Lee V Vien, Lau Ni Yin, Blasiak Agata, Siah Kewin Tien Ho, Ho Dean
The N.1 Institute for Health, National University of Singapore, Singapore.
The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Comput Struct Biotechnol J. 2023 Sep 29;22:41-49. doi: 10.1016/j.csbj.2023.09.034. eCollection 2023.
Patient-reported outcome measures (PROMs) are useful standardized tools to measure current patient health status and well-being. While there are existing constipation-related PROMs, the majority of PROMs were not developed with adequate patient involvement and few examined content validity. Accordingly, the current study aimed to develop a constipation PROM with multiple phases of patient and clinician involvement.
To generate PROM items, 15 patients with chronic constipation (age range =28-79 years, 10 females) underwent a qualitative interview exploring their experiences with chronic constipation. Following that, eight clinical experts completed the content validity index (CVI) ratings of all the items generated to assess content validity. Based on results of the content validity assessment, relevant items were maintained and 12 participants with chronic constipation were re-interviewed to obtain feedback about comprehensibility, comprehensiveness and relevance.
Six themes and 25 sub-themes emerged from the qualitative interview, and an initial list of 33 symptom items and 18 quality of life (QoL) items were generated. Based on the CVIs calculated, 11 symptom items and nine QoL items were maintained with the scale-content validity index indicating excellent content validity. Overall, participants indicated the PROM to be relevant, comprehensive and easy to understand however, minor amendments were made to improve the three qualities of interest.
The current study developed a constipation PROM that measures both symptom severity and constipation-related QoL, with supporting evidence for relevance, comprehensiveness and comprehensibility. Further prioritization should be given to validating and exploring new digital modalities of PROM administration.
患者报告结局测量指标（PROMs）是用于衡量当前患者健康状况和幸福感的有用标准化工具。虽然现已有与便秘相关的PROMs，但大多数PROMs并非在患者充分参与的情况下制定，且很少有研究考察内容效度。因此，本研究旨在通过患者和临床医生多阶段参与来开发一种便秘PROM。
为生成PROM条目，15名慢性便秘患者（年龄范围=28 - 79岁，10名女性）接受了定性访谈，探讨他们的慢性便秘经历。随后，八位临床专家对生成的所有条目完成内容效度指数（CVI）评分，以评估内容效度。根据内容效度评估结果，保留相关条目，并对12名慢性便秘参与者进行再次访谈，以获取关于可理解性、全面性和相关性的反馈。
定性访谈产生了六个主题和25个子主题，并生成了一份包含33个症状条目和18个生活质量（QoL）条目的初始清单。根据计算出的CVI，保留了11个症状条目和9个QoL条目，量表内容效度指数表明具有出色的内容效度。总体而言，参与者表示该PROM相关、全面且易于理解，不过还是进行了一些小的修改以改善这三个相关特性。
本研究开发了一种便秘PROM，可同时测量症状严重程度和与便秘相关的QoL，并具有相关性、全面性和可理解性的支持证据。应进一步优先考虑验证和探索PROM管理的新数字模式。
