Background & Aims
While it is acknowledged that patients’ global assessment measures are important to include in chronic pain clinical trials to help understand meaningful change [1, 2], the perspective of individuals living with chronic pain on what constitutes meaningful change has been largely overlooked. The primary objectives of this study were to understand how individuals with chronic pain define meaningful change in pain and how they decide whether a pain treatment is helpful for them. The study findings will inform subsequent work to modify existing or develop de-novo patient-global assessment measures to capture meaningful change and to build appropriate patient-centered endpoint models for use in clinical trials of chronic pain treatments.
Methods
Individuals with chronic low back pain, chronic postsurgical pain, post-COVID pain, diabetic peripheral neuropathy, fibromyalgia, or osteoarthritis, were recruited from University of Rochester, University of Washington, and Duke University to participate in a phone or videoconference interview delivered. As part of a larger cognitive interview study on pain measurement, we asked participants a set of questions to understand what change in pain intensity ratings (on a 0-10 numeric rating scale [NRS]) is necessary for them to feel their pain is “meaningfully better” and to define what “meaningfully better” means to them. We also asked how they decide if a pain treatment is working for them, whether they consider side effects of a treatment when making that decision and whether achieving a tolerable pain level is more important than improving their life overall. Responses were summarized descriptively based on common themes or by generating frequency distributions as appropriate.
Results
Participants (N=43, roughly evenly distributed across chronic pain conditions) were, on average, 50 years old; primarily cisgender women (58%) or cisgender men (40%); Black or African American (26%) or White (65%); 23% were Hispanic or Latinx; 39% had a high school degree or less; 33% were on disability or unemployed. Median pain duration was 6 years. Participants rated average and worst pain as 4.8±1.6 and 6.4±2.2, respectively, and estimated meaningful change as a reduction of 2.5±1.3 for average and 3.0±1.6 for worst pain. Most participants (79%) defined “meaningfully better” as improved function and activity engagement (time with family, walking). Improved mood or quality of life (26%) and less preoccupation with pain (19%) were also noted. When asked how to decide if treatment is working, participants commonly noted reduced pain (53.5%), improved function or activity (26%), or reliability/duration of pain relief (12%). Only 1 participant noted side effects when deciding if a treatment worked. Yet, when prompted about whether they consider side effects, 84% indicated they do. In general, it was more important that life improved overall (51%) than pain reaching a tolerable level (30%).
Conclusions
Among a diverse sample of people living with chronic pain, definitions of meaningful improvement in pain primarily focused on the ability to participate in daily activities. Participants rarely spontaneously endorsed considering treatment side effects when deciding whether a treatment was effective, but when prompted, most indicated they did. Given that existing patient global assessment measures typically do not specify domains to consider when assessing change, coupled with our preliminary findings of the importance of function and activity engagement and initial oversight of side effects, global assessment measures may be improved by orienting respondents to consider whether their change in pain affected their ability to function or engage in activities that are important to them and to explicitly consider any side effects when making their assessment. These changes may serve to standardize global assessment whilst capturing domains important to people living with chronic pain.
References
1.Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113(1-2):9-19.
2.U.S. Food and Drug Administration. Patient-focused drug development: incorporating clinical outcome assessments into endpoints for regulatory decision-making guidance for industry, Food and Drug Administration staff, and other stakeholders. In: U.S. Department of Health and Human Services editor. Silver Spring, MD: U.S. Food and Drug Administration, 2023.
Presenting Author
Dale Langford
Poster Authors
Dale Langford
PhD
Hospital for Special Surgery, Pain Prevention Research Center & Weill Cornell Medicine
Lead Author
Jennifer S. Gewandter
PhD
University of Rochester
Lead Author
Dagmar Amtmann
PhD
University of Washington
Lead Author
Bryce B. Reeve
PhD
Duke University
Lead Author
Dennis C. Turk
PhD
University of Washington
Lead Author
Robert H. Dworkin
PhD
University of Rochester & Hospital for Special Surgery
Lead Author
Topics
- Assessment and Diagnosis