Delgado-Herrera Leticia, Banderas Benjamin, Ojo Oluwafunke, Kothari Ritesh, Zeiher Bernhardt
Astellas Pharma Global Development, Inc., Northbrook, IL.
Adelphi Values LLC, Boston, MA.
Patient Relat Outcome Meas. 2017 Jul 18;8:83-95. doi: 10.2147/PROM.S126605. eCollection 2017.
Subjects with diarrhea-predominant irritable bowel syndrome (IBS-D) experience abdominal cramping, bloating, pressure, and pain. Due to an absence of clinical biomarkers for IBS-D severity, evaluation of clinical therapy benefits depends on valid and reliable symptom assessments. A patient-reported outcome (PRO) instrument has been developed, comprising of two questionnaires - the IBS-D Daily Symptom Diary and IBS-D Symptom Event Log - suitable for clinical trials and real-world settings. This program aimed to support instrument conversion from pen-and-paper to electronic format.
Digital technology (Android/iOS) and a traditional mode of administration study in the target population were used to migrate or convert the validated PRO IBS-D pen-and-paper measure to an electronic format. Equivalence interviews, conducted in three waves, each had three parts: 1) conceptual equivalence testing between formats, 2) electronic-version report-history cognitive debriefing, and 3) electronic version usability evaluation. After each inter-view wave, preliminary analyses were conducted and modifications made to the electronic version, before the next wave. Final revisions were based on a full analysis of equivalence interviews. The final analysis evaluated subjects' ability to read, understand, and provide meaningful responses to the instruments across both formats. Responses were classified according to conceptual equivalence between formats and mobile-format usability assessed with a questionnaire and open-ended probes.
Equivalence interviews (n=25) demonstrated conceptual equivalence between formats. Mobile-application cognitive debriefing showed some subjects experienced difficulty with font/screen visibility and understanding or reading some report-history charts and summary screens. To address difficulties, minor revisions/modifications were made and landscape orientation and zoom-in/zoom-out features incorporated.
This study indicates that the two administration modes are conceptually equivalent. Since both formats are conceptually equivalent, both are psychometrically reliable, as established in the pen-and-paper version. Subjects found both mobile applications (Android/iOS) offered many advantages over the paper version, such as real-time assessment of their experience.
腹泻型肠易激综合征（IBS-D）患者会经历腹部绞痛、腹胀、压迫感和疼痛。由于缺乏用于评估IBS-D严重程度的临床生物标志物，临床治疗效果的评估依赖于有效且可靠的症状评估。已开发出一种患者报告结局（PRO）工具，它由两份问卷组成——IBS-D每日症状日记和IBS-D症状事件日志，适用于临床试验和实际应用场景。该项目旨在支持将该工具从纸质形式转换为电子形式。
利用数字技术（安卓/苹果系统）以及在目标人群中进行的传统管理模式研究，将经过验证的PRO IBS-D纸质测量工具迁移或转换为电子形式。等价性访谈分三轮进行，每轮有三个部分：1）两种形式之间的概念等价性测试，2）电子版本报告历史的认知反馈，3）电子版本的可用性评估。在每轮访谈之后，进行初步分析并对电子版本进行修改，然后再进行下一轮。最终修订基于对等价性访谈的全面分析。最终分析评估了受试者对两种形式的工具进行阅读、理解并给出有意义回答的能力。回答根据两种形式之间的概念等价性进行分类，并通过问卷和开放式探究对移动形式的可用性进行评估。
等价性访谈（n = 25）表明两种形式在概念上是等价的。移动应用的认知反馈显示，一些受试者在字体/屏幕可见性以及理解或阅读一些报告历史图表和摘要屏幕方面遇到困难。为解决这些困难，进行了一些小的修订/修改，并加入了横向模式以及放大/缩小功能。
本研究表明两种管理模式在概念上是等价的。由于两种形式在概念上是等价的，且正如纸质版本所证实的那样，两者在心理测量学上都是可靠的。受试者发现两种移动应用（安卓/苹果系统）相比纸质版本有许多优势，比如能实时评估他们的体验。
