Research
Print page Print page
Switch language
Rigshospitalet - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Prevalence and incidence of various Cancer subtypes in patients with heart failure vs matched controls

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. The cardiac isovolumetric contraction time is an independent predictor of incident heart failure in the general population

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Carotid atherosclerosis markers and adverse cardiovascular events

    Research output: Contribution to journalLetterResearchpeer-review

  4. Cardiovascular complications in patients with total cavopulmonary connection: A nationwide cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Favorable five-year outcomes for heart failure diagnosed in younger patients without severe comorbidity

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Risk Factors for Morbidity and Mortality Following Hospitalization for Pericarditis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Incidence of acute myocardial infarction-related cardiogenic shock during corona virus disease 19 (COVID-19) pandemic

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Incidence of infective endocarditis during the coronavirus disease 2019 pandemic: A nationwide study

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

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