背景:严重的精神运动性激动和攻击性通常需要立即进行药物干预,但是缺乏在多种选择中进行选择的明确的循证建议.为了解决这个差距,我们计划进行系统评价和个体-参与者-数据网络荟萃分析,以更高的精确度调查它们在现实世界的急诊环境中的相对有效性.
方法:我们将包括研究肌内或静脉内药物干预的随机对照试验,作为单一疗法或联合疗法,在患有严重精神运动性躁动的成年人中,无论其潜在诊断如何,并且在一般情况下或精神紧急情况下需要快速镇静。我们将排除2002年之前的研究,这些研究侧重于躁动的具体原因和安慰剂对照试验,以避免与传递性假设和潜在选择偏差相关的担忧。我们将寻找符合资格的BIOSIS研究,中部,CINAHLPlus,Embase,LILACS,MEDLINE通过Ovid,PubMed,ProQuest,PsycINFO,ClinicalTrials.gov,世卫组织-ICTRP。将要求研究作者提供个人参与者数据,并将其统一为统一格式,汇总数据也将从研究中提取。至少有两名独立评审员将进行研究选择,数据提取,使用RoB2进行偏倚风险评估,并使用RITES工具进行适用性评估。主要结果是治疗后30分钟内达到足够镇静的患者人数。次要结局包括需要额外的干预措施和不良事件,使用赔率比作为效果大小。如果收集到足够的个人参与者数据,我们将在贝叶斯框架内的网络元回归模型中综合它们,纳入研究和参与者水平的特征,探索异质性的潜在来源。在个人参与者数据不可用的情况下,将探索潜在的数据可用性偏差,以及允许纳入仅报告汇总数据的研究的模型将被考虑。我们将使用网络荟萃分析信心(CINeMA)方法评估证据的信心。
结论:本个体-参与者-数据网络荟萃分析的目的是提供一个微调的综合证据,说明在现实世界的紧急情况下,药物干预对严重精神运动躁动的比较有效性。这项研究的发现可以为最有效的治疗提供更清晰的循证指导。
背景:PROSPEROCRD42023402365。
BACKGROUND: Severe psychomotor
agitation and aggression often require immediate pharmacological intervention, but clear evidence-based recommendations for choosing among the multiple options are lacking. To address this gap, we plan a systematic review and individual-participant-data network meta-analysis to investigate their comparative effectiveness in real-world emergency settings with increased precision.
METHODS: We will include randomized controlled trials investigating intramuscular or intravenous pharmacological interventions, as monotherapy or in combination, in adults with severe psychomotor
agitation irrespective of the underlying diagnosis and requiring rapid tranquilization in general or psychiatric emergency settings. We will exclude studies before 2002, those focusing on specific reasons for
agitation and placebo-controlled trials to avoid concerns related to the transitivity assumption and potential selection biases. We will search for eligible studies in BIOSIS, CENTRAL, CINAHL Plus, Embase, LILACS, MEDLINE via Ovid, PubMed, ProQuest, PsycINFO, ClinicalTrials.gov, and WHO-ICTRP. Individual-participant data will be requested from the study authors and harmonized into a uniform format, and aggregated data will also be extracted from the studies. At least two independent reviewers will conduct the study selection, data extraction, risk-of-bias assessment using RoB 2, and applicability evaluation using the RITES tool. The primary outcome will be the number of patients achieving adequate sedation within 30 min after treatment, with secondary outcomes including the need for additional interventions and adverse events, using odds ratios as the effect size. If enough individual-participant data will be collected, we will synthesize them in a network meta-regression model within a Bayesian framework, incorporating study- and participant-level characteristics to explore potential sources of heterogeneity. In cases where individual-participant data are unavailable, potential data availability bias will be explored, and models allowing for the inclusion of studies reporting only aggregated data will be considered. We will assess the confidence in the evidence using the Confidence in Network Meta-Analysis (CINeMA) approach.
CONCLUSIONS: This individual-participant-data network meta-analysis aims to provide a fine-tuned synthesis of the evidence on the comparative effectiveness of pharmacological interventions for severe psychomotor
agitation in real-world emergency settings. The findings from this study can greatly be provided clearer evidence-based guidance on the most effective treatments.
BACKGROUND: PROSPERO CRD42023402365.