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: International Journal of Cardiology, Vol. 289, 2019, p. 1-5.

Research output: Contribution to journalArticle

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', International Journal of Cardiology, 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. International Journal of Cardiology, 289, 1-5. https://doi.org/10.1016/j.ijcard.2019.04.064

CBE

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. International Journal of Cardiology. 289:1-5. https://doi.org/10.1016/j.ijcard.2019.04.064

MLA

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Author

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. / Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI. In: International Journal of Cardiology. 2019 ; Vol. 289. pp. 1-5.

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

PY - 2019

Y1 - 2019

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 - External validity

KW - Randomized controlled trials

KW - Sampling bias

KW - Screening logs

KW - ST-elevation myocardial infarction

U2 - 10.1016/j.ijcard.2019.04.064

DO - 10.1016/j.ijcard.2019.04.064

M3 - Article

C2 - 31078351

AN - SCOPUS:85065138848

VL - 289

SP - 1

EP - 5

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -