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Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study. 2021

Kimberly A Mc Cord, and Hannah Ewald, and Arnav Agarwal, and Dominik Glinz, and Soheila Aghlmandi, and John P A Ioannidis, and Lars G Hemkens
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, 4031 Basel, Switzerland.

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, 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%). 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.

UI MeSH Term Description Entries
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000085143 Routinely Collected Health Data Data collected for purposes other than research. Examples include health administrative data, electronic health record data, and disease or clinical registry data. Health Administrative Data,Registry Data,Routinely Collected Data,Routinely-Collected Data,Routinely-Collected Health Data,Wearable Device Data,Administrative Data, Health,Data, Health Administrative,Data, Registry,Data, Routinely-Collected,Data, Wearable Device,Device Data, Wearable,Health Administrative Datas,Health Data, Routinely-Collected
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D017063 Outcome Assessment, Health Care Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure). Assessment, Outcome,Outcome Assessment,Outcome Assessment (Health Care),Outcomes Research,Assessment, Outcomes,Outcome Measures,Outcome Studies,Outcomes Assessment,Assessment, Outcome (Health Care),Assessments, Outcome,Assessments, Outcome (Health Care),Assessments, Outcomes,Measure, Outcome,Measures, Outcome,Outcome Assessments,Outcome Assessments (Health Care),Outcome Measure,Outcome Study,Outcomes Assessments,Research, Outcomes,Studies, Outcome,Study, Outcome

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