Abstract

BackgroundThe EQ-5D is frequently used to derive utilities for patients with type 2 diabetes (T2D). Despite widely available quantitative psychometric data on the EQ-5D, little is known about content validity in this population. Thus, the purpose of this qualitative study was to examine content validity of the EQ-5D in patients with T2D.MethodsPatients with T2D in the UK completed concept elicitation interviews, followed by administration of the EQ-5D-5L and cognitive interviewing focused on the instrument’s relevance, clarity, and comprehensiveness.ResultsA total of 25 participants completed interviews (52.0 % male; mean age = 53.5 years). Approximately half (52 %) reported that the EQ-5D-5L was relevant to their experience with T2D. When asked if each individual item was relevant to their experience with T2D, responses varied widely (24.0 % said the self-care item was relevant; 68.0 % said the anxiety/depression item was relevant). Participants frequently said items were not relevant to themselves, but could be relevant to patients with more severe diabetes. Most participants (92.0 %) reported that T2D and/or its treatment/monitoring requirements had an impact on their quality of life that was not captured by the EQ-5D-5L. Common missing concepts included food awareness/restriction (n = 13, 52.0 %); activities (n = 11, 44.0 %); emotional functioning other than depression/anxiety (n = 8, 32.0 %); and social/relationship functioning (n = 8, 32.0 %).ConclusionsThe results highlight strengths and potential limitations of the EQ-5D-5L, including missing content that could be important for some patients with T2D. Suggestions for addressing limitations are provided.

Highlights

  • The EQ-5D is frequently used to derive utilities for patients with type 2 diabetes (T2D)

  • The NICE guide adds that utilities derived via other methods may be acceptable for use in cost utility modeling when EQ-5D utilities are not “available” or “appropriate.” The recently updated version of the guide suggests that qualitative data may be useful for examining the appropriateness of the EQ-5D

  • Given that the instrument was intended to provide a brief tool for quantifying health status across all populations, it is encouraging that about half of this T2D sample said the instrument was relevant to their own experience

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Summary

Introduction

The EQ-5D is frequently used to derive utilities for patients with type 2 diabetes (T2D). Generic preference-based instruments are frequently administered to estimate utility values for type 2 diabetes (T2D) health states for use in cost-utility modeling. The NICE guide adds that utilities derived via other methods may be acceptable for use in cost utility modeling when EQ-5D utilities are not “available” or “appropriate.” The recently updated version of the guide suggests that qualitative data may be useful for examining the appropriateness of the EQ-5D. To support a claim that the instrument is inappropriate, NICE suggests “qualitative empirical evidence on the lack of content validity for the EQ-5D should be provided, demonstrating that key dimensions of health are missing. This should be supported by evidence that shows that EQ-5D performs poorly on tests of construct

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