The China Patient-centred Evaluative Assessment of Cardiac Events (PEACE) prospective heart failure study design

Abstract

IntroductionChina faces the prospect of a large growth in the prevalence of heart failure (HF). However, there is limited knowledge about outcomes in patients after HF hospitalisations, including patient-reported outcomes (PROs). This paper is to present the study goal, methodology and data collection of the China Patient-centred Evaluative Assessment of Cardiac Events Prospective Heart Failure Study (China PEACE 5p-HF Study).Methods and analysisThe China PEACE 5p-HF Study, a prospective cohort study, will enrol 5000 patients with HF during 2016–2018 from 52 diverse hospitals throughout China and the follow-up period will be 12 months. Information on patients’ medical history, in-hospital treatment and in-hospital outcomes are being abstracted from medical records. Details of patients’ demographics, socioeconomic status, cardiovascular risk factors, access to healthcare services are being collected through comprehensive baseline interviews. Generic and disease-specific health status, depression, stress, anxiety and cognitive function are being administered using validated PRO instruments. Follow-up interviews will capture PROs and hospitalisation events at 1, 6 and 12 months follow-up. Standardised transthoracic echocardiograms and 6 min walk tests are being done in patients who enrolled in hospitals with these facilities at baseline and at 1 and 12 months after discharge. Collection of blood and urine samples are also being conducted at baseline, 1 and 12 months follow-up and stored for future analyses.Ethics and disseminationThe National Center for Cardiovascular Diseases/Fuwai Hospital ethics committee approved this study, and all collaborating hospitals received approval from their local ethics committee. Written informed consent will be obtained from all patients. Findings will be disseminated in future peer-reviewed papers and will help to support improvements in the quality of care for HF nationwide.Trial registration numberNCT02878811.