文章基本信息

标题：Methodological Challenges in Web-Based Trials: Update and Insights From the Relatives Education and Coping Toolkit Trial
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作者：Heather Robinson ; Duncan Appelbe ; Susanna Dodd 等
期刊名称：JMIR Mental Health
电子版ISSN：2368-7959
出版年度：2020
卷号：7
期号：7
页码：1-28
DOI：10.2196/15878
出版社：JMIR Publications Inc., Toronto, Canada
摘要：UNSTRUCTURED:There has been a growth in the number of web-based trials of web-based interventions, adding to an increasing evidence base for their feasibility and effectiveness. However, there are challenges associated with such trials, which researchers must address. This discussion paper follows the structure of the Down Your Drink trial methodology paper, providing an update from the literature for each key trial parameter (recruitment, registration eligibility checks, consent and participant withdrawal, randomization, engagement with a web-based intervention, retention, data quality and analysis, spamming, cybersquatting, patient and public involvement, and risk management and adverse events), along with our own recommendations based on designing the Relatives Education and Coping Toolkit randomized controlled trial for relatives of people with psychosis or bipolar disorder. The key recommendations outlined here are relevant for future web-based and hybrid trials and studies using iterative development and test models such as the Accelerated Creation-to-Sustainment model, both within general health research and specifically within mental health research for relatives. Researchers should continue to share lessons learned from conducting web-based trials of web-based interventions to benefit future studies.INTERNATIONAL REGISTERED REPORT:RR2-10.1136/bmjopen-2017-016965.
关键词：carers;internet;mental health;methods;randomized controlled trial;relatives;research design;web