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

J Clin Epidemiol. 2012 Apr;65(4):444-53. doi: 10.1016/j.jclinepi.2011.09.011. Epub 2012 Jan 17.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Algorithms
  • Anti-Bacterial Agents / therapeutic use*
  • Chlamydia Infections / complications*
  • Chlamydophila pneumoniae* / isolation & purification
  • Clarithromycin / therapeutic use*
  • Confidence Intervals
  • Coronary Disease / drug therapy*
  • Coronary Disease / microbiology
  • Coronary Disease / mortality
  • Coronary Disease / therapy
  • Denmark
  • Follow-Up Studies
  • Humans
  • Inpatients
  • Myocardial Infarction / drug therapy*
  • Myocardial Infarction / microbiology
  • Myocardial Infarction / therapy
  • Observer Variation
  • Prognosis
  • Risk Assessment
  • Survival Analysis
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Clarithromycin