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

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
OSTEOARTHRITIS OUTCOME RANDOMIZED CONTROLLED TRIAL TREATMENT

Journal

The Journal of rheumatology
ISSN: 0315-162X
Titre abrégé: J Rheumatol
Pays: Canada
ID NLM: 7501984

Informations de publication

Date de publication:
01 2020
Historique:
accepted: 13 02 2019
pubmed: 17 3 2019
medline: 21 5 2021
entrez: 17 3 2019
Statut: ppublish

Résumé

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). 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. 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. 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.

Identifiants

DOI: 10.3899/jrheum.180985 PMID: 30877204
pubmed: 30877204
pii: jrheum.180985
doi: 10.3899/jrheum.180985
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

126-131

Auteurs

Miso Krsticevic (M)

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.
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.

Svjetlana Dosenovic (S)

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.
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.

Daiana Anne-Marie Dimcea (DA)

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.
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.

Dominika Jedrzejewska (D)

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.
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.

Ana Catarina Marques Lameirão (AC)

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.
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.

Eliana Santos Almeida (ES)

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.
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.

Antonia Jelicic Kadic (A)

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.
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.

Milka Jeric Kegalj (M)

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.
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.

Krste Boric (K)

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.
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 (L)

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.
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.
ORCID: 0000-0002-8467-6061

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