Tønning Morten Lindbjerg, Kessing Lars Vedel, Bardram Jakob Eivind, Faurholt-Jepsen Maria
Copenhagen Affective Disorder Research Center, Psychiatric Center Copenhagen, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.
Department of Health Technology, Technical University of Denmark, Lyngby, Denmark.
J Med Internet Res. 2019 Oct 27;21(10):e15362. doi: 10.2196/15362.
Smartphone-based technology is developing at high speed, and many apps offer potential new ways of monitoring and treating a range of psychiatric disorders and symptoms. However, the effects of most available apps have not been scientifically investigated. Within medicine, randomized controlled trials (RCTs) are the standard method for providing the evidence of effects. 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.
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.
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.
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.
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.
基于智能手机的技术正在高速发展，许多应用程序提供了监测和治疗一系列精神疾病及症状的潜在新方法。然而，大多数现有应用程序的效果尚未经过科学研究。在医学领域，随机对照试验（RCT）是提供疗效证据的标准方法。然而，其严格性和较长的时间框架可能与信息技术研究领域存在差异。因此，需要对移动健康领域中设计和开展RCT的方法学挑战进行系统综述。
本系统综述旨在（1）识别并描述调查基于智能手机的治疗对成年精神疾病患者疗效的RCT，（2）讨论设计和开展单个试验的方法学挑战，以及（3）为未来试验提出建议。
截至2019年8月12日，在PubMed、PsycINFO和EMBASE中进行了英文系统检索。检索词为（1）广义的精神疾病及特定疾病，（2）智能手机或应用程序，（3）RCT。采用《试验报告统一标准》电子健康指南作为数据提取模板。重点关注试验设计、方法和报告。仅纳入那些在诊断和可接受的诊断程序方面有足够信息、将智能手机作为治疗核心部分且采用RCT设计的试验。
共纳入27项试验，涉及3312名患有一系列精神疾病诊断的患者。其中，2项试验涉及药物或酒精滥用，3项涉及精神病，10项涉及情感障碍，9项涉及焦虑和创伤后应激障碍，1项涉及饮食失调，1项涉及注意力缺陷多动障碍。此外，1项试验采用了跨诊断设计，7项试验纳入了临床诊断患者，随后由研究人员进行评估和验证，11项试验样本量超过100。总体而言，发现试验间存在较大异质性，在患者招募、诊断程序、试验设计、对照、结局测量和分析方面有多种方法。只有5项试验发表了试验方案。此外，1项试验提供了有关技术更新的信息，只有18项试验报告了利益冲突。没有试验涉及在治疗中使用智能手机的伦理问题。
对调查基于智能手机治疗精神疾病患者的RCT设计和开展中的方法学挑战进行的首次系统综述表明，试验数量在增加，但与经典医学RCT相比质量较低。单个试验中的异质性和方法学问题限制了证据。提出了方法学建议。
