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

TY - JOUR

T1 - Good interobserver agreement was attainable on outcome adjudication in patients with stable coronary heart disease

AU - Kjoller, Erik

AU - Hilden, Jørgen

AU - Winkel, Per

AU - Frandsen, Niels J

AU - Galatius, Søren

AU - Jensen, Gorm

AU - Kastrup, Jens

AU - Hansen, Jorgen Fischer

AU - Kolmos, Hans Jørn Jepsen

AU - Jespersen, Christian M

AU - Hildebrandt, Per

AU - Gluud, Christian Nyfeldt

AU - CLARICOR Trial Group

N1 - Copyright © 2012 Elsevier Inc. All rights reserved.

PY - 2012/4

Y1 - 2012/4

N2 - 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.

AB - 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.

U2 - 10.1016/j.jclinepi.2011.09.011

DO - 10.1016/j.jclinepi.2011.09.011

M3 - Journal article

C2 - 22257841

SN - 0895-4356

VL - 65

SP - 444

EP - 453

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

IS - 4

ER -