Centre for Suicide Research, Department of Psychiatry, University of Oxford, Oxford, UK.
Discipline of Medicine, Pontifícia Universidade Católica do Paraná, Brazil.
J Affect Disord. 2018 Aug 1;235:434-447. doi: 10.1016/j.jad.2018.04.025. Epub 2018 Apr 4.
Randomized controlled trials (RCTs) are the mainstay of evaluations of the efficacy of psychosocial interventions. In a recent Cochrane systematic review we analysed the efficacy of cognitive behavioural-based psychotherapies compared to treatment as usual (TAU) in adults who self-harm. In this study we examine the content and reporting quality of TAU in these trials and their relationship to outcomes.
Five electronic databases (CCDANCTR-Studies and References, CENTRAL, MEDLINE, EMBASE, and PsycINFO) were searched for RCTs, indexed between 1 January 1998 and 30 April 2015, of cognitive-behavioural interventions compared to TAU for adults following a recent (within six months) episode of self-harm. Comparisons were made between outcomes for trials which included different categories of TAU, which were grouped as: multidisciplinary treatment, psychotherapy only, pharmacotherapy only, treatment by primary care physician, minimal contact, or unclear.
18 trials involving 2433 participants were included. The content and reporting quality of TAU varied considerably between trials. The apparent effectiveness of cognitive behavioural psychotherapy varied according to TAU reporting quality and content. Specifically, effects in favour of cognitive-behavioural psychotherapy were strongest in trials in which TAU content was not clearly described (Odds Ratio: 0.29, 95% Confidence Interval 0.15-0.62; three trials) compared to those in which TAU comprised multidisciplinary treatment (Odds Ratio: 0.79, 95% CI 0.63 to 0.97; 12 trials).
The included trials had high risk of bias with respect to participant and clinical personnel blinding, and unclear risk of bias for selective outcome reporting.
TAU content and quality represents an important source of heterogeneity between trials of psychotherapeutic interventions for prevention of self-harm. Before clinical trials begin, researchers should plan to carefully describe both aspects of TAU to improve the overall quality of investigations.
随机对照试验(RCTs)是评估心理社会干预疗效的主要方法。在最近的 Cochrane 系统评价中,我们分析了认知行为为基础的心理疗法与常规治疗(TAU)相比,在近期(六个月内)发生过自伤的成年人中的疗效。在这项研究中,我们检查了这些试验中 TAU 的内容和报告质量及其与结果的关系。
检索了五个电子数据库(CCDANCTR-Studies and References、CENTRAL、MEDLINE、EMBASE 和 PsycINFO),这些数据库收录了 1998 年 1 月 1 日至 2015 年 4 月 30 日期间发表的 RCTs,比较了近期(六个月内)发生过自伤的成年人中认知行为干预与 TAU 的疗效。比较了包含不同类型 TAU 的试验之间的结果,这些 TAU 分为以下几类:多学科治疗、心理治疗、药物治疗、初级保健医生治疗、最低限度接触或不清楚。
共纳入了 18 项涉及 2433 名参与者的试验。试验中 TAU 的内容和报告质量差异很大。认知行为心理治疗的明显效果取决于 TAU 的报告质量和内容。具体来说,在那些未明确描述 TAU 内容的试验中(优势比:0.29,95%置信区间 0.15-0.62;三项试验),认知行为心理治疗的效果明显优于包含多学科治疗的试验(优势比:0.79,95%置信区间 0.63 至 0.97;12 项试验)。
纳入的试验在参与者和临床人员盲法方面存在高偏倚风险,选择性结果报告的偏倚风险不明确。
TAU 的内容和质量是预防自伤的心理治疗干预试验之间异质性的一个重要来源。在临床试验开始之前,研究人员应该计划仔细描述 TAU 的这两个方面,以提高调查的整体质量。