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

Peter Nørkjær Laursen*, Lene Holmvang, Jacob Lønborg, Lars Køber, Dan E Høfsten, Steffen Helqvist, Peter Clemmensen, Henning Kelbæk, Erik Jørgensen, Jens Flensted Lassen, Frants Pedersen, Thomas Høi-Hansen, Bent Raungaard, Christian Juhl Terkelsen, Lisette Okkels Jensen, Golnaz Sadjadieh, Thomas Engstrøm

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

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.

OriginalsprogEngelsk
Sider (fra-til)1-5
Antal sider5
TidsskriftInternational Journal of Cardiology
Vol/bind289
DOI
StatusUdgivet - 15 aug. 2019

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Copyright � 2019 Elsevier B.V. All rights reserved.

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