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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2018-023070 on 15 October 2018. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 29, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-023070 on 15 October 2018. Downloaded from 10-year Risk Prediction Models of Complications and Mortality of Diabetes Mellitus in Chinese Patients in Primary Care in Hong Kong study protocol ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-023070 Article Type: Protocol Date Submitted by the Author: 19-Mar-2018 Complete List of Authors: WAN, Eric Yuk Fai; University of Oxford, Nuffield Department of Population Health Yu, Esther Yee Tak; The University of Hong Kong, Department of Family Medicine and Primary Care Chin, Weng Yee; The University of Hong Kong, Department of Family Medicine & Primary Care Fung, Colman; The University of Hong Kong Kwok, Ruby Lai Ping; Hospital Authority, Primary & Community Services Chao, David Vai Kiong; United Christian Hospital and Tseung Kwan O Hospital, Department of Family Medicine and Primary Health Care Chan, King Hong; Hospital Authority Kowloon Central Cluster, Family Medicine & Primary Healthcare Hui, Eric Ming-Tung; Hospital Authority New Territories East Cluster, Family Medicine http://bmjopen.bmj.com/ Tsui, Wendy Wing Sze; Hospital Authority Hong Kong West Cluster, Family Medicine & Primary Healthcare TAN, Kathryn; The University of Hong Kong, Department of Medicine Fong, Daniel Yee Tak; The University of Hong Kong, School of Nursing Lam, Cindy; The University of Hong Kong, Department of Medicine Diabetes Mellitus, Risk, Complications, Mortality, Cardiovascular Disease, Keywords: Chinese on September 29, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 30 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-023070 on 15 October 2018. Downloaded from 1 2 3 10-year Risk Prediction Models of Complications and Mortality of Diabetes Mellitus in 4 5 Chinese Patients in Primary Care in Hong Kong study protocol 6 7 8 9 Authors: Eric Yuk Fai Wan, PhD1, Esther Yee Tak Yu, MBBS1, Weng Yee Chin, MD1, 10 11 Colman Siu Cheung Fung, MBBS1, Ruby Lai Ping Kwok, MHSE2, David Vai Kiong Chao, 12 13 3 4 5 14 MBBS , King Hong Chan, MBBS , Eric Ming-Tung Hui, MBBS , Wendy Wing Sze Tsui, 15 6 7 8 16 MBBS , KathrynFor Choon Bengpeer Tan, MD review, Daniel Yee Tak Fong,only PhD , Cindy Lo Kuen Lam, 17 18 MD1 19 20 21 22 23 1 24 Department of Family Medicine and Primary Care, The University of Hong Kong, Hong 25 26 Kong 27 28 2 29 Department of Primary & Community Services, Hospital Authority Head Office, Hospital 30 31 Authority, Hong Kong 32 33 http://bmjopen.bmj.com/ 3 Department of Family Medicine & Primary Healthcare, Kowloon East Cluster, Hospital 34 35 36 Authority, Hong Kong 37 38 4 Department of Family Medicine & Primary Healthcare, Kowloon Central Cluster, Hospital 39 40 41 Authority, Hong Kong on September 29, 2021 by guest. Protected copyright. 42 43 5 Department of Family Medicine, New Territories East Cluster, Hospital Authority, Hong 44 45 46 Kong 47 48 6 Department of Family Medicine & Primary Healthcare, Hong Kong West Cluster, Hospital 49 50 51 Authority, Hong Kong 52 53 7 Department of Medicine, the University of Hong Kong, Hong Kong 54 55 56 8 School of Nursing, the University of Hong Kong, Hong Kong 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 30 BMJ Open: first published as 10.1136/bmjopen-2018-023070 on 15 October 2018. Downloaded from 1 2 3 4 5 6 Corresponding Author: 7 8 Cindy Lo Kuen Lam 9 10 11 Email: [email protected] 12 13 14 Telephone: + (852) 25524690 15 16 For peer review only 17 Fax: + (852) 28147475 18 19 20 21 22 Word Count: 3,935 words 23 24 25 Keywords: Diabetes Mellitus; Risk; Complications; Mortality; Cardiovascular Diseases; 26 27 Chinese 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 29, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 30 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-023070 on 15 October 2018. Downloaded from 1 2 3 Abstract 4 5 Introduction 6 7 Diabetes mellitus (DM) is a major disease burden worldwide because it is associated with 8 9 disabling and lethal complications. DM complication risk assessment and stratification is key 10 11 to cost-effective management and tertiary prevention for diabetic patients in primary care. 12 13 14 Existing risk prediction functions were found to be inaccurate in Chinese diabetic patients in 15 16 primary care. ForThis study peer aims to developreview 10-year risk only prediction models for total 17 18 cardiovascular diseases (CVD) and all-cause mortality among Chinese patients with DM in 19 20 primary care. 21 22 23 24 25 Methods and analysis 26 27 A 10-year cohort study on a population-based primary care cohort of Chinese diabetic 28 29 patients, who were receiving care in the Hospital Authority General Out-Patient Clinic on or 30 31 before 1 January 2008, were identified from the clinical management system database of the 32 33 Hospital Authority. All patients with complete baseline risk factors will be included and http://bmjopen.bmj.com/ 34 35 followed from 1 January 2008 to 31 December 2017 for the development and validation of 36 37 prediction models. The analyses will be carried out separately for men and women. Two-third 38 39 40 of subjects will be randomly selected as the training sample for model development. Cox 41 on September 29, 2021 by guest. Protected copyright. 42 regressions will be used to develop 10-year risk prediction models of total CVD and all-cause 43 44 mortality. The validity of models will be tested on the remaining one-third of subjects by 45 46 Harrell's C statistics and calibration plot. Risk prediction models for diabetic complications 47 48 specific to Chinese patients in primary care will enable accurate risk stratification, 49 50 prioritization of resources and more cost-effective interventions for DM patients in primary 51 52 53 care. 54 55 56 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 30 BMJ Open: first published as 10.1136/bmjopen-2018-023070 on 15 October 2018. Downloaded from 1 2 3 Ethics and dissemination 4 5 The study was approved by the Institutional Review Board of the University of Hong Kong - 6 7 the Hospital Authority Hong Kong West Cluster (reference number: UW 15-258). 8 9 10 11 Trial registration: US Clinical Trial Registry NCT03299010 12 13 14 15 16 Strengths and limitationsFor peer of this study review only 17 18 • This is a 10-year retrospective population-based cohort study cohort of Chinese DM 19 20 patients in primary care which can represent the situation in Hong Kong. 21 22 • Two-third of samples in the cohort will be randomly selected for developing risk 23 24 25 prediction models while remaining one-third would be used for validation to ensure the 26 27 performance of models. 28 29 • Risk prediction nomograms and charts will be established based on the risk prediction 30 31 models for a convenient use in clinical setting. 32 http://bmjopen.bmj.com/ 33 • Multiple imputation will be used to handle missing data to minimize the bias in 34 35 36 developing risk prediction models. 37 38 • Misclassification bias may exist by using diagnosis coding such as ICPC-2 and ICD-9CM 39 40 to identify the outcome events of patients. 41 on September 29, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 4 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 30 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-023070 on 15 October 2018. Downloaded from 1 2 3 Manuscript Text 4 5 6 7 Introduction 8 9 Diabetes Mellitus (DM) is a well-recognized public health issue, affecting 415 million people 10 11 and costing HK$5.2 trillion in global health expenditures worldwide.1 DM can lead to many 12 13 14 complications resulting in morbidity and mortality.
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