Department of Anesthesiology, University Hospital RWTH Aachen, Aachen, Germany.
Department of Dermatology, Fachklinik Hornweide, Muenster, Germany.
PLoS One. 2023 Oct 16;18(10):e0292860. doi: 10.1371/journal.pone.0292860. eCollection 2023.
Transparent and complete reporting of randomized controlled trials (RCTs) is essential for critical scientific appraisal of the results. It has been argued whether publications during the COVID-19 pandemic have met reporting standards. In this study, we assessed reporting adherence of RCTs on treatment interventions in COVID-19 patients to the CONSORT checklist and discuss which lessons can be learned to improve reporting in the future.
This was a retrospective, cross-sectional study performed at the University Hospital RWTH Aachen, Germany. We conducted a pragmatic systematic literature search in the PubMed database to identify RCTs on treatment interventions in COVID-19 patients in the first year of publications on the topic (March 2020-February 2021). We investigated the adherence of each publication to the CONSORT checklist and assessed the association between specific predictors and percentage adherence in an exploratory multivariable regression model.
We analyzed 127 RCTs and found that the median percentage adherence to the CONSORT checklist was 54.3% [IQR 38.9 to 65.7]. In the exploratory multivariable regression model, the impact factor (highest tertile of impact factor compared to lowest tertile ß = 21.77, 95% CI 13.89 to 29.66, p<0.001; middle tertile compared lowest tertile ß = 11.79, 95% CI 5.74 to 17.84, p<0.001)) and authors' referral to the CONSORT statement (ß = 9.29, 95% CI 2.98 to 15.60, p = 0.004) were associated with a higher percentage adherence to the CONSORT checklist.
The reporting quality of RCTs on treatment interventions in COVID-19 patients during the first year of publications was poor. Measures to improve reporting quality are urgently needed.
随机对照试验（RCT）的透明和完整报告对于批判性评估结果至关重要。有人质疑在 COVID-19 大流行期间发表的出版物是否符合报告标准。在这项研究中，我们评估了 COVID-19 患者治疗干预 RCT 对 CONSORT 清单的报告遵循情况，并讨论了可以吸取哪些经验教训以提高未来的报告质量。
这是一项在德国亚琛 RWTH 大学医院进行的回顾性、横断面研究。我们在 PubMed 数据库中进行了一项实用的系统文献搜索，以确定在主题发表的第一年（2020 年 3 月至 2021 年 2 月）发表的 COVID-19 患者治疗干预 RCT。我们调查了每个出版物对 CONSORT 清单的遵循情况，并在探索性多变量回归模型中评估了特定预测因素与百分比遵循之间的关联。
我们分析了 127 项 RCT，发现 CONSORT 清单的中位数百分比遵循率为 54.3%[IQR 38.9 至 65.7]。在探索性多变量回归模型中，影响因素（与最低三分位相比，最高三分位的影响因素 ß=21.77，95%CI 13.89 至 29.66，p<0.001；中间三分位与最低三分位相比 ß=11.79，95%CI 5.74 至 17.84，p<0.001）和作者对 CONSORT 声明的引用（ß=9.29，95%CI 2.98 至 15.60，p=0.004）与 CONSORT 清单的更高百分比遵循率相关。
在出版物发表的第一年，COVID-19 患者治疗干预 RCT 的报告质量较差。迫切需要采取措施提高报告质量。
