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The China Patient-centred Evaluative Assessment of Cardiac Events (PEACE) prospective heart failure study design
Xinghe Huang1, Yuan Yu1, Xi Li1
1National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Insights
This study investigates heart failure (HF) patient outcomes in China using the China Patient-centred Evaluative Assessment of Cardiac Events Prospective Heart Failure Study (China PEACE 5p-HF). It collects comprehensive data to improve HF care nationwide.
Area of Science:
- Cardiology
- Public Health
- Patient-Reported Outcomes Research
Background:
- China faces a growing burden of heart failure (HF).
- Limited data exists on post-hospitalization outcomes, including patient-reported outcomes (PROs), for HF patients in China.
- Understanding these outcomes is crucial for improving national HF care.
Purpose of the Study:
- To present the study design, methodology, and data collection plan for the China Patient-centred Evaluative Assessment of Cardiac Events Prospective Heart Failure Study (China PEACE 5p-HF Study).
- To establish a comprehensive dataset on HF patient experiences and clinical outcomes in China.
- To lay the groundwork for future research aimed at enhancing HF management and patient care quality.
Main Methods:
- Prospective cohort study enrolling 5000 HF patients across 52 diverse Chinese hospitals (2016-2018) with 12-month follow-up.
- Data collection includes medical records review, baseline interviews (demographics, socioeconomic status, risk factors, healthcare access), and validated PRO instruments (health status, depression, anxiety, cognitive function).
- Follow-up includes PROs, hospitalization events, echocardiograms, 6-minute walk tests, and biological sample collection.
Main Results:
- This section describes the planned data collection and methodology, not preliminary results.
- The study is designed to capture a wide range of patient-reported outcomes and clinical data.
- Analysis of collected data will provide insights into HF patient trajectories and treatment effectiveness.
Conclusions:
- The China PEACE 5p-HF Study will provide critical insights into the outcomes of HF patients in China.
- Findings are expected to inform evidence-based strategies for improving HF care quality and patient well-being nationwide.
- The study's comprehensive approach, including PROs and clinical data, will enhance understanding of the HF patient journey.
Introduction:
China 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 Analysis:
The 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 Dissemination:
The 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 Number:
NCT02878811.
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