The EQ-5D-5L health status questionnaire in COPD: validity, responsiveness and minimum important difference.
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ABSTRACT:
SUBMITTER: Nolan CM
PROVIDER: S-EPMC4893131 | biostudies-other | 2016 Jun
REPOSITORIES: biostudies-other
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Project description:BackgroundPatient-reported outcomes (PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ) in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM).MethodsPatients were > or = 40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1-7 and 42. A Global Rating of Change (GRC) assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis.Results210 patients were recruited, 168 completed the CCQ questionnaire on Day 42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21.ConclusionThis investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4.
| S-EPMC1508149 | biostudies-literature
Project description:BackgroundThe EQ-5D is a generic questionnaire which generates a health profile as well as index scores for health-related quality of life that may be used in cost-utility analysis.Aims of the studyTo examine validity and responsiveness of the EQ-5D in patients with anxiety disorders.Methods389 patients with anxiety disorders completed the EQ-5D at baseline and 6-month follow-up. Subjective measures of quality of life (WHOQOL-BREF) and psychopathology (BAI, BDI-II, BSQ, ACQ, MI) were used for comparison. Validity was analyzed by assessing associations between EQ-5D scores and related other scores. Responsiveness was analyzed by calculating effect sizes of differences in scores between baseline and follow-up for 3 groups indicating more, constant or less anxiety. Meaningful difference scores for shifting to less or more anxiety were derived by means of regression analysis.Results88.4% of respondents reported problems in at least one of the EQ-5D dimension at baseline; the mean EQ VAS score was 63.8. The EQ-5D dimension most consistently associated with the measures used for comparison was 'anxiety/depression'. EQ VAS and EQ-5D index scores were highly correlated (|r|>0.5) with scores of the WHOQOL-BREF dimensions 'physical', 'mental' and 'overall' as well as BAI and BDI-II. The EQ-5D index tended to be the most responsive score. Standardized meaningful difference scores were not significantly different between EQ VAS, EQ-5D index and measures used for comparison.ConclusionsThe EQ-5D seems to be reasonably valid and moderately responsive in patients with anxiety disorders. The EQ-5D index may be suitable for calculating QALYs in economic evaluation of health care interventions for patients with anxiety disorders.Trial registrationCurrent Controlled Trials ISRCTN15716049.
| S-EPMC2873595 | biostudies-literature
Project description:BackgroundThe discriminatory ability of multi-attribute utility (MAU) measures compared to condition-specific measures (CSM) in assessing health-related quality of life (HRQoL) among patients with chronic obstructive pulmonary disease (COPD) is an unsettled issue. This study investigated the quality of life of patients with COPD with three different HRQoL instruments and examined whether they could differentiate between adjacent severity groups in a statistically and clinically meaningful manner. In the process, the minimal clinically important differences (MCID) of the EQ-5D utility index were estimated.MethodsCross-sectional survey data were collected from patients with mild to very severe COPD in South Korea. In addition to demographic and clinical information, the following HRQoL questionnaires were used: The three-level five-dimensional Euro-Quality of Life tool (EQ-5D-3L), the EQ-Visual Analog Scale (EQ-VAS), and the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Patients' health-related quality of life was analyzed with reference to severity groups based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. To investigate the discriminatory ability of the HRQoL instruments between COPD severity groups, tests examining variance, covariance, and standardized mean difference were performed. After estimating the MCID of the EQ-5D utility index using the anchor-based method, we investigated whether the differences in the EQ-5D utility scores between groups exceeded the clinically meaningful minimum level.ResultsA total of 298 patients completed this study. All the quality of life scores showed statistically significant differences between the GOLD severity groups. The pooled MCID estimate for the EQ-5D utility index was 0.028 (range: 0.017-0.033). Even after adjusting for other factors affecting quality of life, the EQ-5D utility index differentiated the GOLD groups well.ConclusionsWe conclude that the EQ-5D utility index is a valid instrument for measuring the quality of life of patients with COPD, and the pooled MCID estimate for the EQ-5D utility index was 0.028.
| S-EPMC7092534 | biostudies-literature
Project description:Assessments of health-related quality of life and particularly utility values are important components of health economic analyses. Several instruments have been developed to measure utilities. However no consensus has emerged regarding the most appropriate instrument within a therapeutic area such as chronic pain. The study compared two instruments - EQ-5D and SF-6D - for their performance and validity in patients with chronic pain.Pooled data from three randomised, controlled clinical trials with two active treatment groups were used. The included patients suffered from osteoarthritis knee pain or low back pain. Differences between the utility measures were compared in terms of mean values at baseline and endpoint, Bland-Altman analysis, correlation between the dimensions, construct validity, and responsiveness.The analysis included 1977 patients, most with severe pain on the Numeric Rating Scale. The EQ-5D showed a greater mean change from baseline to endpoint compared with the SF-6D (0.43 to 0.58 versus 0.59 to 0.64). Bland-Altman analysis suggested the difference between two measures depended on the health status of a patient. Spearmans rank correlation showed moderate correlation between EQ-5D and SF-6D dimensions. Construct validity showed both instruments could differentiate between patient subgroups with different severities of adverse events and analgesic efficacies but larger differences were detected with the EQ-5D. Similarly, when anchoring the measures to a disease-specific questionnaire - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - both questionnaires could differentiate between WOMAC severity levels but the EQ-5D showed greater differences. Responsiveness was also higher with the EQ-5D and for the subgroups in which improvements in health status were expected or when WOMAC severity level was reduced the improvements with EQ-5D were higher than with SF-6D.This analysis showed that the mean EQ-5D scores were lower than mean SF-6D scores in patients with chronic pain. EQ-5D seemed to have higher construct validity and responsiveness in these patients.
| S-EPMC3722016 | biostudies-literature
Project description:PurposeMeasuring quality of life in acute asthmatics is challenging, especially when asthma attacks can occur sporadically. Several questionnaires can be used to measure quality of life in this patient group; however, psychometric testing is limited on questionnaires that can be used to estimate Quality Adjusted Life years. The objective of this study is to assess the construct validity (convergent and discriminative validity) and responsiveness of the EuroQol-5-Dimensions 5-Level (EQ-5D-5L), Asthma Quality of Life Utility Index-5 Dimensions (AQL-5D) and Time Trade-Off (TTO) in acute asthma patients.MethodsData from a prospective cohort study were used to test the validity and responsiveness of the EQ-5D-5L, AQL-5D and TTO in asthma patients who were recruited from UK accident & emergency departments or hospital wards. The spearman's rank correlation coefficient, the Kruskal-Wallis test statistic and the standardized response mean were used to test for convergent validity, discriminative validity and responsiveness, respectively.ResultsOne hundred and twenty-one participants were included in the available case analysis. The EQ-5D-5L and AQL-5D showed moderate to strong correlations for convergent validity at baseline, week 4 and week 8. The AQL-5D and TTO showed moderate correlations at week 4 and week 8. No statistical significance was observed for discriminative validity at baseline. Both the EQ-5D-5L and the AQL-5D also showed that they were sensitive to change for the recovery responses.ConclusionsThe EQ-5D-5L and AQL-5D showed stronger construct validity and responsiveness compared to the TTO. Therefore, both the EQ-5D-5L and AQL-5D should be considered for use in future economic evaluations.
| S-EPMC7028833 | biostudies-literature
Project description:PurposeThe aim was to investigate the measurement properties of the EQ-5D-5L utility index in patients after arthroscopic rotator cuff repair (RCR), total shoulder arthroplasty (TSA) or thumb carpometacarpal (CMC I) arthroplasty.MethodsIn this prospective study, all patients completed the EQ-5D-5L before surgery and 6 months and 1 year after surgery. In addition, RCR patients completed the Oxford Shoulder Score (OSS), TSA patients completed the Shoulder Pain and Disability Index (SPADI) and CMC I patients completed the brief Michigan Hand Outcomes Questionnaire (brief MHQ) at each designated time point. Construct validity (Pearson's correlation coefficient, r), responsiveness (effect size), minimal important difference (MID), minimal important change (MIC), and floor and ceiling effects of the EQ-5D-5L were determined. To test discriminative ability, EQ-5D-5L utility indices of patients who were in a patient acceptable symptom state (PASS) or not at follow-up were compared using the Mann-Whitney U test.ResultsWe included 153 RCR, 150 TSA, and 151 CMC I patients. The EQ-5D-5L utility index correlated with the OSS (r = 0.73), SPADI (r = - 0.65) and brief MHQ (r = 0.61). The effect sizes were 1.3 (RCR and CMC I group) and 1.1 (TSA). The MID and MIC ranged from 0.027 to 0.209. Ceiling effects were found. The EQ-5D-5L utility index differed significantly between patients being in a PASS versus patients who were not in a PASS.ConclusionThe EQ-5D-5L utility index shows good construct validity, responsiveness and discriminative ability in patients after arthroscopic RCR, TSA and CMC I arthroplasty and is suitable to quantify quality of life.Clinical trial registrationThis auxiliary analysis is part of a primary study that was originally registered at ClinicalTrials.gov (NCT01954433) on October 1, 2013.
| S-EPMC8481200 | biostudies-literature
Project description:To evaluate the internal consistency, validity, responsiveness, and minimal important difference of the Functional Status Score for the ICU, a physical function measure designed for the ICU.Clinimetric analysis.Five international datasets from the United States, Australia, and Brazil.Eight hundred nineteen ICU patients.None.Clinimetric analyses were initially conducted separately for each data source and time point to examine generalizability of findings, with pooled analyses performed thereafter to increase power of analyses. The Functional Status Score for the ICU demonstrated good to excellent internal consistency. There was good convergent and discriminant validity, with significant and positive correlations (r = 0.30-0.95) between Functional Status Score for the ICU and other physical function measures, and generally weaker correlations with nonphysical measures (|r| = 0.01-0.70). Known group validity was demonstrated by significantly higher Functional Status Score for the ICU scores among patients without ICU-acquired weakness (Medical Research Council sum score, ? 48 vs < 48) and with hospital discharge to home (vs healthcare facility). Functional Status Score for the ICU at ICU discharge predicted post-ICU hospital length of stay and discharge location. Responsiveness was supported via increased Functional Status Score for the ICU scores with improvements in muscle strength. Distribution-based methods indicated a minimal important difference of 2.0-5.0.The Functional Status Score for the ICU has good internal consistency and is a valid and responsive measure of physical function for ICU patients. The estimated minimal important difference can be used in sample size calculations and in interpreting studies comparing the physical function of groups of ICU patients.
| S-EPMC5292321 | biostudies-literature
Project description:BACKGROUND: Patients with transient loss of consciousness (TLOC) have poor health-related quality of life (HR-QoL). OBJECTIVE: To test the reliability, validity, and responsiveness of the disease-specific Syncope Functional Status HR-QoL Questionnaire (SFSQ), which yields two summary scales--impairment score (IS) and fear-worry score (FWS). DESIGN: Cohort-study. PARTICIPANTS: 503 adult patients presenting with TLOC. MEASUREMENTS: HR-QoL was assessed using the SFSQ and the Short Form-36 (SF-36) after presentation and 1 year later. To test reliability, score distributions, internal consistency, and test-retest reliability were assessed. To assess validity, scores on the SFSQ and the SF-36 were compared. Clinical validity was tested using known-group comparison. Responsiveness was assessed by comparing changes in SFSQ scores with changes in health status and clinical condition. RESULTS: Response rate was 82% at baseline and 72% at 1-year follow-up. For all scales the full range of scores was seen. Score distributions were asymmetrical. Internal consistency was high (alpha = 0.88 for IS, 0.92 for FWS). Test-retest reliability was moderate to good for individual items and high for summary scales (inter-class correlation = 0.78 for both IS and FWS). Correlations between SFSQ scores and the SF-36 were modest. The SFSQ did not discriminate between patients differing in age and gender but did discriminate between patients differing in number of episodes and comorbid conditions. Changes in SFSQ scores were related to changes in health status and the presence of recurrences but did not vary by TLOC diagnosis. CONCLUSION: The SFSQ is an adequately reliable, valid, and responsive measure to assess HR-QoL in patients with TLOC.
| S-EPMC2039793 | biostudies-other
Project description:EQ-5D is a 5-item questionnaire instrument designed to measure health-related quality of life. It is extremely important, since it is used to measure health benefits in many studies providing evidence for reimbursement decisions by the National Institute for Health and Care Excellence in England and similar policy bodies in other countries. EQ-5D has been redesigned in a more detailed form (EQ-5D-5L), but much existing cost-effectiveness evidence is based on the older version (EQ-5D-3L). Statistical mapping from one version to another is widely used, exploiting data from multi-instrument surveys incorporating both variants. However, little is known about the robustness of data from such multi-instrument surveys. We design a randomized experiment to investigate whether inclusion of both versions at different stages in a single interview gives a reliable picture of the relationship between health measures from the two instruments and embed it in individual interviews from the UK Understanding Society household panel. We find that sequencing of the two versions of EQ-5D within an interview has a significant impact not only on the resulting data but also on the estimated mapping models. We illustrate the non-negligible effects in two real-world cost-effectiveness examples and discuss the implications for future multi-instrument survey design.
| S-EPMC9303872 | biostudies-literature
Project description:PurposeGeneric health measures have been questioned for quantifying mental-health-related outcomes. In patients with anxiety and/or depression, our aim is to assess the psychometric properties of the preference-based EQ-5D-5L (generic health) and ReQoL-UI (recovery-focussed quality of life) for economic evaluation against the PHQ-9 (depression) and GAD-7 (anxiety). EQ-5D-5L anxiety/depression item and ReQoL-10 are also assessed.MethodsA 2:1 (intervention: control) randomised controlled trial collected measures at baseline and 8 weeks post baseline; in the intervention arm, data were also collected 3, 6, 9, and 12-months post baseline. EQ-5D-5L preference-based scores were obtained from the value set for England (VSE) and 'cross-walked' EQ-5D-3L United Kingdom (UK) value set scores. ReQoL-UI preference-based scores were obtained from its UK value set as applied to seven ReQoL-10 items. EQ-5D-5L and ReQoL measures' construct validity and responsiveness were assessed compared against PHQ-9 and GAD-7 scores and group cut-offs.Results361 people were randomised to intervention (241) or control (120). ReQoL-UI/-10 had better construct validity with depression severity than the EQ-5D-5L (VSE/cross-walk scores), which had relatively better construct validity with anxiety severity than the ReQoL-UI/-10. Across all intervention-arm time-points relative to baseline, responsiveness was generally better for EQ-5D-5L (VSE in particular) than ReQoL-UI, but worse than ReQoL-10.ConclusionThere is insufficient evidence to recommend the ReQoL-UI over EQ-5D-5L for economic evaluations to capture anxiety severity. However, there may be rationale for recommending the ReQoL-UI over the EQ-5D-5L to capture depression severity given its better construct validity, albeit poorer responsiveness, and if recovery-focussed quality of life relative to condition-specific symptomology is the construct of interest.
| S-EPMC8034045 | biostudies-literature