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

Autor:	Lotspeich SC; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA., Giganti MJ; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA., Maia M; Departamento de Pediatria, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Vieira R; Departamento de Pediatria, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Machado DM; Departamento de Pediatria, Universidade Federal de São Paulo, São Paulo, Brazil., Succi RC; Departamento de Pediatria, Universidade Federal de São Paulo, São Paulo, Brazil., Ribeiro S; Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil., Pereira MS; Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil., Rodriguez MF; Unidad Médica, Fundación Arriarán, Santiago, Chile., Julmiste G; Le Groupe Haïtien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti., Luque MT; Instituto Hondureño de Seguridad Social and Hospital Escuela Universitario, Tegucigalpa, Honduras., Caro-Vega Y; Departamento de Enfermedades Infecciosas, El Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico., Mejia F; Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru., Shepherd BE; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA., McGowan CC; Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA., Duda SN; Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.
Jazyk:	angličtina
Zdroj:	Journal of clinical and translational science [J Clin Transl Sci] 2019 Dec 26; Vol. 4 (2), pp. 125-132. Date of Electronic Publication: 2019 Dec 26 (Print Publication: 2020).
DOI:	10.1017/cts.2019.442
Abstrakt:	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. (© The Association for Clinical and Translational Science 2019.)
Databáze:	MEDLINE
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