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C. Kopkow1,2, C. Bahns3,2, L. Happe4,2, P. Kasten5
1Brandenburg Technical University Cottbus – Senftenberg, Department of Therapy Science I, Senftenberg, Germany, 2Hochschule für Gesundheit (University of Applied Sciences), Department of Applied Health Sciences, Bochum, Germany, 3University of Lübeck, Institute of Occupational Health, Lübeck, Germany, 4Carl von Ossietzky University Oldenburg, Department for Health Services Research, Oldenburg, Germany, 5Orthopädisch Chirurgisches Centrum, Tübingen, Germany
Background: The number of published clinical trials evaluating conservative and surgical interventions for elbow disorders is growing, but consensus on the outcomes to be measured and the measurement instruments to be used is lacking. This heterogeneity has impeded the ability to compare trial results and synthesize data in systematic reviews. To reduce heterogeneity in measured outcomes between trials, a core outcome set (COS) can be of help. A COS has been defined as an agreed standardized set of outcomes that should be measured and reported as a minimum in all clinical trials in specific areas of health or healthcare.
Purpose: The objective of this systematic review is to systematically identify potential outcome domains relevant for elbow disorders and how they have been measured in clinical trials of interventions for elbow disorders.
Methods: We searched Medline, EMBASE and CENTRAL databases from inception until June 2019 to identify all randomized controlled trials of interventions in adult patients (defined as 18 years of age or older) with traumatic or non-traumatic elbow disorders. Studies published in English, German or Dutch language were included. Screening of titles and abstracts and full texts were performed independently by two reviewers. Any disagreements during the screening process were resolved by consensus or if needed with a third reviewer. Outcome domains reported in identified studies were classified into the outcome taxonomy proposed by Dodd et al., 2018.
Results: In total, 7491 records were screened after removing duplicates, of which 296 publications met the predefined eligibility criteria. Included studies were published between 1981 and 2019 on lateral elbow pain (n=262), fracture of the elbow (n=23), several elbow disorders (n=6), dislocation of the elbow (n=2), nonspecific elbow pain (n=2), medial elbow pain (n=1). Pain was the most frequently evaluated outcome domain, but other outcome domains such as strength, function, range of motion, reasons for withdrawal or adverse events were have also been measured in clinical trials of interventions for elbow disorders.
Conclusion(s): This systematic review identified substantial heterogeneity in the use of outcome domains and measurement instruments in studies including patients with elbow disorders and indicates the clear need for the development of a COS. The large number of outcomes and different instruments used for outcome measurement limits comparing and synthesizing results, thereby hampering usefulness of research evidence for patient benefit.
Implications: The results of this systematic review will be used for the development of a COS for clinical trials of conservative and surgical interventions for elbow disorders.
Funding, acknowledgements: Internal funding from the Hochschule für Gesundheit (University of Applied Sciences) Bochum, Germany.
Keywords: Elbow disorders, Core Outcome Set, Systematic review
Topic: Musculoskeletal: upper limb
Did this work require ethics approval? No
Institution: None
Committee: None
Reason: Systematic review
All authors, affiliations and abstracts have been published as submitted.
