Khurana Laura, Durand Ellen M, Gary Sarah T, Otero Antonio V, Gerzon Millie C, Beck Jamie, Hall Chris, Dallabrida Susan M
eResearch Technologies, Inc., Boston, MA, USA.
Patient Prefer Adherence. 2016 Oct 28;10:2171-2179. doi: 10.2147/PPA.S94247. eCollection 2016.
Electronic data capture is increasingly used to improve collection of patient-reported outcome measures in clinical trials and care. The validation of electronic patient-reported outcome devices requires information on patient preference and ease of use. This study conducted usability testing for a General Symptom Questionnaire and Medication Module™ on a handheld device for subjects with osteoarthritis (OA) to determine whether subjects can report on their symptoms and medication use using an electronic diary.
Nine subjects with OA participating in a large US mode equivalency study were surveyed independently in this study. Subjects completed a General Symptom Questionnaire and Medication Module™ using the LogPad LW handheld device. Demographic and technology use information was collected, and the subjects were queried on device usability.
Subjects reported that the handheld device was easy to use and that they were able to complete a General Symptom Questionnaire and Medication Module™ with little or no assistance. They did not report any issues with the screen or size of the device. Subjects were willing to travel with the device to complete electronic diaries at home or in public. Participants indicated that they would be able to use the handheld device to answer questions during a clinical trial. Subjects with OA experienced no physical discomfort during completion of either questionnaire.
The General Symptom Questionnaire and Medication Module™ were usable and acceptable to subjects with OA on a handheld device. This was consistent regardless of previous experience and confidence with technology, despite the potential physical restrictions for an OA cohort.
在临床试验和医疗中,电子数据采集越来越多地用于改善患者报告结局测量的收集。电子患者报告结局设备的验证需要有关患者偏好和易用性的信息。本研究针对骨关节炎(OA)患者,对手持设备上的通用症状问卷和药物模块™进行了可用性测试,以确定受试者是否可以使用电子日记报告其症状和药物使用情况。
本研究独立调查了9名参与美国大型模式等效性研究的OA患者。受试者使用LogPad LW手持设备完成了通用症状问卷和药物模块™。收集了人口统计学和技术使用信息,并询问了受试者有关设备可用性的问题。
受试者报告称,手持设备易于使用,并且他们能够在很少或没有帮助的情况下完成通用症状问卷和药物模块™。他们没有报告设备屏幕或尺寸方面的任何问题。受试者愿意携带该设备在家中或公共场所完成电子日记。参与者表示,他们能够在临床试验期间使用手持设备回答问题。OA患者在完成任何一份问卷时均未感到身体不适。
通用症状问卷和药物模块™在手持设备上对OA患者是可用且可接受的。无论之前对技术的经验和信心如何,这都是一致的,尽管OA患者群体可能存在身体限制。