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). DESIGN: 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. SETTING: 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.
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). DESIGN: 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. SETTING: 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: Amanda Zatta; Zoe Mcquilten; Rangi Kandane-Rathnayake; James Isbister; Scott Dunkley; John Mcneil; Peter Cameron; Louise Phillips Journal: Blood Transfus Date: 2014-06-05 Impact factor: 3.443