 211 records. We screened 327 full-text articles from which we included 21 studies (reported in 28 publications): two case-studies (which were not included in the synthesis due to inadequate robustness), one case-control, one retrospective cohort, five uBA, three mixed-method (uBA, qualitative), and nine qualitative studies. The 19 studies included in the synthesis detailed the impacts to a total of 3,603 participants: 647 from quantitative intervention studies and 2630 from a retrospective cohort study; and 326 from qualitative studies (one not reporting sample size). Included studies shared the key elements of EECA defined above, but the range of activities varied considerably. Quantitative evaluation methods were heterogeneous. The designs or reporting of quantitative studies, or both, were rated as 'weak' quality with high risk of bias due to one or more of the following: inadequate study design, intervention detail, participant selection, outcome reporting and blinding. Participants' characteristics were poorly reported; eight studies did not report gender or age and none reported socio-economic status. Three quantitative studies reported that participants were referred through health or social services, or due to mental ill health (five quantitative studies), however participants' engagement routes were often not clear. Whilst the majority of quantitative studies (n = 8) reported no effect on one or more outcomes, positive effects were reported in six quantitative studies relating to short-term physiological, mental/emotional health, and quality-of-life outcomes. Negative effects were reported in two quantitative studies; one study reported higher levels of anxiety amongst participants, another reported increased mental health stress. The design or reporting, or both, of the qualitative studies was rated as good in three studies or poor in nine; mainly due to missing detail about participants, methods and interventions. Included qualitative evidence provided rich data about the experience of participation. Thematic analysis identified eight themes supported by at least one good quality study, regarding participants' positive experiences and related to personal/social identity, physical activity, developing knowledge, spirituality, benefits of place, personal achievement, psychological benefits and social contact. There was one report of negative experiences. Authors' conclusions: There is little quantitative evidence of positive or negative health and well-being benefits from participating in EECA. However, the qualitative research showed high levels of perceived benefit among participants. Quantitative evidence resulted from study designs with high risk of bias, qualitative evidence lacked reporting detail. The majority of included studies were programme evaluations, conducted internally or funded by the provider. The conceptual framework illustrates the range of interlinked mechanisms through which people believe they potentially achieve health and well-being benefits, such as opportunities for social contact. It also considers potential moderators and mediators of effect. One main finding of the review is the inherent difficulty associated with generating robust evidence of effectiveness for complex interventions. We developed the conceptual framework to illustrate how people believed they benefited. Investigating such mechanisms in a subsequent theory-led review might be one way of examining evidence of effect for these activities. The conceptual framework needs further refinement through linked reviews and more reliable evidence. Future research should use more robust study designs and report key intervention and participant detail.
Abstract.
Mathers J, Rick C, Jenkinson C, Garside R, Pall H, Mitchell R, Bayliss S, Jones LL (2016). Patients' experiences of deep brain stimulation for Parkinson's disease: a qualitative systematic review and synthesis.
BMJ Open,
6(6).
Abstract:
Patients' experiences of deep brain stimulation for Parkinson's disease: a qualitative systematic review and synthesis.
OBJECTIVE: to review and synthesise qualitative research studies that have explored patients' experience of deep brain stimulation (DBS) in advanced Parkinson's disease (PD). DESIGN: Systematic review and meta-synthesis of 7 original papers, using metaethnography. SETTING: Studies conducted in Denmark, France and Sweden. PARTICIPANTS: 116 patients who had undergone DBS and 9 spouses of patients. RESULTS: Prior to surgery, the experience of advancing PD is one of considerable loss and a feeling of loss of control. There are significant hopes for what DBS can bring. Following surgery, a sense of euphoria is described by many, although this does not persist and there is a need for significant transitions following this. We suggest that normality as a concept is core to the experience of DBS and that a sense of control may be a key condition for normality. Experience of DBS for patients and spouses, and of the transitions that they must undertake, is influenced by their hopes of what surgery will enable them to achieve, or regain (ie, a new normality). CONCLUSIONS: There is a need for further qualitative research to understand the nature of these transitions to inform how best patients and their spouses can be supported by healthcare professionals before, during and after DBS. In assessing the outcomes of DBS and other treatments in advanced PD, we should consider how to capture holistic concepts such as normality and control. Studies that examine the outcomes of DBS require longer term follow-up.
Abstract.
Author URL.
Moore DA, Gwernan-Jones R, Richardson M, Racey D, Rogers M, Stein K, Thompson-Coon J, Ford TJ, Garside R (2016). The experiences of and attitudes toward non-pharmacological interventions for attention-deficit/hyperactivity disorder used in school settings: a systematic review and synthesis of qualitative research.
Emotional and Behavioural Difficulties, 1-22.
Abstract:
The experiences of and attitudes toward non-pharmacological interventions for attention-deficit/hyperactivity disorder used in school settings: a systematic review and synthesis of qualitative research
© 2016 SEBDA School-based non-pharmacological interventions are an important part of the treatment of attention-deficit/hyperactivity disorder (ADHD). We aimed to systematically review qualitative literature relating to the experience of and attitudes towards school-based non-pharmacological interventions for ADHD. Systematic searches of 20 electronic databases were undertaken. Reviewers screened titles, abstracts and full reports of studies, before extracting data and critically appraising 33 included papers. Studies were synthesised using meta-ethnographic methods. Four-key interrelated themes were identified: (1) individualising interventions, (2) structure of interventions, (3) barriers to effectiveness, (4) perceived moderators and impact of interventions. The perceived effectiveness of interventions used in school settings is reported to vary. Therefore, flexible, tailored interventions ought to hold potential. However, highly individualised interventions may negatively affect children with ADHD. Findings point to the need for school-based interventions to take into account the wider school context, as well as core symptoms of ADHD.
Abstract.
Husk K, Blockley K, Lovell R, Bethel A, Bloomfield D, Warber S, Pearson M, Lang I, Byng R, Garside R, et al (2016). What approaches to social prescribing work, for whom, and in what circumstances? a protocol for a realist review.
Syst Rev,
5Abstract:
What approaches to social prescribing work, for whom, and in what circumstances? a protocol for a realist review.
BACKGROUND: the use of non-drug, non-health-service interventions has been proposed as a cost-effective alternative to help those with long-term conditions manage their illness and improve their health and well-being. Interventions typically involve accessing activities run by the third sector or community agencies and may also be described as non-medical referral, community referral or social prescribing. To be effective, patients need to be "transferred" from the primary care setting into the community and to maintain their participation in activities. However, it is not currently known how and why these approaches enable which people under what circumstances to reach community services that may benefit their health and well-being. METHODS: Database searches and extensive searching of grey sources will be carried out in an attempt to find evidence associated with referral and retention in social prescribing. After initial scoping searches, two main phases of searching will be conducted: (a) will focus on the identification of programme theories to illustrate how approaches to social prescribing work for different people and in different contexts and (b) will consist of targeted searches to locate evidence to refine these candidate theories into configurations of the contexts in which populations and the main mechanisms outcomes are achieved. Inclusion criteria will initially be broad in order to develop a clear picture of the ways in which social prescriptions might operate but may iteratively become more focused in response to initially identified evidence, for example, in terms of the population group. An expert advisory group consisting of professionals working in a range of organisations involved in social prescribing will be convened to check the approaches in the review and provide real-life experience of social prescribing. Findings from the review will be disseminated to commissioners, published in a peer-reviewed journal and used to help refine an intervention model for an outdoor nature-based group intervention. DISCUSSION: This realist review will explore why mechanisms of social prescribing work, for what groups of people and their impact on enrolment, attendance and adherence to programmes. The use of realist approaches to detail the social prescribing process is novel and will offer insights into effective transfer of patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016039491.
Abstract.
Author URL.
McKinnon MC, Cheng SH, Dupre S, Edmond J, Garside R, Glew L, Holland MB, Levine E, Masuda YJ, Miller DC, et al (2016). What are the effects of nature conservation on human well-being? a systematic map of empirical evidence from developing countries.
Environmental Evidence,
5(1).
Abstract:
What are the effects of nature conservation on human well-being? a systematic map of empirical evidence from developing countries
Background: Global policy initiatives and international conservation organizations have sought to emphasize and strengthen the link between the conservation of natural ecosystems and human development. While many indices have been developed to measure various social outcomes to conservation interventions, the quantity and strength of evidence to support the effects, both positive and negative, of conservation on different dimensions of human well-being, remain unclear, dispersed and inconsistent. Methods: We searched 11 academic citation databases, two search engines and 30 organisational websites for relevant articles using search terms tested with a library of 20 relevant articles. Key informants were contacted with requests for articles and possible sources of evidence. Articles were screened for relevance against predefined inclusion criteria at title, abstract and full text levels according to a published protocol. Included articles were coded using a questionnaire. A critical appraisal of eight systematic reviews was conducted to assess the reliability of methods and confidence in study findings. A visual matrix of the occurrence and extent of existing evidence was also produced. Results: a total of 1043 articles were included in the systematic map database. Included articles measured effects across eight nature conservation-related intervention and ten human well-being related outcome categories. Linkages between interventions and outcomes with high occurrence of evidence include resource management interventions, such as fisheries and forestry, and economic and material outcomes. Over 25 % of included articles examined linkages between protected areas and aspects of economic well-being. Fewer than 2 % of articles evaluated human health outcomes. Robust study designs were limited with less than 9 % of articles using quantitative approaches to evaluate causal effects of interventions. Over 700 articles occurred in forest biomes with less than 50 articles in deserts or mangroves, combined. Conclusions: the evidence base is growing on conservation-human well-being linkages, but biases in the extent and robustness of articles on key linkages persist. Priorities for systematic review, include linkages between marine resource management and economic/material well-being outcomes; and protected areas and governance outcomes. Greater and more robust evidence is needed for many established interventions to better understand synergies and trade-offs between interventions, in particular those that are emerging or contested.
Abstract.
Bond M, Garside R, Hyde C (2015). A crisis of visibility: the psychological consequences of false-positive screening mammograms, an interview study.
British Journal of Health Psychology,
20(4), 792-806.
Abstract:
A crisis of visibility: the psychological consequences of false-positive screening mammograms, an interview study
Objective to understand the meaning of having a false-positive screening mammogram. Design Qualitative interview study. Methods Twenty-one women, who had experienced false-positive screening mammograms, took part in semi-structured interviews that were analysed with Interpretive Phenomenological Analysis. This research took place in the United Kingdom. Results the analysis revealed a wide range of response to having a false-positive mammogram, from nonchalance to extreme fear. These reactions come from the potential for the belief that one is healthy to be challenged by being recalled, as the worst is frequently assumed. For most, the image of the lesion on the X-ray brought the reality of this challenge into sharp focus, as they might soon discover they had breast cancer. Waiting, whether for the appointment, at the clinic or for biopsy results was considered the worst aspect of being recalled. Generally, the uncertainty was quickly resolved with the pronouncement of the 'all-clear', which brought considerable relief and the restoration of belief in the healthy self. However, for some, lack of information, contradictory information, or poor interpersonal communication meant that uncertainty about their health status lingered at least until their next normal screening mammogram. Mammography screening related anxiety lasted for up to 12 years. Conclusion Breast cancer screening produces a 'crisis of visibility'. Accepting the screening invitation is taking a risk that you may experience unnecessary stress, uncertainty, fear, anxiety, and physical pain. Not accepting the invitation is taking a risk that malignant disease will remain invisible. Statement of contribution What is already known on this subject? More than 50,000 women a year in England have a false-positive mammogram (FPM). Having an FPM can cause anxiety compared with a normal mammogram. The anxiety can last up to 35 months. What does this study add? Refocuses attention from the average response found in quantitative studies to the wide range of individual response. Gives insight into the nature of the anxiety of having FPMs. Highlights the role of uncertainty in provoking distress from an FPM.
Abstract.
Bond M, Garside R, Hyde C (2015). A crisis of visibility: the psychological consequences of false-positive screening mammograms, an interview study.
Br J Health Psychol,
20(4), 792-806.
Abstract:
A crisis of visibility: the psychological consequences of false-positive screening mammograms, an interview study.
OBJECTIVE: to understand the meaning of having a false-positive screening mammogram. DESIGN: Qualitative interview study. METHODS: Twenty-one women, who had experienced false-positive screening mammograms, took part in semi-structured interviews that were analysed with Interpretive Phenomenological Analysis. This research took place in the United Kingdom. RESULTS: the analysis revealed a wide range of response to having a false-positive mammogram, from nonchalance to extreme fear. These reactions come from the potential for the belief that one is healthy to be challenged by being recalled, as the worst is frequently assumed. For most, the image of the lesion on the X-ray brought the reality of this challenge into sharp focus, as they might soon discover they had breast cancer. Waiting, whether for the appointment, at the clinic or for biopsy results was considered the worst aspect of being recalled. Generally, the uncertainty was quickly resolved with the pronouncement of the 'all-clear', which brought considerable relief and the restoration of belief in the healthy self. However, for some, lack of information, contradictory information, or poor interpersonal communication meant that uncertainty about their health status lingered at least until their next normal screening mammogram. Mammography screening related anxiety lasted for up to 12 years. CONCLUSION: Breast cancer screening produces a 'crisis of visibility'. Accepting the screening invitation is taking a risk that you may experience unnecessary stress, uncertainty, fear, anxiety, and physical pain. Not accepting the invitation is taking a risk that malignant disease will remain invisible. Statement of contribution What is already known on this subject? More than 50,000 women a year in England have a false-positive mammogram (FPM). Having an FPM can cause anxiety compared with a normal mammogram. The anxiety can last up to 35 months. What does this study add? Refocuses attention from the average response found in quantitative studies to the wide range of individual response. Gives insight into the nature of the anxiety of having FPMs. Highlights the role of uncertainty in provoking distress from an FPM.
Abstract.
Author URL.
Gwernan-Jones RC, Moore D, Garside R, Richardson M, Thompson-Coon J, Rogers M, Cooper P, Stein K, Ford T (2015). ADHD, parent perspectives and parent—teacher relationships: Grounds for conflict.
British Journal of Special EducationAbstract:
ADHD, parent perspectives and parent—teacher relationships: Grounds for conflict
Educational policy and the school effectiveness movement often involve rhetoric about the benefit of parent involvement in schools, but high quality relationships between parents and teachers are not always straightforwardly achieved, and this may be particularly true for parents of children presenting with academic problems and/or Social, Emotional and Behavioural Difficulties (SEBD). A systematic review of qualitative research was conducted to explore the school-related experiences of parents of pupils diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Six studies reported in seven papers met the inclusion criteria. High quality parent—teacher relationships were found to be the exception, with mothers feeling silenced and criticised. Findings show commonalities with wider research about parents, but identify additional grounds for conflict resulting from parental blame for a pupils’ disruptive behaviour, and the ambivalent nature of the concept of ADHD.
Abstract.
Leonard AFC, Zhang L, Balfour AJ, Garside R, Gaze WH (2015). Human recreational exposure to antibiotic resistant bacteria in coastal bathing waters.
Environment International,
82, 92-100.
Abstract:
Human recreational exposure to antibiotic resistant bacteria in coastal bathing waters
Infections caused by antibiotic resistant bacteria (ARB) are associated with poor health outcomes and are recognised globally as a serious health problem. Much research has been conducted on the transmission of ARB to humans. Yet the role the natural environment plays in the spread of ARB and antibiotic resistance genes is not well understood. Antibiotic resistant bacteria have been detected in natural aquatic environments, and ingestion of seawater during water sports is one route by which many people could be directly exposed. The aim was to estimate the prevalence of resistance to one clinically important class of antibiotics (third-generation cephalosporins (3GCs)) amongst Escherichia coli in coastal surface waters in England and Wales. Prevalence data was used to quantify ingestion of 3GC-resistant E. coli (3GCREC) by people participating in water sports in designated coastal bathing waters. A further aim was to use this value to derive a population-level estimate of exposure to these bacteria during recreational use of coastal waters in 2012. The prevalence of 3GC-resistance amongst E. coli isolated from coastal surface waters was estimated using culture-based methods. This was combined with the density of E. coli reported in designated coastal bathing waters along with estimations of the volumes of water ingested during various water sports reported in the literature to calculate the mean number of 3GCREC ingested during different water sports.0.12% of E. coli isolated from surface waters were resistant to 3GCs. This value was used to estimate that in England and Wales over 6.3 million water sport sessions occurred in 2012 that resulted in the ingestion of at least one 3GCREC.Despite the low prevalence of resistance to 3GCs amongst E. coli in surface waters, there is an identifiable human exposure risk for water users, which varies with the type of water sport undertaken. The relative importance of this exposure is likely to be greater in areas where a large proportion of the population enjoys water sports. Millions of water sport sessions occurred in 2012 that were likely to have resulted in people ingesting E. coli resistant to a single class of antibiotics (3GCs). However, this is expected to be a significant underestimate of recreational exposure to all ARB in seawater. This is the first study to use volumes of water ingested during different water sports to estimate human exposure to ARB. Further work needs to be done to elucidate the health implications and clinical relevance of exposure to ARB in both marine and fresh waters in order to fully understand the risk to public health.
Abstract.
Bond M, Garside R, Hyde C (2015). Improving screening recall services for women with false-positive mammograms: a comparison of qualitative evidence with UK guidelines.
BMJ Open,
5(1).
Abstract:
Improving screening recall services for women with false-positive mammograms: a comparison of qualitative evidence with UK guidelines.
OBJECTIVES: to gain an understanding of the views of women with false-positive screening mammograms of screening recall services, their ideas for service improvements and how these compare with current UK guidelines. METHODS: Inductive qualitative content analysis of semistructured interviews of 21 women who had false-positive screening mammograms. These were then compared with UK National Health Service (NHS) guidelines. RESULTS: Participants' concerns about mammography screening recall services focused on issues of communication and choice. Many of the issues raised indicated that the 1998 NHS Breast Screening Programme guidelines on improving the quality of written information sent to women who are recalled, had not been fully implemented. This included being told a clear reason for recall, who may attend with them, the length of appointment, who they will see and what tests will be carried out. Additionally women voiced a need for: reassurance that a swift appointment did not imply they had cancer; choice about invasive assessment or watchful waiting; the offer of a follow-up mammogram for those uncertain about the validity of their all-clear and an extension of the role of the clinical nurse specialist, outlined in the 2012 NHS Breast Screening Programme (NHSBSP) guidelines, to include availability at the clinic after the all-clear for women with false-positive mammograms. CONCLUSIONS: it is time the NHSBSP 1998 recall information guidelines were fully implemented. Additionally, the further suggestions from this research, including extending the role of the clinical nurses from the 2012 NHSBSP guidelines, should be considered. These actions have the potential to reduce the anxiety of being recalled.
Abstract.
Author URL.
Frost J, Garside R, Cooper C, Britten N (2015). Meta-Study as Diagnostic: Toward Content over Form in Qualitative Synthesis.
Qualitative Health Research,
26, 307-319.
Abstract:
Meta-Study as Diagnostic: Toward Content over Form in Qualitative Synthesis
Having previously conducted qualitative syntheses of the diabetes literature, we wanted to explore the changes in
theoretical approaches, methodological practices, and the construction of substantive knowledge which have recently
been presented in the qualitative diabetes literature. The aim of this research was to explore the feasibility of synthesizing
existing qualitative syntheses of patient perspectives of diabetes using meta-study methodology. A systematic review
of qualitative literature, published between 2000 and 2013, was conducted. Six articles were identified as qualitative
syntheses. The meta-study methodology was used to compare the theoretical, methodological, analytic, and synthetic
processes across the six studies, exploring the potential for an overarching synthesis. We identified that while research
questions have increasingly concentrated on specific aspects of diabetes, the focus on systematic review processes
has led to the neglect of qualitative theory and methods. This can inhibit the production of compelling results with
meaningful clinical applications. Although unable to produce a synthesis of syntheses, we recommend that researchers
who conduct qualitative syntheses pay equal attention to qualitative traditions and systematic review processes, to
produce research products that are both credible and applicable.
Abstract.
Ciani O, Buyse M, Garside R, Peters J, Saad ED, Stein K, Taylor RS (2015). Meta-analyses of randomized controlled trials show suboptimal validity of surrogate outcomes for overall survival in advanced colorectal cancer.
J Clin Epidemiol,
68(7), 833-842.
Abstract:
Meta-analyses of randomized controlled trials show suboptimal validity of surrogate outcomes for overall survival in advanced colorectal cancer.
OBJECTIVES: to quantify and compare the treatment effects on three surrogate end points, progression-free survival (PFS), time to progression (TTP), and tumor response rate (TR) vs. overall survival (OS) based on a meta-analysis of randomized controlled trials (RCTs) of drug interventions in advanced colorectal cancer (aCRC). STUDY DESIGN AND SETTING: We systematically searched for RCTs of pharmacologic therapies in aCRC between 2003 and 2013. Trial characteristics, risk of bias, and outcomes were recorded based on a predefined form. Univariate and multivariate random-effects meta-analyses were used to estimate pooled summary treatment effects. The ratio of hazard ratios (HRs)/odds ratios (ORs) and difference in medians were used to quantify the degree of difference in treatment effects on the surrogate end points and OS. Spearman ρ, surrogate threshold effect (STE), and R(2) were also estimated across predefined trial-level covariates. RESULTS: We included 101 RCTs. In univariate and multivariate meta-analyses, we found larger treatment effects for the surrogates than for OS. Compared with OS, treatment effects were on average 13% higher when HRs were measured and 3% to 45% higher when ORs were considered; differences in median PFS/TTP were higher than on OS by an average of 0.5 month. Spearman ρ ranged from 0.39 to 0.80, mean R(2) from 0.06 to 0.65, and STE was 0.8 for HRPFS, 0.64 for HRTTP, or 0.28 for ORTR. The stratified analyses revealed high variability across all strata. CONCLUSION: None of the end points in this study were found to achieve the level of evidence (ie, mean R(2)trial > 0.60) that has been set to select high or excellent correlation levels by common surrogate evaluation tools. Previous surrogacy relationships observed between PFS and TTP vs. OS in selected settings may not apply across other classes or lines of therapy.
Abstract.
Author URL.
Richardson M, Moore D, Gwernan-Jones R, Thompson-Coon J, Ukoumunne O, Rogers M, Whear R, Newlove-Delgado T, Logan S, Morris C, et al (2015). Non pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) delivered in school settings: Systematic reviews of quantitative and qualitative research. Health Technology Assessment, 19(45)
Moore, DA, Richardson, M, Gwernan-Jones, R, Thompson-Coon, J, Stein, K, Rogers, M, Garside, R, Logan, S, Ford, TJ (2015). Non-pharmacological interventions for ADHD in school settings: an overarching synthesis of systematic reviews.
Journal of Attention Disorders, 1-14.
Abstract:
Non-pharmacological interventions for ADHD in school settings: an overarching synthesis of systematic reviews
Objective: This overarching synthesis brings together the findings of four systematic reviews including 138 studies focused on non-pharmacological interventions for ADHD used in school settings. These reviews considered the effectiveness of school-based interventions for ADHD, attitudes towards and experience of school-based interventions for ADHD, and the experience of ADHD in school settings. Method: We developed novel methods to compare the findings across these reviews inductively and deductively. Results: Key contextual issues that may influence the effectiveness and implementation of interventions include the relationships that pupils with ADHD have with their teachers and peers, the attributions individuals make about the etiology of ADHD, and stigma related to ADHD or intervention attendance. Conclusion: Although we found some positive effects for some outcomes and intervention categories, heterogeneity in effect size estimates and research evidence suggests a range of diverse contextual factors potentially moderate the implementation and effectiveness of school based interventions for ADHD.
Abstract.
McKinnon MC, Cheng SH, Garside R, Masuda YJ, Miller DC (2015). Sustainability: Map the evidence.
NATURE,
528(7581), 185-187.
Author URL.
McKinnon MC, Cheng SH, Garside R, Masuda YJ, Miller DC (2015). Sustainability: Map the evidence. Nature, 528(7581), 185-187.
Lovell R, Husk K, Cooper C, Stahl-Timmins W, Garside R (2015). Understanding how environmental enhancement and conservation activities may benefit health and wellbeing: a systematic review.
BMC Public Health,
15Abstract:
Understanding how environmental enhancement and conservation activities may benefit health and wellbeing: a systematic review.
BACKGROUND: Action taken to enhance or conserve outdoor environments may benefit health and wellbeing through the process of participation but also through improving the environment. There is interest, amongst both health and environmental organisations, in using such activities as health promotion interventions. The objective of this systematic review was to investigate the health and wellbeing impacts of participation in environmental enhancement and conservation activities and to understand how these activities may be beneficial, to whom and in what circumstances or contexts. METHODS: a theory-led mixed-method systematic review was used to assess evidence of effect and to identify pathways to change (protocol: http://onlinelibrary.wiley.com/doi/ 10.1002/14651858.CD010351/full ). Due to the multi-disciplinary, dispersed and disparate body of evidence an extensive multi-stage search strategy was devised and undertaken. Twenty-seven databases and multiple sources of grey literature were searched and over 200 relevant organisations were contacted. The heterogenous evidence was synthesised using a narrative approach and a conceptual model was developed to illustrate the mechanisms of effect. Due to the limited nature of the evidence additional higher order evidence was sought to assess the plausibility of the proposed mechanisms of effect through which health and wellbeing may accrue. RESULTS: the majority of the quantitative evidence (13 studies; all poor quality and lower-order study designs) was inconclusive, though a small number of positive and negative associations were observed. The qualitative evidence (13 studies; 10 poor quality, 3 good) indicated that the activities were perceived to have value to health and wellbeing through a number of key mechanisms; including exposure to natural environments, achievement, enjoyment and social contact. Additional high level evidence indicated that these pathways were plausible. CONCLUSIONS: Despite interest in the use of environmental enhancement activities as a health intervention there is currently little direct evidence of effect, this is primarily due to a lack of robust study designs. Further rigorous research is needed to understand the potential of the activities to benefit health and environment.
Abstract.
Author URL.
Lewin S, Glenton C, Munthe-Kaas H, Carlsen B, Colvin CJ, Gülmezoglu M, Noyes J, Booth A, Garside R, Rashidian A, et al (2015). Using qualitative evidence in decision making for health and social interventions: an approach to assess confidence in findings from qualitative evidence syntheses (GRADE-CERQual).
PLoS Med,
12(10).
Abstract:
Using qualitative evidence in decision making for health and social interventions: an approach to assess confidence in findings from qualitative evidence syntheses (GRADE-CERQual).
Simon Lewin and colleagues present a methodology for increasing transparency and confidence in qualitative research synthesis.
Abstract.
Author URL.
Frost J, Garside R, Cooper C, Britten N (2014). A qualitative synthesis of diabetes self-management strategies for long term medical outcomes and quality of life in the UK.
BMC Health Services ResearchAbstract:
A qualitative synthesis of diabetes self-management strategies for long term medical outcomes and quality of life in the UK
Background
Qualitative research on self-management for people with Type 2 Diabetes Mellitus (T2DM) has typically reported one-off retrospective accounts of individuals’ strategies. The aim of this research was to identify the ways in which self-management strategies are perceived by people with T2DM as being either supportive or unsupportive over time, by using qualitative findings from both longitudinal intervention studies and usual care.
Methods
A systematic review of qualitative literature, published between 2000 and 2013, was conducted using a range of searching techniques. 1374 prospective qualitative papers describing patients’ experiences of self-management strategies for T2DM were identified and screened. of the 98 papers describing qualitative research conducted in the UK, we identified 4 longitudinal studies (3 intervention studies, 1 study of usual care). Key concepts and themes were extracted, reviewed and synthesised using meta-ethnography techniques.
Results
Aspects of self-management strategies in clinical trials (e.g. supported exercise regimens) can be perceived as enabling the control of biomarkers and facilitative of quality of life. In contrast, aspects of self-management strategies outwith trial conditions (e.g. self-monitoring) can be perceived of as negative influences on quality of life. For self-management strategies to be sustainable in the long term, patients require a sense of having a stake in their management that is appropriate for their beliefs and perceptions, timely information and support, and an overall sense of empowerment in managing their diabetes in relation to other aspects of their life. This enables participants to develop flexible diabetes management strategies that facilitate quality of life and long term medical outcomes.
Conclusions
This synthesis has explored how patients give meaning to the experiences of interventions for T2DM and subsequent attempts to balance biomarkers with quality of life in the long term. People with T2DM both construct and draw upon causal accounts as a resource, and a means to counter their inability to balance medical outcomes and quality of life. These accounts can be mediated by the provision of timely and tailored information and support over time, which can allow people to develop a flexible regimen that can facilitate both quality of life and medical outcomes.
Abstract.
Lovell R, Husk K, Cooper C, Stahl-Timmins W, Garside R (2014). Environmental conservation activities for health: building on systematic review methods to consider a disparate, dispersed, and limited evidence base. The Lancet, 384, S46-S46.
Leonard AFC, Zhang L, Balfour AJ, Garside R, Gaze WH (2014). Human recreational exposure to antibiotic resistant bacteria in coastal bathing waters.
Environment InternationalAbstract:
Human recreational exposure to antibiotic resistant bacteria in coastal bathing waters
© 2015 Elsevier Ltd. Infections caused by antibiotic resistant bacteria (ARB) are associated with poor health outcomes and are recognised globally as a serious health problem. Much research has been conducted on the transmission of ARB to humans. Yet the role the natural environment plays in the spread of ARB and antibiotic resistance genes is not well understood. Antibiotic resistant bacteria have been detected in natural aquatic environments, and ingestion of seawater during water sports is one route by which many people could be directly exposed.The aim was to estimate the prevalence of resistance to one clinically important class of antibiotics (third-generation cephalosporins (3GCs)) amongst Escherichia coli in coastal surface waters in England and Wales. Prevalence data was used to quantify ingestion of 3GC-resistant E. coli (3GCREC) by people participating in water sports in designated coastal bathing waters. A further aim was to use this value to derive a population-level estimate of exposure to these bacteria during recreational use of coastal waters in 2012.The prevalence of 3GC-resistance amongst E. coli isolated from coastal surface waters was estimated using culture-based methods. This was combined with the density of E. coli reported in designated coastal bathing waters along with estimations of the volumes of water ingested during various water sports reported in the literature to calculate the mean number of 3GCREC ingested during different water sports.0.12% of E. coli isolated from surface waters were resistant to 3GCs. This value was used to estimate that in England and Wales over 6.3 million water sport sessions occurred in 2012 that resulted in the ingestion of at least one 3GCREC.Despite the low prevalence of resistance to 3GCs amongst E. coli in surface waters, there is an identifiable human exposure risk for water users, which varies with the type of water sport undertaken. The relative importance of this exposure is likely to be greater in areas where a large proportion of the population enjoys water sports. Millions of water sport sessions occurred in 2012 that were likely to have resulted in people ingesting E. coli resistant to a single class of antibiotics (3GCs). However, this is expected to be a significant underestimate of recreational exposure to all ARB in seawater.This is the first study to use volumes of water ingested during different water sports to estimate human exposure to ARB. Further work needs to be done to elucidate the health implications and clinical relevance of exposure to ARB in both marine and fresh waters in order to fully understand the risk to public health.
Abstract.
Garside R (2014). Should we appraise the quality of qualitative research reports for systematic reviews, and if so, how?.
Innovation: the European Journal of Social Science Research,
27(1), 67-79.
Abstract:
Should we appraise the quality of qualitative research reports for systematic reviews, and if so, how?
Systematic reviews of qualitative research have increasing currency for evidence-based policy-making. Potentially, this can prevent further marginalization of qualitative evidence, increase our understanding of the body of work undertaken by qualitative researchers and allow broader, more overarching theories about studied phenomenon to be built. Qualitative researchers have so far failed to agree what constitutes "validity" or "quality" in their work: these debates have mirrored the epistemological differences within which such research is undertaken. This paper explores the arguments about quality appraisal and, drawing on this literature, builds a proposal to which, it is hoped, qualitative researchers from across disciplines may be able to ascribe. Technical reporting standards could be agreed that make the conduct of the research clearer. Additional elements, related to study trustworthiness and theoretical and practical considerations, could be appraised discursively, allowing the intention of the researchers working within their particular milieu to be accommodated. © 2013 © 2013 ICCR Foundation.
Abstract.
Ciani O, Davis S, Tappenden P, Garside R, Stein K, Cantrell A, Saad ED, Buyse M, Taylor RS (2014). Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.
Int J Technol Assess Health Care,
30(3), 312-324.
Abstract:
Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.
OBJECTIVES: Licensing of, and coverage decisions on, new therapies should rely on evidence from patient-relevant endpoints such as overall survival (OS). Nevertheless, evidence from surrogate endpoints may also be useful, as it may not only expedite the regulatory approval of new therapies but also inform coverage decisions. It is, therefore, essential that candidate surrogate endpoints be properly validated. However, there is no consensus on statistical methods for such validation and on how the evidence thus derived should be applied by policy makers. METHODS: We review current statistical approaches to surrogate-endpoint validation based on meta-analysis in various advanced-tumor settings. We assessed the suitability of two surrogates (progression-free survival [PFS] and time-to-progression [TTP]) using three current validation frameworks: Elston and Taylor's framework, the German Institute of Quality and Efficiency in Health Care's (IQWiG) framework and the Biomarker-Surrogacy Evaluation Schema (BSES3). RESULTS: a wide variety of statistical methods have been used to assess surrogacy. The strength of the association between the two surrogates and OS was generally low. The level of evidence (observation-level versus treatment-level) available varied considerably by cancer type, by evaluation tools and was not always consistent even within one specific cancer type. CONCLUSIONS: Not in all solid tumors the treatment-level association between PFS or TTP and OS has been investigated. According to IQWiG's framework, only PFS achieved acceptable evidence of surrogacy in metastatic colorectal and ovarian cancer treated with cytotoxic agents. Our study emphasizes the challenges of surrogate-endpoint validation and the importance of building consensus on the development of evaluation frameworks.
Abstract.
Author URL.
Lovell R, Husk K, Bethel A, Garside R (2014). What are the health and well-being impacts of community gardening for adults and children: a mixed method systematic review protocol. Environmental Evidence, 3(1).
Bottrill M, Cheng S, Garside R, Wongbusarakum S, Roe D, Holland MB, Edmond J, Turner WR (2014). What are the impacts of nature conservation interventions on human well-being: a systematic map protocol.
Environmental Evidence,
3(1).
Abstract:
What are the impacts of nature conservation interventions on human well-being: a systematic map protocol
Background: International policy has sought to emphasize and strengthen the link between the conservation of natural ecosystems and human development. Furthermore, international conservation organizations have broadened their objectives beyond nature-based goals to recognize the contribution of conservation interventions in sustaining ecosystem services upon which human populations are dependent. While many indices have been developed to measure various human well-being domains, the strength of evidence to support the effects, both positive and negative, of conservation interventions on human well-being, is still unclear. Methods/Design: This protocol describes the methodology for examining the research question: What are the impacts of nature conservation interventions on different domains of human well-being in developing countries? Using systematic mapping, this study will scope and identify studies that measure the impacts of nature conservation interventions on human well-being at local to regional scales. The primary objective of this study is to synthesize the state and distribution of the existing evidence base linking conservation and human well-being. In addition, a theory of change approach will be used to identify and characterize the causal linkages between conservation and human well-being, with attention on those studies that examine the role of ecosystem services. Key trends among the resulting studies will be synthesized and the range of studies organized and presented in a graphical matrix illustrating the relationships between types of interventions and types of outcomes. Results of the study are intended to help conservation and development practitioners and the academic community to improve research studies and conservation practices in developing countries in order to achieve both conservation and human well-being outcomes.
Abstract.
Whear R, Coon JT, Bethel A, Abbott R, Stein K, Garside R (2014). What is the impact of using outdoor spaces such as gardens on the physical and mental well-being of those with dementia? a systematic review of quantitative and qualitative evidence.
J Am Med Dir Assoc,
15(10), 697-705.
Abstract:
What is the impact of using outdoor spaces such as gardens on the physical and mental well-being of those with dementia? a systematic review of quantitative and qualitative evidence.
OBJECTIVE: to examine the impact of gardens and outdoor spaces on the mental and physical well-being of people with dementia who are resident in care homes and understand the views of people with dementia, their carers, and care home staff on the value of gardens and outdoor spaces. DESIGN: Systematic review. METHODS: Fourteen databases were searched from inception to February 2013. Forward and backward citation chasing of included articles was conducted; 38 relevant organizations were contacted to identify unpublished reports. Titles, abstracts, and full texts were screened independently by 2 reviewers in a 2-stage process and were discussed with a third reviewer where necessary. Results were synthesized narratively. RESULTS: Seventeen studies were included: 9 quantitative, 7 qualitative, and 1 mixed methods. The quantitative studies were of poor quality but suggested decreased levels of agitation were associated with garden use. The views and experiences of the garden are discussed in relation to themes of how the garden was used, nature of interactions, impact/effect of the gardens, mechanisms/how the garden was thought to have an effect, and negatives (such as perception of the garden as a hazard and the limited staff time). CONCLUSION: There are promising impacts on levels of agitation in care home residents with dementia who spend time in a garden. Future research would benefit from a focus on key outcomes measured in comparable ways with a separate focus on what lies behind limited accessibility to gardens within the residential care setting.
Abstract.
Author URL.
Zhelev Z, Garside R, Hyde C (2013). A qualitative study into the difficulties experienced by healthcare decision makers when reading a Cochrane diagnostic test accuracy review.
Syst Rev,
2Abstract:
A qualitative study into the difficulties experienced by healthcare decision makers when reading a Cochrane diagnostic test accuracy review.
BACKGROUND: Cochrane reviews are one of the best known and most trusted sources of evidence-based information in health care. While steps have been taken to make Cochrane intervention reviews accessible to a diverse readership, little is known about the accessibility of the newcomer to the Cochrane library: diagnostic test accuracy reviews (DTARs). The current qualitative study explored how healthcare decision makers, who varied in their knowledge and experience with test accuracy research and systematic reviews, read and made sense of DTARs. METHODS: a purposive sample of clinicians, researchers and policy makers (n = 21) took part in a series of think-aloud interviews, using as interview material the first three DTARs published in the Cochrane library. Thematic qualitative analysis of the transcripts was carried out to identify patterns in participants' 'reading' and interpretation of the reviews and the difficulties they encountered. RESULTS: Participants unfamiliar with the design and methodology of DTARs found the reviews largely inaccessible and experienced a range of difficulties stemming mainly from the mismatch between background knowledge and level of explanation provided in the text. Experience with systematic reviews of interventions did not guarantee better understanding and, in some cases, led to confusion and misinterpretation. These difficulties were further exacerbated by poor layout and presentation, which affected even those with relatively good knowledge of DTARs and had a negative impact not only on their understanding of the reviews but also on their motivation to engage with the text. Comparison between the readings of the three reviews showed that more accessible presentation, such as presenting the results as natural frequencies, significantly increased participants' understanding. CONCLUSIONS: the study demonstrates that authors and editors should pay more attention to the presentation as well as the content of Cochrane DTARs, especially if the reports are aimed at readers with various levels of background knowledge and experience. It also raises the question as to the anticipated target audience of the reports and suggests that different groups of healthcare decision-makers may require different modes of presentation.
Abstract.
Author URL.
Taylor RS (2013). Comparision of treatment effect sizes associated with surrogate outcomes and final patient related outcomes in randomised controlled trials. BMJ: British Medical Journal
Ciani O, Buyse M, Garside R, Pavey T, Stein K, Sterne JAC, Taylor RS (2013). Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study.
BMJ,
346Abstract:
Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study.
OBJECTIVE: to quantify and compare the treatment effect and risk of bias of trials reporting biomarkers or intermediate outcomes (surrogate outcomes) versus trials using final patient relevant primary outcomes. DESIGN: Meta-epidemiological study. DATA SOURCES: all randomised clinical trials published in 2005 and 2006 in six high impact medical journals: Annals of Internal Medicine, BMJ, Journal of the American Medical Association, Lancet, New England Journal of Medicine, and PLoS Medicine. STUDY SELECTION: Two independent reviewers selected trials. DATA EXTRACTION: Trial characteristics, risk of bias, and outcomes were recorded according to a predefined form. Two reviewers independently checked data extraction. The ratio of odds ratios was used to quantify the degree of difference in treatment effects between the trials using surrogate outcomes and those using patient relevant outcomes, also adjusted for trial characteristics. A ratio of odds ratios >1.0 implies that trials with surrogate outcomes report larger intervention effects than trials with patient relevant outcomes. RESULTS: 84 trials using surrogate outcomes and 101 using patient relevant outcomes were considered for analyses. Study characteristics of trials using surrogate outcomes and those using patient relevant outcomes were well balanced, except for median sample size (371 v 741) and single centre status (23% v 9%). Their risk of bias did not differ. Primary analysis showed trials reporting surrogate endpoints to have larger treatment effects (odds ratio 0.51, 95% confidence interval 0.42 to 0.60) than trials reporting patient relevant outcomes (0.76, 0.70 to 0.82), with an unadjusted ratio of odds ratios of 1.47 (1.07 to 2.01) and adjusted ratio of odds ratios of 1.46 (1.05 to 2.04). This result was consistent across sensitivity and secondary analyses. CONCLUSIONS: Trials reporting surrogate primary outcomes are more likely to report larger treatment effects than trials reporting final patient relevant primary outcomes. This finding was not explained by differences in the risk of bias or characteristics of the two groups of trials.
Abstract.
Author URL.
Husk K, Lovell R, Cooper C, Garside R (2013). Participation in environmental enhancement and conservation activities for health and well-being in adults.
Author URL.
Bond M, Pavey T, Welch K, Cooper C, Garside R, Dean S, Hyde CJ (2013). Psychological consequences of false-positive screening mammograms in the UK.
Evidence-Based Medicine,
18(2), 54-61.
Abstract:
Psychological consequences of false-positive screening mammograms in the UK
Objectives to identify the psychological effects of falsepositive screening mammograms in the UK. Methods Systematic review of all controlled studies and qualitative studies of women with a false-positive screening mammogram. The control group participants had normal mammograms. All psychological outcomes including returning for routine screening were permitted. All studies had a narrative synthesis. Results the searches returned seven includable studies (7/4423). Heterogeneity was such that meta-analysis was not possible. Studies using disease-specific measures found that, compared to normal results, there could be enduring psychological distress that lasted up to 3 years; the level of distress was related to the degree of invasiveness of the assessment. At 3 years the relative risks were, further mammography, 1.28 (95% CI 0.82 to 2.00), fine needle aspiration 1.80 (95% CI 1.17 to 2.77), biopsy 2.07 (95% CI 1.22 to 3.52) and early recall 1.82 (95% CI 1.22 to 2.72). Studies that used generic measures of anxiety and depression found no such impact up to 3 months after screening. Evidence suggests that women with false-positive mammograms have an increased likelihood of failing to reattend for routine screening, relative risk 0.97 (95% CI 0.96 to 0.98) compared with women with normal mammograms. Conclusions Having a false-positive screening mammogram can cause breast cancer-specific distress for up to 3 years. The degree of distress is related to the invasiveness of the assessment. Women with false-positive mammograms are less likely to return for routine assessment than those with normal ones. Copyright © 2013 the BMJ Publishing Group Ltd.
Abstract.
Bond M, Pavey T, Welch K, Cooper C, Garside R, Dean S, Hyde CJ (2013). Psychological consequences of false-positive screening mammograms in the UK.
Evid Based Med,
18(2), 54-61.
Abstract:
Psychological consequences of false-positive screening mammograms in the UK.
OBJECTIVES: to identify the psychological effects of false-positive screening mammograms in the UK. METHODS: Systematic review of all controlled studies and qualitative studies of women with a false-positive screening mammogram. The control group participants had normal mammograms. All psychological outcomes including returning for routine screening were permitted. All studies had a narrative synthesis. RESULTS: the searches returned seven includable studies (7/4423). Heterogeneity was such that meta-analysis was not possible. Studies using disease-specific measures found that, compared to normal results, there could be enduring psychological distress that lasted up to 3 years; the level of distress was related to the degree of invasiveness of the assessment. At 3 years the relative risks were, further mammography, 1.28 (95% CI 0.82 to 2.00), fine needle aspiration 1.80 (95% CI 1.17 to 2.77), biopsy 2.07 (95% CI 1.22 to 3.52) and early recall 1.82 (95% CI 1.22 to 2.72). Studies that used generic measures of anxiety and depression found no such impact up to 3 months after screening. Evidence suggests that women with false-positive mammograms have an increased likelihood of failing to reattend for routine screening, relative risk 0.97 (95% CI 0.96 to 0.98) compared with women with normal mammograms. CONCLUSIONS: Having a false-positive screening mammogram can cause breast cancer-specific distress for up to 3 years. The degree of distress is related to the invasiveness of the assessment. Women with false-positive mammograms are less likely to return for routine assessment than those with normal ones.
Abstract.
Author URL.
Garside R (2013). Should we appraise the quality of qualitative research reports for systematic reviews and if so, how?. Innovation: the European Journal of Social Science Research
Garside R, Bond M, Pavey T, Welch K, Cooper C, Dean S, Hyde C (2013). Systematic Review of the psychological consequences of false-positive screening mammograms. Health Technology Assessment
Bond M, Pavey T, Welch K, Cooper C, Garside R, Dean S, Hyde C (2013). Systematic review of the psychological consequences of false-positive screening mammograms.
Health Technology Assessment,
17, 1-86.
Abstract:
Systematic review of the psychological consequences of false-positive screening mammograms
Background: in the UK, women aged 50-73 years are invited for screening by mammography every 3 years. In 2009-10, more than 2.24 million women in this age group in England were invited to take part in the programme, of whom 73% attended a screening clinic. of these, 64,104 women were recalled for assessment. of those recalled, 81% did not have breast cancer; these women are described as having a false-positive mammogram. Objective: the aim of this systematic review was to identify the psychological impact on women of false positive screening mammograms and any evidence for the effectiveness of interventions designed to reduce this impact. We were also looking for evidence of effects in subgroups of women. Data sources: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Health Management Information Consortium, Cochrane Central Register for Controlled Trials, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination (CRD) Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment (HTA), Cochrane Methodology, Web of Science, Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index-Science, Conference Proceeding Citation Index-Social Science and Humanities, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Sociological Abstracts, the International Bibliography of the Social Sciences, the British Library's Electronic Table of Contents and others. Initial searches were carried out between 8 October 2010 and 25 January 2011. Update searches were carried out on 26 October 2011 and 23 March 2012. Review methods: Based on the inclusion criteria, titles and abstracts were screened independently by two reviewers. Retrieved papers were reviewed and selected using the same independent process. Data were extracted by one reviewer and checked by another. Each included study was assessed for risk of bias. Results: Eleven studies were found from 4423 titles and abstracts. Studies that used disease-specific measures found a negative psychological impact lasting up to 3 years. Distress increased with the level of invasiveness of the assessment procedure. Studies using instruments designed to detect clinical levels of morbidity did not find this effect. Women with false-positive mammograms were less likely to return for the next round of screening [relative risk (RR) 0.97; 95% confidence interval (CI) 0.96 to 0.98] than those with normal mammograms, were more likely to have interval cancer [odds ratio (OR) 3.19 (95% CI 2.34 to 4.35)] and were more likely to have cancer detected at the next screening round [OR 2.15 (95% CI 1.55 to 2.98)]. Limitations: This study was limited to UK research and by the robustness of the included studies, which frequently failed to report quality indicators, for example failure to consider the risk of bias or confounding, or failure to report participants' demographic characteristics. Conclusions: We conclude that the experience of having a false-positive screening mammogram can cause breast cancer-specific psychological distress that may endure for up to 3 years, and reduce the likelihood that women will return for their next round of mammography screening. These results should be treated cautiously owing to inherent weakness of observational designs and weaknesses in reporting. Future research should include a qualitative interview study and observational studies that compare generic and disease-specific measures, collect demographic data and include women from different social and ethnic groups. © Queen's Printer and Controller of HMSO 2013.
Abstract.
Author URL.
Hart MG, Garside R, Rogers G, Stein K, Grant R (2013). Temozolomide for high grade glioma.
COCHRANE DATABASE OF SYSTEMATIC REVIEWS(4).
Author URL.
Pavey T, Hoyle M, Ciani O, Crathorne L, Jones-Hughes T, Cooper C, Osipenko L, Venkatachalam M, Rudin C, Ukoumunne O, et al (2012). Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia: Systematic reviews and economic analyses.
Health Technology Assessment,
16, 1-278.
Abstract:
Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia: Systematic reviews and economic analyses
Background: Nilotinib and dasatinib are now being considered as alternative treatments to imatinib as a first-line treatment of chronic myeloid leukaemia (CML). Objective: This technology assessment reviews the available evidence for the clinical effectiveness and cost-effectiveness of dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of Philadelphia chromosome-positive CML. Data sources: Databases [including MEDLINE (Ovid), EMBASE, Current Controlled Trials, ClinicalTrials.gov, the US Food and Drug Administration website and the European Medicines Agency website] were searched from search end date of the last technology appraisal report on this topic in October 2002 to September 2011. Review methods: a systematic review of clinical effectiveness and cost-effectiveness studies; a review of surrogate relationships with survival; a review and critique of manufacturer submissions; and a model-based economic analysis. Results: Two clinical trials (dasatinib vs imatinib and nilotinib vs imatinib) were included in the effectiveness review. Survival was not significantly different for dasatinib or nilotinib compared with imatinib with the 24-month follow-up data available. The rates of complete cytogenetic response (CCyR) and major molecular response (MMR) were higher for patients receiving dasatinib than for those with imatinib for 12 months' follow-up (CCyR 83% vs 72%, p < 0.001; MMR 46% vs 28%, p < 0.0001). The rates of CCyR and MMR were higher for patients receiving nilotinib than for those receiving imatinib for 12 months' followup (CCyR 80% vs 65%, p < 0.001; MMR 44% vs 22%, p < 0.0001). An indirect comparison analysis showed no difference between dasatinib and nilotinib for CCyR or MMR rates for 12 months' follow-up (CCyR, odds ratio 1.09, 95% CI 0.61 to 1.92; MMR, odds ratio 1.28, 95% CI 0.77 to 2.16). There is observational association evidence from imatinib studies supporting the use of CCyR and MMR at 12 months as surrogates for overall all-cause survival and progression-free survival in patients with CML in chronic phase. In the costeffectiveness modelling scenario, analyses were provided to reflect the extensive structural uncertainty and different approaches to estimating OS. First-line dasatinib is predicted to provide very poor value for money compared with first-line imatinib, with deterministic incremental cost-effectiveness ratios (ICERs) of between £256,000 and £450,000 per quality-adjusted life-year (QALY). Conversely, first-line nilotinib provided favourable ICERs at the willingness-to-pay threshold of £20,000-30,000 per QALY. Limitations: Immaturity of empirical trial data relative to life expectancy, forcing either reliance on surrogate relationships or cumulative survival/treatment duration assumptions. Conclusions: from the two trials available, dasatinib and nilotinib have a statistically significant advantage compared with imatinib as measured by MMR or CCyR. Taking into account the treatment pathways for patients with CML, i.e. assuming the use of secondline nilotinib, first-line nilotinib appears to be more cost-effective than first-line imatinib. Dasatinib was not cost-effective if decision thresholds of £20,000 per QALY or £30,000 per QALY were used, compared with imatinib and nilotinib. Uncertainty in the costeffectiveness analysis would be substantially reduced with better and more UK-specific data on the incidence and cost of stem cell transplantation in patients with chronic CML. Funding: the Health Technology Assessment Programme of the National Institute for Health Research. © Queen's Printer and Controller of HMSO 2012.
Abstract.
Author URL.
Child S, Goodwin V, Garside R, Jones-Hughes T, Boddy K, Stein K (2012). Factors influencing the implementation of
fall-prevention programmes: a systematic review
and synthesis of qualitative studies. Implementation Science, 91(7).
Pearson M, Hunt H, Garside R, Moxham T, Peters J, Anderson R (2012). Preventing unintentional injuries to children under 15 years in the outdoors: a systematic review of the effectiveness of educational programs.
Inj Prev,
18(2), 113-123.
Abstract:
Preventing unintentional injuries to children under 15 years in the outdoors: a systematic review of the effectiveness of educational programs.
INTRODUCTION: Unintentional injuries to children in the outdoors have a significant impact on child mortality, development and healthcare costs. This paper presents the findings of a systematic review about the effectiveness of programs that provided information, advice or education about the prevention of unintentional injuries to children under 15 years during outdoor play and leisure. METHODS: a structured search strategy was conducted in a range of databases. All report titles and abstracts were screened using pre-defined criteria. Included reports were quality appraised using a modified Graphical Appraisal Tool for Epidemiological studies (GATE) tool. All quality appraisals and data extraction were checked by a second reviewer. If not provided in the original reports, ORs and mean differences were calculated, where sufficient data were available. RESULTS: Twenty-three studies met the inclusion criteria. There was a paucity of robust study designs. The majority of studies only reported a short-term follow-up of intermediate outcome measures. Only two studies measured injury rates; both reported a reduction, but both studies also had considerable methodological weaknesses. The five studies that measured the use of protective equipment reported mixed results, although there is some evidence that suggests that more extensive educational programs (such as health fairs and media campaigns) increase their use. The 20 studies that measured behaviour, attitude or knowledge outcomes reported highly mixed results. DISCUSSION: Methodological weaknesses of the included studies limit support for a particular course of action. To better inform policy and practice, future research should (1) use robust study designs and (2) not rely on short-term proxy outcome measures.
Abstract.
Author URL.
Lorenc T, Pearson M, Jamal F, Cooper C, Garside R (2012). The role of systematic reviews of qualitative evidence in evaluating interventions: a case study.
Research Synthesis Methods,
3, 1-10.
Abstract:
The role of systematic reviews of qualitative evidence in evaluating interventions: a case study
Systematic reviews of qualitative evidence have been widely used to provide information on the context and implementation of interventions, and their potential barriers and facilitators. However, such reviews face a number of methodological challenges, and there are ongoing debates as to how qualitative evidence can best be used to inform our understanding of interventions. In this paper, we use a case study of two systematic reviews of qualitative evidence on the prevention of skin cancer to explore these issues. We find that qualitative evidence not directly related to interventions is likely to be of value for such reviews, that it is often not possible to construct fully comprehensive search strategies, and that there are diminishing returns to the synthesis, in terms of added value or insight, from the inclusion of large numbers of primary studies. We conclude that there are a number of ways in which systematic reviews of qualitative evidence can be utilised in conjunction with evidence on intervention effectiveness, without compromising the rigour of the review process. In particular, the use of theory to inform frameworks for synthesis is a promising way to integrate a broader range of qualitative evidence. Copyright © 2012 John Wiley & Sons, Ltd.
Abstract.
Author URL.
Martin Hilber A, Kenter E, Redmond S, Merten S, Bagnol B, Low N, Garside R (2012). Vaginal practices as women's agency in Sub-Saharan Africa: a synthesis of meaning and motivation through meta-ethnography.
Social Science and Medicine,
74(9), 1311-1323.
Abstract:
Vaginal practices as women's agency in Sub-Saharan Africa: a synthesis of meaning and motivation through meta-ethnography
This paper reports on a systematic review of qualitative research about vaginal practices in Sub-Saharan Africa, which used meta-ethnographic methods to understand their origins, their meanings for the women who use them, and how they have evolved in time and place. We included published documents which were based on qualitative methods of data collection and analysis and contained information on vaginal practices. After screening, 16 texts were included which dated from 1951 to 2008. We found that practices evolve and adapt to present circumstances and that they remain an important source of power for women to negotiate challenges that they face. Recent evidence suggests that some practices may increase a woman's susceptibility to HIV and other sexually transmitted infections. The success of new female-controlled prevention technologies, such as microbicides, might be determined by whether they can and will be used by women in the course of their daily life. © 2012 Elsevier Ltd.
Abstract.
Martin Hilber A, Kenter E, Redmond S, Merten S, Bagnol B, Low N, Garside R (2012). Vaginal practices as women's agency in Sub-Saharan Africa: a synthesis of meaning and motivation through meta-ethnography. Social Science and Medicine
Smithson J, Garside R, Pearson M (2011). Barriers to, and facilitators of, the prevention of unintentional injury in children in the home: a systematic review and synthesis of qualitative research.
Inj Prev,
17(2), 119-126.
Abstract:
Barriers to, and facilitators of, the prevention of unintentional injury in children in the home: a systematic review and synthesis of qualitative research.
BACKGROUND: This review considers barriers to, and facilitators of, success for interventions to reduce unintentional injury to children in the home through supply and/or installation of home safety equipment, and looks at risk assessments. METHODS: a systematic review of qualitative research. Bibliographic databases were searched for studies on interventions to reduce unintentional child injury in the home, or on related attitudes and behaviours. Studies were quality appraised, findings extracted, and a conceptual framework was developed to assess factors affecting the success of interventions. RESULTS: Nine peer-reviewed journal articles were included. Barriers and facilitators were highlighted at organisational, environmental and personal levels. Effective provision of safety equipment involves ongoing support with installation and maintenance. Take up and success of interventions depends on adjusting interventions according to practical limitations and parents' cultural expectations. A particular barrier was parents' inability to modify rented or shared accommodation. CONCLUSIONS: the review highlights ways in which health inequalities affect the take up and success of home safety interventions, and how health workers can use this knowledge to facilitate future interventions.
Abstract.
Author URL.
Hart MG, Grant R, Garside R, Rogers G, Somerville M, Stein K (2011). Chemotherapy wafers for high grade glioma.
COCHRANE DATABASE OF SYSTEMATIC REVIEWS(3).
Author URL.
Hoyle M, Crathorne L, Garside R, Hyde C (2011). Ofatumumab for the treatment of chronic lymphocytic leukaemia in patients who are refractory to fludarabine and alemtuzumab: a critique of the submission from GSK.
Health Technol Assess,
15 Suppl 1, 61-67.
Abstract:
Ofatumumab for the treatment of chronic lymphocytic leukaemia in patients who are refractory to fludarabine and alemtuzumab: a critique of the submission from GSK.
This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of ofatumumab for the treatment of refractory chronic lymphocytic leukaemia (CLL), based upon the manufacturer's submission (MS) to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The submitted clinical evidence included one study: a non-randomised, single-arm study. Two other studies were identified but both were non-comparative and provided evidence for therapies other than ofatumumab. For this reason these studies were not discussed in full in the main body of the submission. In the Hx-CD20-406 study, the overall response rate was 58% (99% confidence interval 40% to 74%, p < 0.001). Complete resolution of constitutional symptoms and improved performance status occurred in 57% of patients. Median progression-free survival (PFS) and overall survival (OS) times were 5.7 and 13.7 months, respectively. The most common adverse events during treatment were infusion reactions and infections, which were primarily grade 1 or 2 events. The MS concluded that ofatumumab provides a new, effective and well-tolerated therapy for patients with CLL who are refractory to both fludarabine and alemtuzumab [double refractory (DR)]. The ERG undertook a critical appraisal of the submission. The ERG had a number of concerns regarding the manufacturer's estimates of effectiveness based on evidence from a single-arm, non-randomised study. An 'area-under-the-curve' or 'partitioned-survival' model was used to project expected clinical and economic outcomes for patients with DR CLL who were assumed to receive ofatumumab or best supportive care (BSC). The model had a three-state structure: 'alive pre-progression', 'alive post progression' and 'dead'. Overall, the modelling approach is reasonable given the limited evidence available for the drug in the patient population under review. However, a number of uncertainties were identified in the economic evaluation; for example, the BSC arm used data from patients in the Hx-CD20-406 study who did not respond to ofatumumab treatment - 'non-responders' - and the ofatumumab arm used data from all of those treated in the Hx-CD20-406 study. Further uncertainty arose regarding the choice of utilities, the omission of 17p and 11q chromosomal deletions as factors in the Cox proportional hazards models for PFS and OS, and the omission of the costs of drugs in progressive disease. It was felt that these factors biased cost-effectiveness in favour of ofatumumab. When revisions were made to the assumptions in the model based on the ERG's review of the published and submitted evidence, the revised base-case incremental cost-effectiveness ratio for ofatumumab increased to £ 81,500 per quality-adjusted life-year. The final appraisal determination was issued by NICE in September 2010 (www.nice.org.uk/nicemedia/live/12264/50758/50758.pdf).
Abstract.
Author URL.
Pearson M, Garside R, Moxham T, Anderson R (2011). Preventing unintentional injuries to children in the home: a systematic review of the effectiveness of programmes supplying and/or installing home safety equipment.
Health Promot Int,
26(3), 376-392.
Abstract:
Preventing unintentional injuries to children in the home: a systematic review of the effectiveness of programmes supplying and/or installing home safety equipment.
In children under the age of five, the majority of unintentional injuries occur in the home, with higher levels of injury morbidity and mortality being found among those from more deprived backgrounds. This paper presents the findings of a systematic review about the effectiveness of programmes in decreasing unintentional injury rates to children (aged up to 15 years) in the home. The effectiveness of the provision of home safety equipment with or without installation, safety education or a home risk assessment is presented by outcome: injury rates, installation of smoke alarms and installation of other home safety equipment. Analysis of the statistically significant evidence suggests that few programmes reduce injury rates in children except where home safety equipment is supplied in conjunction with a home risk assessment, although this effect was only evident in households where a child had previously suffered an unintentional injury. The distribution of smoke alarms alone is insufficient for improving installation rates; programmes containing an education component showed more success. Interventions integrated into wider health programmes, where trusting relationships with householders were cultivated and/or where specific safety issues identified by a community were responded to also showed greater success in increasing smoke alarm installation rates. The evidence of effectiveness on installation rates of other home safety equipment is highly mixed, although there is some evidence to suggest that installation rates always decrease after 6 months. Where stair gates are both supplied and installed, inequalities in rates of use may be reduced.
Abstract.
Author URL.
Pearson M, Hunt H, Garside R, Moxham T, Peters J, Anderson R (2011). Preventing unintentional injuries to children under 15 years in the outdoors: a systematic review of the effectiveness of educational programs. Injury Prevention
Garside R, Pearson M, Moxham T (2010). What influences the uptake of information to prevent skin cancer? a systematic review and synthesis of qualitative research.
Health Educ Res,
25(1), 162-182.
Abstract:
What influences the uptake of information to prevent skin cancer? a systematic review and synthesis of qualitative research.
Skin cancer is an increasing problem in Europe, America and Australasia, although largely preventable by avoiding excessive ultraviolet (UV) exposure. This paper presents the findings of a systematic review of qualitative research about the prevention of skin cancer attributable to UV exposure. The aim is to understand elements that may contribute to the successful or unsuccessful conveyance of skin cancer prevention messages and their uptake by the public. A systematic review was undertaken using evidence identified through searching electronic bibliographic databases and Web sites and reference list checks. Predefined inclusion and exclusion criteria were used. Sixteen study reports (relating to 15 separate studies) were included from the United Kingdom, United States, Australia, Canada and New Zealand. Each included study was quality appraised, and the findings were extracted into an evidence table. A coding scheme, framed by the Health Belief Model, was developed by the reviewers and informed analysis and synthesis. This showed that most people perceived their susceptibility to skin cancer, and its severity, as low. While benefits of adopting changed behaviour were acknowledged, there were substantial barriers to this, including positive perceptions of a tan as healthy and attractive and the hassle of covering up or using sunscreen. Peers, parents and media may offer 'cues to action' that encourage adoption of preventative behaviour and finally self-efficacy or the perceived ability to make such changes. Effective health education messages will need to address the barriers to adopting protective behaviours identified through this review.
Abstract.
Author URL.
Rogers G, Elston J, Garside R, Roome C, Taylor R, Younger P, Zawada A, Somerville M (2009). The harmful health effects of recreational ecstasy: a systematic review of observational evidence.
Health Technology Assessment,
13(6).
Abstract:
The harmful health effects of recreational ecstasy: a systematic review of observational evidence
Objectives: to investigate the harmful health effects of taking ecstasy (3,4-methylenedioxymethamphetamine, MDMA) for recreational purposes. Data sources: MEDLINE, EMBASE, PsycINFO and Web of Knowledge were searched. Additional information on deaths was collected from the General Mortality Register (GMR) and the Special Mortality Register collated by the National Programme on Substance Abuse Deaths (np-SAD). Review methods: Studies were categorised according to design, with systematic research syntheses (Level I evidence) the most valid and least open to bias. Where Level I evidence was not available, controlled observational studies (Level II evidence) were systematically reviewed. If neither Level I nor Level II evidence was available, uncontrolled case series and case reports (Level III evidence) were systematically surveyed. Data were extracted by one reviewer and a sample checked by a second. The heterogeneity of Level II evidence was addressed by undertaking stratified analyses for current and former ecstasy users and comparing them either with control groups using other illegal drugs but not ecstasy (polydrug controls) or with controls naïve to illegal drugs (drug-naïve controls). Statistical heterogeneity was minimised by using a random-effects model throughout and investigated using study-level regression analysis (metaregression). Results: Five Level I syntheses were identified; for each it was difficult to ascertain the exact methods adopted and evidence included. Small but significant deficits for ecstasy users compared to controls were reported in areas relating to attention, memory, psychomotor speed, executive systems functioning, and self-reported depressive symptoms. Data from Level II studies were directly pooled for seven individual outcomes, suggesting that ecstasy users performed worse than controls on common measures of immediate and delayed verbal recall (RAVLT, RBMT, digit span). No difference was seen in IQ (NART). The 915 outcome measures identified in Level II studies were analysed in broad domains: immediate and delayed verbal and visual memory, working memory, two measures of attention, three measures of executive function, perceptual organisation, self-rated depression, memory and anxiety, and impulsivity measured objectively and subjectively. Ecstasy users performed significantly worse than polydrug controls in 13/16 domains and significantly worse than drug-naïve controls in 7/12 domains for which sufficient data were available. The largest, most consistent exposure effects were seen in meta-analyses of memory (especially verbal and working memory, with less marked effects seen in visual memory). Former ecstasy users frequently showed deficits that matched or exceeded those seen amongst current users. At aggregate level, the effects do not appear to be dose-related, but are variably confounded by other drug use, particularly alcohol. of Level III evidence, in the 10 years to 2006, the np-SAD and the GMR recorded an average of around 50 drug-related deaths per year involving ecstasy; it was the sole drug implicated in around 10 cases per year. Retrospective case series, based on hospital emergency department records, reported a death rate of 0-2% from emergency admissions related to ecstasy. Two major syndromes are most commonly reported as the immediate cause of death in fatal cases: hyperthermia and hyponatraemia. Conclusions: a broad range of relatively low-quality literature suggests that recreational use of ecstasy is associated with significant deficits in neurocognitive function (particularly immediate and delayed verbal memory) and increased psychopathological symptoms. The clinical significance of the exposure effect in individual cases will be variable but, on average, deficits are likely to be relatively small. Ecstasy is associated with a range of acute harms but appears to be a rare cause of death in isolation. © 2009 Queen's Printer and Controller of HMSO. All rights reserved.
Abstract.
Rogers G, Elston J, Garside R, Roome C, Taylor R, Younger P, Zawada A, Somerville M (2009). The harmful health effects of recreational ecstasy: a systematic review of observational evidence.
Health technology assessment (Winchester, England),
13(6).
Abstract:
The harmful health effects of recreational ecstasy: a systematic review of observational evidence.
To investigate the harmful health effects of taking ecstasy (3,4-methylenedioxymethamphetamine, MDMA) for recreational purposes. MEDLINE, EMBASE, PsycINFO and Web of Knowledge were searched. Additional information on deaths was collected from the General Mortality Register (GMR) and the Special Mortality Register collated by the National Programme on Substance Abuse Deaths (np-SAD). Studies were categorised according to design, with systematic research syntheses (Level I evidence) the most valid and least open to bias. Where Level I evidence was not available, controlled observational studies (Level II evidence) were systematically reviewed. If neither Level I nor Level II evidence was available, uncontrolled case series and case reports (Level III evidence) were systematically surveyed. Data were extracted by one reviewer and a sample checked by a second. The heterogeneity of Level II evidence was addressed by undertaking stratified analyses for current and former ecstasy users and comparing them either with control groups using other illegal drugs but not ecstasy (polydrug controls) or with controls naïve to illegal drugs (drug-naïve controls). Statistical heterogeneity was minimised by using a random-effects model throughout and investigated using study-level regression analysis (metaregression). Five Level I syntheses were identified; for each it was difficult to ascertain the exact methods adopted and evidence included. Small but significant deficits for ecstasy users compared to controls were reported in areas relating to attention, memory, psychomotor speed, executive systems functioning, and self-reported depressive symptoms. Data from Level II studies were directly pooled for seven individual outcomes, suggesting that ecstasy users performed worse than controls on common measures of immediate and delayed verbal recall (RAVLT, RBMT, digit span). No difference was seen in IQ (NART). The 915 outcome measures identified in Level II studies were analysed in broad domains: immediate and delayed verbal and visual memory, working memory, two measures of attention, three measures of executive function, perceptual organisation, self-rated depression, memory and anxiety, and impulsivity measured objectively and subjectively. Ecstasy users performed significantly worse than polydrug controls in 13/16 domains and significantly worse than drug-naïve controls in 7/12 domains for which sufficient data were available. The largest, most consistent exposure effects were seen in meta-analyses of memory (especially verbal and working memory, with less marked effects seen in visual memory). Former ecstasy users frequently showed deficits that matched or exceeded those seen amongst current users. At aggregate level, the effects do not appear to be dose-related, but are variably confounded by other drug use, particularly alcohol. of Level III evidence, in the 10 years to 2006, the np-SAD and the GMR recorded an average of around 50 drug-related deaths per year involving ecstasy; it was the sole drug implicated in around 10 cases per year. Retrospective case series, based on hospital emergency department records, reported a death rate of 0-2% from emergency admissions related to ecstasy. Two major syndromes are most commonly reported as the immediate cause of death in fatal cases: hyperthermia and hyponatraemia. A broad range of relatively low-quality literature suggests that recreational use of ecstasy is associated with significant deficits in neurocognitive function (particularly immediate and delayed verbal memory) and increased psychopathological symptoms. The clinical significance of the exposure effect in individual cases will be variable but, on average, deficits are likely to be relatively small. Ecstasy is associated with a range of acute harms but appears to be a rare cause of death in isolation.
Abstract.
Rogers G, Garside R, Mealing S, Pitt M, Anderson R, Dyer M, Stein K, Somerville M (2008). Carmustine implants for the treatment of newly diagnosed high-grade gliomas: a cost-utility analysis.
Pharmacoeconomics,
26(1), 33-44.
Abstract:
Carmustine implants for the treatment of newly diagnosed high-grade gliomas: a cost-utility analysis.
BACKGROUND: High-grade gliomas are aggressive brain tumours that are extremely challenging to treat effectively. The intracranial implantation of carmustine wafers (BCNU-W), which delivers chemotherapy directly to the affected area, may prolong survival in this population. However, no attention has yet been paid to the economic implications of BCNU-W in this setting. OBJECTIVE: to investigate the cost effectiveness of BCNU-W as an adjunct to surgery followed by radiotherapy, compared with surgery plus radiotherapy alone. Newly diagnosed, operable grade III and IV gliomas in a population with a mean age of 55 years were considered. METHODS: a Markov cost-utility model was developed in Microsoft Excel, adopting a UK NHS perspective. Transition probabilities and cost data (year 2004 values) were obtained from published literature or expert opinion. The model incorporated utility values, obtained from members of the public, reflecting the quality of life associated with high-grade glioma. The effects of uncertainty were explored through extensive one-way and probabilistic sensitivity analysis. RESULTS: Surgery with the implantation of BCNU-W followed by radiotherapy costs pound sterling 54 500 per additional QALY gained when compared with surgery plus radiotherapy alone. Probabilistic sensitivity analysis shows a
Abstract.
Author URL.
Hart MG, Grant R, Garside R, Rogers G, Somerville M, Stein K (2008). Chemotherapeutic wafers for High Grade Glioma.
Cochrane Database Syst Rev(3).
Abstract:
Chemotherapeutic wafers for High Grade Glioma.
BACKGROUND: Standard treatment for high grade glioma (HGG) usually entails biopsy or surgical resection where possible followed by radiotherapy. Systemic chemotherapy is usually only given in selected cases and its use is often limited by side effects. Implanting wafers impregnated with chemotherapy agents into the resection cavity represents a novel means of delivering drugs to the central nervous system (CNS) with fewer side effects. It is not clear how effective this modality is or whether it should be recommended as part of standard care for HGG. OBJECTIVES: to assess whether chemotherapeutic wafers have any advantage over conventional therapy for HGG. SEARCH STRATEGY: the following databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 2, 2007, MEDLINE, EMBASE, SCIENCE CITATION INDEX, Physician Data Query and the meta-Register of Controlled Trials. Reference lists of all identified studies were searched. The Journal of Neuro-Oncology was hand searched from 1999 to 2007, including all conference abstracts. Neuro-oncologists were contacted regarding ongoing and unpublished trials. SELECTION CRITERIA: Patients included those of all ages with a presumed diagnosis of malignant glioma from clinical examination and radiology. Interventions included insertion of chemotherapeutic wafers to the resection cavity at either primary surgery or for recurrent disease. Included studies had to be randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: Quality assessment and data extraction were undertaken by two review authors. Outcome measures included survival, time to progression, quality of life (QOL) and adverse events. MAIN RESULTS: in primary disease two RCTs assessing the effect of carmustine impregnated wafers (Gliadel(R)) and enrolling a total of 272 participants were identified. Survival was increased (hazard ratio (HR) 0.65 confidence interval (CI) 0.48 to 0.86 p = 0.003). In recurrent disease a single RCT was included assessing the effect of Gliadel(R) and enrolling 222 participants. It did not demonstrate a significant survival increase (HR 0.83 CI 0.62 to 1.10 p = 0.2). There was no suitable data for time to progression or QOL. Adverse events were not more common in either arm, and were presented in a descriptive fashion. AUTHORS' CONCLUSIONS: Gliadel(R) results in a prolongation of survival without an increased incidence of adverse events when used as primary therapy. There is no evidence of enhanced progression free survival (PFS) or QOL. In recurrent disease, Gliadel(R) does not appear to confer any added benefit. These findings are based on the results of three RCTs with approximately 500 patients in total.
Abstract.
Author URL.
Somerville M, Garside R, Pitt M, Stein K (2008). Surveillance of Barrett's oesophagus: is it worthwhile?.
Eur J Cancer,
44(4), 588-599.
Abstract:
Surveillance of Barrett's oesophagus: is it worthwhile?
OBJECTIVE: to assess the cost-effectiveness of surveillance of Barrett's oesophagus. DESIGN: Cost-utility model. SETTING: UK NHS. PATIENTS: One thousand 55-year-old men with Barrett's oesophagus. INTERVENTION: Surveillance programme: endoscopy and biopsy at 3 yearly intervals for non-dysplastic Barrett's oesophagus; low-grade dysplasia yearly; high grade-dysplasia 3 monthly. OUTCOME MEASURES: Incremental cost-effectiveness ratio, expected value of perfect information. RESULTS: Non-surveillance dominated surveillance (i.e. cost less and conferred more benefit), but there was substantial uncertainty around many of the model inputs. Probabilistic analyses showed that non-surveillance cost less and conferred more benefit in 75% of model runs. Surveillance was cost-effective at usual levels of willingness to pay in 11% of runs. For people with Barrett's oesophagus in England and Wales, a value of pound6.5 million is placed on acquiring perfect information about surveillance of Barrett's oesophagus. CONCLUSIONS: the PenTAG cost-utility model suggests that surveillance programmes do more harm than good.
Abstract.
Author URL.
Hart MG, Grant R, Garside R, Rogers G, Somerville M, Stein K (2008). Temozolomide for high grade glioma.
Cochrane Database Syst Rev(4).
Abstract:
Temozolomide for high grade glioma.
BACKGROUND: High grade glioma (HGG) is an aggressive form of brain tumour the treatment of which usually entails biopsy or resection where possible followed by radiotherapy. Temozolomide is a novel oral chemotherapeutic drug that penetrates into the brain and has a low incidence of adverse effects. OBJECTIVES: to assess whether temozolomide holds any advantage over conventional therapy for HGG in either primary or recurrent disease settings. SEARCH STRATEGY: the following databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2007. Medline, EMBASE, Science Citation Index, Physician Data Query and the Meta-Register of Controlled Trials. Reference lists of identified studies were searched. The Journal of Neuro-Oncology was hand searched from 1999 to 2007 including conference abstracts. Neuro-oncologists were contacted regarding ongoing and unpublished trials. SELECTION CRITERIA: Randomised controlled trials (RCTs). Interventions included the use of temozolomide during primary therapy or for recurrent disease. Patients included those of all ages with a proven pathological diagnosis of HGG. DATA COLLECTION AND ANALYSIS: Quality assessment and data extraction were undertaken by two review authors. Outcome measures included survival, time to progression, quality of life (QOL) and adverse events. MAIN RESULTS: in primary disease two RCTs were identified, enrolling a total of 703 patients, that investigated concomitant and adjuvant temozolomide in Glioblastoma Multiforme (GBM). Temozolomide increased survival (hazard ratio (HR) 0.84, confidence interval (CI) 0.50 to 0.68, p < 0.001) and an increase in time to progression (HR 0.52 CI 0.42 to 0.64 p < 0.0001). This was without having a statistically significant negative effect on QOL and with a low incidence of early adverse events. Grade 3/4 haematological toxicity was found in 5 to14%. The long term effects of temozolomide are still to be assessed. In recurrent GBM a single trial enrolling 225 patients in total found that temozolomide did not increase overall survival but it did increase time to progression (HR 0.68 CI 0.51 to 0.90 p0.008). Severe adverse events were low in this setting. AUTHORS' CONCLUSIONS: Temozolomide is an effective therapy in GBM for prolonging survival and delaying progression as part of primary therapy without impacting on QoL and with a low incidence of early adverse events. The frequency and severity of late adverse events is unknown. In recurrent GBM it improves time to progression but not overall survival. These findings are from three good quality but non-blinded RCTs of over 900 patients in total.
Abstract.
Author URL.
Garside R, Britten N, Stein K (2008). The experience of heavy menstrual bleeding: a systematic review and meta-ethnography of qualitative studies.
J Adv Nurs,
63(6), 550-562.
Abstract:
The experience of heavy menstrual bleeding: a systematic review and meta-ethnography of qualitative studies.
AIM: This paper is a report of a systematic review and meta-ethnography of the experience of heavy menstrual bleeding. BACKGROUND: Heavy menstrual bleeding is common. Not all women seeking help have heavy menstrual bleeding as measured objectively and, conversely, some who do have this problem do not seek help. DATA SOURCES: Seven electronic databases were searched in 2004 and updated in 2008, and supplemented with hand-searching. METHOD: We identified four papers describing qualitative research among women with heavy menstrual bleeding. Key themes and concepts were extracted and synthesised using meta-ethnography, the key process of which is translation, identifying similar or contradictory findings in primary research. In the updated search three papers were identified. FINDINGS: Three papers were largely descriptive. These provided support for the fourth paper's conceptual framework of a lay model of heavy menstrual bleeding which shows little overlap with the traditional clinical definition. Details of physical, practical and emotional elements of this model were identified. A matrix of uncertainties were identified suggesting reasons why women may or may not seek medical help for heavy menstrual bleeding. Women and healthcare professionals may conspire to privilege blood loss over other symptoms and the disease model of heavy menstrual bleeding is little help to either. Two papers from the updated search were also largely descriptive. The third interpreted key elements of the lay model as relating to the need for concealment demanded by 'menstrual etiquette'. CONCLUSION: a lay model of heavy menstrual bleeding is proposed, detailing key physical, social and emotional impacts that women find problematic.
Abstract.
Author URL.
Garside R, Anderson R, Pitt M, Mealing S, D'Souza R, Stein K (2007). Costutility analysis of cinacalcet in addition to standard of care in the UK - Reply.
NEPHROLOGY DIALYSIS TRANSPLANTATION,
22(11), 3357-3358.
Author URL.
Garside R, Anderson R, Pitt M, Mealing S, D'Souza R, Stein K (2007). Reply [4]. Nephrology Dialysis Transplantation, 22(11), 3357-3358.
Garside R, Anderson R, Mealing S, Pitt M (2007). The cost-utility of cinacaclet in addition to standard care compared to standard care alone for secondary hyperparathyroidism in end-stage renal disease: a UK perspective. Nephrology Dialysis Transplantation, 00, 1428-1436.
Garside R, Pitt M, Anderson R, Mealing S, D'Souza R, Stein K (2007). The cost-utility of cinacalcet in addition to standard care compared to standard care alone for secondary hyperparathyroidism in end-stage renal disease: a UK perspective.
Nephrol Dial Transplant,
22(5), 1428-1436.
Abstract:
The cost-utility of cinacalcet in addition to standard care compared to standard care alone for secondary hyperparathyroidism in end-stage renal disease: a UK perspective.
BACKGROUND: Secondary hyperparathyroidism (SHPT) is a common side effect of end-stage renal disease (ESRD) and is associated with increased risk of fracture and cardiovascular events (CV). Current standard treatment includes dietary control, phosphate binders and vitamin D. However, many patients do not have their parathyroid hormone (PTH), calcium and phosphate levels controlled by this regimen. Cinacalcet is the first of a new class of calcimimetic drugs which suppress PTH production. Although there is convincing evidence of the impact of cinacalcet on serum biomarkers, the long-term clinical implications of treatment are less clear. The aim of this study is to estimate the cost-utility of cinacalcet as an addition to standard treatment of SHPT compared with standard treatment alone. METHODS: a Markov model was developed to estimate the incremental cost-utility of cinacalcet. Uncertainty was explored through extensive sensitivity analysis. RESULTS: Compared with standard treatment, cinacalcet incurs average additional lifetime costs of pound21,167 per person and confers an additional 0.34 quality adjusted life years, resulting in an incremental cost-effectiveness ratio of pound61,890 (approximately euro89,000) per quality-adjusted life-year (QALY). Extensive one-way sensitivity analysis showed that cinacalcet was only likely to be considered cost-effective if the relative risk of mortality for people with very high levels of PTH was 2.2 compared with people whose PTH reached target levels, or if drug costs were considerably reduced. Probabilistic sensitivity analysis showed cinacalcet was very unlikely to be cost-effective at usual levels of willingness to pay in the National Health Service (NHS). CONCLUSION: Unless the cost of cinacalcet is considerably reduced, it is unlikely to be considered a cost-effective treatment for people with SHPT.
Abstract.
Author URL.
Pitt MA, Anderson R, Garside R, Stein K (2007). The effectiveness and cost-effectiveness of carmustine implants and temozolamide for the treatment of newly diagnosed high grade gliomas: a systematic review and economic model.
Garside R, Pitt M, Anderson R, Rogers G, Dyer M, Mealing S, Somerville M, Price A, Stein K (2007). The effectiveness and cost-effectiveness of carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: a systematic review and economic evaluation.
Health Technol Assess,
11(45), iii-221.
Abstract:
The effectiveness and cost-effectiveness of carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: a systematic review and economic evaluation.
OBJECTIVES: to assess the clinical and cost-effectiveness of adjuvant carmustine wafers (BCNU-W) and also of adjuvant and concomitant temozolomide (TMZ), compared with surgery with radiotherapy. DATA SOURCES: Electronic databases were searched up to August 2005. REVIEW METHODS: Included trials were critically appraised for key elements of internal and external validity. Relevant data were extracted and a narrative synthesis of the evidence produced. Where possible, data on absolute survival at a fixed time point were meta-analysed using a random effects model. A Markov (state transition) model was developed to assess the cost-utility of the two interventions. The model compared BCNU-W or TMZ separately with current standard treatment with surgery and radiotherapy. The simulated cohort had a mean age of 55 years and was modelled over 5 years. RESULTS: Two randomised controlled trials (RCTs) (n = 32, n = 240) and two observational studies of BCNU-W compared with placebo wafers as adjuvant therapy to surgery and radiotherapy for newly diagnosed high-grade glioma were identified. All the studies were in adults and provided data on 193 patients who had received BCNU-W. The RCT findings excluded under 65-year-olds and those with a Karnofsky Performance Status of less than 60. The largest multi-centre RCT suggested a possible survival advantage with BCNU-W among a cohort of patients with grade III and IV tumours, adding a median of 2.3 months [95% confidence interval (CI) -0.5 to 5.1]. However, analysis using per-protocol, unstratified methods shows this difference to be not statistically significant (HR 0.77, 95% CI 0.57 to 1.03, p = 0.08). Long-term follow-up suggests a significant survival advantage using unstratified analysis. No difference in progression-free survival (PFS) was demonstrated. Subgroup analysis of those with grade IV tumours also showed no significant survival advantage with BCNU-W [hazard ratio (HR) 0.82, 95% CI 0.55 to 1.11, p = 0.20, unstratified analysis]. It is estimated that the cost of surgery and radiotherapy, with follow-up, treatment of adverse effects and end of life care is around 17,000 pounds per patient. Treatment with BCNU-W adds an additional 6600 pounds. Across the modelled cohort of 1000 patients, use of BCNU-W costs an additional 6.6 million pounds and confers an additional 122 quality-adjusted life-years (QALYs). On average, that is 6600 pounds per patient for 0.122 QALYs (6.3 quality-adjusted life-weeks). The base-case incremental cost-effectiveness ratio (ICER) is 54,500 pounds/QALY. In probabilistic sensitivity analyses, BCNU-W was not cost-effective in 89% of the simulations assuming a willingness to pay threshold of 30,000 pounds/QALY. In 15% of simulations, BCNU-W was dominated (i.e. did more harm than good, conferring fewer QALYs at greater cost). The cost-effectiveness acceptability curve (CEAC) suggests that it is very unlikely to be the most cost-effective option at normal levels of willingness to pay (11% probability at 30,000 pounds/QALY), only becoming likely to be the most cost-effective option at much higher levels of willingness to pay (50% probability at 55,000 pounds/QALY). Two RCTs (n = 130, n = 573) and two observational studies were included, giving evidence for 429 adult patients receiving TMZ. Currently, TMZ is licensed for use in those with newly diagnosed grade IV gliomas only. The RCTs excluded those with lower performance status and, in the larger RCT, those older than 70 years. TMZ provides a small but statistically significant median survival benefit of 2.5 months (95% CI 2.0 to 3.8), giving an HR of 0.63 (95% CI 0.52 to 0.75, p < 0.001). At 2 years, 26.5% of patients treated with TMZ were alive compared with 10.4% of those in the control arm. Median PFS is also enhanced with TMZ, giving a median 1.9 months' advantage (95% CI 1.4 to 2.7, p < 0.001). No analysis of the subgroup of patients with confirmed grade IV tumours was undertaken. Subgroup analysis of patients by O6-methylguanine-DNA methyltransferase (MGMT) activity showed a significant treatment advantage for those with reduced MGMT activity but not for those with normal activity, although this analysis was based on a selected sample of patients and the test used has proved difficult to replicate. A median gain of 6.4 (95% CI 4.4 to 9.5) more life-months is seen with TMZ among those with reduced MGMT, giving an HR of 0.51 (p < 0.007). PFS is increased by a median of 4.4 months (95% CI 1.2 to 6.3), giving an HR of 0.48 (p = 0.001). The model shows a cost per patient for being treated with surgery, radiotherapy and including adverse effects of treatment and end of life care of around 17,000 pounds per patient. TMZ in the adjuvant and concomitant phase adds an additional cost of around 7800 pounds. Across the modelled cohort of 1000 patients, use of TMZ costs an additional 7.8 million pounds and confers an additional 217 QALYs. For the average patient this is 7800 pounds for an additional 0.217 QALYs (11 quality-adjusted life-weeks). The base-case ICER is 36,000 pounds/QALY. Probabilistic sensitivity analyses shows that TMZ was not cost-effective in 77% of the simulations. The CEAC suggests that there is a 23% chance that TMZ is the most cost-effective option at a willingness to pay level of 30,000 pounds/QALY, rising to be more cost-effective than no TMZ at slightly higher levels (50% probability at 35,000 pounds/QALY). CONCLUSIONS: BCNU-W has not been proven to confer a significant advantage in survival for patients with grade III tumours when treated with the drug, compared with placebo. There does not appear to be a survival advantage for patients with grade IV tumours. No increase in PFS has been shown. Limited evidence suggests a small but significant advantage in both overall survival and PFS with TMZ among a mixed population with grade IV and grade III (7-8%) tumours. However, it remains unclear whether this is true in grade IV tumours alone. On the basis of best available evidence, the authors consider that neither BCNU-W nor TMZ is likely to be considered cost-effective by NHS decision-makers. However, data for the model were drawn from limited evidence of variable quality. Tumour type is clearly important in assessing patient prognosis with different treatments. Grade IV tumours are commonest and appear to have least chance of response. There were too few grade III tumours included to carry out a formal assessment, but they appear to respond better and drive results for both drugs. Future use of genetic and biomarkers may help identify subtypes which will respond, but current licensing indications do not specify these. Further research is suggested into the effectiveness of these drugs, and also into areas such as genetic markers, chemotherapy regimens, patient and carer quality of life, and patient views on survival advantages vs treatment disadvantages.
Abstract.
Author URL.
Garside R, Pitt M, Anderson R, Rogers G, Dyer M, Mealing S, Somerville M, Price A, Stein K (2007). The effectiveness and cost-effectiveness of carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: a systematic review and economic evaluation.
Health technology assessment (Winchester, England),
11(45).
Abstract:
The effectiveness and cost-effectiveness of carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: a systematic review and economic evaluation.
To assess the clinical and cost-effectiveness of adjuvant carmustine wafers (BCNU-W) and also of adjuvant and concomitant temozolomide (TMZ), compared with surgery with radiotherapy. Electronic databases were searched up to August 2005. Included trials were critically appraised for key elements of internal and external validity. Relevant data were extracted and a narrative synthesis of the evidence produced. Where possible, data on absolute survival at a fixed time point were meta-analysed using a random effects model. A Markov (state transition) model was developed to assess the cost-utility of the two interventions. The model compared BCNU-W or TMZ separately with current standard treatment with surgery and radiotherapy. The simulated cohort had a mean age of 55 years and was modelled over 5 years. Two randomised controlled trials (RCTs) (n = 32, n = 240) and two observational studies of BCNU-W compared with placebo wafers as adjuvant therapy to surgery and radiotherapy for newly diagnosed high-grade glioma were identified. All the studies were in adults and provided data on 193 patients who had received BCNU-W. The RCT findings excluded under 65-year-olds and those with a Karnofsky Performance Status of less than 60. The largest multi-centre RCT suggested a possible survival advantage with BCNU-W among a cohort of patients with grade III and IV tumours, adding a median of 2.3 months [95% confidence interval (CI) -0.5 to 5.1]. However, analysis using per-protocol, unstratified methods shows this difference to be not statistically significant (HR 0.77, 95% CI 0.57 to 1.03, p = 0.08). Long-term follow-up suggests a significant survival advantage using unstratified analysis. No difference in progression-free survival (PFS) was demonstrated. Subgroup analysis of those with grade IV tumours also showed no significant survival advantage with BCNU-W [hazard ratio (HR) 0.82, 95% CI 0.55 to 1.11, p = 0.20, unstratified analysis]. It is estimated that the cost of surgery and radiotherapy, with follow-up, treatment of adverse effects and end of life care is around 17,000 pounds per patient. Treatment with BCNU-W adds an additional 6600 pounds. Across the modelled cohort of 1000 patients, use of BCNU-W costs an additional 6.6 million pounds and confers an additional 122 quality-adjusted life-years (QALYs). On average, that is 6600 pounds per patient for 0.122 QALYs (6.3 quality-adjusted life-weeks). The base-case incremental cost-effectiveness ratio (ICER) is 54,500 pounds/QALY. In probabilistic sensitivity analyses, BCNU-W was not cost-effective in 89% of the simulations assuming a willingness to pay threshold of 30,000 pounds/QALY. In 15% of simulations, BCNU-W was dominated (i.e. did more harm than good, conferring fewer QALYs at greater cost). The cost-effectiveness acceptability curve (CEAC) suggests that it is very unlikely to be the most cost-effective option at normal levels of willingness to pay (11% probability at 30,000 pounds/QALY), only becoming likely to be the most cost-effective option at much higher levels of willingness to pay (50% probability at 55,000 pounds/QALY). Two RCTs (n = 130, n = 573) and two observational studies were included, giving evidence for 429 adult patients receiving TMZ. Currently, TMZ is licensed for use in those with newly diagnosed grade IV gliomas only. The RCTs excluded those with lower performance status and, in the larger RCT, those older than 70 years. TMZ provides a small but statistically significant median survival benefit of 2.5 months (95% CI 2.0 to 3.8), giving an HR of 0.63 (95% CI 0.52 to 0.75, p. <. 0.001). At 2 years, 26.5% of patients treated with TMZ were alive compared with 10.4% of those in the control arm. Median PFS is also enhanced with TMZ, giving a median 1.9 months' advantage (95% CI 1.4 to 2.7, p. <. 0.001). No analysis of the subgroup of patients with confirmed grade IV tumours was undertaken. Subgroup analysis of patients by O6-methylguanine-DNA methyltransferase (MGMT) activity showed a significant treatment advantage for those with reduced MGMT activity but not for those with normal activity, although this analysis was based on a selected sample of patients and the test used has proved difficult to replicate. A median gain of 6.4 (95% CI 4.4 to 9.5) more life-months is seen with TMZ among those with reduced MGMT, giving an HR of 0.51 (p. <. 0.007). PFS is increased by a median of 4.4 months (95% CI 1.2 to 6.3), giving an HR of 0.48 (p = 0.001). The model shows a cost per patient for being treated with surgery, radiotherapy and including adverse effects of treatment and end of life care of around 17,000 pounds per patient. TMZ in the adjuvant and concomitant phase adds an additional cost of around 7800 pounds. Across the modelled cohort of 1000 patients, use of TMZ costs an additional 7.8 million pounds and confers an additional 217 QALYs. For the average patient this is 7800 pounds for an additional 0.217 QALYs (11 quality-adjusted life-weeks). The base-case ICER is 36,000 pounds/QALY. Probabilistic sensitivity analyses shows that TMZ was not cost-effective in 77% of the simulations. The CEAC suggests that there is a 23% chance that TMZ is the most cost-effective option at a willingness to pay level of 30,000 pounds/QALY, rising to be more cost-effective than no TMZ at slightly higher levels (50% probability at 35,000 pounds/QALY). BCNU-W has not been proven to confer a significant advantage in survival for patients with grade III tumours when treated with the drug, compared with placebo. There does not appear to be a survival advantage for patients with grade IV tumours. No increase in PFS has been shown. Limited evidence suggests a small but significant advantage in both overall survival and PFS with TMZ among a mixed population with grade IV and grade III (7-8%) tumours. However, it remains unclear whether this is true in grade IV tumours alone. On the basis of best available evidence, the authors consider that neither BCNU-W nor TMZ is likely to be considered cost-effective by NHS decision-makers. However, data for the model were drawn from limited evidence of variable quality. Tumour type is clearly important in assessing patient prognosis with different treatments. Grade IV tumours are commonest and appear to have least chance of response. There were too few grade III tumours included to carry out a formal assessment, but they appear to respond better and drive results for both drugs. Future use of genetic and biomarkers may help identify subtypes which will respond, but current licensing indications do not specify these. Further research is suggested into the effectiveness of these drugs, and also into areas such as genetic markers, chemotherapy regimens, patient and carer quality of life, and patient views on survival advantages vs treatment disadvantages.
Abstract.
Garside R, Pitt M, Anderson R, Mealing S, Roome C, Snaith A, D'Souza R, Welch K, Stein K (2007). The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation.
Health Technology Assessment,
11(18).
Abstract:
The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation
Objectives: to establish the effectiveness and cost-effectiveness of cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) for people on dialysis due to end-stage renal disease (ESRD). Data sources: Electronic databases were searched up to February 2006. Review methods: Included randomised controlled trials (RCTs) on the clinical effectiveness of cinacalcet for SHPT in ESRD were critically appraised, had relevant data extracted and were summarised narratively. A Markov (state transition) model was developed that compared cinacalcet in addition to current standard treatment with phosphate binders and vitamin D to standard treatment alone. A simulated cohort of 1000 people aged 55 with SHPT was modelled until the whole cohort was dead. Incremental costs and quality-adjusted life-years (QALYs) were calculated. Extensive one-way sensitivity analysis was undertaken as well as probabilistic sensitivity analysis. Results: Seven trials comparing cinacalcet plus standard treatment with placebo plus standard treatment were included in the systematic review. A total of 846 people were randomised to receive cinacalcet. Cinacalcet was more effective at meeting parathyroid hormone (PTH) target levels (40% vs 5% in placebo, p. <. 0.001). In those patients meeting PTH targets, 90% also experienced a reduction in calcium-phosphate product levels, compared with 1% in placebo. Significantly fewer people treated with cinacalcet were hospitalised for cardiovascular events, although no difference was seen in all-cause hospitalisation or mortality. Significantly fewer fractures and parathyroidectomies were also seen with cinacalcet. Findings on all patient-based clinical outcomes were based on small numbers. The authors' economic model estimated that, compared to standard treatment alone, cinacalcet in addition to standard care costs an additional £21, 167 and confers 0.34 QALYs (or 18 quality-adjusted weeks) per person. The incremental cost-effectiveness ratio (ICER) was £61,890/QALY. In most cases, even extreme adjustments to individual parameters did not result in ah ICER below a willingness-to-pay threshold of £30,000/QALY with probabilistic analysis showing only 0.5% of simulations to be cost-effective at this threshold. Altering the assumptions in the model through using different data sources for the inputs produced a range of ICERs from £39,000 to £92,000/QALY. Conclusions: Cinacalcet in addition to standard care is more effective than placebo plus standard care at reducing PTH levels without compromising calcium levels. However, there is limited information about the impact of this reduction on patient-relevant clinical outcomes. Given the short follow-up in the trials, it is unclear how data should be extrapolated to the long term. Together with the high drug cost, this leads to cinacalcet being unlikely to be considered cost-effective. Recommendations for future research include obtaining accurate estimates of the multivariate relationship between biochemical disruption in SHPT and long-term clinical outcomes. © Queen's Printer and Controller of HMSO 2007. All rights reserved.
Abstract.
Garside R, Pitt M, Anderson R, Mealing S, Roome C, Snaith A, D'Souza R, Welch K, Stein K (2007). The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation.
Health Technology Assessment,
11(18).
Abstract:
The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation
Objectives: to establish the effectiveness and cost-effectiveness of cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) for people on dialysis due to end-stage renal disease (ESRD). Data sources: Electronic databases were searched up to February 2006. Review methods: Included randomised controlled trials (RCTs) on the clinical effectiveness of cinacalcet for SHPT in ESRD were critically appraised, had relevant data extracted and were summarised narratively. A Markov (state transition) model was developed that compared cinacalcet in addition to current standard treatment with phosphate binders and vitamin D to standard treatment alone. A simulated cohort of 1000 people aged 55 with SHPT was modelled until the whole cohort was dead. Incremental costs and quality-adjusted life-years (QALYs) were calculated. Extensive one-way sensitivity analysis was undertaken as well as probabilistic sensitivity analysis. Results: Seven trials comparing cinacalcet plus standard treatment with placebo plus standard treatment were included in the systematic review. A total of 846 people were randomised to receive cinacalcet. Cinacalcet was more effective at meeting parathyroid hormone (PTH) target levels (40% vs 5% in placebo, p < 0.001). In those patients meeting PTH targets, 90% also experienced a reduction in calcium-phosphate product levels, compared with 1% in placebo. Significantly fewer people treated with cinacalcet were hospitalised for cardiovascular events, although no difference was seen in all-cause hospitalisation or mortality. Significantly fewer fractures and parathyroidectomies were also seen with cinacalcet. Findings on all patient-based clinical outcomes were based on small numbers. The authors' economic model estimated that, compared to standard treatment alone, cinacalcet in addition to standard care costs an additional £21, 167 and confers 0.34 QALYs (or 18 quality-adjusted weeks) per person. The incremental cost-effectiveness ratio (ICER) was £61,890/QALY. In most cases, even extreme adjustments to individual parameters did not result in ah ICER below a willingness-to-pay threshold of £30,000/QALY with probabilistic analysis showing only 0.5% of simulations to be cost-effective at this threshold. Altering the assumptions in the model through using different data sources for the inputs produced a range of ICERs from £39,000 to £92,000/QALY. Conclusions: Cinacalcet in addition to standard care is more effective than placebo plus standard care at reducing PTH levels without compromising calcium levels. However, there is limited information about the impact of this reduction on patient-relevant clinical outcomes. Given the short follow-up in the trials, it is unclear how data should be extrapolated to the long term. Together with the high drug cost, this leads to cinacalcet being unlikely to be considered cost-effective. Recommendations for future research include obtaining accurate estimates of the multivariate relationship between biochemical disruption in SHPT and long-term clinical outcomes. © Queen's Printer and Controller of HMSO 2007. All rights reserved.
Abstract.
Garside R, Pitt M, Anderson R, Mealing S, Roome C, Snaith A, D'Souza R, Welch K, Stein K (2007). The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation.
Health technology assessment (Winchester, England),
11(18).
Abstract:
The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation.
To establish the effectiveness and cost-effectiveness of cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) for people on dialysis due to end-stage renal disease (ESRD). Electronic databases were searched up to February 2006. Included randomised controlled trials (RCTs) on the clinical effectiveness of cinacalcet for SHPT in ESRD were critically appraised, had relevant data extracted and were summarised narratively. A Markov (state transition) model was developed that compared cinacalcet in addition to current standard treatment with phosphate binders and vitamin D to standard treatment alone. A simulated cohort of 1000 people aged 55 with SHPT was modelled until the whole cohort was dead. Incremental costs and quality-adjusted life-years (QALYs) were calculated. Extensive one-way sensitivity analysis was undertaken as well as probabilistic sensitivity analysis. Seven trials comparing cinacalcet plus standard treatment with placebo plus standard treatment were included in the systematic review. A total of 846 people were randomised to receive cinacalcet. Cinacalcet was more effective at meeting parathyroid hormone (PTH) target levels (40% vs 5% in placebo, p. <. 0.001). In those patients meeting PTH targets, 90% also experienced a reduction in calcium-phosphate product levels, compared with 1% in placebo. Significantly fewer people treated with cinacalcet were hospitalised for cardiovascular events, although no difference was seen in all-cause hospitalisation or mortality. Significantly fewer fractures and parathyroidectomies were also seen with cinacalcet. Findings on all patient-based clinical outcomes were based on small numbers. The authors' economic model estimated that, compared to standard treatment alone, cinacalcet in addition to standard care costs an additional 21,167 pounds and confers 0.34 QALYs (or 18 quality-adjusted weeks) per person. The incremental cost-effectiveness ratio (ICER) was 61,890 pounds/QALY. In most cases, even extreme adjustments to individual parameters did not result in an ICER below a willingness-to-pay threshold of 30,000 pounds/QALY with probabilistic analysis showing only 0.5% of simulations to be cost-effective at this threshold. Altering the assumptions in the model through using different data sources for the inputs produced a range of ICERs from 39,000 pounds to 92,000 pounds/QALY. Cinacalcet in addition to standard care is more effective than placebo plus standard care at reducing PTH levels without compromising calcium levels. However, there is limited information about the impact of this reduction on patient-relevant clinical outcomes. Given the short follow-up in the trials, it is unclear how data should be extrapolated to the long term. Together with the high drug cost, this leads to cinacalcet being unlikely to be considered cost-effective. Recommendations for future research include obtaining accurate estimates of the multivariate relationship between biochemical disruption in SHPT and long-term clinical outcomes.
Abstract.
Ashcroft DM, Chen LC, Garside R, Stein K, Williams HC (2007). Topical pimecrolimus for eczema.
Cochrane Database of Systematic Reviews(4).
Abstract:
Topical pimecrolimus for eczema
Background: Pimecrolimus was developed as an alternative to topical corticosteroids for treating eczema (atopic dermatitis) but its efficacy and safety compared with existing treatments remains unclear. Objectives: to assess the effects of topical pimecrolimus for treating eczema. Search strategy: We searched the Cochrane Skin Group Specialised Register (to October 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2006), MEDLINE (from 2003 to October 2006), and EMBASE (from 2005 to October 2006). We also contacted researchers and manufacturers in the field. Selection criteria: Randomised controlled trials of 1.0% topical pimecrolimus used twice daily compared against other topical comparators for treating eczema. Data collection and analysis: Two authors independently examined each retrieved study for eligibility and extracted data for efficacy, tolerability and safety. A random-effects model was used to estimate the pooled risk ratios (RRs) and 95% confidence intervals (95% CIs). Main results: We included 31 trials (8019 participants) in the analysis. In short-term (≤ 6 weeks) trials, pimecrolimus cream was significantly more effective and well-tolerated than vehicle (cream base, but not containing pimecrolimus). In long-term trials (≥6 months), pimecrolimus was significantly better than vehicle in preventing flares (9 trials, 3091 participants, RR 1.47, 95% CI 1.32 to 1.64 at six months) and in improving quality of life. Pimecrolimus was significantly less effective than two topical corticosteroids, i.e. 0.1% triamcinolone acetonide for investigators' global assessment (1 trial, 658 participants, RR 0.75, 95% CI 0.67 to 0.83) and 0.1% betamethasone valerate for participants' global assessment (1 trial, 87 participants, RR 0.61, 95% CI 0.45 to 0.81) at three weeks. Pimecrolimus was also associated with significantly more overall withdrawals and skin burning. None of the trials reported on key adverse effects such as thinning of skin. Pimecrolimus was significantly less effective than 0.1% tacrolimus for investigators' global assessment at six weeks (RR 0.58, 95% CI 0.46 to 0.74) and led to more withdrawals due to lack of efficacy (RR 2.37, 95% CI 1.10 to 5.08) based on two trials involving 639 participants, but there was no significant difference in proportions of participants experiencing any adverse events. Authors' conclusions: Topical pimecrolimus is less effective than moderate and potent corticosteroids and 0.1% tacrolimus. The therapeutic role of topical pimecrolimus is uncertain due to the absence of key comparisons with mild corticosteroids. Copyright © 2008 the Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Abstract.
Ashcroft DM, Chen L-C, Garside R, Stein K, Williams HC (2007). Topical pimecrolimus for eczema.
Cochrane Database Syst Rev,
2007(4).
Abstract:
Topical pimecrolimus for eczema.
BACKGROUND: Pimecrolimus was developed as an alternative to topical corticosteroids for treating eczema (atopic dermatitis) but its efficacy and safety compared with existing treatments remains unclear. OBJECTIVES: to assess the effects of topical pimecrolimus for treating eczema. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (to October 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2006), MEDLINE (from 2003 to October 2006), and EMBASE (from 2005 to October 2006). We also contacted researchers and manufacturers in the field. SELECTION CRITERIA: Randomised controlled trials of 1.0% topical pimecrolimus used twice daily compared against other topical comparators for treating eczema. DATA COLLECTION AND ANALYSIS: Two authors independently examined each retrieved study for eligibility and extracted data for efficacy, tolerability and safety. A random-effects model was used to estimate the pooled risk ratios (RRs) and 95% confidence intervals (95% CIs). MAIN RESULTS: We included 31 trials (8019 participants) in the analysis. In short-term (/=6 months), pimecrolimus was significantly better than vehicle in preventing flares (9 trials, 3091 participants, RR 1.47, 95% CI 1.32 to 1.64 at six months) and in improving quality of life. Pimecrolimus was significantly less effective than two topical corticosteroids, i.e. 0.1% triamcinolone acetonide for investigators' global assessment (1 trial, 658 participants, RR 0.75, 95% CI 0.67 to 0.83) and 0.1% betamethasone valerate for participants' global assessment (1 trial, 87 participants, RR 0.61, 95% CI 0.45 to 0.81) at three weeks. Pimecrolimus was also associated with significantly more overall withdrawals and skin burning. None of the trials reported on key adverse effects such as thinning of skin. Pimecrolimus was significantly less effective than 0.1% tacrolimus for investigators' global assessment at six weeks (RR 0.58, 95% CI 0.46 to 0.74) and led to more withdrawals due to lack of efficacy (RR 2.37, 95% CI 1.10 to 5.08) based on two trials involving 639 participants, but there was no significant difference in proportions of participants experiencing any adverse events. AUTHORS' CONCLUSIONS: Topical pimecrolimus is less effective than moderate and potent corticosteroids and 0.1% tacrolimus. The therapeutic role of topical pimecrolimus is uncertain due to the absence of key comparisons with mild corticosteroids.
Abstract.
Author URL.
Pitt M, Garside R, Stein K (2006). A cost-utility analysis of pimecrolimus vs. topical corticosteroids and emollients for the treatment of mild and moderate atopic eczema.
Br J Dermatol,
154(6), 1137-1146.
Abstract:
A cost-utility analysis of pimecrolimus vs. topical corticosteroids and emollients for the treatment of mild and moderate atopic eczema.
BACKGROUND: Conventional treatments for atopic eczema include topical corticosteroids (TCS) and emollients. Pimecrolimus, an immunosuppressant, was licensed in the U.K. in 2003 as an alternative treatment of mild to moderate atopic eczema. OBJECTIVES: to assess the cost-utility of pimecrolimus as a treatment for mild and moderate atopic eczema when compared with conventional treatments which use TCS and emollients. METHODS: a Markov state-transition model was developed to represent the cyclical nature of atopic eczema and provide an economic analysis of cost-utility for treatment alternatives from the perspective of a third party payer (U.K. National Health Service). A range of methods was used to obtain data for transition probabilities, costs and quality of life. These included a systematic review of published effectiveness data, expert opinion, and a utility study conducted by the authors. Separate cohort analyses were modelled to distinguish between children and adult populations and between differing treatment patterns for facial and body eczema. One-way sensitivity analyses and probabilistic sensitivity analysis (using Monte-Carlo simulation) were performed. RESULTS: Baseline cost-utility outputs from the model show that, in all tested scenarios, TCS dominate pimecrolimus (i.e. TCS are both cheaper and more effective). However, the differences in benefits between treatments output by the model are very small. Sensitivity analyses highlight the importance of cost variations in pimecrolimus. Where pimecrolimus is compared with emollient only it is probably cost effective at a willingness-to-pay threshold of 30 000 UK pounds per quality-adjusted life year. CONCLUSIONS: There are likely to be few situations in which the use of pimecrolimus for the treatment of atopic eczema can be justified on economic grounds. Exceptions are likely to be in cases where TCS have been shown to be ineffective, unacceptable due to adverse events, or where a patient is unwilling to accept TCS treatment despite appropriate education and support and emollient alone is the alternative clinical option.
Abstract.
Author URL.
Dalziel K, Stein K, Round A, Garside R, Royle P (2006). Endoscopic sinus surgery for the excision of nasal polyps: a systematic review of safety and effectiveness.
Am J Rhinol,
20(5), 506-519.
Abstract:
Endoscopic sinus surgery for the excision of nasal polyps: a systematic review of safety and effectiveness.
BACKGROUND: Functional endoscopic sinus surgery (FESS) has been used for >20 years for the management of sinus disease including the excision of nasal polyps. Our objective was to perform a systematic review of safety and effectiveness of FESS for the removal of nasal polyps. METHODS: the Cochrane Library, MEDLINE, Embase, Science Citation Index, other databases, and websites were searched in January and December 2005 using key words for nasal polyps and endoscopic surgery. All randomized controlled trials, nonrandomized comparative studies, and case series studies that described outcomes associated with FESS for the excision of nasal polyps were included. Forty-two publications were included from the 632 (6.6%) articles initially identified. Two reviewers assessed validity of included studies and extracted relevant data. RESULTS: Three randomized controlled trials, 4 nonrandomized comparative studies, and 35 case series studies were included in the review. FESS was compared with endoscopic polypectomy, Caldwell-Luc, radical nasalization, and intranasal ethmoidectomy. In general, studies were of poor quality and lacked description of important variables influencing surgical outcome. Overall complications for FESS from case series studies ranged from 0.3 to 22.4% (median, 7.0%). Major complications ranged from 0 to 1.5% (median, 0%) and minor complications ranged from 1.1 to 20.8% (median, 7.5%). The potentially most serious complications were cerebrospinal fluid leaks, injury to the internal carotid artery, dural exposure, meningitis, bleeding requiring transfusion, periorbital/orbital fat exposure, and orbital penetration. Symptomatic improvement ranged from 78 to 88% for FESS compared with 43 to 84% for comparative procedures. From case series, symptomatic improvement ranged from 40 to 98% (median, 88%). CONCLUSION: FESS may offer some advantages in safety and effectiveness over comparative techniques, but wide variation in reported results and methodological shortcomings of studies limit the certainty of these conclusions. Wide variation in complication rates suggests the need for audit of existing practice. Additional high-quality studies with a fuller description of potential confounding factors and effect modifiers will help to define the effectiveness of FESS more clearly.
Abstract.
Author URL.
Garside R, Pitt M, Somerville M, Stein K, Price A, Gilbert N (2006). Surveillance of Barrett's oesophagus: Exploring the uncertainty through systematic review, expert workshop and economic modelling.
Health Technology Assessment,
10(8).
Abstract:
Surveillance of Barrett's oesophagus: Exploring the uncertainty through systematic review, expert workshop and economic modelling
Objectives: to assess what is known about the effectiveness, safety, affordability, cost-effectiveness and organisational impact of endoscopic surveillance in preventing morbidity and mortality from adenocarcinoma in patients with Barrett's oesophagus. In addition, to identify important areas of uncertainty in current knowledge for these programmes and to identify areas for further research. Data sources: El ectronic databases up to March 2004. Experts in Barrett's oesophagus from the UK. Review methods: a systematic review of the effectiveness of endoscopic surveillance of Barrett's oesophagus was carried out following methodological guidelines. Experts in Barrett's oesophagus from the UK were invited to contribute to a workshop held in London in May 2004 on surveillance of Barrett's oesophagus. Small group discussion, using a modified nominal group technique, identified key areas of uncertainty and ranked them for importance. A Markov model was developed to assess the cost-effectiveness of a surveillance programme for patients with Barrett's oesophagus compared with no surveillance and to quantify important areas of uncertainty. The model estimates incremental cost-utility and expected value of perfect information for an endoscopic surveillance programme compared with no surveillance. A cohort of 1000 55-year-old men with a diagnosis of Barrett's oesophagus was modelled for 20 years. The base case used costs in 2004 and took the perspective of the UK NHS. Estimates of expected value of information were included. Results: No randomised controlled trials (RCTs) or well-designed non-ra ndomised controlled studies were identified, although two comparative studies and numerous case series were found. Reaching clear conclusions from these studies was impossible owing to lack of RCT evidence. In addition, there was incomplete reporting of data particularly about cause of death, and changes in surveillance practice over time were mentioned but not explained in several studies. Three cost-utility analyses of surveillance of Barrett's oesophagus were identified, of which one was a further development of a previous study by the same group. Both sets of authors used Markov modelling and confined their analysis to 50- or 55-year-old white men with gastro-oesophageal reflux disease (GORD) symptoms. The models were run either for 30 years or to age 75 years. As these models are American, there are almost certainly differences in practice from the UK and possible underlying differences in the epidemiology and natural history of the disease. The costs of the procedures involved are also likely to be very different. The expert workshop identified the following key areas of uncertainty that needed to be addressed: the contribution of risk factors for the progression of Barrett's oesophagus to the development of high-grade dysplasia (HGD) and adenocarcinoma of the oesophagus; possible techniques for use in the general population to identify patients with high risk of adenocarcinoma; effectiveness of treatments for Barrett's oesophagus in altering cancer incidence; how best to identify those at risk in order to target treatment; whether surveillance programmes should take place at all; and whether there are clinical subgroups at higher risk of adenocarcinoma. Our Markov model suggests that the base case scenario of endoscopic surveillance of Barrett's oesophagus at 3-yearly intervals, with low-grade dysplasia surveyed yearly and HGD 3-monthly, does more harm than good when compared with no surveillance. Surveillance produces fewer quality-adjusted life-years (QALYs) for higher cost than no surveillance, therefore it is dominated by no surveillance. The cost per cancer identified approaches £45,000 in the surveillance arm and there is no apparent survival advantage owing to high recurrence rates and increased mortality due to more oesophagectomies in this arm. Non-surveillance continues to cost less and result in better quality of life whatever the surveillance intervals for Barrett's oesophagus and dysplastic states and whatever the costs (including none) attached to endoscopy and biopsy as the surveillance test. The probabilistic analyses assess the overall uncertainty in the model. According to this, it is very unlikely that surveillance will be cost-effective even at relatively high levels of willingness to pay. The simulation showed that, in the majority of model runs, non-surveillance continued to cost less and result in better quality of life than surveillance. At the population level (i.e. people with Barrett's oesophagus in England and Wales), a value of £6.5 million is placed on acquiring perfect information about surveillance for Barrett's oesophagus using expected value of perfect information (EVPI) analyses, if the surveillance is assumed to be relevant over 10 years. As with the one-way sensitivity analyses, the partial EVPI highlighted recurrence of adenocarcinoma of the oesophagus (ACO) after surgery and time taken for ACO to become symptomatic as particularly important parameters in the model. Conclusions: the systematic review concludes that there is insufficient evidence available to assess the clinical effectiveness of surveillance programmes of Barrett's oesophagus. There are numerous gaps in the evidence, of which the lack of RCT data is the major one. The expert workshop reflected these gaps in the range of topics raised as important in answering the question of the effectiveness of surveillance. Previous models of cost-effectiveness have most recently shown that surveillance programmes either do more harm than good compared with no surveillance or are unlikely to be cost-effective at usual levels of willingness to pay. Our cost-utility model has shown that, across a range of values for the various parameters that have been chosen to reflect uncertainty in the inputs, it is likely that surveillance programmes do more harm than good - costing more and conferring lower quality of life than no surveillance. Probabilistic analysis shows that, in most cases, surveillance does more harm and costs more than no surveillance. It is unlikely, but still possible, that surveillance may prove to be cost-effective. The cost-effectiveness acceptability curve, however, shows that surveillance is unlikely to be cost-effective at either the 'usual' level of willingness to pay (£20,000-30,000 per QALY) or at much higher levels. The expected value of perfect information at the population level is £6.5 million. Future research should target both the overall effectiveness of surveillance and the individual elements that contribute to a surveillance programme, particularly the performance of the test and the effectiveness of treatment for both Barrett's oesophagus and ACO. In addition, of particular importance is the clarification of the natural history of Barrett's oesophagus. © Queen's Printer and Controller of HMSO 2006. All rights reserved.
Abstract.
Garside R, Pitt M, Somerville M, Stein K, Price A, Gilbert N (2006). Surveillance of Barrett's oesophagus: exploring the uncertainty through systematic review, expert workshop and economic modelling.
Health Technol Assess,
10(8), 1-iv.
Abstract:
Surveillance of Barrett's oesophagus: exploring the uncertainty through systematic review, expert workshop and economic modelling.
OBJECTIVES: to assess what is known about the effectiveness, safety, affordability, cost-effectiveness and organisational impact of endoscopic surveillance in preventing morbidity and mortality from adenocarcinoma in patients with Barrett's oesophagus. In addition, to identify important areas of uncertainty in current knowledge for these programmes and to identify areas for further research. DATA SOURCES: Electronic databases up to March 2004. Experts in Barrett's oesophagus from the UK. REVIEW METHODS: a systematic review of the effectiveness of endoscopic surveillance of Barrett's oesophagus was carried out following methodological guidelines. Experts in Barrett's oesophagus from the UK were invited to contribute to a workshop held in London in May 2004 on surveillance of Barrett's oesophagus. Small group discussion, using a modified nominal group technique, identified key areas of uncertainty and ranked them for importance. A Markov model was developed to assess the cost-effectiveness of a surveillance programme for patients with Barrett's oesophagus compared with no surveillance and to quantify important areas of uncertainty. The model estimates incremental cost--utility and expected value of perfect information for an endoscopic surveillance programme compared with no surveillance. A cohort of 1000 55-year-old men with a diagnosis of Barrett's oesophagus was modelled for 20 years. The base case used costs in 2004 and took the perspective of the UK NHS. Estimates of expected value of information were included. RESULTS: No randomised controlled trials (RCTs) or well-designed non-randomised controlled studies were identified, although two comparative studies and numerous case series were found. Reaching clear conclusions from these studies was impossible owing to lack of RCT evidence. In addition, there was incomplete reporting of data particularly about cause of death, and changes in surveillance practice over time were mentioned but not explained in several studies. Three cost--utility analyses of surveillance of Barrett's oesophagus were identified, of which one was a further development of a previous study by the same group. Both sets of authors used Markov modelling and confined their analysis to 50- or 55-year-old white men with gastro-oesophageal reflux disease (GORD) symptoms. The models were run either for 30 years or to age 75 years. As these models are American, there are almost certainly differences in practice from the UK and possible underlying differences in the epidemiology and natural history of the disease. The costs of the procedures involved are also likely to be very different. The expert workshop identified the following key areas of uncertainty that needed to be addressed: the contribution of risk factors for the progression of Barrett's oesophagus to the development of high-grade dysplasia (HGD) and adenocarcinoma of the oesophagus; possible techniques for use in the general population to identify patients with high risk of adenocarcinoma; effectiveness of treatments for Barrett's oesophagus in altering cancer incidence; how best to identify those at risk in order to target treatment; whether surveillance programmes should take place at all; and whether there are clinical subgroups at higher risk of adenocarcinoma. Our Markov model suggests that the base case scenario of endoscopic surveillance of Barrett's oesophagus at 3-yearly intervals, with low-grade dysplasia surveyed yearly and HGD 3-monthly, does more harm than good when compared with no surveillance. Surveillance produces fewer quality-adjusted life-years (QALYs) for higher cost than no surveillance, therefore it is dominated by no surveillance. The cost per cancer identified approaches pound 45,000 in the surveillance arm and there is no apparent survival advantage owing to high recurrence rates and increased mortality due to more oesophagectomies in this arm. Non-surveillance continues to cost less and result in better quality of life whatever the surveillance intervals for Barrett's oesophagus and dysplastic states and whatever the costs (including none) attached to endoscopy and biopsy as the surveillance test. The probabilistic analyses assess the overall uncertainty in the model. According to this, it is very unlikely that surveillance will be cost-effective even at relatively high levels of willingness to pay. The simulation showed that, in the majority of model runs, non-surveillance continued to cost less and result in better quality of life than surveillance. At the population level (i.e. people with Barrett's oesophagus in England and Wales), a value of pound 6.5 million is placed on acquiring perfect information about surveillance for Barrett's oesophagus using expected value of perfect information (EVPI) analyses, if the surveillance is assumed to be relevant over 10 years. As with the one-way sensitivity analyses, the partial EVPI highlighted recurrence of adenocarcinoma of the oesophagus (ACO) after surgery and time taken for ACO to become symptomatic as particularly important parameters in the model. CONCLUSIONS: the systematic review concludes that there is insufficient evidence available to assess the clinical effectiveness of surveillance programmes of Barrett's oesophagus. There are numerous gaps in the evidence, of which the lack of RCT data is the major one. The expert workshop reflected these gaps in the range of topics raised as important in answering the question of the effectiveness of surveillance. Previous models of cost-effectiveness have most recently shown that surveillance programmes either do more harm than good compared with no surveillance or are unlikely to be cost-effective at usual levels of willingness to pay. Our cost--utility model has shown that, across a range of values for the various parameters that have been chosen to reflect uncertainty in the inputs, it is likely that surveillance programmes do more harm than good -- costing more and conferring lower quality of life than no surveillance. Probabilistic analysis shows that, in most cases, surveillance does more harm and costs more than no surveillance. It is unlikely, but still possible, that surveillance may prove to be cost-effective. The cost-effectiveness acceptability curve, however, shows that surveillance is unlikely to be cost-effective at either the 'usual' level of willingness to pay ( pound 20,000-30,000 per QALY) or at much higher levels. The expected value of perfect information at the population level is pound 6.5 million. Future research should target both the overall effectiveness of surveillance and the individual elements that contribute to a surveillance programme, particularly the performance of the test and the effectiveness of treatment for both Barrett's oesophagus and ACO. In addition, of particular importance is the clarification of the natural history of Barrett's oesophagus.
Abstract.
Author URL.
Garside R, Pitt M, Somerville M, Stein K, Price A, Gilbert N (2006). Surveillance of Barrett's oesophagus: exploring the uncertainty through systematic review, expert workshop and economic modelling.
Health technology assessment (Winchester, England),
10(8).
Abstract:
Surveillance of Barrett's oesophagus: exploring the uncertainty through systematic review, expert workshop and economic modelling.
To assess what is known about the effectiveness, safety, affordability, cost-effectiveness and organisational impact of endoscopic surveillance in preventing morbidity and mortality from adenocarcinoma in patients with Barrett's oesophagus. In addition, to identify important areas of uncertainty in current knowledge for these programmes and to identify areas for further research. Electronic databases up to March 2004. Experts in Barrett's oesophagus from the UK. A systematic review of the effectiveness of endoscopic surveillance of Barrett's oesophagus was carried out following methodological guidelines. Experts in Barrett's oesophagus from the UK were invited to contribute to a workshop held in London in May 2004 on surveillance of Barrett's oesophagus. Small group discussion, using a modified nominal group technique, identified key areas of uncertainty and ranked them for importance. A Markov model was developed to assess the cost-effectiveness of a surveillance programme for patients with Barrett's oesophagus compared with no surveillance and to quantify important areas of uncertainty. The model estimates incremental cost--utility and expected value of perfect information for an endoscopic surveillance programme compared with no surveillance. A cohort of 1000 55-year-old men with a diagnosis of Barrett's oesophagus was modelled for 20 years. The base case used costs in 2004 and took the perspective of the UK NHS. Estimates of expected value of information were included. No randomised controlled trials (RCTs) or well-designed non-randomised controlled studies were identified, although two comparative studies and numerous case series were found. Reaching clear conclusions from these studies was impossible owing to lack of RCT evidence. In addition, there was incomplete reporting of data particularly about cause of death, and changes in surveillance practice over time were mentioned but not explained in several studies. Three cost--utility analyses of surveillance of Barrett's oesophagus were identified, of which one was a further development of a previous study by the same group. Both sets of authors used Markov modelling and confined their analysis to 50- or 55-year-old white men with gastro-oesophageal reflux disease (GORD) symptoms. The models were run either for 30 years or to age 75 years. As these models are American, there are almost certainly differences in practice from the UK and possible underlying differences in the epidemiology and natural history of the disease. The costs of the procedures involved are also likely to be very different. The expert workshop identified the following key areas of uncertainty that needed to be addressed: the contribution of risk factors for the progression of Barrett's oesophagus to the development of high-grade dysplasia (HGD) and adenocarcinoma of the oesophagus; possible techniques for use in the general population to identify patients with high risk of adenocarcinoma; effectiveness of treatments for Barrett's oesophagus in altering cancer incidence; how best to identify those at risk in order to target treatment; whether surveillance programmes should take place at all; and whether there are clinical subgroups at higher risk of adenocarcinoma. Our Markov model suggests that the base case scenario of endoscopic surveillance of Barrett's oesophagus at 3-yearly intervals, with low-grade dysplasia surveyed yearly and HGD 3-monthly, does more harm than good when compared with no surveillance. Surveillance produces fewer quality-adjusted life-years (QALYs) for higher cost than no surveillance, therefore it is dominated by no surveillance. The cost per cancer identified approaches pound 45,000 in the surveillance arm and there is no apparent survival advantage owing to high recurrence rates and increased mortality due to more oesophagectomies in this arm. Non-surveillance continues to cost less and result in better quality of life whatever the surveillance intervals for Barrett's oesophagus and dysplastic states and whatever the costs (including none) attached to endoscopy and biopsy as the surveillance test. The probabilistic analyses assess the overall uncertainty in the model. According to this, it is very unlikely that surveillance will be cost-effective even at relatively high levels of willingness to pay. The simulation showed that, in the majority of model runs, non-surveillance continued to cost less and result in better quality of life than surveillance. At the population level (i.e. people with Barrett's oesophagus in England and Wales), a value of pound 6.5 million is placed on acquiring perfect information about surveillance for Barrett's oesophagus using expected value of perfect information (EVPI) analyses, if the surveillance is assumed to be relevant over 10 years. As with the one-way sensitivity analyses, the partial EVPI highlighted recurrence of adenocarcinoma of the oesophagus (ACO) after surgery and time taken for ACO to become symptomatic as particularly important parameters in the model. The systematic review concludes that there is insufficient evidence available to assess the clinical effectiveness of surveillance programmes of Barrett's oesophagus. There are numerous gaps in the evidence, of which the lack of RCT data is the major one. The expert workshop reflected these gaps in the range of topics raised as important in answering the question of the effectiveness of surveillance. Previous models of cost-effectiveness have most recently shown that surveillance programmes either do more harm than good compared with no surveillance or are unlikely to be cost-effective at usual levels of willingness to pay. Our cost--utility model has shown that, across a range of values for the various parameters that have been chosen to reflect uncertainty in the inputs, it is likely that surveillance programmes do more harm than good -- costing more and conferring lower quality of life than no surveillance. Probabilistic analysis shows that, in most cases, surveillance does more harm and costs more than no surveillance. It is unlikely, but still possible, that surveillance may prove to be cost-effective. The cost-effectiveness acceptability curve, however, shows that surveillance is unlikely to be cost-effective at either the 'usual' level of willingness to pay ( pound 20,000-30,000 per QALY) or at much higher levels. The expected value of perfect information at the population level is pound 6.5 million. Future research should target both the overall effectiveness of surveillance and the individual elements that contribute to a surveillance programme, particularly the performance of the test and the effectiveness of treatment for both Barrett's oesophagus and ACO. In addition, of particular importance is the clarification of the natural history of Barrett's oesophagus.
Abstract.
Stein K, Dalziel K, Garside R, Castelnuovo E, Round A (2005). Association between methodological characteristics and outcome in health technology assessments which included case series.
Int J Technol Assess Health Care,
21(3), 277-287.
Abstract:
Association between methodological characteristics and outcome in health technology assessments which included case series.
OBJECTIVES: Case series constitute a weak form of evidence for effectiveness of health technologies. However, for a variety of reasons, such studies may be included in health technology assessments. There are no clear criteria for assessing the quality of case series. We carried out an empirical investigation of the association between outcome frequency and methodological characteristics in a sample of health technology assessments. METHODS: Systematic reviews of functional endoscopic sinus surgery for nasal polyps, spinal cord stimulation for chronic back pain, and percutaneous transluminal coronary angioplasty and coronary artery bypass grafting for chronic stable angina were identified as containing more than forty case series. Data were extracted by one reviewer and checked by a second on population characteristics, outcomes, and the following methodological features: sample size, prospective/retrospective approach, consecutive recruitment, multi- or single-center organization, length of follow-up, independence of outcome measurement, and date of publication. Association between methodological features and outcome were explored in univariate and multivariate analyses using parametric and nonparametric tests and robust regression or analysis of variance/analysis of covariance, as appropriate. RESULTS: Included reviews contained between forty-two and seventy-six case series studies, involving 5 to 172,283 participants. Reporting of methodological features was poor and limited the analyses. In general, we found little evidence of any association between methodological characteristics and outcome. Sample size is used as an inclusion criterion in many reviews of'case series but was consistently shown to have no relationship to outcome in all analyses. A prospective approach was not associated with outcome. Insufficient data were available to explore consecutive recruitment. Mixed results were shown for length of follow-up, independence of outcome measurement, and publication date. CONCLUSIONS: We found little evidence to support the use of many of the factors included in tools used for quality assessment of case series. Importantly, we found no relationship between study size and outcome across the four examples studied. Isolated examples of a potentially important relationship between other methodological factors and outcome were shown, for example, blinding of outcome measurement, but these examples were not shown consistently across the small number of examples studied. Further research into the determinants of quality in case series studies is required to support health technology assessment.
Abstract.
Author URL.
Dalziel K, Round A, Garside R, Stein K (2005). Cost effectiveness of imatinib compared with interferon-alpha or hydroxycarbamide for first-line treatment of chronic myeloid leukaemia.
Pharmacoeconomics,
23(5), 515-526.
Abstract:
Cost effectiveness of imatinib compared with interferon-alpha or hydroxycarbamide for first-line treatment of chronic myeloid leukaemia.
OBJECTIVE: to evaluate the cost utility of imatinib compared with interferon (IFN)-alpha or hydroxycarbamide (hydroxyurea) for first-line treatment of chronic myeloid leukaemia. DESIGN AND SETTING: a cost-utility (Markov) model within the setting of the UK NHS and viewed from a health system perspective was adopted. Transition probabilities and relative risks were estimated from published literature. Costs of drug treatment, outpatient care, bone marrow biopsies, radiography, blood transfusions and inpatient care were obtained from the British National Formulary and local hospital databases. Costs (pound, year 2001-03 values) were discounted at 6%. Quality-of-life (QOL) data were obtained from the published literature and discounted at 1.5%. The main outcome measure was cost per QALY gained. Extensive one-way sensitivity analyses were performed along with probabilistic (stochastic) analysis. RESULTS: the incremental cost-effectiveness ratio (ICER) of imatinib, compared with IFNalpha, was pound26,180 per QALY gained (one-way sensitivity analyses ranged from pound19,449 to pound51,870) and compared with hydroxycarbamide was pound86,934 per QALY (one-way sensitivity analyses ranged from pound69,701 to pound147,095) [ pound1=$US1.691=euro1.535 as at 31 December 2002].Based on the probabilistic sensitivity analysis, 50% of the ICERs for imatinib, compared with IFNalpha, fell below a threshold of approximately pound31,000 per QALY gained. Fifty percent of ICERs for imatinib, compared with hydroxycarbamide, fell below approximately pound95,000 per QALY gained. CONCLUSIONS: This model suggests, given its underlying data and assumptions, that imatinib may be moderately cost effective when compared with IFNalpha but considerably less cost effective when compared with hydroxycarbamide. There are, however, many uncertainties due to the lack of long-term data.
Abstract.
Author URL.
Dalziel K, Round A, Stein K, Garside R, Castelnuovo E, Payne L (2005). Do the findings of case series studies vary significantly according to methodological characteristics?.
Health Technology Assessment,
9(2).
Abstract:
Do the findings of case series studies vary significantly according to methodological characteristics?
Objectives: to review the use of case series in National Institute for Clinical Excellence (NICE) Health Technology Assessment (HTA) reports, to review systematically the methodological literature for papers relating to the validity of aspects of case series design, and to investigate characteristics and findings of case series using examples from the UK's Health Technology Assessment programme. Data sources: Electronic databases. NICE website. Reports produced as part of the UK's HTA programme. Review methods: NICE HTAs that used information from case series studies were obtained from the NICE website and a range of quality criteria applied. Searches of electronic databases, handsearched journals and the bibliographies of papers were made in order to find studies that assessed aspects of case series design, analysis or quality in relation to study validity. Hypotheses relating to the design of case series studies were developed and empirically investigated using four case examples from existing reports produced as part of the UK's HTA programme (functional endoscopic sinus surgery for nasal polyps, spinal cord stimulation for chronic back pain, percutaneous transluminal coronary angioplasty and coronary artery bypass grafting for chronic angina). Analysis was undertaken comparing studies within each review. Results: There was no consensus on which case series to include in HTAs, how to use them or how to assess their quality, despite them being used in 30% of NICE HTAs. No previous studies empirically investigating methodological characteristics of case series were found. However, it is possible that the search strategy failed to find relevant studies. Poor reporting of case series characteristics severely constrained analysis and there were insufficient data to investigate all the hypotheses. Findings were not consistent across the different topics and were subject to considerable uncertainty. All the examples in our analysis were surgical interventions, which are prone to additional confounding factors due to difficulties of standardisation compared with drug treatment. Our findings may not be generalisable outside the interventions studied. The case series reports included generally exhibited poor reporting of methodological characteristics. This constrained our analysis. The use of several methods of analysis has led to apparently discrepant results. Given the number of analysis performed, the usual level of significance (p = 0.05) should be viewed with caution. The most important limitation of this study is the small number of cases on which the findings are based. The results are therefore tentative and should be viewed with caution. Conclusions: Case series are incorporated in a significant proportion of health technology assessments. Quality criteria have been used to appraise the quality of case series and decide on their inclusion in reviews of studies using this design. In this small series of case studies drawn from HTAs carried out for the NHS HTA programme, little evidence was found to support the use of many of the factors included in quality assessment tools. Importantly, no relationship was found between study size and outcome across the four examples studied. Isolated examples of a potentially important relationship between other methodological factors and outcome were shown, such as blinding of outcome measurement, but these were not shown consistently across the small number of examples studied. This study is based on a very small sample of studies and should therefore be considered as exploratory. Further investigation of the relationship between methodological features and outcome is justified given the frequency of use of case series in health technology assessments. Further research into the methodological features of case series and their outcome is justified in a wider sample of technologies and larger sets of case series. Value of information analyses including case series could be explored. Further exploration of the differences between case series and randomised controlled trial results, preferably using registry or comprehensive case series data, would be valuable. © Queen's Printer and Controller of HMSO 2005. All rights reserved.
Abstract.
Garside R, Ashcroft DM, Dimmock P, Stein K (2005). Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomized controlled trials. BMJ, 330(7490).
Garside R, Round A, Stein K, Wyatt K (2005). Microwave and thermal balloon ablation for heavy menstrual bleeding: a systematic review. BJOG an International Journal of Obstetrics and Gynaecology, 112(1), 12-23.
Pitt MA, Garside R, Somerville M, Stein K (2005). Surveillance of Barrett's Oesophagus: Exploring the uncertainty through systematic review, expert workshop and economic modelling.
Pitt MA, Castelnuovo E, Stein K, Garside R (2005). The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.
Castelnuovo E, Stein K, Pitt M, Garside R, Payne E (2005). The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.
Health Technol Assess,
9(43), iii-246.
Abstract:
The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.
OBJECTIVES: to estimate the effectiveness and cost-effectiveness of dual-chamber pacemakers versus single-chamber atrial or single-chamber ventricular pacemakers in the treatment of bradycardia due to sick sinus syndrome (SSS) or atrioventricular block (AVB). DATA SOURCES: Electronic databases and relevant Internet sites. Contact with device manufacturers and experts in the field. REVIEW METHODS: a systematic review was carried out of randomised controlled trials (RCTs). The quality of selected studies was appraised using standard frameworks. Meta-analyses, using random effects models, were carried out where appropriate. Limited exploration of heterogeneity was possible. Critical appraisal of economic evaluations was carried out using two frameworks. A decision-analytic model was developed using a Markov approach, to estimate the cost-effectiveness of dual-chamber versus ventricular or atrial pacing over 5 and 10 years as cost per quality-adjusted life-year (QALY). Uncertainty was explored using one-way and probabilistic sensitivity analyses. RESULTS: the searches retrieved a systematic review of effectiveness and cost-effectiveness published in 2002, four parallel group RCTs and 28 cross-over trials. Dual-chamber pacing was associated with lower rates of atrial fibrillation, particularly in SSS, than ventricular pacing, and prevents pacemaker syndrome. Higher rates of atrial fibrillation were seen with dual-chamber pacing than with atrial pacing. Complications occurred more frequently in dual-chamber pacemaker insertion. The cost of a dual-chamber system, over 5 years, including cost of complications and subsequent clinical events in the population, was estimated to be around 7400 pounds. The overall cost difference between single and dual systems is not large over this period: around 700 pounds more for dual-chamber devices. The cost-effectiveness of dual-chamber compared with ventricular pacing was estimated to be around 8500 pounds per QALY in AVB and 9500 pounds in SSS over 5 years, and around 5500 pounds per QALY in both populations over 10 years. Under more conservative assumptions, the cost-effectiveness of dual-chamber pacing is around 30,000 pounds per QALY. The probabilistic sensitivity analysis showed that, under the base-case assumptions, dual-chamber pacing is likely to be considered cost-effective at levels of willingness to pay that are generally considered acceptable by policy makers. In contrast, atrial pacing may be cost-effective compared with dual-chamber pacing. CONCLUSIONS: Dual-chamber pacing results in small but potentially important benefits in populations with SSS and/or AVB compared with ventricular pacemakers. Pacemaker syndrome is a crucial factor in determining cost-effectiveness; however, difficulties in standardising diagnosis and measurement of severity make it difficult to quantify. Dual-chamber pacing is in common usage in the UK. Recipients are more likely to be younger. Insufficient evidence is currently available to inform policy on specific groups who may benefit most from pacing with dual-chamber devices. Further important research is underway. Outstanding research priorities include the economic evaluation of UKPACE studies of the classification, diagnosis and utility associated with pacemaker syndrome and evidence on the effectiveness of pacemakers in children.
Abstract.
Author URL.
Garside R, Stein K, Castelnuovo E, Pitt M, Ashcroft D, Dimmock P, Payne L (2005). The effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation.
Health Technol Assess,
9(29), iii-230.
Abstract:
The effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation.
OBJECTIVES: to consider the effectiveness and cost-effectiveness of pimecrolimus for mild to moderate atopic eczema and tacrolimus for moderate to severe atopic eczema compared with current standard treatment in adults and children. DATA SOURCES: Electronic databases. Experts and the manufacturers of these agents were also approached for information. REVIEW METHODS: the systematic review was carried out using standard methodological guidelines and a stringent quality assessment strategy. A state transition (Markov) model was developed to estimate cost--utility of tacrolimus and pimecrolimus separately, compared with current standard practice with topical corticosteroids, (a) as first-line treatment and (b) as second-line treatment. Pimecrolimus was also compared to emollients only. RESULTS: the pimecrolimus trial reports were of varying quality; however when compared with a placebo (emollient), pimecrolimus was found to be more effective and to provide quality of life improvements. There is very little evidence available about pimecrolimus compared with topical corticosteroids. Compared with a placebo (emollient), both 0.03% and 0.1% tacrolimus were found to be more effective. Compared with a mild corticosteroid, 0.03% tacrolimus is more effective in children as measured by a 90% or better improvement in the Physician's Global Evaluation (PGE). Compared with potent topical corticosteroids, no significant difference in effectiveness is seen with 0.1% tacrolimus as measured by a 75% or greater improvement in the PGE. Minor application site adverse effects are common with tacrolimus. However, this did not lead to increased rates of withdrawal from treatment in trial populations. The PenTag economic model demonstrates a large degree of uncertainty, which was explored in both deterministic and stochastic analyses. This is the case for the cost-effectiveness of pimecrolimus and tacrolimus in first- or second-line use compared with topical steroids. In all cases immunosuppressant regimes were estimated to be more costly than alternatives and differences in benefits to be small and subject to considerable uncertainty. CONCLUSIONS: There is limited evidence from a small number of randomised controlled trials (RCTs) that pimecrolimus is more effective than placebo treatment in controlling mild to moderate atopic eczema. Although greater than for pimecrolimus, the evidence base for tacrolimus in moderate to severe atopic eczema is also limited. At both 0.1% and 0.03% potencies, tacrolimus appears to be more effective than the placebo treatment and mild topical corticosteroids. However, these are not the most clinically relevant comparators. Compared with potent topical corticosteroids, no significant difference was shown. Short-term adverse effects with both immunosuppressants are relatively common, but appear to be mild. Experience of long-term use of the agents is lacking so the risk of rare but serious adverse effects remains unknown. No conclusions can be confidently drawn about the cost-effectiveness of pimecrolimus or tacrolimus compared with active topical corticosteroid comparators. Areas for further research should focus on the effectiveness and safety of the treatments through good-quality RCTs and further economic analysis.
Abstract.
Author URL.
Garside R, Stein K, Wyatt K, Round A, Pitt M (2004). A cost-utility analysis of microwave and thermal balloon endometrial ablation techniques for the treatment of heavy menstrual bleeding.
BJOG,
111(10), 1103-1114.
Abstract:
A cost-utility analysis of microwave and thermal balloon endometrial ablation techniques for the treatment of heavy menstrual bleeding.
OBJECTIVE: to assess the cost effectiveness of the second-generation surgical treatments for heavy menstrual bleeding (microwave and thermal balloon endometrial ablation) compared with existing endometrial ablation techniques (transcervical resection and rollerball, alone or in combination) and hysterectomy. DESIGN: a state transition (Markov) cost-utility economic model. POPULATION: Women with heavy menstrual bleeding. METHODS: a Markov model was developed using spreadsheet software. Transition probabilities, costs and quality of life data were obtained from a systematic review of effectiveness undertaken by the authors, from published sources, and expert opinion. Cost data were obtained from the literature and from a NHS trust hospital. Indirect comparison of thermal balloon endometrial ablation versus microwave endometrial ablation or either second-generation endometrial ablation method versus hysterectomy, and comparison of second-generation versus first-generation techniques were carried out from the perspective of health service payers. The effects of uncertainty were explored through extensive one-way sensitivity analyses and Monte Carlo simulation. MAIN OUTCOME MEASURES: Incremental cost effectiveness ratios based on cost per quality adjusted life year (QALY) gained, and cost effectiveness acceptability curves. RESULTS: Compared with first-generation techniques, both microwave and thermal balloon endometrial ablation cost less and accrued more QALYs. Hysterectomy was more expensive, but accrued more QALYs than all endometrial ablation methods. Baseline results showed that differences between microwave endometrial ablation and thermal balloon endometrial ablation were slight. Sensitivity analyses showed that small changes in values may have a marked effect on cost effectiveness. Probabilistic simulation highlighted the uncertainty in comparisons between different endometrial ablation options, particularly between second-generation techniques. CONCLUSIONS: Despite limitations in available data, the analysis suggests that second-generation techniques are likely to be more cost effective than first-generation techniques in most cases. Hysterectomy, where a woman finds this option acceptable, continues to be a very cost effective procedure compared with all endometrial ablation methods.
Abstract.
Author URL.
KStein, Garside R, Round A, Wyatt K (2004). A cost-utility analysis of microwave and thermal balloon endometrial ablation techniques for the treatment off heavy menstrual bleeding. BJOG an International Journal of Obstetrics and Gynaecology, 111(10), 1103-1114.
Dalziel K, Round A, Stein K, Garside R, Price A (2004). Effectiveness and cost-effectiveness of imatinib for first-line treatment of chronic myeloid leukaemia in chronic phase: a systematic review and economic analysis.
Health Technol Assess,
8(28), iii-120.
Abstract:
Effectiveness and cost-effectiveness of imatinib for first-line treatment of chronic myeloid leukaemia in chronic phase: a systematic review and economic analysis.
OBJECTIVES: to evaluate the effectiveness of imatinib as first-line treatment for chronic myeloid leukaemia (CML) compared with interferon-alpha (IFN-alpha), hydroxyurea and bone marrow transplantation (BMT), and the cost-effectiveness of imatinib compared with IFN-alpha and hydroxyurea. DATA SOURCES: Electronic databases. REVIEW METHODS: Selected studies and full-text articles were screened and rigorously selected. Survival was the key outcome measure. Surrogate outcome measures included haematological (blood) response and cytogenetic (bone marrow) response (CR). As no published cost-effectiveness studies were found that compared imatinib and IFN-alpha, an independent Markov model was constructed and this was compared with models submitted to the National Institute for Clinical Excellence by the manufacturer of imatinib. RESULTS: Intention-to-treat analysis showed that imatinib was associated with complete CR at 12 months follow-up of 68% compared with 20% for the IFN-alpha plus Ara-C group. The estimated proportion of people taking imatinib who had not progressed to accelerated or blast phases at 12 months was 98.5%, and 93.1% for IFN-alpha plus Ara-C. Overall survival was not statistically significantly different. Withdrawal due to side-effects was 2% for imatinib and 5.6% for IFN-alpha plus Ara-C. Cross-over due to intolerance was 0.7% and 22.8% for imatinib and for IFN-alpha plus Ara-C, respectively. Quality of life was better in the imatinib group than the IFN-alpha group when assessed at 1, 3 and 6 months. Median survival across the four IFN-alpha versus hydroxyurea studies was 66 and 56.2 months, respectively. Median complete CR was 6% for IFN-alpha and 0 for hydroxyurea. Median withdrawal due to side-effects was 24% and 4% for IFN-alpha and hydroxyurea, respectively. Four out of the five studies comparing BMT and IFN-alpha showed a long-term survival advantage for BMT over IFN-alpha, but a short-term disadvantage. In four of the five studies comparing BMT and IFN-alpha, median survival had not yet been reached in the BMT groups in 6--10 years. Median survival in the IFN-alpha arms ranged from 5.2 to 7 years. The BMT group gained a survival advantage over IFN-alpha at 3--5.5 years. In the BMT group death due to transplant-related complications ranged from 36 to 45%. The incremental cost-effectiveness ratio (ICER) of imatinib compared with IFN-alpha from the independent model was GBP26,180 per quality-adjusted-life-years (QALY) gained and was relatively robust. Imatinib was less cost-effective than hydroxyurea with an ICER of GBP86,934. CONCLUSIONS: Imatinib appears to be more effective than current standard drug treatments in terms of cytogenetic response and progression-free survival, with fewer side-effects. However, there is uncertainty concerning longer term outcomes, the development of resistance to imatinib, the duration of response and the place of imatinib relative to BMT. New issues are continually arising, such as optimal management pathways and combination therapies. Recommendations for research include: long-term follow-up data from the first- and second-line imatinib trials; investigation into specific subgroups, e.g. high-risk patients, the elderly, children or those eligible for BMT; long-term comparisons of imatinib with BMT performed in early stages of CML; the use of imatinib in combination with other therapies, and further detailed economic studies. Investigation of the impact of CML and imatinib on quality of life is also important.
Abstract.
Author URL.
KWyatt, Garside R, Round A, Stein K (2004). The effectiveness and cost-effectiveness of microwave and thermal balloon endometrial ablation for heavy menstrual bleeding: a systematic review and economic modelling.
Garside R, Stein K, Wyatt K, Round A, Price A (2004). The effectiveness and cost-effectiveness of microwave and thermal balloon endometrial ablation for heavy menstrual bleeding: a systematic review and economic modelling.
Health Technol Assess,
8(3), iii-155.
Abstract:
The effectiveness and cost-effectiveness of microwave and thermal balloon endometrial ablation for heavy menstrual bleeding: a systematic review and economic modelling.
OBJECTIVES: to estimate the clinical effectiveness and cost-effectiveness of microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA) for heavy menstrual bleeding (HMB), compared with the existing (first-generation) endometrial ablation (EA) techniques of transcervical resection (TCRE) and rollerball (RB) ablation, and hysterectomy. DATA SOURCES: Electronic databases, bibliographies of articles, and also experts in the field and relevant industry bodies were asked to provide information. REVIEW METHODS: a detailed search strategy was carried out to identify systematic reviews and controlled trials of MEA and TBEA versus first-generation techniques for EA. In addition to electronic database searching, reference lists were hand-searched and information sought from manufacturers of EA devices and by experts in the field. A deterministic Markov model was developed to assess cost-effectiveness. Data for the model were taken from a range of sources. RESULTS: the systematic review of first-generation EA techniques versus hysterectomy found that EA offered an alternative to hysterectomy for HMB, with fewer complications and a shorter recovery period. Satisfaction and effectiveness were high for both MEA and TBEA. Costs were lower with EA although the difference narrows over time. Second-generation EA techniques are an alternative treatment to first-generation techniques for HMB, and first-generation techniques are known to offer an alternative to hysterectomy. Although no trials of second-generation techniques and hysterectomy have been undertaken, it seems reasonable to assume that second-generation techniques also offer an alternative surgical treatment. Using the model to assess cost-effectiveness, costs were very slightly higher for MEA when compared to TBEA, and differences in quality-adjusted life-years (QALYs) were negligible. For MEA compared with transcervical resection of the endometrium (TCRE) and RB ablation, costs were slightly lower with MEA and MEA accrued very slightly more QALYs. Compared with hysterectomy, MEA costs less and accrues slightly fewer QALYs. For TBEA compared with TCRE and RB ablation, costs were lower with TBEA and TBEA accrued slightly more QALYs. Compared with hysterectomy, TBEA costs moderately less and accrues moderately fewer QALYs. CONCLUSIONS: Overall, there were few significant differences between the outcomes of first- and second-generation techniques including bleeding, satisfaction and QoL measures and repeat surgery rates. Second-generation techniques had significantly shorter operating and theatre times and there appear to be fewer serious perioperative adverse effects with second-generation techniques and postoperative effects are similar. Compared with hysterectomy, TCRE and RB are quicker to perform and result in shorter hospitalisation and faster return to work. Hysterectomy results in more adverse effects and is more expensive, although the need for retreatment leads this difference to decrease over time. Satisfaction with hysterectomy is initially higher, but there is no significant difference after 2 years. The economic model suggests that second-generation techniques are more cost-effective than first-generation techniques of EA for HMB. Both TBEA and MEA appear to be less costly than hysterectomy, although the latter results in more QALYs. Further research is suggested to make direct comparisons of the cost-effectiveness of second-generation EA techniques, to carry out longer term follow-up for all methods of EA in RCTs, and to develop more sophisticated modelling studies. Further research is also recommended into HMB to establish health-state utility values, its surgical treatment, convalescence, complications of treatment, symptoms and patient satisfaction.
Abstract.
Author URL.
Dalziel K, Stein K, Round A, Garside R, Royle P (2003). Systematic review of endoscopic sinus surgery for nasal polyps.
Health Technology Assessment,
7(17).
Abstract:
Systematic review of endoscopic sinus surgery for nasal polyps
Objectives: to provide a systematic review of the clinical effectiveness of endoscopic sinus surgery (ESS) for the removal of nasal polyps. Data sources: Searches of electronic databases, websites and reference lists were made to identify relevant studies. Review methods; an extensive search was performed to identify all articles where FESS is used for the excision of nasal polyps. Two reviewers independently screened articles for inclusion according to predefined criteria. Comparative studies were included if they were primary research, focused on FESS for the removal of nasal polyps, reported patient relevant outcomes and were published in English. In addition, case series studies were included if they met the above criteria and enrolled more than 50 patients with polyps. Data were then extracted by one reviewer and checked by a second. A structured form was used to assess the internal and external validity of included studies. Comparative data were reported where available. Excluded case series and case reports were grouped and described. A group of nine ear, nose and throat (ENT) experts were selected, then using the literature and their own experience, they generated a list of priority research questions. Existing economic evaluations were sought and described. Results: of the 33 studies included, the randomised controlled trials and controlled trials reported overall symptomatic improvement that ranged from 78 to 88% for FESS compared with 43 to 84% for similar techniques (including polypectomy, Caldwell-Luc and intranasal ethmoidectomy). Disease recurrence was 8% for FESS compared with 14% for Caldwell-Luc and polyp recurrence was 28% for endoscopic ethmoidectomy compared with 35% for polypectomy. Revision surgery was reported in one study only and was the same for FESS and Caldwell-Luc procedures. Percentage of overall complications was reported in only one comparative study and was 1.4% for FESS compared with 0.8% for conventional procedures. The case series studies reported overall symptomatic improvement for patients with nasal polyps ranging from 37 to 99% (median 89%). For the mixed patient groups (with and without polypoid disease) overall symptomatic improvement ranged from 40 to 98% (median 88%). Total complications in the case series studies ranged from 22.4 to 0.3% (median 6%). Conclusions: the majority of studies report that symptoms improve following FESS with relatively few complications; however, only a small proportion of evidence is comparative. Results from non-comparative studies do not inform the choices that need to be made by ENT surgeons and commissioners. Health economics data are also lacking and therefore cannot inform these decisions. FESS may offer some advantages in effectiveness over comparative techniques, but there is enormous variation in the range of results reported and there are severe methodological limitations. There is a clear need for quality-controlled trials in order to answer questions regarding the effectiveness of FESS. A number of priority research questions from a selection of ENT surgeons within the UK are identified and presented.
Abstract.
Dalziel K, Stein K, Round A, Garside R, Royle P (2003). Systematic review of endoscopic sinus surgery for nasal polyps.
Health Technol Assess,
7(17), iii-159.
Abstract:
Systematic review of endoscopic sinus surgery for nasal polyps.
OBJECTIVES: to provide a systematic review of the clinical effectiveness of endoscopic sinus surgery (ESS) for the removal of nasal polyps. DATA SOURCES: Searches of electronic databases, websites and reference lists were made to identify relevant studies. REVIEW METHODS: an extensive search was performed to identify all articles where FESS is used for the excision of nasal polyps. Two reviewers independently screened articles for inclusion according to predefined criteria. Comparative studies were included if they were primary research, focused on FESS for the removal of nasal polyps, reported patient relevant outcomes and were published in English. In addition, case series studies were included if they met the above criteria and enrolled more than 50 patients with polyps. Data were then extracted by one reviewer and checked by a second. A structured form was used to assess the internal and external validity of included studies. Comparative data were reported where available. Excluded case series and case reports were grouped and described. A group of nine ear, nose and throat (ENT) experts were selected, then using the literature and their own experience, they generated a list of priority research questions. Existing economic evaluations were sought and described. RESULTS: of the 33 studies included, the randomised controlled trials and controlled trials reported overall symptomatic improvement that ranged from 78 to 88% for FESS compared with 43 to 84% for similar techniques (including polypectomy, Caldwell-Luc and intranasal ethmoidectomy). Disease recurrence was 8% for FESS compared with 14% for Caldwell-Luc and polyp recurrence was 28% for endoscopic ethmoidectomy compared with 35% for polypectomy. Revision surgery was reported in one study only and was the same for FESS and Caldwell-Luc procedures. Percentage of overall complications was reported in only one comparative study and was 1.4% for FESS compared with 0.8% for conventional procedures. The case series studies reported overall symptomatic improvement for patients with nasal polyps ranging from 37 to 99% (median 89%). For the mixed patient groups (with and without polypoid disease) overall symptomatic improvement ranged from 40 to 98% (median 88%). Total complications in the case series studies ranged from 22.4 to 0.3% (median 6%). CONCLUSIONS: the majority of studies report that symptoms improve following FESS with relatively few complications; however, only a small proportion of evidence is comparative. Results from non-comparative studies do not inform the choices that need to be made by ENT surgeons and commissioners. Health economics data are also lacking and therefore cannot inform these decisions. FESS may offer some advantages in effectiveness over comparative techniques, but there is enormous variation in the range of results reported and there are severe methodological limitations. There is a clear need for quality-controlled trials in order to answer questions regarding the effectiveness of FESS. A number of priority research questions from a selection of ENT surgeons within the UK are identified and presented.
Abstract.
Author URL.
Dalziel K, Stein K, Round A, Garside R, Royle P (2003). Systematic review of endoscopic sinus surgery for nasal polyps.
Health technology assessment (Winchester, England),
7(17).
Abstract:
Systematic review of endoscopic sinus surgery for nasal polyps.
To provide a systematic review of the clinical effectiveness of endoscopic sinus surgery (ESS) for the removal of nasal polyps. Searches of electronic databases, websites and reference lists were made to identify relevant studies. An extensive search was performed to identify all articles where FESS is used for the excision of nasal polyps. Two reviewers independently screened articles for inclusion according to predefined criteria. Comparative studies were included if they were primary research, focused on FESS for the removal of nasal polyps, reported patient relevant outcomes and were published in English. In addition, case series studies were included if they met the above criteria and enrolled more than 50 patients with polyps. Data were then extracted by one reviewer and checked by a second. A structured form was used to assess the internal and external validity of included studies. Comparative data were reported where available. Excluded case series and case reports were grouped and described. A group of nine ear, nose and throat (ENT) experts were selected, then using the literature and their own experience, they generated a list of priority research questions. Existing economic evaluations were sought and described. of the 33 studies included, the randomised controlled trials and controlled trials reported overall symptomatic improvement that ranged from 78 to 88% for FESS compared with 43 to 84% for similar techniques (including polypectomy, Caldwell-Luc and intranasal ethmoidectomy). Disease recurrence was 8% for FESS compared with 14% for Caldwell-Luc and polyp recurrence was 28% for endoscopic ethmoidectomy compared with 35% for polypectomy. Revision surgery was reported in one study only and was the same for FESS and Caldwell-Luc procedures. Percentage of overall complications was reported in only one comparative study and was 1.4% for FESS compared with 0.8% for conventional procedures. The case series studies reported overall symptomatic improvement for patients with nasal polyps ranging from 37 to 99% (median 89%). For the mixed patient groups (with and without polypoid disease) overall symptomatic improvement ranged from 40 to 98% (median 88%). Total complications in the case series studies ranged from 22.4 to 0.3% (median 6%). The majority of studies report that symptoms improve following FESS with relatively few complications; however, only a small proportion of evidence is comparative. Results from non-comparative studies do not inform the choices that need to be made by ENT surgeons and commissioners. Health economics data are also lacking and therefore cannot inform these decisions. FESS may offer some advantages in effectiveness over comparative techniques, but there is enormous variation in the range of results reported and there are severe methodological limitations. There is a clear need for quality-controlled trials in order to answer questions regarding the effectiveness of FESS. A number of priority research questions from a selection of ENT surgeons within the UK are identified and presented.
Abstract.
Garside R, Ayres R, Owen M, Pearson VAH, Roizen J (2002). Anonymity and confidentiality: rural teenagers' concerns when accessing sexual health services.
J Fam Plann Reprod Health Care,
28(1), 23-26.
Abstract:
Anonymity and confidentiality: rural teenagers' concerns when accessing sexual health services.
CONTEXT: While confidentiality is recognised as a key aspect of successful health services aimed at young people, most research has looked at the concerns of those in urban centres. This paper reports on qualitative and quantitative data collected from general practitioners (GPs) and young people in a rural health district. OBJECTIVE: to assess the concerns of rural teenagers regarding anonymity and confidentiality when accessing sexual health services. DESIGN: the views of teenagers about using health services for issues of sexual health were sought through an in-school survey of 311 Year 9 and 119 Year 11 students. In addition, 18 single-sex focus groups discussions were conducted in North and East Devon. All GPs in the district were asked to complete a questionnaire. RESULTS: These reveal that the particular concerns of young people from small communities are more to do with the difficulties of remaining anonymous, which are related to visibility and lack of privacy in small communities. These problems were more pervasive among rural young people than those concerns more usually reported about confidential consultations.
Abstract.
Author URL.
Garside R, Round A, Dalziel K, Stein K, Royle P (2002). The effectiveness and cost-effectiveness of imatinib in chronic myeloid leukaemia: a systematic review. Health Technology Assessment, 6(33).
Garside R, Round A, Dalziel K, Stein K, Royle P (2002). The effectiveness and cost-effectiveness of imatinib in chronic myeloid leukaemia: a systematic review. Health Technology Assessment, 6(33).
Garside R, Round A, Dalziel K, Stein K, Royle P (2002). The effectiveness and cost-effectiveness of imatinib in chronic myeloid leukaemia: a systematic review. Health technology assessment (Winchester, England), 6(33), 1-162.
Garside R, Round A, Dalziel K, Stein K, Royle P (2002). The effectiveness and cost-effectiveness of imatinib in chronic myeloid leukaemia: a systematic review.
Health Technol Assess,
6(33), 1-162.
Author URL.
Garside R, Ayres R, Owen MR, Pearson VH (2001). 'They never tell you about the consequences' Young people's awareness of sexually transmitted infections. International Journal of STD & AIDS, 12(9), 582-588.
Roizen J, Garside R, Barnett L (2001). Repeat use of emergency contraception: How frequent is it?.
Journal of Family Planning and Reproductive Health,
27(4), 197-202.
Abstract:
Repeat use of emergency contraception: How frequent is it?
Objective. To measure the level of repeat use of emergency contraception (EC) in family planning clinics (FPCs) in North and East Devon. Design. An audit of repeat use of EC was carried out in seven FPCs, in parallel with a client survey. All women seeking EC in the study period were included (n = 572). Results. Nearly 70% of women had 'ever' used EC prior to the study visit; over half had previously used EC in the year of the study; a quarter had previously used EC three or more times in the same period. Teenagers were more likely to have previously used EC in the study year, but half of all repeat users were aged 20 and older. Asked why EC was needed today, most women reported current use of regular contraception, but almost a quarter had had unprotected sex, and half reported a condom mishap. Conclusions. These results show frequent repeat use of EC and do not support recent research based on general practice records, which suggests that repeat use is rare. If EC users use multiple sources of EC, or prefer alternative sources, repeat use of EC will be underestimated if calculated using general practitioner (GP) records alone.
Abstract.
Garside R, Ayres R, Owen MR, Pearson VH, Roizen J (2000). General practitioners' attitudes to sexual activity in under-sixteens.
J R Soc Med,
93(11), 563-564.
Abstract:
General practitioners' attitudes to sexual activity in under-sixteens.
In the UK, under-sixteen-year-olds with some exceptions can be provided with contraceptive care even if unwilling to inform their parents. Nonetheless, many teenagers express doubts about confidentiality in these circumstances, as well as fear of being judged. The attitudes of general practitioners in North and East Devon towards the Gillick ruling regarding the treatment of under sixteens for sexual health matters were assessed. They were asked to indicate their level of agreement or disagreement with a series of statements. 235 (73%) responded, and only 15 (6.5%) rejected the notion that the same duty of confidentiality applies to under-sixteens as to older patients. 76% did, however, prefer parents to know they had been consulted about contraception. Only 7 GPs believed that provision of contraception encourages under-age sex. Despite GPs' general acknowledgment of the importance of confidentiality in relation to sexual activity, teenagers may well be discouraged from seeking advice if they expect strong pressure to tell their parents.
Abstract.
Author URL.
Garside R (1999). Condom shape: a neglected factor influencing use and acceptability? UK Family Planning Research Network.
Int J STD AIDS,
10(12), 785-790.
Abstract:
Condom shape: a neglected factor influencing use and acceptability? UK Family Planning Research Network.
Improving condom acceptability amongst users is one way to enhance efficacy. This study aimed to test whether or not the shape of a condom influenced users' perceptions of condom acceptability as measured through their ratings of condom comfort, sensitivity and security. Four types of condoms were tested which had 3 different shapes, and one of which also had a small diameter. Participants were recruited at 15 UK Family Planning Research Network Clinics and one Student Health Centre in England and Wales in late 1997. A total of 1193 people initially volunteered to take part and of these 204 men and 251 women completed the trial, giving an overall response rate of 38%. Results suggest that both men and women were able to detect differences in the shapes of the condoms and that differences led to preference for a particular condom type. Similar proportions preferred a straight-sided, a flared and a contoured condom, whilst the smaller, contoured condom was preferred by a minority of respondents. To optimize consistent condom use, providers should consider encouraging users to try a range of condoms to ensure that they are using the one most suitable for them.
Abstract.
Author URL.
