title: Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial.
abstract: 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.
authors: Department of Cardiology, Herlev Hospital, Copenhagen University Hospital and The Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: kjoller@dadlnet.dk.
authors: Erik
authors: E
authors: Kjøller
authors: The Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, and Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark. Electronic address: jhil@sund.ku.dk.
authors: Jørgen
authors: J
authors: Hilden
authors: The Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: pwinkel@ctu.dk.
authors: Per
authors: P
authors: Winkel
authors: Department of Cardiology, Gentofte Hospital, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: galatius@dadlnet.dk.
authors: Søren
authors: S
authors: Galatius
authors: Department of Cardiology, Amager Hospital, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: nj.frandsen@mail.dk.
authors: Niels Jørgen
authors: NJ
authors: Frandsen
authors: Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: Gorm.Jensen@hvh.regionh.dk.
authors: Gorm B
authors: GB
authors: Jensen
authors: Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: fischer_hansen@hotmail.com.
authors: Jørgen
authors: J
authors: Fischer Hansen
authors: Department of Medicine B, The Heart Center, Rigshospitalet, Copenhagen University Hospital and Faculty of Health Sciences, Copenhagen, Denmark. Electronic address: jkastrup@rh.dk.
authors: Jens
authors: J
authors: Kastrup
authors: Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: crmj@novonordisk.com.
authors: Christian M
authors: CM
authors: Jespersen
authors: Department of Cardiology, Frederiksberg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: p.hildebrandt@dadlnet.dk.
authors: Per
authors: P
authors: Hildebrandt
authors: Department of Clinical Microbiology, Odense University Hospital, Odense, Denmark. Electronic address: Hans.Joern.Kolmos@ouh.regionsyddanmark.dk.
authors: Hans Jørn
authors: HJ
authors: Kolmos
authors: The Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: cgluud@ctu.dk.
authors: Christian
authors: C
authors: Gluud
mesh_terms: D002318:Cardiovascular Diseases / Q000401:mortality*; D002423:Cause of Death; D026661:Clinical Trials Data Monitoring Committees; D006801:Humans; D017202:Myocardial Ischemia / Q000401:mortality*; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic; D012042:Registries / Q000592:standards; D015203:Reproducibility of Results