Who should value children's health and how? An international Delphi study.

Valuing child health necessitates normative methodological decisions on whose preferences should be elicited and who should be imagined as experiencing impaired health. Formal guidance is limited and expert consensus unclear. This study sought to establish the degree of consensus among expert stakeholders on normative issues of who to ask and who should be imagined when valuing child health (7-17 years) to inform UK health technology assessment. Sixty-two experts (n = 47 in Round 2) from 18 countries participated in a modified, two-round online Delphi survey (Round 1: May-June 2023; Round 2: September-October 2023). Participants were expert stakeholders in child health valuation, including academics (n = 38); industry/consultancy representatives (including the charity/not-for-profit sector; n = 13); and UK policy/government representatives (n = 11). The Delphi survey was modified between rounds and consisted of 9-point Likert, categorical, multiple-choice, and free-text questions on normative issues in valuing child health. Responses were analysed descriptively and thematically. An a priori criterion of ≥75% agreement was established for formal consensus, while areas approaching consensus (≥70% agreement) and without consensus were identified as a future research primer. Consensus was observed that older adolescents (aged 16-17 years) and adults (18+ years) should be asked to value child health states. There was consensus that the former should think about themselves when valuing the health states and the latter should imagine a child of some form (e.g., imagining themselves as a child or another hypothetical child). However, no consensus was evident on what form this should take. Several other methodological issues also reached consensus. These findings are largely consistent with recent views elicited qualitatively from members of the public and other stakeholders on normative issues in valuing child health. The results mean that, contrary to what has been done in previous child health valuation studies, efforts should be made to involve both older adolescents (16+ years) and adults in child health valuation.

Psychometric Performance of the EQ Health and Wellbeing Short in a United Kingdom Population Sample.

OBJECTIVES: This study assessed the psychometric performance and construct validity of the EQ Health and Wellbeing Short (EQ-HWB-S), using a validated measure, the EQ-5D-5L, as a comparator. METHODS: The experimental version of the EQ-HWB-S was compared with the EQ-5D-5L to assess the psychometric performance of the measures. Data were drawn from the valuation stages of the Extending the Quality-Adjusted Life-Year project (UK general population, n = 429) and the EQ-5D-5L UK valuation pilot study (UK general population, n = 248). Construct validity was assessed based on convergent validity, using Spearman correlations and Pearson correlations. Known-group validity was assessed by estimating effect sizes to assess the ability of the EQ-HWB-S and EQ-5D-5L to discriminate between known groups based on "healthy" status, presence of a long-term condition, health and life satisfaction, age, and employment status. The degree of agreement in utility values across instruments was also evaluated using Bland-Altman plots. RESULTS: Strong associations (rs ≥ 0.5, P < .001) were found between conceptually overlapping dimensions and the utility scores of the EQ-HWB-S and EQ-5D-5L. The instruments performed comparably in discriminating between known groups including healthy versus unhealthy groups (based on the visual analog scale ≥ 80), long-term condition (vs no long-term condition), and above versus below average health and life satisfaction and employed (vs unemployed and long-term sick). CONCLUSIONS: The EQ-HWB-S performs favorably with utility values successfully discriminating between groups in which differences are expected. Convergence between the EQ-HWB-S and EQ-5D-5L is evident, especially between conceptually overlapping dimensions.

Mapping functions for the PHQ-9 and GAD-7 to generate EQ-5D-3L for economic evaluation.

PURPOSE: Generic preferenced-based measures, such as EQ-5D-3L, that are used to estimate quality adjusted life years (QALYs) for economic evaluation are not always available in clinical trials. Predicting EQ-5D-3L values from the commonly used Patient Health Questionnaire 9 (PHQ-9) and Generalised Anxiety Disorder-7 (GAD-7) would allow estimation of QALYs from such trials. The aim was to provide mapping functions to estimate EQ-5D-3L from PHQ-9 and GAD-7 to facilitate economic evaluation. METHODS: Data was drawn from four trials of patients with symptoms of depression testing collaborative care or computerised cognitive behavioural therapy. Patients completed PHQ-9, GAD-7, and EQ-5D-3L at different timepoints. Mapping was undertaken using adjusted limited dependent variable mixture models (ALDVMM), ordinary least squares (OLS), and Tobit models based on PHQ-9, GAD-7 scores or questions, and age to predict EQ-5D-3L utilities. Models were selected based on mean error (ME), mean absolute error (MAE), root mean squared error (RMSE), model goodness of fit, and visual inspection of the predictions. RESULTS: There were 5583 and 3942 observations for EQ-5D-3L combined with PHQ-9 and GAD-7 respectively. ALDVMM models had low ME ( ≤|0.0018|) and MAE ranging from 0.189 to 0.192, while RMSE was from 0.251 to 0.254 and had better predictions than OLS and Tobit models. ALDVMM models with four components based on PHQ-9 and GAD-7 scores are recommended for estimating EQ-5D-3L utilities. CONCLUSIONS: Recommended mapping functions provide users with an approach to estimate EQ-5D-3L utilities for economic evaluation using PHQ-9, GAD-7, or both scores where they have been used together.

Content validity of the EQ-HWB and EQ-HWB-S in a sample of Italian patients, informal caregivers and members of the general public.

BACKGROUND: The EuroQol Group recently developed two new instruments, the EQ Health and Wellbeing (EQ-HWB) and the EQ Health and Wellbeing short version (EQ-HWB-S). The EQ-HWB and EQ-HWB-S are intended to capture a broad range of health and broader quality of life aspects, which may be relevant to general public members, patients, their families, social care users and informal carers. This study assesses the content validity of the Italian version of the two instruments in a sample of Italian patients, social care users and informal carers. METHODS: Participants were recruited using a convenience sampling approach. One-on-one interviews were carried out using video-conferencing interviews. A semi-structured topic guide was used to guide the interview procedures, with open-ended questions supplemented by probes. Participants were asked to explain important aspects of their health and quality of life, to complete the questionnaires and verbalize their thoughts. RESULTS: Twenty participants comprising of patients (n = 9), informal carers (n = 6), and members of the general public (n = 5) participated to the study. Content validity was summarized into six main themes: comprehension, interpretation, acceptability, relevance, response options and recall period. All participants found the instruments easy or quite easy to understand and to respond to. Items were relevant for all three groups of participants, and response options appropriate. CONCLUSIONS: The Italian version of the EQ-HWB showed content validity in measuring health and wellbeing in a mixed Italian population.

The Measurement Properties of the EQ-HWB and the EQ-HWB-S in Italian Population: A Comparative Study With EQ-5D-5L.

OBJECTIVES: The EQ Health and Well-being, EQ-HWB (25-item) and the EQ-HWB-S (9-item), are new generic measures of health and well-being. The purpose of this study was to examine the measurement properties of the EQ-HWB and EQ-HWB-S measures in relation to the EQ-5D-5L among the Italian general population. METHODS: A cross-sectional survey was conducted from October 2020 to February 2021, followed by secondary analysis of collected data from Italian adults. This analysis included response pattern distributions, correlation strength, and known-group comparison. Known-group comparison was assessed using effect sizes (ES) across health conditions, caregiver status, and social care usage. The EQ-HWB-S index-based score was based on the UK pilot value set, whereas the Italian value set was used for scoring the EQ-5D-5L index. RESULTS: Out of the 1182 participants, 461 reported having a chronic condition, 185 identified as caregivers, and 42 were social care users. EQ-HWB items (7.5%) showed fewer ceiling effects than EQ-5D-5L items (34.7%). Strong correlations (rs > 0.5) were found between overlapping EQ-HWB and EQ-5D-5L items. EQ-HWB-S and EQ-5D-5L index scores demonstrated similar discrimination based on symptomatic chronic conditions (ES d = 0.68 vs d = 0.71), but EQ-HWB-S had slightly higher ES for social care users (ES d = 0.84 vs d = 0.74). CONCLUSIONS: Initial evidence supports the validity of EQ-HWB/EQ-HWB-S because outcome measures in the Italian population. EQ-HWB-S performed comparably to EQ-5D-5L among patients and was better in differentiating social care users. A slight decrease in discriminative properties for caregivers was observed when transitioning from EQ-HWB to EQ-HWB-S.

Psychometric performance of the CFQ-R-8D compared to the EQ-5D-3L and SF-6D in people with cystic fibrosis.

OBJECTIVE: This study aimed to compare the psychometric performance of the Cystic Fibrosis Questionnaire-Revised-8 Dimensions (CFQ-R-8D), a new, condition-specific, preference-based measure, with that of generic preference-based measures EQ-5D-3L and Short Form 6 dimensions (SF-6D). METHODS: Data from three trials of participants with CF aged ≥ 14 years who completed the CFQ-R and EQ-5D-3L or SF-6D were used. Analyses were undertaken to evaluate convergent validity based on correlations with CFQ-R domain scores. Known-group validity was assessed based on percent predicted forced expiratory volume in one second and pulmonary exacerbations. Responsiveness was based on correlation of change and sensitivity to change based on change in symptom severity. Effect sizes and standardized response means were estimated. RESULTS: CFQ-R-8D utilities and dimensions were strongly correlated with most of the overlapping CFQ-R domain scores (ρ > 0.5); EQ-5D-3L and SF-6D utilities and dimensions had moderate (ρ > 0.3) to strong correlations in dimensions capturing similar concepts. All measures showed evidence of known-group validity (P < 0.05). Change correlations were strong for CFQ-R-8D utilities and dimensions and CFQ-R, but they were moderate for SF-6D and mostly weak ((ρ > 0.1) for EQ-5D-3L. The SF-6D had the largest mean change over time and effect sizes, followed by CFQ-R-8D and then EQ-5D-3L. Neither CFQ-R-8D or SF-6D utility scores had ceiling effects (< 9% responses in full health) compared with those of EQ-5D-3L (61-62%). In participants classified as being in full health by EQ-5D-3L, CFQ-R-8D captured CF-specific health problems, particularly cough, abdominal pain, and breathing difficulty. CONCLUSIONS: The CFQ-R-8D reflected known-group differences and changes over time with stronger evidence of good psychometric performance than EQ-5D-3L and similar evidence as SF-6D. Additionally, the CFQ-R-8D captured more condition-specific symptoms than EQ-5D-3L or SF-6D, which are important determinants of health-related quality of life for people with CF.

Estimating the SF-6Dv1 Value Set for a Population-Based Sample in Lebanon.

OBJECTIVES: The SF-6Dv1 is a preference-based measure derived from the SF-36 for use in quality-adjusted life-year estimation for cost-utility analysis. Country-specific value sets for SF-6Dv1 are needed to reflect societal preferences but none are available for Lebanon and other Arabic countries. This study aimed to generate a value set for SF-6Dv1 for Lebanon and to compare results with the UK set. METHODS: A sample of 249 health states defined by the SF-6Dv1 were valued by a representative sample of 577 members of the Lebanon general population, using standard gamble. Several multivariate regression models at mean and individual level were fitted to estimate utilities for all SF-6Dv1 states with selection of best fitting models based on predictive ability, consistency, and model fit. The best fitting models were compared with those fitted in the UK study. RESULTS: Data from 553 eligible respondents providing 3308 valuations were used for the analysis. Lebanese values were consistently higher than UK values, indicating differences in preferences, and there were no negative values. The random effects model using only main effects was the best performing model. There were inconsistencies in 2 dimensions, thereby consistent models were estimated with values ranging from 0.367 to 1. The results are consistent with the UK results. CONCLUSIONS: This study provides the first population-based value set for SF-6Dv1 health states for Lebanon, making it possible to generate quality-adjusted life-years for cost-utility analysis studies. The potential for applications of a standardized utility measure is enormous both in Lebanon and all Arab countries.

Understanding UK public views on normative decisions made to value health-related quality of life in children: A qualitative study.

Developing methodology for measuring and valuing child health-related quality of life (HRQoL) is a priority for health technology agencies. One aspect of this is normative decisions that are made in child HRQoL valuation. This qualitative study aimed to better understand adult public opinion on the normative questions of whose preferences to elicit (adults, children, or both) and from which perspective (who should be imagined living in impaired health), when valuing child HRQoL. Opinions of the adult UK public (N = 32) were solicited using online semi-structured focus groups, featuring a breadth of age, sex, ethnicities, and responsibility for children under 18 years. Participants were provided with bespoke informational material on health state valuation and were probed for their views. Arguments for and against different positions were discussed. Data was analysed using framework analysis. Participants demonstrated near-to-universal agreement that children should be involved in valuation in some form, yet this should differ depending on age or maturity. There was strong support for approaches combining involvement from children and adults (e.g., their parents), especially for younger children. There was little intuitive support for the 'taxpayer argument' for asking taxpaying adults. In the context of greater involvement of children in valuation, most participants supported using an 'own' perspective. Most participants thought that valuation study participants should know the exercise is about valuing child health states for ethical reasons. Informed views from the UK public on who should be asked and with what perspective when valuing child HRQoL appear to differ from normative positions previously advocated by some health economists, such as prioritising the preferences of taxpaying adults. In contrast, the results suggest including adults and children in valuation, with the proviso that the children are of an appropriate age and level of maturity, and that an own perspective is used wherever possible.

UK Valuation of EQ-5D-5L, a Generic Measure of Health-Related Quality of Life: A Study Protocol.

OBJECTIVES: A high-quality and widely accepted UK EQ-5D-5L value set is urgently required to enable the latest version of EQ-5D scored using recent UK public preferences to inform policy including health technology assessments submitted to the National Institute for Health and Care Excellence. This article outlines the study protocol for the generation of a new EQ-5D-5L UK value set. METHODS: Twelve hundred interviews will be undertaken using the composite time trade-off elicitation technique for 102 health states (86 from the international EQ-5D-5L valuation protocol, plus 16 with best predictive performance in an extended design used in the Native American EQ-5D-5L valuation). The sample will be UK adults (age ≥18 years) proportionately representative across England, Wales, Scotland, and Northern Ireland, representative for age, sex, ethnicity, and socioeconomic group, with inclusion of participants with/without health problems. Participants will choose to be interviewed via videoconference (by Zoom) or in-person in a central venue. Data quality will be rigorously assessed. RESULTS: The value set will be generated using tobit random effects and heteroscedastic tobit models (with censoring at -1) using all data, excluding time trade-off values highlighted by participants as ones they would reconsider and data from interviewers failing protocol compliance. Quality and acceptance will be achieved by public involvement, regular Steering Group meetings, independent assessment of data quality at 4 time points, and final endorsement of data and analyses. CONCLUSION: This study will produce a UK value set for the EQ-5D-5L for use in prospective and retrospective data sets containing EQ-5D-5L data.

Valuing the EQ Health and Wellbeing Short Using Time Trade-Off and a Discrete Choice Experiment: A Feasibility Study.

OBJECTIVES: The EQ Health and Wellbeing Short (EQ-HWB-S) is a new generic measure that covers health and wellbeing developed for use in economic evaluation in health and social care. The aim was to test the feasibility of using composite time trade-off (cTTO) and a discrete choice experiment (DCE) based on an international protocol to derive utilities for the EQ-HWB-S and to generate a pilot value set. METHODS: A representative UK general population was recruited. Online videoconference interviews were undertaken where cTTO and DCE tasks were administered using EuroQol Portable Valuation Technology. Quality control (QC) was used to assess interviewers' performance. Data were modeled using Tobit, probit, and hybrid models. Feasibility was assessed based on the distribution of data, participants, and reports of understanding from the interviewer, QC and modeling results. RESULTS: cTTO and DCE data were available for 520 participants. Demographic characteristics were broadly representative of the UK general population. Interviewers met QC requirements. cTTO values ranged between -1 to 1 with increasing disutility associated with more severe states. Participants understood the tasks and the EQ-HWB-S states; and the interviewers reported high levels of understanding and engagement. The hybrid Tobit heteroscedastic model was selected for the pilot value set with values ranging from -0.384 to 1. Pain, mobility, daily activities, and sad/depressed had the largest disutilities, followed by loneliness, anxiety, exhaustion, control, and cognition in the selected model. CONCLUSIONS: EQ-HWB-S can be valued using cTTO and DCE. Further methodological work is recommended to develop a valuation protocol specific to the EQ-HWB-S.

Systematic Review of the Effect of a One-Day Versus Seven-Day Recall Duration on Patient Reported Outcome Measures (PROMs).

BACKGROUND: There is ongoing uncertainty around the most suitable recall period for patient-reported outcome measures (PROMs). METHOD: This systematic review integrates quantitative and qualitative literature across health, economics, and psychology to explore the effect of a one-day (or '24-h') versus seven-day (or 'one week') recall period. The following databases were searched from database inception to 30 November 2021: MEDLINE, EMBASE, PsycINFO, Web of Science, EconLit, CINAHL Complete, Cochrane Library, and Sociological Abstracts. Studies were included that compared a one-day (or '24-h') versus seven-day (or weekly) recall period condition on patient-reported scores for PROM and Health-Related Quality-of-Life (HRQoL) instrument scores in adult populations (aged 18 and above) or combined paediatric and adult populations with a majority of respondents aged over 18 years. Studies were excluded if they assessed health behaviours only, used ecological momentary assessment to derive an index of daily recall, or incorporated clinician reports of patient symptoms. We extracted results relevant to six domains with generic health relevance: physical functioning, pain, cognition, psychosocial wellbeing, sleep-related symptoms and aggregated disease-specific signs and symptoms. Quantitative studies compared weekly recall scores with the mean or maximum score over the last seven days or with the same-day recall score. RESULTS: Overall, across the 24 quantitative studies identified, 158 unique results were identified. Symptoms tended to be reported as more severe and HRQoL lower when assessed with a weekly recall than a one-day recall. A narrative synthesis of 33 qualitative studies integrated patient perspectives on the suitability of a one-day versus seven-day recall period for assessing health state or quality of life. Participants had mixed preferences, some noted the accuracy of recall for the one-day period but others preferred the seven-day recall for conditions characterised by high symptom variability, or where PROMs concepts required integration of infrequent experiences or functioning over time. CONCLUSION: This review identified a clear trend toward higher symptom scores and worse quality of life being reported for a seven-day compared to a one-day recall. The review also identified anomalies in this pattern for some wellbeing items and a need for further research on positively framed items. A better understanding of the impact of using different recall periods within PROMs and HRQoL instruments will help contextualise future comparisons between instruments. Questionnaires ask patients about their health over different time periods (e.g., "what were your symptoms like over the last week?" versus "what were your symptoms like today?"). Studies find that people may report their symptoms as more severe when they are asked to think about their symptoms over the last week compared to the last day. Understanding how different time periods influence patient responses will allow researchers to compare and develop new questionnaires and may help clinicians to choose the best questionnaire to understand their patient's condition. We conducted a systematic literature review on studies which had looked at the impact of using different recall periods on patient responses. We found 24 studies that compared patient scores from questionnaires asking their health "over the last day" compared to "over the last week". Overall, symptoms tended to be reported as more severe and health as poorer when they were reported over the last week compared to the last day on average. We also found 33 studies that asked patients to describe which recall period they preferred. Patients had mixed preferences with more preferring a seven-day recall where symptoms and health impacts varied a lot.

Comparing EQ-5D-3L and EQ-5D-5L in measuring the HRQoL burden of 4 health conditions in China.

BACKGROUND: EQ-5D-3L has been used in the National Health Services Survey of China since 2008 to monitor population health. The five-level version of EQ-5D was developed, but there lacks evidence to support the use of five-level version of EQ-5D in China. This study was conducted to compare the measurement properties of both the EQ-5D-3L and EQ-5D-5L in quantifying health-related quality of life (HRQoL) burden for 4 different health conditions in China. METHODS: Participants from China were recruited to complete the 3L and 5L questionnaire via Internet. Quota was set to recruit five groups of individuals, with one group of individuals without any health condition and one group of generalized anxiety disorder (GAD), HIV/AIDS, chronic Hepatitis B (CHB), or depression, respectively. The 3L and 5L were compared in terms of response distributions, percentages of reporting 'no problems', index value distributions, known-group validity and their relative efficiency. RESULTS: In total, 500 individuals completed the online survey, including 140 healthy individuals, 122 individuals with hepatitis B, 107 with depression, 90 individuals with GAD and 101 with HIV/AIDS. 5L also had smoother and less clustered index value distributions. Healthy group showed different response distributions to the four condition groups. The percentage of reporting 'no problems' decreased significantly in the 5L in all domains (P < 0.01), especially in the pain/discomfort dimension (relative difference: 43.10%). Relative efficiency suggested that 5L had a higher absolute discriminatory power than the 3L version between healthy participant and the other 4 condition groups, especially for the HIV/AIDS group when the 3L results was not significant. CONCLUSIONS: The 5L version may be preferable to the 3L, as it demonstrated superior performance with respect to higher sensitivity to mild health problems, better relative efficiency and responses and index value distributions.

Developing an Australian utility value set for MacNew-7D health states.

BACKGROUND: A new preference-based measure (MacNew-7D) has recently been developed to allow condition-specific data to be used to capture the quality of life in health economic evaluations in cardiology; however, a general population value set has not yet been developed. This study developed a population utility value set for the MacNew-7D heart disease-specific instrument. METHODS: The discrete choice experiments (DCE) technique was chosen as the preference-elicitation method. The DCE asked respondents to compare two options and to state their preferences. The survey was conducted using an online panel of respondents, with quota sampling using age groups, sex and jurisdictions to achieve representativeness of the Australian population. The total design consisted of 200 choice sets, of which each respondent answered eight. Additionally, each respondent answered two quality control choice sets. The best-fitting models were selected on the basis of consistency, parsimony, and goodness of fit. RESULTS: In total, 1903 respondents were included in the analyses. The MacNew-7D utility value set ranged from -0.4456 to 1.000 for health states defined by the classification system. The best-fitting model retained all levels for five dimensions and collapsed one adjacent level for the other two dimensions. Findings were robust to sensitivity analyses related to the inclusion or exclusion of dominancy and repeat tasks. CONCLUSION: Findings indicated that the MacNew-7D utility value set is likely suitable for estimating quality-adjusted life years derived from the MacNew heart disease health-related quality-of-life questionnaire. This value set was derived from an Australian population-based sample and may not be generalisable to dissimilar populations.

Development of the Cystic Fibrosis Questionnaire-Revised-8 Dimensions: Estimating Utilities From the Cystic Fibrosis Questionnaire-Revised.

OBJECTIVES: Cystic fibrosis (CF) limits survival and negatively affects health-related quality of life (HRQOL). Cost-effectiveness analysis (CEA) may be used to make reimbursement decisions for new CF treatments; nevertheless, generic utility measures used in CEA, such as EQ-5D, are insensitive to meaningful changes in lung function and HRQOL in CF. Here we develop a new, CF disease-specific, preference-based utility measure based on the adolescent/adult version of the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a widely used, CF-specific, patient-reported measure of HRQOL. METHODS: Blinded CFQ-R data from 4 clinical trials (NCT02347657, NCT02392234, NCT01807923, and NCT01807949) were used to identify discriminating items for a classification system using psychometric (eg, factor and Rasch) analyses. Thirty-two health states were selected for a time trade-off (TTO) exercise with a representative sample of the UK general population. TTO utilities were used to estimate a preference-based scoring algorithm by regression analysis (tobit models with robust standard errors clustered on participants with censoring at -1). RESULTS: A classification system with 8 dimensions (CFQ-R-8 dimensions; physical functioning, vitality, emotion, role functioning, breathing difficulty, cough, abdominal pain, and body image) was generated. TTO was completed by 400 participants (mean age, 47.3 years; 49.8% female). Among the regression models evaluated, the tobit heteroscedastic-ordered model was preferred, with a predicted utility range from 0.236 to 1, no logical inconsistencies, and a mean absolute error of 0.032. CONCLUSION: The CFQ-R-8 dimensions is the first disease-specific, preference-based scoring algorithm for CF, enabling estimation of disease-specific utilities for CEA based on the well-validated and widely used CFQ-R.

Assessing the comparative feasibility, acceptability and equivalence of videoconference interviews and face-to-face interviews using the time trade-off technique.

This study examines the comparative equivalence, feasibility and acceptability of video and in-person interviews in generating time trade-off (TTO) values. Sample participants in England were recruited using a blended approach of different methods and sampled based on age, gender, ethnicity, and index of multiple deprivation. Participants were randomly allocated to be interviewed either via video or in-person. Participants completed TTO tasks for the same block of 10 EQ-5D-5L health states using the EQ-VTv2 software. Feasibility, acceptability and equivalence was assessed across mode using: sample representativeness; participant understanding, engagement and feedback; participant preferred mode of interview; data quality; mean utility and distribution of values for each health state; and regression analyses assessing the impact of mode whilst controlling for participant characteristics. The video and in-person samples had statistically significant differences in ethnicity and income but were otherwise broadly similar. Video interviews generated marginally lower quality data across some criteria. Participant understanding and feedback was positive and similar across modes. TTO values were similar across modes; whilst mean in-person TTO values were lower for the more severe states, mode was insignificant in most regression analyses. There was no clear preference of mode across all participants, though the characteristics of participants preferring to be interviewed in-person or by video differs. Video and in-person TTO interviews were feasible, acceptable and generated good-quality data, though video interviews had lower quality data across some criteria. Whilst TTO values differed across modes for the more severe states, mode does not appear to be the cause. The study found that the characteristics of people preferring each mode differed, and this should be taken into account in future valuation studies since sample representativeness for some characteristics, and therefore potentially TTO values, could be affected by the choice of mode.

A Systematic Review of the Methodologies and Modelling Approaches Used to Generate International EQ-5D-5L Value Sets.

BACKGROUND: The international protocol for valuing EQ-5D-5L focuses upon prescribed preference elicitation methods and design. However, there are no recommendations around sampling, recruitment, data analysis or modelling to generate the EQ-5D-5L value set. This review examines methods used to generate international EQ-5D-5L values sets, across sampling, recruitment, data analysis, modelling, assessing model performance and selection of the recommended value set. METHODS: All published EQ-5D-5L value sets were identified by a systematic search and confirmed by the EuroQol Group. Data were extracted to assess sampling, recruitment, preference elicitation techniques and design, data analysis, modelling, assessing model performance, and vale set selection. These are summarised in tables. RESULTS: The review included 29 studies with 27 value sets generated using time-trade-off (TTO) data (n = 10) only or using a hybrid model that combines TTO and discrete choice experiment data (n = 17). TTO data were most commonly estimated using a heteroscedastic Tobit model with censoring at - 1, and the hybrid model using a specially created program. Model performance was generally assessed using goodness of fit, logical consistency and significance of coefficients, suitability of the model for the data characteristics and parsimony, though not all selected models account for the specific characteristics of the data. DISCUSSION: Different assessments of model performance and reasoning are provided for the selection of the recommended value set for a country. This raises the question of valid criteria for selecting a recommended value set and whether this should rely upon researchers' recommendations when value sets are often used to inform public policy.

A qualitative investigation of the relevance of skin irritation and self-confidence bolt-ons and their conceptual overlap with the EQ-5D in patients with psoriasis.

OBJECTIVES: A number of bolt-ons have been proposed for the EQ-5D, including two psoriasis-specific bolt-ons, skin irritation and self-confidence. The study investigates and compares the relevance and comprehensiveness of these psoriasis-specific bolt-ons and the EQ-5D-5L and explores the potential conceptual overlaps between the existing five dimensions and the two bolt-ons. METHODS: Psoriasis patients were purposively sampled according to age and gender. Semi-structured interviews, where participants were asked to complete the EQ-5D-5L and the bolt-ons while thinking aloud, were conducted. Probes were used to investigate the thought processes of patients regarding the dimensions, wording, recall period and relevant concepts not captured by the EQ-5D-5L and bolt-ons. Data were analysed thematically. A focus group was used to confirm the findings. RESULTS: Overall, 16 patients completed the interviews. Sixteen and fifteen patients considered skin irritation and self-confidence relevant areas to describe psoriasis problems. Three patients considered itching a form of discomfort, and thus, pointed out a potential overlap between pain/discomfort and skin irritation. Twelve patients reported overall 10 general health- or psoriasis-related concepts that are not captured by the EQ-5D-5L, including itching, social relationships and sex life. Eleven patients reported that the recall period of the EQ-5D-5L might be subject to bias because of the daily or within-day fluctuations of their symptoms. CONCLUSIONS: The skin irritation and self-confidence bolt-ons contribute to improve content validity of the EQ-5D-5L in patients with psoriasis. The qualitative approach taken in this study expands the existing methodological framework for the development and testing validity of bolt-ons for the EQ-5D.

Should We Consider Including a Value for "Hope" as an Additional Benefit Within Health Technology Assessment?

Health technology assessment (HTA) typically uses average health-related quality of life gain as its main measure of benefit used in economic evaluation. Nevertheless, there have been calls to consider novel aspects of benefit including the "value of hope," defined as a patients' potential preferences for a wider distribution of treatment benefit with a positive skew, in the hope that they will be one of the lucky ones. The value of hope may also derive from feeling hopeful as a positive mental state, which may be missing from current measures of health-related quality of life. The value attributed to feeling hopeful could be related to, or additional to, the value derived from possible risk-seeking preferences. Here, we reflect upon the strength of the case for the inclusion of the "value of hope" taking a critical look at the commonly referenced evidence for including the "value of hope" as risk-seeking preferences. We also draw attention to other conceptions of hope-as an emotion, a cognitive process, or a combination of both-and reflect upon the potential of including these broader notions of hope into HTA. The case for the inclusion of the "value of hope" based on risk-seeking preferences is weak. We suggest research questions that could give further evidence on whether hope is an important missing value from HTA.

Qualitative Review on Domains of Quality of Life Important for Patients, Social Care Users, and Informal Carers to Inform the Development of the EQ-HWB.

OBJECTIVES: To identify the themes to inform the content of a new generic measure, the EQ-HWB (EQ Health and Wellbeing), that can be used in economic evaluation across health, social care, and public health, based on the views of users and beneficiaries of these services including informal carers. METHODS: A qualitative review was undertaken. Systematic and citation searches were undertaken focusing on qualitative evidence of the impact on quality of life from reviews for selected health conditions, informal carers, social care users, and primary qualitative work used in the development of selected measures. A subset of studies was included in the review. Framework analysis and synthesis were undertaken based on a conceptual model. RESULTS: A total of 42 reviews and 24 primary studies were selected for inclusion in the review. Extraction and synthesis resulted in 7 high-level themes (with subthemes): (1) feelings and emotions (sadness, anxiety, hope, frustration, safety, guilt/shame); (2) cognition (concentration, memory, confusion, thinking clearly); (3) self-identity (dignity/respect, self-esteem); (4) "coping, autonomy, and control" relationships; (5) social connections (loneliness, social engagement, stigma, support, friendship, belonging, burden); (6) physical sensations (pain, discomfort, sleep, fatigue); and (7) activity (self-care, meaningful activities, mobility, communication, hearing, vision). Apart from physical sensations, most of the other themes and subthemes were relevant across both health and social care, including for informal carers. CONCLUSIONS: The findings from this broad review identified themes that go beyond health and that are relevant to patients, informal carers, and social care users. The themes and subthemes informed the domains for the EQ-HWB.