TY - JOUR

T1 - Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial

AU - Kjøller, Erik

AU - Hilden, Jørgen

AU - Winkel, Per

AU - Galatius, Søren

AU - Frandsen, Niels Jørgen

AU - Jensen, Gorm B

AU - Fischer Hansen, Jørgen

AU - Kastrup, Jens

AU - Jespersen, Christian M

AU - Hildebrandt, Per

AU - Kolmos, Hans Jørn

AU - Gluud, Christian

AU - CLARICOR Trial Group

N1 - Copyright © 2014 Mosby, Inc. All rights reserved.

PY - 2014/8

Y1 - 2014/8

N2 - UNLABELLED: The objective of this study is to describe the agreement between randomized trial outcome assessment by committee and outcomes entirely identified through public registers.METHODS: In the CLARICOR trial, 4,372 patients with stable coronary heart disease received a short course of clarithromycin versus placebo and were followed up for 2.6 years. The pertinent hospital records and death certificates had originally been evaluated by the adjudication committee using common definitions of outcomes mapped into a 6-category list. We now mechanically converted the International Classification of Diseases-coded diagnoses of the public registries into the same categories. After cross-tabulation of the committee diagnoses with National Patient Register diagnoses and Register of Causes of Death, we calculate agreement and compare the estimated intervention effects of the 2 data sets.RESULTS: With public register data, the protocol-specified categories were slightly more frequent. Overall agreement was 74% for hospital discharges and 60% for cause of death, but the intervention effect, expressed as a hazard ratio, stayed within 4% of the value originally obtained with the adjudication committee (P ≥ .35).CONCLUSIONS: Our results show a modest agreement between formal adjudication and outcomes deducible from public registers. However, the estimated intervention effect did not differ noticeably between the 2 data sources. If studies on a wide range of public registers confirm these findings, register outcomes may be considered as a replacement for adjudication committees.

AB - UNLABELLED: The objective of this study is to describe the agreement between randomized trial outcome assessment by committee and outcomes entirely identified through public registers.METHODS: In the CLARICOR trial, 4,372 patients with stable coronary heart disease received a short course of clarithromycin versus placebo and were followed up for 2.6 years. The pertinent hospital records and death certificates had originally been evaluated by the adjudication committee using common definitions of outcomes mapped into a 6-category list. We now mechanically converted the International Classification of Diseases-coded diagnoses of the public registries into the same categories. After cross-tabulation of the committee diagnoses with National Patient Register diagnoses and Register of Causes of Death, we calculate agreement and compare the estimated intervention effects of the 2 data sets.RESULTS: With public register data, the protocol-specified categories were slightly more frequent. Overall agreement was 74% for hospital discharges and 60% for cause of death, but the intervention effect, expressed as a hazard ratio, stayed within 4% of the value originally obtained with the adjudication committee (P ≥ .35).CONCLUSIONS: Our results show a modest agreement between formal adjudication and outcomes deducible from public registers. However, the estimated intervention effect did not differ noticeably between the 2 data sources. If studies on a wide range of public registers confirm these findings, register outcomes may be considered as a replacement for adjudication committees.

KW - Cardiovascular Diseases

KW - Cause of Death

KW - Clinical Trials Data Monitoring Committees

KW - Humans

KW - Myocardial Ischemia

KW - Outcome Assessment (Health Care)

KW - Randomized Controlled Trials as Topic

KW - Registries

KW - Reproducibility of Results

U2 - 10.1016/j.ahj.2013.12.032

DO - 10.1016/j.ahj.2013.12.032

M3 - Journal article

C2 - 25066559

VL - 168

SP - 197–204.e4

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 2

ER -