Abstract

Background:The development of new therapies to treat symptomatic osteoarthritis (OA) often requires targeting patient subgroups such as mild and/or moderate and/or severe. Multiple assessments for pain are used in clinical and research settings, yet to quantify patient burden with increasing pain severity it is important to understand the potential variability in outcomes based on definitions of severity used1.Objectives:The objective of this study was to examine studies in the published literature that report the burden of OA pain by severity to assess similarities and/or differences across study methodologies and outcomes.Methods:A targeted literature review of PubMed and Google Scholar was conducted January 2021 and included search terms: osteoarthritis, severity, United States (US), burden, quality of life, medication/treatment, and healthcare resource utilization. The search was limited to the English language, full-text articles, and no restriction on publication date. Results included a recent study of the burden of symptomatic OA pain respondents by severity level in the US2,3. Over 100 publication titles were reviewed. Comparison of findings was descriptive in nature.Results:Nine publications were identified representing 7 unique studies, 6 being patient and/or healthcare provider surveys. Two studies focused on OA severity: the remaining 5 stratified patients by pain severity, and all but 2 of the 5 identified and confirmed pain as OA-related. Pain measures included numeric rating scales (generic 0-10, Western Ontario and McMaster Universities Arthritis Index [WOMAC] NRS 3.1), visual analog scales (generic 0-100, Short-Form McGill Pain Questionnaire Visual Analog Scale [SF-MPQ-VAS]) or Pain Interference with Activities (PIA) scale derived from the 12-Item Short Form Health Survey [SF-12v2] developed for the Medical Outcomes Study, with recall periods varying from 48 hours to 7 days to 4 weeks. Only one study exclusively assessed symptomatic patients only i.e., patients with pain scores of 0 were excluded; the remainder compared cohorts of no/mild pain with increasing severity cohorts. Four of the 7 studies examined pairwise differences among mild, moderate, and severe patients (1 study vs. a non-OA cohort); 2 compared no/mild vs. moderate-to-severe OA pain and 1 study compared mild to moderate-to-severe OA pain. For most outcomes examined like clinical comorbidities, quality of life, and healthcare resource utilization, increasing burden was observed with increasing OA and/or pain severity despite study variability.Conclusion:Pain severity levels represent an important and distinguishing factor that contributes to health outcomes in OA patients in the US. Considerable heterogeneity across studies may impact how OA pain is defined, perceived by patients, and treated. Selecting appropriate OA pain severity assessments, including cut-points, may contribute to the successful monitoring of outcomes or comparisons of therapies to manage symptomatic OA pain, especially those that target specific pain severity subgroups.

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