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Outcome Domains, Outcome Measures, and Characteristics of Randomized Controlled Trials Testing Nonsurgical
Miso Krsticevic1,2, Svjetlana Dosenovic1,2, Daiana Anne-Marie Dimcea1,2
1From the Department of Orthopedics, and the Department of Anesthesiology and Intensive Care Medicine, and the Department of Pediatrics, University Hospital Split, Split; Department of Dermatovenerology, General Hospital Zadar, Zadar; Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia, Zagreb, Croatia; Faculty of Medicine, Transilvania University of Brasov, Brasov, Romania; Medical School, Medical University of Lodz, Lodz, Poland; Medical School, Abel Salazar Institute of Biomedical Sciences, Porto; Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
Objective:
Core outcome set (COS) is the minimum set of outcome domains that should be measured and reported in clinical trials. We analyzed outcome domains, prevalence of use of COS published by Outcome Measures in Rheumatology (OMERACT) initiative, outcome measures for outcome domains recommended by OMERACT COS, duration and size of randomized controlled trials (RCT) testing nonsurgical interventions for osteoarthritis (OA).
Methods:
We searched PubMed and analyzed RCT about nonsurgical interventions for OA published from June 2012 to June 2017. We extracted data about trial type, use of OMERACT COS, efficacy outcome domains, safety outcome domains, outcome measures used for COS assessment, duration, and sample size.
Results:
Among 334 analyzed trials, complete OMERACT-recommended COS was used by 14% of trials. Higher median prevalence of using OMERACT COS was found in trials explicitly described as phase III, and trials of pharmacological interventions with followup ≥ 1 year, but both with wide range of COS usage. Trialists used numerous different outcome measures for analyzing core outcome domains: 50 different outcome measures for pain, 74 for physical function, 9 for patient's global assessment, and 5 for imaging.
Conclusion:
Suboptimal use of recommended COS and heterogeneity of outcome measures is reducing quality and comparability of OA trials and hinders conclusions about efficacy and comparative efficacy of nonsurgical interventions. Interventions for improving study design of trials in this field would be beneficial.
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