Impact of biological agents and tofacitinib for moderate-to-severe ulcerative colitis on health-related quality of life: a protocol for a network meta-analysis.
Impact of biological agents and tofacitinib for moderate-to-severe ulcerative colitis on health-related quality of life: a protocol for a network meta-analysis.
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生物制剂和托法替布治疗中重度溃疡性结肠炎对健康相关生活质量的影响：网络荟萃分析方案
DOI：
10.1136/bmjopen-2021-055182
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发表时间：
2021-12-30
期刊：
影响因子：
2.9
通讯作者：
Zhang D
中科院分区：
文献类型：
--
作者：
Ma X;Xu H;Zhang D
前言在过去的几年中，已经提出了几种选择作为中重度溃疡性结肠炎（UC）的替代和更有效的治疗药物，如生物制剂和托法替尼。大多数与UC相关的临床研究旨在评价药物对疾病活动和副作用等临床结局的疗效。本综述旨在比较英夫利西单抗、阿达木单抗、戈利木单抗、优特克单抗、Vedolizumab和托法替尼治疗中重度UC对健康相关生活质量（HRQoL）的影响，从而指导该疾病的临床治疗和科学研究。方法和分析我们将检索PubMed、Embase和科克伦图书馆从开始到2021年7月的所有随机对照试验（RCT），这些随机对照试验（RCT）以英文报告为双盲，比较英夫利昔单抗、阿达木单抗、戈利木单抗、乌司奴单抗、Vedolizumab或托法替尼作为诱导或维持治疗与另一种或安慰剂治疗中重度UC的HRQoL。本研究的主要结局是HRQoL评分平均差异的变化。将对每个成对比较的数据进行综合，以获得连续结局的汇总标准化平均差异和二分结局的OR。然后，将进行网络荟萃分析（NMA），并对二分结局进行共同效应Mantel-Haenszel NMA，而对所有其他结局使用随机效应NMA。最后，我们将遵循建议、评估、发展和评价的分级方法，评估从NMA得出的主要成果估计值的置信度。伦理和传播本研究仅使用已发表的次要数据，因此不需要伦理批准。研究结果将发表在同行评议的医学杂志上。PROSPERO注册号CRD 42021225048。
Introduction In the past few years, several options have been proposed as alternative and more effective therapeutic drugs for moderate-to-severe ulcerative colitis (UC), such as biological agents and tofacitinib. Most of the clinical studies related to UC aimed to evaluate the efficacy of the drugs on clinical outcomes such as disease activity and side effects. This review aims to compare the impact of infliximab, adalimumab, golimumab, ustekinumab, vedolizumab and tofacitinib for moderate-to-severe UC on health-related quality of life (HRQoL), thereby guiding clinical treatment and scientific research of this disease. Methods and analysis We will search PubMed, Embase and Cochrane Library from inception until July 2021 for all randomised controlled trials (RCTs) reported in English as double-blind comparing infliximab, adalimumab, golimumab, ustekinumab, vedolizumab or tofacitinib as induction or maintenance therapies with another or with placebo in moderate-to-severe UC on HRQoL. The primary outcome of this study is changes in the mean difference in HRQoL scores. Data of each pairwise comparison will be synthesised to obtain summary standardised mean differences for continuous outcomes and ORs for dichotomous outcomes. Then, a network meta-analysis (NMA) will be performed, and a common-effects Mantel-Haenszel NMA will be conducted for dichotomous outcomes, while a random-effects NMA will be used for all other outcomes. Finally, we will follow the Grading of Recommendations, Assessment, Development and Evaluations approach to assess the confidence in estimates derived from NMA of the main outcomes. Ethics and dissemination Only published secondary data will be used in this study, and therefore ethics approval is not required. The findings will be published in a peer-reviewed medical journal. PROSPERO registration number CRD42021225048.
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DOI：
10.1136/bmj.b2535
发表时间：
2009-07-21
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moher D;Liberati A;Tetzlaff J;Altman DG;PRISMA Group
通讯作者：
PRISMA Group
影响因子：
158.5
作者：
Sands, Bruce E.;Peyrin-Biroulet, Laurent;Schreiber, Stefan
通讯作者：
Schreiber, Stefan
影响因子：
158.5
作者：
Sands, B. E.;Sandborn, W. J.;Marano, C.
通讯作者：
Marano, C.
影响因子：
39.2
作者：
Hutton, Brian;Salanti, Georgia;Moher, David
通讯作者：
Moher, David
影响因子：
2.2
作者：
DerSimonian R;Laird N
通讯作者：
Laird N