欧洲五维五水平量表在中国慢性乙型肝炎病毒感染者中的适用性调查

目的了解欧洲五维五水平量表（EQ-5D-5L）在中国慢性乙型肝炎（乙肝）病毒（Hepatitis B Virus,HBV）感染者中的适用性。方法采取整群抽样的方法,从山东省3家医院中连续调查HBV携带者、慢性乙肝（Chronic Hepatitis B,CHB）非活动期、CHB活动期、代偿性肝硬化（Compensated Cirrhosis,CC）、失代偿性肝硬化（Decompensated Cirrhosis,DC）和肝细胞癌（Hepatocellular Carcinoma,HCC）病人各至少100名。病人自填调查表。一周后对住院病人进行复查,询问医生了解病人病情的转归。采用日本模型获得不同病人的健康相关生命质量（Health-Related QualityofLife,HRQoL）,进行效度、信度、敏感度和响应度的评价,使用多重线性回归进行影响因素分析。结果初次调查645人,复查183人。HBV携带者、CHB非活动期、CHB活动期、CC、DC和HCC病人的HRQoL均数分别为0．813、0．808、0．771、0．763、0．699和0．661;除HBV携带者与CHB非活动期、CHB活动期与CC外,不同HBV感染状态HRQoL的差异均有统计学意义;除CHB非活动期外,其他HBV感染状态的HRQoL与视觉模拟标尺均有较高的相关性。对病情稳定的各类病人,前后两次调查HRQoL的差异无统计学意义,且组内相关系数较高;量表存在一定程度的天花板效应;对病情好转的各类病人,第二次调查的HRQoL均显著升高。结论EQ-5D-5L适用于我国慢性HBV感染人群,具有较好的效度、信度和响应度,但敏感度较低,对轻症病人有一定程度的天花板效应。     

Comparison of the PROMIS Preference Score (PROPr) and EQ-5D-5L Index Value in General Population Samples in the United Kingdom,France, and Germany

ObjectivesThe Patient-Reported Outcome Measurement Information System (PROMIS) Preference score (PROPr) can be used to assess health state utility (HSU) and estimate quality-adjusted life-years in cost-effectiveness analyses. It is based on item response theory and promises to overcome limitations of existing HSU scores such as ceiling effects. The PROPr contains 7 PROMIS domains: cognitive abilities, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities. We aimed to compare the PROPr with the 5-level EQ-5D (EQ-5D-5L) in terms of psychometric properties using data from 3 countries.MethodsWe collected PROMIS-29 profile and EQ-5D-5L data from 3 general population samples (United Kingdom = 1509, France = 1501, Germany = 1502). Given that cognition is not assessed by the PROMIS-29, it was predicted by the recommended linear regression model. We compared the convergent validity, known-groups construct validity, and ceiling and floor effects of the PROPr and EQ-5D-5L.ResultsThe mean PROPr (0.48, 0.53, 0.48; P<.01) and EQ-5D-5L scores (0.82, 0.85, 0.83; P<.01) showed significant differences of similar magnitudes (d = 0.34; d = 0.32; d = 0.35; P<.01) across all samples. The differences were invariant to sex, income, occupation, education, and most conditions but not for age. The Pearson correlation coefficients between both scores were r = 0.74, r = 0.69, and r = 0.72. PROPr’s ceiling and floor effects both were minor to moderate. The EQ-5D-5L’s ceiling (floor) effects were major (negligible).ConclusionsBoth the EQ-5D-5L and the PROPr assessed by the PROMIS-29 show high validity. The PROPr yields considerably lower HSU values than the EQ-5D-5L. Consequences for quality-adjusted life-year measurements should be investigated in future research.     

Quebec Health-Related Quality-of-Life Population Norms Using the EQ-5D-5L: Decomposition by Sociodemographic Data and Health Problems

ObjectivesPopulation norms for the EQ-5D-5L were published in Canada but only for Alberta province. The purpose of this study was to derive Quebec population norms from the EQ-5D-5L.MethodsThe data came from a larger study conducted between September 2016 and March 2018 using elicitation techniques for a quality-adjusted life-year project. The online survey was distributed randomly in the province of Quebec. To best describe the entire population, data were stratified by various sociodemographic characteristics such as age, gender, urban and rural populations, whether disadvantaged or not, immigrant or nonimmigrant, and health problems.ResultsA total of 2704 (53.8%) respondents completed the EQ-5D-5L. Mean (95% confidence interval) and median (interquartile range) utility scores were 0.824 (0.818-0.829) and 0.867 (0.802-0.911), respectively. The EQ-VAS scores were estimated at 75.9 (75.2-76.6) and 80 (69-90). Subjects with lower scores were those who had a low or high body mass index; were smokers; were single, divorced, or widowed; had no children; were unemployed or sick; had lower education or lower annual income; and had a family or personal history of serious illness. Immigrants had higher scores. There was no difference in gender and urban or rural population. The score logically decreased with worsening health status, from a mean score of 0.896 (0.884-0.908) to 0.443 (0.384-0.501; P < .0001. Similar results were observed for subjects’ satisfaction with their health or life. Subjects with lower scores were less willing to take risks. Subjects who declared they were affected by health problems presented significant lower utility scores, ranging from 0.554 (nervous problem) to 0.750 (cancer), compared with those without health problems (0.871; confidence interval: 0.867-0.876).ConclusionThis is the first study to present utility score norms for EQ-5D-5L for the Quebec population. These results will be useful for comparison with quality-adjusted life-year studies to better interpret their results. Moreover, utility norms were provided for 21 health problems, which was rarely done.     

Less Is More: Cross-Validation Testing of Simplified Nonlinear Regression Model Specifications for EQ-5D-5L Health State Values

Background

The conventional method for modeling of the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) health state values in national valuation studies is an additive 20-parameter main-effects regression model. Statistical models with many parameters are at increased risk of overfitting—fitting to noise and measurement error, rather than the underlying relationship.

An Experience-Based Value Set for the EQ-5D-5L in Germany

Objective

Valuation of health states provides a summary measure useful to health care decision makers. Results may depend on whether the currently experienced health state or a hypothetical health state is being evaluated. This study derives a value set for the EuroQoL Five-Dimensional Five-Level Questionnaire (EQ-5D-5L) by focusing on the individual’s current experience.

Acceptability and Validity of the EQ-5D in Patients Living With Dementia

ObjectivesTo assess the acceptability and validity of the 3 levels of the EQ-5D (EQ-5D-3L) compared with the Quality of Life in Alzheimer’s Diseases (QoL-AD) in patients living with dementia.MethodsThe analysis was based on 560 dyads of persons with dementia and their caregivers of the multicenter observational study of dementia care networks in Germany (DemNet-D). Health-related quality of life was assessed by face-to-face interviews using the EQ-5D-3L (self-rating) and the QoL-AD (self- and proxy-rating). The number of missing values, the score ranges (observed vs possible range) and the floor and ceiling effects were used to assess the acceptability. We used one-way analyses of variance and multivariate linear regression models to evaluate the discriminative ability. The convergent validity was assessed using Spearman's correlation coefficient (r_s) and multivariate regression models.ResultsThe EQ-5D index had a higher response rate (89% vs 84%) and a comparable floor (>1%) but a higher ceiling effect (18% vs >1%) compared with the QoL-AD. Both measures can significantly differentiate between different stages of general health, instrumental activities of daily living, and depression. The EQ-5D index and the visual analog scale self-rating scores strongly correlated with the QoL-AD self-rating (r_s = 0.644 and 0.553, respectively) but not with the proxy-rating score (r_s = 0.314 and r_s = 0.170, respectively), which was confirmed by multivariate regression analyses.ConclusionThe results satisfy acceptability, discriminative ability, and convergent validity for moderately cognitively and functionally impaired patients living with dementia. The EQ-5D-3L performed comparably with the QoL-AD, and could, therefore, be used in economic evaluations in dementia. The differences between self- and proxy-ratings should be evaluated and considered in the interpretation of health-related quality of life scores.     

A Program of Methodological Research to Arrive at the New International EQ-5D-5L Valuation Protocol

ObjectivesTo describe the research that has been undertaken by the EuroQol Group to improve current methods for health state valuation, to summarize the results of an extensive international pilot program, and to outline the key elements of the five-level EuroQol five-dimensional (EQ-5D-5L) questionnaire valuation protocol, which is the culmination of that work.MethodsTo improve on methods of health state valuation for the EQ-5D-5L questionnaire, we investigated the performance of different variants of time trade-off and discrete choice tasks in a multinational setting. We also investigated the effect of three modes of administration on health state valuation: group interviews, online self-completion, and face-to-face interviews.ResultsThe research program provided the basis for the EQ-5D-5L questionnaire valuation protocol. Two different types of tasks are included to derive preferences: a newly developed composite time trade-off task and a forced-choice paired comparisons discrete choice task. Furthermore, standardized blocked designs for the selection of the states to be valued by participants were created and implemented together with all other elements of the valuation protocol in a digital aid, the EuroQol Valuation Technology, which was developed in conjunction with the protocol.ConclusionsThe EuroQol Group has developed a standard protocol, with accompanying digital aid and interviewer training materials, that can be used to create value sets for the EQ-5D-5L questionnaire. The use of a well-described, consistent protocol across all countries enhances the comparability of value sets between countries, and allows the exploration of the influence of cultural and other factors on health state values.     

The Impact of Differences between Patient and General Population EQ-5D-3L Values on the Mean Tariff Scores of Different Patient Groups

BackgroundHealth states can be valued by those who currently experience a health state (experienced health states [EHS]) or by the general public, who value a set of given health states (GHS) described to them. There has been debate over which method is more appropriate when making resource allocation decisions.ObjectiveThis article informs this debate by assessing whether differences between these methods have an effect on the mean EQ-5D-3L tariff scores of different patient groups.MethodsThe European tariff based on GHS valuations was compared with a German EHS tariff. Comparison was made in the context of EQ-5D-3L health states describing a number of diagnosed chronic diseases (stroke, diabetes, myocardial infarction, and cancer) taken from the Cooperative Health Research in the Augsburg Region population surveys. Comparison was made of both the difference in weighting of the dimensions of the EQ-5D-3L and differences in mean tariff scores for patient groups.ResultsWeighting of the dimensions of the EQ-5D-3L were found to be systematically different. The EHS tariff gave significantly lower mean scores for most, but not all, patient groups despite tariff scores being lower for 213 of 243 EQ-5D-3L health states using the GHS tariff. Differences were found to vary between groups, with the largest change in difference being 5.45 in the multiple stoke group.ConclusionsThe two tariffs have systematic differences that in certain patient groups could drive the results of an economic evaluation. Therefore, the choice as to which is used may be critical when making resource allocation decisions.     

基于EQ-5D-3L和ICECAP-A量表的我国普通人群生命质量研究

目的:分析EQ-5D-3L和ICECAP-A量表评价我国普通人群生命质量的差异以及对干预方案价值评价的影响,为研究者选择合适的生命质量测量工具提供参考。方法:采用配额抽样选取802名受访者进行生命质量评价,并分别采用因子分析、多分格相关性和Bland-Altman plot一致性分析等方法探讨两量表测量结果的差异。结果:Wilcoxon秩和检验表明EQ-5D-3L量表的健康效用均值高于ICECAP-A量表的测量结果;ICECAP-A量表五个维度均主要加载于反映社会心理健康的因子1,而EQ-5D-3L量表的大部分维度主要加载于反映生理健康的因子2。部分维度之间也存在显著的相关性,但均较弱。两量表效用值的ICC为0.32,一致性分析显示5.74%的受访者超出了95%的一致性界限。结论:前者的测量内涵是健康相关生命质量,而后者则反映的是幸福感、可行能力等更广义的生命质量,其对于旨在提升公众广义幸福感和社会福祉的干预措施效果评估方面具有较好的适用性。研究者可根据测量目的及量表属性选择合适的量表,鉴于两个量表在测量内涵中的互补性,也可以在研究中同时采用两种量表以便更全面地反映干预措施的效果或受访者的生命质量。     

Estimating Health-State Utility Values in Kidney Transplant Recipients and Waiting-List Patients Using the EQ-5D-5L

Objectives

To report health-state utility values measured using the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) in a large sample of patients with end-stage renal disease and to explore how these values vary in relation to patient characteristics and treatment factors.

An International Comparison of EQ-5D-5L and EQ-5D-3L for Use in Cost-Effectiveness Analysis

ObjectivesTo estimate the impact of using EQ5D-5L (5L) compared with EQ5D-3L (3L) in cost-effectiveness analyses in 6 countries with 3L and 5L values: Germany, Japan, Korea, The Netherlands, China, and Spain.MethodsEight cost-effectiveness analyses based on clinical studies with 3L provided 11 pairwise comparisons. We estimated cost-effectiveness by applying the appropriate country values for 3L to observed responses. We re-estimated cost-effectiveness for each country by predicting the 5L tariff score for each respondent, for each country, using a previously published mapping method. We compared results in terms of impact on estimated incremental quality-adjusted life-year (QALY) gain and cost-effectiveness ratios.ResultsFor most countries the impact of moving from 3L to 5L is to lower the incremental QALY gain in the majority of comparisons. The only exception to this was Japan, where 4 out of 11 cases (37%) saw lower QALYs gained when using 5L. The mean and median reductions in health gain, in those case studies where 5L does lead to lower health gain, are largest in The Netherlands (84% mean reduction, 41% median reduction), Germany (68% and 27%), and Spain (30% and 31%). For most countries, those studies where 5L leads to lower health gain see larger reductions than the gains in studies showing the opposite tendency.ConclusionsOverall, 3L and 5L are not interchangeable in these countries. Differences between results are large, but the direction of change can be unpredictable. These findings should prompt further investigation into the reasons for differences.     

A Direct Comparison of the Measurement Properties of EQ-5D-5L,PROMIS-29+2 and PROMIS Global Health Instruments and EQ-5D-5L and PROPr Utilities in a General Population Sample

ObjectivesWe aimed to compare measurement properties of the 5-level version of EQ-5D (EQ-5D-5L) and 2 Patient-Reported Outcomes Measurement Information System (PROMIS) short forms, PROMIS-29+2 and PROMIS Global Health (PROMIS-GH-10), and of EQ-5D-5L and PROMIS-preference scoring system (PROPr) utilities.MethodsA cross-sectional survey was conducted in a general population sample in Hungary (N = 1631). We compared the following measurement properties at the level of items, domains, and utilities, the latter using corresponding US value sets: ceiling and floor, informativity (Shannon’s indices), agreement, convergent, and known-group validity. For the analyses, PROMIS items/domains were matched to EQ-5D-5L domains that cover similar concepts of health.ResultsThe majority of PROMIS items showed enhanced distributional characteristics, including lower ceilings and higher informativity than the EQ-5D-5L. Good convergent validity was established between EQ-5D-5L and PROMIS domains capturing similar aspects of health. Mean EQ-5D-5L utilities were substantially higher than those of PROPr (0.864 vs 0.535). EQ-5D-5L utilities correlated moderately or strongly with PROPr (r = 0.61), PROMIS-GH-10 physical (r = 0.68), and mental health summary scores (r = 0.53). EQ-5D-5L utilities decreased with age, whereas PROPr utilities slightly increased with age. EQ-5D-5L utilities discriminated significantly better in 12/28 (ratio of F-statistics) and 18/26 (area under the receiver-operating characteristics curve ratio) known groups defined by age, self-perceived health status, and self-reported physician-diagnosed health conditions, including hypertension, diabetes, coronary heart disease, chronic kidney disease, and stroke.ConclusionsThis study provides comparative evidence on the measurement properties of EQ-5D-5L, PROMIS-29+2, and PROMIS-GH-10 and informs decisions about the choice of instruments in population health surveys for assessment of patients’ health and for cost-utility analyses.     

Why Do Patients with Inflammatory Arthritis Often Score States “Worse than Death” on the EQ-5D? An Investigation of the EQ-5D Classification System

Objective:  Using inflammatory arthritis patients as an example, we investigate EuroQol-5D (EQ-5D) profiles resulting in states worse than death (WTD), and the heath status of patients occupying these states.
Methods:  Baseline data from two UK trials were used that reflected the range of arthritis states/severity found in routine practice. EQ-5D profiles resulting in negative valuations (i.e., states WTD) based on UK weights were identified. EQ-5D scores for these profiles from alternative valuation sets, including a reanalysis of the UK weights, were compared. The health status and characteristics of patients, and factors associated with patients in the low distribution of the EQ-5D and those with WTD EQ-5D scores were identified.
Results:  Seven hundred patients were included in the analysis. Sixty-two (9%) patients occupied states WTD. Patients occupied 9 of the possible 84health profiles with negative scores (53% occupied one profile); this profile was not rated WTD by any of the alternative EQ-5D scoring algorithms. All WTD profiles included severe pain/discomfort plus moderate problems in ≥3 other domains. Patients with WTD valuations reported higher levels of pain, and feeling downhearted and low on alternative health status measures.
Conclusions:  Pain was the predominant factor in the WTD EQ-5D profiles occupied by arthritis patients. Patients occupying states WTD have poorer health-related quality of life than patients in low "better than death" states. Valuations of profiles vary according to how sets of preference weights for health profiles were developed. Further research should explore whether WTD valuations are supported by qualitative evidence and reflect the patient's health and experience of disease.     

An Assessment of the Impact of Informative Dropout and Nonresponse in Measuring Health-Related Quality of Life Using the EuroQol (EQ-5D) Descriptive System

OBJECTIVES: To investigate the impact of imputing EQ-5D values to allow for informative dropout and nonresponse in a longitudinal assessment of the health-related quality of life (HRQL) of liver transplant recipients. METHODS: The EQ-5D was administered at defined time intervals pre- and post-transplantation to all adults who were listed to receive liver transplants as National Health Service (NHS) treatment at each of the six Department of Health designated centers in England and Wales over a time-period of 36 months (12 month recruitment period and 24 month follow-up period). During the course of the study missing data arose for two main reasons, informative dropout and nonresponse. Informative dropout was accounted for by giving those patients who died an EQ-5D score of 0 and those patients who were too ill to respond to an EQ-5D score equivalent to the 5th percentile of respondents for each time point pretransplantation. Nonresponse was accounted for using relatively naive approaches (last value carried forward, and upper/lower 95% confidence interval around the mean) and contrasted with a more sophisticated multiple imputation method. RESULTS: Adjusting for informative dropout in isolation resulted in a marked deterioration in mean scores over time pretransplant relative to the base case situation in which no such adjustments were made. Nevertheless, adjusting for informative dropout and/or nonresponders did not alter the base case conclusion of no statistically significant differences in mean EQ-5D scores over time pretransplant. In contrast, post-transplant data indicated highly statistically significant improvements in quality of life over time for the base case (P < 0.001) whereas no statistically significant improvements over time were found when informative dropout was allowed for in isolation (P = 0.402) or when informative dropout and nonresponse were allowed for simultaneously (P = 0.105-0.185). CONCLUSIONS: It is important that future studies which purport to assess the HRQL over time of patients, such as these with end-stage liver disease, include an allowance for informative dropout and nonresponse within the analysis.     

Measurement of HRQL Using EQ-5D in Patients with Type 2 Diabetes Mellitus in Japan

OBJECTIVES: We measured the health-related quality of life (HRQL) of diabetes mellitus patients using the Japanese version of EQ-5D, and examined the relationship between clinical condition and health status. METHODS: A study was conducted on 220 patients with type 2 diabetes mellitus at a hospital in Saitama Prefecture on the day of their visit from November 17 to December 24, 1998. Patients evaluated their health status using five dimensions (5D) and a visual analog scale (VAS). The EQ-5D score was calculated based on the 5D responses using the Japanese version of the value set. RESULTS: There were no responses of "extreme problem." The frequency of "some problem" was significantly higher in patients with complications than in those without for mobility (27.4% and 14.4%) and anxiety/depression (25.7% and 13.5%). The mean EQ-5D score was 0.846 (95% confidence interval [CI] 0.817-0.874) in patients with complications versus 0.884 (95% CI 0.855-0.914) in those without complications. There was no statistically significant difference between VAS scores according to the presence or absence of diabetic complications, but a significant difference in VAS scores was seen according to the presence or absence of retinopathy. CONCLUSION: These findings suggest the value of measuring health status in diabetes mellitus patients, because it is able to comprehensively evaluate the patient's health condition, and add another dimension to the subjective symptoms and laboratory data.