TY - JOUR
T1 - Benchmarking Observational Analyses Before Using Them to Address Questions Trials Do Not Answer
T2 - An Application to Coronary Thrombus Aspiration
AU - Matthews, Anthony A.
AU - Dahabreh, Issa J.
AU - Fröbert, Ole
AU - Lindahl, Bertil
AU - James, Stefan
AU - Feychting, Maria
AU - Jernberg, Tomas
AU - Berglund, Anita
AU - Hernán, Miguel A.
N1 - Publisher Copyright:
© The Author(s) 2022. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.
PY - 2022/9
Y1 - 2022/9
N2 - To increase confidence in the use of observational analyses when addressing effectiveness questions beyond those addressed by randomized trials, one can first benchmark the observational analyses against existing trial results. We used Swedish registry data to emulate a target trial similar to the Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) randomized trial, which found no difference in the risk of death or myocardial infarction by 1 year with or without thrombus aspiration among individuals with ST-elevation myocardial infarction. We benchmarked the emulation against the trial at 1 year and then extended the emulation's follow-up to 3 years and estimated effects in subpopulations underrepresented in the trial. As in the TASTE trial, the observational analysis found no differences in risk of outcomes by 1 year between groups (risk difference = 0.7 (confidence interval, -0.7, 2.0) and -0.2 (confidence interval, -1.3, 1.0) for death and myocardial infarction, respectively), so benchmarking was considered successful. We additionally showed no difference in risk of death or myocardial infarction by 3 years, or within subpopulations by 1 year. Benchmarking against an index trial before using observational analyses to answer questions beyond those the trial could address allowed us to explore whether the observational data can be trusted to deliver valid estimates of treatment effects.
AB - To increase confidence in the use of observational analyses when addressing effectiveness questions beyond those addressed by randomized trials, one can first benchmark the observational analyses against existing trial results. We used Swedish registry data to emulate a target trial similar to the Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) randomized trial, which found no difference in the risk of death or myocardial infarction by 1 year with or without thrombus aspiration among individuals with ST-elevation myocardial infarction. We benchmarked the emulation against the trial at 1 year and then extended the emulation's follow-up to 3 years and estimated effects in subpopulations underrepresented in the trial. As in the TASTE trial, the observational analysis found no differences in risk of outcomes by 1 year between groups (risk difference = 0.7 (confidence interval, -0.7, 2.0) and -0.2 (confidence interval, -1.3, 1.0) for death and myocardial infarction, respectively), so benchmarking was considered successful. We additionally showed no difference in risk of death or myocardial infarction by 3 years, or within subpopulations by 1 year. Benchmarking against an index trial before using observational analyses to answer questions beyond those the trial could address allowed us to explore whether the observational data can be trusted to deliver valid estimates of treatment effects.
KW - benchmarking
KW - causal inference
KW - observational analyses
KW - randomized trial
KW - target trial emulation
KW - ST Elevation Myocardial Infarction/therapy
KW - Humans
KW - Benchmarking
KW - Thrombectomy/methods
KW - Treatment Outcome
KW - Coronary Thrombosis/therapy
KW - Myocardial Infarction
KW - Percutaneous Coronary Intervention
UR - http://www.scopus.com/inward/record.url?scp=85136478851&partnerID=8YFLogxK
U2 - 10.1093/aje/kwac098
DO - 10.1093/aje/kwac098
M3 - Journal article
C2 - 35641151
AN - SCOPUS:85136478851
SN - 0002-9262
VL - 191
SP - 1652
EP - 1665
JO - American Journal of Epidemiology
JF - American Journal of Epidemiology
IS - 9
ER -