Are trials of psychological and psychosocial interventions for schizophrenia and psychosis included in the NICE guidelines pragmatic? A systematic review

IntroductionThe NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled trials (RCTs), which may not be studies with a pragmatic design, leading to uncertainty on applicability or recommendations to everyday clinical practice.AimTo assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses.Material and methodsWe conducted a systematic and critical appraisal of RCTs used to develop the ‘psychological therapy and psychosocial interventions’ section of the NICE guideline on the treatment and management of psychosis and schizophrenia in adults, published in 2014. For each study we assessed pragmatism using the pragmatic–explanatory continuum indicator summary-2 (PRECIS-2) and the Cochrane risk of bias tool. The mean score of PRECIS-2, averaging across nine domains, was calculated to describe the level of pragmatism of each individual study.ResultsA total of 143 studies were included in the analysis. Based on the PRECIS-2 tool, 16.8% were explanatory, 33.6% pragmatic, and 49.7% were rated in an intermediate category. Compared to explanatory studies, pragmatic studies showed a lower risk of bias. Additionally, pragmatism did not significantly improve over time, and no associations were found between pragmatism and a number of trial characteristics. However, studies with a UK leading investigator had the highest mean score of pragmatism. Cognitive behavioural therapy (CBT), art therapy, family intervention, psychoeducation, and adherence therapy, showed the higher average pragmatism scores.ConclusionsTwo third of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design.

引言
英国国家卫生与临床优化研究所（NICE）针对成人精神分裂症与精神病性障碍治疗的社会心理干预临床指南，其制定依据为随机对照试验（randomized controlled trials, RCTs）的研究结果，但此类试验未必采用实用型研究设计，由此导致指南推荐方案在日常临床实践中的适用性存疑。

研究目的
评估用于制定NICE成人精神病性障碍社会心理干预指南的相关证据的实用化程度。

材料与方法
本研究对2014年发布的《成人精神病性障碍与精神分裂症治疗及管理指南》中“心理治疗与社会心理干预”章节所纳入的随机对照试验进行系统批判性评价。针对每项研究，我们分别采用实用-解释性连续统一指标总结量表2（pragmatic–explanatory continuum indicator summary-2, PRECIS-2）与Cochrane偏倚风险工具评估其实用化程度。通过计算9个维度的PRECIS-2平均得分，以描述每项研究的实用化水平。

结果
本分析共纳入143项研究。依据PRECIS-2量表评估结果，16.8%的研究为解释型研究，33.6%为实用型研究，剩余49.7%被归类为中间型研究。与解释型研究相比，实用型研究的偏倚风险更低。此外，研究的实用化程度并未随时间推移出现显著提升，且实用化程度与多项试验特征均无显著关联。但由英国主导研究者牵头的研究，其实用化平均得分最高。认知行为疗法（cognitive behavioural therapy, CBT）、艺术治疗、家庭干预、心理教育与依从性治疗的平均实用化得分均较高。

结论
用于制定NICE成人精神分裂症与精神病性障碍社会心理干预推荐方案的研究中，三分之二的研究未采用实用型研究设计。