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Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention.

ABSTRACT: During the past decade, the volume of percutaneous coronary intervention (PCI) in China has risen by more than 20-fold. Yet little is known about patterns of care and outcomes across hospitals, regions and time during this period of rising cardiovascular disease and dynamic change in the Chinese healthcare system.Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, the Retrospective Study of Coronary Catheterisation and Percutaneous Coronary Intervention (China PEACE-Retrospective CathPCI Study) will examine a nationally representative sample of 11 900 patients who underwent coronary catheterisation or PCI at 55 Chinese hospitals during 2001, 2006 and 2011. We selected patients and study sites using a two-stage cluster sampling design with simple random sampling stratified within economical-geographical strata. A central coordinating centre will monitor data quality at the stages of case ascertainment, medical record abstraction and data management. We will examine patient characteristics, diagnostic testing patterns, procedural treatments and in-hospital outcomes, including death, complications of treatment and costs of hospitalisation. We will additionally characterise variation in treatments and outcomes by patient characteristics, hospital, region and study year.The China PEACE collaboration is designed to translate research into improved care for patients. The study protocol was approved by the central ethics committee at the China National Center for Cardiovascular Diseases (NCCD) and collaborating hospitals. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of coronary catheterisation and PCI in China.http://www.clinicaltrials.gov (NCT01624896).

SUBMITTER: Li J

PROVIDER: S-EPMC3948460 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention.

Li Jing J Dharmarajan Kumar K Li Xi X Lin Zhenqiu Z Normand Sharon-Lise T SL Krumholz Harlan M HM Jiang Lixin L

BMJ open 20140307 3

<h4>Introduction</h4>During the past decade, the volume of percutaneous coronary intervention (PCI) in China has risen by more than 20-fold. Yet little is known about patterns of care and outcomes across hospitals, regions and time during this period of rising cardiovascular disease and dynamic change in the Chinese healthcare system.<h4>Methods and analysis</h4>Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, the Retrospective Study of Coronary ...[more]

PMID: 24607563

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Project description:BackgroundThe number of percutaneous coronary interventions (PCI) in China has increased more than 20-fold over the last decade. Consequently, there is a need for national-level information to characterize PCI indications and long-term patient outcomes, including health status, to understand and improve evolving practice patterns.ObjectivesThis nationwide prospective study of patients receiving PCI is to: (1) measure long-term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient-reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient- and hospital-level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures.MethodsThe China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012-2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in-hospital outcomes from medical charts, and conducted baseline, 1-, 6-, and 12-month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12-month follow-up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys.ConclusionChina PEACE Prospective Study of PCI will be the first study to generate novel, high-quality, comprehensive national data on patients' socio-demographic, clinical, treatment, and metabolic/genetic factors, and importantly, their long-term outcomes following PCI, including health status. This will build the foundation for PCI performance improvement efforts in China. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc.

Project description:BackgroundCardiovascular diseases are rising as a cause of death and disability in China. To improve outcomes for patients with these conditions, the Chinese government, academic researchers, clinicians, and >200 hospitals have created China Patient-Centered Evaluative Assessment of Cardiac Events (China PEACE), a national network for research and performance improvement. The first study from China PEACE, the Retrospective Study of Acute Myocardial Infarction (China PEACE-Retrospective AMI Study), is designed to promote improvements in acute myocardial infarction (AMI) quality of care by generating knowledge about the characteristics, treatments, and outcomes of patients hospitalized with AMI across a representative sample of Chinese hospitals during the past decade.Methods and resultsThe China PEACE-Retrospective AMI Study will examine >18 000 patient records from 162 hospitals identified using a 2-stage cluster sampling design within economic-geographic regions. Records were chosen from 2001, 2006, and 2011 to identify temporal trends. Data quality will be monitored by a central coordinating center and will, in particular, address case ascertainment, data abstraction, and data management. Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results by time and site of care. In addition to publications, data will be shared with participating hospitals and the Chinese government to develop strategies to promote quality improvement.ConclusionsThe China PEACE-Retrospective AMI Study is the first to leverage the China PEACE platform to better understand AMI across representative sites of care and during the past decade in China. The China PEACE collaboration among government, academicians, clinicians, and hospitals is poised to translate research about trends and patterns of AMI practices and outcomes into improved care for patients.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01624883.

Project description:INTRODUCTION:Collection of high-quality data from large populations is considered essential to generate knowledge that is critical to an era of precision medicine. Cardiovascular disease (CVD) is a leading cause of mortality in China and is a suitable focus of an initiative to discover factors that would improve our ability to assess and modify individual risk. METHODS AND ANALYSIS:The pilot phase of China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Million Persons Project is being conducted during 2014-2015 in four provinces across China to demonstrate the feasibility of a population-based assessment. It is designed to screen 0.4 million community-dwelling residents aged 40-75 years with measurements of blood pressure, height and weight, a lipid blood test, and a questionnaire on cardiovascular-related health status. Participants identified at high risk of CVD receive further health assessments, including ECG, ultrasound scan, blood and urine analysis, and a questionnaire on lifestyle and medical history. Collection of blood and urine samples is used to establish a biobank. High-risk subjects are also counselled with suggestions regarding potential lifestyle changes. In addition, high-risk subjects are followed-up either in a return clinic visit or by telephone interview, with measurement of blood pressure, weight, ECG, and a questionnaire on survival status, hospitalisations and lifestyle. The first 0.1 million participants screened were used to conduct a preliminary analysis, with information on baseline characteristics, health-related behaviours, anthropometric variables, medical history, and prevalence of high-risk subjects. ETHICS AND DISSEMINATION:The central ethics committee at the China National Center for Cardiovascular Disease (NCCD) approved the pilot. Written informed consent is obtained from all participants on entry into the project. Findings will be disseminated in future peer-reviewed papers and will inform strategies aimed at developing precise methods of assessing and modifying risk. TRIAL REGISTRATION NUMBER:NCT02536456.

Project description:The use of coronary catheterization and percutaneous coronary intervention (PCI) is increasing in China, but, to date, there are no nationally representative assessments of the quality of care and outcomes in patients undergoing these procedures.To assess the quality of care and outcomes of patients undergoing coronary catheterization and PCI in China.In a clinical observational study (China PEACE [Patient-Centered Evaluative Assessment of Cardiac Events]-Retrospective CathPCI Study), we used a 2-stage, random sampling strategy to create a nationally representative sample of 11 241 patients undergoing coronary catheterization and PCI at 55 urban Chinese hospitals in calendar years 2001, 2006, and 2011. Data analysis was performed from July 11, 2014, to November 20, 2015.Patient characteristics, treatment patterns, quality of care, and outcomes associated with these procedures and changes over time.Of the 11?241 patients included in the study, the samples included, for 2001, 285 women (weighted percentage, 28.6%); for 2006, 826 women (weighted percentage, 32.2%), and for 2011, 2588 women (weighted percentage, 35.7%). Mean (SD) ages were 58 (8), 60 (11), and 61 (11) years, respectively. Between 2001 and 2011, estimated national rates of hospitalizations for coronary catheterization increased from 26?570 to 452 784 and for PCI, from 9678 to 208 954 (17-fold and 21-fold), respectively. More than half of stable patients undergoing coronary catheterization had nonobstructive coronary artery disease; this amount did not change significantly over time (2001: 60.3% [95% CI, 56.1%-64.5%]; 2011: 57.5% [95% CI, 55.8%-59.3%], P?=?.05 for trend). The proportion of PCI procedures performed via radial approach increased from 3.5% (95% CI, 1.7%-5.3%) in 2001 to 79.0% (95% CI, 77.7%-80.3%) in 2011 (P?<?.?001 for trend). The use of drug-eluting stents (DESs) increased from 18.0% (95% CI, 14.2%-21.7%) in 2001 to 97.3% (95% CI, 96.9%-97.7%) in 2011 (P?<?.001 for trend) largely owing to increased use of domestic DESs. The median length of stay decreased from 14 days (interquartile range [IQR], 9-20) in 2001 to 10 days (IQR, 7-14) in 2011 (P?<?.001 for trend). In-hospital mortality did not change significantly, but both adjusted risk of any bleeding (odds ratio [OR], 0.53 [95% CI, 0.36-0.79], P?<?.001 for trend) and access bleeding (OR, 0.23 [95% CI, 0.12-0.43], P?<?.001) were decreased between 2001 and 2011. The medical records lacked documentation needed to calculate commonly used process metrics including door to balloon times for primary PCI and the prescription of evidence-based medications at discharge.Although the use of catheterization and PCI in China has increased dramatically, we identified critical quality and documentation gaps that represent opportunities to improve care. Our findings can serve as a foundation to guide future quality improvement initiatives in China.

Project description: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.

Project description:ImportanceDespite a rapid increase in percutaneous coronary intervention (PCI) procedures in China, little is known about patient-reported health status before and after PCI in patients without acute myocardial infarction (AMI).ObjectiveTo describe self-perceived angina-specific health status prior to PCI and 1 year after the procedure in patients without AMI in China.Design, setting, and participantsThe China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI was a population-based, multicenter cohort study of a consecutive sample of 1611 patients without AMI undergoing elective PCI. Participants were enrolled from 40 hospitals in 18 provinces in China from December 2012 to August 2014. Participants were eligible if they underwent PCI for stable and unstable angina and did not have AMI. Participants were excluded if they died in hospital, withdrew from follow-up, or had missing data on self-reported health status at baseline or at 1 year after PCI. The date of the analysis was September 15, 2018.ExposuresPercutaneous coronary intervention for ischemic heart disease.Main outcomes and measuresAngina frequency and angina-related quality of life were assessed with the Seattle Angina Questionnaire (SAQ) immediately prior to PCI and 1 year after the procedure. Either (1) an increase in the SAQ Angina Frequency score of 10 or more points or (2) an increase in the SAQ Quality-of-Life score of 10 or more points was considered to represent clinically significant improvement.ResultsOf 1611 patients, 520 (32.3%) were women; mean (SD) age was 61.3 (9.8) years. Among these patients, 443 (27.5%) had stable coronary artery disease and 1168 (72.5%) had unstable angina. One hundred fourteen of 443 patients undergoing PCI for stable coronary artery disease (25.7%) and 175 of 1168 undergoing PCI for unstable angina (15.0%) had no reported angina symptoms at the time of the procedure (SAQ Angina Frequency score = 100). Moreover, 18% of all patients (290) had minimal angina symptoms (SAQ Angina Frequency score >90) and, thus, no potential for substantial clinical improvement. Patients with smaller clinical improvements in angina symptom burden at 1 year following PCI had significantly higher baseline SAQ scores for all scales than patients with greater clinical improvement, but generally similar sociodemographic and procedural characteristics.Conclusions and relevanceIn this study, 25.7% of patients undergoing PCI for stable coronary artery disease had no reported angina symptoms at the time of the procedure. Patients with smaller clinical improvements in angina symptom burden had higher baseline SAQ scores, which highlights the importance of ascertaining impairment from angina among patients without AMI prior to performing PCI.

Project description:BackgroundChina is experiencing a marked increase in ST-segment elevation myocardial infarction hospitalizations, with 30% occurring among women and higher risk of in-hospital death in relatively younger age groups (<70). Yet, little is known about sex differences in ST-segment elevation myocardial infarction presentation and management.Methods and resultsIn a nationally representative sample of patients with ST-segment elevation myocardial infarction admitted to 162 Chinese hospitals in 2001, 2006, and 2011, we examined sex differences in hospitalization rates, clinical profiles, and quality of care. Among 11 986 patients, the proportion of women was unchanged between 2001 and 2011. The estimated national rates of hospital admission per 100 000 people increased from 4.6 in 2001 to 18.0 in 2011 among men (3.9-fold increase) and from 1.9 to 8.0 among women (4.2-fold increase) (Ptrend<0.0001). The median age of women increased from 68 years in 2001 to 72 years in 2011 (Ptrend<0.001); however, there was no age change in men (63 years in 2011) (Ptrend=0.48). After accounting for age, women had a higher frequency of comorbidities. Although there were significant sex differences in the time interval of >12 hours between symptom onset and admission time in 2001, since 2006 delays in presentation were comparable between women and men. Fewer women without contraindications received evidence-based therapies than men, including reperfusion (57.5% versus 44.2%), early aspirin (88.8% versus 85.9%), and clopidogrel (56.9% versus 52.5%, P<0.001 for all) and the differences were largely unchanged over time.ConclusionsWomen experienced a higher increase in hospitalization rates for ST-segment elevation myocardial infarction in China between 2001 and 2011 and were less likely to receive evidence-based therapies, especially reperfusion. In addition to efforts to improve quality of care generally, understanding the reasons for this sex disparity and addressing these differences in care should be a priority.Clinical trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01624883.

Dataset Information

Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention.

Publications

Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention.

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