PRM32 - How Well the Pragmatic Randomized Controls in Joint Replacement Field: Results from Precis, Consort and Iom Tools' Assessment

Abstract

Evidence from real world are important for patients care. Pragmatic randomized control trial (PRCT) as one of the research methods of Comparative Effectiveness Research (CER) is used in many medical fields recently. This study aims to assess design and reporting qualities of PRCTs published in joint replacement fields. We searched the Medline, Embase, CENTRAL to February 2014 and the reference lists of retrieved studies to identify the full-report pragmatic randomized trials in English that compared Total Hip Replacement (THR) or Total Knee Replacement (TKR) with a conventional treatment. Three reviewers independently assess the quality of PRCTs by using the pragmatic-explanatory continuum indicator summary (PRECIS) tool, CONSORT statement guidelines and the six CER defining characteristics of the Institute of Medicine (IOM). We screened 55 potentially eligible abstracts and identified 6 full-text PRCTs of joint replacement fields. Finally 3 trials with 4,152 patients were assessed. Three reviewers scored the 3 trials based on PRECIS tool (39.5 vs 44 vs 36); CONSORT statement guidelines (36.5 vs 39 vs 37.5); IOM defining characteristics of CER (26.5 vs 29 vs 29). All 3 trials reported the clinical, economic and patient-centered outcomes. The Knee Arthroplasty Trial with 10 years’ follow-up was scored the highest and considered to be more closer to the real world than other two trials as it was conducted in 2352 patients from 34 UK centers and 116 surgeons in the study could adjusted their treatments based on individual patients’ characteristics. PRCT is different from standard RCT in many aspects. The number of PRCT in joint replacement field is limited and the quality need to be improved. PRECIS, CONSORT guidelines are useful for researchers in designing and reporting the PRCT.