Outcome Domains, Outcome Measures, and Characteristics of Randomized Controlled Trials Testing Nonsurgical Interventions for Osteoarthritis

Miso Krsticevic; Svjetlana Dosenovic; Daiana Anne-Marie Dimcea; Dominika Jedrzejewska; Ana Catarina Marques Lameirão; Eliana Santos Almeida; Antonia Jelicic Kadic; Milka Jeric Kegalj; Krste Boric; Livia Puljak

doi:10.3899/jrheum.180985

Outcome Domains, Outcome Measures, and Characteristics of Randomized Controlled Trials Testing Nonsurgical Interventions for Osteoarthritis

J Rheumatol. 2020 Jan;47(1):126-131. doi: 10.3899/jrheum.180985. Epub 2019 Mar 15.

Authors

Miso Krsticevic^{1

2}, Svjetlana Dosenovic^{1

2}, Daiana Anne-Marie Dimcea^{1

2}, Dominika Jedrzejewska^{1

2}, Ana Catarina Marques Lameirão^{1

2}, Eliana Santos Almeida^{1

2}, Antonia Jelicic Kadic^{1

2}, Milka Jeric Kegalj^{1

2}, Krste Boric^{1

2}, Livia Puljak^{3

4}

Affiliations

¹ From 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.
² M. Krsticevic, MD, Department of Orthopedics, University Hospital Split; S. Dosenovic, MD, Department of Anesthesiology and Intensive Care Medicine, University Hospital Split; D.A. Dimcea, Medical Student, Faculty of Medicine, Transilvania University of Brasov; D. Jedrzejewska, Medical Student, Medical School, Medical University of Lodz; A.C. Marques Lameirão, Medical Student, Medical School, Abel Salazar Institute of Biomedical Sciences; E.S. Almeida, Medical Student, Faculty of Medicine, University of Coimbra; A. Jelicic Kadic, MD, PhD, Department of Pediatrics, University Hospital Split; M. Jeric Kegalj, MD, PhD, Department of Dermatovenerology, General Hospital Zadar; K. Boric, MD, PhD, Department of Orthopedics, University Hospital Split; L. Puljak, MD, PhD, Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia.
³ From 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. livia.puljak@gmail.com livia.puljak@unicath.hr.
⁴ M. Krsticevic, MD, Department of Orthopedics, University Hospital Split; S. Dosenovic, MD, Department of Anesthesiology and Intensive Care Medicine, University Hospital Split; D.A. Dimcea, Medical Student, Faculty of Medicine, Transilvania University of Brasov; D. Jedrzejewska, Medical Student, Medical School, Medical University of Lodz; A.C. Marques Lameirão, Medical Student, Medical School, Abel Salazar Institute of Biomedical Sciences; E.S. Almeida, Medical Student, Faculty of Medicine, University of Coimbra; A. Jelicic Kadic, MD, PhD, Department of Pediatrics, University Hospital Split; M. Jeric Kegalj, MD, PhD, Department of Dermatovenerology, General Hospital Zadar; K. Boric, MD, PhD, Department of Orthopedics, University Hospital Split; L. Puljak, MD, PhD, Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia. livia.puljak@gmail.com livia.puljak@unicath.hr.

PMID: 30877204
DOI: 10.3899/jrheum.180985

Abstract

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.

Keywords: OSTEOARTHRITIS; OUTCOME; RANDOMIZED CONTROLLED TRIAL; TREATMENT.

MeSH terms

Clinical Trials, Phase III as Topic
Cross-Sectional Studies
Follow-Up Studies
Hand Joints / pathology*
Humans
Osteoarthritis, Hip / therapy*
Osteoarthritis, Knee / therapy*
Outcome Assessment, Health Care*
Pain
Randomized Controlled Trials as Topic*
Retrospective Studies
Rheumatology / methods
Treatment Outcome
Visual Analog Scale