A Comparison of Items and Constructs of Standardized Health-Related Quality of Life and Mental Well-Being Measures.

OBJECTIVES: This study aimed to explore the internal constructs of the concepts being measured by EQ-5D-5L (a health-related quality of life measure that can produce preference-based utility values) and the 12-item General Health Questionnaire (GHQ-12, a mental well-being measure) and to understand to what extent the items of EQ-5D-5L and GHQ-12 associate with each other. METHODS: We used data from 12 701 respondents participating in a Belgian survey in 2022. Correlation coefficients between GHQ-12 and EQ-5D-5L were calculated at both the aggregate and item levels. Multidimensional scaling, exploratory factor analysis, and regression models were performed to investigate the underlying constructs that are associated with the items. RESULTS: Despite a moderate correlation (0.39) between the EQ-5D-5L and GHQ-12 total scores, only a trivial or weak correlation (<0.3) was observed between the first 4 EQ-5D-5L items and any GHQ-12 item. Multidimensional scaling and exploratory factor analysis showed the first 4 EQ-5D-5L dimensions were clustered together with EuroQol visual analog scale and positively phrased GHQ-12 items were close to each other, whereas EQ-anxiety/depression and negatively phrased GHQ-12 items were grouped with overall life satisfaction. In the regression models, not all GHQ-12 items had a significant coefficient to predict EQ-5D-5L responses. CONCLUSIONS: To the best of our knowledge, we present the first comparison of items and underlying constructs of GHQ-12 and EQ-5D-5L. The results showed that GHQ-12 can only partially predict the responses of EQ-5D-5L and the 2 instruments measure different constructs. Researchers should carefully consider conceptual legitimacy while applying the mapping technique and consider sensitivity analyses for the mapping estimates.

COVID-19 and EQ-5D-5L health state valuation.

BACKGROUND: We investigate whether and how general population health state values were influenced by the initial stages of the COVID-19 pandemic. Changes could have important implications, as general population values are used in health resource allocation. DATA: In Spring 2020, participants in a UK general population survey rated 2 EQ-5D-5L states, 11111 and 55555, as well as dead, using a visual analogue scale (VAS) from 100 = best imaginable health to 0 = worst imaginable health. Participants answered questions about their pandemic experiences, including COVID-19's effect on their health and quality of life, and their subjective risk/worry about infection. ANALYSIS: VAS ratings for 55555 were transformed to the full health = 1, dead = 0 scale. Tobit models were used to analyse VAS responses, as well as multinomial propensity score matching (MNPS) to create samples balanced according to participant characteristics. RESULTS: Of 3021 respondents, 2599 were used for analysis. There were statistically significant, but complex associations between experiences of COVID-19 and VAS ratings. For example, in the MNPS analysis, greater subjective risk of infection implied higher VAS ratings for dead, yet worry about infection implied lower ratings. In the Tobit analysis, people whose health was affected by COVID-19 rated 55555 higher, whether the effect on health was positive or negative. CONCLUSION: The results complement previous findings that the onset of the COVID-19 pandemic may have impacted EQ-5D-5L health state valuation, and different aspects of the pandemic had different effects.

Stability of health-related quality of life and morbidity burden from 18 months after diagnosis of prostate cancer: results of a UK-wide population-based outcome cohort.

OBJECTIVE: To evaluate the dynamic nature of self-reported health-related quality of life (HRQL) and morbidity burden in men diagnosed with prostate cancer, we performed a follow-up study of the Life After Prostate Cancer Diagnosis (LAPCD) study cohort 12 months after initial survey. METHODS: The LAPCD study collected information from 35,823 men across the UK who were 18-42 months post-diagnosis of prostate cancer. Men who were still alive 12 months later were resurveyed. Generic HRQL (EQ-5D-5L plus self-assessed health rating) and prostate cancer-specific outcomes (EPIC-26) were assessed. Treatment(s) received was self-reported. Previously defined clinically meaningful differences were used to evaluate changes in outcomes over time. RESULTS: A total of 28,450 men across all disease stages completed follow-up surveys (85.8% response). Of the 21,700 included in this study, 89.7% reported no additional treatments since the first survey. This group experienced stable urinary and bowel outcomes, with good function for most men at both time points. On-going poor (but stable) urinary issues were associated with previous surgery. Sexual function scores remained low (mean: 26.8/100). Self-assessed health ratings were stable over time. The largest declines in HRQL and functional outcomes were experienced by men reporting their first active treatment between surveys. DISCUSSION: The results suggest stability of HRQL and most specific morbidities by 18-42 months for men who report no further treatment in the subsequent 12 months. This is reassuring for those with good function and HRQL but re-enforces the need for early intervention and support for men who experience poor outcomes.

A pilot study on the validity and psychometric properties of the electronic EQ-5D-5L in routine clinical practice.

BACKGROUND: Electronic measurement of health-related quality of life (HRQOL) may facilitate timely and regular assessments in routine clinical practice. This study evaluated the validity and psychometric properties of an electronic version of the EQ-5D-5L (e-EQ-5D-5L) in Chinese patients with chronic knee and/or back problems. METHODS: 151 Chinese subjects completed an electronic version of the Chinese (Hong Kong) EQ-5D-5L when they attended a primary care or orthopedics specialist out-patient clinic in Hong Kong. They also completed the Chinese Western Ontario and McMaster University Osteoarthritis Index (WOMAC), a Pain Rating Scale, and a structured questionnaire on socio-demographics, co-morbidities and health service utilization. 32 subjects repeated the e-EQ-5D-5L two weeks after the baseline. 102 subjects completed e-EQ-5D-5L and 99 completed the Global Rating on Change Scale at three-month clinic follow up. Construct validity was assessed by the association of EQ-5D-5L scores with external criterion of WOMAC scores. We tested mean differences of WOMAC scores between adjacent response levels of the EQ-5D-5L dimensions by one-way ANOVA, test-retest reliability by intra-class correlation, sensitivity by known group comparisons and responsiveness by changes in EQ-5D-5L scores over 3 months. RESULTS: There was an association between EQ-5D-5L and WOMAC scores. Mean WOMAC scores increased with the increase in adjacent response levels of EQ-5D-5L dimensions. Test-retest intraclass correlation coefficient (ICC) of EQ-5D-5L utility and EQ-VAS scores were 0.76 and 0.83, respectively, indicating good reliability. There were significant differences in the proportions reporting limitations in the EQ-5D-5L dimensions, the utility and VAS scores between the mild and severe pain groups (utility = 0.28, p = 0.001; VAS = 11.46, p < 0.001), and between primary care and specialist out-patient clinic patients (utility = 0.15, p = 0.001; VAS = 10.21, p < 0.001), supporting sensitivity. Among those reporting 'better' global health at three-months, their EQ-5D-5L utility and EQ-VAS scores were significantly increased from baseline (utility = 0.18, p < 0.001; VAS = 10.75, p = 0.005). CONCLUSIONS: The electronic version of the EQ-5D-5L is valid, reliable, sensitive and responsive in the measurement of HRQOL in Chinese patients with chronic knee or back pain in routine clinical practice.

Does a health crisis change how we value health?

General population health state values are used in healthcare resource allocation, including health technology assessment. We examine whether UK general population health valuations changed during the COVID-19 pandemic. Ratings of EQ-5D-5L health states 11111 (no problems), 55555 (extreme problems), and dead were collected in a UK general population survey during the pandemic (April-May 2020) using the 0 = worst imaginable health, 100 = best imaginable health visual analog scale (EQ-VAS). Ratings for 55555 were transformed to a full health = 1, dead = 0 scale. Responses were compared to similar data collected pre-pandemic (2018). After propensity score matching to minimize sample differences, EQ-VAS responses were analyzed using Tobit regressions. On the 0-100 scale, 11111 was rated on average 8.67 points lower, 55555 rated 9.56 points higher, and dead rated 7.45 points lower post-pandemic onset compared to pre-pandemic. On the full health = 1, dead = 0 scale, 55555 values were 0.09 higher post-pandemic onset. There was evidence of differential impacts of COVID-19 by gender, age, and ethnicity, although only age impacted values on the 1-0 scale. COVID-19 may have affected how people value health. It is unknown whether the effect is large enough to have policy relevance, but caution should be taken in assuming pre-COVID-19 values are unchanged.

Estimation of Health-Related Quality of Life Losses Owing to a Technological Disaster in Brazil Using EQ-5D-3L: A Cross-Sectional Study.

OBJECTIVES: In 2015, a dam collapsed at Samarco iron ore mine in the municipality of Mariana, Brazil, and contaminated more than 600 km of watercourses and destroyed almost 1600 acres of vegetation. Nineteen people died and more than 600 families lost their homes. This study aimed to estimate health-related quality of life (HRQoL) losses owing to this disaster. METHODS: We collected data from a probabilistic sample of 459 individuals aged 15 years or older. Household face-to-face interviews were conducted in December 2018. Pre-event data were not available for this population, so respondents were asked to evaluate at present and in retrospect their health status using EQ-5D-3L. The Minas Gerais societal value sets for EQ-5D-3L health preferences, estimated in 2011, were used to calculate utility losses. The health loss estimation from EQ-5D will form the basis for the calculation of compensation payments for the victims. RESULTS: Approximately 74% of the study population suffered some HRQoL loss. On average, EQ-5D index values decreased from 0.95 to 0.76. The greatest effects were observed for the anxiety/depression dimension, followed by pain/discomfort. Before the tragedy, the proportion of individuals with severe anxiety/depression and pain/discomfort was equal to 1% rising to 23% and 11%, respectively. CONCLUSIONS: Catastrophic losses owing to the Samarco disaster were found. The EQ-5D-3L instrument showed feasibility and sensitiveness to measure HRQoL losses owing to a negative health shock in a low-income Brazilian population.

The Unfolding Method to Explore Health-Related Quality of Life Constructs in a Chinese General Population.

OBJECTIVES: Health-related quality of life (HRQOL) is a complicated concept that can be measured using multiple health items. Although HRQOL is closely associated with people's subjective assessment of their own health, a limited number of studies have investigated which health items are considered most important and relevant by the general population. Even fewer empirical studies have investigated how HRQOL is understood in non-Western populations. This study used multidimensional unfolding analysis in a Chinese general population to explore the constructs of HRQOL. METHODS: A scoping review of Chinese generic HRQOL measures and a series of qualitative interviews produced a list of 42 potentially important health items in a Chinese cultural setting; 110 Chinese participants in face-to-face interviews ranked the health items from most important to least important. Responses were coded into a rectangular 110 × 42 matrix, and multidimensional unfolding was conducted to analyze participants' preferences for health items. RESULTS: It was found that demographic characteristics and one's health condition affected views of HRQOL. Meanwhile, 3 health items were considered to be most important across the whole sample: sleep quality, body constitution, and spiritual appearance. CONCLUSION: This study used a novel approach to explore how people coming from a Chinese cultural setting may perceive HRQOL and which aspects of HRQOL are most important to them. The study shows that multidimensional unfolding is a feasible approach to assess preferences in a general population. Future studies using this approach are recommended to further explore the constructs of HRQOL in other general populations.

Investigating the Self-Reported Health Status of Domestic and Overseas Chinese Populations during the COVID-19 Pandemic.

To control the spread of COVID-19, governments in different countries and regions implemented various types of lockdown and outdoor restrictions. The research aimed to describe and compare the health status of Chinese people both domestically and abroad in this global health crisis. An online questionnaire survey was distributed to Chinese mainland citizens living in Hubei (the lockdown province), outside Hubei, and those living abroad in 2020. A total of 1000 respondents were recruited and reported worse health status compared with Chinese population norms. People living in Hubei reported worse health status than those living outside Hubei but revealed better health status than overseas respondents. It was clear that the pandemic as well as strict lockdown and outdoor restriction policies affected Chinese people's health. It is important for the Chinese government to be aware of the negative impact of such strict policies and to take measures to reduce the panic of society when implementing similar policies in the future. It also implies that governments in other countries should promote social support for those who live far from home and actively call for support for non-discriminatory attitudes toward ethnic minorities.

Similarities and Differences in Health-Related Quality-of-Life Concepts Between the East and the West: A Qualitative Analysis of the Content of Health-Related Quality-of-Life Measures.

OBJECTIVES: Most of the commonly used health-related quality of life (HRQoL) measures were developed in the West and have been introduced into other countries for use worldwide. Arguably, this adaptation process assumes that health, as a concept, has universal cultural equivalence. This study identified those Chinese-developed HRQoL measures and summarized their contents, with which the Western-developed HRQoL measures were compared, aiming to explore cultural differences in defining and measuring health between the East and the West. METHODS: A systematic literature search was conducted to identify Chinese-developed generic HRQoL measures. Two Western-developed HRQoL measures (EQ-5D, SF-36) and a cross-culturally developed measure (WHOQOL-100) were included for comparison. A qualitative content analysis was undertaken both deductively and inductively to categorize and summarize the content of the questionnaires in analyzing similarities and differences between Western and Chinese-developed HRQoL measures. RESULTS: Eight HRQoL measures that were designed in a Chinese cultural context were identified and compared with the 3 non-Chinese-developed HRQoL measures. Although there is an agreement between the East and the West regarding the domains and subdomains of HRQoL, health concepts including "emotion control," "weather adaption," "social adaption," "spirit," and "complexion" were exclusively introduced by the Chinese measures. CONCLUSIONS: The results demonstrate that health is a culturally grounded concept, and because of cultural differences, it cannot be taken for granted that a well-recognized Western HRQoL measure is always appropriate for use in other cultural contexts. This study implies the necessity of further examining the legitimacy of applying Western-developed HRQoL measures in other cultural settings.

Measuring Quality of Life in Carers of People With Dementia: Development and Psychometric Evaluation of Scales measuring the Impact of DEmentia on CARers (SIDECAR).

BACKGROUND AND OBJECTIVES: A 2008 European consensus on research outcome measures in dementia care concluded that measurement of carer quality of life (QoL) was limited. Three systematic reviews (2012, 2017, and 2018) of dementia carer outcome measures found existing instruments wanting. In 2017, recommendations were published for developing reliable measurement tools of carers' needs for research and clinical application. The aim of this study was to develop a new instrument to measure the QoL of dementia carers (family/friends). METHODS: Items were generated directly from carers following an inductive needs-led approach. Carers (n = 566) from 22 English and Welsh locations then completed the items and comparator measures at three time points. Rasch, factor, and psychometric (reliability, validity, responsiveness, and minimally important differences [MIDs]) analyses were undertaken. RESULTS: Following factor analysis, the pool of 70 items was refined to three independent scales: primary SIDECAR-D (direct impact of caring upon carer QOL, 18 items), secondary SIDECAR-I (indirect impact, 10 items), and SIDECAR-S (support and information, 11 items). All three scales satisfy Rasch model assumptions. SIDECAR-D, I, S psychometrics: reliability (internal ≥ .70; test-retest ≥ .85); convergent validity (as hypothesized); responsiveness (effect sizes: D: moderate; I and S: small); MIDs (D = 9/100, I = 10/100, S = 11/100). DISCUSSION AND IMPLICATIONS: SIDECAR scales demonstrate robust measurement properties, meeting COSMIN quality standards for study design and psychometrics. SIDECAR provides a theoretically based needs-led QoL profile specifically for dementia carers. SIDECAR is free for use in public health, social care, and voluntary sector services, and not-for-profit organizations.

Effectiveness of routine measurement of health-related quality of life in improving the outcomes of patients with musculoskeletal problems-a cluster randomised controlled trial: protocol paper.

INTRODUCTION: Managing chronic musculoskeletal problems usually focuses on pain control using medications, but outcomes are often unsatisfactory and sometimes harmful. Information on a patient's health-related quality of life (HRQOL) may trigger a doctor to tailor management improving quality of life. The aim of this trial is to find out whether routine measurement and reporting of a patient's EuroQoL 5-Dimension 5-Level (EQ-5D-5L) HRQOL data using an electronic platform can improve HRQOL and pain in patients with chronic knee or back problems in primary care. We will also assess the acceptability of routine electronic measurements and reporting of the EQ-5D-5L in primary care settings. METHODS: This is a multicentre, prospective, cluster randomised controlled trial set in six public primary care clinics in Hong Kong. At the intervention clinics, subjects will complete an electronic EQ-5D-5L form at recruitment and at each clinic follow-up over 12 months. A report of the patient's longitudinal EQ-5D-5L data will be provided to the doctor. Subjects in the control clinics will receive care as usual. All subjects will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a 10-point Pain Rating Scale and a structured questionnaire to collect sociodemographic information and data on morbidity and service utilisation at recruitment at baseline, 3, 6 and 12 months. Primary outcome is the change in WOMAC total score. Secondary outcomes are change in pain, other patient-reported outcome scores and doctor-rated severity of disease. Group differences in the changes in WOMAC and other outcome scores over time will be analysed using generalised estimating equation model with an intention-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval has been obtained from The University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-270). The results of the trial will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03609762.

Influence of deprivation and rurality on patient-reported outcomes of men living with and beyond prostate cancer diagnosis in the UK: A population-based study.

BACKGROUND: In the UK, inequalities exist in prostate cancer incidence, survival and treatment by area deprivation and rurality. This work aimed to identify variation in patient-reported outcomes of men with prostate cancer by area type. METHODS: A population-based survey of men 18-42 months after prostate cancer diagnosis (N = 35608) measured self-assessed health (SAH) using the EQ-5D and five functional domains using the Expanded Prostate Cancer Index Composite (EPIC-26). RESULTS: Mean SAH was higher for men in least deprived areas compared to most deprived (difference 6.3 (95 %CI 5.6-7.2)). SAH scores were lower for men in most urban areas compared to most rural (difference 2.4 (95 %CI 1.8-3.0)). Equivalent estimates in the general population reported a 13 point difference by deprivation and a 4 point difference by rurality. For each EPIC-26 domain, functional outcomes were better for men in the least deprived areas, with clinically meaningful differences observed for urinary incontinence and hormonal function. There were no clinically meaningful differences in EPIC-26 outcomes by rurality with less than a three point difference in scores for each domain between urban and rural areas. CONCLUSION: In men 18-42 months post diagnosis of prostate cancer in the UK, impacts of area deprivation and rurality on self-assessed health related quality of life were not greater than would be expected in the general population. However, clinically meaningful differences were identified for some prostate functional outcomes (urinary and hormonal function) by deprivation. No impact by rurality of residence was identified.

Measurement properties of EQ-5D-3L and EQ-5D-5L in recording self-reported health status in older patients with substantial multimorbidity and polypharmacy.

BACKGROUND: The EQ-5D-3L and EQ-5D-5L are two generic health-related quality of life measures, which may be used in clinical and health economic research. They measure impairment in 5 aspects of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The aim of this study was to assess the performance of the EQ-5D-3L and EQ-5D-5L in measuring the self-reported health status of older patients with substantial multimorbidity and associated polypharmacy. METHODS: Between 2017 and 2019, we administered EQ-5D-3L and EQ-5D-5L to a subset of patients participating in the OPERAM trial at 6 months and 12 months after enrolment. The OPERAM trial is a two-arm multinational cluster randomised controlled trial of structured medication review assisted by a software-based decision support system versus usual pharmaceutical care, for older people (aged ≥ 70 years) with multimorbidity and polypharmacy. In the psychometric analyses, we only included participants who completed the measures in full at 6 and 12 months. We assessed whether responses to the measures were consistent by assessing the proportion of EQ-5D-5L responses, which were 2 or more levels away from that person's EQ-5D-3L response. We also compared the measures in terms of informativity, and discriminant validity and responsiveness relative to the Barthel Index, which measures independence in activities of daily living. RESULTS: 224 patients (mean age of 77 years; 56% male) were included in the psychometric analyses. Ceiling effects reported with the EQ-5D-5L (22%) were lower than with the EQ-5D-3L (29%). For the mobility item, the EQ-5D-5L demonstrated better informativity (Shannon's evenness index score of 0.86) than the EQ-5D-3L (Shannon's evenness index score of 0.69). Both the 3L and 5L versions of EQ-5D demonstrated good performance in terms of discriminant validity, i.e. (out of all items of the EQ-5D-3L and EQ-5D-5L, the pain/discomfort and anxiety/depression items had the weakest correlation with the Barthel Index. Both the 3L and 5L versions of EQ-5D demonstrated good responsiveness to changes in the Barthel Index. CONCLUSION: Both EQ-5D-3L and EQ-5D-5L demonstrated validity and responsiveness when administered to older adults with substantial multimorbidity and polypharmacy who were able to complete the measures.

UK General Population Utility Values for the SIDECAR-D Instrument Measuring the Impact of Caring for People With Dementia.

OBJECTIVES: Dementia affects many people, with numbers expected to grow as populations age. Many people with dementia receive informal/family/unpaid care, for example, from a spouse or child, which may affect carer quality of life. Measuring the effectiveness of health/social care interventions for carers requires a value measure of the quality-of-life impact of caring. This motivated development of the Scales Measuring the Impact of Dementia on Carers-D (SIDECAR-D) instrument. This study aimed to obtain general population values for SIDECAR-D to aid incorporating the impact of caring in economic evaluation. METHODS: Members of the UK general public completed a best-worst scaling object case survey, which included the 18 SIDECAR-D items and EQ-5D-3L descriptions. Responses were analyzed using scale-adjusted finite mixture models. Relative importance scores (RISs) for the 18 SIDECAR-D items formed the SIDECAR-D relative scale measuring the relative impact of caring. The SIDECAR-D tariff, on the full health = 1, dead = 0 scale, was derived by rescaling EQ-5D-3L and SIDECAR-D RISs so the EQ-5D-3L RISs equaled anchored valuations of the EQ-5D-3L pits state from a visual analog scale task. RESULTS: Five hundred ten respondents completed the survey. The model had 2 parameter and 3 scale classes. Additive utility decrements of SIDECAR-D items ranged from -0.05 to -0.162. Utility scores range from 0.95 for someone affirming 1 item to -0.297 for someone affirming all 18. CONCLUSION: SIDECAR-D is a needs-based scale of the impact on quality of life of caring for someone with dementia, with a valuation tariff to support its use in economic evaluation.

Exploring subjective constructions of health in China: a Q-methodological investigation.

BACKGROUND: With an increasing awareness of people's satisfaction and feeling, health-related quality of life (HRQoL) has become an essential aspect of measuring health. HRQoL is fundamentally a foreign concept introduced to China from the West. While a growing number of studies applied western HRQoL measures, few content validity tests examined the legitimacy of applying Western developed HRQoL measures in a Chinese cultural setting. If there are distinct differences in health conceptualisation between China and the West, it can be argued that those western measures may fail to ask the most appropriate and important questions among a Chinese population in assessing health. As a limited number of studies have investigated Chinese people's understandings of health, this study aimed to explore how health is defined and described in China. METHODS: A Q-methodological study was conducted to explore subjective constructions of health among Chinese participants. A scoping review of Chinese generic HRQoL measures, supplemented by a series of qualitative interviews conducted in China, produced a list of 42 statements representing aspects of health considered as being important in a Chinese cultural setting. Chinese participants in face-to-face interviews ranked and sorted these statements. Data were analysed to identify clusters of participants who shared a similar perspective, using a by-person factor analysis procedure. RESULTS: 110 Chinese participants with various demographics characteristics completed sorting interviews. Five independent factors emerged: (I) "Physical independence and social interaction skills"; (II) "Physical health"; (III) "Sensations and feelings"; (IV) "Lifestyles"; (V) "Learning and working abilities". CONCLUSIONS: The Q-study showed that many health statements were rated highly as most important by a diverse range of Chinese participants but were not covered in the commonly used Western HRQoL measure EQ-5D. It then suggests that the EQ-5D descriptive system might need modification to improve its capacity to measure health status in China. The study thus raises a general question as to how appropriate the Western-developed HRQoL measures are when used to assess health in a significantly different cultural setting.

Transforming discrete choice experiment latent scale values for EQ-5D-3L using the visual analogue scale.

BACKGROUND: Discrete choice experiments (DCEs) are widely used to elicit health state preferences. However, additional information is required to transform values to a scale with dead valued at 0 and full health valued at 1. This paper presents DCE-VAS, an understandable and easy anchoring method with low participant burden based on the visual analogue scale (VAS). METHODS: Responses from 1450 members of the UK general public to a discrete choice experiment (DCE) were analysed using mixed logit models. Latent scale valuations were anchored to a full health = 1, dead = 0 scale using participants' VAS ratings of three states including the dead. The robustness of results was examined. This included a filtering procedure with the influence each individual respondent had on valuation being calculated, and those whose influence was more than two standard deviations away from the mean excluded. RESULTS: Coefficients in all models were in the expected direction and statistically significant. Excluding respondents who self-reported not understanding the VAS task did not significantly influence valuation, but excluding a small number who valued 33333 extremely low did. However, after eight respondents were removed via the filtering procedure, valuations were robust to removing other participants. CONCLUSION: DCE-VAS is a feasible way of anchoring DCE results to a 0-1 anchored scale with low additional respondent burden.

Decision regret in men living with and beyond nonmetastatic prostate cancer in the United Kingdom: A population-based patient-reported outcome study.

OBJECTIVE: Clinical options for managing nonmetastatic prostate cancer (PCa) vary. Each option has side effects associated with it, leading to difficulty in decision-making. This study aimed to assess the relationship between patient involvement in treatment decision-making and subsequent decision regret (DR), and quantify the impact of health-related quality of life (HRQL) outcomes on DR. METHODS: Men living in the United Kingdom, 18 to 42 months after diagnosis of PCa, were identified from cancer registration data and sent a questionnaire. Measures included the Decision Regret Scale (DRS), Expanded Prostate cancer Index Composite short form (EPIC-26), EQ-5D-5L, and an item on involvement in treatment decision-making. Multivariable ordinal regression was utilized, with DR categorized as none, mild, or moderate/severe regret. RESULTS: A total of 17 193 men with stage I-III PCa completed the DRS: 36.6% reported no regret, 43.3% mild regret, and 20.0% moderate/severe regret. The odds of reporting DR were greater if men indicated their views were not taken into account odds ratio ([OR] = 6.42, 95% CI: 5.39-7.64) or were involved "to some extent" in decision-making (OR = 4.63, 95% CI: 4.27-5.02), compared with men who were "definitely" involved. After adjustment, including for involvement, men reporting moderate/big problems with urinary, bowel, or sexual function were more likely to experience regret compared with men with no/small problems. Better HRQL scores were associated with lower levels of DR. CONCLUSIONS: This large-scale study demonstrates the benefit of patient involvement in treatment decision-making for nonmetastatic PCa. However, men experiencing side effects and poorer HRQL report greater DR. Promoting engagement in clinical decision-making represents good practice and may reduce the risk of subsequent regret.

Moving Towards Accountability for Reasonableness - A Systematic Exploration of the Features of Legitimate Healthcare Coverage Decision-Making Processes Using Rare Diseases and Regenerative Therapies as a Case Study.

BACKGROUND: The accountability for reasonableness (A4R) framework defines 4 conditions for legitimate healthcare coverage decision processes: Relevance, Publicity, Appeals, and Enforcement. The aim of this study was to reflect on how the diverse features of decision-making processes can be aligned with A4R conditions to guide decision-making towards legitimacy. Rare disease and regenerative therapies (RDRTs) pose special decision-making challenges and offer therefore a useful case study. METHODS: Features operationalizing each A4R condition as well as three different approaches to address these features (cost-per-QALY-focused and multicriteria-based) were defined and organized into a matrix. Seven experts explored these features during a panel run under the Chatham House Rule and provided general and RDRT-specific recommendations. Responses were analyzed to identify converging and diverging recommendations. RESULTS: Regarding Relevance, recommendations included supporting deliberation, stakeholder participation and grounding coverage decision criteria in normative and societal objectives. Thirteen of 17 proposed decision criteria were recommended by a majority of panelists. The usefulness of universal cost-effectiveness thresholds to inform allocative efficiency was challenged, particularly in the RDRT context. RDRTs raise specific issues that need to be considered; however, rarity should be viewed in relation to other aspects, such as disease severity and budget impact. Regarding Publicity, panelists recommended transparency about the values underlying a decision and value judgements used in selecting evidence. For Appeals, recommendations included a life-cycle approach with clear provisions for re-evaluations. For Enforcement, external quality reviews of decisions were recommended. CONCLUSION: Moving coverage decision-making processes towards enhanced legitimacy in general and in the RDRT context involves designing and refining approaches to support participation and deliberation, enhancing transparency, and allowing explicit consideration of multiple decision criteria that reflect normative and societal objectives.

Regional Variations in Quality of Survival Among Men with Prostate Cancer Across the United Kingdom.

BACKGROUND: Prostate cancer incidence, treatment, and survival rates vary throughout the UK, but little is known about regional differences in quality of survival. OBJECTIVE: To investigate variations in patient-reported outcomes between UK countries and English Cancer Alliances. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional postal survey of prostate cancer survivors diagnosed 18-42mo previously. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Urinary, bowel, and sexual problems and vitality were patient reported using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. General health was also self-assessed. Regional variations were identified using multivariable log-linear regression. RESULTS AND LIMITATIONS: A total of 35823 men responded, 60.8% of those invited. Self-assessed health was significantly lower than the UK average in Wales and Scotland. Respondents reported more urinary incontinence in Scotland, more urinary irritation/obstruction in Scotland and Northern Ireland (NI), poorer bowel function in Scotland and NI, worse sexual function in Scotland, and reduced vitality/hormonal function in Scotland, Wales, and NI. Self-assessed health was poorer than the English average in South Yorkshire and North-East and Cumbria, with more urinary incontinence in North-East and Cumbria and Peninsula, greater sexual problems in West Midlands, and poorer vitality in North-East and Cumbria and West Midlands. Limitations include difficulty identifying clinically significant differences and limited information on pretreatment conditions. CONCLUSIONS: Despite adjustment for treatment, and clinical and sociodemographic factors, quality of survival among prostate cancer survivors varied by area of residence. Adoption of best practice from areas performing well could support enhanced survival quality in poorer performing areas, particularly with regard to bowel problems and vitality, where clinically relevant differences were reported. PATIENT SUMMARY: We conducted a UK-wide survey of patient's quality of life after treatment for prostate cancer. Outcomes were found to vary depending upon where patients live. Different service providers need to ensure that all prostate cancer patients receive the same follow-up care.

EQ-5D-5L population norms and health inequalities for Trinidad and Tobago.

The EQ-5D instrument is now used in many health systems as a health outcomes measure. Recently an EQ-5D valuation study was conducted for Trinidad and Tobago, but thus far there have been no population norms published for Trinidad and Tobago or for any Caribbean country. The objective of this study is to provide a set of population norms, and to investigate inequalities in health in Trinidad and Tobago. The EQ-5D-5L questionnaire was included in the 2012/2013 Adult Population Survey of the Global Entrepreneurship Monitor for Trinidad and Tobago. This survey covered a representative sample of 2,036 adults aged 18 and over. Demographic data and self-reported health using EQ-5D-5L were collected. The Trinidad and Tobago value set was used to obtain EQ-5D index values. The Kakwani index and logistic regression models were used to evaluate inequalities in health. Mean EQ-5D index values and EQ-VAS values were calculated by age group, ethnicity, gender, income, educational attainment, employment status and place of residence. The 10 most commonly observed EQ-5D-5L states accounted for 90% of the respondents. The mean VAS value for the sample was 83.6 and the mean EQ-5D-5L index value was 0.95. Pain/discomfort was found to be the EQ-5D dimension with the highest prevalence of reported problems with 22% of the population reporting pain at any level. Self-care was the dimension with the lowest prevalence of problems reported at any level (3%). Health declines with increasing age, and men reported fewer problems and higher levels of self-reported health than women. Age, gender and education level were found to be important drivers of health status as measured by the EQ-5D instrument. Being in a very low income group was also observed to affect EQ-VAS values among younger respondents. The population norms provided in this study can be used by clinicians, academics and policy makers in several ways. They can be used in comparing different demographic groups or patient groups, or as a basis for tracking the progress of patients through a treatment regimen. They can also provide a baseline for cost utility analysis of health interventions for Trinidad and Tobago.