Clinical InvestigationAcute Ischemic Heart DiseaseAgreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial
Section snippets
Methods
The CLARICOR trial (ControlledTrials.gov NCT00121550) is a randomized, placebo-controlled, multicenter trial including 4,372 patients with stable coronary heart disease, using central randomization and blinding of all parties in all phases. All patients in Copenhagen with a hospital diagnosis of myocardial infarction or angina pectoris (International Classification of Diseases [ICD] codes I 20.9-21.9) during the years 1993 to 1999 were identified and, if alive, invited by mail in late 1999.
Results
During the follow-up period, 5,475 hospital discharges (type 1 events) and 384 deaths (types 2 and 3 events) occurred, out of which the RCD had no information on cause of death in 8 patients. Table I shows how each category is reproduced by the registers (liberal approach); the supplementary tables give the analogous features of the restrictive approach (online Appendix Supplementary Table I) and present the underlying complete 6-by-6 tables (online Supplementary Table II, Supplementary Table
Discussion
In patients with stable coronary heart disease participating in a randomized clinical trial where the health care contacts of the patients were traceable through existing public registries throughout follow-up, we observed that a literal, mechanical reading of ICD-coded register diagnoses would have produced nearly the same trial results as procurement of all underlying documents and dedicated assessment thereof by an AC. Specifically, the hazard ratios for the 3 protocol composite outcomes
Conclusions
All public or local registers are unique, and the quality of registers as seen from a research viewpoint varies greatly. The present study clearly demonstrates the ability of the health care system in Denmark, and presumably in other Scandinavian countries, to maintain accurate and complete public registers that may be used for research purposes. It is undoubtedly necessary to perform studies similar to ours before a clinical trial or an extended follow-up thereof can convincingly rely on
Disclosures
Funding: This study was funded by The Copenhagen Trial Unit, Center for Clinical Intervention Research. No extramural funding was used to support this work.
Conflict of Interest: None declared.
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