Lin Otto S, La Selva Danielle, Cha Jae-Myung, Gluck Michael, Ross Andrew, Chiorean Michael, Kozarek Richard A
Digestive Disease Institute, Virginia Mason Medical Center, 1100 Ninth Avenue, Seattle, WA, 98101, USA.
Gastroenterology Division, Kyung Hee University School of Medicine, Seoul, Korea.
Surg Endosc. 2016 Apr;30(4):1607-13. doi: 10.1007/s00464-015-4389-1. Epub 2015 Jul 15.
Endoscopic documentation software can generate research data on large numbers of subjects automatically. There are increasing numbers of published studies based on endoscopic databases such as the Clinical Outcomes Research Initiative. However, no study has yet validated such data. We compared colonoscopic findings reported by an endoscopic documentation software (Provation) against manually collected medical records data from two similar patient cohorts in the same endoscopy unit.
In November 2011, our unit switched from dictation-based text documentation to the Provation system. As a quality control initiative, we collected data on 9614 patients who had undergone colonoscopies from January 2010 to November 2011, using manual electronic chart review. We compared these data against those generated by Provation on 7091 similar patients who underwent colonoscopy from November 2011 to March 2013.
Age, sex and procedural indication distribution were similar between the Manual and Provation cohorts, as were the large (≥1 cm) polyp (7.6 vs. 8.1%; p = 0.25) and advanced neoplasia (8.3 vs. 8.2%; p = 0.80) prevalences. However, there were significant differences in the polyp (46.9 vs. 49.8%) and adenoma prevalences (31.3 vs. 26.8%; p < 0.001). Furthermore, the Manual cohort had a higher prevalence of diverticulosis and hemorrhoids, and a lower colonoscopy completion rate. Stratification by indication resulted in additional discrepancies between the two cohorts for screening and surveillance patients. There were also differences in the anatomic (right vs. left colon) distribution of large polyps.
There were significant discrepancies between data from Provation and manually collected medical records data. Although the two cohorts were enrolled during slightly different time periods, they came from the same endoscopy unit, had the same endoscopists and indications, and demonstrated similar demographics, making it unlikely for there to be true differences between the cohorts independent of documentation method. Thus, caution is advised when using endoscopic data for research.
内镜记录软件可自动生成大量受试者的研究数据。基于诸如临床结局研究倡议等内镜数据库发表的研究数量日益增多。然而，尚无研究对这类数据进行验证。我们将一款内镜记录软件（Provation）报告的结肠镜检查结果与来自同一内镜科室两个相似患者队列的手动收集的病历数据进行了比较。
2011年11月，我们科室从基于口述的文本记录转换为Provation系统。作为一项质量控制举措，我们通过手动电子病历审查收集了2010年1月至2011年11月期间接受结肠镜检查的9614例患者的数据。我们将这些数据与Provation生成的7091例2011年11月至2013年3月期间接受结肠镜检查的相似患者的数据进行了比较。
手动收集队列和Provation队列之间的年龄、性别和检查指征分布相似，大息肉（≥1 cm）患病率（7.6%对8.1%；p = 0.25）和高级别瘤变患病率（8.3%对8.2%；p = 0.80）也相似。然而，息肉患病率（46.9%对49.8%）和腺瘤患病率（31.3%对26.8%；p < 0.001）存在显著差异。此外，手动收集队列的憩室病和痔疮患病率更高，结肠镜检查完成率更低。按检查指征分层导致两个队列在筛查和监测患者方面存在更多差异。大息肉的解剖学（右半结肠对左半结肠）分布也存在差异。
Provation数据与手动收集的病历数据之间存在显著差异。尽管两个队列的入组时间略有不同，但它们来自同一内镜科室，有相同的内镜医师和检查指征，且人口统计学特征相似，因此两个队列之间不太可能存在与记录方法无关的真实差异。因此，在将内镜数据用于研究时建议谨慎。
