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在线实用随机对照试验的实施:方法学案例研究。

Implementation of an online pragmatic randomized controlled trial: a methodological case study.

机构信息

Division of Pulmonary & Critical Care, Department of Medicine, Georgetown University Medical Center, Washington, DC USA ; MeYou Health, LLC, Boston, MA USA.

出版信息

Transl Behav Med. 2013 Sep;3(3):295-303. doi: 10.1007/s13142-013-0223-2.

Abstract

Rigorous evaluation of eHealth interventions is acutely needed but can be challenging to execute in a cost- and time-efficient way. The purpose of this study is to describe a randomized controlled trial carried out as part of an approach that evaluates and informs product development throughout an intervention's life cycle. We present the methodological case of a pragmatic randomized controlled trial evaluating the effectiveness of the web-based intervention "Daily Challenge." We conducted the trial entirely online and leveraged existing resources to implement it quickly and within budget. One thousand five hundred three participants were recruited in 49 days (17.1 % of candidates assessed for eligibility). Then, 68.7 % of participants were reached for follow-up at 30 days and 62.5 % at 90 days. Data collection (baseline to 90-day follow-up) was completed within 5 months. Rigorous trials can be conducted efficiently and in a timely manner, enabling evaluation on a continuous basis. Development should include ongoing empirical input to inform product iterations.

摘要

迫切需要对电子健康干预措施进行严格评估,但以具有成本效益和高效的方式执行可能具有挑战性。本研究的目的是描述一项随机对照试验,该试验是作为一种在干预措施整个生命周期内评估和为产品开发提供信息的方法的一部分进行的。我们介绍了一项实用随机对照试验的方法学案例,该试验评估了基于网络的干预措施“每日挑战”的有效性。我们完全在网上进行了试验,并利用现有资源快速且在预算内实施。在 49 天内(评估合格性的候选人的 17.1%)招募了 1503 名参与者。然后,在 30 天和 90 天对 68.7%和 62.5%的参与者进行了随访。数据收集(基线至 90 天随访)在 5 个月内完成。可以高效且及时地进行严格的试验,从而能够进行持续评估。开发应包括持续的实证投入,以告知产品迭代。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f25/3771016/5fd6a0e0ada1/13142_2013_223_Fig1_HTML.jpg

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