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Published in: Health and Quality of Life Outcomes 1/2015

Open Access 01-12-2015 | Research

A qualitative examination of the content validity of the EQ-5D-5L in patients with type 2 diabetes

Authors: Louis S. Matza, Kristina S. Boye, Katie D. Stewart, Bradley H. Curtis, Matthew Reaney, Amanda S. Landrian

Published in: Health and Quality of Life Outcomes | Issue 1/2015

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Abstract

Background

The 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.

Methods

Patients 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.

Results

A 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 %).

Conclusions

The 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.
Literature
1.
go back to reference Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Making. 2002;22:340–9.CrossRefPubMed Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Making. 2002;22:340–9.CrossRefPubMed
2.
go back to reference Glasziou P, Alexander J, Beller E, Clarke P, Advance Collaborative Group. Which health-related quality of life score? a comparison of alternative utility measures in patients with type 2 diabetes in the ADVANCE trial. Health Qual Life Outcomes. 2007;5:21.PubMedCentralCrossRefPubMed Glasziou P, Alexander J, Beller E, Clarke P, Advance Collaborative Group. Which health-related quality of life score? a comparison of alternative utility measures in patients with type 2 diabetes in the ADVANCE trial. Health Qual Life Outcomes. 2007;5:21.PubMedCentralCrossRefPubMed
3.
go back to reference Grandy S, Fox KM, Shield Study Group. Change in health status (EQ-5D) over 5 years among individuals with and without type 2 diabetes mellitus in the SHIELD longitudinal study. Health Qual Life Outcomes. 2012;10:99.PubMedCentralCrossRefPubMed Grandy S, Fox KM, Shield Study Group. Change in health status (EQ-5D) over 5 years among individuals with and without type 2 diabetes mellitus in the SHIELD longitudinal study. Health Qual Life Outcomes. 2012;10:99.PubMedCentralCrossRefPubMed
4.
go back to reference Koopmanschap M. Code- advisory board: coping with type II diabetes: the patient's perspective. Diabetologia. 2002;45:S18–22.CrossRefPubMed Koopmanschap M. Code- advisory board: coping with type II diabetes: the patient's perspective. Diabetologia. 2002;45:S18–22.CrossRefPubMed
5.
go back to reference Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, et al. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013;11:217. Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, et al. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013;11:217.
6.
go back to reference U.K. Prospective Diabetes Study Group. Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). Diabetes Care. 1999;22:1125–36.CrossRef U.K. Prospective Diabetes Study Group. Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). Diabetes Care. 1999;22:1125–36.CrossRef
7.
go back to reference Janssen MF, Lubetkin EI, Sekhobo JP, Pickard AS. The use of the EQ-5D preference-based health status measure in adults with Type 2 diabetes mellitus. Diabet Med. 2011;28:395–413.CrossRefPubMed Janssen MF, Lubetkin EI, Sekhobo JP, Pickard AS. The use of the EQ-5D preference-based health status measure in adults with Type 2 diabetes mellitus. Diabet Med. 2011;28:395–413.CrossRefPubMed
9.
go back to reference Food & Drug Administration. Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Silver Spring, MD: FDA; 2009. Food & Drug Administration. Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Silver Spring, MD: FDA; 2009.
10.
go back to reference Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health. 2011;14:978–88. Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health. 2011;14:978–88.
11.
go back to reference Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011;14:967–77. Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011;14:967–77.
12.
go back to reference Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health. 2009;12:1075–83.CrossRefPubMed Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health. 2009;12:1075–83.CrossRefPubMed
13.
go back to reference Brod M, Tesler LE, Christensen TL. Qualitative research and content validity: developing best practices based on science and experience. Qual Life Res. 2009;18:1263–78.CrossRefPubMed Brod M, Tesler LE, Christensen TL. Qualitative research and content validity: developing best practices based on science and experience. Qual Life Res. 2009;18:1263–78.CrossRefPubMed
14.
go back to reference Leidy NK, Vernon M. Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics. 2008;26:363–70. Leidy NK, Vernon M. Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics. 2008;26:363–70.
15.
go back to reference Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3 L across eight patient groups: a multi-country study. Qual Life Res. 2013;22:1717–27. Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3 L across eight patient groups: a multi-country study. Qual Life Res. 2013;22:1717–27.
16.
go back to reference Matza LS, Boye KS, Yurgin N, Brewster-Jordan J, Mannix S, Shorr JM, et al. Utilities and disutilities for type 2 diabetes treatment-related attributes. Qual Life Res. 2007;16:1251–65. Matza LS, Boye KS, Yurgin N, Brewster-Jordan J, Mannix S, Shorr JM, et al. Utilities and disutilities for type 2 diabetes treatment-related attributes. Qual Life Res. 2007;16:1251–65.
17.
go back to reference Mulhern B, Meadows K. The construct validity and responsiveness of the EQ-5D, SF-6D and Diabetes Health Profile-18 in type 2 diabetes. Health Qual Life Outcomes. 2014;12:42.PubMedCentralCrossRefPubMed Mulhern B, Meadows K. The construct validity and responsiveness of the EQ-5D, SF-6D and Diabetes Health Profile-18 in type 2 diabetes. Health Qual Life Outcomes. 2014;12:42.PubMedCentralCrossRefPubMed
18.
go back to reference Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes. Diabet Med. 2009;26:315–27.CrossRefPubMed Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes. Diabet Med. 2009;26:315–27.CrossRefPubMed
20.
go back to reference Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–36. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–36.
21.
go back to reference McGrath C, Rofail D, Gargon E, Abetz L. Using qualitative methods to inform the trade-off between content validity and consistency in utility assessment: the example of type 2 diabetes and Alzheimer's disease. Health Qual Life Outcomes. 2010;8:23.PubMedCentralCrossRefPubMed McGrath C, Rofail D, Gargon E, Abetz L. Using qualitative methods to inform the trade-off between content validity and consistency in utility assessment: the example of type 2 diabetes and Alzheimer's disease. Health Qual Life Outcomes. 2010;8:23.PubMedCentralCrossRefPubMed
22.
go back to reference Longworth L, Yang Y, Young T, Mulhern B, Hernández Alava M, Mukuria C, et al. Use of generic and condition-specific measures of health-related quality of life in NICE decision-making: a systematic review, statistical modelling and survey. Health Technol Assess. 2014;18. Longworth L, Yang Y, Young T, Mulhern B, Hernández Alava M, Mukuria C, et al. Use of generic and condition-specific measures of health-related quality of life in NICE decision-making: a systematic review, statistical modelling and survey. Health Technol Assess. 2014;18.
23.
go back to reference Swinburn P, Lloyd A, Boye KS, Edson-Heredia E, Bowman L, Janssen B. Development of a disease-specific version of the EQ-5D-5L for Use in patients suffering from psoriasis: lessons learned from a feasibility study in the UK. Value in Health. 2013;16:1156–62.CrossRefPubMed Swinburn P, Lloyd A, Boye KS, Edson-Heredia E, Bowman L, Janssen B. Development of a disease-specific version of the EQ-5D-5L for Use in patients suffering from psoriasis: lessons learned from a feasibility study in the UK. Value in Health. 2013;16:1156–62.CrossRefPubMed
24.
go back to reference Yang Y, Brazier J, Tsuchiya A. Effect of adding a sleep dimension to the EQ-5D descriptive system: a "bolt-on" experiment. Med Decis Making. 2014;34:42–53.CrossRefPubMed Yang Y, Brazier J, Tsuchiya A. Effect of adding a sleep dimension to the EQ-5D descriptive system: a "bolt-on" experiment. Med Decis Making. 2014;34:42–53.CrossRefPubMed
25.
go back to reference Brazier JE, Yang Y, Tsuchiya A, Rowen DL. A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ. 2010;11:215–25.CrossRefPubMed Brazier JE, Yang Y, Tsuchiya A, Rowen DL. A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ. 2010;11:215–25.CrossRefPubMed
26.
go back to reference Longworth L, Rowen D. Mapping to obtain EQ-5D utility values for use in NICE health technology assessments. Value Health. 2013;16:202–10.CrossRefPubMed Longworth L, Rowen D. Mapping to obtain EQ-5D utility values for use in NICE health technology assessments. Value Health. 2013;16:202–10.CrossRefPubMed
27.
go back to reference Brazier JE, Rowen D, Mavranezouli I, Tsuchiya A, Young T, Yang Y, et al. Developing and testing methods for deriving preference-based measures of health from condition-specific measures (and other patient-based measures of outcome). Health Technol Assess. 2012;16:1–114. Brazier JE, Rowen D, Mavranezouli I, Tsuchiya A, Young T, Yang Y, et al. Developing and testing methods for deriving preference-based measures of health from condition-specific measures (and other patient-based measures of outcome). Health Technol Assess. 2012;16:1–114.
28.
go back to reference Boye KS, Matza LS, Walter KN, Van Brunt K, Palsgrove AC, Tynan A. Utilities and disutilities for attributes of injectable treatments for type 2 diabetes. Eur J Health Econ. 2011;12:219–30.CrossRefPubMed Boye KS, Matza LS, Walter KN, Van Brunt K, Palsgrove AC, Tynan A. Utilities and disutilities for attributes of injectable treatments for type 2 diabetes. Eur J Health Econ. 2011;12:219–30.CrossRefPubMed
29.
go back to reference Matza LS, Boye KS, Yurgin N. Validation of two generic patient-reported outcome measures in patients with type 2 diabetes. Health Qual Life Outcomes. 2007;5:47.PubMedCentralCrossRefPubMed Matza LS, Boye KS, Yurgin N. Validation of two generic patient-reported outcome measures in patients with type 2 diabetes. Health Qual Life Outcomes. 2007;5:47.PubMedCentralCrossRefPubMed
30.
go back to reference European Network for Health Technology Assessment (Eunethta). Endpoints used for relative effectiveness assessment of pharmaceuticals: Health-related quality of life and utility measures. February 2013; Final version. European Network for Health Technology Assessment (Eunethta). Endpoints used for relative effectiveness assessment of pharmaceuticals: Health-related quality of life and utility measures. February 2013; Final version.
31.
go back to reference Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2:i-iv:1–74. Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2:i-iv:1–74.
Metadata
Title
A qualitative examination of the content validity of the EQ-5D-5L in patients with type 2 diabetes
Authors
Louis S. Matza
Kristina S. Boye
Katie D. Stewart
Bradley H. Curtis
Matthew Reaney
Amanda S. Landrian
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2015
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-015-0373-7

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