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Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI.
- Source :
-
International Journal of Cardiology . Aug2019, Vol. 289, p1-5. 5p. - Publication Year :
- 2019
-
Abstract
- 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). 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). 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. • Participants in the DANAMI-3 trial were not representative to the background population with STEMI. • Participants in the DANAMI-3 trial were not representative to the per protocol target population. • Sampling bias and unreported screening had occurred. • Screening logs may not be suitable for addressing issues of external validity. [ABSTRACT FROM AUTHOR]
- Subjects :
- *RANDOMIZED controlled trials
*MYOCARDIAL infarction
Subjects
Details
- Language :
- English
- ISSN :
- 01675273
- Volume :
- 289
- Database :
- Academic Search Index
- Journal :
- International Journal of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 136660676
- Full Text :
- https://doi.org/10.1016/j.ijcard.2019.04.064