Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands.
Department of Clinical and Experimental Medicine, Translational Research Centre for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
Neurogastroenterol Motil. 2021 Sep;33(9):e14136. doi: 10.1111/nmo.14136. Epub 2021 May 2.
Due to important biases, conventional end-of-day and end-of-week assessment methods of gastrointestinal symptoms in functional dyspepsia (FD) are considered suboptimal. Real-time symptom assessment based on the experience sampling method (ESM) could be a more accurate measurement method. This study aimed to evaluate validity and reliability of an ESM-based patient-reported outcome measure (PROM) for symptom assessment in FD.
Thirty-five patients with FD (25 female, mean age 44.7 years) completed the ESM-based PROM (a maximum of 10 random moments per day) and an end-of-day symptom diary for 7 consecutive days. On day 7, end-of-week questionnaires were completed including the Nepean Dyspepsia Index (NDI) and Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM).
Experience sampling method and corresponding end-of-day scores for gastrointestinal symptoms were significantly associated (ICCs range 0.770-0.917). However, end-of-day scores were significantly higher (Δ0.329-1.031) than mean ESM scores (p < 0.05). Comparing ESM with NDI and PAGI-SYM scores, correlations were weaker (Pearson's r range 0.467-0.846). Cronbach's α coefficient was good for upper gastrointestinal symptoms (α = 0.842). First half-week and second half-week scores showed very good consistency (ICCs range 0.913-0.975).
Good validity and reliability of a novel ESM-based PROM for assessing gastrointestinal symptoms in FD patients was demonstrated. Moreover, this novel PROM allows to evaluate individual symptom patterns and can evaluate interactions between symptoms and environmental/contextual factors. ESM has the potential to increase patients' disease insight, provide tools for self-management, and improve shared decision making. Hence, this novel tool may aid in the transition toward personalized health care for FD patients.
由于存在重要的偏倚，功能性消化不良（FD）的传统日内和周末胃肠道症状评估方法被认为并不理想。基于经验采样法（ESM）的实时症状评估可能是一种更准确的测量方法。本研究旨在评估基于 ESM 的患者报告结局测量（PROM）用于 FD 症状评估的有效性和可靠性。
35 例 FD 患者（25 名女性，平均年龄 44.7 岁）连续 7 天完成 ESM 基 PROM（每天最多 10 个随机时刻）和日内症状日记。第 7 天，完成包括 Nepean 消化不良指数（NDI）和患者胃肠道症状严重程度指数（PAGI-SYM）在内的周内问卷。
ESM 和相应的日内胃肠道症状评分具有显著相关性（ICC 范围 0.770-0.917）。然而，日内评分显著高于平均 ESM 评分（p < 0.05）。与 NDI 和 PAGI-SYM 评分相比，ESM 评分的相关性较弱（Pearson r 范围 0.467-0.846）。上胃肠道症状的 Cronbach's α 系数为 0.842。前半周和后半周评分具有很好的一致性（ICC 范围 0.913-0.975）。
新型基于 ESM 的 PROM 用于评估 FD 患者的胃肠道症状具有良好的有效性和可靠性。此外，这种新型 PROM 可以评估个体症状模式，并评估症状与环境/背景因素之间的相互作用。ESM 有可能增加患者对疾病的了解，为自我管理提供工具，并改善共同决策。因此，这种新型工具可能有助于 FD 患者向个性化医疗的转变。
