Department of Epidemiology and Biometry, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany
Department of Epidemiology and Biometry, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany.
BMJ Open. 2022 Jun 22;12(6):e056982. doi: 10.1136/bmjopen-2021-056982.
Patients with inflammatory bowel diseases (IBD) often report psychological problems, unemployment, disability, sick leave and compromised quality of life. The effect of psychological interventions on health-related outcomes in IBD is controversial as previous reviews faced the obstacle of high heterogeneity among provided multimodular interventions. The heterogeneity can be addressed with network meta-analysis (NMA) and (multi)component NMA (CNMA). We aim to investigate whether psychological interventions can improve quality of life, clinical and social outcomes in IBD using NMA and CNMA. This is the study protocol.
We will consider randomised, quasi-randomised and non-randomised controlled trials, including cluster randomised and cross-over trials with 2 months of minimum follow-up. The conditions to be studied comprise Crohn's disease and ulcerative colitis in children, adolescents and adults. We will include any psychological intervention aiming to change the health status of the study participant.We will search Medline, Embase, Web of Science, CENTRAL, LILACS, Psyndex, PsycINFO, Google Scholar and trial registries from inception (the search will be updated before the review completion). Two authors will independently screen all references based on titles and abstracts. For data extraction, standard forms are developed and tested before extraction. All information will be assessed independently by at least two reviewers, and disagreements solved by consensus discussion or a third rater if necessary.The data synthesis will include a pairwise meta-analysis supported by meta-regression. We will conduct NMA (all treatments will constitute single nodes of the network) and CNMA (we will define all treatments as sums of core components, eg, cognitive +behaviour, or cognitive +behaviour + relaxation, and additionally consider interactions) using the R Package netmeta.
No ethical approval is required. Reports will include the final report to the funder, conference presentation, peer-reviewed publication and a patient report.
CRD42021250446.
炎症性肠病（IBD）患者常报告存在心理问题、失业、残疾、病假和生活质量受损。心理干预对 IBD 患者健康相关结局的影响存在争议，因为先前的综述面临所提供的多模块干预措施高度异质性的障碍。通过网络荟萃分析（NMA）和（多）成分 NMA（CNMA）可以解决这种异质性。我们旨在使用 NMA 和 CNMA 研究心理干预是否可以改善 IBD 患者的生活质量、临床和社会结局。这是研究方案。
我们将考虑随机、准随机和非随机对照试验，包括最小随访时间为 2 个月的群组随机和交叉试验。要研究的条件包括儿童、青少年和成年人的克罗恩病和溃疡性结肠炎。我们将纳入旨在改变研究参与者健康状况的任何心理干预。我们将检索 Medline、Embase、Web of Science、CENTRAL、LILACS、Psyndex、PsycINFO、Google Scholar 和试验注册处的从成立之初开始的文献（在综述完成之前，将对检索进行更新）。两位作者将独立根据标题和摘要筛选所有参考文献。对于数据提取，制定并测试了标准表格。所有信息将由至少两名审阅者独立评估，如果有必要，将通过共识讨论或第三位审阅者解决分歧。数据综合将包括基于荟萃回归的成对荟萃分析。我们将进行 NMA（所有治疗都将构成网络的单个节点）和 CNMA（我们将定义所有治疗为核心成分的总和，例如认知+行为，或认知+行为+放松，并且还考虑相互作用）使用 R 包 netmeta。
不需要伦理批准。报告将包括给资助者的最终报告、会议报告、同行评议的出版物和患者报告。
PROSPERO 注册号：CRD42021250446。
