Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
PLoS One. 2024 Jan 2;19(1):e0292184. doi: 10.1371/journal.pone.0292184. eCollection 2024.
Transparent and detailed reporting of randomized controlled trials (RCTs) is essential to judge its validity and generalizability. We assessed the reporting quality of RCTs examining the effects of inulin-type fructans supplementation on cardiovascular risk factors, before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) in 2010.
We searched MEDLINE, EMBASE, Emcare, AMED, the Cochrane Library, and CINAHL from inception to May 15, 2022, including the reference lists of selected RCTs. We screened titles and abstracts and extracted the data independently and in duplicate. We included RCTs that investigated the effects of inulin-type fructans on cardiovascular disease risk factors (e.g., low-density lipoprotein cholesterol, triglycerides, fasting blood glucose) in adults (18 years or older). The primary outcomes of this study were: the overall reporting quality of RCTs (defined as the total number of items [0 to 36] present from the CONSORT checklist) published before and after CONSORT; and the study characteristics (e.g., sample size, significance of primary outcome) predictive of the CONSORT score. The secondary outcome was the reporting of each specific item of the CONSORT checklist during pre- and post-CONSORT periods. The mean difference in the total number of reported items in studies published before and after CONSORT were compared using a t-test and Poisson regression to explore the factors associated with overall reporting quality of RCTs. We used Fisher's exact test to compare the adherence to each of the 36 items during pre- and post-CONSORT periods.
We identified 1,767 citations from our systematic search, of which 55 were eligible. There was a significant increase in the reporting of CONSORT items (mean difference 8.5, 95% confidence interval [CI] 5.24 to 11.71) between studies published before and after publication of CONSORT. The sole variable that was predictive of better reporting quality of RCTs was whether the study was published before or after CONSORT (incidence rate ratio 1.67, 95% CI 1.40 to 2.02). Completeness of reporting of RCTs only improved in 15 out of 36 items (41.6%) after the publication of CONSORT.
The completeness of reporting in RCTs investigating inulin-type fructans supplementation on cardiovascular disease risk factors remains inadequate after the publication of CONSORT. Greater adherence to CONSORT by authors and enforcement of CONSORT by journals may improve the quality of reporting among RCTs.
透明和详细的报告随机对照试验（RCT）对于判断其有效性和可推广性至关重要。我们评估了在 2010 年 CONSORT 报告标准发布前后，关于菊粉型果聚糖补充对心血管风险因素影响的 RCT 的报告质量。
我们从开始到 2022 年 5 月 15 日在 MEDLINE、EMBASE、Emcare、AMED、Cochrane 图书馆和 CINAHL 进行了搜索，包括选定 RCT 的参考文献列表。我们独立地筛选标题和摘要并提取数据。我们纳入了研究菊粉型果聚糖对成年人（18 岁或以上）心血管疾病风险因素（如低密度脂蛋白胆固醇、甘油三酯、空腹血糖）影响的 RCT。本研究的主要结局是：在 CONSORT 之前和之后发表的 RCT 的总体报告质量（定义为 CONSORT 清单上存在的项目总数[0 至 36]）；以及预测 CONSORT 评分的研究特征（例如，样本量、主要结局的显著性）。次要结局是在 CONSORT 前后时期报告 CONSORT 清单的每个特定项目。使用 t 检验和泊松回归比较 CONSORT 前后发表的研究中报告项目总数的平均值差异，以探讨与 RCT 总体报告质量相关的因素。我们使用 Fisher 精确检验比较 CONSORT 前后时期对 36 个项目中每个项目的遵守情况。
我们从系统搜索中确定了 1767 条引文，其中 55 条符合条件。在 CONSORT 发布前后发表的研究中，CONSORT 项目的报告数量显著增加（平均差异 8.5，95%置信区间 [CI] 5.24 至 11.71）。唯一可以预测 RCT 报告质量更好的变量是研究是在 CONSORT 之前还是之后发表的（发生率比 1.67，95%CI 1.40 至 2.02）。在 CONSORT 发布后，仅在 36 个项目中的 15 个（41.6%）项目中报告 RCT 的完整性有所提高。
在 CONSORT 发布后，关于菊粉型果聚糖补充对心血管疾病风险因素影响的 RCT 的报告完整性仍然不足。作者更严格地遵守 CONSORT 标准，期刊更严格地执行 CONSORT 标准，可能会提高 RCT 报告的质量。
