TY - JOUR
T1 - Routinely collected data for randomized trials
T2 - promises, barriers, and implications
AU - Mc Cord, Kimberly A.
AU - Al-Shahi Salman, Rustam
AU - Treweek, Shaun P
AU - Gardner, Heidi Rebecca
AU - Strech, Daniel
AU - Whiteley, William
AU - Ioannidis, John P. A.
AU - Hemkens, Lars
N1 - This work was supported by Stiftung Institut für klinische Epidemiologie. The Meta-Research Innovation Center at Stanford University is funded by a grant from the Laura and John Arnold Foundation. The funders had no role in design and conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript or its submission for publication.
PY - 2018/1/11
Y1 - 2018/1/11
N2 - Routinely collected health data (RCD) are increasingly used for randomized controlled trials (RCTs). This can provide three major benefits: increasing value through better feasibility (reducing costs, time, and resources), expanding the research agenda (performing trials for research questions otherwise not amenable to trials), and offering novel design and data collection options (e.g., point-of-care trials and other designs directly embedded in routine care). However, numerous hurdles and barriers must be considered pertaining to regulatory, ethical, and data aspects, as well as the costs of setting up the RCD infrastructure. Methodological considerations may be different from those in traditional RCTs: RCD are often collected by individuals not involved in the study and who are therefore blinded to the allocation of trial participants. Another consideration is that RCD trials may lead to greater misclassification biases or dilution effects, although these may be offset by randomization and larger sample sizes. Finally, valuable insights into external validity may be provided when using RCD because it allows pragmatic trials to be performed.
AB - Routinely collected health data (RCD) are increasingly used for randomized controlled trials (RCTs). This can provide three major benefits: increasing value through better feasibility (reducing costs, time, and resources), expanding the research agenda (performing trials for research questions otherwise not amenable to trials), and offering novel design and data collection options (e.g., point-of-care trials and other designs directly embedded in routine care). However, numerous hurdles and barriers must be considered pertaining to regulatory, ethical, and data aspects, as well as the costs of setting up the RCD infrastructure. Methodological considerations may be different from those in traditional RCTs: RCD are often collected by individuals not involved in the study and who are therefore blinded to the allocation of trial participants. Another consideration is that RCD trials may lead to greater misclassification biases or dilution effects, although these may be offset by randomization and larger sample sizes. Finally, valuable insights into external validity may be provided when using RCD because it allows pragmatic trials to be performed.
KW - routinely collected health data
KW - electronic health records
KW - registries
KW - evidence-based medicine
KW - trials
KW - clinical epidemiology
U2 - 10.1186/s13063-017-2394-5
DO - 10.1186/s13063-017-2394-5
M3 - Article
VL - 19
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 29
ER -