Social and Health Care Research Center, Universidad de Castilla-La Mancha, Cuenca, Spain.
Faculty of Nursing, Universidad de Castilla-La Mancha, Albacete, Spain
BMJ Open. 2021 Oct 19;11(10):e054962. doi: 10.1136/bmjopen-2021-054962.
Monitoring type 1 diabetes (T1D) trends across most European countries using objectively measured data and how this incidence has evolved over the past three decades should be considered a public health priority. This study protocol provides a standardised and transparent methodology to assess TD1 trends among 0-14-year-old children and adolescents across Europe from 1994 to 2021.
This protocol is guided by the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and the Cochrane Collaboration Handbook. The literature search will be conducted using MEDLINE, Embase, CINAHL and Web of Science databases from 1994 to 2021. Observational cohort studies providing incidence rates for European children and adolescents diagnosed with T1D aged ≤14.9 years and studies written in English, Spanish or Portuguese will be included. The risk of bias of the included studies will be assessed using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies from the National Heart, Lung, and Blood Institute. Subgroup analyses will be performed based on gender, age, study year, country or European region. Metaregression analysis will be conducted using economic and geographic variables, such as gross national income of the country or geographic latitude.
The systematic review based on this protocol will provide a comprehensive description of T1D incidence trends in children and adolescents across Europe from 1994 to 2021. The results will be disseminated in a peer-reviewed journal and in mass media. This study will exclusively use data from published research, so institutional ethical approval is not required.
CRD42021239480.
使用客观测量数据监测大多数欧洲国家的 1 型糖尿病 (T1D) 趋势，以及在过去三十年中这种发病率是如何演变的，这应被视为公共卫生的重点。本研究方案提供了一种标准化和透明的方法，用于评估 1994 年至 2021 年间欧洲 0-14 岁儿童和青少年的 T1D 趋势。
本方案以系统评价和荟萃分析报告的首选条目以及 Cochrane 协作手册为指导。文献检索将使用 MEDLINE、Embase、CINAHL 和 Web of Science 数据库进行，检索时间为 1994 年至 2021 年。纳入的研究将提供在欧洲≤14.9 岁被诊断为 T1D 的儿童和青少年的发病率数据，并以英语、西班牙语或葡萄牙语撰写。使用美国国立心肺血液研究所的观察性队列研究和横断面研究质量评估工具评估纳入研究的偏倚风险。将根据性别、年龄、研究年份、国家或欧洲地区进行亚组分析。将使用经济和地理变量（如国家的国民总收入或地理纬度）进行荟萃回归分析。
基于本方案的系统评价将全面描述 1994 年至 2021 年期间欧洲儿童和青少年的 T1D 发病率趋势。研究结果将在同行评议的期刊和大众媒体上发表。本研究将仅使用已发表研究的数据，因此不需要机构伦理批准。
PROSPERO 注册号：CRD42021239480。
