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Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Quality of life and the associated risk of all-cause mortality in nonischemic heart failure

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Patient-reported outcomes predict high readmission rates among patients with cardiac diagnoses. Findings from the DenHeart study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Quality of life and the associated risk of all-cause mortality in nonischemic heart failure

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. One-year outcomes in atrial fibrillation presenting during infections: a nationwide registry-based study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftInternational Journal of Cardiology
Vol/bind289
Sider (fra-til)1-5
Antal sider5
ISSN0167-5273
DOI
StatusUdgivet - 15 aug. 2019

Bibliografisk note

Copyright © 2019 Elsevier B.V. All rights reserved.

ID: 58230092