Calibrating a network meta-analysis of diabetes trials of sodium glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor analogues and dipeptidyl peptidase-4 inhibitors to a representative routine population: a systematic review protocol.
Calibrating a network meta-analysis of diabetes trials of sodium glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor analogues and dipeptidyl peptidase-4 inhibitors to a representative routine population: a systematic review protocol.
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DOI：
10.1136/bmjopen-2022-066491
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发表时间：
2022-10-27
期刊：
影响因子：
2.9
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中科院分区：
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随机对照试验的参与者通常比临床实践中遇到的许多人更年轻、更健康。因此，试验结果的适用性往往是不确定的。为了解决这个问题，可以将试验结果校准为更具代表性的数据源。在一项网络meta分析中，我们将使用一种新颖的方法，无论是否有个人水平的参与者数据（IPD），我们都会将三种药物类别（葡萄糖共转运蛋白2钠（SGLT2）抑制剂，胰高血糖素样肽-1 （GLP1）受体类似物和二肽基肽酶-4 （DPP4）抑制剂）的试验校准到苏格兰糖尿病登记册。从2002年1月1日起检索Medline和EMBASE数据库、美国临床试验注册中心（clinicaltrials.gov）和中国临床试验注册中心（chictr.org.cn）。两名独立审稿人将应用资格标准来确定纳入的试验。纳入的试验将是SGLT2抑制剂、GLP1受体类似物或DPP4抑制剂、安慰剂或活性比较物的3期或4期试验，受试者为2型糖尿病患者，至少有一项血糖控制、体重改变或主要不良心血管事件作为结局。未注册的试验将被排除。我们从以人群为基础的苏格兰糖尿病登记中确定了目标人群。选择的队列包括苏格兰2型糖尿病患者，他们要么(1)由于血糖控制不佳而需要进一步治疗，三种药物中的任何一种都可能适合，要么(2)血糖控制足够，但已经在使用三种感兴趣的药物或胰岛素中的一种。IPD的使用已获得格拉斯哥大学MVLS学院伦理委员会（项目：200160070）的伦理批准。苏格兰糖尿病登记已获得苏格兰A研究伦理委员会（11/AL/0225）的批准，并获得卫生和社会保健公共利益和隐私小组的批准（1617-0147）。CRD42020184174。
Participants in randomised controlled trials (trials) are generally younger and healthier than many individuals encountered in clinical practice. Consequently, the applicability of trial findings is often uncertain. To address this, results from trials can be calibrated to more representative data sources. In a network meta-analysis, using a novel approach which allows the inclusion of trials whether or not individual-level participant data (IPD) is available, we will calibrate trials for three drug classes (sodium glucose cotransporter 2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP1) receptor analogues and dipeptidyl peptidase-4 (DPP4) inhibitors) to the Scottish diabetes register. Medline and EMBASE databases, the US clinical trials registry (clinicaltrials.gov) and the Chinese Clinical Trial Registry (chictr.org.cn) will be searched from 1 January 2002. Two independent reviewers will apply eligibility criteria to identify trials for inclusion. Included trials will be phase 3 or 4 trials of SGLT2 inhibitors, GLP1 receptor analogues or DPP4 inhibitors, with placebo or active comparators, in participants with type 2 diabetes, with at least one of glycaemic control, change in body weight or major adverse cardiovascular event as outcomes. Unregistered trials will be excluded. We have identified a target population from the population-based Scottish diabetes register. The chosen cohort comprises people in Scotland with type 2 diabetes who either (1) require further treatment due to poor glycaemic control where any of the three drug classes may be suitable, or (2) who have adequate glycaemic control but are already on one of the three drug classes of interest or insulin. Ethical approval for IPD use was obtained from the University of Glasgow MVLS College Ethics Committee (Project: 200160070). The Scottish diabetes register has approval from the Scottish A Research Ethics Committee (11/AL/0225) and operates with Public Benefit and Privacy Panel for Health and Social Care approval (1617-0147). CRD42020184174.
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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
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影响因子：
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作者：
Saunders, C.;Byrne, C. D.;Wild, S. H.
通讯作者：
Wild, S. H.
DOI：
10.1007/s13300-017-0254-7
发表时间：
2017-04
期刊：
Diabetes therapy : research, treatment and education of diabetes and related disorders
影响因子：
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作者：
McGovern A;Feher M;Munro N;de Lusignan S
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de Lusignan S