Gastroenterology Unit 2, Università degli Studi di Milano and Fondazione IRCCS "Ca' Granda" - Ospedale Maggiore Policlinico, Milan, Italy.
Gastroenterology Unit, Università degli Studi di Verona and Policlinico GB Rossi, Verona, Italy.
J Neurogastroenterol Motil. 2014 Apr 30;20(2):205-11. doi: 10.5056/jnm.2014.20.2.205.
BACKGROUND/AIMS: Symptom reflux association analysis is especially helpful for evaluation and management of proton pump inhibitor (PPI) re-fractory patients. An accurate calculation requires manual editing of 24-hour multichannel intraluminal impedance-pH (MII-pH) tracings after automatic analysis. Intra- and inter-observer agreement as well as reliability of rapid editing confined to the time around symptomatic episodes are unknown. Aim of this study was to explore these topics in a prospective multicenter study.
Forty consecutive patients who were off PPI therapy underwent MII-pH recordings. After automatic analysis, their tracings were anonymized and randomized. Three experienced observers, each one trained in a different European center, independently per-formed manual editing of 24-hour tracings on 2 separate occasions. Values of symptom index and symptom association proba-bility for acid and non acid reflux were transformed into binary response (i.e., positive or negative).
Intra-observer agreement on symptom reflux association was 92.5% to 100.0% for acid and 85.0% to 97.5% for non-acid reflux. Inter-observer agreement was 100.0% for acid and 82.5% to 95.0% for non-acid reflux. Values for symptom index and symptom association probability were similar. Concordance between 24-hour and rapid (2 minutes-window before each symp-tomatic episode) editings for symptom reflux association occured in 39 to 40 patients (acid) and in 37 to 40 (non-acid), de-pending on the observer.
Intra- and inter-observer agreement in classifying patients with or without symptom reflux association at manual editing of 24-hour tracings was high, especially for acid reflux. Classifying patients according to a rapid editing showed excellent con-cordance with the 24-hour one and can be adopted in clinical practice.
背景/目的：症状反流关联分析对于质子泵抑制剂（PPI）难治性患者的评估和管理特别有帮助。准确计算需要在自动分析后手动编辑 24 小时多通道腔内阻抗-pH（MII-pH）记录。关于在症状发作期间进行快速编辑的观察者内和观察者间一致性以及可靠性尚不清楚。本研究的目的是在一项前瞻性多中心研究中探讨这些问题。
40 例连续接受 MII-pH 记录的 PPI 治疗停药患者。在自动分析后，他们的记录被匿名化并随机化。三位经验丰富的观察者，每位观察者都在不同的欧洲中心接受过培训，分别在 2 个不同的时间独立进行 24 小时记录的手动编辑。症状指数和症状关联概率的酸和非酸反流值转换为二进制响应（即阳性或阴性）。
酸反流的观察者内一致性为 92.5%至 100.0%，非酸反流的观察者内一致性为 85.0%至 97.5%。酸反流的观察者间一致性为 100.0%，非酸反流的观察者间一致性为 82.5%至 95.0%。症状指数和症状关联概率的值相似。在 24 小时和快速编辑（每个症状发作前 2 分钟窗口）之间，对于症状反流关联，39 至 40 名患者（酸）和 37 至 40 名患者（非酸）之间存在一致性，这取决于观察者。
在手动编辑 24 小时记录时，对患者是否存在症状反流关联进行分类的观察者内和观察者间一致性较高，尤其是对于酸反流。根据快速编辑对患者进行分类与 24 小时编辑具有极好的一致性，可在临床实践中采用。
