(1) Background: Applied health services research (AHSR) relies upon coordination across multiple organizational boundaries. Our aim was to understand how competing organizational and professional goals enhance or impede the conduct of high quality AHSR. (2) Methods: a qualitative study was conducted in two local health care systems in the UK, linked to a feasibility trial of a clinic-based intervention in secondary care. Data collection involved 24 semi-structured interviews with research managers, clinical research staff, health professionals, and patients. (3) Results: This study required a dynamic network of interactions between heterogeneous health and social care stakeholders, each characterized by differing ways of organizing activities which constitute their core functions; cultures of collaboration and interaction and understanding of what research involves and how it contributes to patient care. These interrelated factors compounded the occupational and organizational boundaries that hindered communication and coordination. (4) Conclusions: Despite the strategic development of multiple organizations to foster inter-professional collaboration, the competing goals of research and clinical practice can impede the conduct of high quality AHSR. To remedy this requires the alignment and streamlining of organizational goals, so that all agencies involved in AHSR develop a shared understanding and mutual respect for the progress of evidence-based medicine and the complex and often nuanced environments in which it is created and practiced.

OBJECTIVE: to explore whether a preconsultation web-based intervention enables patients with diabetes to articulate their agenda in a consultation in the hospital outpatient clinic with their diabetologist. METHODS AND DESIGN: a qualitative study embedded in a pragmatic pilot randomised controlled trial. SETTING: Two city outpatient departments in England. PARTICIPANTS: 25 patients attending a follow-up consultation and 6 diabetologists. INTERVENTION: the PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist. DATA COLLECTION: 25 participants had their consultation with their diabetologist audio-recorded: 12 in the control arm and 13 in the intervention arm; 12 of the latter also had their PACE-D intervention session and a consultation recorded. Semi-structured interviews with 6 diabetologists, and 12 patients (6 in the intervention group and 6 in the control group). ANALYSIS: Thematic discourse analysis undertaken with patient representatives trained in qualitative data analysis techniques. RESULTS: We identified four consultation types: diabetologist facilitated; patient identified; consultant facilitated and patient initiated and patient ignored. We also identified three critical aspects that explained the production and utilisation of the agenda form: existing consultative style; orientation to the use of the intervention and impact on the consultation. Where patients and diabetologists have a shared preference for a consultant-led or patient-led consultation, the intervention augments effective communication and shared decision making. However, where preferences diverge (eg, there is a mismatch in patients' and diabetologists' preferences and orientations), the intervention does not improve the potential for shared decision making. CONCLUSION: a simple web-based intervention facilitates the articulation of patients' unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making. More needs to be done to translate patient empowerment in the consultation setting into genuine self-efficacy. TRIAL REGISTRATION NUMBER: ISRCTN75070242.

It is common to undertake qualitative research alongside randomised controlled trials (RCTs) when evaluating complex interventions. Researchers tend to analyse these datasets one by one and then consider their findings separately within the discussion section of the final report, rarely integrating quantitative and qualitative data or findings, and missing opportunities to combine data in order to add rigour, enabling thorough and more complete analysis, provide credibility to results, and generate further important insights about the intervention under evaluation. This paper reports on a 2 day expert meeting funded by the United Kingdom Medical Research Council Hubs for Trials Methodology Research with the aims to identify current strengths and weaknesses in the integration of quantitative and qualitative methods in clinical trials, establish the next steps required to provide the trials community with guidance on the integration of mixed methods in RCTs and set-up a network of individuals, groups and organisations willing to collaborate on related methodological activity. We summarise integration techniques and go beyond previous publications by highlighting the potential value of integration using three examples that are specific to RCTs. We suggest that applying mixed methods integration techniques to data or findings from studies involving both RCTs and qualitative research can yield insights that might be useful for understanding variation in outcomes, the mechanism by which interventions have an impact, and identifying ways of tailoring therapy to patient preference and type. Given a general lack of examples and knowledge of these techniques, researchers and funders will need future guidance on how to undertake and appraise them.

Background: Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low. Design and methods: the aim of this multicentre randomized trial was to compare the REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction (HFrEF). The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ)) at 12 months compared with usual care alone. Results: the study recruited 216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34%. Overall, 185 (86%) participants provided data for the primary outcome. At 12 months, there was a significant and clinically meaningful between-group difference in the MLHFQ score of –5.7 points (95% confidence interval –10.6 to –0.7) in favour of the REACH-HF intervention group (p = 0.025). With the exception of patient self-care (p < 0.001) there was no significant difference in other secondary outcomes, including clinical events (p > 0.05) at follow-up compared with usual care. The mean cost of the REACH-HF intervention was £418 per participant. Conclusions: the novel REACH-HF home-based facilitated intervention for HFrEF was clinically superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure.

Surgical specialties account for a high proportion of antimicrobial use in hospitals, and misuse has been widely reported resulting in unnecessary patient harm and antimicrobial resistance. We aimed to synthesize qualitative studies on surgical antimicrobial prescribing behavior, in hospital settings, to explain how and why contextual factors act and interact to influence practice. Stakeholder engagement was integrated throughout to ensure consideration of varying interpretive repertoires and that the findings were clinically meaningful. The meta-ethnography followed the seven phases outlined by Noblit and Hare. Eight databases were systematically searched without date restrictions. Supplementary searches were performed including forwards and backwards citation chasing and contacting first authors of included papers to highlight further work. Following screening, 14 papers were included in the meta-ethnography. Repeated reading of this work enabled identification of 48 concepts and subsequently eight overarching concepts: hierarchy; fear drives action; deprioritized; convention trumps evidence; complex judgments; discontinuity of care; team dynamics; and practice environment. The overarching concepts interacted to varying degrees but there was no consensus among stakeholders regarding an order of importance. Further abstraction of the overarching concepts led to the development of a conceptual model and a line-of-argument synthesis, which posits that social and structural mediators influence individual complex antimicrobial judgements and currently skew practice towards increased and unnecessary antimicrobial use. Crucially, our model provides insights into how we might 'tip the balance' towards more evidence-based antimicrobial use. Currently, healthcare workers deploy antimicrobials across the surgical pathway as a safety net to allay fears, reduce uncertainty and risk, and to mitigate against personal blame. Our synthesis indicates that prescribing is unlikely to change until the social and structural mediators driving practice are addressed. Furthermore, it suggests that research specifically exploring the context for effective and sustainable quality improvement stewardship initiatives in surgery is now urgent.

BACKGROUND: Expert opinion is that about 20% of emergency stroke patients should receive thrombolysis. Currently, 11% to 12% of patients in England and Wales receive thrombolysis, ranging from 2% to 24% between hospitals. The aim of this study was to assess how much variation is due to differences in local patient populations, and how much is due to differences in clinical decision-making and stroke pathway performance, while estimating a realistic target thrombolysis use. METHODS: Anonymised data for 246 676 emergency stroke admissions to 132 acute hospitals in England and Wales between 2016 and 2018 was obtained from the Sentinel Stroke National Audit Programme data. We used machine learning to learn decisions on who to give thrombolysis to at each hospital. We used clinical pathway simulation to model effects of changing pathway performance. Qualitative research was used to assess clinician attitudes to these methods. Three changes were modeled: (1) arrival-to-treatment in 30 minutes, (2) proportion of patients with determined stroke onset times set to at least the national upper quartile, (3) thrombolysis decisions made based on majority vote of a benchmark set of hospitals. RESULTS: of the modeled changes, any single change was predicted to increase national thrombolysis use from 11.6% to between 12.3% to 14.5% (clinical decision-making having the most effect). Combined, these changes would be expected to increase thrombolysis to 18.3%, but there would still be significant variation between hospitals depending on local patient population. Clinicians engaged well with the modeling, but those from hospitals with lower thrombolysis use were most cautious about the methods. CONCLUSIONS: Machine learning and clinical pathway simulation may be applied at scale to national stroke audit data, allowing extended use and analysis of audit data. Stroke thrombolysis rates of at least 18% look achievable in England and Wales, but each hospital should have its own target.

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.

BACKGROUND: Current NHS policy encourages an integrated approach to provision of mental and physical care for individuals with long term mental health problems. The 'PARTNERS2' complex intervention is designed to support individuals with psychosis in a primary care setting. AIM: the trial will evaluate the clinical and cost-effectiveness of the PARTNERS2 intervention. DESIGN & SETTING: This is a cluster randomised controlled superiority trial comparing collaborative care (PARTNERS2) with usual care, with an internal pilot to assess feasibility. The setting will be primary care within four trial recruitment areas: Birmingham & Solihull, Cornwall, Plymouth, and Somerset. GP practices are randomised 1:1 to either (a) the PARTNERS2 intervention plus modified standard care ('intervention'); or (b) standard care only ('control'). METHOD: PARTNERS2 is a flexible, general practice-based, person-centred, coaching-based intervention aimed at addressing mental health, physical health, and social care needs. Two hundred eligible individuals from 39 GP practices are taking part. They were recruited through identification from secondary and primary care databases. The primary hypothesis is quality of life (QOL). Secondary outcomes include: mental wellbeing, time use, recovery, and process of physical care. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action, and look for unintended consequences. An economic evaluation will estimate its cost-effectiveness. Intervention delivery and follow-up have been modified during the COVID-19 pandemic. CONCLUSION: the overarching aim is to establish the clinical and cost-effectiveness of the model for adults with a diagnosis of schizophrenia, bipolar, or other types of psychoses.

Background: Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. Methods: Process evaluation sub-study parallels to a single-centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients’ and caregivers’ experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers. Results: Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation, or both. Conclusions: the REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial. Trial registration: ISRCTN78539530 (date of registration 7 July 2015).

Background: an estimated 6.5 million people are providing unpaid care in the UK. Cardiorespiratory illnesses, including heart failure, chronic obstructive pulmonary disease and coronary artery disease are amongst the leading causes of mortality and hospitalisations globally. People living with these conditions are required to adapt their lifestyle and behavioural to manage their illness. Caregivers are increasingly relied upon to provide support in these lifestyle and behavioural changes. However, understanding the impact of including caregivers on the health outcomes of patients living with long-term cardiorespiratory illness is inconsistent. Additionally, understanding the impact of including caregivers in self-management interventions on caregivers' quality of life lacks clarity.
Aim: This first aim of this research was to understand the impact of including caregivers in self-management interventions for patients and caregivers living with long-term cardiorespiratory illnesses. The second aim of this research was to understand how inclusion in a self-management intervention informed caregivers in their role and the subsequent caregiver actions which influenced patient health related quality of life.
Methods: Four linked research studies were completed. First, a mixed-methods systematic review was undertaken to understand the lived experience of being a caregiver for patients living with long-term cardiorespiratory illness (chapter 3). Second, a meta-analysis was conducted to synthesise the current body of evidence of randomised controlled trials (RCTs), which included caregivers in intervention delivery for long-term cardiorespiratory illnesses (chapter 4). Third, quantitative and qualitative secondary analyses of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) trials were undertaken. REACH-HF is a home-based self-management intervention for heart failure patients and their caregivers that formally included caregivers in its design and delivery. Quantitative analyses were completed at 4 and 6 months follow-up. These analyses examined three aspects of caregiver involvement in REACH-HF. The impact on patient health-related quality of life when formally involving caregivers in the REACH-HF intervention. The impact on caregiver quality of life following participation in the REACH-HF intervention and, lastly, whether there were factors that predicted caregiver health outcomes in response to the REACH-HF intervention (chapter 5). A qualitative secondary analysis utilised a cross-case analysis approach. The purpose of this analysis was to explain the quantitative findings and examine the nature of caregiving and how this contributed to patient self-care (chapter 6).
Results: the mixed-methods systematic review synthesised 54 studies (26,453 caregivers) (chapter 3). The concepts identified in this review emphasised the complexity of caregiving for adults with long-term cardiorespiratory illnesses and demonstrated the impact of caregiving on: (1) mental health, (2) caregiver role, (3) lifestyle change, (4) support for caregivers (5) knowledge, and (6) relationships. Four concepts were explicitly identified in the qualitative literature: (7) expert by experience, (8) vigilance, (9) time, and (10) shared-care. The quantitative meta-analysis of 13 RCTs (1,701 patient-caregiver dyads) (chapter 4) demonstrated that the pooled effect of patient health-related quality of life in RCTs that included caregivers in intervention delivery compared with studies that did not include caregivers were not significantly different (p = 0.84). Quantitative analysis of the pooled REACH-HF randomised controlled trials included 266 heart failure patients and 118 caregivers. The univariate analysis demonstrated improved health-related quality of life outcomes for patients when a caregiver was included in the intervention. Mean increase in overall Minnesota Living with Heart Failure Questionnaire score of 10.6 (CI 95% 2.7 to 18.4, p = 0.008) at 4 months follow-up. The direction of effect towards caregiver presence remained at 6 months follow-up (9.6, CI 95% 1.1 to 18.2, p =0.026). Multivariate analysis demonstrated that an interaction effect on patient HRQoL in favour of patients with a caregiver remained at 4 months follow-up (9.9, 1.9 to 18.0, p = 0.015). However, this was not sustained at 6 months follow-up (2.2, -0.5 to 4.9, p = 0.113). Increased patient illness severity was the most consistent predictor of caregiver outcomes, however this was not observed across all caregiver outcomes measures. REACH-HF did not consistently demonstrate improvements across all caregiver outcomes; however, it did demonstrate potential to improve caregiver anxiety as well as social and lifestyle burden. The qualitative secondary analysis demonstrated that as a result of REACH-HF, caregivers were enabled to engage in overt and discrete caregiving tasks. Overt caregiving tasks included use of the REACH-HF progress tracker to communicate effectively about HF self-management. Discrete caregiving tasks included utilising the knowledge obtained from the patient manual and caregiver resource to make decisions about how much assistance to provide to the patient dependent on what the caregiver observed (e.g. face colour, tone of voice). Sustained change was difficult to achieve for some patient-caregiver dyads, some caregivers had difficulties motivating the patient to maintain engagement with self-management strategies. A combination of factors was identified by patient-caregiver dyads who reported difficulty maintaining change. These included, the duration of diagnosis, the severity of illness, the demands on the caregivers’ time, and the concept of the meaningfulness of the task for the patient.
Conclusions: Caregivers do have a key role in the self-management of patients with long-term cardiorespiratory illnesses, such as HF and COPD. Understanding the caregiver role and the nature of the patient-caregiver relationship can significantly influence how we can better engage patients in the self-management of their illness. REACH-HF facilitated patients and caregivers to communicate effectively about HF self-management, increased their HF knowledge and skills and enabled caregivers to feel supported with the inclusion of the wider family. That disease severity was the most consistent predictor of poor caregiver outcomes, and the challenges of sustaining behaviour change indicates the need for ongoing healthcare support for both patients and caregivers as disease progresses. The value of engaging in self-management tasks that are meaningful to the patient and caregiver was an important finding and is an approach that may facilitate sustained behaviour change. This thesis discusses the methodological and practical implications of these findings on the involvement of caregivers in healthcare interventions for long-term cardiorespiratory illnesses and future research.

(1) Background: Applied health services research (AHSR) relies upon coordination across multiple organizational boundaries. Our aim was to understand how competing organizational and professional goals enhance or impede the conduct of high quality AHSR. (2) Methods: a qualitative study was conducted in two local health care systems in the UK, linked to a feasibility trial of a clinic-based intervention in secondary care. Data collection involved 24 semi-structured interviews with research managers, clinical research staff, health professionals, and patients. (3) Results: This study required a dynamic network of interactions between heterogeneous health and social care stakeholders, each characterized by differing ways of organizing activities which constitute their core functions; cultures of collaboration and interaction and understanding of what research involves and how it contributes to patient care. These interrelated factors compounded the occupational and organizational boundaries that hindered communication and coordination. (4) Conclusions: Despite the strategic development of multiple organizations to foster inter-professional collaboration, the competing goals of research and clinical practice can impede the conduct of high quality AHSR. To remedy this requires the alignment and streamlining of organizational goals, so that all agencies involved in AHSR develop a shared understanding and mutual respect for the progress of evidence-based medicine and the complex and often nuanced environments in which it is created and practiced.

Abstract
Background
Current quantitative methods for personalising psychotherapies for depression are unlikely to be able to inform clinical decision-making for hundreds of years. Novel alternative methods to generate hypotheses for prospective testing are therefore required, and we showcase mixed methods as one such approach. By exploring patients’ perspectives in depth, and integrating qualitative and quantitative data at the level of the individual, we may identify new potential psychosocial predictors of psychotherapy outcomes, potentially informing the personalisation of depression treatment in a shorter timeframe. Using Morita therapy (a Japanese psychotherapy) as an exemplar, we thus explored how Morita therapy recipients’ views on treatment acceptability explain their adherence and response to treatment.

Methods
The Morita trial incorporated a pilot randomised controlled trial of Morita therapy versus treatment as usual for depression, and post-treatment qualitative interviews. We recruited trial participants from general practice record searches in Devon, UK, and purposively sampled data from 16 participants for our mixed methods analysis. We developed typologies of participants’ views from our qualitative themes, and integrated these with quantitative data on number of sessions attended and whether participants responded to treatment in a joint typologies and statistics display. We enriched our analysis using participant vignettes to demonstrate each typology.

Results
We demonstrated that (1) participants who could identify with the principles of Morita therapy typically responded to treatment, regardless of how many sessions they attended, whilst those whose orientation towards treatment was incompatible with Morita therapy did not respond to treatment, again regardless of treatment adherence and (2) participants whose personal circumstances impeded their opportunity to engage in Morita therapy attended the fewest sessions, though still benefitted from treatment if the principles resonated with them.

Conclusions
We identified new potential relationships between “orientation” and outcomes, and “opportunity” and adherence, which could not have been identified using existing non-integrative methods. This mixed methods approach warrants replication in future trials and with other psychotherapies to generate hypotheses, based on typologies (or profiles) of patients for whom a treatment is more or less likely to be suitable, to be tested in prospective trials.

Trial registration
Current Controlled Trials, ISRCTN17544090. Registered on 23 July 2015.

BACKGROUND: Surgical specialities use extensive amounts of antimicrobials, and misuse has been widely reported, making them a key target for antimicrobial stewardship initiatives. Interventions informed by, and tailored to, a clear understanding of the contextual barriers to appropriate antimicrobial use are more likely to successfully improve practice. However, this approach has been under utilised. Our aim is to synthesise qualitative studies on surgical antimicrobial prescribing behaviour (APB) in hospital settings to explain how and why contextual factors act and interact to influence APB amongst surgical teams. We will develop new theory to advance understanding and identify knowledge gaps to inform further research. METHODS: the meta-ethnography will follow the seven-phase method described by Noblit and Hare. We will conduct a comprehensive search using eight databases (AMED, CINAHL, EMBASE, MEDLINE, MEDLINE-in-process, Web of Science, Cochrane Library and PsycINFO) with no date restrictions; forwards and backwards citation searches; and contacting first authors of relevant papers. Studies will be dual screened and included if they use recognised qualitative methods and analysis; focus on contextual factors associated with surgical APB within hospital settings; are available in full in English; and are relevant to the research question. Any disagreements between reviewers will be resolved through discussion to reach consensus. Included studies will be read repeatedly to illuminate key concepts and the relationship between key concepts across studies. Then, key concepts will be sorted into conceptual categories or 'piles' which will be further abstracted to form a conceptual framework explaining surgical APB. During the synthesis, emerging interpretations will be discussed with stakeholders (including authors of included studies where possible; surgical and stewardship practitioners; and patient representatives) to ensure new knowledge is meaningful. DISCUSSION: This research has several strengths: (1) the protocol has been written with reference to established guidance maximising rigour and transparency; (2) the multi-disciplinary research team bring varied interpretative repertoires and relevant methodological skills; and (3) stakeholders will be involved to ensure that findings are relevant, and disseminated via suitable channels, to support improved patient care. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020184343.

Abstract
Morita Therapy is a Japanese psychotherapy which contrasts with established Western approaches in teaching, through behavioural experience, that symptoms are part of the natural ecology of human experience. Morita Therapy has received increasing international interest over the decades, and the first randomized controlled trial of Morita Therapy to be published outside of China has recently demonstrated the promise of the approach in treating Western patients. To respond to the resulting interest in Morita Therapy from patients and practitioners, and facilitate further Morita Therapy research, it is necessary to provide the detailed explanation of Morita Therapy which is currently rare in the West. In this article, we fill this gap with a thorough description of Morita Therapy in terms of the key principles, objectives and processes of the approach; its basis in Eastern philosophy and naturalism; its sociohistorical context and development over a wide range of formats, patient conditions, and countries. To enable Western practitioners to appreciate and capitalize on the potential value of Morita Therapy as a distinct alternative for patients, we illustrate the approach’s unique method and objective compared to Western psychotherapies, and provide recommendations for practitioners applying Morita Therapy across cultures.

BACKGROUND: Caregivers frequently provide support to people living with long-term conditions. However, there is paucity of evidence of interventions that support caregivers in their role. Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) is a novel home-based, health-professional-facilitated, self-management programme for patients with heart failure (HF) and their caregivers. METHODS: Based on the random allocation of individual adult patients with reduced ejection fraction (HFrEF) and left ventricular ejection fraction

OBJECTIVE: to explore whether a preconsultation web-based intervention enables patients with diabetes to articulate their agenda in a consultation in the hospital outpatient clinic with their diabetologist. METHODS AND DESIGN: a qualitative study embedded in a pragmatic pilot randomised controlled trial. SETTING: Two city outpatient departments in England. PARTICIPANTS: 25 patients attending a follow-up consultation and 6 diabetologists. INTERVENTION: the PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist. DATA COLLECTION: 25 participants had their consultation with their diabetologist audio-recorded: 12 in the control arm and 13 in the intervention arm; 12 of the latter also had their PACE-D intervention session and a consultation recorded. Semi-structured interviews with 6 diabetologists, and 12 patients (6 in the intervention group and 6 in the control group). ANALYSIS: Thematic discourse analysis undertaken with patient representatives trained in qualitative data analysis techniques. RESULTS: We identified four consultation types: diabetologist facilitated; patient identified; consultant facilitated and patient initiated and patient ignored. We also identified three critical aspects that explained the production and utilisation of the agenda form: existing consultative style; orientation to the use of the intervention and impact on the consultation. Where patients and diabetologists have a shared preference for a consultant-led or patient-led consultation, the intervention augments effective communication and shared decision making. However, where preferences diverge (eg, there is a mismatch in patients' and diabetologists' preferences and orientations), the intervention does not improve the potential for shared decision making. CONCLUSION: a simple web-based intervention facilitates the articulation of patients' unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making. More needs to be done to translate patient empowerment in the consultation setting into genuine self-efficacy. TRIAL REGISTRATION NUMBER: ISRCTN75070242.

It is common to undertake qualitative research alongside randomised controlled trials (RCTs) when evaluating complex interventions. Researchers tend to analyse these datasets one by one and then consider their findings separately within the discussion section of the final report, rarely integrating quantitative and qualitative data or findings, and missing opportunities to combine data in order to add rigour, enabling thorough and more complete analysis, provide credibility to results, and generate further important insights about the intervention under evaluation. This paper reports on a 2 day expert meeting funded by the United Kingdom Medical Research Council Hubs for Trials Methodology Research with the aims to identify current strengths and weaknesses in the integration of quantitative and qualitative methods in clinical trials, establish the next steps required to provide the trials community with guidance on the integration of mixed methods in RCTs and set-up a network of individuals, groups and organisations willing to collaborate on related methodological activity. We summarise integration techniques and go beyond previous publications by highlighting the potential value of integration using three examples that are specific to RCTs. We suggest that applying mixed methods integration techniques to data or findings from studies involving both RCTs and qualitative research can yield insights that might be useful for understanding variation in outcomes, the mechanism by which interventions have an impact, and identifying ways of tailoring therapy to patient preference and type. Given a general lack of examples and knowledge of these techniques, researchers and funders will need future guidance on how to undertake and appraise them.

OBJECTIVE: to explore the views of UK-based recipients of Morita Therapy (MT) on the acceptability of MT. DESIGN: Qualitative study nested within a pilot randomised controlled trial of MT (a Japanese psychological therapy largely unknown in the UK) versus treatment as usual, using post-treatment semistructured interviews analysed with a framework approach. SETTING AND PARTICIPANTS: Participants who received MT as part of the Morita Trial, recruited for the trial from General Practice record searches in Devon, UK. Data from 16 participants were purposively sampled for analysis. RESULTS: We identified five themes which, together, form a model of how different participants viewed and experienced MT. Overall, MT was perceived as acceptable by many participants who emphasised the value of the approach, often in comparison to other treatments they had tried. These participants highlighted how accepting and allowing difficulties as natural phenomena and shifting attention from symptoms to external factors had facilitated symptom reduction and a sense of empowerment. We found that how participants understood and related to the principles of MT, in light of their expectations of treatment, was significantly tied to the extent to which MT was perceived as acceptable. Our findings also highlighted the distinction between MT in principle and practice, with participants noting challenges of engaging with the process of therapy such as fear and discomfort around rest, needing sufficient support from the therapist and others, and the commitment of treatment. CONCLUSIONS: People in the UK can accept the premise of MT, and consider the approach beneficial and novel. Therefore, proceeding to a large-scale trial of MT is appropriate with minor modifications to our clinical protocol. Participants' expectations and understandings of treatment play a key role in acceptability, and future research may investigate these potential moderators of acceptability in MT. TRIAL REGISTRATION NUMBERC: ISRCTN17544090; Pre-results.

BACKGROUND: the REACH-HF (Rehabilitation EnAblement in CHronic Heart Failure) trial found that the REACH-HF home-based cardiac rehabilitation intervention resulted in a clinically meaningful improvement in disease-specific health-related quality of life in patients with reduced ejection fraction heart failure (HFrEF). The aims of this study were to assess the long-term cost-effectiveness of the addition of REACH-HF intervention or home-based cardiac rehabilitation to usual care compared with usual care alone in patients with HFrEF. DESIGN AND METHODS: a Markov model was developed using a patient lifetime horizon and integrating evidence from the REACH-HF trial, a systematic review/meta-analysis of randomised trials, estimates of mortality and hospital admission and UK costs at 2015/2016 prices. Taking a UK National Health and Personal Social Services perspective we report the incremental cost per quality-adjusted life-year (QALY) gained, assessing uncertainty using probabilistic and deterministic sensitivity analyses. RESULTS: in base case analysis, the REACH-HF intervention was associated with per patient mean QALY gain of 0.23 and an increased mean cost of £400 compared with usual care, resulting in a cost per QALY gained of £1720. Probabilistic sensitivity analysis indicated a 78% probability that REACH-HF is cost effective versus usual care at a threshold of £20,000 per QALY gained. Results were similar for home-based cardiac rehabilitation versus usual care. Sensitivity analyses indicate the findings to be robust to changes in model assumptions and parameters. CONCLUSIONS: Our cost-utility analyses indicate that the addition of the REACH-HF intervention and home-based cardiac rehabilitation programmes are likely to be cost-effective treatment options versus usual care alone in patients with HFrEF.

Background: Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low. Design and methods: the aim of this multicentre randomized trial was to compare the REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction (HFrEF). The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ)) at 12 months compared with usual care alone. Results: the study recruited 216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34%. Overall, 185 (86%) participants provided data for the primary outcome. At 12 months, there was a significant and clinically meaningful between-group difference in the MLHFQ score of –5.7 points (95% confidence interval –10.6 to –0.7) in favour of the REACH-HF intervention group (p = 0.025). With the exception of patient self-care (p < 0.001) there was no significant difference in other secondary outcomes, including clinical events (p > 0.05) at follow-up compared with usual care. The mean cost of the REACH-HF intervention was £418 per participant. Conclusions: the novel REACH-HF home-based facilitated intervention for HFrEF was clinically superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure.

BACKGROUND: Reducing unnecessary prescribing remains a key priority for tackling the global rise of antibiotic-resistant infections. AIM: the 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 SETTING: Systematic review and meta-ethnography of qualitative studies. METHOD: a 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. RESULTS: in 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). CONCLUSION: Contrary 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.

AIMS AND OBJECTIVES: to determine the effects of nursing interventions for people's nutrition, elimination, mobility and hygiene needs. BACKGROUND: Patient experience of health care is sensitive to nursing quality. A refocus on fundamental nursing care is undermined by lack of evidence of effectiveness for interventions in core areas such as elimination, nutrition, mobility and hygiene. DESIGN: Systematic review. METHODS: We searched for and included experimental studies on interventions by professionally qualified and unregistered nurses that addressed participants' nutrition, elimination, mobility and hygiene needs. We extracted data on scope, quality and results of studies followed by descriptive narrative synthesis of included study outcomes using a novel form of harvest plots. RESULTS: We included 149 studies, 35 nutrition, 56 elimination, 16 mobility, 39 hygiene and three addressing two or more areas simultaneously (67 randomised controlled trials, 32 non-randomised controlled trials and 50 uncontrolled trials). Studies into interventions on participant self-management of nutrition (n = 25), oral health (n = 26), catheter care (n = 23) and self-management of elimination (n = 21) were the most prevalent. Most studies focussed their outcomes on observational or physiological measures, with very few collecting patient-reported outcomes, such as quality of life, experience or self-reported symptoms. All but 13 studies were of low quality and at significant risk of bias. The majority of studies did not define primary outcomes, included multiple measures of identical concepts, used inappropriate analyses and did not conform to standard reporting quality criteria. CONCLUSIONS: the current evidence for fundamental nursing care interventions is sparse, of poor quality and unfit to provide evidence-based guidance to practising nurses. RELEVANCE TO CLINICAL PRACTICE: Researchers in nursing internationally should now undertake a programme of work to produce evidence for clinical practice in the fundamentals of care that is reliable, replicable and robust.

OBJECTIVE: to address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible. DESIGN: Pilot parallel group randomised controlled feasibility trial. SETTING AND PARTICIPANTS: Participants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK. INTERVENTIONS: We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention). OUTCOMES: Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores. RESULTS: We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively. CONCLUSIONS: a large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments. TRIAL REGISTRATION NUMBER: ISRCTN17544090; Pre-results.

Background: We conducted a pilot study of an intervention to facilitate patients’ agenda setting in clinical consultations. The primary aim of the study was to test the feasibility of running the randomized controlled trial. A secondary objective was to assess the extent to which patient and public involvement (PPI) could contribute to the process of qualitative data analysis (QDA). Aims: to describe a novel approach to including patient partners in QDA; to illustrate the kinds of contribution that patient partners made to QDA in this context; and to propose a characterization of a process by which patient involvement can contribute to knowledge production. Methods: Six patient and public representatives were supported to contribute to data analysis via a range of modalities. During a series of QDA workshops, experienced research staff role-played consultations and interviews, and provided vignettes. Workshop data and PPI diaries were analysed using thematic discourse analysis. Results: We characterized a process of thesis, antithesis and synthesis. This PPI group contributed to the rigour and validity of the study findings by challenging their own and the researchers’ assumptions, and by testing the emerging hypotheses. By training PPI representatives to undertake qualitative data analysis, we transformed our understanding of doctor–patient consultations. Conclusions: This research required changes to our usual research practices but was in keeping with the objective of establishing meaningful patient involvement for a future definitive trial. This work was informed by concepts of critical humility, and a process of knowledge production enabled via the construction of a knowledge space.

OBJECTIVE: to test the feasibility of running a randomised controlled trial of a preconsultation web-based intervention (Presenting Asking Checking Expressing (PACE-D)) to improve the quality of care and clinical outcomes in patients with diabetes. DESIGN AND SETTING: a feasibility study (with randomisation) conducted at outpatient diabetes clinics at two secondary care hospitals in Devon, UK. PARTICIPANTS: People with diabetes (type 1 and type 2) attending secondary care general diabetes outpatient clinics. INTERVENTION: the PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist. OUTCOMES: the percentage of eligible patients who were recruited and the percentage of participants for whom routine glycosylated haemoglobin (HbA1c) data (the putative primary outcome) could be extracted from medical notes and who completed secondary outcome assessments via questionnaire at follow-up were reported. RESULTS: in contrast with the planned recruitment of 120 participants, only 71 participants were randomised during the 7-month recruitment period. This comprised 18.7% (95% CI 14.9% to 23.0%) of those who were eligible. Mean (SD) age of the participants was 56.5 (12.4) years and 66.2% had type 1 diabetes. Thirty-eight patients were randomised to the intervention arm and 33 to the control arm. HbA1c data were available for only 73% (95% CI 61% to 83%) of participants at the 6â€
months follow-up. The questionnaire-based data were collected for 66% (95% CI 54% to 77%) of the participants at 6â€
months follow-up. Participants reported that the PACE-D tool was easy to use. CONCLUSIONS: a randomised controlled trial of the preconsultation web-based intervention as set out in our current protocol is not feasible without significant modification to improve recruitment and follow-up of participants. The study also provides insights into the feasibility and challenges of conducting complex intervention trials in everyday clinical practice. TRIAL REGISTRATION: ISRCTN75070242.

This article explores how people with progressive multiple sclerosis give meaning to their experiences. It builds upon the self-management literature, which has captured the tension between the desire for retaining normalcy and the increasing burden of self-management associated with chronic disease progression. This repeat interview study is empirically grounded in 28 interviews with 14 people with progressive multiple sclerosis. We identified gender differences in diagnosis-seeking which impacted subsequent sense-making. Male respondents found a diagnosis of multiple sclerosis difficult to come to terms with, and an enduring sense of loss or anger could inhibit further sense-making. A diagnosis of multiple sclerosis was more difficult to obtain for women respondents, and any sense of certainty that diagnosis provided framed their subsequent sense-making strategies. The complex sequelae of multiple sclerosis require that self-management strategies are both contextual and timely, although even the most accomplished self-managers can lose their sense of self with neurodegeneration. Disease progression can be associated with suicidal ideation, suggesting the need for greater dialogue to ensure that people with multiple sclerosis are adequately supported to fulfil their quality of life at all stages of neurodegeneration. These lay perspectives emphasise the articulation of affect rather than the rendering of a medical diagnosis, although diagnosis may provide a degree of certainty in the short term. The ethos of self-management ensures people attempt to retain their sense of 'normality' and existent social roles for as long as possible, but this ethos can negate both one's ability to self-manage and the management of self.

We continue the conversation initiated by Sally Thorne's observations about "metasynthetic madness." We note that the variety of labels used to describe qualitative syntheses often reflect authors' disciplines and geographical locations. The purpose of systematic literature searching is to redress authors' lack of citation of relevant earlier work and to reassure policy makers that qualitative syntheses are systematic and transparent. There is clearly a need to develop other methods of searching to supplement electronic searches. If searches produce large numbers of articles, sampling strategies may be needed to choose which articles to synthesize. The quality of any synthesis is dependent on the quality of the primary articles; both primary research and qualitative synthesis need to move beyond description and toward theory and explanation. Synthesizers need to pay attention to those articles which do not seem to fit their emerging analysis if they are to avoid stifling new ideas.

BACKGROUND: Caregivers support self-management in heart failure but often experience stress, anxiety and ill health as a result of providing care. AIMS: 1. To identify the factors that contribute to the experience of anguish.2. To understand how caregivers learn to live with what is frequently a challenging and demanding role. METHODS: Individual interviews with caregivers who had been caring for someone with heart failure for a minimum of 6 months. We used thematic analysis to inductively analyse transcripts. RESULTS: Twenty-two caregivers, from three centres in the United Kingdom, took part in individual interviews. The caregivers were aged between 39 and 84 years, and six were men. Twenty were in spousal or partner relationships. We found that caregivers often hide the extent of their emotional stress or anguish. We identified four main themes with explanatory subthemes-emotional impact (fear for the future and sense of hopelessness), role definition (changing sense of who I am, reduced resilience, learning care skills, role conflict and changing role), exclusion (exclusion by the cared-for person and by health professionals and feeling alone) and ignoring one's own health-that were associated with anguish. From these findings, we produced a caregiver needs assessment model in the context of caring for a person with heart failure. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Caregivers have many unmet and hidden needs. Primary care health professionals are well placed to meet the needs of caregivers. The model may be used by health and social care professionals to identify needs and to provide caregivers with targeted practical and emotional support; and for researchers developing interventions to enhance self-management in heart failure.

BACKGROUND: Guidelines and evidence-based drug treatment recommendations are usually based on the results of clinical trials, which have limited generalisability in routine clinical settings due to their restrictive eligibility criteria. These trials are also conducted in ideal and rigorously controlled settings. N of 1 trials, which are single patient multiple crossover studies, offer a means of increasing the evidence base and individualising care for individuals in clinical practice. This systematic review of the N of 1 drug treatment trial aims to investigate its usefulness for achieving optimal individualised patient care. METHODS: the following databases will be searched for relevant articles: MEDLINE, EMBASE, PsycINFO (all via Ovid), AMED, CINAHAL (via EBSCO), the Cochrane Library (including CENTRAL, NHS EED, and DARE), and Web of Science (Thomson Reuters). Supplementary searches will include ongoing trial databases and organisational websites. All N of 1 trials in which patients have been treated with a drug will be considered. Outcomes will include information on the clinical usefulness of N of 1 trials-i.e. achievement of optimal individualised care, health-care utilisation of patients, frequently used practices, experiences of clinical care or participation in N of 1 trials, adherence to treatment plan, and unwanted effects of the treatment. Screening of included papers will be undertaken independently by two reviewers, while data extraction and the quality of reporting will be conducted by one reviewer and checked by another. Both quantitative and qualitative summaries will be reported using appropriate methods. DISCUSSION: This review will provide new insights into the clinical utility of N of 1 drug trials in helping participants find the most acceptable treatment as defined by patients and clinicians based on the selected outcome measures and the perspectives of participants involved in such trials. Findings from this review will inform the development of a stakeholder workshop and guidance to help physicians find the optimum therapy for their patients and will help guide future research on N of 1 trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016032452.

BACKGROUND: the aim of this paper is to showcase best practice in intervention development by illustrating a systematic, iterative, person-based approach to optimising intervention acceptability and feasibility, as applied to the cross-cultural adaptation of Morita therapy for depression and anxiety. METHODS: We developed the UK Morita therapy outpatient protocol over four stages integrating literature synthesis and qualitative research. Firstly, we conducted in-depth interviews combining qualitative and cognitive interviewing techniques, utilising vignettes of Morita therapy being delivered and analysed using Framework analysis to investigate potential patients and therapists' perceptions of Morita therapy. Secondly, we developed qualitative themes into recommendations for optimising Morita therapy and synthesised Morita therapy literature in line with these to develop a draft protocol. Thirdly, we conducted repeat interviews with therapists to investigate their views of the protocol. Finally, we responded to these qualitative themes through protocol modification and tailoring our therapist training programme. RESULTS: As a consequence of literature describing Morita therapy and participants' perceptions of the approach, we developed both a therapy protocol and therapist training programme which were fit for purpose in proceeding to a UK-based Morita therapy feasibility study. As per our key qualitative findings and resulting recommendations, we structured our protocol according to the four-phased model of Morita therapy, included detailed guidance and warning points, and supported therapists in managing patients' expectations of the approach. CONCLUSIONS: Our systematic approach towards optimising intervention acceptability and feasibility prioritises the perspectives of those who will deliver and receive the intervention. Thus, we both showcase best practice in intervention development and demonstrate the application of this process to the careful cross-cultural adaptation of an intervention in which balancing both optimisation of and adherence to the approach are key. This presentation of a generalisable process in a transparent and replicable manner will be of interest to those both developing and evaluating complex interventions in the future.

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.

BACKGROUND: Morita Therapy, a psychological therapy for common mental health problems, is in sharp contrast to established western psychotherapeutic approaches in teaching that undesired symptoms are natural features of human emotion rather than something to control or eliminate. The approach is widely practiced in Japan, but untested and little known in the UK. A clinical trial of Morita Therapy is required to establish the effectiveness of Morita Therapy for a UK population. However, a number of methodological, procedural and clinical uncertainties associated with such a trial first require addressing. METHODS/DESIGN: the Morita Trial is a mixed methods study addressing the uncertainties associated with an evaluation of Morita Therapy compared with treatment as usual for depression and anxiety. We will undertake a pilot randomised controlled trial with embedded qualitative study. Sixty participants with major depressive disorder, with or without anxiety disorders, will be recruited predominantly from General Practice record searches and randomised to receive Morita Therapy plus treatment as usual or treatment as usual alone. Morita Therapy will be delivered by accredited psychological therapists. We will collect quantitative data on depressive symptoms, general anxiety, attitudes and quality of life at baseline and four month follow-up to inform future sample size calculations; and rates of recruitment, retention and treatment adherence to assess feasibility. We will undertake qualitative interviews in parallel with the trial, to explore people's views of Morita Therapy. We will conduct separate and integrated analyses on the quantitative and qualitative data. DISCUSSION: the outcomes of this study will prepare the ground for the design and conduct of a fully-powered evaluation of Morita Therapy plus treatment as usual versus treatment as usual alone, or inform a conclusion that such a trial is not feasible and/or appropriate. We will obtain a more comprehensive understanding of these issues than would be possible from either a quantitative or qualitative approach alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17544090 registered on 23 July 2015.

BACKGROUND: We aimed to establish the support needs of people with heart failure and their caregivers and develop an intervention to improve their health-related quality of life. METHODS: We used intervention mapping to guide the development of our intervention. We identified "targets for change" by synthesising research evidence and international guidelines and consulting with patients, caregivers and health service providers. We then used behaviour change theory, expert opinion and a taxonomy of behaviour change techniques, to identify barriers to and facilitators of change and to match intervention strategies to each target. A patient and public involvement group helped to identify patient and caregiver needs, refine the intervention objectives and strategies and deliver training to the intervention facilitators. A feasibility study (ISRCTN25032672) involving 23 patients, 12 caregivers and seven trained facilitators at four sites assessed the feasibility and acceptability of the intervention and quality of delivery and generated ideas to help refine the intervention. RESULTS: the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention is a comprehensive self-care support programme comprising the "Heart Failure Manual", a choice of two exercise programmes for patients, a "Family and Friends Resource" for caregivers, a "Progress Tracker" tool and a facilitator training course. The main targets for change are engaging in exercise training, monitoring for symptom deterioration, managing stress and anxiety, managing medications and understanding heart failure. Secondary targets include managing low mood and smoking cessation. The intervention is facilitated by trained healthcare professionals with specialist cardiac experience over 12 weeks, via home and telephone contacts. The feasibility study found high levels of satisfaction and engagement with the intervention from facilitators, patients and caregivers. Intervention fidelity analysis and stakeholder feedback suggested that there was room for improvement in several areas, especially in terms of addressing caregivers' needs. The REACH-HF materials were revised accordingly. CONCLUSIONS: We have developed a comprehensive, evidence-informed, theoretically driven self-care and rehabilitation intervention that is grounded in the needs of patients and caregivers. A randomised controlled trial is underway to assess the effectiveness and cost-effectiveness of the REACH-HF intervention in people with heart failure and their caregivers.

Self-management policies have presented opportunities for patients with long-term conditions to take control and actively improve their health. However, the work of self-management appears to be packaged in the form of essential and desirable skills and attributes required for success. This article presents the findings of a qualitative study, employing longitudinal diary interviews with 21 patients aged between 60 and 85 years diagnosed with coronary heart disease from three contrasting general practice areas. Drawing on concepts of the care of the self and the reflexive self, this article presents the diversity of self-management practices by older patients in the context of their lifeworld. Illustrated through individual case studies, it clearly identifies where patients are engaged self-managers with the agency, knowledge and self-discipline to modify their behaviour for an improved health outcome. This study highlights their life and illness perspectives as well as those of patients who are burdened with emotional insecurity, comorbidities and caring responsibilities. It shows the spectrum of relationships with health professionals that influence engaged self-management. We suggest that policy initiatives that favour behavioural change neglect social context and the individualised practices that are a necessary response to structural and psychosocial constraints.

OBJECTIVES: to identify the needs of caregivers supporting a person with heart failure and to inform the development of a caregiver resource to be used as part of a home-based self-management programme. METHODS: a qualitative study informed by thematic analysis involving 26 caregivers in individual interviews or a focus group. RESULTS: Three distinct aspects of caregiver support in heart failure management were identified. Firstly, caregivers identified needs about supporting management of heart failure including: coping with the variability of heart failure symptoms, what to do in an emergency, understanding and managing medicines, providing emotional support, promoting exercise and physical activity, providing personal care, living with a cardiac device and supporting depression management. Secondly, as they make the transition to becoming a caregiver, they need to develop skills to undertake difficult discussions about the role; communicate with health professionals; manage their own mental health, well-being and sleep; and manage home and work. Thirdly, caregivers require skills to engage social support, and voluntary and formal services while recognising that the long-term future is uncertain. DISCUSSION: the identification of the needs of caregiver has been used to inform the development of a home-based heart failure intervention facilitated by a trained health care practitioner.

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.

OBJECTIVES: Patients and policy makers advocate that drug treatments should be individualised. However, the term is used in a variety of ways. We set out to identify the range of related terminology and concepts in the general field of individualisation, map out the relationships between these concepts and explore how patients' perspectives are considered. DESIGN: We consulted members of an established patient and public involvement group about their experience of medicine taking for long-term conditions and their ideas about individualisation. We then conducted a scoping review of the literature to explore how terms surrounding individualisation of drug treatment are used and defined in the literature, and to explore the extent to which patients' perspectives are represented, with a view to informing future recommendations as to how individualisation can be operationalised. METHODS: We identified relevant literature using a range of search strategies. Two researchers independently extracted definitions of terms using a template. Inductive and deductive methods were used to explore the data. RESULTS: Definitions were categorised according to the following themes: medical management; pharmacogenetics, the patient's perspective; interactions between the healthcare provider and patient and management of long-term conditions. CONCLUSIONS: Within the literature reviewed, the involvement of patients in the ongoing management of drug treatment was largely absent. We propose the use of a new term 'mutually agreed tailoring' (MAT). This describes the ongoing pharmacological management of conditions that incorporates patients' specific needs, experiences and existing strategies for using their medications, and the professionals' clinical judgement. This usually includes patients monitoring their symptoms and, with the support of the professional, making appropriate product, dose or timing adjustments as necessary. Our previous work suggests that many patients and doctors are successfully practising MAT, so we suggest that a formal description may facilitate wider utilisation of strategies that will improve patient outcomes.

INTRODUCTION: Diabetes is a chronic condition associated with many long-term complications. People with diabetes need to actively manage their condition, which can be complex. In consultations with healthcare professionals, patients receive advice about their diabetes but do not always discuss things which concern them, perhaps because of the perceived limited time or embarrassment. We want to test a 'preconsultation' intervention in which the patient is supported by a healthcare assistant to complete a web-based intervention aimed at producing an agenda to help them identify important areas for discussion in the consultation. Use of this agenda may enable the patient to play a more active role in that consultation and consequently become more confident, and hence more successful, in managing their condition. METHODS AND ANALYSIS: in this pilot randomised controlled trial, 120 people with diabetes will be randomised with equal allocation to receive the intervention or usual clinical care. The primary outcome is reduction in glycosylated haemoglobin(HbA1c). Secondary outcomes are patient-reported communication, enablement, self-care activity, diabetes-dependent quality of life, empowerment, satisfaction, health-related quality of life and resource use. The aim of the pilot study was to estimate parameters to inform the design of the definitive trial. Follow-up on quantitative outcomes will be at 3 and 6 months. A nested qualitative study will collect data on the patients' experiences of producing an agenda. Resource use data and medication use will also be collected via a review of medical records for a sample of participants. ETHICS AND DISSEMINATION: Approval was granted by the NHS Research Ethics Committee North West-Preston (13/NW/0123). Dissemination will include publication of quantitative and qualitative findings, and experience of public involvement in peer-reviewed journals. Results will also be disseminated to trial participants via workshops led by lay coapplicants. TRIAL REGISTRATION: ISRCTN75070242.

OBJECTIVE: to explore doctors' understanding of individualisation of drug treatments, and identify the methods used to achieve individualisation. DESIGN: in this exploratory study, we used in-depth qualitative interviews with doctors to gain insight into their understanding of the term 'individualised treatments' and the methods that they use to achieve it. PARTICIPANTS: 16 general practitioners in 6 rural and 10 urban practices, 2 geriatricians and 2 clinical academics were recruited. SETTING: Primary and secondary care in South West of England. RESULTS: Understanding of individualisation varied between doctors, and their initial descriptions of individualisation were not always consistent with subsequent examples of the patients they had treated. Understandings of, and methods used to achieve, individualised treatment were frequently discussed in relation to making drug treatment decisions. Few doctors spoke of using strategies to support patients to individualise their own treatments after the consultation. CONCLUSIONS: Despite its widespread use, variation in doctors' understanding of the term individualisation highlights the need for it to be defined. Efforts are needed to develop effective methods that would offer a structured approach to support patients to manage their treatments after consultations.

In this article, we present a qualitative exploration of the psychological and communication processes that occur within an intervention to improve self-care for people with asthma. In the context of a primary-care-based trial of the intervention, we collected data at three time points for 21 patients, comprising 2 audiotaped consultations (nurse and patient together) and individual semistructured interviews 3 months after the second consultation. Using framework analysis, we identified both psychological processes (illness understanding, affective response to asthma, and reasoned motivation) and patient-provider interactions (active patient involvement and individual tailoring). We use these findings to extend and refine the pre-existing theoretical model of behavior change underpinning the intervention, in particular with relation to patient-provider interaction processes. We conclude that it is important for developers and providers of asthma self-care interventions to attend to the style of delivery as well as the behavior change techniques involved.

The majority of people with degenerative neurological conditions are cared for within their own families. Cognitive impairment can be a significant and increasing symptom of these conditions. In this article we report how a team of experienced researchers carried out a meta-ethnography of qualitative research articles focusing on the impact of caring for a loved one with cognitive impairment. We followed the seven-step process outlined by Noblit and Hare. Synthesized findings from 31 papers suggest emotional impact is complex and uncertain and varies from day to day. The benefit of using meta-ethnography is that the results represent a larger sample size and a reinterpretation of multiple studies can hold greater application for practice. The results of this study offer an opportunity for nurses to be aware of both the positive and negative sides of caring and being cared for. This knowledge can be used to discuss with patients and carers how best to prepare for decreasing cognition and still maintain a worthwhile quality of life.

OBJECTIVE: to obtain the views of women on their experiences of decision making about the method of delivery following a previous caesarean section and the role of decision aids in this process. DESIGN: Qualitative study nested within a randomised controlled trial, using repeat semi-structured interviews conducted pre- and postnatally. Data were analysed using a framework approach. SETTING: Three maternity units in south-west England and Scotland. SAMPLE: Purposive sample of 30 women participating in a randomised controlled trial of two decision aids for women making a decision about mode of next delivery following a previous caesarean section (Decision Aids for Mode of next Delivery). RESULTS: Thirty women were interviewed during pregnancy about their experience of decision making about the mode of delivery and 22 were re-interviewed postnatally. Key themes were: role of decision aids in reducing decisional conflict and uncertainty during the pregnancy; impact of decision aids on knowledge and anxiety; the relationship between prior preferences, decisions and actual outcome; and the mediating role of decision aids. CONCLUSIONS: Women making a decision about mode of delivery following previous caesarean section value some form of structured information to help reduce decisional conflict. Information provision for women making this decision needs to be relevant to their individual needs. Decision analysis may help reconcile prior preferences and the actual mode of delivery.

In this article I discuss the challenges of managing and analysing qualitative data produced from in-depth interviews. I detail how two methods of data analysis have been combined to explore older women’s (over 35yrs) accounts of early pregnancy loss -. which formed the data for the authors PhD research. A computer assisted qualitative data analysis (CAQDAS) package, in this case NUDIST4. was a useful tool for managing the breadth of data, and permitted the initial coding in line with the objectives of a larger qualitative study. However, pertinent themes were obscured by the sheer volume of data that had been collected. In contrast, the voice relational method was of value in exploring the depth of the data, and the ways in which these women contextualised their experiences in relation to other aspects of their lived biography. Researchers new to qualitative data analysis are often concerned that CAQDAS techniques will in some way dictate how the data will be analysed. In this article I suggest that this anxiety is unfounded – as the analysis technique depends upon the researcher(s) and the theoretical perspective(s) that inform(s) the research process. I propose that CAQDAS packages are effective tools for data management, but a more theoretically informed means, such as the voice relational method, can augment the process of analysis. I suggest that it is essential that, whichever means we employ, as researchers we are explicit about how we actually do data analysis.

This paper explores the special nature of bereavement in the case of first trimester miscarriage. It is theoretically informed by the sociological literature concerning death and bereavement and is empirically grounded in interviews with 79 women. We argue that the 'scientisation of death' in modern societies contributes to the uncertainty and isolation which distinguish early miscarriage as a unique form of loss. In the absence of clear cultural scripts to draw upon, many women interviewed gave meaning to their loss as 'what might have been' or what we call 'the loss of possibility'. Some women juxtaposed the failure of their pregnancy with that of modern medicine either to prevent the loss or provide a credible explanation for their miscarriage. Little research has been conducted in this area, since the pioneering work of Lovell (1983) and Cecil (1984). Our research draws on one of the largest and most systematic bodies of data ever collected on early miscarriage, and provides continued evidence of the traumas of miscarriage. The strategies employed by women to make sense of, and come to terms with, their experience of miscarriage are explored, employing a typology of pre-modern, modern and postmodern responses.

This paper examines the endurance of an idealized version of birth – the natural (intervention free) birth – and the tensions between the discourse surrounding natural birth and the experiences of women who had operative deliveries (surgically assisted hospital births). The paper uses utopian theory to explore the discourse of natural birth. It draws on empirical research with 27 women who had experienced operative delivery. Interviews with these women highlight the contested and
problematic nature of the natural birth discourse. While these women desire and support the idea of natural birth their own experience is of a range of medical and surgical interventions – an experience that was, for many of these women, difficult to reconcile. Notwithstanding this experience many of the women maintain a strong commitment to the natural birth ideal, indicating its enduring power. Rather than
employing a traditional utopian approach ourselves (one that dictates the form and content of a possible future), we employ a more recent approach, drawing on the work of Levitas and Sargisson, and Foucault’s notion of heterotopia, which has the potential to encompass and facilitate a range of possible birth experiences.

Background: Miscarriage affects around one in six pregnancies. Much research has taken place identifying the consequences of this for parents but is mainly quantitative. of the limited qualitative studies, none have explored women's experiences of the methods of miscarriage management received. Aim: to assess the social and personal impact of different management methods (expectant, medical and surgical) on women's experience of first trimester miscarriage. Design of study: Qualitative interviews using a topic guide with a purposive cohort of four categories of women (each management method plus non-participants) 6 months to 1 year after first trimester miscarriage. Focus groups with both research participants and health workers. Setting: Women from three hospitals in the South West of England that participated in the Miscarriage Treatment (MIST) trial. Method: Seventy -two interviews were undertaken between September 1999 and June 2000. There were also five focus groups (47 participants) and two feedback sessions (8 participants) with written feedback from 12 women. Interviews lasted 0.5-2.5 hours generating over 2000 A4 pages of transcripts. The transcripts were analysed for common themes, using standard proformas, which were filled in by individual team members and then discussed by the whole research team. Iterative readings in the light of new emerging issues ensured that new themes could be identified throughout the analytical process. All transcripts were then encoded for the identified themes using NUDIST. Results: Common themes emerged across all management options although some were specific to just one or two management options. The five major themes arising out of the data analysis were: intervention; experiences of care; finality; the 'baby'; and pain and bleeding. Conclusions: Women's experiences and beliefs vary widely and their preferences need to be considered in their early miscarriage management. The three methods have different benefits and problems from the women's point of view. Competence and caring from professionals are especially important. ©British Journal of General Practice 2006.

Objective: to obtain the views of women on the impact of operative delivery in the second stage of labour. Design: Qualitative interview study. Setting: Two urban teaching hospitals in the United Kingdom. Participants: Purposive sample of 27 women who had undergone operative delivery in the second stage of labour between January 2000 and January 2002. Key themes: Preparation for birth, understandings of the indications for operative delivery, and explanation or debriefing after birth. Results: the women felt unprepared for operative delivery and thought that their birth plan or antenatal classes had not catered adequately for this event. They emphasised the importance of maintaining an open mind about the management of labour. They had difficulty understanding the need for operative delivery despite a review by medical and midwifery staff before discharge. Operative delivery had a noticeable impact on women's views about future pregnancy and delivery. Conclusions: Women consider postnatal debriefing and medical review important deficiencies in current care. Those who experienced operative delivery in the second stage of labour would welcome the opportunity to have a later review of their intrapartum care, physical recovery, and management of future pregnancies.