An Analysis of the Study Participants and Patient-Reported Outcome Measures Used to Inform Clinical Practice
Tina Mai1, Kaitlyn R Julian1, Derek T Ward1
1Department of Orthopaedic Surgery, University of California-San Francisco, San Francisco, California.
Background:
Clinical practice guidelines (CPGs) are developed based on the best available evidence to guide clinical decisions. Because patient language, race, and ethnicity can affect the outcomes of a clinical study, the diversity of patients in studies informing CPGs is increasingly important as it shapes the conclusions that are drawn. As such, we: (1) examined the linguistic, racial, and ethnic representation of patients enrolled in studies informing CPGs for hip and knee osteoarthritis (OA); and (2) evaluated the utilization of appropriately translated and culturally adapted patient-reported outcome measures (PROMs) in these studies.
Methods:
Studies utilized to develop the American Academy of Orthopaedic Surgeons CPGs for hip and/or knee OA were evaluated, including their registered clinical trials, if applicable. Variables extracted included country of study, inclusion and exclusion criteria, patient language and proficiency, patient race and ethnicity, report of PROM translation, and/or cultural adaptation. Extracted variables were reported descriptively.
Results:
In the American Academy of Orthopaedic Surgeons CPGs, 65 studies were identified for hip OA, 503 for knee OA, and 16 examined OA of both joints. Among all the included articles, 46 (8%) reported patient language, 76 (13%) reported race, 18 (3%) reported ethnicity, 70 (14%) reported use of translated PROMs, and 21 (4%) reported use of culturally adapted PROMs. Among 30 multinational studies that utilized PROMs, two (7%) reported the use of translated or culturallyadapted PROMs. Individual analysis of registered clinical trial databases revealed similar reporting rates of these variables.
Conclusions:
Patient language, race, and ethnicity are infrequently reported among studies used to inform CPGs for hip and knee OA. Moreover, linguistic and cultural adaptations of PROMs are often not reported or utilized. Orthopaedic studies, especially those informing CPGs, should report patient demographic data to promote inclusivity, enhance validity, and ensure results are generalizable to diverse patient populations.
Level Of Evidence:
III.
