Complex Interventions Division, Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Complex Interventions Division, Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
BMJ Open. 2021 May 3;11(5):e049255. doi: 10.1136/bmjopen-2021-049255.
Up to 10% of adolescents report self-harm in the previous year. Non-fatal repetition is common (18% in 1 year), death from any cause shows a fourfold and suicide a 10-fold excess. Despite the scale of the problem, there is insufficient evidence for effective interventions for self-harm. Those who self-harm do so for a variety of different reasons. Different treatments may be more effective for subgroups of adolescents; however, little is known about which subgroups are appropriate for further study. This protocol outlines a systematic review and individual participant data meta-analysis (IPD-MA) to identify subgroups of adolescents for which therapeutic interventions for self-harm show some evidence of benefit.
A systematic literature search was conducted in August 2019 (including Cochrane Library, Embase, trial registers and other databases). An update search is planned. Study selection will identify randomised controlled trials examining interventions to reduce self-harm in adolescents who have self-harmed and presented to services. Identified research teams will be invited to contribute data and form a collaborative group. Two-stage IPD-MA will be used to evaluate effectiveness of different therapeutic interventions compared with any active or non-active control on repetition of self-harm, general psychopathology, depression, suicidal ideation, quality of life and death. Subgroup analyses will identify adolescent subgroups in whom different therapeutic interventions may be more effective. Meta-regression will explore moderating study and intervention effects. Sensitivity analyses will incorporate aggregate data from studies lacking IPD and test the robustness of results to methods for handling missing data, within-study clustering, non-adherence and study quality.
Ethical approval is provided by the University of Leeds, Faculty of Medicine and Health Ethics Committee (18-098). Outcomes will inform research recommendations and will be disseminated internationally through the collaborative group, a service user advisory group, open-access peer-reviewed publication and conference presentations.
CRD42019152119.
多达 10%的青少年在过去一年报告过自伤。非致命性重复自伤很常见（1 年内 18%），任何原因导致的死亡风险增加 4 倍，自杀风险增加 10 倍。尽管问题严重，但针对自伤的有效干预措施的证据仍然不足。自伤的人出于各种不同的原因而自伤。不同的治疗方法可能对青少年亚组更有效；然而，对于哪些亚组适合进一步研究，我们知之甚少。本方案概述了一项系统评价和个体参与者数据荟萃分析（IPD-MA），以确定治疗自伤的干预措施对哪些亚组的青少年有一定益处。
我们于 2019 年 8 月进行了系统文献检索（包括 Cochrane 图书馆、Embase、试验注册处和其他数据库）。计划进行更新检索。研究选择将确定针对曾到服务机构就诊并自伤的青少年进行的减少自伤的干预措施的随机对照试验。将邀请确定的研究团队提供数据并组成合作小组。我们将采用两阶段 IPD-MA 来评估不同治疗干预措施与任何活性或非活性对照相比，在重复自伤、一般精神病理学、抑郁、自杀意念、生活质量和死亡方面的有效性。亚组分析将确定不同治疗干预措施可能对哪些青少年亚组更有效。荟萃回归分析将探索调节研究和干预效果的因素。敏感性分析将纳入缺乏 IPD 的研究的汇总数据，并测试结果对处理缺失数据、研究内聚类、不依从和研究质量的稳健性。
利兹大学医学与健康伦理委员会（18-098）提供了伦理批准。研究结果将为研究建议提供信息，并通过合作小组、服务用户咨询小组、开放获取同行评审出版物和会议演讲在国际上传播。
PROSPERO 注册号：CRD42019152119。
