Background Unlike drugs, medical devices (MDs) are not submitted for health authority marketing authorization based on in-depth clinical evaluation: critical review on an evidence-based medicine approach is essential for practitioners. The Consolidated Standards of Reporting Trials (CONSORT) statement is an international consensus expert guideline aimed at improving the reporting quality of clinical trials reports.
Purpose To evaluate the usefulness and applicability of the CONSORT for journal articles reporting randomised controlled trials (RCTs) evaluating an implantable MD.
Materials and Methods Original articles published before 2012 reporting RCTs assessing single-incision slings (SISs) in the treatment of female stress urinary incontinence were searched for in PubMed and Embase databases. Reporting quality was assessed by two hospital pharmacists and two urological surgeons according to three CONSORT checklists: abstract (17 items), standard (37 items) and extension for non-pharmacological trials (20 items); the results were discussed to reach a consensus.
Results Among 135 articles retrieved, eight articles met the inclusion criteria and were assessed. Abstract scores ranged from 4.7 to 14.1 out of 20. Standard scores were greater than 10.0 out of 20 for most articles; the extension scores did not exceed 5.0 out of 10. Half the reported trials were not identified as randomised in the title. Three articles did not mention any confidence interval or standard deviation for outcomes. The interventions were incompletely described; only four articles reported the configuration of the devices. Four articles reported whether blinding was achieved but lack of blinding was never discussed as a potential source of bias. Few articles reported the operators and centres’ characteristics and their impact on statistical analysis.
Conclusions The reporting quality of SISs RCTs should be improved because readers require complete, clear and transparent information to assess the relevance and applicability of results. Our study supports further use of the CONSORT criteria to enhance and assess the reporting quality of surgical trials.
No conflict of interest.
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