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Abstract: Recent publications outline developments in eliciting probabilistic opinions from clinical experts with which to inform structural assumptions and parameter estimates in health economic models. We outline approaches taken to date to elicit probabilistic distributions from experts within the health economic literature and outline the appropriate considerations and the resulting process in developing a new elicitation program with the aim of allowing low-cost elicitation of expert opinion from a heterogeneous and geographically dispersed opinion pool while preserving the essential features of good practice elicitation methods. [Copyright &y& Elsevier]

Abstract: Objective: To assess the cost-effectiveness of eplerenone versus spironolactone as an adjunctive therapy to standard care in patients with heart failure (HF) following a myocardial infarction (post-MI) from the perspective of the National Health Service in the United Kingdom. Methods: A systematic review was conducted, and a Bayesian meta-regression approach was used to establish the relative effectiveness of eplerenone and spironolactone by using evidence from randomized controlled trials. A decision analytic model was developed to assess the costs and consequences associated with the primary outcome of the trials over a lifetime time horizon. Results: The incremental cost-effectiveness ratio of eplerenone compared with that of standard care alone was £4457 and £7893 for each additional quality-adjusted life-year when 2-year and lifetime treatment duration was assumed, respectively. In both scenarios, spironolactone did not appear cost-effective compared with eplerenone. The results were sensitive to the higher relative effectiveness estimated for eplerenone compared with spironolactone from the meta-regression. When a class effect was assumed for the effect on mortality and hospitalizations, spironolactone emerged as the most cost-effective treatment. Conclusions: Eplerenone appears more cost-effective than spironolactone for the treatment of post-MI HF. These findings, however, remain subject to important uncertainties regarding the effects of treatment on major clinical events. An adequately powered, well-conducted randomized controlled trial that directly compares spironolactone and eplerenone may be required to provide more robust evidence on the optimal management of post-MI HF. Despite these uncertainties, the use of an aldosterone antagonist was consistently demonstrated to be a highly cost-effective strategy for the management of post-MI HF in the National Health Service. [Copyright &y& Elsevier]

Abstract: This paper explores the spread of ideas within health economics, in relation to the impact of the capability approach to date and the extent to which it might impact in the future. The paper uses UK decision making to illustrate this spread of ideas. Within health economics, Culyer used the capability approach in developing the extra-welfarist perspective (where health status directly influences which social state is preferred). It is not a direct application of capability as the evaluation''s focus remains narrow; the concern is with functioning, and maximisation is retained. Culyer''s work provided a theoretical basis for using quality-adjusted life-years in decision making and this perspective is accepted as the basis for evaluation by the UK National Institute of Health and Clinical Excellence (NICE). To the extent that extra-welfarism represents a capability approach, capabilities influence NICE''s decision making and hence UK health care provision. This paper explores the extent to which extra-welfarism draws on the capability approach; the spread of extra-welfarist ideas; and recent interest in more direct applications of the capability approach. [Copyright &y& Elsevier]

Purpose: The purpose of the study was to compare completeness, timeliness and cost of patient-reported outcome measures (PROMs) collection using telephone, email and post in men with prostate cancer.Methods: A parallel, three-arm randomised controlled equivalence trial. 1168 patients were randomised to telephone (n = 295), postal (n = 388) and email (n = 385) arms. Participants were asked to provide self-reported responses for 26 items of Expanded Prostate Cancer Index Composite. Cost and resource data were collected from a provider perspective.Results: Equivalence tests showed no difference in completeness in the three arms within a 10% equivalence margin. Men diagnosed in public hospitals were less likely to complete the survey compared to those in private hospitals, OR = 0.19 (95% CI 0.04-0.89) (p = 0.035). The email survey required significantly less time to complete than telephone and postal methods [median time of 2 min (IQR 1,8) vs. 7 min (IQR 6,9) vs. 10 min (IQR 9,12), respectively (p < 0.001)]. The incremental cost effectiveness ratio for email compared to telephone was AUD$1.90, cost-effective if users valued an additional 1% improvement in survey completion greater than AUD$1.90.Conclusion: Email method took less time and cost and should be used as the primary PROMs collection, with telephone if men without email or do not respond to email. [ABSTRACT FROM AUTHOR]

Objectives To identify parameters that drive the cost-effectiveness of precision medicine by comparing the use of multiplex targeted sequencing (MTS) to select targeted therapy based on tumour genomic profiles to either no further testing with chemotherapy or no further testing with best supportive care in the fourth-line treatment of metastatic lung adenocarcinoma. Methods A combined decision tree and Markov model to compare costs, life-years, and quality-adjusted life-years over a ten-year time horizon from an Australian healthcare payer perspective. Data sources included the published literature and a population-based molecular cohort study (Cancer 2015). Uncertainty was assessed using deterministic sensitivity analyses and quantified by estimating expected value of perfect/partial perfect information. Uncertainty due to technological/scientific advancement was assessed through a number of plausible future scenario analyses. Results Point estimate incremental cost-effective ratios indicate that MTS is not cost-effective for selecting fourth-line treatment of metastatic lung adenocarcinoma. Lower mortality rates during testing and for true positive patients, lower health state utility values for progressive disease, and targeted therapy resulting in reductions in inpatient visits, however, all resulted in more favourable cost-effectiveness estimates for MTS. The expected value to decision makers of removing all current decision uncertainty was estimated to be between AUD 5,962,843 and AUD 13,196,451, indicating that additional research to reduce uncertainty may be a worthwhile investment. Plausible future scenarios analyses revealed limited improvements in cost-effectiveness under scenarios of improved test performance, decreased costs of testing/interpretation, and no biopsy costs/adverse events. Reductions in off-label targeted therapy costs, when considered together with the other scenarios did, however, indicate more favourable cost-effectiveness of MTS. Conclusion As more clinical evidence is generated for MTS, the model developed should be revisited and cost-effectiveness re-estimated under different testing scenarios to further understand the value of precision medicine and its potential impact on the overall health budget. [ABSTRACT FROM AUTHOR]

Objective This paper aims to describe cancer survival and examine association between survival and socio-demographic characteristics across Barwon South- Western region ( BSWR) in Victoria, Australia. Design This study is based on the retrospective cohort database of patients accessing oncology services across BSWR. Setting Six rural and three urban hospital settings across the BSWR. Participants The participants were patients who were diagnosed with cancer in 2009. Main outcome measures Overall survival (OS) of participants was the main outcome measure. Results Total of 1778 eligible patients had four-year OS for all cancers combined of 59.7% (95% CI, 57.4-62.0). Improved OS was observed for patients in the upper socio-economic tertile (64.2%; 95% CI, 60.9-67.5) compared to the middle (59.3%; 95% CI, 55.5-63.1) and lowest tertiles (49.6%; 95% CI, 44.2-54.9) ( P < 0.01). On multivariate analyses, higher socio-economic status remained a significant predictor of OS adjusting for gender, remoteness and age ( HR [hazard ratio] 0.81; 95% CI 0.74-0.89; P < 0.01). Remoteness was significantly associated with improved OS after adjusting for age, gender and socio-economic status ( HR 0.86; 95% CI, 0.77-0.97; P = 0.01). Older age ≥70 years compared to <70 years conferred inferior OS ( HR 3.08; 95% CI, 2.64-3.59; P < 0.01). Conclusions Our study confirmed improved survival outcomes for patients of higher socio-economic status and younger age. Future research to explain the unexpected survival benefit in patients who lived in more remote areas should examine factors including the correlation between geographical residence and eventual treatment facility as well as compare the BSWR care model to other regions' approaches. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost-effectiveness of an occupational therapy-led lifestyle approach to treating panic disorder in primary care compared with routine general practitioner's (GP) care. The burden of mental health disorders is considerable. Cost-effective interventions are necessary to alleviate some of these burdens. Habitual lifestyle behaviours influence mood, although to date mainly single lifestyle factor trials have been conducted to examine the effects on anxiety.Methods: An economic evaluation was conducted alongside an unblinded pragmatic randomised controlled trial with assessment at 5 and 10 months. Costs and consequences, as measured by the Beck anxiety inventory (BAI) and quality adjusted life years (QALYs), were compared using incremental cost-effectiveness ratios (ICERs).Results: The occupational therapy-led lifestyle intervention was more costly than routine GP care at both 5 and 10 months. Significant outcome improvements were evident at 5 months when using the BAI, although these were not maintained at 10 months. Small differences in mean QALYs were found. The estimated ICER was 36 pounds per BAI improvement for 5 months and 39 pounds for 10 months, and 18,905 pounds per QALY gained for 5 months and 8,283 pounds for 10 months.Conclusions: If the maximum willingness to pay per additional QALY is 30,000 pounds, then there is an 86% chance that a lifestyle intervention may be considered to be value-for-money over 10 months. [ABSTRACT FROM AUTHOR]

Objectives: To investigate healthcare utilisation and cost in individuals with long COVID (LC) at population level., Design: Case-control cohort analysis with multiple age-, sex-, ethnicity-, deprivation-, region- and comorbidity-matched control groups: (1) COVID only, no LC; (2) pre-pandemic; (3) contemporary non-COVID; and (4) pre-LC (self-controlled, pre-COVID pandemic)., Setting: National, population-based, linked UK electronic health records (British Heart Foundation/NHS England Secure Data Environment)., Participants: Adults aged ≥18 years with LC between January 2020 and January 2023., Main Outcome Measures: Healthcare utilisation (number of consultations/visits per person: primary care (general practitioner [GP]), secondary care (outpatient [OP], inpatient [IP] and emergency department [ED], investigations and procedures) and inflation-adjusted cost (£) for LC and control populations per month, calendar year and pandemic year for each category., Results: A total of 282,080 individuals with LC were included between January 2020 and January 2023. The control groups were COVID only, no LC ( n  = 1,112,370), pre-pandemic ( n  = 1,031,285), contemporary non-COVID ( n  = 1,118,360) and pre-LC ( n  = 282,080). Healthcare utilisation per person (per month/year) was higher in LC than controls across GP, OP and ED. For IP, LC had higher healthcare utilisation than pre-LC and contemporary non-COVID (all p  < 0.0001). Healthcare utilisation of the LC group increased progressively between 2020 and 2023, compared with controls. Median cost per patient/year was also higher in individuals with LC than all control groups., Conclusions: LC has been associated with substantial, persistent healthcare utilisation and cost over the last three years. Future funding, resources and staff for LC prevention, treatment and research must be prioritised to reduce sustained primary and secondary healthcare utilisation and costs.

Objective: To identify how value is defined in studies that focus on the value of molecular testing in cancer and the extent to which broadening the conceptualisation of value in healthcare has been applied in the molecular testing literature., Methods: A scoping review was undertaken using Joanna Briggs Institute (JBI) guidance. Medline, Embase, EconLit and Cochrane Library were searched in August 2023. Articles were eligible if they reported costs relative to outcomes, novel costs, or novel outcomes of molecular testing in cancer. Results were synthesised and qualitative content analysis was performed with deductive and inductive frameworks., Results: Ninety-one articles were included in the review. The majority (75/91) were conventional economic analyses (comparative economic evaluations and budget impact assessments) and undertaken from a healthcare system perspective (38/91). Clinical outcomes dominate the assessment of value (61/91), with quality-adjusted life-years (QALYs) the most common outcome measure (45/91). Other definitions of value were diverse (e.g. psychological impact, access to trials), inconsistent, and largely not in keeping with evolving guidance., Conclusions: Broader concepts of value were not commonly described in the molecular testing literature focusing on cancer. Conventional approaches to measuring the health costs and outcomes of molecular testing in cancer prevail with little focus on non-clinical elements of value. There are emerging reports of non-clinical outcomes of testing information, particularly psychological consequences. Intrinsic attributes of the testing process and preferences of those who receive testing information may determine the realised societal value of molecular testing and highlight challenges to implementing such a value framework., (© 2024. The Author(s).)

Background: A Pay-for-Performance (P4P) programme, known as Prescribed Specialised Services Commissioning for Quality and Innovation (PSS CQUIN), was introduced for specialised services in the English NHS in 2013/2014. These services treat patients with rare and complex conditions. We evaluate the implementation of PSS CQUIN contracts between 2016/2017 and 2018/2019., Methods: We used a mixed methods evaluative approach. In the quantitative analysis, we used a difference-in-differences design to evaluate the effectiveness of ten PSS CQUIN schemes across a range of targeted outcomes. Potential selection bias was addressed using propensity score matching. We also estimated impacts on costs by scheme and financial year. In the qualitative analysis, we conducted semi-structured interviews and focus group discussions to gain insights into the complexities of contract design and programme implementation. Qualitative data analysis was based on the constant comparative method, inductively generating themes., Results: The ten PSS CQUIN schemes had limited impact on the targeted outcomes. A statistically significant improvement was found for only one scheme: in the clinical area of trauma, the incentive scheme increased the probability of being discharged from Adult Critical Care within four hours of being clinically ready by 7%. The limited impact may be due to the size of the incentive payments, the complexity of the schemes' design, and issues around ownership, contracting and flexibility., Conclusion: The PSS CQUIN schemes had little or no impact on quality improvements in specialised services. Future P4P programmes in healthcare could benefit from lessons learnt from this study on incentive design and programme implementation., (© 2023. The Author(s).)

Over the last twenty years, there has been a growing interest in measuring sexual wellbeing, including by a WHO/UNFPA working group in 2007, which sought clarity on key dimensions and asked for indicators of these to be devised. However, there remains a lack of conceptual clarity surrounding the concept of sexual wellbeing, which may create variation in what is being assessed and to what we are referring. This paper proposes one way in which to achieve conceptual clarity might be through the utilisation of a Capability Approach, thereby posing a new set of normative questions about what sexual wellbeing is. The central argument in this paper is for researchers, theorists and practitioners to focus more fully on a person's freedom to achieve sexual wellbeing within a particular social and cultural context. We suggest the kinds of data that might need to be captured to operationalise and measure such an understanding. By offering new critical insights, we hope to drive forward empirical and methodological development in the evaluation of sexual wellbeing.

Importance: Several international guidelines have endorsed more conservative treatment of low-risk differentiated thyroid cancer (LRDTC), yet patients are facing more treatment options with similar oncologic outcomes and are expressing feelings of confusion, dissatisfaction, and anxiety. Shared decision-making, which considers the patient's values and preferences along with the most reliable medical evidence, has been proposed to optimize patient satisfaction in the context of the current clinical equipoise., Objectives: To understand key individual and behavioral factors affecting the patient and clinician decision-making process in treatment decision for LRDTC., Evidence Review: This systematic review and meta-ethnography involved a comprehensive literature search of MEDLINE, Embase, PubMed, and CINAHL databases for qualitative and mixed-method studies on patient and clinician experiences with the decision-making process for LRDTC treatment. The quality of the studies was assessed using the Mixed Methods Appraisal Tool; meta-ethnography was used for data analysis. Primary and secondary themes of the included studies were extracted, compared, and translated across articles to produce a lines-of-argument synthesis., Findings: Of 1081 publications identified, 12 articles met the inclusion criteria. The qualitative synthesis produced 4 themes: (1) a bimodal distribution of patient preferences for treatment decisions; (2) clinician anxiety affected equipoise and biased their recommendations; (3) clinicians struggled to identify patient concerns and preferences; and (4) the clinician-patient relationship and psychosocial support were key to shared decision-making but were frequently overlooked., Conclusions and Relevance: The findings of this systematic review and meta-ethnography emphasize the need for better patient-clinician communication, particularly with respect to eliciting patient concerns and preferences. With an ever-increasing pool of thyroid cancer survivors, future efforts should be directed at establishing and evaluating tools that will aid in shared decision-making for treatment of patients with LRDTC., Trial Registration: PROSPERO Identifier: CRD42022286395.

Introduction: Prostate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of three sequences: T2-weighted sequence (T2W), diffusion-weighted sequence (DWI) and dynamic contrast-enhanced sequence (DCE). Prior studies suggest that a biparametric MRI (bpMRI) approach, omitting the DCE sequences, may not compromise clinically significant cancer detection, though there are limitations to these studies, and it is not known how this may affect treatment eligibility. A bpMRI approach will reduce scanning time, may be more cost-effective and, at a population level, will allow more men to gain access to an MRI than an mpMRI approach., Methods: Prostate Imaging Using MRI±Contrast Enhancement (PRIME) is a prospective, international, multicentre, within-patient diagnostic yield trial assessing whether bpMRI is non-inferior to mpMRI in the diagnosis of clinically significant PCa. Patients will undergo the full mpMRI scan. Radiologists will be blinded to the DCE and will initially report the MRI using only the bpMRI (T2W and DWI) sequences. They will then be unblinded to the DCE sequence and will then re-report the MRI using the mpMRI sequences (T2W, DWI and DCE). Men with suspicious lesions on either bpMRI or mpMRI will undergo prostate biopsy. The main inclusion criteria are men with suspected PCa, with a serum PSA of ≤20 ng/mL and without prior prostate biopsy. The primary outcome is the proportion of men with clinically significant PCa detected (Gleason score ≥3+4 or Gleason grade group ≥2). A sample size of at least 500 patients is required. Key secondary outcomes include the proportion of clinically insignificant PCa detected and treatment decision., Ethics and Dissemination: Ethical approval was obtained from the National Research Ethics Committee West Midlands, Nottingham (21/WM/0091). Results of this trial will be disseminated through peer-reviewed publications. Participants and relevant patient support groups will be informed about the results of the trial., Trial Registration Number: NCT04571840., Competing Interests: Competing interests: AN is an academic clinical fellow funded by the National Institute for Health and Care Research. PK is an academic clinical fellow funded by the National Institute for Health and Care Research and The Urology Foundation. FG is a recipient of the 2020 Young Investigator Award (20YOUN15) funded by the Prostate Cancer Foundation / CRIS Cancer Foundation. SP is supported by the National Institute of Health and Care Research (NIHR), UCLH and UCL Biomedical Research Centre. ME receives research support from the National Institute of Health and Care Research (NIHR), UCLH and UCL Biomedical Research Centre. YT is funded by a UK NIHR Postdoctoral Fellowship and supported by the NIHR Birmingham Biomedical Research Centre. CMM is an NIHR Research Professor, and receives grants from MRC, CRUK, Movember, and Prostate Cancer UK. VK is funded by Prostate Cancer UK and The John Black Charitable Foundation. He receives speaker fees from the European Association of Urology, Singapore Urology Association, The Clinical Comms Group and Got IT consulting SL. All authors declare that there are no conflicts of interest. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, NIHR, or the Department of Health and Social Care., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

While the negative impact of unemployment on health is relatively well established, the extent to which that impact reflects on changes in health and social care utilisation is not well understood. This paper critically reviews the direction, magnitude and drivers of the impact of unemployment and job insecurity on health and social care utilisation across different care settings. We identified 28 relevant studies, which included 79 estimates of association between unemployment/job insecurity and healthcare utilisation. Positive associations dominated mental health services (N = 8 out of 11), but not necessarily primary care (N = 25 out of 43) or hospital care (N = 5 out of 22). We conducted a meta-analysis to summarise the magnitude of the impact and found that unemployed individuals were about 30% more likely to use health services compared to those employed, although this was largely driven by mental health service use. Key driving factors included financial pressure, health insurance, social network, disposable time and depression/anxiety. This review suggests that unemployment is likely to be associated with increased mental health service use, but there is considerable uncertainty around primary and hospital care utilisation. Future work to examine the impact across other settings, including community and social care, and further explore non-health determinants of utilisation is needed. The protocol was registered in PROSPERO (CRD42020177668)., (© 2022. The Author(s).)

Introduction: The incidence of renal tumours is increasing and anatomic imaging cannot reliably distinguish benign tumours from renal cell carcinoma. Up to 30% of renal tumours are benign, with oncocytomas the most common type. Biopsy has not been routinely adopted in many centres due to concerns surrounding non-diagnostic rate, bleeding and tumour seeding. As a result, benign masses are often unnecessarily surgically resected. 99m Tc-sestamibi SPECT/CT has shown high diagnostic accuracy for benign renal oncocytomas and other oncocytic renal neoplasms of low malignant potential in single-centre studies. The primary aim of MULTI-MIBI is to assess feasibility of a multicentre study of 99m Tc-sestamibi SPECT/CT against a reference standard of histopathology from surgical resection or biopsy. Secondary aims of the study include obtaining estimates of 99m Tc-sestamibi SPECT/CT sensitivity and specificity and to inform the design and conduct of a future definitive trial., Methods and Analysis: A feasibility prospective multicentre study of participants with indeterminate, clinical T1 renal tumours to undergo 99m Tc-sestamibi SPECT/CT (index test) compared with histopathology from biopsy or surgical resection (reference test). Interpretation of the index and reference tests will be blinded to the results of the other. Recruitment rate as well as estimates of sensitivity, specificity, positive and negative predictive value will be reported. Semistructured interviews with patients and clinicians will provide qualitative data to inform onward trial design and delivery. Training materials for 99m Tc-sestamibi SPECT/CT interpretation will be developed, assessed and optimised. Early health economic modelling using a decision analytic approach for different diagnostic strategies will be performed to understand the potential cost-effectiveness of 99m Tc-sestamibi SPECT/CT., Ethics and Dissemination: Ethical approval has been granted (UK HRA REC 20/YH/0279) protocol V.5.0 dated 21/6/2022. Study outputs will be presented and published nationally and internationally., Trial Registration Number: ISRCTN12572202., Competing Interests: Competing interests: GDS has received educational grants from Pfizer, AstraZeneca and Intuitive Surgical; consultancy fees from Pfizer, Merck, EUSA Pharma and CMR Surgical; Travel expenses from Pfizer and Speaker fees from Pfizer. SD provides educational consultancy for GE Healthcare, Bayer, AAA and AVAANT diagnostics., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

How the Coronavirus Disease 2019 (COVID-19) pandemic has affected prevention and management of cardiovascular disease (CVD) is not fully understood. In this study, we used medication data as a proxy for CVD management using routinely collected, de-identified, individual-level data comprising 1.32 billion records of community-dispensed CVD medications from England, Scotland and Wales between April 2018 and July 2021. Here we describe monthly counts of prevalent and incident medications dispensed, as well as percentage changes compared to the previous year, for several CVD-related indications, focusing on hypertension, hypercholesterolemia and diabetes. We observed a decline in the dispensing of antihypertensive medications between March 2020 and July 2021, with 491,306 fewer individuals initiating treatment than expected. This decline was predicted to result in 13,662 additional CVD events, including 2,281 cases of myocardial infarction and 3,474 cases of stroke, should individuals remain untreated over their lifecourse. Incident use of lipid-lowering medications decreased by 16,744 patients per month during the first half of 2021 as compared to 2019. By contrast, incident use of medications to treat type 2 diabetes mellitus, other than insulin, increased by approximately 623 patients per month for the same time period. In light of these results, methods to identify and treat individuals who have missed treatment for CVD risk factors and remain undiagnosed are urgently required to avoid large numbers of excess future CVD events, an indirect impact of the COVID-19 pandemic., (© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Background: Information asymmetries and the agency relationship are two defining features of the healthcare system. These market failures are often used as a rationale for government intervention. Many countries have government financing and provision of healthcare in order to correct for this, while health technology agencies also exist to improve efficiency. However, informational asymmetries and the resulting principal-agent problem still persist, and one example is the lack of cost awareness amongst clinicians. This study explores the cost awareness of clinicians across different settings., Methods: We targeted four clinical cohorts: medical students, Senior House Officers/Interns, Mid-grade Senior Registrar/Residents, and Consultant/Attending Physicians, in six hospitals in the United Kingdom, the United States, Australia, New Zealand and Spain. The survey asked respondents to report the cost (as they recalled) of different types of scans, visits, medications and tests. Our analysis focused on the differential between the perceived/recalled cost and the actual cost. We explored variation across speciality, country and other potential confounders. Cost-awareness levels were estimated based on the cost estimates within 25% of the actual cost., Results: We received 705 complete responses from six sites across five countries. Our analysis found that respondents often overestimated the cost of common tests while underestimating high-cost tests. The mean cost-awareness levels varied between 4 and 23% for different items. Respondents acknowledged that they did not feel they had received adequate training in cost awareness., Discussion: The current financial climate means that cost awareness and the appropriate use of scarce healthcare resources is more paramount than perhaps ever before. Much of the focus of health economics research is on high-cost innovative technologies, yet there is considerable waste in the system with respect to overtreatment and overdiagnosis. Common reasons put forward for this include defensive medicine, poor education, clinical uncertainty and the institution of protocols., Conclusion: Given the role of clinicians in the healthcare system, as agents both for patients and for providers, more needs to be done to remove informational asymmetries and improve clinician cost awareness., (© 2022. Crown.)

Background: Several countries paused their rollouts of the Oxford-AstraZeneca coronavirus disease-19 (COVID-19) vaccine in mid-March 2021 due to concerns about vaccine-induced thrombosis and thrombocytopenia. Many warned that this risked damaging public confidence during a critical period of pandemic response. This study investigated whether the pause in the use of the Oxford-AstraZeneca vaccine had an impact on subsequent vaccine uptake in European countries., Methods: We used a difference-in-differences approach capitalizing on the fact that some countries halted their rollouts whilst others did not. A longitudinal panel was constructed for European Economic Area countries spanning 15 weeks in early 2021. Media reports were used to identify countries that paused the Oxford-AstraZeneca vaccine and the timing of this. Data on vaccine uptake were available through the European Centre for Disease Control and Prevention COVID-19 Vaccine Tracker. Difference-in-differences linear regression models controlled for key confounders that could influence vaccine uptake, and country and week fixed effects. Further models and robustness checks were performed., Results: The panel included 28 countries, with 19 in the intervention group and 9 in the control group. Pausing the Oxford-AstraZeneca vaccine was associated with a 0.52% decrease in uptake for the first dose of a COVID-19 vaccine and a 1.49% decrease in the uptake for both doses, comparing countries that paused to those that did not. These estimates are not statistically significant (P = 0.86 and 0.39, respectively). For the Oxford-AstraZeneca vaccine only, the pause was associated with a 0.56% increase in uptake for the first dose and a 0.07% decrease in uptake for both doses. These estimates are also not statistically significant (P = 0.56 and 0.51, respectively). All our findings are robust to sensitivity analyses., Conclusions: As new COVID-19 vaccines emerge, regulators should be cautious to deviate from usual protocols if further investigation on clinical or epidemiological grounds is warranted., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Public Health Association.)

Objectives: Disease control is important to limit the social, economic and health effects of COVID-19 and reduce the risk of novel variants emerging. Evidence suggests vaccines are less effective against the Omicron variant, but their impact on disease control is unclear. Methods: We used a longitudinal fixed effects Poisson regression model to assess the impact of vaccination on COVID-19 case rates across 32 countries in Europe from 13th October to 01st January 2022. We controlled for country and time fixed effects and the severity of public health restrictions. Results: Full vaccination coverage increased by 4.2%, leading to a 54% reduction in case rates across Europe ( p < 0.001). This protection decreased over time but remained significant at 5 weeks after the detection of Omicron. Mean booster vaccination rates increased from 2.71% to 24.5% but provided no significant additional benefit. For every one-unit increase in the severity of public health restrictions, case rates fell by a further 2% ( p = 0.019). Conclusion: Full vaccination significantly limited the spread of COVID-19 and blunted the impact of the Omicron variant, despite becoming less useful over time., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Jain, Serisier and Lorgelly.)

The equitable global allocation of COVID-19 vaccines has received much attention yet been poorly defined. Understanding equity requires assessing needs for vaccines across countries. Making distinctions is especially challenging when countries perform similarly on traditional epidemiological metrics. This Viewpoint offers a novel conceptual framework (COVID-NEEDS) based on empirical evidence and public health guidance. It encompasses health, social, and economic impacts of COVID-19 and associated non-pharmaceutical interventions. We intend this framework to complement existing needs assessment methods to help identify countries most in need of vaccines. We present factors to consider, but future work will be required to understand how to weight the factors and to determine the practical utility of the framework for supplementing existing COVID-19 vaccine allocation mechanisms., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Artificial intelligence (AI) is a broad discipline that aims to understand and design systems that display properties of intelligence. Machine learning (ML) is a subset of AI that describes how algorithms and models can assist computer systems in progressively improving their performance. In health care, an increasingly common application of AI/ML is software as a medical device (SaMD), which has the intention to diagnose, treat, cure, mitigate, or prevent disease. AI/ML includes either "locked" or "continuous learning" algorithms. Locked algorithms consistently provide the same output for a particular input. Conversely, continuous learning algorithms, in their infancy in terms of SaMD, modify in real-time based on incoming real-world data, without controlled software version releases. This continuous learning has the potential to better handle local population characteristics, but with the risk of reinforcing existing structural biases. Continuous learning algorithms pose the greatest regulatory complexity, requiring seemingly continuous oversight in the form of special controls to ensure ongoing safety and effectiveness. We describe the challenges of continuous learning algorithms, then highlight the new evidence standards and frameworks under development, and discuss the need for stakeholder engagement. The paper concludes with 2 key steps that regulators need to address in order to optimize and realize the benefits of SaMD: first, international standards and guiding principles addressing the uniqueness of SaMD with a continuous learning algorithm are required and second, throughout the product life cycle and appropriate to the SaMD risk classification, there needs to be continuous communication between regulators, developers, and SaMD end users to ensure vigilance and an accurate understanding of the technology., (©Jane Elizabeth Carolan, John McGonigle, Andrea Dennis, Paula Lorgelly, Amitava Banerjee. Originally published in JMIR Medical Informatics (https://medinform.jmir.org), 27.01.2022.)

Background: Uncertainty about the benefits new cancer medicines will deliver in clinical practice risks delaying patient access to new treatment options in countries such as England, where the cost effectiveness of new medicines affects reimbursement decisions. Outcome-based payment (OBP) schemes, whereby the price paid for the drug is linked to patients' real-world treatment outcome(s) has been put forward as a mechanism to accelerate access. Although OBP schemes have generally focused on clinical outcomes to determine reimbursement, the degree to which these represent the outcomes that are important to patients is unclear., Objective: To advance the application of OBP we ask, what outcomes do patients with cancer value (most) that might form a practical basis for OBP?, Methods: A review of the literature on outcomes in cancer produced a long list of candidates. These were evaluated in a focus group with patients with cancer and were then, in a second focus group, distilled to a shortlist of ten outcomes using a card sort method. The ten outcomes were included in an online survey of patients with cancer and carers, who were asked to rank the importance of each outcome., Results: The focus groups identified a range of both clinical and functional outcomes that are important to patients. Analyses of the 164 survey responses suggested that the four most important outcomes to patients and carers are survival; progression, relapse or recurrence; post-treatment side effects; and return to normal activities of daily life., Conclusion: Commissioners of cancer services wishing to instigate an OBP scheme should prioritise collecting data on these outcomes as they are important to patients. Of these, only mortality data are routinely collected within the national health service (NHS). Progression and some morbidity data exist but are not currently linked, creating a challenge for OBP.

In 2018, a panel of health economics and meningococcal disease experts convened to review methodologies, frameworks, and decision-making processes for economic evaluations of vaccines, with a focus on evaluation of vaccines targeting invasive meningococcal disease (IMD). The panel discussed vaccine evaluation methods across countries; IMD prevention benefits that are well quantified using current methods, not well quantified, or missing in current cost-effectiveness methodologies; and development of recommendations for future evaluation methods. Consensus was reached on a number of points and further consideration was deemed necessary for some topics. Experts agreed that the unpredictability of IMD complicates an accurate evaluation of meningococcal vaccine benefits and that vaccine cost-effectiveness evaluations should encompass indirect benefits, both for meningococcal vaccines and vaccines in general. In addition, the panel agreed that transparency in the vaccine decision-making process is beneficial and should be implemented when possible. Further discussion is required to ascertain: how enhancing consistency of frameworks for evaluating outcomes of vaccine introduction can be improved; reviews of existing tools used to capture quality of life; how indirect costs are considered within models; and whether and how the weighting of quality-adjusted life-years (QALY), application of QALY adjustment factors, or use of altered cost-effectiveness thresholds should be used in the economic evaluation of vaccines.

Pay-for-Performance (P4P) schemes have become increasingly common internationally, yet evidence of their effectiveness remains ambiguous. P4P has been widely used in England for over a decade both in primary and secondary care. A prominent P4P programme in secondary care is the Commissioning for Quality and Innovation (CQUIN) framework. The most recent addition to this framework is Prescribed Specialised Services (PSS) CQUIN, introduced into the NHS in England in 2013. This study offers a review and critique of the PSS CQUIN scheme for specialised care. A key feature of PSS CQUIN is that whilst it is centrally developed, performance targets are agreed locally. This means that there is variation across providers in the schemes selected from the national menu, the achievement level needed to earn payment, and the proportion of the overall payment attached to each scheme. Specific schemes vary in terms of what is incentivised - structure, process and/or outcome - and how they are incentivised. Centralised versus decentralised decision making, the nature of the performance measures, the tiered payment structure and the dynamic nature of the schemes have created a sophisticated but complex P4P programme which requires evaluation to understand the effect of such incentives on specialised care., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Purpose: Developmental coordination disorder (DCD) is a neurodevelopmental disorder with an estimated prevalence of 2-6% in school-aged children. Children with DCD score lower in multiple quality of life (QOL) domains. However, the effect of a child's DCD on their parents' and family's QOL has not previously been assessed in a UK population. We aimed to assess parental and family QOL within UK families containing at least one child aged 6-18 years who was diagnosed with DCD., Methods: A mixed-methods study was designed, using an online questionnaire that incorporated the Family QOL Scale and the 12-Item Short Form Health Survey., Results: The emotional and disability support domains of family QOL were markedly negatively affected by DCD, with lack of support by medical and educational professionals cited as a major source of stress. Parental mental health was also negatively affected. In many cases, the child's DCD impacted on parental work life, family social life and siblings' well-being., Conclusions: Having a child with DCD has a considerable impact on families. This needs to be recognised by healthcare and other professionals; otherwise, services and support may not be appropriately targeted and the negative sequelae of DCD may ripple beyond the individual with costly social and economic consequences.

Systematic differences in the ways that people use and interpret response categories (differential item functioning, DIF) can introduce bias when using self-assessments to compare health or quality of life across heterogeneous groups. This paper reports on an exploratory analysis involving the use of anchoring vignettes to identify DIF in a commonly used measure for assessing health-related quality of life - namely the EQ-5D. Using data from a bespoke (i.e. custom) survey that recruited a representative sample of 4300 respondents from the general Australian population in 2014 and 2015, we find that the assumptions of response consistency (RC) and vignette equivalence (VE) hold in a sub-sample of respondents aged 55-65 years (n = 914), which demonstrates that vignettes can appropriately identify DIF in EQ-5D reporting for this age group. We find that the EQ-5D is indeed subject to DIF, and that failure to account for DIF can lead to conclusions that are misleading when using the instrument to compare health or quality of life across heterogeneous groups. We also provide several important insights in terms of the identifying assumptions of RC and VE. We conclude that the implications of DIF could be of considerable importance, not only for outcomes research, but for funding decisions in healthcare more broadly given the strong reliance on patient-reported outcome measures in economic evaluations for health technology assessment., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Purpose: It has been argued that generic health-related quality of life measures are not sensitive to certain disease-specific improvements; condition-specific preference-based measures may offer a better alternative. This paper assesses the validity, responsiveness and sensitivity of a cancer-specific preference-based measure, the EORTC-8D, relative to the EQ-5D-3L., Methods: A longitudinal prospective population-based cancer genomic cohort, Cancer 2015, was utilised in the analysis. EQ-5D-3L and the EORTC QLQ-C30 (which gives EORTC-8D values) were asked at baseline (diagnosis) and at various follow-up points (3 months, 6 months, 12 months). Baseline values were assessed for convergent validity, ceiling effects, agreement and sensitivity. Quality-adjusted life-years (QALYs) were estimated and similarly assessed. Multivariate regression analyses were employed to understand the determinants of the difference in QALYs., Results: Complete case analysis of 1678 patients found that the EQ-5D-3L values at baseline were significantly lower than the EORTC-8D values (0.748 vs 0.829, p < 0.001). While the correlation between the instruments was high, agreement between the instruments was poor. The baseline health state values using both instruments were found to be sensitive to a number of patient and disease characteristics, and discrimination between disease states was found to be similar. Mean generic QALYs (estimated using the EQ-5D-3L) were significantly lower than condition-specific QALYs (estimated using the EORTC-8D) (0.860 vs 0.909, p < 0.001). The discriminatory power of both QALYs was similar., Conclusions: When comparing a generic and condition-specific preference-based instrument, divergences are apparent in both baseline health state values and in the estimated QALYs over time for cancer patients. The variability in sensitivity between the baseline values and the QALY estimations means researchers and decision makers are advised to be cautious if using the instruments interchangeably.

This paper discusses two types of response-scale heterogeneity, which may impact upon the EQ-5D. Response-scale heterogeneity in reporting occurs when individuals systematically differ in their use of response scales when responding to self-assessments. This type of heterogeneity is widely observed in relation to other self-assessed measures but is often overlooked with regard to the EQ-5D. Analogous to this, preference elicitation involving the EQ-5D could be subject to a similar type of heterogeneity, where variations across respondents may occur in the interpretations of the levels (response categories) being valued. This response-scale heterogeneity in preference elicitation may differ from variations in preferences for health states, which have been observed in the literature. This paper explores what these forms of response-scale heterogeneity may mean for the EQ-5D and the potential implications for researchers who rely on the instrument as a measure of health and quality of life. We identify situations where they are likely to be problematic and present potential avenues for overcoming these issues. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Purpose: To determine the external validity of existing mapping algorithms for predicting EQ-5D-3L utility values from EORTC QLQ-C30 responses and to establish their generalizability in different types of cancer., Methods: A main analysis (pooled) sample of 3560 observations (1727 patients) and two disease severity patient samples (496 and 93 patients) with repeated observations over time from Cancer 2015 were used to validate the existing algorithms. Errors were calculated between observed and predicted EQ-5D-3L utility values using a single pooled sample and ten pooled tumour type-specific samples. Predictive accuracy was assessed using mean absolute error (MAE) and standardized root-mean-squared error (RMSE). The association between observed and predicted EQ-5D utility values and other covariates across the distribution was tested using quantile regression. Quality-adjusted life years (QALYs) were calculated using observed and predicted values to test responsiveness., Results: Ten 'preferred' mapping algorithms were identified. Two algorithms estimated via response mapping and ordinary least-squares regression using dummy variables performed well on number of validation criteria, including accurate prediction of the best and worst QLQ-C30 health states, predicted values within the EQ-5D tariff range, relatively small MAEs and RMSEs, and minimal differences between estimated QALYs. Comparison of predictive accuracy across ten tumour type-specific samples highlighted that algorithms are relatively insensitive to grouping by tumour type and affected more by differences in disease severity., Conclusions: Two of the 'preferred' mapping algorithms suggest more accurate predictions, but limitations exist. We recommend extensive scenario analyses if mapped utilities are used in cost-utility analyses.

Public health programmes tend to be complex and may combine social strategies with aspects of empowerment, capacity building and knowledge across sectors. The nature of the programmes means that some effects are likely to occur outside the healthcare sector; this breadth impacts on the choice of health and non-health outcomes to measure and value in an economic evaluation. Employing conventional outcome measures in evaluations of public health has been questioned. There are concerns that such measures are too narrow, overlook important dimensions of programme effect and, thus, lead to such interventions being undervalued. This issue is of particular importance for low-income and middle-income countries, which face considerable budget constraints, yet deliver a large proportion of health activities within public health programmes. The need to develop outcome measures, which include broader measures of quality of life, has given impetus to the development of a variety of new, holistic approaches, including Sen's capability framework and measures of subjective wellbeing. Despite their promise, these approaches have not yet been widely applied, perhaps because they present significant methodological challenges. This paper outlines the methodological challenges for the identification and measurement of broader outcomes of public health interventions in economic evaluation in low-income and middle-income countries., (© 2016 The Authors. Health Economics published by John Wiley & Sons Ltd.)

There is a growing appetite for large complex databases that integrate a range of personal, socio-demographic, health, genetic and financial information on individuals. It has been argued that 'Big Data' will provide the necessary catalyst to advance both biomedical research and health economics and outcomes research. However, it is important that we do not succumb to being data rich but information poor. This paper discusses the benefits and challenges of building Big Data, analysing Big Data and making appropriate inferences in order to advance cancer care, using Cancer 2015 (a prospective, longitudinal, genomic cohort study in Victoria, Australia) as a case study. Cancer 2015 has been linked to State and Commonwealth reimbursement databases that have known limitations. This partly reflects the funding arrangements in Australia, a country with both public and private provision, including public funding of private healthcare, and partly the legislative frameworks that govern data linkage. Additionally, linkage is not without time delays and, as such, achieving a contemporaneous database is challenging. Despite these limitations, there is clear value in using linked data and creating Big Data. This paper describes the linked Cancer 2015 dataset, discusses estimation issues given the nature of the data and presents panel regression results that allow us to make possible inferences regarding which patient, disease, genomic and treatment characteristics explain variation in health expenditure.

There is growing interest in operationalising the capability approach to measure quality of life. This paper reports the results of a research project undertaken in 2007 that sought to reduce and refine a longer survey in order to provide a summary measure of wellbeing and capability in the realm of public health. The reduction and refinement of the questionnaire took place across a number of stages, using both qualitative (five focus group discussions and 17 in-depth interviews) and quantitative (secondary data analysis, N = 1048 and primary data collection using postal surveys and interviews, N = 45) approaches. The questionnaire was reduced from its original 60+ questions to 24 questions (including demographic questions). Each of Nussbaum's ten Central Human Capabilities are measured using one (or more) of the 18 specific capability items which are included in the questionnaire (referred to as the OCAP-18). Analysis of the questionnaire responses (N = 198) found that respondents differed with respect to the levels of capabilities they reported, and that these capabilities appear to be sensitive to one's gender, age, income and deprivation decile. An index of capability, estimated by assuming equal weight for each capability question, found that the average level of capability amongst respondents was 12.44 (range 3-17.75). This index was found to be highly correlated with a measure of health (EQ-5D) and wellbeing (global QoL), although some differences were apparent. This project operationalised the capability approach to produce an instrument to measure the effectiveness (and cost effectiveness) of public health interventions; the resulting OCAP-18 appears to be responsive and measure something supplementary to health and wellbeing, thus offers a promising addition to the current suite of outcome measures that are available., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

The last decade has seen a renewed interest in Sen's capability approach; health economists have been instrumental in leading much of this work. One particular stream of research is the application of the approach to outcome measurement. To date, there have been a dozen attempts (some combined) to operationalise the approach, and produce an outcome measure that offers a broader evaluative space than health-related quality-of-life measures. Applications have so far been confined to public health, physical, mental health and social care interventions, but the capability approach could be of benefit to evaluations of pharmacotherapies and other technologies. This paper provides an introduction to the capability approach, reviews the measures that are available for use in an economic evaluation, including their current applications, and then concludes with a discussion of a number of issues that require further consideration before the approach is adopted more widely to inform resource allocation decisions.

Background: Health care expenditure (HCE) is not distributed evenly over a person's life course. How much is spent on the elderly is important as they are a population group that is increasing in size. However other factors, such as death-related costs that are known to be high, need be considered as well in any expenditure projections and budget planning decisions., Objective: This article analyses, for the first time in Scotland, how expenditure projections for acute inpatient care are influenced when applying two different analytical approaches: (1) accounting for healthcare (HC) spending at the end of life and (2) accounting for demographic changes only. The association between socioeconomic status and HC utilisation and costs at the end of life is also estimated., Methods: A representative, longitudinal data set is used. Survival analysis is employed to allow inclusion of surviving sample members. Cost estimates are derived from a two-part regression model. Future population estimates were obtained for both methods and multiplied separately by cost estimates., Results: Time to death (TTD), age at death and the interaction between these two have a significant effect on HC costs. As individuals approach death, those living in more deprived areas are less likely to be hospitalised than those individuals living in the more affluent areas, although this does not translate into incurring statistically significant higher costs. Projected HCE for acute inpatient care for the year 2028 was approximately 7% higher under the demographic approach as compared to a TTD approach., Conclusion: The analysis showed that if death is postponed into older ages, HCE (and HC budgets) would not increase to the same extent if these factors were ignored. Such factors would be ignored if the population that is in their last year(s) of life were not taken into consideration when obtaining cost estimates.

Introduction: Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care., Methods and Analysis: 48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother-infant relationship and intimate partner relationship, and healthcare costs and outcomes., Ethics and Dissemination: Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised., Trial Registration Number: Australian New Zealand Clinical Trials Registry ACTRN12613000506796. UTN: U1111-1125-8208., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Purpose: Self-rated health (SRH) is widely used to measure and compare the health status of different groups of individuals. However, SRH can suffer from heterogeneity in reporting styles, making health comparisons problematic. Anchoring vignettes is a promising technique for improving inter-group comparisons of SRH. A key identifying assumption of the approach is response consistency-that respondents rate themselves using the same underlying response scale that they rate the vignettes. Despite growing research into response consistency, it remains unclear how respondents rate vignettes and why respondents may not assess vignettes and themselves consistently., Method: Vignettes for the EQ-5D-5L were developed and included in an online survey. In-depth interviews were conducted with participants following survey completion. Response consistency was examined through qualitative analysis of the interview responses and quantitative coding of participants' thought processes., Results: Our analysis showed that anchoring vignettes for the EQ-5D-5L is feasible, but that response consistency may not hold for some participants. Respondents are more likely to rate their own health and vignettes in the same way if presented with overall health state vignettes than single health dimension vignettes, and if they imagined themselves in the health state of the hypothetical individual., Conclusion: This research highlights opportunities to improve the design of anchoring vignettes in order to enhance response consistency. It additionally provides new evidence on the feasibility of employing anchoring vignettes for the EQ-5D-5L, which is promising for future work to address reporting heterogeneity in the EQ-5D-5L.

Objectives: To evaluate the effectiveness of multidisciplinary foot-care, and to evaluate the methodological considerations of a trial of multidisciplinary care in juvenile idiopathic arthritis., Design: Exploratory randomised controlled trial., Subjects/patients: Children/adolescents with juvenile idio-pathic arthritis and inflammatory joint disease affecting the foot/ankle., Methods: Standard medical care was compared with a 12 month program of multidisciplinary foot-care informed by musculoskeletal ultrasound. This program was centred on strict disease control through rigorous examination and interventions delivered by a team comprised of a paediatric rheumatologist, podiatrist, physiotherapist and musculoskeletal ultrasonographer. Patients were assessed on foot impairment and disability scores using the Juvenile Arthritis Foot Disability Index., Results: Forty-four participants, aged 3-17 years were randomly assigned to receive the experimental (n = 21) or usual care (n = 23) interventions. There was an overall improvement in levels of foot related impairments in both groups over 12 months. Between-group differences in change scores for the Juvenile Arthritis Foot Disability Index were not statistically significant at 6 or 12 month follow-ups., Conclusion: The integrated multidisciplinary foot care interventions described in this trial were safe, but did not improve foot impairment levels relative to usual care. This trial identified several methodological challenges including recruitment/retention, difficulties with outcome tools and potential confounders.

Social support in addition to antiretroviral therapy (ART) has been indicated to be beneficial to person living with HIV/AIDS (PLWHA) and their families, but very few ART service providers go beyond ART. This study investigates whether receipt of social support in addition to ART for PLWHA makes the households that they reside in better off than households that have PLWHA but are without social support. The analysis uses data comprising of 450 households, which is a sub-sample from the 2010/2011 Centre for Health Economics Ugandan HIV Survey, a cross-sectional survey of 596 households that was undertaken in Uganda. Data were collected from households of clients that obtained ART from two major ART service providers in Central Uganda; The AIDS Support Organisation (TASO) and Ministry of Health (MOH), Uganda. Probit models and ordinary least squares regressions are employed to compare outcomes for individuals from households with a TASO or MOH client. Outcomes for individuals in households with a TASO PLWHA are hypothesised to be superior to those from households with an MOH PLWHA given that the benefits from social support accrue not only to the PLWHA but also to the household and communities they belong to. The results confirm that individuals from a household with a TASO PLWHA are better off in terms of physical health outcomes including better productivity as non-wage labour hours and having more cash in hand and having savings. The findings highlight the importance of additional support to HIV/AIDS clients and have implications for supplementation of ART service provision with other services to maximise the benefits from ART in resource constrained countries like Uganda.

Objective: To explore the perceived impact of disease-related foot problems and foot care in juvenile idiopathic arthritis (JIA) from the perspectives of patients, parents, pediatric rheumatologists, and health professionals., Design: A qualitative study using an interpretative phenomenological approach., Setting: Outpatients department, public health service children's hospital., Participants: Patients (N=15; 4 adult patients, 2 parents of children with JIA, 3 pediatric rheumatologists, and 6 health professionals) from 2 National Health Service rheumatology centers (1 pediatric and 1 adult)., Interventions: Not applicable., Main Outcome Measures: Qualitative outcomes were participants' perceptions elicited using semistructured interviews (telephone or face-to-face) and focus groups using an interpretative phenomenological approach. A data-driven inductive approach to coding and theme development was adopted for transcript analysis., Results: Participants volunteered to take part in a total of 7 interviews and 2 focus groups. The analysis revealed 6 key themes related to the impact of foot problems and perceptions of foot care from respective groups. These were the following: (1) pain, (2) mobility impairment, (3) reduced ability to perform activities of daily living, (4) footwear difficulties, (5) poor referral pathways/delayed access to care, and (6) lack of evidence in support of conservative foot care., Conclusions: Several areas for development of foot care services were identified including a need for improved referral pathways, shorter waiting times for initial consultations, greater attention to patient compliance, and a need for better evidence in support of customized foot orthoses. Several key foot health-related outcomes were identified, which may be of importance for measuring therapeutic response to foot-related interventions., (Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To compare the effects of free nicotine replacement therapy or proactive telephone counselling in addition to standard smoking cessation support offered through a telephone quitline., Design: Parallel group, 2 × 2 factorial, randomised controlled trial., Setting: National quitline, England., Participants: 2591 non-pregnant smokers aged 16 or more residing in England who called the quitline between February 2009 and February 2010 and agreed to set a quit date: 648 were each randomised to standard support, proactive support, or proactive support with nicotine replacement therapy, and 647 were randomised to standard support with nicotine replacement therapy., Interventions: Two interventions were offered in addition to standard support: six weeks' nicotine replacement therapy, provided free, and proactive counselling sessions (repeat telephone calls from, and interaction with, cessation advisors)., Main Outcome Measures: The primary outcome was self reported smoking cessation for six or more months after the quit date. The secondary outcome was cessation validated by exhaled carbon monoxide measured at six or more months., Results: At six months, 17.7% (n = 229) of those offered nicotine replacement therapy reported smoking cessation compared with 20.1% (n = 261) not offered such therapy (odds ratio 0.85, 95% confidence interval 0.70 to 1.04), and 18.2% (n = 236) offered proactive counselling reported smoking cessation compared with 19.6% (n = 254) offered standard support (0.91, 0.75 to 1.11). Data validated by carbon monoxide readings changed the findings for nicotine replacement therapy only, with smoking cessation validated in 6.6% (85/1295) of those offered nicotine replacement therapy compared with 9.4% (122/1296) not offered such therapy (0.67, 0.50 to 0.90)., Conclusions: Offering free nicotine replacement therapy or additional (proactive) counselling to standard helpline support had no additional effect on smoking cessation., Trial Registration: ClinicalTrials.gov NCT00775944.

Objectives: To describe how funds were pooled or otherwise jointly managed by National Health Service (NHS) primary care trusts and local authorities in England. To compare expenditure on local children's services by health, education and social services., Methods: We conducted a questionnaire survey of all 35 children's trust pathfinders, six months after they were launched, with a follow-up at 2.5 years. We also undertook an in-depth analysis of local authorities and primary care trusts, within eight pathfinder areas and three non-pathfinder areas, whereby we compared expenditure on children's services, interviewed managers and professionals and examined financial documents., Results: Local authorities and NHS trusts coordinated expenditure in various ways, most commonly through informal agreements and aligning budgets but also by formally pooling budgets. The latter were usually for selected services such as child and adolescent mental health services, though four children's trusts pathfinders pooled (or aligned) their budgets for all children's services. Total expenditure per child was greatest for education, lowest for social services and intermediate for health. However, it was difficult to quantify education expenditure on children with health and social care needs, and health care expenditure on children., Conclusions: Sharing money for local children's services requires shared objectives, trust, and legal and accounting expertise. Several different mechanisms are permitted and many are feasible but programme budgeting for children's services could make them more effective.