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

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  1. Association between the E-wave propagation index and left ventricular thrombus formation after ST-elevation myocardial infarction

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  2. Temporal changes in the incidence of infective endocarditis in Denmark 1997-2017: A nationwide study

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  5. Diagnostic findings and follow-up outcomes in relatives to young non-autopsied sudden death victims

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  1. Temporal changes in the incidence of infective endocarditis in Denmark 1997-2017: A nationwide study

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  2. Atrial fibrillation is a marker of increased mortality risk in non-ischemic heart failure - results from the DANISH Trial

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  3. Work exposure and associated risk of hospitalisation with pneumonia and influenza: A nationwide study

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  4. Switching from Vitamin K Antagonist to Dabigatran in Atrial Fibrillation: Differences According to Dose

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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.

Original languageEnglish
JournalInternational Journal of Cardiology
Volume289
Pages (from-to)1-5
Number of pages5
ISSN0167-5273
DOIs
Publication statusPublished - 15 Aug 2019

    Research areas

  • External validity, Randomized controlled trials, Sampling bias, Screening logs, ST-elevation myocardial infarction

ID: 58230092