Central Interdisciplinary Endoscopy Unit, Department of Gastroenterology, Charité University Medical Hospitals, Berlin, Germany.
Endoscopy. 2013 Oct;45(10):813-8. doi: 10.1055/s-0033-1344583. Epub 2013 Sep 9.
The German screening colonoscopy program is accompanied by a central registry that records the main outcome quality indicators, namely colonoscopy completion rate, adenoma detection rate (ADR), and complication rate. The aim of the present study was to assess the quality of these registry data by comparing them with data from a prospective quality assurance study based on a self-reporting audit and patient feedback of screening colonoscopy.
The completeness of registry information was analyzed by comparing it with prospective data gathered by audit and patient feedback in a previous quality assurance study (ClinicalTrials.gov registration number: NCT00860665) between October 2006 and March 2008. The main outcome parameters were colonoscopy completion rate, ADR, and complication rate. Complications were recorded in three steps in the audit study using case report forms (immediate and subsequent documentation by physicians [CRF-1 and CRF-2], and patient follow-up [CRF-3]), but were documented in the registry without differentiation.
A total of 12 134 individuals (mean age 64.5 years; 47 % men) who underwent screening colonoscopy at 19 private practices in Berlin over the 18-month period were included in the audit study. Patient feedback was obtained for 90.1 %. A total of 12 150 cases had been recorded in the registry by the same private practices during the same period. Colonoscopy completion rate and ADR data were comparable in the audit study and registry (completion rate 98.2 % vs. 97.7 %; ADR 21.0 % vs. 20.5 %). However, compared with the registry data, the complication rate was 3.1-fold higher in the audit (0.46 % vs. 0.15 %; P < 0.001), and double (0.33 % vs. 0.15 %; P < 0.05) when patient feedback was not included.
Of the screening colonoscopy quality parameters, colonoscopy completion rate and ADR, but not complication rates, were reliably documented in the German national screening colonoscopy registry. Data on complications need to be appropriately standardized and audited in order to be used for credentialing and benchmarking purposes.
德国筛查结肠镜计划配有一个中央登记处，记录主要的结果质量指标，即结肠镜完成率、腺瘤检出率（ADR）和并发症发生率。本研究的目的是通过将这些登记处数据与基于自我报告审计和患者对筛查结肠镜检查反馈的前瞻性质量保证研究的数据进行比较，来评估这些数据的质量。
通过将登记处信息与之前的一项质量保证研究（ClinicalTrials.gov 注册号：NCT00860665）中 2006 年 10 月至 2008 年 3 月期间通过审计和患者反馈收集的前瞻性数据进行比较，分析了登记处信息的完整性。主要结果参数为结肠镜完成率、ADR 和并发症发生率。在审计研究中，使用病例报告表（医生立即和随后的记录[CRF-1 和 CRF-2]和患者随访[CRF-3]）分三步记录并发症，但在登记处中没有区分地记录。
共有 12134 名（平均年龄 64.5 岁；47%为男性）在柏林的 19 家私人诊所接受筛查结肠镜检查的个体被纳入了审计研究。获得了 90.1%患者的反馈。在同一时期，同一私人诊所共记录了 12150 例病例。在审计研究和登记处中，结肠镜完成率和 ADR 数据具有可比性（完成率为 98.2%对 97.7%；ADR 为 21.0%对 20.5%）。然而，与登记处数据相比，审计中的并发症发生率高 3.1 倍（0.46%对 0.15%；P<0.001），且未纳入患者反馈时为 2 倍（0.33%对 0.15%；P<0.05）。
在德国国家筛查结肠镜检查登记处中，可靠地记录了筛查结肠镜检查的质量参数，包括结肠镜完成率和 ADR，但不包括并发症发生率。为了用于认证和基准目的，需要对并发症数据进行适当的标准化和审计。
