title: Identifying and improving unreliable items in registries through data auditing.
abstract: OBJECTIVE
  Assessing the reliability of clinical registries is important for ensuring the availability of credible data. Therefore, this study aimed to investigate the reliability of data collected by the Australian and New Zealand Haemostasis Registry (the registry).
  
  
  METHODS
  Data from 5% of randomly selected registry cases were re-abstracted by an independent data auditor who was blinded to the results of the original data abstraction. Categorical data were investigated for agreement between original and re-abstracted data. The mean difference and standard deviations (SD) of differences were calculated for continuous variables. We estimated a 'prediction interval' as the mean difference ± twice the SD of differences. We computed a coefficient of variation as the SD of differences.
  
  
  METHODS
  The registry records all cases of off-licence use of recombinant activated factor VII (rFVIIa) at participating institutions (on-licence use of rFVIIa is not recorded).
  
  
  RESULTS
  Data on 76 registry cases (6% of registry) were re-abstracted. Various parameters demonstrated high levels of inter-rater reliability, including age, gender and intensive care unit admission (88, 99 and 99% agreement, respectively). Other variables were highly unreliable, including crystalloid infusion volumes (coefficient of variation 123.01%), red blood cell units (92.05%) and time from bleeding onset to administration of rFVIIa (153.06%).
  
  
  CONCLUSIONS
  Registry audits are useful for identifying variables with poor reliability. Repeated audits will not improve data reliability; however, they can assist in identifying and evaluating the impact of modified data collection processes on improving data reliability.
authors: School of Population Health and Clinical Practice, The University of Adelaide, SA 5005, Australia. cameron.willis@adelaide.edu.au
authors: Cameron D
authors: CD
authors: Willis
authors: Damien J
authors: DJ
authors: Jolley
authors: John J
authors: JJ
authors: McNeil
authors: Peter A
authors: PA
authors: Cameron
authors: Louise E
authors: LE
authors: Phillips
mesh_terms: D001315:Australia; D054869:Clinical Audit; D015942:Factor VIIa / Q000627:therapeutic use; D006490:Hemostatics / Q000627:therapeutic use; D006801:Humans; D009520:New Zealand; D056687:Off-Label Use; D011786:Quality Control; D011994:Recombinant Proteins / Q000627:therapeutic use; D012042:Registries / Q000592:standards*; D015203:Reproducibility of Results; D016037:Single-Blind Method
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa