Child Health Evaluative Sciences, The Hospital for Sick Children, University of Toronto, Toronto, Ontario.
Pain Res Manag. 2013 May-Jun;18(3):142-52. doi: 10.1155/2013/369541.
While paper headache pain diaries have been used to determine the effectiveness of headache treatments in clinical trials, recent advances in information and communication technologies have resulted in the burgeoning use of electronic diaries (e-diaries) for headache pain.
To qualitatively review headache e-diaries, assess their measurement properties, examine measurement components and compare these components with recommended reporting guidelines.
The databases Medline, the Cumulative Index to Nursing and Allied Health Literature, Embase, PsychInfo, the Education Resources Information Centre and ISI Web of Science were searched for self-report headache e-diaries for children and adults. A total of 21 publications that involved e-diaries were found; five articles reported on the development of an e-diary and 16 used an e-diary as an outcome measure in randomized controlled trials or observational studies. The diary measures' components, features and psychometric properties, as well as the quality of evidence of their psychometric properties, were evaluated.
Five headache e-diaries met the a priori criteria and were included in the final analysis. None of these e-diaries had well-developed evidence of reliability and validity. Three e-diaries showed evidence of feasibility. E-diaries with ad hoc measures developed by the study investigators were most common, with little to no supportive evidence of reliability and⁄or validity. Compliance with the reporting guidelines was variable, with only one-half of the e-diaries measuring the recommended primary outcome of headache frequency.
Specific recommendations regarding the development (including essential components) and testing of headache e-diaries are discussed. Further research is needed to strengthen the measurement of headache pain in clinical trials using headache e-diaries.
虽然纸质头痛日记已被用于确定临床试验中头痛治疗的效果,但信息和通信技术的最新进展使得电子日记(e 日记)在头痛疼痛方面的使用日益增多。
定性审查头痛电子日记,评估其测量特性,检查测量组件,并将这些组件与推荐的报告指南进行比较。
在 Medline、护理和联合健康文献累积索引、Embase、PsychInfo、教育资源信息中心和 ISI Web of Science 数据库中搜索儿童和成人的自我报告头痛电子日记。共发现 21 篇涉及电子日记的出版物;其中 5 篇文章报道了电子日记的开发,16 篇文章将电子日记用作随机对照试验或观察性研究的结果测量。评估日记测量的组成部分、特征和心理测量特性,以及其心理测量特性的证据质量。
符合事先设定标准的 5 个头痛电子日记被纳入最终分析。这些电子日记均未具有可靠和有效的充分证据。其中 3 个电子日记具有可行性的证据。最常见的是研究人员专门开发的特定措施的电子日记,几乎没有可靠和/或有效的支持证据。报告指南的一致性各不相同,只有一半的电子日记测量了推荐的头痛频率主要结局。
讨论了头痛电子日记的开发(包括基本组成部分)和测试的具体建议。需要进一步研究,以加强使用头痛电子日记进行临床试验中头痛疼痛的测量。