小柯机器人

瑞士巴塞尔大学医院Lars G Hemkens团队研究了使用常规收集数据进行疗效评估的随机试验与传统试验的疗效比较。2021年3月3日，该研究发表在《英国医学杂志》上。

为了比较使用常规收集数据的随机临床试验（RCD-RCT）与不使用常规收集数据的传统试验的疗效评估结果，研究组在Cochrane综述中纳入同一荟萃分析的研究，再进行荟萃分析。

随机效应荟萃分析总结了使用或不使用常规收集数据的试验的疗效评估。使用常规收集数据和不使用此类数据的试验的（总结）治疗效果评估的一致性用优势比表示。亚组分析探讨了基于不同类型常规收集数据的试验效果。由两名研究人员独立评估每个数据源的质量。

研究组共纳入随机对照试验84项，传统试验463项，涉及22个临床问题。使用常规收集数据来确定结果的试验显示，比传统试验的治疗效果估计值低20%，比值比为0.80。不同类型的患者结局、数据来源和数据质量的评估结果均相差不大。

研究结果表明，使用常规收集数据来确定结果的随机临床试验，与不使用常规收集数据的传统试验相比，治疗效益显著降低。

附：英文原文

Title: Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study

Author: Kimberly A Mc Cord, Hannah Ewald, Arnav Agarwal, Dominik Glinz, Soheila Aghlmandi, John P A Ioannidis, Lars G Hemkens

Issue&Volume: 2021/03/03

Abstract:

Objective 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.

Design Meta-research study.

Data source Studies included in the same meta-analysis in a Cochrane review.

Eligibility criteria for study selection 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.

Review methods 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.

Results 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, I2=14%). Results were similar across various types of outcomes (mortality outcomes: 0.92, 0.74 to 1.15, I2=12%; non-mortality outcomes: 0.71, 0.60 to 0.84, I2=8%), data sources (electronic health records: 0.81, 0.59 to 1.11, I2=28%; registries: 0.86, 0.75 to 0.99, I2=20%; administrative data: 0.84, 0.72 to 0.99, I2=0%), and data quality (high data quality: 0.82, 0.72 to 0.93, I2=0%).

Conclusions 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.

DOI: 10.1136/bmj.n450

Source: https://www.bmj.com/content/372/bmj.n450

BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
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