A Survey of the Perceptions, Knowledge, and Use of Core Outcome Sets in Knee and Hip Osteoarthritis Trials: A Cross-Sectional Study

Background: Osteoarthritis (OA) of the knee and hip is a prevalent and financially burdening cause of disability globally. Thus, significant effort towards developing effective clinical practices to manage this disease is warranted. Clinical trials play an integral role in guiding clinical practices, and thus an increase in the number of trials performed. With this increasing number of trials, it is imperative to decrease outcome reporting heterogeneity. Core outcome sets (COS) are used to standardize clinical trial outcomes which serves to increase the comparability of clinical trial results and reduce reporting bias. By gathering our data from clinical researchers themselves, our goal is to gain an understanding into the decision-making behind outcomes used and assess the researchers’ perspectives on the current OA COS.

Methods: In a previous investigation, we assessed the alignment of the COS for knee and hip OA. This 20-question survey targets clinical trialists who planned, executed, or analyzed OA trials in years prior. All participants will have informed consent and maintain complete anonymity. The participants' familiarity with COS will determine the survey path they follow. Surveys will be administered to trialists via REDCap (Research Electronic Data Capture), a secure web-based application designed for research data collection. Data analysis may include both descriptive and inferential statistics. Additionally, open-ended questions will be used to obtain qualitative data.

Results: Data is currently in the collection phase of this study. Analysis of survey responses will include the following: Descriptive statistics: summarizes patient demographics and responses to close-ended questions; Inferential statistics: examples include chi-square tests and t-tests which may be used to identify relationships between variables or differences among subgroups; Qualitative data: derived from responses to open-ended questions, which will undergo thematic analysis to discern recurring themes and patterns.

Conclusions: Upon completion, the collected OA data will give us insight into clinical trialists’ use and knowledge of COS. This research could lay the groundwork to focus on improving the efforts, intervention, and adoption of COS among future clinical trials. Additionally, findings from this experiment may potentially foster consistency in reporting outcome sets, leading to enhanced OA patient outcomes.