PMID- 29284543 OWN - NLM STAT- MEDLINE DCOM- 20181126 LR - 20191210 IS - 2046-4053 (Electronic) IS - 2046-4053 (Linking) VI - 6 IP - 1 DP - 2017 Dec 29 TI - External validation of type 2 diabetes computer simulation models: definitions, approaches, implications and room for improvement-a protocol for a systematic review. PG - 267 LID - 10.1186/s13643-017-0664-7 [doi] LID - 267 AB - BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017069983 . FAU - Ogurtsova, Katherine AU - Ogurtsova K AUID- ORCID: 0000-0002-3002-1916 AD - 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, Dusseldorf, Germany. Katherine.Ogurtsova@ddz.uni-duesseldorf.de. AD - German Center for Diabetes Research (DZD), Neuherberg, Germany. Katherine.Ogurtsova@ddz.uni-duesseldorf.de. FAU - Heise, Thomas L AU - Heise TL AD - Institute for Public Health and Nursing Research-IPP, Health Sciences Bremen, University of Bremen, Bremen, Germany. AD - Research Group for Evidence-Based Public Health, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany. FAU - Linnenkamp, Ute AU - Linnenkamp U AD - 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, Dusseldorf, Germany. AD - German Center for Diabetes Research (DZD), Neuherberg, Germany. FAU - Dintsios, Charalabos-Markos AU - Dintsios CM FAU - Lhachimi, Stefan K AU - Lhachimi SK AD - Institute for Public Health and Nursing Research-IPP, Health Sciences Bremen, University of Bremen, Bremen, Germany. AD - Research Group for Evidence-Based Public Health, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany. FAU - Icks, Andrea AU - Icks A AD - 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, Dusseldorf, Germany. AD - Institute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich-Heine University Dusseldorf, Dusseldorf, Germany. AD - German Center for Diabetes Research (DZD), Neuherberg, Germany. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Validation Study DEP - 20171229 PL - England TA - Syst Rev JT - Systematic reviews JID - 101580575 SB - IM MH - Computer Simulation/*trends MH - Delivery of Health Care/methods MH - Diabetes Mellitus, Type 2/*epidemiology MH - Disease Progression MH - Humans PMC - PMC5746956 OTO - NOTNLM OT - Diabetes models OT - External validation OT - Simulation OT - Systematic review OT - Type 2 diabetes mellitus COIS- AUTHORS' INFORMATION: KO is a modeller and statistician in the Institute for Health Services Research and Health Economics at the German Diabetes Centre, Dusseldorf, Germany. TLH is currently a research associate with the Research Group for Evidence-based Public Health, BIPS & University Bremen, Bremen, Germany. UL is a researcher in the Institute for Health Services Research and Health Economics at the German Diabetes Centre, Dusseldorf, Germany. CMD is, next to his industrial affiliation, a visiting researcher at the Institute for Health Services Research and Health Economics at the Heinrich-Heine-University, Dusseldorf, Germany. SKL is the group head of the Research Group for Evidence-based Public Health, BIPS & University Bremen, Bremen, Germany. AX is the head of the Institute for Health Services Research and Health Economics at the German Diabetes Centre in Dusseldorf and the head of the Institute for Health Services Research and Health Economics at the Heinrich-Heine-University, Dusseldorf, Germany. ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Not applicable. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: Apart from his academic affiliation, CMD is employed by Bayer Vital GmbH, Leverkusen, Germany. Other authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2017/12/30 06:00 MHDA- 2018/11/27 06:00 PMCR- 2017/12/29 CRDT- 2017/12/30 06:00 PHST- 2017/08/15 00:00 [received] PHST- 2017/12/12 00:00 [accepted] PHST- 2017/12/30 06:00 [entrez] PHST- 2017/12/30 06:00 [pubmed] PHST- 2018/11/27 06:00 [medline] PHST- 2017/12/29 00:00 [pmc-release] AID - 10.1186/s13643-017-0664-7 [pii] AID - 664 [pii] AID - 10.1186/s13643-017-0664-7 [doi] PST - epublish SO - Syst Rev. 2017 Dec 29;6(1):267. doi: 10.1186/s13643-017-0664-7.