title: Measuring the quality of observational study data in an international HIV research network.
abstract: Observational studies of health conditions and outcomes often combine clinical care data from many sites without explicitly assessing the accuracy and completeness of these data. In order to improve the quality of data in an international multi-site observational cohort of HIV-infected patients, the authors conducted on-site, Good Clinical Practice-based audits of the clinical care datasets submitted by participating HIV clinics. Discrepancies between data submitted for research and data in the clinical records were categorized using the audit codes published by the European Organization for the Research and Treatment of Cancer. Five of seven sites had error rates >10% in key study variables, notably laboratory data, weight measurements, and antiretroviral medications. All sites had significant discrepancies in medication start and stop dates. Clinical care data, particularly antiretroviral regimens and associated dates, are prone to substantial error. Verifying data against source documents through audits will improve the quality of databases and research and can be a technique for retraining staff responsible for clinical data collection. The authors recommend that all participants in observational cohorts use data audits to assess and improve the quality of data and to guide future data collection and abstraction efforts at the point of care.
authors.affiliation: Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America. stephany.duda@vanderbilt.edu
authors.forename: Stephany N
authors.initials: SN
authors.lastname: Duda
authors.forename: Bryan E
authors.initials: BE
authors.lastname: Shepherd
authors.forename: Cynthia S
authors.initials: CS
authors.lastname: Gadd
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Masys
authors.forename: Catherine C
authors.initials: CC
authors.lastname: McGowan
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015331:Cohort Studies; D003625:Data Collection / Q000592:standards*; D016208:Databases, Factual; D005260:Female; D006678:HIV / Q000187:drug effects / Q000502:physiology; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007391:International Cooperation; D007843:Latin America; D008297:Male; D008485:Medical Audit; D019370:Observation; D011786:Quality Control; D014481:United States
chemical_list: D019380:Anti-HIV Agents