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

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Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI. / Laursen, Peter Nørkjær; Holmvang, Lene; Lønborg, Jacob; Køber, Lars; Høfsten, Dan E; Helqvist, Steffen; Clemmensen, Peter; Kelbæk, Henning; Jørgensen, Erik; Lassen, Jens Flensted; Pedersen, Frants; Høi-Hansen, Thomas; Raungaard, Bent; Terkelsen, Christian Juhl; Jensen, Lisette Okkels; Sadjadieh, Golnaz; Engstrøm, Thomas.

In: INT J CARDIOL, Vol. 289, 15.08.2019, p. 1-5.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Laursen, PN, Holmvang, L, Lønborg, J, Køber, L, Høfsten, DE, Helqvist, S, Clemmensen, P, Kelbæk, H, Jørgensen, E, Lassen, JF, Pedersen, F, Høi-Hansen, T, Raungaard, B, Terkelsen, CJ, Jensen, LO, Sadjadieh, G & Engstrøm, T 2019, 'Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI', INT J CARDIOL, vol. 289, pp. 1-5. https://doi.org/10.1016/j.ijcard.2019.04.064

APA

Laursen, P. N., Holmvang, L., Lønborg, J., Køber, L., Høfsten, D. E., Helqvist, S., Clemmensen, P., Kelbæk, H., Jørgensen, E., Lassen, J. F., Pedersen, F., Høi-Hansen, T., Raungaard, B., Terkelsen, C. J., Jensen, L. O., Sadjadieh, G., & Engstrøm, T. (2019). Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI. INT J CARDIOL, 289, 1-5. https://doi.org/10.1016/j.ijcard.2019.04.064

Vancouver

Laursen PN, Holmvang L, Lønborg J, Køber L, Høfsten DE, Helqvist S et al. Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI. INT J CARDIOL. 2019 Aug 15;289:1-5. https://doi.org/10.1016/j.ijcard.2019.04.064

Bibtex

@article{6cd6ec935dd54e4899714b16bdf3ffa6,
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 = "Cause of Death/trends, Denmark/epidemiology, Follow-Up Studies, Humans, Morbidity/trends, Percutaneous Coronary Intervention/methods, Randomized Controlled Trials as Topic/methods, Registries, ST Elevation Myocardial Infarction/epidemiology, Selection Bias, Survival Rate/trends, Time Factors",
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",
note = "Copyright {\textcopyright} 2019 Elsevier B.V. All rights reserved.",
year = "2019",
month = aug,
day = "15",
doi = "10.1016/j.ijcard.2019.04.064",
language = "English",
volume = "289",
pages = "1--5",
journal = "INT J CARDIOL",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

RIS

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.

KW - Cause of Death/trends

KW - Denmark/epidemiology

KW - Follow-Up Studies

KW - Humans

KW - Morbidity/trends

KW - Percutaneous Coronary Intervention/methods

KW - Randomized Controlled Trials as Topic/methods

KW - Registries

KW - ST Elevation Myocardial Infarction/epidemiology

KW - Selection Bias

KW - Survival Rate/trends

KW - Time Factors

U2 - 10.1016/j.ijcard.2019.04.064

DO - 10.1016/j.ijcard.2019.04.064

M3 - SCORING: Journal article

C2 - 31078351

VL - 289

SP - 1

EP - 5

JO - INT J CARDIOL

JF - INT J CARDIOL

SN - 0167-5273

ER -