Purpose
Capability wellbeing measures, such as the ICECAP measures, have been proposed for use in economic evaluations to capture broader outcomes of health and care interventions. The ICECAP ...measures have been developed to reflect capabilities at different stages of life. Some patient groups include patients of different ages and at different stages of life, so it is not always apparent which ICECAP measure is most relevant. This study explores the impact of age and life stage on completion, where both ICECAP-A and ICECAP-O were completed by the same patient.
Methods
A think-aloud study, and an associated semi-structured interview were conducted with people receiving kidney care as a renal outpatient, kidney transplant outpatient, or through receiving facility-based haemodialysis. Qualitative analysis focused on (1) differences in responses across measures by individuals, where attributes had conceptual overlap, (2) key factors in self-reported capability levels, and (3) measure preference.
Results
Thirty participants were included in the study, with a mix of older and younger adults. Attributes with similar wording across measures produced similar responses compared to attributes where wording differed. Age and health were key factors for self-reported capability levels. ICECAP-A was slightly preferred overall, including by older adults.
Conclusion
This study suggests use of ICECAP-A in patients with certain chronic health conditions that include a mix of adults across the life course. This study highlights the importance of considering the stage of life when using capability measures and in economic evaluations of health and care interventions more generally.
There is ongoing debate about the harms and benefits of a national prostate cancer screening programme. Several model-based cost-effectiveness analyses have been developed to determine whether the ...benefits of prostate cancer screening outweigh the costs and harms caused by over-detection and over-treatment, and the different approaches may impact results.
To identify models of prostate cancer used to assess the cost-effectiveness of prostate cancer screening strategies, a systematic review of articles published since 2006 was conducted using the NHS Economic Evaluation Database, Medline, EMBASE and HTA databases. The NICE website, UK National Screening website, reference lists from relevant studies were also searched and experts contacted. Key model features, inputs, and cost-effectiveness recommendations were extracted.
Ten studies were included. Four of the studies identified some screening strategies to be potentially cost-effective at a PSA threshold of 3.0 ng/ml, including single screen at 55 years, annual or two yearly screens starting at 55 years old, and delayed radical treatment. Prostate cancer screening was modelled using both individual and cohort level models. Model pathways to reflect cancer progression varied widely, Gleason grade was not always considered and clinical verification was rarely outlined. Where quality of life was considered, the methods used did not follow recommended practice and key issues of overdiagnosis and overtreatment were not addressed by all studies.
The cost-effectiveness of prostate cancer screening is unclear. There was no consensus on the optimal model type or approach to model prostate cancer progression. Due to limited data availability, individual patient-level modelling is unlikely to increase the accuracy of cost-effectiveness results compared with cohort-level modelling, but is more suitable when assessing adaptive screening strategies. Modelling prostate cancer is challenging and the justification for the data used and the approach to modelling natural disease progression was lacking. Country-specific data are required and recommended methods used to incorporate quality of life. Influence of data inputs on cost-effectiveness results need to be comprehensively assessed and the model structure and assumptions verified by clinical experts.
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).
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.
Guidelines recommend walking to increase moderate to vigorous physical activity (MVPA) for health benefits.
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.
Parallel three-arm trial, cluster randomised by household.
Seven London-based general practices.
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 (
= 338), postal intervention (
= 339) or nurse support (
= 346). The recruitment rate was 10% (1023/10,467). A total of 956 participants (93%) provided outcome data.
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.
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.
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).
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.
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.
Exploring different recruitment strategies to increase uptake. Integrating the Pedometer And Consultation Evaluation-UP (PACE-UP) trial with evolving PA monitoring technologies.
Current Controlled Trials ISRCTN98538934.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
; Vol. 22, No. 37. See the NIHR Journals Library website for further project information.
Recurrent fluctuations in health states can occur as a result of long-term conditions with episodic symptoms or through side effects of cycles of treatment. Fluctuations and associated duration of ...symptoms can be predictable (eg, side effects of chemotherapy treatment) or unpredictable (eg, relapse in multiple sclerosis). Such recurrent fluctuations in health states can have an important impact on a person’s health-related quality of life. When symptoms vary by time of day, day of the week, or during the month, it is challenging to obtain reliable health-related quality of life estimates for use in assessing cost-effectiveness of interventions. The adequacy of the quality of life estimate will be affected by (1) the standard recall period associated with the chosen measure (eg, “health today” EQ-5D, “past 4 weeks” for SF-36/SF-6D) and the way that respondents understand and make judgments about these recall periods, (2) the chosen time points for assessing health-related quality of life in relation to the fluctuations in health, and (3) the assumptions used to interpolate between measurement time points and thus calculate the quality-adjusted life-years. These issues have not received sufficient methodological attention and instead remain poorly accounted for in economic analyses. There is potential for these issues to considerably distort treatment decisions away from the optimal allocation. This article brings together evidence from health economics, psychology, and behavioral economics to explore these challenges in depth; presents the solutions that have been applied to date; and details a methodological research agenda for measuring quality-adjusted life-years in recurrent fluctuating health states.
•The challenges in measuring quality of life when health fluctuates for use in economic evaluation have received little attention, with only a few studies focusing on particular issues within specific conditions.•This article highlights the potential issues in measuring quality of life and calculating quality-adjusted life-years more broadly when health fluctuates as well as its influence on economic evaluation.•There is potential in the current practice of economic evaluations of conditions with fluctuating health states to distort treatment decisions away from the optimal allocation.
Heavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited.
To 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.
A pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study.
Women who presented in primary care.
A 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.
LNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment.
The 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.
The 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 < 0.001. However, this difference between groups was reduced and no longer significant by 5 years (mean difference in scores 3.9 points, 95% CI -0.6 to 8.3 points; 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.
The 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.
Current Controlled Trials ISRCTN86566246.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 88. See the NIHR Journals Library website for further project information.
ObjectiveConduct an economic evaluation based on best currently available evidence comparing alternative treatments levonorgestrel-releasing intrauterine system, depot-medroxyprogesterone acetate, ...combined oral contraceptive pill (COCP) and ‘no treatment’ to prevent recurrence of endometriosis after conservative surgery in primary care, and to inform the design of a planned trial-based economic evaluation.MethodsWe developed a state transition (Markov) model with a 36-month follow-up. The model structure was informed by a pragmatic review 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). As available data were limited, intentionally wide distributions were assigned around model inputs, and the average costs and outcome of the probabilistic sensitivity analyses were reported.ResultsOn average, all strategies were more expensive and generated fewer QALYs compared to no treatment. However, uncertainty attributing to the transition probabilities affected the results. Inputs relating to effectiveness, changes in treatment and the time at which the change is made were the main causes of uncertainty, illustrating areas where robust and specific data collection is required.ConclusionsThere is currently no evidence to support any treatment being recommended to prevent the recurrence of endometriosis following conservative surgery. The study highlights the importance of developing decision models at the outset of a trial to identify data requirements to conduct a robust post-trial analysis.
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.
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.
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.
Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective 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.
The contingent valuation (CV) method is used to estimate the willingness to pay (WTP) for services and products to inform cost benefit analyses (CBA). A long-standing criticism that stated WTP ...estimates may be poor indicators of actual WTP, calls into question their validity and the use of such estimates for welfare evaluation, especially in the health sector. Available evidence on the validity of CV studies so far is inconclusive. We systematically reviewed the literature to (1) synthesize the evidence on the criterion validity of WTP/willingness to accept (WTA), (2) undertake a meta-analysis, pooling evidence on the extent of variation between stated and actual WTP values and, (3) explore the reasons for the variation.
Eight electronic databases were searched, along with citations and reference reviews. 50 papers detailing 159 comparisons were identified and reviewed using a standard proforma. Two reviewers each were involved in the paper selection, review and data extraction. Meta-analysis was conducted using random effects models for ratios of means and percentage differences separately. Meta-bias was investigated using funnel plots.
Hypothetical WTP was on average 3.2 times greater than actual WTP, with a range of 0.7–11.8 and 5.7 (0.0–13.6) for ratios of means and percentage differences respectively. However, key methodological differences between surveys of hypothetical and actual values were found. In the meta-analysis, high levels of heterogeneity existed. The overall effect size for mean summaries was 1.79 (1.56–2.04) and 2.37 (1.93–2.80) for percent summaries. Regression analyses identified mixed results on the influence of the different experimental protocols on the variation between stated and actual WTP values. Results indicating publication bias did not account for differences in study design.
The evidence on the criterion validity for CV studies is more mixed than authors are representing because substantial differences in study design between hypothetical and actual WTP/WTA surveys are not accounted for.
•The debate on the criterion validity of CV-WTP is a subject of ongoing concern.•The majority of published papers confirm the presence of hypothetical bias.•The assessment of the drivers of criterion validity is largely exploratory.•Estimates reported variedly, limiting analyses and clouds clarity of comparison.•The evidence on the criterion validity of CV-WTP is more mixed than is reported.
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