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Review
. 2022 Feb 22;23(1):171.
doi: 10.1186/s12891-022-05116-z.

Adherence to the OARSI recommendations for designing, conducting, and reporting of clinical trials in knee osteoarthritis: a targeted literature review

Charles D Hummer  1 , Yili Huang  2 , Brendan Sheehan  3
Affiliations
Review

Adherence to the OARSI recommendations for designing, conducting, and reporting of clinical trials in knee osteoarthritis: a targeted literature review

Charles D Hummer et al. BMC Musculoskelet Disord. .

Abstract

Background: The Osteoarthritis Research Society International (OARSI) updated their guideline for clinical trials on knee osteoarthritis (KOA) in 2015, which contains recommendations for the conduct, design, and reporting of clinical trials. The purpose of this study was to assess the quality of clinical trials published between 2010 and 2020 investigating intra-articular interventions in patients with KOA using the OARSI recommendations.

Methods: A targeted literature review was conducted to identify randomized controlled trials in patients with KOA receiving intra-articular interventions, published between 2010 and 2020. Included studies were assessed using the OARSI recommendations. For a comparison between the time periods before and after the introduction of the new OARSI recommendations, the year 2016 was selected as the cut-off.

Results: One hundred forty-eight publications, representing 139 unique trials, were included in this review. Included studies adhered to between 9 and 24 recommendations (median: 19). The highest increase in adherence from studies published in 2016 or earlier compared to after 2016 was seen in the reporting and registration of trials and the use of structural outcome measures. Overall, adherence to the recommendations related to the collection of biochemical biomarkers and the use of structural outcome measures remained low.

Conclusion: An improvement can be made in the conduct, design, and reporting of clinical trials for intra-articular therapies in KOA. Despite proper guidelines, quality of clinical trials varies, and the methodological deficiencies found are preventable and can be corrected. The quality of research should be considered when making treatment decisions for patients with KOA in clinical practice.

Keywords: Intra-articular therapies; Knee osteoarthritis; OARSI; Quality assessment; Randomized clinical trials.

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Conflict of interest statement

Charles D. Hummer is a consultant for Sanofi, member of the American Academy of Orthopaedic Surgeons (AAOS) Board of Councilors and member of the Pennsylvania Orthopaedic Society Board of Directors. Yili Huang is a consultant for Sanofi and member of the Eastern Pain Association Board of Directors. Brendan Sheehan is a consultant for Sanofi, CONMED and Smith & Nephew.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram
Fig. 2
Fig. 2
Distribution of the number of addressed OARSI recommendations across trials (max. Number of 25 recommendations; median was 19 recommendations)
Fig. 3
Fig. 3
Distribution of the number of addressed OARSI recommendations across trials (max. Number of 25 recommendations), stratified by publication year
Fig. 4
Fig. 4
Proportion of studies that fully addressed the OARSI recommendations per domain, stratified by publication year
Fig. 5
Fig. 5
Proportion of low adherence studies that fully addressed the OARSI recommendations per domain, stratified by publication year
Fig. 6
Fig. 6
Proportion of high adherence studies that fully addressed the OARSI recommendations per domain, stratified by publication year
See this image and copyright information in PMC

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