Background: the effect of a cancer diagnosis is wide ranging with the potential to affect income, employment and risk of poverty. The aim of this systematic review is to identify the economic impact of a cancer diagnosis for patients and their families/caregivers.
Methods: the search covered peer-reviewed journals using MEDLINE, EMBASE, CINAHL, Cochrane Library, Epistemonikos and PsycINFO databases. Quality appraisal was undertaken using CASP tools. Monetary values were converted to US Dollars/2019 using a purchasing power parities (PPP) conversion factor. The review included articles up to and including January 2020, written in English language, for patients with cancer aged ≥18 years and focused on the costs up to five years following a cancer diagnosis.
Results: the search was run in January 2020 and updated in November 2021. of 7973 articles identified, 18 met the inclusion criteria. Studies were undertaken in the USA, Ireland, Canada, Australia, France, UK, Malaysia, Pakistan, China and Sri Lanka. The majority were cohort studies. Twelve reported out-of-pocket costs (range US$16–US$2,523/month per patient/caregiver) consisting of medical expenses (e.g. surgery, radiotherapy and chemotherapy) and non-medical expenses (e.g. travel, food and childcare). Fourteen studies reported patient/caregiver loss of income and lost productivity (range 14–57.8%).
Conclusions: a high percentage of cancer patients and their families/caregivers experience out-of-pocket expenditure, loss of income and lost productivity. Future research is needed to observe the effects of continuing changes to healthcare policies and social protections on the economic burden among cancer patients and their families/caregivers.

People are disabled by barriers in society, not by their impairment. Barriers can be physical or be caused by people's implicit and explicit attitudes towards people with disabilities. We utilise the Implicit Association Test to investigate implicit attitudes towards people with disabilities among Human Resource professionals and people involved in making hiring decisions. We find no significant differences between people who work for large companies or Small- to Medium-sized Enterprises. Similarly, working in Human Resources (or making recruitment decisions) has no effect on implicit bias. We supply the first evidence linking a person’s own health status (measured using EQ-5D-5L) to their implicit bias. We find that a worse health status is associated with lower implicit bias towards people with disabilities. In addition, we find women have lower implicit bias than men. The discussion reflects on the need for greater disability representation within the workplace – especially in making hiring decisions.

Abstract
. Background
. Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist ‘Tier 3’ Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity.
.
. Methods
. This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted.
.
. Discussion
. This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients.
.
. Trial registration
. ISRCTN number 22088800.
.

Abstract
. Background
. Prostate-specific antigen (PSA) is a commonly used test to detect prostate cancer. Attention has mostly focused on the use of PSA in screening asymptomatic patients, but the diagnostic accuracy of PSA for prostate cancer in patients with symptoms is less well understood.
.
. Methods
. A systematic database search was conducted of Medline, EMBASE, Web of Science, and the Cochrane library. Studies reporting the diagnostic accuracy of PSA for prostate cancer in patients with symptoms were included. Two investigators independently assessed the titles and abstracts of all database search hits and full texts of potentially relevant studies against the inclusion criteria, and data extracted into a proforma. Study quality was assessed using the QUADAS-2 tool by two investigators independently. Summary estimates of diagnostic accuracy were calculated with meta-analysis using bivariate mixed effects regression.
.
. Results
. Five hundred sixty-three search hits were assessed by title and abstract after de-duplication, with 75 full text papers reviewed. Nineteen studies met the inclusion criteria, 18 of which were conducted in secondary care settings with one from a screening study cohort. All studies used histology obtained by transrectal ultrasound-guided biopsy (TRUS) as a reference test; usually only for patients with elevated PSA or abnormal prostate examination. Pooled data from 14,489 patients found estimated sensitivity of PSA for prostate cancer was 0.93 (95% CI 0.88, 0.96) and specificity was 0.20 (95% CI 0.12, 0.33). The area under the hierarchical summary receiver operator characteristic curve was 0.72 (95% CI 0.68, 0.76). All studies were assessed as having a high risk of bias in at least one QUADAS-2 domain.
.
. Conclusions
. Currently available evidence suggests PSA is highly sensitive but poorly specific for prostate cancer detection in symptomatic patients. However, significant limitations in study design and reference test reduces the certainty of this estimate. There is very limited evidence for the performance of PSA in primary care, the healthcare setting where most PSA testing is performed.
.

ObjectiveTo investigate the importance of key characteristics relating to diagnostic testing for ovarian cancer and to understand how previous test experience influences priorities.DesignCase 1 best–worst scaling embedded in an online survey.SettingPrimary care diagnostic testing in England and Wales.Participants150 women with ovaries over 40 years old living in England and Wales.MethodsWe used best–worst scaling, a preference-based survey method, to elicit the relative importance of 25 characteristics relating to ovarian cancer testing following a systematic review. Responses were modelled using conditional logit regression. Subgroup analysis investigated variations based on testing history.Main outcome measuresRelative importance scores.Results‘Chance of dying from ovarian cancer’ (0.380, 95% CI 0.26 to 0.49) was the most important factor to respondents, closely followed by ‘test sensitivity’ (0.308, 95% CI 0.21 to 0.40). In contrast, ‘time away from usual activities’ (−0.244, 95% CI −0.33 to −0.15) and ‘gender of healthcare provider’ (−0.243, 95% CI −0.35 to −0.14) were least important to respondents overall. Women who had previously undergone testing placed higher importance on certain characteristics including ‘openness of healthcare providers’ and ‘chance of diagnosing another condition’ at the expense of reduced emphasis on characteristics such as ‘pain and discomfort’ and ‘time away from usual activities’.ConclusionsThe results clearly demonstrated items at the extreme, which were most and least important to women considering ovarian cancer testing. Differences in priorities by testing history demonstrate an experience effect, whereby preferences adapt over time based on evidence and experience. Acknowledging these differences helps to identify underlying barriers and facilitators for women with no test experience as well as shortcomings of current service based on women with experience.

Objectives: Pilot feasibility randomised controlled trial (RCT) for the ‘Singing groups for People with Aphasia’ (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.
Design: a two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.
Setting: Three community-based cohorts in the South-West of England.
Participants: Eligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.
Intervention: the manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.
Outcome measures: Collected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.
Results: of 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, Control=21); 36 participants (SPA=17, Control=19) completed 3-month follow-up, 34 (SPA=18, Control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.
Conclusions: the SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.

. Background
. Tools based on diagnostic prediction models are available to help general practitioners diagnose cancer. It is unclear whether or not tools expedite diagnosis or affect patient quality of life and/or survival.
.
.
. Objectives
. The objectives were to evaluate the evidence on the validation, clinical effectiveness, cost-effectiveness, and availability and use of cancer diagnostic tools in primary care.
.
.
. Methods
. Two systematic reviews were conducted to examine the clinical effectiveness (review 1) and the development, validation and accuracy (review 2) of diagnostic prediction models for aiding general practitioners in cancer diagnosis. Bibliographic searches were conducted on MEDLINE, MEDLINE In-Process, EMBASE, Cochrane Library and Web of Science) in May 2017, with updated searches conducted in November 2018. A decision-analytic model explored the tools’ clinical effectiveness and cost-effectiveness in colorectal cancer. The model compared patient outcomes and costs between strategies that included the use of the tools and those that did not, using the NHS perspective. We surveyed 4600 general practitioners in randomly selected UK practices to determine the proportions of general practices and general practitioners with access to, and using, cancer decision support tools. Association between access to these tools and practice-level cancer diagnostic indicators was explored.
.
.
. Results
. Systematic review 1 – five studies, of different design and quality, reporting on three diagnostic tools, were included. We found no evidence that using the tools was associated with better outcomes. Systematic review 2 – 43 studies were included, reporting on prediction models, in various stages of development, for 14 cancer sites (including multiple cancers). Most studies relate to QCancer® (ClinRisk Ltd, Leeds, UK) and risk assessment tools.
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.
. Decision model
. In the absence of studies reporting their clinical outcomes, QCancer and risk assessment tools were evaluated against faecal immunochemical testing. A linked data approach was used, which translates diagnostic accuracy into time to diagnosis and treatment, and stage at diagnosis. Given the current lack of evidence, the model showed that the cost-effectiveness of diagnostic tools in colorectal cancer relies on demonstrating patient survival benefits. Sensitivity of faecal immunochemical testing and specificity of QCancer and risk assessment tools in a low-risk population were the key uncertain parameters.
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.
. Survey
. Practitioner- and practice-level response rates were 10.3% (476/4600) and 23.3% (227/975), respectively. Cancer decision support tools were available in 83 out of 227 practices (36.6%, 95% confidence interval 30.3% to 43.1%), and were likely to be used in 38 out of 227 practices (16.7%, 95% confidence interval 12.1% to 22.2%). The mean 2-week-wait referral rate did not differ between practices that do and practices that do not have access to QCancer or risk assessment tools (mean difference of 1.8 referrals per 100,000 referrals, 95% confidence interval –6.7 to 10.3 referrals per 100,000 referrals).
.
.
. Limitations
. There is little good-quality evidence on the clinical effectiveness and cost-effectiveness of diagnostic tools. Many diagnostic prediction models are limited by a lack of external validation. There are limited data on current UK practice and clinical outcomes of diagnostic strategies, and there is no evidence on the quality-of-life outcomes of diagnostic results. The survey was limited by low response rates.
.
.
. Conclusion
. The evidence base on the tools is limited. Research on how general practitioners interact with the tools may help to identify barriers to implementation and uptake, and the potential for clinical effectiveness.
.
.
. Future work
. Continued model validation is recommended, especially for risk assessment tools. Assessment of the tools’ impact on time to diagnosis and treatment, stage at diagnosis, and health outcomes is also recommended, as is further work to understand how tools are used in general practitioner consultations.
.
.
. Study registration
. This study is registered as PROSPERO CRD42017068373 and CRD42017068375.
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.
. Funding
. This project was funded by the National Institute for Health Research (NIHR) Health Technology programme and will be published in full in Health Technology Assessment; Vol. 24, No. 66. See the NIHR Journals Library website for further project information.
.

We examine the suitability of three methods using patient-level data to evaluate the time-varying impacts of national healthcare guidelines. Such guidelines often codify progressive change and are implemented gradually; for example, National Institute for Health and Care Excellence (NICE) suspected-cancer referral guidelines. These were revised on June 23, 2015, to include more cancer symptoms and test results (“features”), partly reflecting changing practice. We explore the time-varying impact of guideline revision on time to colorectal cancer diagnosis, which is linked to improved outcomes in decision-analytic models. We included 11,842 patients diagnosed in 01/01/2006–31/12/2017 in the Clinical Practice Research Datalink with England cancer registry data linkage. Patients were classified by whether their first pre-diagnostic cancer feature was in the original guidelines (NICE-2005) or was added during the revision (NICE-2015-only). Outcome was diagnostic interval: time from first cancer feature to diagnosis. All analyses adjusted for age and sex. Two difference-in-differences analyses used either a Pre (01/08/2012–31/12/2014, n = 2243) and Post (01/08/2015–31/12/2017, n = 1017) design, or event-study cohorts (2006–2017 vs 2015) to estimate change in diagnostic interval attributable to official implementation of the revised guidelines. A semiparametric varying-coefficient model analysed the difference in diagnostic interval between the NICE groups over time. After model estimation, primary and broader treatment effects of guideline content and implementation were measured. The event-study difference-in-differences and the semiparametric varying-coefficient methods showed that shorter diagnostic intervals were attributable to official implementation of the revised guidelines. This impact was only detectable by pre-to-post difference-in-differences when the pre/post periods were selected according to the estimation results from the varying-coefficient model. Formal tests of the parametric models, which are special cases of the semiparametric model, suggest that they are misspecified. We conclude that the semiparametric method is well suited to explore the time-varying impacts of guidelines codifying progressive change.

Background
There is an inherent tension in neonatal services between the efficiency and specialised care that comes with centralisation and the provision of local services with associated ease of access and community benefits. This study builds on previous work in South West England to address these issues at a national scale.

Objectives
(1) to develop an analytical framework to address key issues of neonatal service configuration in England, (2) to investigate visualisation tools to facilitate the communication of findings to stakeholder groups and (3) to assess parental preferences in relation to service configuration alternatives.

Main outcome measures
The ability to meet nurse staffing guidelines, volumes of units, costs, mortality, number and distance of transfers, travel distances and travel times for parents.

Design
Descriptive statistics, location analysis, mathematical modelling, discrete event simulation and economic analysis were used. Qualitative methods were used to interview policy-makers and parents. A parent advisory group supported the study.

Setting
NHS neonatal services across England.

Data
Neonatal care data were sourced from the National Neonatal Research Database. Information on neonatal units was drawn from the National Neonatal Audit Programme. Geographic and demographic data were sourced from the Office for National Statistics. Travel time data were retrieved via a geographic information system. Birth data were sourced from Hospital Episode Statistics. Parental cost data were collected via a survey.

Results
Location analysis shows that to achieve 100% of births in units with ≥ 6000 births per year, the number of birth centres would need to be reduced from 161 to approximately 72, with more parents travelling > 30 minutes. The maximum number of neonatal intensive care units (NICUs) needed to achieve 100% of very low-birthweight infants attending high-volume units is 36 with existing NICUs, or 48 if NICUs are located wherever there is currently a neonatal unit of any level. Simulation modelling further demonstrated the workforce implications of different configurations. Mortality modelling shows that the birth of very preterm infants in high-volume hospitals reduces mortality (a conservative estimate of a 1.2-percentage-point lower risk) relative to these births in other hospitals. It is currently not possible to estimate the impact of mortality for infants transferred into NICUs. Cost modelling shows that the mean length of stay following a birth in a high-volume hospital is 9 days longer and the mean cost is £5715 more than for a birth in another neonatal unit. In addition, the incremental cost per neonatal life saved is £460,887, which is comparable to other similar life-saving interventions. The analysis of parent costs identified unpaid leave entitlement, food, travel, accommodation, baby care and parking as key factors. The qualitative study suggested that central concerns were the health of the baby and mother, communication by medical teams and support for families.

Limitations
The following factors could not be modelled because of a paucity of data – morbidity outcomes, the impact of transfers and the maternity/neonatal service interface.

Conclusions
An evidence-based framework was developed to inform the configuration of neonatal services and model system performance from the perspectives of both service providers and parents.

Future work
To extend the modelling to encompass the interface between maternity and neonatal services.

OBJECTIVE: to establish the level of opioid prescribing for patients with chronic musculoskeletal pain in a sample of patients from primary care and to estimate prescription costs. DESIGN: Secondary data analyses from a two-arm pragmatic randomised controlled trial (COPERS) testing the effectiveness of group self-management course and usual care against relaxation and usual care for patients with chronic musculoskeletal pain (ISRCTN 24426731). SETTING: 25 general practices and two community musculoskeletal services in the UK (London and Midlands). PARTICIPANTS: 703 chronic pain participants; 81% white, 67% female, enrolled in the COPERS trial. MAIN OUTCOME MEASURES: Anonymised prescribing data over 12 months extracted from GP electronic records. RESULTS: of the 703 trial participants with chronic musculoskeletal pain, 413 (59%) patients were prescribed opioids. Among those prescribed an opioid, the number of opioid prescriptions varied from 1 to 52 per year. A total of 3319 opioid prescriptions were issued over the study period, of which 53% (1768/3319) were for strong opioids (tramadol, buprenorphine, morphine, oxycodone, fentanyl and tapentadol). The mean number of opioid prescriptions per patient prescribed any opioid was 8.0 (SD=7.9). A third of patients on opioids were prescribed more than one type of opioid; the most frequent combinations were: codeine plus tramadol and codeine plus morphine. The cost of opioid prescriptions per patient per year varied from £3 to £4844. The average annual prescription cost was £24 (SD=29) for patients prescribed weak opioids and £174 (SD=421) for patients prescribed strong opioids. Approximately 40% of patients received >3 prescriptions of strong opioids per year, with an annual cost of £236 per person. CONCLUSIONS: Long-term prescribing of opioids for chronic musculoskeletal pain is common in primary care. For over a quarter of patients receiving strong opioids, these drugs may have been overprescribed according to national guidelines. TRIAL REGISTRATION NUMBER: ISRCTN24426731; Post-results.

There is recent interest in using discrete choice experiments (DCEs) to derive health state utility values, and results can differ from time tradeoff (TTO). Clearly, DCE is "choice based," whereas TTO is generally considered a "matching" task. We explore whether procedural adaptations to the TTO, which make the method more closely resemble a DCE, make TTO and choice converge. In particular, we test whether making the matching procedure in TTO less "transparent" to the respondent reduces disparities between TTO and DCE. We designed an interactive survey that was hosted on the Internet, and 2022 interviews were achieved in the United Kingdom in a representative sample of the population. We found a marked divergence between TTO and DCE, but this was not related to the "transparency" of the TTO procedure. We conclude that a difference in the error structure between TTO and choice and that factors other than differences in utility are affecting choices is driving the divergence. The latter has fundamental implications for the way choice data are analyzed and interpreted.

BackgroundChronic musculoskeletal pain is a common problem that is difficult to treat. Self-management support interventions may help people to manage this condition better; however, there is limited evidence showing that they improve clinical outcomes. Our overarching research question was ‘Does a self-management support programme improve outcomes for people living with chronic musculoskeletal pain?’.AimTo develop, evaluate and test the clinical effectiveness and cost-effectiveness of a theoretically grounded self-management support intervention for people living with chronic musculoskeletal pain.MethodsIn phase 1 we carried out two systematic reviews to synthesise the evidence base for self-management course content and delivery styles likely to help those with chronic pain. We also considered the psychological theories that might underpin behaviour change and pain management principles. Informed by these data we developed the Coping with persistent Pain, Evaluation Research in Self-management (COPERS) intervention, a group intervention delivered over 3 days with a top-up session after 2 weeks. It was led by two trained facilitators: a health-care professional and a layperson with experience of chronic pain. To ensure that we measured the most appropriate outcomes we reviewed the literature on potential outcome domains and measures and consulted widely with patients, tutors and experts. In a feasibility study we demonstrated that we could deliver the COPERS intervention in English and, to increase the generalisability of our findings, also in Sylheti for the Bangladeshi community. In phase 2 we ran a randomised controlled trial to test the clinical effectiveness and cost-effectiveness of adding the COPERS intervention to a best usual care package (usual care plus a relaxation CD and a pain toolkit leaflet). We recruited adults with chronic musculoskeletal pain largely from primary care and musculoskeletal physiotherapy services in two localities: east London and Coventry/Warwickshire. We collected follow-up data at 12 weeks (self-efficacy only) and 6 and 12 months. Our primary outcome was pain-related disability (Chronic Pain Grade disability subscale) at 12 months. We also measured costs, health utility (European Quality of Life-5 Dimensions), anxiety, depression [Hospital Anxiety and Depression Scale (HADS)], coping, pain acceptance and social integration. Data on the use of NHS services by participants were extracted from NHS electronic records.ResultsWe recruited 703 participants with a mean age of 60 years (range 19–94 years); 81% were white and 67% were female. Depression and anxiety symptoms were common, with mean HADS depression and anxiety scores of 7.4 [standard deviation (SD) 4.1] and 9.2 (SD 4.6), respectively. Intervention participants received 85% of the course content. At 12 months there was no difference between treatment groups in our primary outcome of pain-related disability [difference –1.0 intervention vs. control, 95% confidence interval (CI) –4.9 to 3.0]. However, self-efficacy, anxiety, depression, pain acceptance and social integration all improved more in the intervention group at 6 months. At 1 year these differences remained for depression (–0.7, 95% CI –1.2 to –0.2) and social integration (0.8, 95% CI, 0.4 to 1.2). The COPERS intervention had a high probability (87%) of being cost-effective compared with usual care at a threshold of £30,000 per quality-adjusted life-year.ConclusionsAlthough the COPERS intervention did not affect our primary outcome of pain-related disability, it improved psychological well-being and is likely to be cost-effective according to current National Institute for Health and Care Excellence criteria. The COPERS intervention could be used as a substitute for less well-evidenced (and more expensive) pain self-management programmes. Effective interventions to improve hard outcomes in chronic pain patients, such as disability, are still needed.Trial registrationCurrent Controlled Trials ISRCTN22714229.FundingThe project was funded by the National Institute for Health Research Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 4, No. 14. See the NIHR Journals Library website for further project information.

BACKGROUND: Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. METHODS AND FINDINGS: We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost-utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference -1.0, intervention versus control, 95% CI -4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (-0.7, 95% CI -1.2 to -0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US$214). The cost-utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95% CI -0.0074 to 0.0724), and on the cost side the intervention was a little more expensive than usual care (i.e. £188 [US$277], 95% CI -£125 [-US$184] to £501 [US$738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US$8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components. CONCLUSIONS: While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups. TRIAL REGISTRATION: ISRCTN Registry 24426731.

The marine environment provides a number of services which contribute to human well-being including the provision of food, regulation of climate and the provision of settings for cultural gains. To ensure these services continue to be provided, effective management is required and is being strategically implemented through the development of marine spatial plans. These plans require an understanding of the costs and benefits associated with alternative marine uses and how they contribute to human well-being. One benefit which is often difficult to quantify is the health benefit of engaging with the marine environment. To address this, the research develops an approach which can estimate the contribution aquatic physical activities makes to quality adjusted life years (QALYs) in monetary and non-monetary terms. Using data from the Health Survey for England, the research estimates that physical activities undertaken in aquatic environments at a national level provides a total gain of 24,853 QALYs. A conservative estimate of the monetary value of a QALY gain of this magnitude is £176 million. This approach provides estimates of health benefits which can be used in more comprehensive impact assessments, such as cost-benefit analysis, to compare alternative marine spatial plans. The paper concludes by discussing future steps.

Background Vitamin D status, as measured by serum 25-hydroxyvitamin D (25(OH)D), has been shown in some studies to be inversely associated with gestational diabetes risk. Recently, it has been suggested that maternal smoking status may modify this relationship. We explored the association between 25(OH)D concentration and gestational diabetes and determined if there was an interaction between smoking and 25(OH)D. Methods a nested case-control study was conducted in Halifax, Nova Scotia and Quebec City, Quebec. Women were recruited before 20 weeks gestation and 25(OH)D was measured. Cases were women who developed gestational diabetes and controls were frequency matched to cases on study site, gestational age at blood draw, and season and year of blood draw. Logistic regression models estimated adjusted odds ratios (aOR) and 95% confidence intervals (CI). Models were tested for multiplicative and additive interaction, which was estimated by relative excess risk due to interaction (RERI). Results the study included 395 gestational diabetes cases and 1925 controls. Women who smoked during pregnancy and had 25(OH)D concentrations

BACKGROUND: There has been recent interest in using the discrete choice experiment (DCE) method to derive health state utilities for use in quality-adjusted life year (QALY) calculations, but challenges remain. OBJECTIVES: We set out to develop a risk-based DCE approach to derive utility values for health states that allowed 1) utility values to be anchored directly to normal health and death and 2) worse than dead health states to be assessed in the same manner as better than dead states. Furthermore, we set out to estimate alternative models of risky choice within a DCE model. METHOD: a survey was designed that incorporated a risk-based DCE and a "modified" standard gamble (SG). Health state utility values were elicited for 3 EQ-5D health states assuming "standard" expected utility (EU) preferences. The DCE model was then generalized to allow for rank-dependent expected utility (RDU) preferences, thereby allowing for probability weighting. A convenience sample of 60 students was recruited and data collected in small groups. RESULTS: Under the assumption of "standard" EU preferences, the utility values derived within the DCE corresponded fairly closely to the mean results from the modified SG. Under the assumption of RDU preferences, the utility values estimated are somewhat lower than under the assumption of standard EU, suggesting that the latter may be biased upward. CONCLUSION: Applying the correct model of risky choice is important whether a modified SG or a risk-based DCE is deployed. It is, however, possible to estimate a probability weighting function within a DCE and estimate "unbiased" utility values directly, which is not possible within a modified SG. We conclude by setting out the relative strengths and weaknesses of the 2 approaches in this context.

BACKGROUND: Condition-specific measures are frequently used to assess the health-related quality of life of people with multiple sclerosis (MS). Such measures are unsuitable for use in economic evaluations that require estimates of cost per quality-adjusted life-year because they are not based on preferences. OBJECTIVES: to report the estimation of a preference-based single index for an eight-dimensional instrument for MS, the Multiple Sclerosis Impact Scale - Eight Dimensions (MSIS-8D), derived from an MS-specific measure of health-related quality of life, the 29-item Multiple Sclerosis Impact Scale (MSIS-29). METHODS: We elicited preferences for a sample of MSIS-8D states (n = 169) from a sample (n = 1702) of the UK general population. Preferences were elicited using the time trade-off technique via an Internet-based survey. We fitted regression models to these data to estimate values for all health states described by the MSIS-8D. Estimated values were assessed against MSIS-29 scores and values derived from generic preference-based measures in a large, representative sample of people with MS. RESULTS: Participants reported that the time trade-off questions were easy to understand. Observed health state values ranged from 0.08 to 0.89. The best-performing model was a main effects, random effects model (mean absolute error = 0.04). Validation analyses support the performance of the MSIS-8D index: it correlated more strongly than did generic measures with MSIS-29 scores, and it discriminated effectively between subgroups of people with MS. CONCLUSIONS: the MSIS-8D enables health state values to be estimated from the MSIS-29, adding to the methods available to assess health outcomes and to estimate quality-adjusted life-years for MS for use in health technology assessment and decision-making contexts.

BackgroundThere is a tension in many health-care services between the expertise and efficiency that comes with centralising services and the ease of access for patients. Neonatal care is further complicated by the organisation of care into networks where different hospitals offer different levels of care and where capacity across, or between, networks may be used when local capacity is exhausted.ObjectivesTo develop a computer model that could mimic the performance of a neonatal network and predict the effect of altering network configuration on neonatal unit workloads, ability to meet nurse staffing guidelines, and distance from the parents’ home location to the point of care. The aim is to provide a model to assist in planning of capacity, location and type of neonatal services.DesignDescriptive analysis of a current network, economic analysis and discrete event simulation. During the course of the project, two meetings with parents were held to allow parent input.SettingThe Peninsula neonatal network (Devon and Cornwall) with additional work extending to the Western network.Main outcome measuresAbility to meet nurse staffing guidelines, cost of service provision, number and distance of transfers, average travel distances for parents, and numbers of parents with an infant over 50 km from home.Data sourcesAnonymised neonatal data for 7629 infants admitted into a neonatal unit between January 2011 and June 2013 were accessed from Badger patient care records. Nurse staffing data were obtained from a daily ring-around audit. Further background data were accessed from NHS England general practitioner (GP) Practice Profiles, Hospital Episode Statistics, Office for National Statistics and NHS Connecting for Health. Access to patient care records was approved by the Research Ethics Committee and the local Caldicott Guardian at the point of access to the data.ResultsWhen the model was tested against a period of data not used for building the model, the model was able to predict the occupancy of each hospital and care level with good precision (R2 > 0.85 for all comparisons). The average distance from the parents’ home location (GP location used as a surrogate) was predicted to within 2 km. The number of transfers was predicted to within 2%. The model was used to forecast the effect of centralisation. Centralisation led to reduced nurse requirements but was accompanied by a significant increase in parent travel distances. Costs of nursing depend on how much of the time nursing guidelines are to be met, rising from £4500 per infant to meet guidelines 80% of the time, to £5500 per infant to meet guidelines 95% of the time. Using network capacity, rather than local spare capacity, to meet local peaks in workloads can reduce the number of nurses required, but the number of transfers and the travel distance for parents start to rise significantly above ≈ 70% network capacity utilisation.ConclusionsWe have developed a model that predicts performance of a neonatal network from the perspectives of both the service provider and the parents of infants in care.Future workApplication of the model at a national level.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

Objective We sought to examine the association between maternal serum 25-hydroxyvitamin D (25[OH]D) concentration in early pregnancy and the subsequent diagnosis of preeclampsia (PE). Study Design This was a nested case-control study from 2 prospective Canadian cohorts conducted in Quebec City, Quebec, and Halifax, Nova Scotia, from 2002 through 2010. Participants were pregnant women (n = 169 cases with PE and 1975 controls). Maternal serum was drawn

OBJECTIVE: Proxy measures are an alternative source of data for care home residents who are unable to complete the health utility measure, but the agreement levels between residents and care home staff for the EQ-5D have not been investigated previously. The objective of the present study was to examine the inter-rater agreement levels for the reporting of EQ-5D by care home residents and staff, adjusting for the impact of clustering. STUDY DESIGN AND SETTING: the data consist of EQ-5D scores for 565 pairs of care home residents and proxies and quality-adjusted life-years (QALYs) for 248 pairs. Cluster-adjusted agreement was compared for the domains, index scores, and QALYs from the EQ-5D. Factors influencing index score agreement are also described. RESULTS: the results show poor to fair agreement at the domain level (cluster-adjusted Kappa -0.03 to 0.26) and moderate agreement at the score level (cluster-adjusted intra-class correlation coefficient [ICC] 0.44-0.50) and for QALYs (cluster-adjusted ICC 0.59). A higher likelihood of depression and lower cognitive impairment were both associated with smaller discrepancy between proxy and self-completed scores. CONCLUSION: Proxies appear to be an acceptable source of data for index scores and QALYs but may be less reliable if individual domains are considered.

Introduction: Accurate ascertainment of pregnant women with pre-existing diabetes allows for the comprehensive surveillance of maternal and neonatal outcomes associated with this chronic disease. Method: to determine the accuracy of case definitions for pre-existing diabetes mellitus when applied to a pregnant population, a cohort of women who were pregnant in Nova Scotia, Canada, between 1991 and 2003 was obtained from a population-based provincial perinatal database, the Nova Scotia Atlee Perinatal Database (NSAPD). Person-level data from administrative databases using hospital discharge abstract data and outpatient physician services data were linked to this cohort. Various algorithms for defining diabetes mellitus from the administrative data, including the algorithm suggested by the National Diabetes Surveillance System (NDSS), were compared to a reference standard definition from the NSAPD. Results: Validation of the NDSS case definition applied to this pregnant population demonstrated a sensitivity of 87% and a positive predictive value (PPV) of 66.4%. Use of ICD-9 and ICD-10 diagnostic codes among hospitalizations with diabetes mellitus in pregnancy showed important increases in sensitivity and PPV, especially for those pregnancies delivered in tertiary centres. In this population, pregnancy-related administrative data from the hospitalization database alone appear to be a more accurate data source for identifying pre-existing diabetes than applying the NDSS case definition, particularly when pregnant women are delivered in a tertiary hospital. Conclusion: Although the NDSS definition of diabetes performs reasonably well compared to a reference standard definition of diabetes, using this definition for evaluating maternal and perinatal outcomes associated with diabetes in pregnancy will result in a certain degree of misclassification and, therefore, biased estimates of outcomes.

OBJECTIVE: the Identification and Referral to Improve Safety (IRIS) cluster randomised controlled trial tested the effectiveness of a training and support intervention to improve the response of primary care to women experiencing domestic violence (DV). The aim of this study is to estimate the cost-effectiveness of this intervention. DESIGN: Markov model-based cost-effectiveness analysis. SETTING: General practices in two urban areas in the UK. PARTICIPANTS: Simulated female individuals from the general UK population who were registered at general practices, aged 16 years and older. INTERVENTION: General practices received staff training, prompts to ask women about DV embedded in the electronic medical record, a care pathway including referral to a specialist DV agency and continuing contact from that agency. The trial compared the rate of referrals of women with specialist DV agencies from 24 general practices that received the IRIS programme with 24 general practices not receiving the programme. The trial did not measure outcomes for women beyond the intermediate outcome of referral to specialist agencies. The Markov model extrapolated the trial results to estimate the long-term healthcare and societal costs and benefits using data from other trials and epidemiological studies. RESULTS: the intervention would produce societal cost savings per woman registered in the general practice of UK£37 (95% CI £178 saved to a cost of £136) over 1 year. The incremental quality-adjusted life-year was estimated to be 0.0010 (95% CI -0.0157 to 0.0101) per woman. Probabilistic sensitivity analysis found 78% of model replications under a willingness to pay threshold of £20 000 per quality-adjusted life-year. CONCLUSIONS: the IRIS programme is likely to be cost-effective and possibly cost saving from a societal perspective. Better data on the trajectory of abuse and the effect of advocacy are needed for a more robust model. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN74012786.

Objective: to determine whether neonatal outcomes differ between women vaccinated during pregnancy and those not vaccinated. Methods: Self-reported history of receipt of influenza vaccination during pregnancy was collected from women at the time of admission for obstetrical delivery at the IWK Health Centre in Halifax, Nova Scotia, beginning in April 2006. The cohort for this study included women who delivered a singleton infant prior to November 2009, reflecting the pre-pandemic H1N1 vaccination period. Neonatal outcomes were compared using logistic regression between vaccinated and non-vaccinated women. Results: Overall, 1957 of 9781 women (20%) included in the cohort received influenza vaccine during their pregnancy. The adjusted odds ratio and 95% confidence interval for a small for gestational age infant (lowest 10th percentile birth weight for gestational age and sex) was 0.80 (95% CI 0.65 to 0.95) for vaccinated women relative to non-vaccinated women. The adjusted odds ratio for a low birth weight infant was 0.74 (95% CI 0.58 to 0.95). Rates of preterm birth and a composite indicator of adverse neonatal outcomes were lower among vaccinated women, but were not statistically significant. The effects of maternal vaccination on neonatal outcomes did not differ between high- and low-risk women. Conclusion: As evidence continues to mount in support of improved neonatal outcomes associated with receiving influenza vaccination during pregnancy, enhanced public health measures are necessary to encourage pregnant women to receive the influenza vaccine.

Objective: Primary care clinicians often fail to detect women who are victims of intimate partner violence (IPV). Our aim was to investigate the cost-effectiveness of a programme in primary care to detect and support such women. Methods: We developed a Markov model to estimate the cost-effectiveness of education and support for primary care clinicians to increase their identification of survivors of IPV and to refer them to a specialist advocacy agency or a psychologist with specialist skills. The programme was implemented in three general practices in the United Kingdom (with an additional practice acting as a control) and provided cost data and rates of identification and referral. Other cost data and the effectiveness of IPV advocacy came from published sources. Results: the model gave an incremental cost-effectiveness ratio (ICER) of approximately £2,450 per quality adjusted life year (QALY). Although the ratio increased in some of the sensitivity analyses, most were under a conventional willingness to pay threshold (£30,000/QALY). Conclusions: While there is considerable uncertainty in the underlying parameters, a training programme for primary care teams to increase identification and referral of women experiencing IPV is likely to be costeffective. © the Royal Society of Medicine Press Ltd 2010.

The setting up of a database of children with autism spectrum disorder (ASD) in the north east of England is described. Best practice has been followed and included involving parents in planning and implementation at all stages, oversight by a multi-agency group, management by a multidisciplinary steering group, and independent administration of the database. From a potential listing of 986 children with ASD aged 3-12 years, the parents of 511 have so far responded (51.8%), although response rate varies considerably by local authority. Data checking has shown the information to be valid and case ascertainment broadly representative. The uses to which the data are being put and the continuing challenges are outlined.

It is necessary to monitor autism prevalence in order to plan education support and health services for affected children. This study was conducted to assess the accuracy of administrative health databases for autism diagnoses. Three administrative health databases from the province of Nova Scotia were used to identify diagnoses of autism spectrum disorders (ASD): the Hospital Discharge Abstract Database, the Medical Services Insurance Physician Billings Database and the Mental Health Outpatient Information System database. Seven algorithms were derived from combinations of requirements for single or multiple ASD claims from one or more of the three administrative databases. Diagnoses made by the Autism Team of the IWK Health Centre, using state-of-the-art autism diagnostic schedules, were compared with each algorithm, and the sensitivity, specificity and C-statistic (i.e. a measure of the discrimination ability of the model) were calculated. The algorithm with the best test characteristics was based on one ASD code in any of the three databases (sensitivity = 69.3%). Sensitivity based on an ASD code in either the hospital or the physician billing databases was 62.5%. Administrative health databases are potentially a cost efficient source for conducting autism surveillance, especially when compared to methods involving the collection of new data. However, additional data sources are needed to improve the sensitivity and accuracy of identifying autism in Canada.

OBJECTIVE: Advice to use topical or oral NSAIDs is equally effective for the treatment of knee pain in older people. The ingredient cost of topical preparations is typically more than oral preparations, but could save costs because they have fewer adverse effects. A cost-utility study is needed to decide on their comparative cost effectiveness. METHODS: We recruited 585 people aged >or=50 yrs with knee pain; 282 participated in a randomized controlled trial and 303 in a patient preference study from 26 MRC General Practice Research Framework practices in the UK. They received advice to preferentially use topical or oral NSAIDs for knee pain. We calculated the comparative cost per quality-adjusted life year (QALY) from both a National Health Service (NHS) and a societal perspective over 12 and 24 months. RESULTS: Compared with the topical route, oral NSAIDs cost the NHS pound191 and pound72 more over 1 yr in the randomized trial and preference study, respectively. The cost per QALY, from an NHS perspective, was in the range of pound9000- pound12000 in the randomized trial. In the preference study, it was pound2564 over 1 yr, but over 2 yrs the oral route was dominant. CONCLUSIONS: Our cost-effectiveness analysis supports the use of oral NSAIDs in selected patients. Nevertheless, deciding to recommend oral NSAIDs in preference to topical NSAIDs could have a substantial impact on NHS costs because of the uncertainty in the cost-effectiveness estimate.

OBJECTIVES: to determine whether GPs should advise their older patients with chronic knee pain to use topical or oral non-steroidal anti-inflammatory drugs (NSAIDs). DESIGN: an equivalence study was designed to compare the effect of advice to use preferentially oral or topical ibuprofen (an NSAID) on knee pain and disability, NSAID-related adverse effects and NHS/societal costs, using a randomised controlled trial (RCT) and a patient preference study (PPS). Reasons for patient preferences for topical or oral preparations, and attitudes to adverse effects, were explored in a qualitative study. SETTING: Twenty-six general practices in the UK. PARTICIPANTS: Participants comprised 585 people with knee pain, aged 50 years or over; 44% were male, mean age 64 years. The RCT had 282 participants: 144 in the oral group and 138 in the topical group. The PPS had 303 participants: 79 in the oral group and 224 in the topical group. INTERVENTIONS: Advice to use preferentially oral or topical NSAIDs for knee pain. OUTCOME MEASURES: the primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures were the Short Form with 36 Items (SF-36), perceived troublesomeness of knee pain, satisfaction with health status, major adverse effects (unplanned hospital admissions and deaths) and minor adverse events over 12 months. The health economic analysis measured the comparative cost per quality-adjusted life-year (QALY) from both an NHS and a societal perspective over 1 and 2 years. RESULTS: Changes in the global WOMAC score at 12-months were equivalent in both studies: topical - oral, RCT difference=2 [95% confidence interval (CI) -2 to 6], PPS difference=1 (95% CI -4 to 6). There were no differences in the secondary outcomes, except for a suggestion, in the RCT, that those in the topical group were more likely to have more severe overall pain and disability as measured by the chronic pain grade, and more likely to report changing treatment because of inadequate pain relief. There were no differences in the rate of major adverse effects but some differences in the number of minor ones. In the RCT, 17% and 10% in the oral and the topical group, respectively, had a defined respiratory adverse effect (95% CI of difference -17% to -2.0%); after 12 months, the change in serum creatinine was 3.7 mmol/l (95% CI 0.9 to 6.5) less favourable in the oral than in the topical group, and 11% of those in the oral group reported changing treatment because of adverse effects compared with 1% in the topical group (p=0.02). None of these differences were seen in the PPS. Oral NSAIDs cost the NHS 191 pounds and 72 pounds more per participant over 1 year in the RCT and PPS respectively. In the RCT the cost per QALY in the oral group, from an NHS perspective, was in the range 9000-12,000 pounds. In the PPS it was 2564 pounds over 1 year, but over 2 years the oral route was more cost-effective. Patient preference for medication type was affected by previous experience of medication (including adverse reactions), other illness, pain elsewhere, anecdotes, convenience, severity of pain and perceived degree of degeneration. Lack of understanding about knee pain and the action of medication led to increased tolerance of symptoms. Potentially important symptoms may inadvertently have been disregarded, increasing participants' risk of suffering a major adverse effect. CONCLUSIONS: Advice to use either oral or topical preparations has an equivalent effect on knee pain, but oral NSAIDs appear to produce more minor adverse effects than topical NSAIDs. Generally, these results support advising older people with knee pain to use topical rather than oral NSAIDS. However, for patients who prefer oral NSAID preparations rather than a topical NSAID, particularly those with more widespread or severe pain, the oral route is a reasonable treatment option, provided that patients are aware of the risks of potentially serious adverse effects from oral medication. Further research is needed into strategies to change prescribing behaviour and ensure that older patients are aware of the potential risks and benefits of using NSAIDs. Observational studies are needed to estimate rates of different predefined minor adverse effects associated with the use of oral NSAIDs in older people as are long-term studies of topical NSAIDs in those for whom oral NSAIDs are not appropriate.

In the conventional quality adjusted life year (QALY) model, people's preferences are assumed to satisfy utility independence. When health varies over time, utility independence implies that the value attached to a health state is independent of the health state that arise before or after it. Two separate studies were conducted involving a total of 155 respondents. In study one, we conducted five tests of utility independence using a standard gamble question. Three of the tests of utility independence were repeated in study two after randomisation was introduced in order to take account of possible ordering effects. Utility independence holds in the majority of cases examined here and so our work generally supports the use of utility independence to derive more tractable models.

BACKGROUND AND OBJECTIVE: to assess whether completing a questionnaire on risk of falling could affect outcome measures: fear of falling, reported falls, and health service contacts in older people (panel conditioning). METHODS: We used a postal questionnaire to assess the effect on falls risk of implementing falls injury prevention guidelines within a single locality in outer London, UK. We compared responses for the baseline and 6-month follow-up surveys with those for a fresh survey. The latter was sent to a new pool of subjects drawn from the same population, and was sent only once; timing coincided with the follow-up survey. RESULTS: at baseline, we received 498 responses for 1,000 (50%) surveys sent; of these, 358 (72%) subsequently returned the follow-up survey. For the fresh survey, we received 1,261 out of 2,000 (61%) responses to the fresh survey. The odds ratio for the effect of panel conditioning on fear of falling was 0.92 (95% confidence interval CI = 0.64-1.33), within our predefined limit for equivalence. Odds ratios for the effect on reported falls and health service contacts were 0.87 (95% CI = 0.59-1.29) and 0.75 (95% CI = 0.55-1.02), respectively. CONCLUSION: the proportions of subjects who feared falling in the follow-up survey and in the fresh survey were equivalent. Reduced reporting of falls and health service use in the follow-up survey suggest that the potential for panel effects cannot be ignored.

Personal Medical Services (PMS) contracts, introduced in 1997, provide a new financial model for providing general practice. The aim of this study was to measure the costs and consequences of the PMS first wave contracts for sites that aimed to increase the accessibility and the quality of care for vulnerable population groups; to describe the problems encountered in this measurement. A purposive sample of first wave PMS sites targeting vulnerable population groups were selected. A two-stage data collection procedure was used, to obtain micro-level data on the quantity and costs of capital and recurrent funds, and top-down data on costs and apportioning of monies received from central source to broad expenditure categories. The costs data focused on the largest cost components, such as staff and prescribing as well as alternative stakeholders’ contributions.The consequences data measured the accessibility and the quality of care for vulnerable population groups. Five case studies were considered. Sites that were formerly independent general medical practitioner (GP) contractors consolidated their staff with few changes in their staff-skill mix. In all sites the prescribing costs per patient were below the national average in 2000/01. Access was either consolidated or improved over the period and improved quality of care was in evidence through appropriate prescribing patterns. Though the evaluation found that the PMS sites were addressing their main objectives the data collection revealed difficulties in tracking the flows of PMS resources under the current budgetary system. We highlight the limitations of the PMS data monitoring procedures and discuss how these limitations can be overcome so that future National Health Services (NHS) reforms can be appropriately evaluated in the future. © 2005, Cambridge University Press. All rights reserved.

The quality-adjusted life year makes a number of restrictive assumptions about the nature of one's preference over health. The healthy year equivalent was originally proposed over 10 years ago as a major theoretic advance on the quality-adjusted life year. This article reviews the theoretic, empiric and normative bases for the healthy year equivalent and quality-adjusted life year approaches to valuing health profiles that vary over time. Although critics have argued that the two-stage procedure proposed by the developers of healthy year equivalent is theoretically equivalent to a generalized time trade-off question, the notion of directly valuing a series of health states in a health profile has been an important contribution to the literature. Since then, new quality-adjusted life year approaches have been developed to combine health states that vary over time. However, these approaches have yet to be tested empirically. The empiric evidence comparing quality-adjusted life years with healthy year equivalents is equivocal, and the size and direction of difference is context specific. In some studies, no differences have been found. At the same time, where differences are observed, it is difficult to interpret the healthy year equivalent values as the gold standard since there is evidence of cognitive confusion in the answers being given to the valuations of complex health profiles. Based on the evidence to date, it is not clear that healthy year equivalents provide a better measure of preferences than quality-adjusted life years. © 2005 Future Drugs Ltd.

BACKGROUND: Many older people have chronic knee pain. Both topical and oral non- steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat this. Oral NSAIDS are effective, at least in the short term, but can have severe adverse effects. Topical NSAIDs also appear to be effective, at least in the short term. One might expect topical NSAIDs both to be less effective and to have fewer adverse effects than oral NSAIDs. If topical NSAIDs have fewer adverse effects this may outweigh both the reduction in effectiveness and the higher cost of topical compared to oral treatment. Patient preferences may influence the comparative effectiveness of drugs delivered via different routes. METHODS: TOIB is a randomised trial comparing topical and oral ibuprofen, with a parallel patient preference study. We are recruiting people aged 50 or over with chronic knee pain, from 27 MRC General Practice Research Framework practices across the UK. We are seeking to recruit 283 participants to the RCT and 379 to the PPS. Participants will be followed up for up to two years (with the majority reaching one year). Outcomes will be assessed by postal questionnaire, nurse examination, laboratory tests and medical record searches at one and two years or the end of the study. DISCUSSION: This study will provide new evidence on the overall costs and benefits of treating chronic knee pain with either oral or topical ibuprofen. The use of a patient preference design is unusual, but will allow us to explore how preference influences response to a medication. In addition, it will provide more information on adverse events. This study will provide evidence to inform primary care practitioners, and possibly influence practice.

OBJECTIVES: to develop a cost-effectiveness model of a complex intervention from pilot study data in order to inform the viability and design of a subsequent falls prevention trial. METHODS: We used two models; the first estimated the probability of falling over a 12-month period based on a probability tree; the second used Markov simulation to assess the impact of the programme over time. RESULTS: the first model indicated that our intervention would reduce the proportion falling by only 2.8% over a 12-month period. The major reason for this small effect was that less than a quarter of older people at risk of falling were assessed using our screening tool. Even if policy-makers were willing to spend 30,000 pounds per quality-adjusted life-year gained, there is only a 40% chance that the intervention would be cost-effective. Sensitivity analyses showed that the only scenarios that produced a substantial increase in the effect of the intervention were those in which all older people are assessed. CONCLUSIONS: the model-building approach described in this paper is vital when designing complex trials and where a trial is not possible. Information from the modelling can be used to re-design the intervention. The effectiveness of our proposed intervention appears very small due to its inability to reach those at risk of falling. It is most likely not to be cost-effective. If inability to reach the target group is a weakness common to other similar interventions, this suggests an area for further research.

We consider the impact of introducing intermediate stages, chained together, into the standard gamble (SG) and time trade-off (TTO) methods. Less is known about the impact of intermediate stages, chained together, in the TTO method. We broadly replicate the patterns of responses observed in other SG studies which have been accounted for by loss aversion. We find that the TTO responses do not replicate the patterns found in the SG responses. The results support the notion that additional issues arise in the TTO method that counteract loss aversion.

Quality-adjusted life years (QALYs) estimate the utility derived from health profiles by taking account of life expectancy and quality of life. In applying QALYs to situations where health varies over time, it is usual to assume that we can add the utilities from constituent health states. This paper investigates the QALY approach to combining health states over time using two tests. The first test rejects additive independence, the central assumption of the QALY model, for individual respondents. The second test is equivocal. The tests are, therefore, unable to conclusively reject the QALY approach to combining health states over time.

In a pilot study we investigate whether the inferences we draw about people's preferences towards health care treatments are altered if we vary the procedure that is used to elicit these preferences. In a conventional time trade-off (TTO) question, respondents express their preferences towards treatment by comparing a period of ill-health with a shorter period in a higher quality of life. In our less conventional TTO question, we vary the procedure by asking respondents their preferences towards treatment by comparing a period of ill-health with a longer period in a lower quality of life. The quantitative data are equivocal about whether preferences for treatment differ between the conventional and unconventional questions. The qualitative data support the notion of contrasting issues in the questions that involve prolonging time in a lower quality of life and appear to account for a failure to find quantitative differences in all of the questions.

This article reports the results of two studies aimed at testing and refining a procedure for estimating willingness-to-pay based monetary values of safety using the contingent valuation method. In spite of the fact that respondents were given the opportunity to discuss various safety issues and key concepts in focus group meetings held in advance of individual interviews, and were also given ample opportunity to revise their responses in the light of the overall pattern of these responses, the results show clear evidence of extensive and persistent insensitivity to the scale and scope of the safety improvements that were specified in the contingent valuation questions, as well as vulnerability to framing effects. This clearly casts serious doubt on the reliability and validity of willingness-to-pay based monetary values of safety estimated using conventional contingent valuation procedures.