Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI

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@article{3598e7e1742a44569f0446ba4482c9d0,
title = "Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI",
abstract = "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.",
keywords = "External validity, Randomized controlled trials, Sampling bias, Screening logs, ST-elevation myocardial infarction",
author = "Laursen, {Peter N{\o}rkj{\ae}r} and Lene Holmvang and Jacob L{\o}nborg and Lars K{\o}ber and H{\o}fsten, {Dan E.} and Steffen Helqvist and Peter Clemmensen and Henning Kelb{\ae}k and Erik J{\o}rgensen and Lassen, {Jens Flensted} and Frants Pedersen and Thomas H{\o}i-Hansen and Bent Raungaard and Terkelsen, {Christian Juhl} and Jensen, {Lisette Okkels} and Golnaz Sadjadieh and Thomas Engstr{\o}m",
year = "2019",
doi = "10.1016/j.ijcard.2019.04.064",
language = "English",
volume = "289",
pages = "1--5",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier",

}