Lepage Simone, Conway Aislinn, Goodson Noah, Wicks Paul, Devane Declan
HRB-Trials Methodology Research Network, School of Nursing and Midwifery, National University of Ireland, Galway, Galway, Co. Galway, H91E3YV, Ireland.
Health Technology Assessment Directorate, Health Information and Quality Authority, Dublin 7, Co Dublin, D07E98Y, Ireland.
HRB Open Res. 2022 Jun 20;5:46. doi: 10.12688/hrbopenres.13566.1. eCollection 2022.
This scoping review will determine how online, randomised trials with children are conducted. The objectives of the review are: (a) to determine what methods and tools have been used to create and conduct online trials with children and (b) to identify the gaps in the knowledge in this field. Over the last decade, randomised trials employing online methods have gained traction. Decentralised methods lend themselves to certain types of trials and can offer advantages over traditional trial methods, potentially increasing participant reach and diversity and decreasing research waste. However, decentralised trials that have all aspects of the trial exclusively online are not yet common, and those involving children even less so. This scoping review will describe and evaluate the methods used in these trials to understand how they may be effectively employed. Methods are informed by guidance from the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. The search strategy was developed in consultation with an information specialist for the following databases: MEDLINE, CENTRAL, CINAHL, and Embase. Grey literature searches will be completed with the consultation of experts in decentralised trials and digital health using internet searches and suitable trial registries. Once identified, included full-text studies' references will be manually searched for any trials that may have been missed. We will include randomised and quasi-randomised trials conducted exclusively online with participants under the age of 18 published in English. We will not limit by country of conduct or date of publication. Data will be collected using a data charting tool and presented in text, graphical, and tabular formats. Ethical approval is not needed since all data sources used are publicly available. The review will be available as a preprint before publication in an open-access, peer-reviewed journal.
本综述性研究将确定针对儿童的在线随机试验是如何开展的。该综述的目标如下：（a）确定用于开展针对儿童的在线试验的方法和工具，以及（b）找出该领域知识中的空白。在过去十年中，采用在线方法的随机试验越来越受到关注。去中心化方法适用于某些类型的试验，并且与传统试验方法相比可能具有优势，有可能增加参与者的数量和多样性，并减少研究浪费。然而，完全在线进行试验各个方面的去中心化试验并不常见，涉及儿童的此类试验更是少见。本综述性研究将描述和评估这些试验中所使用的方法，以了解如何能有效地运用它们。方法依据乔安娜·布里格斯研究所的指南以及系统评价与荟萃分析优先报告项目（PRISMA）扩展版中关于综述性研究的指南制定。搜索策略是在与信息专家协商后针对以下数据库制定的：医学期刊数据库（MEDLINE）、考克兰系统评价数据库（CENTRAL）、护理学与健康领域数据库（CINAHL）和荷兰医学文摘数据库（Embase）。将通过互联网搜索和合适的试验注册库，在去中心化试验和数字健康领域专家的咨询协助下完成灰色文献检索。一旦确定，将手动搜索纳入的全文研究的参考文献，以查找可能遗漏的任何试验。我们将纳入仅在线进行的、参与者年龄在18岁以下且以英文发表的随机和半随机试验。我们不会受开展国家或出版日期的限制。数据将使用数据图表工具收集，并以文本、图形和表格形式呈现。由于所使用的所有数据来源都是公开可用的，因此无需伦理批准。该综述将在发表于开放获取、同行评审期刊之前以预印本形式提供。
