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Good interobserver agreement was attainable on outcome adjudication in patients with stable coronary heart disease
Erik Kjoller1, Jorgen Hilden, Per Winkel
1Department of Cardiology, Copenhagen University Hospital, Herlev Hospital, Herlev Ringvej 75, Herlev, Denmark. kjoller@dadlnet.dk
Insights
Cardiology specialists achieved good agreement on outcomes in stable coronary heart disease trials. This ensures reliable intervention effect estimations in clinical research.
Area of Science:
- Cardiology
- Clinical Trials
- Medical Research
Background:
- Accurate outcome assessment is crucial for valid clinical trial results.
- Limited data exists on adjudicator agreement in cardiology trials.
- This study addresses the need to evaluate agreement among specialists in stable coronary heart disease.
Purpose of the Study:
- To assess the level of agreement among three cardiology specialists.
- To evaluate the adjudication of events in a randomized controlled trial for stable coronary heart disease patients.
Main Methods:
- Three blinded cardiology specialists adjudicated all events.
- Two adjudicators reviewed cases; a third arbitrated disagreements.
- Data included 5,475 nonfatal and 362 fatal events.
Main Results:
- Pairwise kappa values for nonfatal outcomes ranged from 0.75-0.80.
- Adjudicator classifications were overruled in 4.3%-9.5% of nonfatal outcomes.
- Pairwise kappa values for fatal outcomes ranged from 0.65-0.90, with 9%-12% overruled.
Conclusions:
- Cardiology specialists can achieve reasonably high agreement on outcomes.
- This level of agreement supports the validity of intervention effect estimations in stable coronary heart disease trials.
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.
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