Lotspeich Sarah C, Giganti Mark J, Maia Marcelle, Vieira Renalice, Machado Daisy Maria, Succi Regina Célia, Ribeiro Sayonara, Pereira Mario Sergio, Rodriguez Maria Fernanda, Julmiste Gaetane, Luque Marco Tulio, Caro-Vega Yanink, Mejia Fernando, Shepherd Bryan E, McGowan Catherine C, Duda Stephany N
Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.
Departamento de Pediatria, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
J Clin Transl Sci. 2019 Dec 26;4(2):125-132. doi: 10.1017/cts.2019.442. eCollection 2020 Apr.
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."
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.
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.
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.
审核在维护观察性队列数据的完整性方面发挥着关键作用。虽然之前的工作已经验证了审核过程，但派遣训练有素的审核员到各个地点（“实地审核”）成本可能很高。我们研究了培训各地点进行“自我审核”的效果。
2017年，加勒比地区、中美洲和南美洲的八个艾滋病毒流行病学研究小组网络各自审核了范德比尔特数据协调中心随机抽取的一部分患者记录。每个地点指定的研究人员将提取的研究数据与原始临床源文件进行比较，并以电子方式记录审核结果。此外，2017年夏末，两名范德比尔特研究人员在三个随机选择的地点（一个成人地点和两个儿科地点）进行了实地审核。
自我审核员和实地审核员分别报告称，在65名患者的28个独特临床变量中捕获的8919条数据条目中，93%和92%输入正确。在所有条目中，8409条（94%）在自我审核员和实地审核员那里得到了相同的评估（7988条正确，421条错误）。在双方共同评估为“错误”的421条条目中，304条（82%）被自我审核员和实地审核员都进行了修正，其中250条（72%）得到了相同的修正。抗逆转录病毒治疗（ART）方案变更原因、ART结束日期、病毒载量值、CD4%和艾滋病毒诊断日期的修正差异最大。
总体错误率相似，研究结果表明，由经过培训的当地研究人员进行的数据审核可以替代外部审核员的实地审核，以确保数据质量持续良好。然而，修正之间存在的差异表明，即使进行了审核，在确定正确值方面仍存在挑战。
