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Background There is currently no formal prostate cancer screening programme in the UK. Early detection using age-based prostate-specific antigen (PSA) testing is unlikely to be cost-effective due to limited mortality benefit and harms associated with overdetection. However, the discovery of new prostate cancer specific biomarkers and more accurate diagnostic strategies (e.g. magnetic resonance imaging (MRI)) could improve the outcomes of screening. A systematic review was conducted to assess the evidence base on cost-effectiveness of such innovations and areas for further development. Methods To identify model-based economic evaluations of screening and diagnostic tests for prostate cancer, a systematic review of the literature using the NHS Economic Evaluation Database, Medline, EMBASE, HTA databases, NICE guidelines, and UK National Screening Committee guidance was carried out, between 2009 and 2019. Relevant data were extracted on study type, model inputs, modelling methods and cost-effectiveness conclusions and the results narratively synthesized. Results Sixteen studies were included in the review. Seven studies compared the cost-effectiveness of new urinary or blood biomarkers compared to each other or the PSA test and found the biomarkers e.g. the Prostate Health Index (PHI) and SelectMDx, to be the most cost-effective. Seven studies compared newer prostate biopsy methods, including MRI-guided, to TRUS guided biopsy and found MRI-guided methods to be most cost-effective. The newer detection methods showed a reduction in unnecessary biopsies and overtreatment. However, there was uncertainty around the most cost-effective pathway of follow-up strategies (MRI/biomarkers) in men who have a negative initial biopsy. Many studies did not model stage or grade of cancer, cancer progression or the entire testing, screening and treatment pathway. Very few studies fully accounted for uncertainty in their analysis. Conclusions This review brings together the cost-effectiveness literature for novel screening and testing methods used in the diagnosis of prostate cancer. Several limitations of the published models were identified. The models generally either compared new biomarkers or new imaging techniques which highlights the importance of future work in this area, as biomarkers and imaging are likely to be used in combination.

Background Optimal management strategies for clinically localised prostate cancer are debated. Using median 10-year data from the largest randomised controlled trial to date (ProtecT), the lifetime cost-effectiveness of three major treatments (radical radiotherapy, radical prostatectomy and active monitoring) was explored according to age and risk subgroups. Methods A decision-analytic (Markov) model was developed and informed by clinical input. The economic evaluation adopted a UK NHS perspective and the outcome was cost per Quality-Adjusted Life Year (QALY) gained (reported in UK£), estimated using EQ-5D-3L. Results Costs and QALYs extrapolated over the lifetime were mostly similar between the three randomised strategies and their subgroups, but with some important differences. Across all analyses, active monitoring was associated with higher costs, probably associated with higher rates of metastatic disease and changes to radical treatments. When comparing the value of the strategies (QALY gains and costs) in monetary terms, for both low-risk prostate cancer subgroups, radiotherapy generated the greatest net monetary benefit (£293,446 [95% CI £282,811 to £299,451] by D’Amico and £292,736 [95% CI £284,074 to £297,719] by Grade group 1). However, the sensitivity analysis highlighted uncertainty in the finding when stratified by Grade group, as radiotherapy had 53% probability of cost-effectiveness and prostatectomy had 43%. In intermediate/high risk groups, using D’Amico and Grade group > = 2, prostatectomy generated the greatest net monetary benefit (£275,977 [95% CI £258,630 to £285,474] by D’Amico and £271,933 [95% CI £237,864 to £287,784] by Grade group). This finding was supported by the sensitivity analysis. Prostatectomy had the greatest net benefit (£290,487 [95% CI £280,781 to £296,281]) for men younger than 65 and radical radiotherapy (£201,311 [95% CI £195,161 to £205,049]) for men older than 65, but sensitivity analysis showed considerable uncertainty in both findings. Conclusion Over the lifetime, extrapolating from the ProtecT trial, radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates. Longer ProtecT trial follow-up is required to reduce uncertainty in the model. Trial registration Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).

ObjectivesTo determine the response process validity, feasibility of completion, acceptability and preferences for three patient-reported outcome measures that could be used in economic evaluation—the EQ-5D-5L, ICECAP-A and ICECAP-O—in people requiring kidney care.DesignParticipants were asked to ‘think-aloud’ while completing the EQ-5D-5L, ICECAP-A and ICECAP-O, followed by a semistructured interview. Five raters identified errors or struggles in completing the measures from the think-aloud component of the transcripts. Patient preferences for measures were extracted from the semistructured interview.SettingEligible patients were identified through a large UK secondary care renal centre.ParticipantsIn total, 30 participants were included in the study, consisting of patients attending renal outpatients for chronic kidney disease (n=18), with a functioning kidney transplant (n=6) and receiving haemodialysis (n=6).ResultsParticipants had few errors and struggles in completing the EQ-5D-5L (11% error rate, 3% struggle rate), ICECAP-A (2% error rate, 2% struggle rate) and ICECAP-O (4% error rate, 3% struggle rate). The main errors with the EQ-5D-5L were judgements that did not comply with the ‘your health today’ instruction. Comprehension errors were most prominent on ICECAP-O. Judgement errors were the only errors reported on ICECAP-A. Although the EQ-5D-5L had slightly more errors and struggles, it was the measure most preferred, with participants able to make a clearer link with EQ-5D-5L and their health condition.ConclusionsThe EQ-5D-5L, ICECAP-A and ICECAP-O are feasible for people requiring kidney care to complete and can be included in studies conducting economic evaluations of kidney care interventions. Further research is required to assess how health (eg, EQ-5D) and capability (eg, ICECAP) measures can be included in an economic evaluation simultaneously, as well as what ICECAP measure(s) to include when patient groups straddle the age ranges for ICECAP-A (18 years and older) and ICECAP-O (65 years and older).

Background Guidelines recommend walking to increase moderate to vigorous physical activity (MVPA) for health benefits. Objectives To assess the effectiveness, cost-effectiveness and acceptability of a pedometer-based walking intervention in inactive adults, delivered postally or through dedicated practice nurse physical activity (PA) consultations. Design Parallel three-arm trial, cluster randomised by household. Setting Seven London-based general practices. Participants A total of 11,015 people without PA contraindications, aged 45–75 years, randomly selected from practices, were invited. A total of 6399 people were non-responders, and 548 people self-reporting achieving PA guidelines were excluded. A total of 1023 people from 922 households were randomised to usual care (n = 338), postal intervention (n = 339) or nurse support (n = 346). The recruitment rate was 10% (1023/10,467). A total of 956 participants (93%) provided outcome data. Interventions Intervention groups received pedometers, 12-week walking programmes advising participants to gradually add ‘3000 steps in 30 minutes’ most days weekly and PA diaries. The nurse group was offered three dedicated PA consultations. Main outcome measures The primary and main secondary outcomes were changes from baseline to 12 months in average daily step counts and time in MVPA (in ≥ 10-minute bouts), respectively, from 7-day accelerometry. Individual resource-use data informed the within-trial economic evaluation and the Markov model for simulating long-term cost-effectiveness. Qualitative evaluations assessed nurse and participant views. A 3-year follow-up was conducted. Results Baseline average daily step count was 7479 [standard deviation (SD) 2671], average minutes per week in MVPA bouts was 94 minutes (SD 102 minutes) for those randomised. PA increased significantly at 12 months in both intervention groups compared with the control group, with no difference between interventions; additional steps per day were 642 steps [95% confidence interval (CI) 329 to 955 steps] for the postal group and 677 steps (95% CI 365 to 989 steps) for nurse support, and additional MVPA in bouts (minutes per week) was 33 minutes per week (95% CI 17 to 49 minutes per week) for the postal group and 35 minutes per week (95% CI 19 to 51 minutes per week) for nurse support. Intervention groups showed no increase in adverse events. Incremental cost per step was 19p and £3.61 per minute in a ≥ 10-minute MVPA bout for nurse support, whereas the postal group took more steps and cost less than the control group. The postal group had a 50% chance of being cost-effective at a £20,000 per quality-adjusted life-year (QALY) threshold within 1 year and had both lower costs [–£11M (95% CI –£12M to –£10M) per 100,000 population] and more QALYs [759 QALYs gained (95% CI 400 to 1247 QALYs)] than the nurse support and control groups in the long term. Participants and nurses found the interventions acceptable and enjoyable. Three-year follow-up data showed persistent intervention effects (nurse support plus postal vs. control) on steps per day [648 steps (95% CI 272 to 1024 steps)] and MVPA bouts [26 minutes per week (95% CI 8 to 44 minutes per week)]. Limitations The 10% recruitment level, with lower levels in Asian and socioeconomically deprived participants, limits the generalisability of the findings. Assessors were unmasked to the group. Conclusions A primary care pedometer-based walking intervention in 45- to 75-year-olds increased 12-month step counts by around one-tenth, and time in MVPA bouts by around one-third, with similar effects for the nurse support and postal groups, and persistent 3-year effects. The postal intervention provides cost-effective, long-term quality-of-life benefits. A primary care pedometer intervention delivered by post could help address the public health physical inactivity challenge. Future work Exploring different recruitment strategies to increase uptake. Integrating the Pedometer And Consultation Evaluation-UP (PACE-UP) trial with evolving PA monitoring technologies. Trial registration Current Controlled Trials ISRCTN98538934. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 37. See the NIHR Journals Library website for further project information.

ObjectivesAn effectiveness and cost-effectiveness analyses of two-staged community sports interventions; taster sports sessions compared with portfolio of community sport sessions.DesignQuasi-experiment using an interrupted time series design.SettingCommunity sports projects delivered by eight lead partners in London Borough of Hounslow, UK.ParticipantsInactive people aged 14 plus years (n=246) were recruited between May 2013 and February 2014.InterventionsCommunity sports interventions delivered in two stages, 6-week programme of taster sport sessions (stage 1) and 6-week programme of portfolio of community sporting sessions delivered by trained coaches (stage 2).Outcome measures(a) Change in days with ≥30 min of self-reported vigorous intensity physical activity (PA), moderate intensity PA, walking and sport; and (b) change in subjective well-being and EQ5D5L quality-adjusted life-years (QALYs).MethodsInterrupted time series analysis evaluated the effectiveness of the two-staged sports programmes. Cost-effectiveness analysis compares stage 2 with stage 1 from a provider’s perspective, reporting outcomes of incremental cost per QALY (2015/2016 price year). Uncertainty was assessed using deterministic and probabilistic sensitivity analyses.ResultsCompared with stage 1, counterfactual change at 21 days in PA was lower for vigorous (log odds: −0.52; 95% CI −1 to –0.03), moderate PA (−0.50; 95% CI 0.94 to 0.05) and sport(−0.56; 95% CI −1.02 to –0.10). Stage 2 increased walking (0.28; 95% CI 0.3 to 0.52). Effect overtime was similar. Counterfactual change at 21 days in well-being was positive particularly for ‘happiness’ (0.29; 95% CI 0.06 to 0.51). Stage 2 was more expensive (£101 per participant) but increased QALYs (0.001; 95% CI −0.034 to 0.036). Cost per QALY for stage 2 was £50 000 and has 29% chance of being cost-effective (£30 000 threshold).ConclusionCommunity-based sport interventions could increase PA among inactive people. Less intensive sports sessions may be more effective and cost-effective.

BackgroundHeavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®, Bayer) compared with usual medical treatment, with exploration of women’s perspectives on treatment.DesignA pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study.SettingWomen who presented in primary care.ParticipantsA total of 571 women with HMB. A purposeful sample of 27 women who were randomised or ineligible owing to treatment preference participated in semistructured face-to-face interviews around 2 and 12 months after commencing treatment.InterventionsLNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen–progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment.Outcome measuresThe primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) assessed over a 2-year period and then again at 5 years. Secondary outcomes included general quality of life (QoL), sexual activity, surgical intervention and safety. Data were analysed using iterative constant comparison. A state transition model-based cost–utility analysis was undertaken alongside the randomised trial. Quality-adjusted life-years (QALYs) were derived from the European Quality of Life-5 Dimensions (EQ-5D) and the Short Form questionnaire-6 Dimensions (SF-6D). The intention-to-treat analyses were reported as cost per QALY gained. Uncertainty was explored by conducting both deterministic and probabilistic sensitivity analyses.ResultsThe MMAS total scores improved significantly in both groups at all time points, but were significantly greater for the LNG-IUS than for usual treatment [mean difference over 2 years was 13.4 points, 95% confidence interval (CI) 9.9 to 16.9 points;p p = 0.09). By 5 years, only 47% of women had a LNG-IUS in place and 15% were still taking usual medical treatment. Five-year surgery rates were low, at 20%, and were similar, irrespective of initial treatments. There were no significant differences in serious adverse events between groups. Using the EQ-5D, at 2 years, the relative cost-effectiveness of the LNG-IUS compared with usual medical treatment was £1600 per QALY, which by 5 years was reduced to £114 per QALY. Using the SF-6D, usual medical treatment dominates the LNG-IUS. The qualitative findings show that women’s experiences and expectations of medical treatments for HMB vary considerably and change over time. Women had high expectations of a prompt effect from medical treatments.ConclusionsThe LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women’s assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause.Trial registrationCurrent Controlled Trials ISRCTN86566246.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 88. See the NIHR Journals Library website for further project information

Background The extra-welfarist theoretical framework tends to focus on health-related quality of life, whilst the welfarist framework captures a wider notion of well-being. EQ-5D and SF-6D are commonly used to value outcomes in chronic conditions with episodic symptoms, such as heavy menstrual bleeding (clinically termed menorrhagia). Because of their narrow-health focus and the condition’s periodic nature these measures may be unsuitable. A viable alternative measure is willingness to pay (WTP) from the welfarist framework. Objective We explore the use of WTP in a preliminary cost-benefit analysis comparing pharmaceutical treatments for menorrhagia. Methods A cost-benefit analysis was carried out based on an outcome of WTP. The analysis is based in the UK primary care setting over a 24-month time period, with a partial societal perspective. Ninety-nine women completed a WTP exercise from the ex-ante (pre-treatment/condition) perspective. Maximum average WTP values were elicited for two pharmaceutical treatments, levonorgestrel-releasing intrauterine system (LNG-IUS) and oral treatment. Cost data were offset against WTP and the net present value derived for treatment. Qualitative information explaining the WTP values was also collected. Results Oral treatment was indicated to be the most cost-beneficial intervention costing £107 less than LNG-IUS and generating £7 more benefits. The mean incremental net present value for oral treatment compared with LNG-IUS was £113. The use of the WTP approach was acceptable as very few protests and non-responses were observed. Conclusion The preliminary cost-benefit analysis results recommend oral treatment as the first-line treatment for menorrhagia. The WTP approach is a feasible alternative to the conventional EQ-5D/SF-6D approaches and offers advantages by capturing benefits beyond health, which is particularly relevant in menorrhagia. Electronic supplementary material The online version of this article (doi:10.1007/s40273-015-0280-0) contains supplementary material, which is available to authorized users.

‘Menorrhagia’, or heavy menstrual bleeding, is a common problem affecting women. The principal driver for treatment is women's experience of its interference in their lives, so a measure of quality of life (QoL) is increasingly used as the primary outcome to assess treatment success. QoL measures need to accurately reflect women's concerns as these measures are often used to inform resource allocation decisions within the healthcare service. Healthcare decision-makers often advocate the use of generic measures so as to achieve consistency when making decisions. Generic measures, by definition, have a broad focus on QoL in contrast to disease-specific measures that focus on dimensions of health relevant to the condition. We report a systematic review of studies that have either used or assessed economic outcome measures in menorrhagia, and present criteria for assessing which measure is the most appropriate. Studies including women presenting with menorrhagia, and using or assessing economic measures were sought by searching nine electronic databases. Fifty-six eligible studies were identified. A narrative synthesis was most suitable to the review question. Eleven studies assessed the psychometric properties of the outcome measures, twelve studies applied the measures in an economic evaluation, and thirty-three used them in effectiveness studies. Mixed results on the psychometric properties of the instruments were observed. Studies were often found to include both a disease-specific and a generic measure. We found no consensus on the most appropriate economic outcome measure to use when assessing the cost-effectiveness of treatment for menorrhagia. This is an important finding as QoL is the primary focus for treatment decisions. The cyclical nature of the condition has a large impact on the reliability and validity of outcome measurement. Alternative measures, such as willingness-to-pay, which embrace more than health and avoid standard recall periods should be explored.

INTRODUCTION: Breast feeding can promote positive long-term and short-term health outcomes in infant and mother. The UK has one of the lowest breastfeeding rates (duration and exclusivity) in the world, resulting in preventable morbidities and associated healthcare costs. Breastfeeding rates are also socially patterned, thereby potentially contributing to health inequalities. Financial incentives have been shown to have a positive effect on health behaviours in previously published studies.METHODS AND ANALYSIS: Based on data from earlier development and feasibility stages, a cluster (electoral ward) randomised trial with mixed-method process and content evaluation was designed. The 'Nourishing Start for Health' (NOSH) intervention comprises a financial incentive programme of up to 6 months duration, delivered by front-line healthcare professionals, in addition to existing breastfeeding support. The intervention aims to increase the prevalence and duration of breast feeding in wards with low breastfeeding rates. The comparator is usual care (no offer of NOSH intervention). Routine data on breastfeeding rates at 6-8 weeks will be collected for 92 clusters (electoral wards) on an estimated 10 833 births. This sample is calculated to provide 80% power in determining a 4% point difference in breastfeeding rates between groups. Content and process evaluation will include interviews with mothers, healthcare providers, funders and commissioners of infant feeding services. The economic analyses, using a healthcare provider's perspective, will be twofold, including a within-trial cost-effectiveness analysis and beyond-trial modelling of longer term expectations for cost-effectiveness. Results of economic analyses will be expressed as cost per percentage point change in cluster level in breastfeeding rates between trial arms. In addition, we will present difference in resource use impacts for a range of acute conditions in babies aged 0-6 months.ETHICS AND DISSEMINATION: Participating organisations Research and Governance departments approved the study. Results will be published in peer-reviewed journals and at conference presentations.TRIAL REGISTRATION NUMBER: ISRCTN44898617; Pre-results.

Objectives A short-term and long-term cost-effectiveness analysis (CEA) of two pedometer-based walking interventions compared with usual care. Design (A) Short-term CEA: parallel three-arm cluster randomised trial randomised by household. (B) Long-term CEA: Markov decision model. Setting Seven primary care practices in South London, UK. Participants (A) Short-term CEA: 1023 people (922 households) aged 45–75 years without physical activity (PA) contraindications. (b) Long-term CEA: a cohort of 100 000 people aged 59–88 years. Interventions Pedometers, 12-week walking programmes and PA diaries delivered by post or through three PA consultations with practice nurses. Primary and secondary outcome measures Accelerometer-measured change (baseline to 12 months) in average daily step count and time in 10 min bouts of moderate to vigorous PA (MVPA), and EQ-5D-5L quality-adjusted life-years (QALY). Methods Resource use costs (£2013/2014) from a National Health Service perspective, presented as incremental cost-effectiveness ratios for each outcome over a 1-year and lifetime horizon, with cost-effectiveness acceptability curves and willingness to pay per QALY. Deterministic and probabilistic sensitivity analyses evaluate uncertainty. Results (A) Short-term CEA: At 12 months, incremental cost was £3.61 (£109)/min in ≥10 min MVPA bouts for nurse support compared with control (postal group). At £20 000/QALY, the postal group had a 50% chance of being cost saving compared with control. (B) Long-term CEA: The postal group had more QALYs (+759 QALYs, 95% CI 400 to 1247) and lower costs (−£11 million, 95% CI −12 to −10) than control and nurse groups, resulting in an incremental net monetary benefit of £26 million per 100 000 population. Results were sensitive to reporting serious adverse events, excluding health service use, and including all participant costs. Conclusions Postal delivery of a pedometer intervention in primary care is cost-effective long term and has a 50% chance of being cost-effective, through resource savings, within 1 year. Further research should ascertain maintenance of the higher levels of PA, and its impact on quality of life and health service use., This research was supported by the Health Technology Assessment (HTA) Programme, National Institute for Health Research (project number HTA 10/32/02 ISRCTN42122561).

Objective: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS') and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. Methods: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov) model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY) estimated using both EQ-5D and SF-6D. Results: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100) and generated 0.002 more QALYs. Conclusion: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most costeffective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial. Copyright: © 2014 Sanghera et al.