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Self-audits as alternatives to travel-audits for improving data quality in the Caribbean, Central and South America network for HIV epidemiology

  • Sarah C. Lotspeich (a1), Mark J. Giganti (a1), Marcelle Maia (a2), Renalice Vieira (a2), Daisy Maria Machado (a3), Regina Célia Succi (a3), Sayonara Ribeiro (a4), Mario Sergio Pereira (a4), Maria Fernanda Rodriguez (a5), Gaetane Julmiste (a6), Marco Tulio Luque (a7), Yanink Caro-Vega (a8), Fernando Mejia (a9), Bryan E. Shepherd (a1), Catherine C. McGowan (a10) and Stephany N. Duda (a11)...

Abstract

Introduction:

Audits play a critical role in maintaining the integrity of observational cohort data. While previous work has validated the audit process, sending trained auditors to sites (“travel-audits”) can be costly. We investigate the efficacy of training sites to conduct “self-audits.”

Methods:

In 2017, eight research groups in the Caribbean, Central, and South America network for HIV Epidemiology each audited a subset of their patient records randomly selected by the data coordinating center at Vanderbilt. Designated investigators at each site compared abstracted research data to the original clinical source documents and captured audit findings electronically. Additionally, two Vanderbilt investigators performed on-site travel-audits at three randomly selected sites (one adult and two pediatric) in late summer 2017.

Results:

Self- and travel-auditors, respectively, reported that 93% and 92% of 8919 data entries, captured across 28 unique clinical variables on 65 patients, were entered correctly. Across all entries, 8409 (94%) received the same assessment from self- and travel-auditors (7988 correct and 421 incorrect). Of 421 entries mutually assessed as “incorrect,” 304 (82%) were corrected by both self- and travel-auditors and 250 of these (72%) received the same corrections. Reason for changing antiretroviral therapy (ART) regimen, ART end date, viral load value, CD4%, and HIV diagnosis date had the most mismatched corrections.

Conclusions:

With similar overall error rates, findings suggest that data audits conducted by trained local investigators could provide an alternative to on-site audits by external auditors to ensure continued data quality. However, discrepancies observed between corrections illustrate challenges in determining correct values even with audits.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Corresponding author

Address for correspondence: S. C. Lotspeich, BS, Department of Biostatistics, Vanderbilt University School of Medicine, 2525 West End Ave, Nashville, TN37203, USA, Email: sarah.c.lotspeich@vanderbilt.edu

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Self-audits as alternatives to travel-audits for improving data quality in the Caribbean, Central and South America network for HIV epidemiology

  • Sarah C. Lotspeich (a1), Mark J. Giganti (a1), Marcelle Maia (a2), Renalice Vieira (a2), Daisy Maria Machado (a3), Regina Célia Succi (a3), Sayonara Ribeiro (a4), Mario Sergio Pereira (a4), Maria Fernanda Rodriguez (a5), Gaetane Julmiste (a6), Marco Tulio Luque (a7), Yanink Caro-Vega (a8), Fernando Mejia (a9), Bryan E. Shepherd (a1), Catherine C. McGowan (a10) and Stephany N. Duda (a11)...

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