Abstract

BackgroundThe aim of this study was to assess the psychometric properties, namely acceptability, validity, reliability, interpretability and responsiveness of the EuroQol EQ-5D (EQ-5D visual analogue (VAS) and EQ-5D (utility)), Short Form 12 Dimensions (SF-12), SF-6D and Michigan Hand Outcome Questionnaire (MHQ) in patients with rheumatoid arthritis (RA) of the hand.MethodsThe empirical investigation was based upon data from a randomised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the hands and/or wrists. Participants completed the EQ-5D, SF-12 and MHQ at baseline and at 4 and 12 months follow up. Acceptability was measured using completion rates over time; construct validity using the “known groups” approach, based on pain troublesomeness; convergent validity using spearman’s rho correlation (ρ); reliability using internal consistency (Cronbach’s alpha); interpretability using minimal important differences (MID); and responsiveness using effect sizes and standardised response means (SRM) stratified by level of self-rated improvement in hand and wrist function or level of self-rated benefit and satisfaction from trial treatments.ResultsAt baseline, the study population had a mean age of 62.4 years, a mean MHQ score of 52.1 and included 76% women. The EQ-5D (utility) had the highest completion rates across time points. All instruments discriminated between pre-specified groups based on pain troublesomeness. Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D (ρ = 0.65) and SF-6D (ρ = 0.63) utility scores. The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months, whilst minimal important differences varied considerably across PROMs.ConclusionsThe instruments evaluated in this study displayed varying psychometric properties in the context of RA of the hand. The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.

Highlights

  • The aim of this study was to assess the psychometric properties, namely acceptability, validity, reliability, interpretability and responsiveness of the EuroQol EQ-5D (EQ-5D visual analogue (VAS) and EQ-5D), Short Form 12 Dimensions (SF-12), Short Form 6 Dimensions (SF-6D) and Michigan Hand Outcome Questionnaire (MHQ) in patients with rheumatoid arthritis (RA) of the hand

  • The main advantages of generic preference-based Patient reported outcome measures (PROMs) are their ease of administration and high rate of completion, the generalizability of their results and their ability to meet the requirements of decision-making bodies, such as the National Institute for Health and Care Excellence (NICE) in England and Wales, concerned with costeffectiveness comparisons [6]

  • This finding is not in line with the study by Marra et al [9], which found that of the Health Utilities Index 2 and 3 (HUI2, HUI3), EQ-5D, SF-6D, RA Quality of Life Questionnaire (RAQoL) and the Health Assessment Questionnaire (HAQ) only EQ-5D and SF-6D scores significantly differed by level of RA severity

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Summary

Introduction

The aim of this study was to assess the psychometric properties, namely acceptability, validity, reliability, interpretability and responsiveness of the EuroQol EQ-5D (EQ-5D visual analogue (VAS) and EQ-5D (utility)) , Short Form 12 Dimensions (SF-12), SF-6D and Michigan Hand Outcome Questionnaire (MHQ) in patients with rheumatoid arthritis (RA) of the hand. A report by the National Rheumatoid Arthritis Society (NRAS) in 2010 found that the overall cost of RA to the UK economy was almost £8 billion per annum with National Health Service (NHS) expenditure totalling approximately £700 million per annum [3]. Patient reported outcome measures (PROMs) are increasingly used to measure health-related quality of life (HRQoL) from the patient perspective. PROMs have increasingly been used in randomised controlled trials (RCTs) and other evaluative studies to measure the benefits of interventions in terms of health status or HRQoL. The main advantages of generic preference-based PROMs are their ease of administration and high rate of completion, the generalizability of their results and their ability to meet the requirements of decision-making bodies, such as the National Institute for Health and Care Excellence (NICE) in England and Wales, concerned with costeffectiveness comparisons [6]. Given the increasing diffusion of PROMS within evaluative research and the increasing use of the outputs of preference-based outcome measures within decisionmaking processes, it is important to establish the relative merits of alternative PROMS in specific clinical and research contexts

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