@文章{信息:doi/10.2196/15362，作者=“T{\o}nning, Morten Lindbjerg和Kessing, Lars Vedel和Bardram, Jakob Eivind和Faurholt-Jepsen, Maria”，标题=“基于智能手机的精神病学治疗随机控制试验的方法挑战:系统综述”，期刊=“J Med Internet Res”，年=“2019”，月=“10月”，日=“27”，卷=“21”，数=“10”，页=“e15362”，关键词=“精神病学;方法;智能手机;移动健康;移动健康;数字健康;数字精神病学;背景:基于智能手机的技术正在高速发展，许多应用程序为监测和治疗一系列精神疾病和症状提供了潜在的新方法。然而，大多数可用应用程序的影响都没有经过科学调查。在医学领域，随机对照试验(rct)是提供疗效证据的标准方法。 However, their rigidity and long time frame may contrast with the field of information technology research. Therefore, a systematic review of methodological challenges in designing and conducting RCTs within mobile health is needed. Objective: This systematic review aimed to (1) identify and describe RCTs investigating the effect of smartphone-based treatment in adult patients with a psychiatric diagnosis, (2) discuss methodological challenges in designing and conducting individual trials, and (3) suggest recommendations for future trials. Methods: A systematic search in English was conducted in PubMed, PsycINFO, and EMBASE up to August 12, 2019. The search terms were (1) psychiatric disorders in broad term and for specific disorders AND (2) smartphone or app AND (3) RCT. The Consolidated Standards of Reporting Trials electronic health guidelines were used as a template for data extraction. The focus was on trial design, method, and reporting. Only trials having sufficient information on diagnosis and acceptable diagnostic procedures, having a smartphone as a central part of treatment, and using an RCT design were included. Results: A total of 27 trials comprising 3312 patients within a range of psychiatric diagnoses were included. Among them, 2 trials were concerning drug or alcohol abuse, 3 psychosis, 10 affective disorders, 9 anxiety and posttraumatic stress disorder, 1 eating disorder, and 1 attention-deficit/hyperactivity disorder. In addition, 1 trial used a cross-diagnostic design, 7 trials included patients with a clinical diagnosis that was subsequently assessed and validated by the researchers, and 11 trials had a sample size above 100. Generally, large between-trial heterogeneity and multiple approaches to patient recruitment, diagnostic procedures, trial design, comparator, outcome measures, and analyses were identified. Only 5 trials published a trial protocol. Furthermore, 1 trial provided information regarding technological updates, and only 18 trials reported on the conflicts of interest. No trial addressed the ethical aspects of using smartphones in treatment. Conclusions: This first systematic review of the methodological challenges in designing and conducting RCTs investigating smartphone-based treatment in psychiatric patients suggests an increasing number of trials but with a lower quality compared with classic medical RCTs. Heterogeneity and methodological issues in individual trials limit the evidence. Methodological recommendations are presented. ", issn="1438-8871", doi="10.2196/15362", url="//www.mybigtv.com/2019/10/e15362/", url="https://doi.org/10.2196/15362", url="http://www.ncbi.nlm.nih.gov/pubmed/31663859" }