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Makerere University Research Repository >
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Please use this identifier to cite or link to this item:
http://hdl.handle.net/123456789/1835
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| Title: | Quality of data collection in a large HIV observational clinic database in sub-Saharan Africa: implications for clinical research and audit of care |
| Authors: | Kiragga, Agnes N
Castelnuovo, Barbara
Schaefer, Petra
Muwonge, Timothy
Easterbrook, Philippa J |
| Keywords: | Data collection
HIV/AIDS
Database management
HIV Care and treatment
Antiretroviral therapy (ART) |
| Issue Date: | 2011 |
| Publisher: | BioMed Central |
| Citation: | Kiragga, A., Castelnuovo, B., Schaefer, P., Muwonge, T., Easterbrook, P.J. (2011).Quality of data collection in a large HIV observational clinic database in sub-Saharan Africa: implications for clinical research and audit of care. Journal of the International AIDS Society,14(3) |
| Abstract: | Background: Observational HIV clinic databases are now widely used to answer key questions related to HIV care
and treatment, but there has been no systematic evaluation of their quality of data. Our objective was to evaluate
the completeness and accuracy of recording of key data HIV items in a large routine observational HIV clinic
database.
Methods: We looked at the number and rate of opportunistic infections (OIs) per 100 person years at risk in the
24 months following antiretroviral therapy (ART) initiation in 559 patients who initiated ART in 2004-2005 and
enrolled into a research cohort. We compared this with data in a routine clinic database for the same 559 patients,
and a further 1233 patients who initiated ART in the same period. The Research Cohort database was considered
as the reference “gold standard” for the assessment of data accuracy. A crude percentage of underreporting of OIs
in the clinic database was calculated based on the difference between the OI rates reported in both databases.
We reviewed 100 clinic patient medical records to assess the accuracy of recording of key data items of OIs, ART
toxicities and ART regimen changes.
Results: The overall incidence rate per 100 person years at risk for the initial OI in the 559 patients in the research
cohort and clinic databases was 24.1 (95% CI: 20.5-28.2) and 13.2 (95% CI: 10.8-16.2) respectively, and 10.4 (95% CI:
9.1-11.9) for the 1233 clinic patients. This represents a 1.8- and 2.3-fold higher rate of events in the research cohort
database compared with the same 599 patients and 1233 patients in the routine clinic database, or a 45.1% and
56.8% rate of underreporting, respectively. The combined error rate of missing and incorrect items from the
medical records’ review was 67% for OIs, 52% for ART-related toxicities, and 83% and 58% for ART discontinuation
and modification, respectively.
Conclusions: There is a high rate of underreporting of OIs in a routine HIV clinic database. This has important
implications for the use and interpretation of routine observational databases for research and audit, and highlights
the need for regular data validation of these databases. |
| URI: | http://www.jiasociety.org/content/14/1/3
http://hdl.handle.net/123456789/1835 |
| ISSN: | 1758-2652 |
| Appears in Collections: | Research Articles (IDI)
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| kiragga-idi-res.pdf | | 242Kb | Adobe PDF | View/Open |
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