TY - JOUR
T1 - Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI
AU - Laursen, Peter Nørkjær
AU - Holmvang, Lene
AU - Lønborg, Jacob
AU - Køber, Lars
AU - Høfsten, Dan E
AU - Helqvist, Steffen
AU - Clemmensen, Peter
AU - Kelbæk, Henning
AU - Jørgensen, Erik
AU - Lassen, Jens Flensted
AU - Pedersen, Frants
AU - Høi-Hansen, Thomas
AU - Raungaard, Bent
AU - Terkelsen, Christian Juhl
AU - Jensen, Lisette Okkels
AU - Sadjadieh, Golnaz
AU - Engstrøm, Thomas
N1 - Copyright � 2019 Elsevier B.V. All rights reserved.
PY - 2019/8/15
Y1 - 2019/8/15
N2 - AIMS: To assess the impact of sampling bias due to reported as well as unreported exclusion of the target population in a multi-center randomized controlled trial (RCT) of ST-elevation myocardial infarction (STEMI).METHODS AND RESULTS: We compared clinical characteristics and mortality between participants in the DANAMI-3 trial to contemporary non-participants with STEMI using unselected registries. A total of 179 DANAMI-3 participants (8%) and 617 contemporary non-participants (22%) had died (Log-Rank: P?<?0.001) after a median follow-up of 1333?days (range: 1-2021?days). In an unadjusted Cox regression model all groups of non-participants had a higher hazard ratio to predict mortality compared to participants: eligible excluded (n?=?144) (hazard ratio: 3.41 (95% CI: (2.69-4.32)), ineligible excluded (n?=?472) (hazard ratio: 3.42 (95% CI: (2.44-4.80), eligible non-screened (n?=?154) (hazard ratio: 3.37 (95% CI: (2.36-4.82)), ineligible non-screened (n?=?154) (hazard ratio: 6.48 (95% CI: (4.77-8.80).CONCLUSION: Sampling bias had occurred due to both reported and unreported exclusion of eligible patients and the difference in mortality between participants and non-participants could not be explained only by the trial exclusion criteria. Thus, screening logs may not be suited to address the risks of sampling bias.
AB - AIMS: To assess the impact of sampling bias due to reported as well as unreported exclusion of the target population in a multi-center randomized controlled trial (RCT) of ST-elevation myocardial infarction (STEMI).METHODS AND RESULTS: We compared clinical characteristics and mortality between participants in the DANAMI-3 trial to contemporary non-participants with STEMI using unselected registries. A total of 179 DANAMI-3 participants (8%) and 617 contemporary non-participants (22%) had died (Log-Rank: P?<?0.001) after a median follow-up of 1333?days (range: 1-2021?days). In an unadjusted Cox regression model all groups of non-participants had a higher hazard ratio to predict mortality compared to participants: eligible excluded (n?=?144) (hazard ratio: 3.41 (95% CI: (2.69-4.32)), ineligible excluded (n?=?472) (hazard ratio: 3.42 (95% CI: (2.44-4.80), eligible non-screened (n?=?154) (hazard ratio: 3.37 (95% CI: (2.36-4.82)), ineligible non-screened (n?=?154) (hazard ratio: 6.48 (95% CI: (4.77-8.80).CONCLUSION: Sampling bias had occurred due to both reported and unreported exclusion of eligible patients and the difference in mortality between participants and non-participants could not be explained only by the trial exclusion criteria. Thus, screening logs may not be suited to address the risks of sampling bias.
U2 - 10.1016/j.ijcard.2019.04.064
DO - 10.1016/j.ijcard.2019.04.064
M3 - Article
C2 - 31078351
SN - 0167-5273
VL - 289
SP - 1
EP - 5
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -