Department of Psychological Medicine, The University of Auckland, Auckland, New Zealand.
Trials. 2011 May 26;12:135. doi: 10.1186/1745-6215-12-135.
People who present to hospital after intentionally harming themselves pose a common and important problem. Previous reviews of interventions have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and regular written communications after the self-harm attempt may be an effective treatment. This protocol describes a large pragmatic trial of a package of measures which include problem solving therapy, regular written communication, patient support, cultural assessment, improved access to primary care and a risk management strategy in people who present to hospital after self-harm using a novel design.
We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enroll a large representative cohort of patients. The main outcome will be hospital attendance following repetition of self-harm, in the 12 months after recruitment with secondary outcomes of self reported self-harm, hopelessness, anxiety, depression, quality of life, social function and hospital use at three months and one year.
A strength of the study is that it is a pragmatic trial which aims to recruit large numbers and does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. However the primary analysis is a true intention to treat analysis of everyone randomised which includes both those who consent and do not consent to participate in the study. This provides information about how the intervention will work in practice in a representative population which is a major advance in this study compared to what has been done before.
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000641291.
故意伤害自己后到医院就诊的人是一个常见且重要的问题。先前干预措施的综述结果并不明确，因为现有试验的效力不足且针对的人群不具代表性。然而，这些综述表明，问题解决疗法和在自残尝试后定期进行书面沟通可能是一种有效的治疗方法。本方案描述了一项针对一揽子措施的大型实用试验，这些措施包括问题解决疗法、定期书面沟通、患者支持、文化评估、改善初级保健的机会以及在因自残而到医院就诊的人群中实施的风险管理策略，该试验采用了新颖的设计。
我们建议使用双同意 Zelen 设计，在参与者同意入组之前，先对其进行随机分组，以纳入大量具有代表性的患者队列。主要结局是在招募后的 12 个月内重复自残后到医院就诊的情况，次要结局是自我报告的自残、绝望、焦虑、抑郁、生活质量、社会功能和在招募后 3 个月和 1 年时的医院就诊情况。
该研究的一个优势在于，它是一项实用试验，旨在招募大量患者，并且不会因英语不是第一语言而排除患者。潜在的局限性在于结果分析较为复杂，如果在随机分配到问题解决疗法组的人中，有大量人拒绝同意参与研究，那么分析结果可能会低估任何效果，因为他们实际上会交叉到常规治疗组。然而，主要分析是对所有随机分组的人的真实意向治疗分析，其中包括同意和不同意参与研究的人。这提供了有关干预措施在代表性人群中实际效果的信息，这是该研究与之前研究相比的一个重大进展。
澳大利亚和新西兰临床试验注册中心（ANZCTR）：ACTRN12609000641291。
