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Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study
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 re...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group Ltd.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926294/ https://www.ncbi.nlm.nih.gov/pubmed/33658187 http://dx.doi.org/10.1136/bmj.n450 |
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author | Mc Cord, Kimberly A Ewald, Hannah Agarwal, Arnav Glinz, Dominik Aghlmandi, Soheila Ioannidis, John P A Hemkens, Lars G |
author_facet | Mc Cord, Kimberly A Ewald, Hannah Agarwal, Arnav Glinz, Dominik Aghlmandi, Soheila Ioannidis, John P A Hemkens, Lars G |
author_sort | Mc Cord, Kimberly A |
collection | PubMed |
description | 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, I(2)=14%). Results were similar across various types of outcomes (mortality outcomes: 0.92, 0.74 to 1.15, I(2)=12%; non-mortality outcomes: 0.71, 0.60 to 0.84, I(2)=8%), data sources (electronic health records: 0.81, 0.59 to 1.11, I(2)=28%; registries: 0.86, 0.75 to 0.99, I(2)=20%; administrative data: 0.84, 0.72 to 0.99, I(2)=0%), and data quality (high data quality: 0.82, 0.72 to 0.93, I(2)=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. |
format | Online Article Text |
id | pubmed-7926294 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-79262942021-03-19 Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study Mc Cord, Kimberly A Ewald, Hannah Agarwal, Arnav Glinz, Dominik Aghlmandi, Soheila Ioannidis, John P A Hemkens, Lars G BMJ Research 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, I(2)=14%). Results were similar across various types of outcomes (mortality outcomes: 0.92, 0.74 to 1.15, I(2)=12%; non-mortality outcomes: 0.71, 0.60 to 0.84, I(2)=8%), data sources (electronic health records: 0.81, 0.59 to 1.11, I(2)=28%; registries: 0.86, 0.75 to 0.99, I(2)=20%; administrative data: 0.84, 0.72 to 0.99, I(2)=0%), and data quality (high data quality: 0.82, 0.72 to 0.93, I(2)=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. BMJ Publishing Group Ltd. 2021-03-03 /pmc/articles/PMC7926294/ /pubmed/33658187 http://dx.doi.org/10.1136/bmj.n450 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Research Mc Cord, Kimberly A Ewald, Hannah Agarwal, Arnav Glinz, Dominik Aghlmandi, Soheila Ioannidis, John P A Hemkens, Lars G Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study |
title | Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study |
title_full | Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study |
title_fullStr | Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study |
title_full_unstemmed | Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study |
title_short | Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study |
title_sort | treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926294/ https://www.ncbi.nlm.nih.gov/pubmed/33658187 http://dx.doi.org/10.1136/bmj.n450 |
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