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Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee.

Publication ,  Journal Article
Petersen, JL; Haque, G; Hellkamp, AS; Flaker, GC; Mark Estes, NA; Marchlinski, FE; McAnulty, JH; Greenspon, AJ; Marinchak, RA; Lee, KL ...
Published in: Contemp Clin Trials
June 2006

Clinical events committees (CECs) are the current standard for endpoint adjudication in clinical trials. However, little data exist with which to compare CEC and site investigator determinations or to evaluate internal agreement among CEC members. Using data from the Mode Selection Trial in Sinus Node Dysfunction (MOST), we analyzed classifications of death in order to compare internal agreement among CEC physician reviewers and agreement between the CEC and site investigators. Death was classified at 2 levels: by major cause (cardiac, noncardiac, or unknown) and by minor subclassification of the major classifications. Reviewer agreement was tabulated at the major and minor levels, and standard and weighted kappa statistics were calculated. Disagreement at both levels was also determined. Individual decision-making was tabulated in terms of frequency in classifying death as unknown. All 404 deaths were classified by the CEC. Site investigators determined major classifications in 382 cases and minor classification in 379 cases. The CEC and the site investigators disagreed in classifying 41 cases (10.7%) at the major level and 117 (30.9%) at the minor level. CEC reviewers disagreed internally at the major level in 64 cases (15.8%), at the minor level in 63 cases (15.6%), and at any level in 127 cases (31.4%) (kappa = 0.60, 95% confidence interval (CI) [0.55, 0.66]; weighted kappa = 0.66, 95% CI [0.62, 0.75]). In resolving internal disagreements, the full CEC agreed with 1 of 2 CEC reviewers in 85.9% of cases. Disagreements occurred between site investigators and CEC reviewers in classifying deaths. Endpoint determination and decision-making varied among individual CEC reviewers, but second-tier reviews by the full CEC resolved all disagreements. These findings support continued use of CECs for endpoint adjudication in clinical trials.

Duke Scholars

Published In

Contemp Clin Trials

DOI

ISSN

1551-7144

Publication Date

June 2006

Volume

27

Issue

3

Start / End Page

260 / 268

Location

United States

Related Subject Headings

  • Research Personnel
  • Public Health
  • Peer Review
  • Outcome Assessment, Health Care
  • Observer Variation
  • Interdisciplinary Communication
  • Humans
  • General Clinical Medicine
  • Decision Making
  • Clinical Trials as Topic
 

Citation

APA
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ICMJE
MLA
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Petersen, J. L., Haque, G., Hellkamp, A. S., Flaker, G. C., Mark Estes, N. A., Marchlinski, F. E., … MOST Clinical Events Committee, . (2006). Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials, 27(3), 260–268. https://doi.org/10.1016/j.cct.2006.02.002
Petersen, John L., Ghazala Haque, Anne S. Hellkamp, Greg C. Flaker, N. A. Mark Estes, Francis E. Marchlinski, John H. McAnulty, et al. “Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee.Contemp Clin Trials 27, no. 3 (June 2006): 260–68. https://doi.org/10.1016/j.cct.2006.02.002.
Petersen JL, Haque G, Hellkamp AS, Flaker GC, Mark Estes NA, Marchlinski FE, et al. Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials. 2006 Jun;27(3):260–8.
Petersen, John L., et al. “Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee.Contemp Clin Trials, vol. 27, no. 3, June 2006, pp. 260–68. Pubmed, doi:10.1016/j.cct.2006.02.002.
Petersen JL, Haque G, Hellkamp AS, Flaker GC, Mark Estes NA, Marchlinski FE, McAnulty JH, Greenspon AJ, Marinchak RA, Lee KL, Lamas GA, Mahaffey KW, MOST Clinical Events Committee. Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials. 2006 Jun;27(3):260–268.
Journal cover image

Published In

Contemp Clin Trials

DOI

ISSN

1551-7144

Publication Date

June 2006

Volume

27

Issue

3

Start / End Page

260 / 268

Location

United States

Related Subject Headings

  • Research Personnel
  • Public Health
  • Peer Review
  • Outcome Assessment, Health Care
  • Observer Variation
  • Interdisciplinary Communication
  • Humans
  • General Clinical Medicine
  • Decision Making
  • Clinical Trials as Topic