Department of Preventive Medicine and Public Health. School of Medicine, Universidad Autónoma de Madrid/IdiPAZ, Madrid, Spain.
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús. Research Institute "La Princesa", Madrid, Spain.
Syst Rev. 2019 Nov 4;8(1):259. doi: 10.1186/s13643-019-1171-9.
Optimal type 1 diabetes mellitus (T1D) care requires lifelong appropriate insulin treatment, which can be provided either by multiple daily injections (MDI) of insulin or by continuous subcutaneous insulin infusion (CSII). An increasing number of trials and previous systematic reviews and meta-analyses (SRMA) have compared both CSII and MDI but have provided limited information on equity and fairness regarding access to, and the effect of, those insulin devices. This study protocol proposes a clear and transparent methodology for conducting a SRMA of the literature (1) to assess the effect of CSII versus MDI on glycemic and patient-reported outcomes (PROs) among young patients with T1D and (2) to identify health inequalities in the use of CSII.
This protocol was developed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P), the PRISMA-E (PRISMA-Equity 2012 Guidelines), and the Cochrane Collaboration Handbook. We will include randomized clinical trials and non-randomized studies published between January 2000 and June 2019 to assess the effectiveness of CSII versus MDI on glycemic and PROs in young patients with T1D. To assess health inequality among those who received CSII, we will use the PROGRESS framework. To gather relevant studies, a search will be conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews, and the Health Technology Assessment (HTA) database. We will select studies that compared glycemic outcomes (the glycosylated hemoglobin values, severe hypoglycemia episodes, diabetic ketoacidosis events, and/or time spent in range or in hyper-hypoglycemia), and health-related quality of life, as a PRO, between therapies. Screening and selection of studies will be conducted independently by two researchers. Subgroup analyses will be performed according to age group, length of follow-up, and the use of adjunctive technological therapies that might influence glycemic outcomes.
Studies of the average effects of CSII versus MDI may have not assessed their impact on health equity, as some intended populations have been excluded. Therefore, this study will address health equity issues when assessing effects of CSII. The results will be published in a peer-review journal. Ethics approval will not be needed.
PROSPERO CRD42018116474.
优化 1 型糖尿病（T1D）的治疗需要终生接受适当的胰岛素治疗，这种治疗可以通过多次皮下胰岛素注射（MDI）或持续皮下胰岛素输注（CSII）来实现。越来越多的试验以及之前的系统评价和荟萃分析（SRMA）已经比较了 CSII 和 MDI，但对于获得这些胰岛素设备的机会以及这些设备的效果方面，提供的信息有限。本研究方案提出了一种清晰透明的方法，用于对文献进行 SRMA（1）评估 CSII 与 MDI 在 T1D 年轻患者的血糖和患者报告结局（PRO）方面的效果，以及（2）确定 CSII 使用方面的健康不平等问题。
本方案是根据系统评价和荟萃分析报告的首选条目（PRISMA-P）、PRISMA-E（PRISMA-Equity 2012 指南）和 Cochrane 协作手册制定的。我们将纳入 2000 年 1 月至 2019 年 6 月期间发表的随机临床试验和非随机研究，以评估 CSII 与 MDI 在 T1D 年轻患者血糖和 PRO 方面的效果。为了评估接受 CSII 治疗的患者的健康不平等问题，我们将使用 PROGRESS 框架。为了收集相关研究，我们将在 MEDLINE、EMBASE、Cochrane 对照试验中心注册库（CENTRAL）、Cochrane 系统评价数据库和卫生技术评估（HTA）数据库中进行检索。我们将选择比较两种治疗方法的血糖结局（糖化血红蛋白值、严重低血糖发作、糖尿病酮症酸中毒事件和/或血糖达标或高血糖时间）和健康相关生活质量（作为 PRO）的研究。研究的筛选和选择将由两名研究人员独立进行。根据年龄组、随访时间以及可能影响血糖结局的辅助技术治疗的使用情况，将进行亚组分析。
CSII 与 MDI 的平均效果研究可能没有评估其对健康公平的影响，因为一些预期的人群已被排除在外。因此，本研究将在评估 CSII 效果时解决健康公平问题。研究结果将发表在同行评议的期刊上。不需要伦理批准。
PROSPERO CRD42018116474。
