Analysis of the quality of description of usual care interventions in clinical trials involving exercise for knee osteoarthritis: a systematic review protocol

Abstract

Introduction: Treatment for Osteoarthritis (OA) includes exercises, educational and self-management programs, with new therapeutic interventions often compared to “Usual Care”. Objectives: To investigate the quality of description of Usual Care as a comparator group in randomized clinical trials (RCTs) using exercise in the treatment of knee OA through a Systematic Review (SR). Methods: A search will be conducted in the MEDLINE, Embase, Cochrane Central, PEDro, CINAHL, and SPORTDiscus databases to identify RCTs that used Usual Care as a comparator in the treatment of knee OA with exercise. After selection, eligible studies will be assessed by a pair of trained researchers. The PEDro scale will be used to evaluate the risk of bias, with each study classified as “poor,” “fair,” “good,” or “excellent,” and intervention description will be assessed using the TIDieR checklist. The quality of the intervention descriptions in each RCT will be classified as “High” if the score is equal to or greater than 50% of the total score, or “Low” if it is lower. Unpaired t-tests and the chi-square test will be used for the evaluation of numerical and categorical variables, respectively. Expected Results: The results of this review are expected to summarize the quality of intervention description in RCTs in OA that are often inadequately described, especially concerning the control group, making replication in RCTs and comparison between tested therapies challenging. A well-constructed SR protocol is necessary to help clarify uncertainties about interventions generically referred to as Usual Care. Key-Words: knee osteoarthritis; patient care; exercise.