BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 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). 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Downloaded from The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Heart Failure Study Design ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-020918 Article Type: Protocol Date Submitted by the Author: 30-Nov-2017 Complete List of Authors: Yu, Yuan; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital Zhang, Hongzhao; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital Li, Xi; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital Lu, Yuan; Yale University School of Medicine Masoudi, Frederick; University of Colorado at Denver - Anschutz Medical Campus Bookstore http://bmjopen.bmj.com/ Krumholz, Harlan; Yale University School of Medicine; Yale University School of Public Health Li, Jing; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease Heart failure < CARDIOLOGY, quality of care, outcomes, Cardiac Keywords: Epidemiology < CARDIOLOGY, China on September 29, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 The China Patent-centered Evaluative Assessment of Cardiac Events (China PEACE) 5 6 Retrospective Heart Failure Study Design 7 8 9 Yuan Yu1, Hongzhao Zhang1, Xi Li1, Yuan Lu2, Frederick A Masoudi3, Harlan M. Krumholz2,4,5, 10 Jing Li1* 11 12 13 Professor Krumholz and Professor Li are joint senior authors. 14 15 Author Affiliations 16 1 National ClinicalFor Research peer Center of Cardiovascular review Diseases, only State Key Laboratory of 17 18 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 19 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's 20 Republic of China; 21 2 Center for Outcomes Research and Evaluation, YaleNew Haven Hospital, and Department 22 of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, United 23 24 States; 25 3 Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, 26 United States; 27 4 Department of Health Policy and Management, Yale School of Public Health, New Haven, 28 29 Connecticut, United States; 5 30 Section of Cardiovascular Medicine, and the Robert Wood Johnson Clinical Scholars 31 Program the Robert Wood Johnson Clinical Scholars Program, Department of Internal 32 Medicine, Yale University School of Medicine, New Haven, Connecticut, United States. http://bmjopen.bmj.com/ 33 34 35 * Corresponding author: Professor Jing Li 36 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of 37 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 167 38 BeilishiRoad, Beijing 100037, People’s Republic of China; Tel: +86 10 8839 6077; Email: 39 [email protected] 40 on September 29, 2021 by guest. Protected copyright. 41 42 Key words: heart failure, quality of care, outcomes, epidemiology, China 43 44 Word count: 2,823 (main manuscript text excluding title page, abstract, acknowledgments, 45 46 contributor statement, competing interests statement, funding statement, ethical approval 47 statement, transparency statement, data sharing statement, references, figures, and tables) 48 49 50 51 52 53 54 55 56 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Abstract 4 5 Introduction: Heart failure (HF) is a leading cause of hospitalization in China, which is 6 7 experiencing a rapid increase in cardiovascular disease prevalence. Yet, little is known about 8 9 10 current burden of disease, quality of care, and treatment outcomes of heart failure in China. 11 12 Methods and analysis: The China Patient-centered Evaluative Assessment of Cardiac 13 14 Events Retrospective Heart Failure study (China PEACE 5r-HF) will examine a nationally 15 16 For peer review only 17 representative sample of more than 10,000 patient records hospitalized for HF in 2015 in 18 19 China. Patients have been selected using a 2stage sampling design stratified by economic– 20 21 22 geographic regions. Data quality will be monitored by a central coordinating center and will 23 24 address case ascertainment, data abstraction, and data management. Analyses will examine 25 26 27 patient characteristics, diagnostic testing, inhospital treatments, inhospital outcomes, costs 28 29 of hospitalization, and hospital-level variations in these factors. As of October 2017, we have 30 31 sampled 15,438 medical records from 189 hospitals, and have received 15,057 (97.5%) of 32 http://bmjopen.bmj.com/ 33 34 these for data collection, and completed data abstraction and quality control on 7,971. 35 36 37 Ethics and dissemination: The Central Ethics Committee at the Chinese National Center 38 39 for Cardiovascular Diseases approved the study. All collaborating hospitals accepted central 40 on September 29, 2021 by guest. Protected copyright. 41 ethics approval with the exception of 15, which obtained local approval by internal ethics 42 43 44 committees. Findings will be disseminated in future peer-reviewed papers and will serve as a 45 46 foundation for improving the care for HF in China. 47 48 49 Trial registration number: NCT02877914. 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 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Strengths and limitations of this study 5 6 A nationally representative sample of hospitals was generated and the study will 7 8 generate the largest reported cohort of patients with HF in China 9 10 11 Medical records were centrally abstracted guided by a standardized data dictionary and 12 13 governed by rigorous data quality standards. 14 15 16 Data collectedFor included peer national disease review burden, patient only characteristics, pattern of care, 17 18 inhospital costs, and short-term patient outcomes, which will provide pivotal information 19 20 21 for policymakers to improve healthcare quality. 22 23 Data collection is limited to information available in medical records and patient 24 25 outcomes are limited to those occurring during hospitalization. 26 27 28 29 30 31 32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39 40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 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 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 INTRODUCTION 5 6 Heart failure (HF) is a significant public health challenge around the world, including in 7 8 China1-4, where cardiovascular disease is the leading cause of death.5 Approximately 4.5 9 10 11 million Chinese residents have HF in 2003, and approximately 500,000 incident cases occur 12 13 every year.6 Given China’s aging population and increasing prevalence of cardiovascular 14 15 7,8 16 diseases, the diseaseFor burden peer of HF will risereview rapidly in the coming only years. 17 18 Despite the substantially increasing HF burden in China, little is known about patients 19 20 21 hospitalized for HF. The most recent data on the national epidemiology of HF in China derives 22 23 from a survey performed in 2003.9 While studies from single centers reported the average 24 25 age of patients with HF has increased and comorbidities have shifted markedly during the 26 27 28 past decades,10-12 national data on demographic characteristics, precipitating factors, 29 30 comorbidities and echocardiographic characteristics of patients with HF remain unknown. 31 32 http://bmjopen.bmj.com/ 33 Due to their limited scope, existing studies also report different proportions of HF with 34 35 preserved ejection fraction (HFpEF) and with mildly reduced ejection fraction (HFmrEF).13-15 36 37 38 Further, while it is widely known that use of guidelinedirected medication is suboptimal in 39 16,17 40 patients with HF and reduced EF (HFrEF), none studies have considered patients’ on September 29, 2021 by guest.