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Evaluating the Quality of Reporting in Randomized Controlled Trial Abstracts on Diabetic Foot: A Cross-Sectional
Luciana Tonkic1, Marin Rudan2, Tanja Milicevic Milardovic1
1Department of Internal Medicine, Division of Endocrinology, Diabetology and Metabolism, University Hospital of Split, 21000 Split, Croatia.
Abstract:
Background/Objectives: The aim of this study was to assess the extent to which published abstracts of randomized controlled trials on diabetic foot complied with the Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) guidelines and to identify factors associated with the quality of reporting. Methods: A cross-sectional observational study was designed using the MEDLINE/PubMed database, and the timeframe from 1994 to 2026 was covered by this review. In total, 606 abstracts of randomized controlled trials (RCTs) focusing on diabetic foot were assessed for compliance with the CONSORT-A checklist criteria. Results: Ratio of non-pharmacological and pharmacological studies was approximately 1:1. Most of the included abstracts did not report a multicenter design (84.3%) and reported less than one hundred participants included (78.9%). The median total score was six of 17 items (35.29%, IQR 29.41-47.06%). The objective of the study, conclusion and intervention had been reported by over ninety percent of the studies. Randomization method (3.6%), funding (4.8%), recruitment process (6.8%) and numbers of analyzed participants in the study (7.4%) were all reported by less than ten percent of the abstracts. Following CONSORT-A, in 2008, median abstract reporting score improved from 35.29% to 41.18% (p < 0.001). Conclusions: However, segmented regression showed a secular trend of +0.63 percentage points per year (95% CI 0.14-1.12, p = 0.012) with no change in level (p = 0.261) or slope (p = 0.278) at 2008, indicating that the improvement is not attributable to the guideline itself.