双重提取可减少数据提取的错误率

Effects of double data extraction on errors in evidence synthesis: a crossover, multicenter, investigator-blinded, randomized controlled trial

双重数据提取对证据综合误差的影响：一项交叉、多中心、研究者设盲的随机对照试验

Authors: Lijun Tang, Ruoxi Wang, Suhail A R Doi, Luis Furuya-Kanamori, Lifeng Lin, Zongshi Qin, Fangbiao Tao, Chang Xu.

Source: Postgrad Med J.

Doi: 10.1093/postmj/qgae195. 

Abstract

Objectives: The objective was to investigate the role of double extraction in reducing data errors in evidence synthesis for pharmaceutical and non-pharmaceutical interventions.

Design: Crossover randomized controlled trial (RCT).

Setting: University and hospital with teaching programs in evidence-based medicine.

Participants: One hundred eligible participants were randomly assigned in a 1:1 ratio to perform data extraction tasks for either 10 RCTs of pharmaceutical interventions or 10 RCTs of non-pharmaceutical interventions, followed by a crossover pattern and a further cross-checking process (double extraction). Only data on binary adverse outcomes were extracted.

Intervention: Double data extraction versus single extraction.

Primary and secondary outcome measures:The primary outcome was the error rate before and after the cross-checking process. The secondary outcome was the absolute difference in error rates. Error rates were assessed at both the study level and the cell level.

Results: Error rates in the pharmaceutical and non-pharmaceutical groups were 64.65% and 59.90%, respectively, with an absolute difference of 4.75% and an odds ratio (OR) of 1.29 [95% confidence interval (CI): 1.06-1.57, P = .01] when measured at the study level. After cross-checking, error rates decreased to 44.88% and 39.54%, with the difference between the two groups remaining at 5.34%, and an OR of 1.27 (95%CI: 1.1-1.46; P < .01). Similar differences were observed when measured at the cell level.

Conclusion: Although double extraction reduced data errors, the error rate remained high after the process. Evidence synthesis research may consider triple data extraction to further minimize potential data errors.

Trial registration number: Chinese Clinical Trial Registry Center (Identifier: ChiCTR2200062206).

Keywords: cross-checking; data extraction errors; evidence synthesis; randomized controlled trial.

摘要

目的：目的是探讨双重数据提取在减少药物和非药物干预证据综合数据错误中的作用。

设计：交叉随机对照试验（Crossover randomized controlled trial ，RCT）。

地点：拥有循证医学教学项目的大学和医院。

参与者：100名符合条件的参与者以1:1的比例随机分配，执行10项药物干预的RCT或10项非药物干预RCT的数据提取任务，然后采用交叉设计并进行进一步的交叉检查过程（双重数据提取）。仅提取了二分类不良结局的数据。

干预：双重数据提取与单次提取。

主要和次要结局指标：主要结局指标是交叉检查过程前后的错误率。次要结局指标是错误率的绝对差异。在研究水平和单元格水平上评估错误率。

结果：在研究水平的评估中，药物组和非药物组的错误率分别为64.65%和59.90%，绝对差异为4.75%，OR：1.29 [95%CI：1.06-1.57，P = .01]。交叉检查后，错误率降至44.88%和39.54%，两组差异保持在5.34%，OR：1.27（95%CI：1.1-1.46; P＜0 .01）。在单元水平评估中观察到类似的差异。

结论：虽然双重数据提取减少了数据错误，但处理后错误率仍然很高。证据综合研究可以考虑三重数据提取，以进一步减少潜在的数据错误。

试验注册号：Chinese Clinical Trial Registry Center（标识符：ChiCTR2200062206）。

关键词：交叉检查；数据提取错误；证据综合；随机对照试验。