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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 and Lassen, Jens Flensted , et al. (2019) In International Journal of Cardiology 289. p.1-5
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 =... (More)

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.

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published
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keywords
External validity, Randomized controlled trials, Sampling bias, Screening logs, ST-elevation myocardial infarction
in
International Journal of Cardiology
volume
289
pages
1 - 5
publisher
Elsevier
external identifiers
  • scopus:85065138848
  • pmid:31078351
ISSN
0167-5273
DOI
10.1016/j.ijcard.2019.04.064
language
English
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yes
id
3598e7e1-742a-4456-9f04-46ba4482c9d0
date added to LUP
2019-05-17 14:50:06
date last changed
2020-02-15 03:00:27
@article{3598e7e1-742a-4456-9f04-46ba4482c9d0,
  abstract     = {<p>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 &lt; 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.</p>},
  author       = {Laursen, Peter Nørkjær and Holmvang, Lene and Lønborg, Jacob and Køber, Lars and Høfsten, Dan E. and Helqvist, Steffen and Clemmensen, Peter and Kelbæk, Henning and Jørgensen, Erik and Lassen, Jens Flensted and Pedersen, Frants and Høi-Hansen, Thomas and Raungaard, Bent and Terkelsen, Christian Juhl and Jensen, Lisette Okkels and Sadjadieh, Golnaz and Engstrøm, Thomas},
  issn         = {0167-5273},
  language     = {eng},
  pages        = {1--5},
  publisher    = {Elsevier},
  series       = {International Journal of Cardiology},
  title        = {Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI},
  url          = {http://dx.doi.org/10.1016/j.ijcard.2019.04.064},
  doi          = {10.1016/j.ijcard.2019.04.064},
  volume       = {289},
  year         = {2019},
}