Protocol for individual participant data meta-analysis of randomised controlled trials of patients with psychosis to investigate treatment effect modifiers for CBT versus treatment as usual or other psychosocial interventions.
Protocol for individual participant data meta-analysis of randomised controlled trials of patients with psychosis to investigate treatment effect modifiers for CBT versus treatment as usual or other psychosocial interventions.
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DOI：
10.1136/bmjopen-2019-035062
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发表时间：
2021-05-28
期刊：
影响因子：
2.9
通讯作者：
Varese F
中科院分区：
文献类型：
--
作者：
Sudell M;Tudur-Smith C;Liao X;Longden E;Dunn G;Kendall T;Emsley R;Morrison A;Varese F
综合数据荟萃分析显示，认知行为疗法（CBT）对精神分裂症谱系诊断患者的治疗效果不同。这种异质性可能源于可能影响CBT临床疗效的特定干预措施或患者特征，称为治疗效果调节剂。这项个体参与者数据荟萃分析将调查CBT疗效的一系列潜在治疗效果调节因素。我们将对精神分裂症谱系诊断患者的CBT与常规治疗或CBT与其他社会心理干预的研究进行系统回顾和荟萃分析。检索Cochrane中央对照试验登记处（Central）、PubMed、EMBASE以及美国政府、欧盟、世卫组织和当前对照试验的在线临床试验登记处。两名研究人员将筛选通过搜索确定的标题和摘要。任何符合条件的研究都需要个体参与者的数据，包括主要结局（总体精神病症状）、次要结局和治疗效果调整因素。根据制定的统计分析计划对数据进行核对和记录。将进行一阶段和两阶段随机效应荟萃分析，调查潜在的治疗效果调节剂。将产生一份CBT潜在治疗效果调节剂的清单，激励未来对特定调节剂的研究。本研究不需要伦理批准，因为它是基于现有研究的数据，尽管将遵循临床数据二次分析的最佳伦理实践。研究结果将在同行评议的期刊上发表，并向相关利益相关者宣传。CRD42017060068。
Aggregate data meta-analyses have shown heterogeneous treatment effects for cognitive–behavioural therapy (CBT) for patients with schizophrenia spectrum diagnoses. This heterogeneity could stem from specific intervention or patient characteristics that could influence the clinical effectiveness of CBT, termed treatment effect modifiers. This individual participant data meta-analysis will investigate a range of potential treatment effect modifiers of the efficacy of CBT. We will perform a systematic review and meta-analysis of studies investigating CBT versus treatment as usual, or CBT versus other psychosocial interventions, for patients with schizophrenia spectrum diagnoses. The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE and the online clinical trials registers of the US government, European Union, WHO and Current Controlled Trials will be searched. Two researchers will screen titles and abstracts identified by the search. Individual participant data will be requested for any eligible study, for the primary outcome (overall psychotic symptoms), secondary outcomes and treatment effect modifiers. Data will be checked and recoded according to an established statistical analysis plan. One-stage and two-stage random effects meta-analyses investigating potential treatment effect modifiers will be conducted. A list of potential treatment effect modifiers for CBT will be produced, motivating future research into particular modifiers. This study does not require ethical approval as it is based on data from existing studies, although best ethical practice for secondary analysis of clinical data will be followed. The findings will be submitted for publication in peer-reviewed journals, and promoted to relevant stakeholders. CRD42017060068.
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影响因子：
6.6
作者：
Wykes, Til;Steel, Craig;Tarrier, Nicholas
通讯作者：
Tarrier, Nicholas
影响因子：
2
作者：
Riley, Richard D.;Lambert, Paul C.;Boutitie, Florent
通讯作者：
Boutitie, Florent
影响因子：
11.3
作者：
Lincoln, Tania M.;Rief, Winfried;Mehl, Stephanie
通讯作者：
Mehl, Stephanie
DOI：
10.1016/0197-2456(86)90046-2
发表时间：
1986-09-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
DERSIMONIAN, R;LAIRD, N
通讯作者：
LAIRD, N
影响因子：
5.3
作者：
Hermes, Eric D. A.;Sokoloff, Daniel;Rosenheck, Robert A.
通讯作者：
Rosenheck, Robert A.