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Objectives: To determine the cost to the NHS resulting from multiple pregnancies arising from IVF treatment in the UK, and to compare those costs with the cost to the NHS due to singleton pregnancies resulting from IVF treatment. Design: A modelling study using data from published literature and cost data from national sources in the public domain, calculating direct costs from the diagnosis of a clinical pregnancy until the end of the first year after birth. Setting: Academic Unit of Reproductive and Developmental Medicine. Population: Theoretic core modelling study using data from published literature. Methods: The analysis was based on the total annual number of births resulting from an IVF treatment in the UK. Main outcome measures total direct costs to the NHS per IVF singleton, twin or triplet family. Main Outcome Measures: Cost of singleton, twin and triplet IVF pregnancies in the UK. Results: Total direct costs to the NHS per IVF twin or triplet family (maternal + infant costs) are substantially higher than per IVF singleton family (singleton: pounds 3313; twin: pounds 9122; and triplet: pounds 32,354). Multiple pregnancies after IVF are associated with 56% of the direct cost of IVF pregnancies, although they represent less than 1/3 of the total annual number of maternities in the UK. Conclusions: Multiple pregnancies after IVF are associated with high direct costs to the NHS. Redirection of money saved by implementation of a mandatory 'two embryo transfer' policy into increased provision of IVF treatment could double the number of NHS-funded IVF treatment cycles at no extra cost. Further savings could be made if a selective 'single embryo transfer' policy were to be adopted. [ABSTRACT FROM AUTHOR]

Background: Suspicious pigmented lesions are a common presenting problem in general practice consultations; while the majority are benign a small minority are melanomas. Differentiating melanomas from other pigmented lesions in primary care is challenging: currently, 95% of all lesions referred to a UK specialist are benign. The MoleMate system is a new diagnostic aid, incorporating a hand-held SIAscopy scanner with a primary care diagnostic algorithm. This trial tests the hypothesis that adding the MoleMate system to current best primary care practice will increase the proportion of appropriate referrals of suspicious pigmented lesions to secondary care compared with current best practice alone. Methods/design: The MoleMate UK Trial is a primary care based multi-centre randomised controlled trial, with randomisation at patient level using a validated block randomisation method for two age groups (45 years and under; 46 years and over). We aim to recruit adult patients seen in general practice with a pigmented skin lesion that cannot immediately be diagnosed as benign and the patient reassured. The trial has a 'two parallel groups' design, comparing 'best practice' with 'best practice' plus the MoleMate system in the intervention group. The primary outcome is the positive predictive value (PPV) of referral defined as the proportion of referred lesions seen by secondary care experts that are considered 'clinically significant' (i.e. biopsied or monitored). Secondary outcomes include: the sensitivity, specificity and negative predictive value (NPV) of the decision not to refer; clinical outcomes (melanoma thickness, 5 year melanoma incidence and mortality); clinician outcomes (Index of Suspicion, confidence, learning effects); patient outcomes (satisfaction, general and cancer-specific worry), and cost-utility. Discussion: The MoleMate UK Trial tests a new technology designed to improve the management of suspicious pigmented lesions in primary care. If effective, the MoleMate system could reduce the burden on skin cancer clinics of patients with benign pigmented skin lesions, and improve patient care in general practice. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost-effectiveness of modifying current antenatal screening by adding first trimester structural anomaly screening to standard of care second trimester anomaly screening., Design: Health economic decision model., Setting: National Health Service (NHS) in England and Wales., Population: Pregnant women attending for first trimester antenatal screening., Methods: The decision model estimated pregnancy outcomes (maternal and foetal) and 20-year costs for current screening practice and for a policy adding a protocol screening for eight major structural anomalies to the current first trimester ultrasound scan. Event probabilities, costs, and outcomes for the model were informed by meta-analyses, published literature, and expert opinion., Main Outcomes Measures: Expected numbers of pregnancy outcomes, healthcare costs, and maternal quality-adjusted life years (QALYs). Estimation of the incremental cost-effectiveness ratio (ICER), likelihood of cost-effectiveness, and a value of information (VoI) analysis assessing if further research is needed before making a decision about screening., Results: First trimester anomaly screening increased mean per woman costs by £11 (95% CI £1-£29) and maternal QALYs by 0.002065 (95% CI 0.00056-0.00358). The ICER was £5270 per QALY and the probability of cost-effectiveness at a willingness to pay value for a QALY of £20 000, exceeded 95%. VoI analysis showed further research would be unlikely to represent value for money. The protocol would likely lead to a reduction in infant healthcare costs and QALYs., Conclusions: A protocol to screen for eight major structural anomalies during the first trimester appears to represent value for money for the NHS. The opposing implications for mothers and infants, however, raise complex, challenging, and sensitive issues., (© 2025 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Objectives: Vitamin A deficiency is the leading cause of childhood blindness worldwide, affecting mostly Sub-Saharan Africa. We aimed to predict the cost-effectiveness of home gardening (HG) of yellow cassava and orange maize to prevent nutritional blindness in children below 5 years and to assess the likely value of obtaining additional information in reducing uncertainty surrounding its cost-effectiveness., Methods: We developed a Markov model and carried out probabilistic sensitivity analysis with a value of information analysis. We costed resources from a societal perspective and outcomes were measured in disability-adjusted life years (DALYs)., Results: HG was estimated to cost an additional Intl$395.00 per DALY averted, with a 72.27% likelihood of being cost-effective at a threshold of Intl$2800 per DALY. The expected value of information was estimated to be Intl$29 843.50 for 1 child or Intl$925 billion for 31 million Nigerian children affected by the decision. Further research is only worthwhile for 1 parameter (relative risk of low serum retinol; expected value of perfect parameter information Intl$29 854.53 per child and Intl$925 billion for 31 million children)., Conclusion: HG of yellow cassava and orange maize is expected to be highly cost-effective in preventing nutritional blindness in Nigerian children. Worthwhile further research includes a cost analysis of the intervention and a high-quality randomized trial to assess the effectiveness of HG on serum retinol levels in young children., (Copyright © 2023 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: Although the ISPOR Value of Information (VOI) Task Force's reports outline VOI concepts and provide good-practice recommendations, there is no guidance for reporting VOI analyses. VOI analyses are usually performed alongside economic evaluations for which the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Statement provides reporting guidelines. Thus, we developed the CHEERS-VOI checklist to provide reporting guidance and checklist to support the transparent, reproducible, and high-quality reporting of VOI analyses., Methods: A comprehensive literature review generated a list of 26 candidate reporting items. These candidate items underwent a Delphi procedure with Delphi participants through 3 survey rounds. Participants rated each item on a 9-point Likert scale to indicate its relevance when reporting the minimal, essential information about VOI methods and provided comments. The Delphi results were reviewed at 2-day consensus meetings and the checklist was finalized using anonymous voting., Results: We had 30, 25, and 24 Delphi respondents in rounds 1, 2, and 3, respectively. After incorporating revisions recommended by the Delphi participants, all 26 candidate items proceeded to the 2-day consensus meetings. The final CHEERS-VOI checklist includes all CHEERS items, but 7 items require elaboration when reporting VOI. Further, 6 new items were added to report information relevant only to VOI (eg, VOI methods applied)., Conclusions: The CHEERS-VOI checklist should be used when a VOI analysis is performed alongside economic evaluations. The CHEERS-VOI checklist will help decision makers, analysts and peer reviewers in the assessment and interpretation of VOI analyses and thereby increase transparency and rigor in decision making., (Copyright © 2023. Published by Elsevier Inc.)

Background: The Ambient Intelligent Geriatric Management (AmbIGeM) system combines wearable sensors with artificial intelligence to trigger alerts to hospital staff before a fall. A clinical trial found no effect across a heterogenous population, but reported a reduction in the injurious falls rate in a post hoc analysis of patients on Geriatric Evaluation Management Unit (GEMU) wards. Cost-effectiveness and Value of Information (VoI) analyses of the AmbIGeM system in GEMU wards was undertaken., Methods: An Australian health-care system perspective and 5-year time horizon were used for the cost-effectiveness analysis. Implementation costs, inpatient costs and falls data were collected. Injurious falls were defined as causing bruising, laceration, fracture, loss of consciousness, or if the patient reported persistent pain. To compare costs and outcomes, generalised linear regression models were used to adjust for baseline differences between the intervention and usual care groups. Bootstrapping was used to represent uncertainty. For the VoI analysis, 10,000 different sample sizes with randomly sampled values ranging from 1 to 50,000 were tested to estimate the optimal sample size of a new trial that maximised the Expected Net Benefits of Sampling., Results: An adjusted 0.036 fewer injurious falls (adjusted rate ratio of 0.56) and AUD$4554 lower costs were seen in the intervention group. However, uncertainty that the intervention is cost effective for the prevention of an injurious fall was present at all monetary values of this effectiveness outcome. A new trial with a sample of 4376 patients was estimated to maximise the Expected Net Benefit of Sampling, generating a net benefit of AUD$186,632 at a benefit-to-cost ratio of 1.1., Conclusions: The benefits to cost ratio suggests that a new trial of the AmbIGeM system in GEMU wards may not be high-value compared to other potential trials, and that the system should be implemented. However, a broader analysis of options for preventing falls in GEMU is required to fully inform decision making., Trial Registration: Australian and New Zealand Clinical Trial Registry (ACTRN 12617000981325)., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Value of information (VoI) is a decision-theoretic approach to estimating the expected benefits from collecting further information of different kinds, in scientific problems based on combining one or more sources of data. VoI methods can assess the sensitivity of models to different sources of uncertainty and help to set priorities for further data collection. They have been widely applied in healthcare policy making, but the ideas are general to a range of evidence synthesis and decision problems. This article gives a broad overview of VoI methods, explaining the principles behind them, the range of problems that can be tackled with them, and how they can be implemented, and discusses the ongoing challenges in the area.

Objectives: To determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes., Design: Multicentre, parallel, cluster randomised controlled trial., Setting: Long term care homes in the UK, registered to care for older people or those with dementia., Participants: 1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care., Interventions: Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care., Main Outcome Measures: Primary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation., Results: Mean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval -£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (-0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively., Conclusions: The GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency., Trial Registration: ISRCTN34353836., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: funding from the National Institute for Health Research; no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Biopsy of the prostate for suspected cancer is usually performed transrectally under local anaesthesia in the outpatient clinic setting. As this involves piercing the bowel wall, the procedure is associated with a risk of infection. Recently, devices that facilitate transperineal biopsy approaches have been developed that avoid piercing the bowel and so should reduce the risk of infection., Objective: The aim of this study was to estimate the cost effectiveness of transperineal versus transrectal ultrasound-guided local anaesthesia procedures for prostate biopsy from the perspective of the UK NHS and to estimate the value of further research in the area., Methods: a) Decision tree and Markov model synthesising all relevant evidence estimating the life-time costs and QALYs accrued from each biopsy mode. b) Value of information analysis to predict the return from further research and thus guide future research efforts., Results: Transperineal biopsy yields an ICER below £20,000 per QALY gained at a per-procedure device acquisition cost below £81, or £41 for cost-neutrality. These results are driven by differences in consumables cost, reduced cost of treating infections, and QALY gains associated with reduced infections. There is value in future research on the diagnostic accuracy of transperineal versus transrectal biopsies and the incidence of iatrogenic infection and sepsis; consideration should be given to enriching the patient population with men with intermediate-risk disease., Conclusions: Transperineal biopsy devices may be cost effective compared with transrectal biopsy at per-procedure acquisition costs below £81 and cost-neutral if under £41. Future research is required to confirm or refute these findings, particularly randomised comparisons of the diagnostic accuracy and infection risks between the methods., (© 2021. The Author(s).)

When making decisions under uncertainty, it is reasonable to choose the path that leads to the highest expected net benefit. Therefore, to inform decision making, decision-model-based health economic evaluations should always present expected outputs (i.e. the mean costs and outcomes associated with each course of action). In non-linear models such as Markov models, a single 'run' of the model with each input at its mean (a deterministic analysis) will not generate the expected value of the outputs. In a worst-case scenario, presenting deterministic analyses as the base case can lead to misleading recommendations. Therefore, the base-case analysis of a non-linear model should always be the means from a probabilistic analysis. In this paper, I explain why this is the case and provide recommendations for reporting economic evaluations based on Markov models, noting that the same principle applies to other non-linear structures such as partitioned survival models and individual sampling models. I also provide recommendations for conducting one-way sensitivity analyses of such models. Code illustrating the examples is provided in both Microsoft Excel and R, along with a video abstract and user guides in the electronic supplementary material. Supplementary file 6 (MP4 20900 kb)., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objectives: Our aim was to undertake an economic evaluation of patient direct access to physiotherapy in the UK NHS by comparing the number of patients treated, waiting time, cost and health gain from a direct access pathway versus traditional GP-referral to NHS physiotherapy., Design: The authors used a discrete event simulation (DES) model to represent a hypothetical GP practice of 10,000 patients. Costs were measured from the perspective of the NHS and society. Outcomes were predicted waiting times, the total number of patients with musculoskeletal conditions who received physiotherapy and quality adjusted life years (QALYs) gained, each estimated over a one year period. Model inputs were based on a pilot cluster randomised controlled trial (RCT) conducted in four general practices in Cheshire, UK, and other sources from the literature., Results: Direct access could increase the number of patients receiving at least one physiotherapy appointment by 63%, but without investment in extra physiotherapist capacity would increase waiting time dramatically. The increase in activity is associated with a cost of £4999 per QALY gained., Conclusions: Direct access to physiotherapy services would be cost-effective and benefit patients given current cost per QALY thresholds used in England. This is because physiotherapy itself is cost-effective, rather than through savings in GP time. Direct access without an increase in supply of physiotherapists would increase waiting times and would be unlikely to be cost saving for the NHS owing to the likely increase in the use of physiotherapy services., (Crown Copyright © 2021. Published by Elsevier Ltd. All rights reserved.)

Purpose: We examined the association between the school policy, social and physical environment and change in adolescent physical activity (PA) and explored how sex and socioeconomic status modified potential associations., Methods: Data from the GoActive study were used for these analyses. Participants were adolescents (n = 1765, mean age±SD 13.2±0.4y) from the East of England, UK. Change in longitudinal accelerometer assessed moderate-to-vigorous physical activity (MVPA) was the outcome. School policy, social and physical environment features (n = 267) were exposures. The least absolute shrinkage and selection operator variable selection method (LASSO) was used to determine exposures most relevant to the outcome. Exposures selected by the LASSO were added to a multiple linear regression model with estimates of change in min/day of MVPA per 1-unit change in each exposure reported. Post-hoc analyses, exploring associations between change in variables selected by the LASSO and change in MVPA, were undertaken to further explain findings., Findings: No school policy or physical environment features were selected by the LASSO as predictors of change in MVPA. The LASSO selected two school social environment variables (participants asking a friend to do physical activity; friend asking a participant to do physical activity) as potential predictors of change in MVPA but no significant associations were found in subsequent linear regression models for all participants (β [95%CI] -1.01 [-2.73;0.71] and 0.65 [-2.17;0.87] min/day respectively). In the post-hoc analyses, for every unit increase in change in participants asking a friend to do PA and change in a friend asking participants to do PA, an increase in MVPA of 2.78 (1.55;4.02) and 1.80 (0.48;3.11) min/day was predicted respectively., Conclusions: The school social environment is associated with PA during adolescence. Further exploration of how friendships during adolescence may be leveraged to support effective PA promotion in schools is warranted., Competing Interests: The authors have declared that no competing interests exist.

Background: Fetal growth restriction is a major risk factor for stillbirth. A routine late-pregnancy ultrasound scan could help detect this, allowing intervention to reduce the risk of stillbirth. Such a scan could also detect fetal presentation and predict macrosomia. A trial powered to detect stillbirth differences would be extremely large and expensive., Objectives: It is therefore critical to know whether this would be a good investment of public research funds. The aim of this study is to estimate the cost-effectiveness of various late-pregnancy screening and management strategies based on current information and predict the return on investment from further research., Methods: Synthesis of current evidence structured into a decision model reporting expected costs, quality-adjusted life-years, and net benefit over 20 years and value-of-information analysis reporting predicted return on investment from future clinical trials., Results: Given a willingness to pay of £20 000 per quality-adjusted life-year gained, the most cost-effective strategy is a routine presentation-only scan for all women. Universal ultrasound screening for fetal size is unlikely to be cost-effective. Research exploring the cost implications of induction of labor has the greatest predicted return on investment. A randomized, controlled trial with an endpoint of stillbirth is extremely unlikely to be a value for money investment., Conclusion: Given current value-for-money thresholds in the United Kingdom, the most cost-effective strategy is to offer all pregnant women a presentation-only scan in late pregnancy. A randomized, controlled trial of screening and intervention to reduce the risk of stillbirth following universal ultrasound to detect macrosomia or fetal growth restriction is unlikely to represent a value for money investment., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: Health economics analysis plans (HEAPs) currently lack consistency, with uncertainty surrounding appropriate content. We aimed to develop a list of essential items that should be included in HEAPs for economic evaluations conducted alongside randomized trials., Methods: A list of potential items for inclusion was developed by examining existing HEAPs. An electronic Delphi survey was conducted among professional health economists. Respondents were asked to rate potential items from 1 (least important) to 9 (most important), suggest additional items, and comment on proposed items (round 1). A second survey (round 2) was emailed to participants, including the participant's own scores from round 1 along with summary results from the whole panel; participants were asked to rerate each item. Consensus criteria for inclusion in the final list were predefined as >70% of participants rating an item 7-9 and <15% rating it 1-3 after round 2. A final item selection meeting was held to scrutinize the results and adjudicate on items lacking consensus., Results: 62 participants completed round 1 of the survey. The initial list included 72 potential items; all 72 were carried forward to round 2, and no new items were added. 48 round 1 respondents (77.4%) completed round 2 and reached consensus on 53 items. At the final meeting, the expert panel (n = 9) agreed that 58 items should be included in the essential list, moved 9 items to an optional list, and dropped 5 items., Conclusions: Via expert consensus opinion, this study identified 58 items that are considered essential in a HEAP., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Screening for renal cell carcinoma (RCC) has been identified as a key research priority; however, no randomised control trials have been performed. Value of information analysis can determine whether further research on this topic is of value., Objective: To determine (1) whether current evidence suggests that screening is potentially cost-effective and, if so, (2) in which age/sex groups, (3) identify evidence gaps, and (4) estimate the value of further research to close those gaps., Design, Setting, and Participants: A decision model was developed evaluating screening in asymptomatic individuals in the UK. A National Health Service perspective was adopted., Intervention: A single focused renal ultrasound scan compared with standard of care (no screening)., Outcome Measurements and Statistical Analysis: Expected lifetime costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER), discounted at 3.5% per annum., Results and Limitations: Given a prevalence of RCC of 0.34% (0.18-0.54%), screening 60-yr-old men resulted in an ICER of £18 092/QALY (€22 843/QALY). Given a prevalence of RCC of 0.16% (0.08-0.25%), screening 60-yr-old women resulted in an ICER of £37327/QALY (€47 129/QALY). In the one-way sensitivity analysis, the ICER was <£30000/QALY as long as the prevalence of RCC was ≥0.25% for men and ≥0.2% for women at age 60yr. Given the willingness to pay a threshold of £30000/QALY (€37 878/QALY), the population-expected values of perfect information were £194 million (€244 million) and £97 million (€123 million) for 60-yr-old men and women, respectively. The expected value of perfect parameter information suggests that the prevalence of RCC and stage shift associated with screening are key research priorities., Conclusions: Current evidence suggests that one-off screening of 60-yr-old men is potentially cost-effective and that further research into this topic would be of value to society., Patient Summary: Economic modelling suggests that screening 60-yr-old men for kidney cancer using ultrasound may be a good use of resources and that further research on this topic should be performed., (Copyright © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

School-based multi-component physical activity (PA) promotion is advocated; however, research has indicated that a multi-component approach may not always be effective at increasing adolescent PA. Evaluation of the GoActive 12-week multi-component school-based intervention showed no effect on adolescent PA. A mixed-methods process evaluation was embedded to facilitate greater understanding of the results, to elicit subgroup perceptions, and to provide insight into contextual factors influencing intervention implementation. This paper presents the reach, recruitment, dose, and fidelity of GoActive, and identifies challenges to implementation. The process evaluation employed questionnaires (1543 Year 9s), individual interviews (16 Year 9s; 7 facilitators; 9 contact teachers), focus groups (48 Year 9s; 58 mentors), alongside GoActive website analytics and researcher observations. GoActive sessions reached 39.4% of Year 9s. Intervention satisfaction was relatively high for mentors (87.3%) and facilitators (85.7%), but lower for Year 9s (59.5%) and teachers (50%). Intervention fidelity was mixed within and between schools. Mentorship was the most implemented component. Factors potentially contributing to low implementation included ambiguity of the roles subgroups played within intervention delivery, Year 9 engagement, institutional support, and further school-level constraints. Multiple challenges and varying contextual considerations hindered the implementation of GoActive in multiple school sites. Methods to overcome contextual challenges to implementation warrant in-depth consideration and innovative approaches.

Background: Prevention of secondary stroke following initial ictus is an important focus of after-stroke care. Blood pressure (BP) is a key risk factor, so usual care following stroke or transient ischaemic attack includes regular BP checks and monitoring of anti-hypertensive medication. This is traditionally carried out in primary care, but the evidence supporting self-monitoring and self-guided management of BP in the general population with hypertension is growing., Objective: Our objective was to estimate the cost effectiveness of treatment as usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN)., Methods: This was a within-trial economic evaluation of a randomised controlled trial estimating the incremental cost per 1 mmHg BP reduction and per quality-adjusted life-year (QALY) gained over a 6-month time horizon from the perspective of the UK National Health Service (NHS)., Results: Data were evaluable for 140 participants. Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively. No statistically significant differences in incremental costs or outcomes were detected. On average, S-MAN was dominated or extended dominated. The incremental cost per 1 mmHg BP reduction from S-MON versus TAU was £137., Conclusion: On average, S-MAN is an inefficient intervention. S-MON may be cost effective, depending on the willingness to pay for a 1 mmHg BP reduction, although it yielded fewer QALYs over the within-trial time horizon. Decision modelling is required to explore the longer-term costs and outcomes.

Background: Less than 20% of adolescents globally meet recommended levels of physical activity, and not meeting these recommended levels is associated with social disadvantage and rising disease risk. The determinants of physical activity in adolescents are multilevel and poorly understood, but the school's social environment likely plays an important role. We conducted a cluster randomised controlled trial to assess the effectiveness of a school-based programme (GoActive) to increase moderate-to-vigorous physical activity (MVPA) among adolescents., Methods and Findings: Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion. Within participating schools (n = 16), all Year 9 students were eligible and invited to participate. Participants were 2,862 13- to 14-year-olds (84% of eligible students). After baseline assessment, schools were computer-randomised, stratified by school-level pupil premium funding (below/above county-specific median) and county (control: 8 schools, 1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43]). Measurement staff were blinded to allocation. The iteratively developed, feasibility-tested 12-week intervention, aligned with self-determination theory, trained older adolescent mentors and in-class peer-leaders to encourage classes to conduct 2 new weekly activities. Students and classes gained points and rewards for engaging in any activity in or out of school. The primary outcome was average daily minutes of accelerometer-assessed MVPA at 10-month follow-up; a mixed-methods process evaluation evaluated implementation. Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5%). At 10 months, there was a mean (SD) decrease in MVPA of 8.3 (19.3) minutes in the control group and 10.4 (22.7) minutes in the intervention group (baseline-adjusted difference [95% confidence interval] -1.91 minutes [-5.53 to 1.70], p = 0.316). The programme cost £13 per student compared with control; it was not cost-effective. Overall, 62.9% of students and 87.3% of mentors reported that GoActive was fun. Teachers and mentors commented that their roles in programme delivery were unclear. Implementation fidelity was low. The main methodological limitation of this study was the relatively affluent and ethnically homogeneous sample., Conclusions: In this study, we observed that a rigorously developed school-based intervention was no more effective than standard school practice at preventing declines in adolescent physical activity. Interdisciplinary research is required to understand educational-setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale., Trial Registration: ISRCTN Registry ISRCTN31583496., Competing Interests: The authors have declared that no competing interests exist.

Background: The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness., Objective: This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone., Methods: The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients., Results: The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020., Conclusions: iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered., Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004., International Registered Report Identifier (irrid): DERR1-10.2196/17160., (©Joanna Proctor, Felix Naughton, Melanie Sloan, Sarah Hopewell, James Brimicombe, A Toby Prevost, Edward C F Wilson, Tim Coleman, Stephen Sutton. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.07.2020.)

Value of information (VOI) analyses can help policy makers make informed decisions about whether to conduct and how to design future studies. Historically a computationally expensive method to compute the expected value of sample information (EVSI) restricted the use of VOI to simple decision models and study designs. Recently, 4 EVSI approximation methods have made such analyses more feasible and accessible. Members of the Collaborative Network for Value of Information (ConVOI) compared the inputs, the analyst's expertise and skills, and the software required for the 4 recently developed EVSI approximation methods. Our report provides practical guidance and recommendations to help inform the choice between the 4 efficient EVSI estimation methods. More specifically, this report provides: (1) a step-by-step guide to the methods' use, (2) the expertise and skills required to implement the methods, and (3) method recommendations based on the features of decision-analytic problems., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care., Methods and Findings: The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment., Conclusions: In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up., Trial Registration: Current Controlled Trials (ISRCTN72691150)., Competing Interests: All authors have read the journal's policy and have declared that no competing interests exist.

Transparency in decision modelling is an evolving concept. Recently, discussion has moved from reporting standards to open-source implementation of decision analytic models. However, in the debate about the supposed advantages and disadvantages of greater transparency, there is a lack of definition. The purpose of this article is not to present a case for or against transparency, but rather to provide a more nuanced understanding of what transparency means in the context of decision modelling and how it could be addressed. To this end, we review and summarise the discourse to date, drawing on our collective experience. We outline a taxonomy of the different manifestations of transparency, including reporting standards, reference models, collaboration, model registration, peer review and open-source modelling. Further, we map out the role and incentives for the various stakeholders, including industry, research organisations, publishers and decision makers. We outline the anticipated advantages and disadvantages of greater transparency with respect to each manifestation, as well as the perceived barriers and facilitators to greater transparency. These are considered with respect to the different stakeholders and with reference to issues including intellectual property, legality, standards, quality assurance, code integrity, health technology assessment processes, incentives, funding, software, access and deployment options, data protection and stakeholder engagement. For each manifestation of transparency, we discuss the 'what', 'why', 'who' and 'how'. Specifically, their meaning, why the community might (or might not) wish to embrace them, whose engagement as stakeholders is required and how relevant objectives might be realised. We identify current initiatives aimed to improve transparency to exemplify efforts in current practice and for the future.

Background: Population screening for renal cell carcinoma (RCC) using ultrasound has the potential to improve survival outcomes; however, a cost-effectiveness analysis (CEA) has yet to be performed. Owing to the lack of existing evidence, we performed structured expert elicitation to derive unknown quantities to inform the CEA., Objective: To elicit the cancer stage distribution (proportion of individuals with each stage of cancer) for different RCC screening scenarios and the annual transition probabilities for undiagnosed disease becoming diagnosed in the National Health Service., Methods: The study design and reporting adhered to the Reporting Guidelines for the Use of Expert Judgement in Model-Based Economic Evaluations. The elicitation was conducted face-to-face or via telephone between each individual expert and the facilitator, aided by online material. For multinomial data, Connor-Mosimann and modified Connor-Mosimann distributions were fitted for each expert and for all experts combined using mathematical linear pooling., Results: A total of 24 clinical experts were invited, and 71% participated (7 urologists, 6 oncologists, 4 radiologists). The modified Connor-Mosimann distribution provided the best fit for most elicited quantities. Greater uncertainty was noted for the elicited transition probabilities compared with the elicited stage distributions., Conclusion: We performed the first expert elicitation of RCC screening parameters, crucial information that will inform the CEA of screening. In addition, the elicited quantities may enable future health economic evaluations assessing the value of diagnostic tools and pathways in RCC., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Our group has developed a noninvasive blood-based microRNA (miRNA) test for improving diagnosis, disease monitoring, and relapse detection in malignant testicular germ-cell tumors (TGCTs). Performance analysis suggests the test is likely to have comparable sensitivity and specificity in detecting TGCT as computed tomography (CT), thus reducing the need for serial CT scans for follow-up monitoring, with associated reductions in cumulative radiation burden and second cancer risk. To facilitate clinical adoption, we undertook a cost analysis to identify the budget impact of replacing CT scans with miRNA testing within health care systems., Methods: The TGCT aftercare pathway was mapped out using National Comprehensive Cancer Network guidelines. A Markov model was built to simulate the impact of the miRNA test on TGCT aftercare costs. Incidence, treatment probabilities, relapse rate, and death rate data were collected from published studies to populate the model., Results: Applying our model to the US health care system, the miRNA test has the potential to save up to $69 million per year in aftercare expenses related to TGCT treatment, with exact savings depending on the adoption rate and test price., Conclusion: This analysis demonstrates the potential positive budget impact of adopting miRNA testing in place of CT scans in the clinical management of TGCTs., (Copyright © 2019. Published by Elsevier Inc.)

Introduction: Studies of prognosis for surgery and corticosteroid injection for carpal tunnel syndrome (CTS) have considered only a limited range of explanatory variables for outcome., Methods: Data were prospectively collected on patient-reported symptoms, physical and psychological functioning, comorbidity, and quality of life at baseline and every 6 months for up to 2 years. Outcomes were patient-rated change over a 6-month period and symptom-severity score at 18 months., Results: In total, 754 patients with CTS completed baseline questionnaires, and 626 (83%) completed follow-up to 18 months. Multivariable modeling identified, independent of symptom severity at outset, higher health utility, fewer comorbidities, and lower anxiety as significant predictors of better outcome from surgery. In patients treated by steroid injection, independent of symptom severity at outset, shorter duration of symptoms and having no prior injection were significant predictors of better outcome., Discussion: These multivariable models of outcome may inform shared decision making about treatment for CTS. Muscle Nerve, 2019., (© 2019 Wiley Periodicals, Inc.)

Background: Despite the relative ease with which breech presentation can be identified through ultrasound screening, the assessment of foetal presentation at term is often based on clinical examination only. Due to limitations in this approach, many women present in labour with an undiagnosed breech presentation, with increased risk of foetal morbidity and mortality. This study sought to determine the cost effectiveness of universal ultrasound scanning for breech presentation near term (36 weeks of gestational age [wkGA]) in nulliparous women., Methods and Findings: The Pregnancy Outcome Prediction (POP) study was a prospective cohort study between January 14, 2008 and July 31, 2012, including 3,879 nulliparous women who attended for a research screening ultrasound examination at 36 wkGA. Foetal presentation was assessed and compared for the groups with and without a clinically indicated ultrasound. Where breech presentation was detected, an external cephalic version (ECV) was routinely offered. If the ECV was unsuccessful or not performed, the women were offered either planned cesarean section at 39 weeks or attempted vaginal breech delivery. To compare the likelihood of different mode of deliveries and associated long-term health outcomes for universal ultrasound to current practice, a probabilistic economic simulation model was constructed. Parameter values were obtained from the POP study, and costs were mainly obtained from the English National Health Service (NHS). One hundred seventy-nine out of 3,879 women (4.6%) were diagnosed with breech presentation at 36 weeks. For most women (96), there had been no prior suspicion of noncephalic presentation. ECV was attempted for 84 (46.9%) women and was successful in 12 (success rate: 14.3%). Overall, 19 of the 179 women delivered vaginally (10.6%), 110 delivered by elective cesarean section (ELCS) (61.5%) and 50 delivered by emergency cesarean section (EMCS) (27.9%). There were no women with undiagnosed breech presentation in labour in the entire cohort. On average, 40 scans were needed per detection of a previously undiagnosed breech presentation. The economic analysis indicated that, compared to current practice, universal late-pregnancy ultrasound would identify around 14,826 otherwise undiagnosed breech presentations across England annually. It would also reduce EMCS and vaginal breech deliveries by 0.7 and 1.0 percentage points, respectively: around 4,196 and 6,061 deliveries across England annually. Universal ultrasound would also prevent 7.89 neonatal mortalities annually. The strategy would be cost effective if foetal presentation could be assessed for £19.80 or less per woman. Limitations to this study included that foetal presentation was revealed to all women and that the health economic analysis may be altered by parity., Conclusions: According to our estimates, universal late pregnancy ultrasound in nulliparous women (1) would virtually eliminate undiagnosed breech presentation, (2) would be expected to reduce foetal mortality in breech presentation, and (3) would be cost effective if foetal presentation could be assessed for less than £19.80 per woman., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: GS reports grants from the National Institute for Health Research (NIHR), Stillbirth and Neonatal Death Society, and MRC and reports other from GE and NIHR Cambridge Clinical Research Facility, during the study; reports personal fees and other from GlaxoSmithKline and Roche, and reports other from Chiesi, outside of the study. GS is an Academic Editor on PLOS Medicine's editorial board. DW, AM, AD, US, and EW declare no competing interests.

Background: There is a need for high-quality research aiming to increase physical activity in families. This study assessed the feasibility and acceptability of FRESH (Families Reporting Every Step to Health), a child-led family-based physical activity intervention delivered online., Methods: In a two-armed randomised feasibility study, 12 families (with an 8-10-year-old index child) were allocated to a 'child-only' (CO) or 'family' arm (FAM) of the theory-based FRESH intervention. Both received access to the FRESH website, allowing participants to select step challenges to 'travel' to target cities around the world, log their steps, and track their progress as they virtually globetrot. Only index children wore pedometers in CO; in FAM, all family members wore pedometers and worked towards collective goals. All family members were eligible to participate in the evaluation. Mixed-methods process evaluation (questionnaires and family focus groups) at 6-week follow-up consisted of completing questionnaires assessing acceptability of the intervention and accompanying effectiveness evaluation, focussed on physical (e.g. fitness, blood pressure), psychosocial (e.g. social support), and behavioural (e.g. objectively-measured family physical activity) measures., Results: All families were retained (32 participants). Parents enjoyed FRESH and all children found it fun. More FAM children wanted to continue with FRESH, found the website easy to use, and enjoyed wearing pedometers. FAM children also found it easier to reach goals. Most CO families would have preferred whole family participation. Compared to CO, FAM exhibited greater website engagement as they travelled to more cities (36 ± 11 vs. 13 ± 8) and failed fewer challenges (1.5 ± 1 vs. 3 ± 1). Focus groups also revealed that most families wanted elements of competition. All children enjoyed being part of the evaluation, and adults disagreed that there were too many intervention measures (overall, 2.4 ± 1.3) or that data collection took too long (overall, 2.2 ± 1.1)., Conclusion: FRESH was feasible and acceptable to participating families; however, findings favoured the FAM group. Recruitment, intervention fidelity and delivery and some measurement procedures are particular areas that require further attention for optimisation. Testing the preliminary effectiveness of FRESH on family physical activity is a necessary next step., Trial Registration: This study was registered and given an International Standard Randomised Controlled Trials Number (ISRCTN12789422). Registered 16 March 2016. http://www.isrctn.com/ISRCTN12789422., Competing Interests: All participants provided their written informed consent/assent. This study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge.Not applicable.The authors declare that they have no competing interest. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: A key step in the design of a RCT is the estimation of the number of participants needed in the study. The most common approach is to specify a target difference between the treatments for the primary outcome and then calculate the required sample size. The sample size is chosen to ensure that the trial will have a high probability (adequate statistical power) of detecting a target difference between the treatments should one exist. The sample size has many implications for the conduct and interpretation of the study. Despite the critical role that the target difference has in the design of a RCT, the way in which it is determined has received little attention. In this article, we summarise the key considerations and messages from new guidance for researchers and funders on specifying the target difference, and undertaking and reporting a RCT sample size calculation. This article on choosing the target difference for a randomised controlled trial (RCT) and undertaking and reporting the sample size calculation has been dual published in the BMJ and BMC Trials journals METHODS: The DELTA 2 (Difference ELicitation in TriAls) project comprised five major components: systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2); a Delphi study (stage 3); a two-day consensus meeting bringing together researchers, funders and patient representatives (stage 4); and the preparation and dissemination of a guidance document (stage 5)., Results and Discussion: The key messages from the DELTA 2 guidance on determining the target difference and sample size calculation for a randomised caontrolled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided.

Objective: To assess the fidelity of general practitioners' (GPs) adherence to a long-term pragmatic trial protocol., Design: Retrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010., Setting: Primary care surgeries in the East of England., Study Sample/participants: A subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40-69 years old with screen-detected diabetes mellitus., Interventions: In the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPs/nurses and patients, and GPs were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm., Outcome Measures: The number of annual contacts between patients and GPs/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1-5 after diabetes diagnosis and the adherence to prescription algorithms., Results: The difference in the number of annual GP contacts (β=0.65) and nurse contacts (β=-0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up., Conclusions: The adherence of GPs to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects., Trial Registration Number: ISRCTN86769081., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Expert elicitation is required to inform decision making when relevant "better quality" data either do not exist or cannot be collected. An example of this is to inform decisions as to whether to screen for melanoma. A key input is the counterfactual, in this case the natural history of melanoma in patients who are undiagnosed and hence untreated., Objectives: To elicit expert opinion on the probability of disease progression in patients with melanoma that is undetected and hence untreated., Methods: A bespoke webinar-based expert elicitation protocol was administered to 14 participants in the United Kingdom, Australia, and New Zealand, comprising 12 multinomial questions on the probability of progression from one disease stage to another in the absence of treatment. A modified Connor-Mosimann distribution was fitted to individual responses to each question. Individual responses were pooled using a Monte-Carlo simulation approach. Participants were asked to provide feedback on the process., Results: A pooled modified Connor-Mosimann distribution was successfully derived from participants' responses. Feedback from participants was generally positive, with 86% willing to take part in such an exercise again. Nevertheless, only 57% of participants felt that this was a valid approach to determine the risk of disease progression. Qualitative feedback reflected some understanding of the need to rely on expert elicitation in the absence of "hard" data., Conclusions: We successfully elicited and pooled the beliefs of experts in melanoma regarding the probability of disease progression in a format suitable for inclusion in a decision-analytic model., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Population-wide screening for melanoma is unlikely to be cost-effective. Nevertheless, targeted surveillance of high-risk individuals may be., Objectives: To estimate the cost-effectiveness of various surveillance strategies in the UK population, stratified by risk using a simple self-assessment tool scoring between 0 and 67., Methods: A decision model comparing alternative surveillance policies from the perspective of the UK National Health Service over 30 years was developed. The strategy with the highest expected net benefit for each risk score was identified, resulting in a compound risk-stratified policy describing the most cost-effective population-wide strategy. The overall expected cost and quality-adjusted life-years (QALYs), the incremental cost-effectiveness ratio, and associated uncertainty were reported., Results: The most cost-effective strategy is for those with a Williams score of 15 to 21 (relative risk [RR] of 0.79-1.60 vs. a mean score of 17 in the United Kingdom) to be offered a one-off full-body skin examination, and for those with a score of 22 or more (RR 1.79+) to be enrolled into a quinquennial monitoring program, rising to annual recall for those with a risk score greater than 43 (RR 20.95+). Expected incremental cost would be £164 million per annum (~0.1% of the National Health Service budget), gaining 15,947 additional QALYs and yielding an incremental cost-effectiveness ratio of £10,199/QALY gained (51.3% probability <£30,000)., Conclusions: The risk-stratified policy would be expensive to implement but cost-effective compared with typical UK thresholds (£20,000-£30,000/QALY gained), although decision uncertainty is high. Phased implementation enrolling only higher risk individuals would be substantially less expensive, but with consequent foregone health gain., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Brief interventions (BIs) delivered in primary care have shown potential to increase physical activity levels and may be cost-effective, at least in the short-term, when compared with usual care. Nevertheless, there is limited evidence on their longer term costs and health benefits., Objectives: To estimate the cost-effectiveness of BIs to promote physical activity in primary care and to guide future research priorities using value of information analysis., Methods: A decision model was used to compare the cost-effectiveness of three classes of BIs that have been used, or could be used, to promote physical activity in primary care: 1) pedometer interventions, 2) advice/counseling on physical activity, and (3) action planning interventions. Published risk equations and data from the available literature or routine data sources were used to inform model parameters. Uncertainty was investigated with probabilistic sensitivity analysis, and value of information analysis was conducted to estimate the value of undertaking further research., Results: In the base-case, pedometer interventions yielded the highest expected net benefit at a willingness to pay of £20,000 per quality-adjusted life-year. There was, however, a great deal of decision uncertainty: the expected value of perfect information surrounding the decision problem for the National Health Service Health Check population was estimated at £1.85 billion., Conclusions: Our analysis suggests that the use of pedometer BIs is the most cost-effective strategy to promote physical activity in primary care, and that there is potential value in further research into the cost-effectiveness of brief (i.e., <30 minutes) and very brief (i.e., <5 minutes) pedometer interventions in this setting., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate patterns of early repeat prescriptions and treatment switching over an 11-year period to estimate differences in the cost of medication wastage, dispensing fees and prescriber time for short (<60 days) and long (≥60 days) prescription lengths from the perspective of the National Health Service in the UK., Setting: Retrospective, multiple cohort study of primary care prescriptions from the Clinical Practice Research Datalink., Participants: Five random samples of 50 000 patients each prescribed oral drugs for (1) glucose control in type 2 diabetes mellitus (T2DM); (2) hypertension in T2DM; (3) statins (lipid management) in T2DM; (4) secondary prevention of myocardial infarction; and (5) depression., Primary and Secondary Outcome Measures: The volume of medication wastage from early repeat prescriptions and three other types of treatment switches was quantified and costed. Dispensing fees and prescriber time were also determined. Total unnecessary costs (TUC; cost of medication wastage, dispensing fees and prescriber time) associated with <60 day and ≥60 day prescriptions, standardised to a 120-day period, were then compared., Results: Longer prescription lengths were associated with more medication waste per prescription. However, when including dispensing fees and prescriber time, longer prescription lengths resulted in lower TUC. This finding was consistent across all five cohorts. Savings ranged from £8.38 to £12.06 per prescription per 120 days if a single long prescription was issued instead of multiple short prescriptions. Prescriber time costs accounted for the largest component of TUC., Conclusions: Shorter prescription lengths could potentially reduce medication wastage, but they may also increase dispensing fees and/or the time burden of issuing prescriptions., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: There is uncertainty about the cost effectiveness of early intensive treatment versus routine care in individuals with type 2 diabetes detected by screening., Objectives: To derive a trial-informed estimate of the incremental costs of intensive treatment as delivered in the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care-Europe (ADDITION) trial and to revisit the long-term cost-effectiveness analysis from the perspective of the UK National Health Service., Methods: We analyzed the electronic primary care records of a subsample of the ADDITION-Cambridge trial cohort (n = 173). Unit costs of used primary care services were taken from the published literature. Incremental annual costs of intensive treatment versus routine care in years 1 to 5 after diagnosis were calculated using multilevel generalized linear models. We revisited the long-term cost-utility analyses for the ADDITION-UK trial cohort and reported results for ADDITION-Cambridge using the UK Prospective Diabetes Study Outcomes Model and the trial-informed cost estimates according to a previously developed evaluation framework., Results: Incremental annual costs of intensive treatment over years 1 to 5 averaged £29.10 (standard error = £33.00) for consultations with general practitioners and nurses and £54.60 (standard error = £28.50) for metabolic and cardioprotective medication. For ADDITION-UK, over the 10-, 20-, and 30-year time horizon, adjusted incremental quality-adjusted life-years (QALYs) were 0.014, 0.043, and 0.048, and adjusted incremental costs were £1,021, £1,217, and £1,311, resulting in incremental cost-effectiveness ratios of £71,232/QALY, £28,444/QALY, and £27,549/QALY, respectively. Respective incremental cost-effectiveness ratios for ADDITION-Cambridge were slightly higher., Conclusions: The incremental costs of intensive treatment as delivered in the ADDITION-Cambridge trial were lower than expected. Given UK willingness-to-pay thresholds in patients with screen-detected diabetes, intensive treatment is of borderline cost effectiveness over a time horizon of 20 years and more., (Copyright © 2017. Published by Elsevier Inc.)

Background: There is a growing interest in using group cognitive-behavioral therapy (CBT) with people who have Asperger syndrome (AS) and comorbid mental health problems. This study aims to assess the cost-effectiveness of modified group CBT for adults with AS experiencing co-occurring anxiety compared to treatment-as-usual. Methods: Economic evaluation alongside a pilot, multicenter, single-blind, randomized controlled crossover trial. Costs from the UK public sector (National Health Service and Social Services) and societal perspectives, quality-adjusted life years (QALYs), incremental net (monetary) benefit (INB), expected value of perfect information, expected value of sample information, expected net gain of sampling, and efficient sample size of a future trial are reported. Results: Over 48 weeks, from the societal perspective, CBT results in additional costs of £6,647, with only a 0.015 incremental gain in QALYs, leading to a negative INB estimate of £6,206 and a 23% probability of cost-effectiveness at a threshold of £30,000/QALY. Results from sensitivity analyses support the unlikely cost-effectiveness of CBT but indicate the potential for cost-effectiveness over longer time horizons. Eliminating decision uncertainty is valued at £277 million, and the efficient sample size for a future trial is estimated at 1,200 participants per arm. Limitations: Relatively small sample size and prevalence of missing data present challenges to the interpretation of the results. Conclusions: Current evidence from this small pilot study suggests that, on average, modified group CBT is not cost-effective. However, there is much decision uncertainty so such a conclusion could be wrong. A large, full-scale trial to reduce uncertainty would be an efficient investment for the UK health economy.