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

Health and Quality of Life Outcomes

Volumn 13, Issue 1, 2015, Pages

  Matza, Louis S ^a   Boye, Kristina S ^b   Stewart, Katie D ^a   Curtis, Bradley H ^b   Reaney, Matthew ^c   Landrian, Amanda S ^a  

^a EVIDERA   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c ERT   (United Kingdom)

Author keywords

Cognitive interviews; Content validity; EQ 5D; Qualitative research; Type 2 diabetes

Indexed keywords

INSULIN; ORAL ANTIDIABETIC AGENT;

ADULT; ANALYTICAL PARAMETERS; ANXIETY; ARTICLE; AWARENESS; CLINICAL ARTICLE; COGNITION; CONTENT VALIDITY; DEPRESSION; DIABETIC PATIENT; DIET RESTRICTION; DISEASE SEVERITY; EMOTIONALITY; EQ-5D-5L QUESTIONNAIRE; FEMALE; HUMAN; INTERVIEW; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT MONITORING; PERSONAL EXPERIENCE; QUALITATIVE RESEARCH; QUALITY OF LIFE; QUESTIONNAIRE; RELIABILITY; SELF CARE; SOCIAL INTERACTION; UNITED KINGDOM; DEVICES; MIDDLE AGED; PSYCHOLOGY; PSYCHOMETRY; REPRODUCIBILITY;

ADULT; DIABETES MELLITUS, TYPE 2; FEMALE; HUMANS; MALE; MIDDLE AGED; PSYCHOMETRICS; QUALITATIVE RESEARCH; QUALITY OF LIFE; REPRODUCIBILITY OF RESULTS; SURVEYS AND QUESTIONNAIRES; UNITED KINGDOM;

EID: 84948975286     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/s12955-015-0373-7     Document Type: Article

References (31)

1. 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.
2. 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.
3. 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.
4. Koopmanschap M. Code- advisory board: coping with type II diabetes: the patient's perspective. Diabetologia. 2002;45:S18-22.
5. 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. 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.
7. 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.
8. NICE (National Institute for Health and Care Excellence): Process and methods guides: Guide to the methods of technology appraisal 2013. London, UK: National Institute for Care Excellence (NICE); 2013. http://www.nice.org.uk/article/pmg9/chapter/Foreword. Accessed: August 19, 2013.
9. 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. 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. 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. 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.
13. 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.
14. 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. 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. 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. 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.
18. 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.
19. Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35:1095-108.
20. 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. 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.
22. 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. 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.
24. 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.
25. 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.
26. Longworth L, Rowen D. Mapping to obtain EQ-5D utility values for use in NICE health technology assessments. Value Health. 2013;16:202-10.
27. 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. 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.
29. 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.
30. 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. 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.