Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, 4031 Basel, Switzerland.
University Medical Library, University of Basel, Basel, Switzerland.
BMJ. 2021 Mar 3;372:n450. doi: 10.1136/bmj.n450.
To compare effect estimates of randomised clinical trials that use routinely collected data (RCD-RCT) for outcome ascertainment with traditional trials not using routinely collected data.
Meta-research study.
Studies included in the same meta-analysis in a Cochrane review.
Randomised clinical trials using any type of routinely collected data for outcome ascertainment, including from registries, electronic health records, and administrative databases, that were included in a meta-analysis of a Cochrane review on any clinical question and any health outcome together with traditional trials not using routinely collected data for outcome measurement.
Effect estimates from trials using or not using routinely collected data were summarised in random effects meta-analyses. Agreement of (summary) treatment effect estimates from trials using routinely collected data and those not using such data was expressed as the ratio of odds ratios. Subgroup analyses explored effects in trials based on different types of routinely collected data. Two investigators independently assessed the quality of each data source.
84 RCD-RCTs and 463 traditional trials on 22 clinical questions were included. Trials using routinely collected data for outcome ascertainment showed 20% less favourable treatment effect estimates than traditional trials (ratio of odds ratios 0.80, 95% confidence interval 0.70 to 0.91, I=14%). Results were similar across various types of outcomes (mortality outcomes: 0.92, 0.74 to 1.15, I=12%; non-mortality outcomes: 0.71, 0.60 to 0.84, I=8%), data sources (electronic health records: 0.81, 0.59 to 1.11, I=28%; registries: 0.86, 0.75 to 0.99, I=20%; administrative data: 0.84, 0.72 to 0.99, I=0%), and data quality (high data quality: 0.82, 0.72 to 0.93, I=0%).
Randomised clinical trials using routinely collected data for outcome ascertainment show smaller treatment benefits than traditional trials not using routinely collected data. These differences could have implications for healthcare decision making and the application of real world evidence.
比较使用常规收集数据（RCD-RCT）进行结局评估的随机临床试验与不使用常规收集数据的传统试验的效果估计值。
元研究。
同一 Cochrane 综述中包含的同一荟萃分析中的研究。
使用任何类型的常规收集数据（包括来自登记处、电子健康记录和行政数据库）进行结局评估的随机临床试验，以及纳入 Cochrane 综述中关于任何临床问题和任何健康结局的传统试验，不使用常规收集数据进行结局测量。
使用或不使用常规收集数据的试验的效应估计值在随机效应荟萃分析中进行总结。使用常规收集数据的试验和不使用此类数据的试验的（汇总）治疗效果估计值的一致性表示为比值比的比值。亚组分析探讨了基于不同类型常规收集数据的试验的效果。两名调查员独立评估了每个数据源的质量。
纳入了 22 个临床问题的 84 项 RCD-RCT 和 463 项传统试验。使用常规收集数据进行结局评估的试验的治疗效果估计值比传统试验低 20%（比值比为 0.80，95%置信区间为 0.70 至 0.91，I=14%）。结果在各种结局类型（死亡率结局：0.92，0.74 至 1.15，I=12%；非死亡率结局：0.71，0.60 至 0.84，I=8%）、数据来源（电子健康记录：0.81，0.59 至 1.11，I=28%；登记处：0.86，0.75 至 0.99，I=20%；行政数据：0.84，0.72 至 0.99，I=0%）和数据质量（高数据质量：0.82，0.72 至 0.93，I=0%）方面相似。
使用常规收集数据进行结局评估的随机临床试验显示出比不使用常规收集数据的传统试验更小的治疗益处。这些差异可能对医疗保健决策和真实世界证据的应用产生影响。
