Abstract：
Adequate reporting of limitations is crucial to enable clinicians to accurately interpret the clinical trial findings. This meta-epidemiological study aimed to evaluate whether study limitations are reported in full-text articles of randomized controlled trials (RCTs) published in the leading dental journals. Associations between the trial characteristics and the reporting of limitations were also explored.
RCTs published between 1st January and 31st December in the years 2011, 2016 and 2021 were identified from the 12 high impact factor dental journals (general and specialty). RCT characteristics were extracted, and reporting of limitations was recorded for the selected studies. Descriptive statistics were calculated for trial and limitations related characteristics. Univariable ordinal logistic regression models were fit to explore univariable associations between trial characteristics and reporting of limitations.
Two hundred and sixty-seven trials were included and analyzed. Most RCTs were published in 2021 (40.8%), had authors based in Europe (50.2%), did not have a statistician involved (88.8%) and assessed a procedure/method intervention type (40.5%). The reporting of trial limitations was generally sub-optimal. More recent trials and studies with a published protocol were associated with better reporting of limitations. The type of journal was a significant predictor for limitation reporting.
Within this study, the clear reporting of study limitations in the manuscripts of dental RCTs is sub-optimal and requires improvement.
The reporting of limitations should not be viewed as a weakness of a trial but due diligence, so clinicians can fully interpret the impact of these limitations on both the validity and generalisability of the results.
RCTs published between 1st January and 31st December in the years 2011, 2016 and 2021 were identified from the 12 high impact factor dental journals (general and specialty). RCT characteristics were extracted, and reporting of limitations was recorded for the selected studies. Descriptive statistics were calculated for trial and limitations related characteristics. Univariable ordinal logistic regression models were fit to explore univariable associations between trial characteristics and reporting of limitations.
Two hundred and sixty-seven trials were included and analyzed. Most RCTs were published in 2021 (40.8%), had authors based in Europe (50.2%), did not have a statistician involved (88.8%) and assessed a procedure/method intervention type (40.5%). The reporting of trial limitations was generally sub-optimal. More recent trials and studies with a published protocol were associated with better reporting of limitations. The type of journal was a significant predictor for limitation reporting.
Within this study, the clear reporting of study limitations in the manuscripts of dental RCTs is sub-optimal and requires improvement.
The reporting of limitations should not be viewed as a weakness of a trial but due diligence, so clinicians can fully interpret the impact of these limitations on both the validity and generalisability of the results.
摘要：
目的：充分报告局限性对于临床医生准确解释临床试验结果至关重要。这项元流行病学研究旨在评估研究局限性是否在领先的牙科期刊上发表的随机对照试验（RCT）全文文章中报道。还探讨了试验特征与局限性报告之间的关联。
方法：2011年、2016年和2021年1月1日至12月31日发表的RCT从12个高影响因子牙科期刊（一般和专业）中确定。提取RCT特征,并记录所选研究的局限性报告.对试验和局限性相关特征进行描述性统计。单变量序数逻辑回归模型适用于探索试验特征和局限性报告之间的单变量关联。
结果：纳入并分析了230项试验。大多数RCT于2021年发布（40.8%），作者来自欧洲（50.2%），没有参与的统计学家（88.8%），并评估了程序/方法干预类型（40.5%）。试验限制的报告通常是次优的。最近的试验和研究发表的方案与更好的局限性报告相关。期刊类型是限制报告的重要预测因子。
结论：在本研究中，在牙科随机对照试验的手稿中明确报告研究局限性并不理想,需要改进.
结论：限制报告不应被视为试验的弱点，而应视为尽职调查，因此，临床医生可以充分解释这些局限性对结果的有效性和普遍性的影响。
方法：2011年、2016年和2021年1月1日至12月31日发表的RCT从12个高影响因子牙科期刊（一般和专业）中确定。提取RCT特征,并记录所选研究的局限性报告.对试验和局限性相关特征进行描述性统计。单变量序数逻辑回归模型适用于探索试验特征和局限性报告之间的单变量关联。
结果：纳入并分析了230项试验。大多数RCT于2021年发布（40.8%），作者来自欧洲（50.2%），没有参与的统计学家（88.8%），并评估了程序/方法干预类型（40.5%）。试验限制的报告通常是次优的。最近的试验和研究发表的方案与更好的局限性报告相关。期刊类型是限制报告的重要预测因子。
结论：在本研究中，在牙科随机对照试验的手稿中明确报告研究局限性并不理想,需要改进.
结论：限制报告不应被视为试验的弱点，而应视为尽职调查，因此，临床医生可以充分解释这些局限性对结果的有效性和普遍性的影响。
