Creating a personalized evaluation framework for patient-reported outcomes: an illustration using the EQ-5D visual analogue scale

ABSTRACT

Background: This paper outlines the creation of an intuitive, personalized evaluation framework for Patient-Reported Outcomes, using the EQ-5D visual analog scale (VAS) as an illustration.

Methods: A draft framework asked patients to divide and label the EQ-5D-VAS into different levels or categories of health. Comprehension of the framework and patient-defined health level labels, and how they map onto the EQ-5D-VAS, were tested through in-person, semi-structured interviews with individuals self-reporting cardiovascular disease. Interviews were conducted in three waves, with the framework revised between waves.

Results: Analyses included 14 participants. Eight participants (57.1%) felt that four levels of health were appropriate and there was general agreement on the labels; Poor, Fair, Good, and Excellent. There was substantial variability in where patients drew lines to indicate the level boundaries; Poor ranged between 0 and 50; Fair 10–75; Good 40–91; Excellent 60–100. In wave 3, all participants demonstrated appropriate comprehension of the framework.

Conclusions: The framework was well understood. The wide range of margins and the extent of overlap between the levels provide strong evidence for the relevance of the personalized evaluation framework approach, and specifically a personalized EQ-5D-VAS evaluation framework, to better understand and interpret each individual’s response to the item.

KEYWORDS:

• EQ-5D
• health levels
• personalized framework
• qualitative

Author contributions

M Reaney and C Gwaltney conceptualized the study; M Reaney, C Gwaltney, L Stassek, M Martin, K McCarrier, A Slagle & A Shields were involved in design, analysis and interpretation of the data, drafting or revising the paper and approving it for publication. All authors agree to be accountable for all aspects of the work.

Declaration of interest

M Reaney is an employee and Stock Holder of Sanofi. L Stassek, ML Martin and K McCarrier are employees of Health Research Associates (HRA) and HRA received funding to conduct this study. A Slagle is employed at Aspen Consulting and A Shields is employed by Adelphi Values, both of which provide outcomes consultancy and services for pharmaceutical development companies. C Gwaltney is an employee of Gwaltney Consulting who received funding to conduct this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This study was sponsored by Sanofi.