Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at Heinrich Heine University, Auf'm Hennekamp 65, 40225, Düsseldorf, Germany.
German Center for Diabetes Research (DZD), Neuherberg, Germany.
Syst Rev. 2017 Dec 29;6(1):267. doi: 10.1186/s13643-017-0664-7.
Type 2 diabetes mellitus (T2DM), a highly prevalent chronic disease, puts a large burden on individual health and health care systems. Computer simulation models, used to evaluate the clinical and economic effectiveness of various interventions to handle T2DM, have become a well-established tool in diabetes research. Despite the broad consensus about the general importance of validation, especially external validation, as a crucial instrument of assessing and controlling for the quality of these models, there are no systematic reviews comparing such validation of diabetes models. As a result, the main objectives of this systematic review are to identify and appraise the different approaches used for the external validation of existing models covering the development and progression of T2DM.
We will perform adapted searches by applying respective search strategies to identify suitable studies from 14 electronic databases. Retrieved study records will be included or excluded based on predefined eligibility criteria as defined in this protocol. Among others, a publication filter will exclude studies published before 1995. We will run abstract and full text screenings and then extract data from all selected studies by filling in a predefined data extraction spreadsheet. We will undertake a descriptive, narrative synthesis of findings to address the study objectives. We will pay special attention to aspects of quality of these models in regard to the external validation based upon ISPOR and ADA recommendations as well as Mount Hood Challenge reports. All critical stages within the screening, data extraction and synthesis processes will be conducted by at least two authors. This protocol adheres to PRISMA and PRISMA-P standards.
The proposed systematic review will provide a broad overview of the current practice in the external validation of models with respect to T2DM incidence and progression in humans built on simulation techniques.
PROSPERO CRD42017069983 .
2 型糖尿病（T2DM）是一种高发的慢性疾病，给个人健康和医疗保健系统带来了巨大负担。计算机模拟模型被用于评估处理 T2DM 的各种干预措施的临床和经济效果，已成为糖尿病研究中一种成熟的工具。尽管人们普遍认为验证，特别是外部验证，作为评估和控制这些模型质量的重要工具，但目前还没有系统评价比较糖尿病模型的这种验证。因此，本系统评价的主要目的是确定和评估现有的用于 T2DM 发展和进展的模型外部验证的不同方法。
我们将通过应用各自的搜索策略进行适应性搜索，以从 14 个电子数据库中识别合适的研究。根据本方案中定义的预设纳入和排除标准，检索到的研究记录将被纳入或排除。其中，出版物筛选器将排除 1995 年以前发表的研究。我们将进行摘要和全文筛选，然后通过填写预定义的数据提取电子表格从所有选定的研究中提取数据。我们将对研究结果进行描述性、叙述性综合，以解决研究目标。我们将特别关注基于 ISPOR 和 ADA 建议以及 Mount Hood 挑战报告的这些模型的外部验证的质量方面。筛选、数据提取和综合过程的所有关键阶段都将由至少两名作者进行。本方案符合 PRISMA 和 PRISMA-P 标准。
拟议的系统评价将提供一个广泛的概述，说明当前在基于模拟技术的人类 T2DM 发病和进展的模型外部验证方面的实践情况。
PROSPERO CRD42017069983 。
