PMID- 29961021 OWN - NLM STAT- MEDLINE DCOM- 20190920 LR - 20221207 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 8 IP - 6 DP - 2018 Jun 30 TI - Using electronic health records to quantify and stratify the severity of type 2 diabetes in primary care in England: rationale and cohort study design. PG - e020926 LID - 10.1136/bmjopen-2017-020926 [doi] LID - e020926 AB - INTRODUCTION: The increasing prevalence of type 2 diabetes mellitus (T2DM) presents a significant burden on affected individuals and healthcare systems internationally. There is, however, no agreed validated measure to infer diabetes severity from electronic health records (EHRs). We aim to quantify T2DM severity and validate it using clinical adverse outcomes. METHODS AND ANALYSIS: Primary care data from the Clinical Practice Research Datalink, linked hospitalisation and mortality records between April 2007 and March 2017 for patients with T2DM in England will be used to develop a clinical algorithm to grade T2DM severity. The EHR-based algorithm will incorporate main risk factors (severity domains) for adverse outcomes to stratify T2DM cohorts by baseline and longitudinal severity scores. Provisionally, T2DM severity domains, identified through a systematic review and expert opinion, are: diabetes duration, glycated haemoglobin, microvascular complications, comorbidities and coprescribed treatments. Severity scores will be developed by two approaches: (1) calculating a count score of severity domains; (2) through hierarchical stratification of complications. Regression models estimates will be used to calculate domains weights. Survival analyses for the association between weighted severity scores and future outcomes-cardiovascular events, hospitalisation (diabetes-related, cardiovascular) and mortality (diabetes-related, cardiovascular, all-cause mortality)-will be performed as statistical validation. The proposed EHR-based approach will quantify the T2DM severity for primary care performance management and inform the methodology for measuring severity of other primary care-managed chronic conditions. We anticipate that the developed algorithm will be a practical tool for practitioners, aid clinical management decision-making, inform stratified medicine, support future clinical trials and contribute to more effective service planning and policy-making. ETHICS AND DISSEMINATION: The study protocol was approved by the Independent Scientific Advisory Committee. Some data were presented at the National Institute for Health Research School for Primary Care Research Showcase, September 2017, Oxford, UK and the Diabetes UK Professional Conference March 2018, London, UK. The study findings will be disseminated in relevant academic conferences and peer-reviewed journals. CI - (c) Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. FAU - Zghebi, Salwa S AU - Zghebi SS AUID- ORCID: 0000-0002-7978-1094 AD - Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. AD - NIHR School for Primary Care Research, Centre for Primary Care, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. FAU - Rutter, Martin K AU - Rutter MK AD - Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. AD - Manchester Diabetes Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre (MAHSC), Manchester, UK. FAU - Ashcroft, Darren M AU - Ashcroft DM AD - Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. FAU - Salisbury, Chris AU - Salisbury C AUID- ORCID: 0000-0002-4378-3960 AD - Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Mallen, Christian AU - Mallen C AD - Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, UK. FAU - Chew-Graham, Carolyn A AU - Chew-Graham CA AD - Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, UK. FAU - Reeves, David AU - Reeves D AD - Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. FAU - van Marwijk, Harm AU - van Marwijk H AD - Division of Primary Care and Public Health, Brighton and Sussex Medical School, University of Brighton, Brighton, UK. FAU - Qureshi, Nadeem AU - Qureshi N AD - Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK. FAU - Weng, Stephen AU - Weng S AD - Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK. FAU - Peek, Niels AU - Peek N AD - Division of Informatics, Imaging & Data Sciences (L5), School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. FAU - Planner, Claire AU - Planner C AD - Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. FAU - Nowakowska, Magdalena AU - Nowakowska M AD - Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. AD - NIHR School for Primary Care Research, Centre for Primary Care, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. FAU - Mamas, Mamas AU - Mamas M AD - Keele Cardiovascular Research group, Centre for Prognosis Research, Institute for Primary Care and Health Sciences, Keele University, Stoke-on-Trent, UK. FAU - Kontopantelis, Evangelos AU - Kontopantelis E AUID- ORCID: 0000-0001-6450-5815 AD - Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. AD - NIHR School for Primary Care Research, Centre for Primary Care, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK. LA - eng GR - MC_PC_13042/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180630 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Glycated Hemoglobin A) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Algorithms MH - Cardiovascular Diseases/*epidemiology/mortality MH - Cohort Studies MH - Comorbidity MH - Diabetes Mellitus, Type 2/*diagnosis/mortality/therapy MH - Electronic Health Records/*statistics & numerical data MH - England/epidemiology MH - Female MH - Glycated Hemoglobin/analysis MH - Hospitalization/*statistics & numerical data MH - Humans MH - Male MH - Middle Aged MH - Primary Health Care MH - Research Design MH - Risk Factors MH - Severity of Illness Index PMC - PMC6042592 OTO - NOTNLM OT - cardiovascular disease OT - diabetes severity algorithm OT - electronic health records OT - hospitalisation records OT - primary care OT - type 2 diabetes COIS- Competing interests: EK, HvM, MM, DR, CACG, CP, CM, NP and MN declare no competing interests. SSZ reports support by the NIHR SPCR during this study. DMA has received grant funding from Abbvie and has served on advisory boards for Pfizer and GSK. MKR has received educational grant support from MSD and Novo Nordisk; has modest stock ownership in GSK; and has consulted for Roche. NQ reports grants from the NIHR SPCR during the conduct of the study. CS reports grants from NIHR SPCR during the conduct of the study; grants from NHS CLAHRC West, grants from Avon Primary Care Research Collaborative, outside the submitted work. SW serves as a member of the Clinical Practice Research Datalink Independent Scientific Committee (ISAC) at the UK Medicines and Health Regulatory Agency. EDAT- 2018/07/02 06:00 MHDA- 2019/09/21 06:00 PMCR- 2018/06/30 CRDT- 2018/07/02 06:00 PHST- 2018/07/02 06:00 [entrez] PHST- 2018/07/02 06:00 [pubmed] PHST- 2019/09/21 06:00 [medline] PHST- 2018/06/30 00:00 [pmc-release] AID - bmjopen-2017-020926 [pii] AID - 10.1136/bmjopen-2017-020926 [doi] PST - epublish SO - BMJ Open. 2018 Jun 30;8(6):e020926. doi: 10.1136/bmjopen-2017-020926.