Good interobserver agreement was attainable on outcome adjudication in patients with stable coronary heart disease

Erik Kjoller, Jørgen Hilden, Per Winkel, Niels J Frandsen, Søren Galatius, Gorm Jensen, Jens Kastrup, Jorgen Fischer Hansen, Hans Jørn Jepsen Kolmos, Christian M Jespersen, Per Hildebrandt, Christian Nyfeldt Gluud, CLARICOR Trial Group

11 Citations (Scopus)

Abstract

Objective: In clinical trials, agreement on outcomes is of utmost importance for valid estimation of intervention effects. As there is limited knowledge about adjudicator agreement in cardiology, we examined the level of agreement among three cardiology specialists adjudicating all possible events in a randomized controlled clinical trial of patients with stable coronary heart disease. Study Design and Setting: All information (hospital records, death certificates, etc.) was forwarded to two randomly selected blinded adjudicators. If they disagreed, the third arbiter had to choose the more likely of the two alternatives. Files of 5,475 nonfatal and 362 fatal events were evaluated. Results: For nonfatal outcomes, pairwise kappa values ranged from 0.75 to 0.80. The three adjudicators had 4.3%, 9.5%, and 6.1% of their nonfatal outcome classifications overruled by their arbiter. If stable angina pectoris, unstable angina pectoris, and acute myocardial infarction were treated as one, agreement increased minimally. For fatal outcomes, the pairwise kappa values ranged from 0.65 to 0.90. The three adjudicators had 12%, 9%, and 10% of their death classifications overruled. Conclusion: Specialists in cardiology can attain a reasonably high agreement on outcomes in patients with stable coronary heart disease.

Original languageEnglish
JournalJournal of Clinical Epidemiology
Volume65
Issue number4
Pages (from-to)444-53
Number of pages10
ISSN0895-4356
DOIs
Publication statusPublished - Apr 2012

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