Background: The treatment of chronic limb-threatening ischemia (CLTI) involves a broad spectrum of therapies including many new and emerging techniques. To standardize the results of studies examining this pathology and to allow critical analysis and comparison between studies, the Society for Vascular Surgery (SVS) recommended reporting standard guidelines for the endovascular management of CLTI in 2016. Research studies that do not adhere to complete reporting standards are often more ambiguous in impact and external validity, leading to bias and misinformation that has potentially damaging effects on clinical decision-making. We thus sought to examine adherence to and factors associated with noncompliance with these recommended guidelines.
Methods: A literature database search was conducted to include all clinical trials, randomized controlled trials, and retrospective comparative studies written in English examining the endovascular treatment of peripheral artery disease (PAD)/CLTI from January 2020 to August 2022. Systematic reviews, case reports, and meta-analysis were excluded. The manuscripts were reviewed for adherence with the SVS guidelines (overall and by guideline subcategories based on demographics, treatment methods, and outcomes), and factors associated with this adherence were determined. These data were used to calculate descriptive and comparative statistics.
Results: Fifty-four manuscripts were identified from this time frame. On average, articles reviewed reported on 42.0% of the SVS reporting standards (range, 25.0-65.2%, Fig 1) with 74.1% of articles (n = 40) not adhering to at least 50.0% of the standards. Manuscripts most completely followed guidelines regarding "patient factors" and were least likely to demonstrate adherence to the description of CLTI and study complications. Within the guideline subcategories, complete adherence to guidelines was not demonstrated in any manuscript in stent trials, disease outcome measures, technical outcome measures, patient factors and critical limb ischemia description, and complete adherence rates within the other subcategories was low (range, 5.6-18.6%). Studies conducted within the United States and those with industry sponsorship were more likely to adhere to >50% of the reporting standards (P < 0.05). Journal impact factor, year of publication, and number of authors had no correlation to the percent adherence to guidelines in specific categories or adherence overall.
Conclusions: Adherence to reporting standard guidelines for endovascular treatment of lower extremity PAD specifically outlined by the SVS is suboptimal regardless of the quality of the journal the research is published in. Increasing adherence to reporting standards to provide a framework for comparison of studies across techniques used should be prioritized by authors, journal editors, and vascular societies.
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http://dx.doi.org/10.1016/j.avsg.2024.06.013 | DOI Listing |
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