Görlich Dennis, Faldum Andreas
Westfälische Wilhelms-Universität Münster, Institute of Biostatistics and Clinical Research, Schmeddingstraße 56, D-48149 Münster, Germany.
Internet Interv. 2019 Jan 11;16:5-11. doi: 10.1016/j.invent.2018.12.004. eCollection 2019 Apr.
The implementation of research studies is a highly complex process. All decisions with respect to the study design impact the statistical analyses and interpretation of the results. Within the ICare research project (EU H2020 Grant agreement 634757) seven research trials are conducted to generate evidence on efficacy, effectiveness and the dissemination potential of online interventions targeting eating disorders, common mental health problems and resilience. Within the project a central biometrical unit was established to manage and coordinate data collection, processing and statistical data analysis. This allows for harmonized trial planning, conduct, data management processes and analysis strategies. The purpose of this article is to describe the common concepts underlying all seven ICare trials. This includes development of (adaptive sequential) study designs, handling of missing values, general data management and processing as well as data protection aspects.
研究性研究的实施是一个高度复杂的过程。所有与研究设计相关的决策都会影响结果的统计分析和解读。在ICare研究项目（欧盟H2020资助协议634757）中，开展了七项研究试验，以获取关于针对饮食失调、常见心理健康问题和恢复力的在线干预措施的疗效、有效性及传播潜力的证据。在该项目中，设立了一个中央生物统计学单位，以管理和协调数据收集、处理及统计数据分析。这使得试验规划、实施、数据管理流程及分析策略得以统一。本文的目的是描述所有七项ICare试验所共有的概念。这包括（适应性序贯）研究设计的制定、缺失值的处理、一般数据管理与处理以及数据保护方面。
