Feasibility and Validity of Asking Patients to Define Individual Levels of Meaningful Change on Patient-Reported Outcomes

Abstract

Purpose: Patient-reported outcomes (PROs) are frequently used in clinical care to monitor treatment response. However, most guidelines on PRO use treat all patients the same. This study tested the feasibility and validity of a method for determining individually meaningful change in PRO measures. Methods: Participants (n = 398) completed 12 pain and distress questions to define individually meaningful change. This mixed-methods study used both quantitative and qualitative analyses, including descriptive statistics, inferential statistics, and content analysis. Results: Two-thirds (67%) of the sample reported at least one medical condition, including depression and back pain. Most participants (70%–90%) were able to answer the questions as intended. Participants varied widely in the amount of change they considered meaningful (coefficients of variation: 40%–99%). Higher symptom levels were associated with larger amounts of change considered meaningful and with greater likelihood of answering questions as intended. Participants reported a variety of reasons for why they considered an amount of change in pain or distress meaningful. The hypothetical nature of the questions and the need to reference previous questions was found to be confusing. Conclusions: Asking patients to define an individual level for meaningful change on PROs was feasible and valid. Having patients define their own goals on PROs for treatment of pain or distress could make treatment more patient-centered.

Keywords

• patient-reported outcomes
• minimal clinically important difference
• treatment response
• mixed methods
• qualitative
• quantitative
• pain
• distress