The Deficits of the Methodological and Reporting Quality of Randomized Controlled Trials in the Field of Prosthetics and Orthotics in Iran: A Systematic Review.

Introduction: Due to the development of the academic field of prosthetics and orthotics (P&O) in recent years, scientific studies in this domain have increased. However, relevant published studies, especially randomized controlled trials (RCTs), are not always of acceptable quality. Therefore, this study aimed to evaluate the methodological and reporting quality of RCTs in the field of P&O in Iran to recognize existing shortcomings.

Methods: Six electronic databases, including PubMed, Scopus, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and the Physiotherapy Evidence Database, were searched from January 1, 2000, to July 15, 2022. The Cochrane risk of bias tool was applied to evaluate the methodological quality of the included studies. In addition, the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist was used to assess the reporting quality of the included studies.

Results: 35 RCTs published from 2007 to 2021 were included in our final analysis. The methodological quality of 18 RCTs was poor, and the quality of the rest of the studies was good (n = 7) or fair (n = 10). In addition, the median score (IQR) of the reporting quality of RCTs in accordance with the CONSORT items was 18 (13-24.5) out of 35. The results of the relationship analysis indicated a moderate correlation between the CONSORT score and the publication year of the included RCTs. Nonetheless, there was a low correlation between the CONSORT scores and the journals' impact factors.

Conclusion: The overall methodological and reporting quality of RCTs in the field of P&O in Iran was not found to be optimal. To enhance the methodological quality, some items should be considered more strictly, such as blinding of outcome assessment, allocation concealment, and random sequence generation. Furthermore, the criteria of CONSORT, as reporting quality checklist, should be adopted in writing the papers, especially methods-related items.