Willingness to participate in a randomized trial of surgical vs. nonoperative care among patients with meniscal tear and knee pain after a course physical therapy

Objective: Randomized controlled trials (RCTs) frequently fail to meet sample size requirements within their proposed timeline. Prospective preference assessments (PPAs) estimate the number of eligible individuals likely to enroll. The COSMIC Trial (Conservative care or Surgery for Meniscal tear after IneffeCtive physical therapy), currently in planning stages, will compare arthroscopic partial meniscectomy (APM) to non-operative treatment among those with meniscal tear who experience knee pain following a course of physical therapy (PT). We conducted a PPA to estimate willingness to enroll in the hypothetical trial and identify factors associated with willingness. Method: We invited eligible patients 45–85 years old with meniscal tear who were prescribed PT to participate in the PPA. Participants completed up to two questionnaires: one prior to a course of PT (Baseline questionnaire), and another following 10 weeks of PT (End of PT questionnaire). Both questionnaires assessed willingness to enroll in the COSMIC trial and knee treatment preferences. Results: In total, 94 participants completed both questionnaires, and 50 completed the End of PT questionnaire only. For those who completed both questionnaires, willingness to enroll in the hypothetical COSMIC RCT fell from 62 ​% at Baseline to 46 ​% in the End of PT questionnaires. Respondents’ strongest preference was to avoid APM (47 ​%). Preference for APM at baseline was associated with willingness to enroll. Conclusions: Our findings suggest that about half of eligible patients would be willing to participate in the COSMIC RCT and that, except for APM, participants’ preference for treatments was not strongly related to willingness to participate.