Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, 150040, People's Republic of China.
The First Department of Cardiovascular, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, 26 Heping Road, Xiangfang, Harbin, Heilongjiang, 150040, People's Republic of China.
Sci Rep. 2024 Mar 21;14(1):6819. doi: 10.1038/s41598-024-57514-z.
Randomised controlled trials (RCTs) provide clinicians with the best evidence of the effectiveness of an intervention, and complete and transparent trial reports help to critically assess and use trial results. The objective of our study was to assess the quality of reporting in RCTs of sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for heart failure (HF) and identify factors associated with improved reporting quality. Two researchers conducted a comprehensive search in four databases (PubMed, Web of Science, EMBASE, and Cochrane). The quality of each report was assessed using a 25-point Overall Quality Score (OQS) based on the guidelines provided in the 2010 Consolidated Standards for Reporting of Trials (CONSORT) statement. We included a total of 58 relevant RCTs. The median OQS in the 2010 CONSORT statement was 15 (range 7.5-24). The missing items were primarily found in the 'Methods' and 'Results' sections of the 2010 CONSORT statement. Multivariate regression modeling revealed that a more recent publication year, high impact factor, and large sample size were significant predictors of OQS improvement. The findings suggest that the overall quality of reported RCTs of SGLT2 inhibitors in HF is unsatisfactory, which reduces their potential usefulness.
随机对照试验(RCTs)为临床医生提供了干预措施有效性的最佳证据,而完整和透明的试验报告有助于批判性地评估和使用试验结果。我们的研究目的是评估钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂治疗心力衰竭(HF)的 RCT 报告质量,并确定与报告质量提高相关的因素。两位研究人员在四个数据库(PubMed、Web of Science、EMBASE 和 Cochrane)中进行了全面检索。每个报告的质量使用基于 2010 年 CONSORT 声明提供的指南的 25 分总体质量评分(OQS)进行评估。我们共纳入了 58 项相关 RCT。2010 年 CONSORT 声明中的中位数 OQS 为 15 分(范围为 7.5-24 分)。缺失的项目主要出现在 2010 年 CONSORT 声明的“方法”和“结果”部分。多变量回归模型显示,较新的出版年份、高影响因子和较大的样本量是 OQS 提高的显著预测因素。研究结果表明,HF 中 SGLT2 抑制剂报告的 RCT 总体质量不尽如人意,降低了它们的潜在有用性。