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Home >> Publications >> Measuring the quality of observational study data in an international HIV research network.

Publication

Author(s):

Duda SN, Shepherd BE, Gadd CS, Masys DR, McGowan CC.

Pub Title:

Measuring the quality of observational study data in an international HIV research network.

Pub Date:

Apr 30 2012

Journal Issue:

4

Page Number:
e33908

Journal:

Title: 
PLoS One
Link: 
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0033908

PubMed: 22493676
Pub PDF: PDF icon 22493676.pdf

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.

 

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Citation:

Duda SN, Shepherd BE, Gadd CS, Masys DR, McGowan CC. Measuring the quality of observational study data in an international HIV research network. PLoS One. 2012;7(4):e33908. doi: 10.1371/journal.pone.0033908. Epub 2012 Apr 6. PubMed PMID: 22493676; PubMed Central PMCID: PMC3320898.