understanding major adverse events and patient - reported outcomes ( pros ) after acute myocardial infarction ( ami ) is fundamental to improving the quality and effectiveness of health care . with the emergence of validated instruments to measure health status , physical function , and other pros , several observational studies in western countries
have explored these outcomes after ami , providing an opportunity for driving both cost - effectiveness and clinical quality improvement . however , due to substantial differences in health care systems , treatment patterns , lifestyle , and environment , data from western countries may not necessarily be extrapolated elsewhere .
china , home to one - fifth of the world 's population , has experienced an epidemiological transition , marked by a shift from a predominance of infectious to noncommunicable diseases in a much shorter time span than many other countries .
the number of patients hospitalized with st - segment elevation myocardial infarction in china has quadrupled over the last decade .
these epidemiological shifts have created an imperative to understand a broad range of outcomes in longitudinal follow - up for high - impact noncommunicable conditions as ami . despite the increasing prevalence of ami in china ,
little is known about the experience of patients after the acute event , including mortality , major adverse vascular events , and pros .
previous studies in china have found that patients with acute coronary syndromes have worse in - hospital outcomes compared with patients in western countries , and the use and maintenance of appropriate combinations of evidence - based treatment are suboptimal over both the short- and long - term .
existing studies , however , have been either limited to in - hospital mortality and in - hospital clinical events or lacking the comprehensive evaluation of a broad range of outcomes , including pros .
no information is currently available on longitudinal outcomes , risk factors , risk prediction tools , and in - hospital and long - term management of a national sample of patients following ami in china .
such information would provide a perspective on the current results that are achieved and identify areas for improvement . to understand the experience of patients after ami and guide quality improvement initiatives for post - ami care in china , we designed and implemented the china patient - centered evaluative assessment of cardiac events prospective study of ami ( china peace - prospective ami study ) , which is the first longitudinal study on clinical outcomes and pros among ami patients who are discharged alive in china .
it aims to ( 1 ) examine major vascular events and a broad range of pros ( i.e. , health status , depression , social support , cognitive function , and sexual health ) in patients with ami in the short- ( i.e. , within 1 month ) and long - term ( i.e. , within 12 months ) ; ( 2 ) determine risk factors associated with these patient outcomes , including patient characteristics ( e.g. , demographic , clinical , psychosocial , and behavioral factors ) , in - hospital care , and hospital attributes ; ( 3 ) generate tools for risk prediction among chinese patients with ami ; and ( 4 ) evaluate the control of risk factors for subsequent events after ami hospitalization .
the china peace - prospective ami study is based on the china peace platform , a collaborative effort among china national center for cardiovascular diseases ( nccd ) , the yale - new haven hospital , center for outcomes research and evaluation , the chinese government , and 208 chinese hospitals to improve cardiovascular disease outcomes in china [ figure 1 ] .
the china peace - prospective ami study recruited 4000 patients treated for ami in 53 hospitals ( 35 tertiary and 18 secondary hospitals ) located in 21 of the 31 provinces in china ( supplementary material 1 ) and followed them prospectively for 12 months .
the first patient was enrolled in december 2012 ; follow - up finished in june 2015 .
data were collected at baseline ( i.e. , index hospitalization for ami ) , as well as at 1 , 6 , and 12 months following hospital discharge .
key partners include the chinese government , collaborating hospitals , the china national center for cardiovascular disease , and the yale - new haven hospital , center for outcomes research and evaluation .
ami : acute myocardial infarction ; pci : percutaneous coronary intervention ; 3vd : revascularization in patients with triple - vessel disease .
the national coordinating center ( ncc ) of this study is based at the nccd / fuwai hospital in beijing , and works in close collaboration with 10 regional coordinating centers in various regions of china .
the nccd / fuwai hospital ethics committee approved this study and , where required , individual hospitals received approval from their local ethics committee .
the chinese government , which provides financial support for the study , has no role in the design or conduct of the study ; in the collection , management , analysis , and interpretation of the data ; or in the preparation or approval of the article or any of the articles that will be derived from the study .
nct01624909 ) . we selected geographically matched hospitals , consisting of one secondary and at least one tertiary hospital in each geographic region ( typically a province ) .
this design was implemented to examine the treatment outcomes and associated risk factors of patients following ami , under different treatment circumstances and patterns with the ability to compare tertiary hospitals ( with the capacity of performing primary percutaneous coronary intervention [ pci ] ) with secondary hospitals ( without the capacity of performing primary pci ) . although selecting pairs of secondary and tertiary hospitals from the same city was a priority , when this was not feasible , we selected secondary and tertiary hospitals from geographically proximal cities .
eligible patients included those age 18 years or older admitted to a participating hospital for ami within 24 h of symptom onset .
the diagnosis of ami was defined as an increase in cardiac biomarker levels ( troponin or creatine kinase [ ck]-mb ) with at least one value above the 99 percentile of the upper reference limit , and clinical evidence of acute myocardial ischemia ( i.e. , symptoms of ischemia , or electrocardiogram changes indicative of new ischemia ) .
patients were excluded if they have any of the following : ami caused by physical trauma , elevated cardiac biomarkers as a complication of elective coronary revascularization . the diagnosis confirmed by local physicians
all eligible patients were registered and invited to participate in the study by trained / certified investigators at each site .
hospitals with enrollment rates that were lower than expected were provided assistance from the ncc , which shares the best practices and strategies used by more successfully enrolling hospitals .
we established the study cohort for follow - up , which included all enrolled ami patients who were alive at discharge . in order to evaluate potential selection bias by comparing enrolled versus nonenrolled patients , we collected information on baseline characteristics , in - hospital care , and in - hospital outcomes for all eligible patients through medical chart abstraction .
the china patient - centered evaluative assessment of cardiac events prospective study of acute myocardial infarction study flow chart .
ami : acute myocardial infarction ; acs : acute coronary syndrome ; ua : unstable angina .
data are collected via central medical chart abstraction , interviews , and physical examinations by site investigators , local lab tests , and central lab analysis [ table 1 ] .
all data are treated as protected health information and are securely stored in an encrypted and password - protected database at the ncc with frequent local and offsite backup on secure servers .
data collected during the ami index hospitalization and follow - up * only performed in 6 hospitals ( 3 tertiary and 3 secondary hospitals , from 3 provinces ) ; only collected in secondary hospitals .
ami : acute myocardial infarction ; cvd : cardiovascular disease ; saq : seattle angina questionnaire ; eq-5d : euroqol group 5-dimension self - report questionnaire ; phq-8 : patient health questionnaire 8-item depression scale ; pss : perceived stress scale ; essi : enhancing recovery in coronary heart disease ( enrichd ) social support inventory ; mbq : modified berlin questionnaire ; mmse : mini mental state examination ; tcm : traditional chinese medicine ; bun : blood urea nitrogen ; hba1c : hemoglobin a1c ; hs - crp : high - sensitivity c - reactive protein ; dna : deoxyribonucleic acid ; rna : ribonucleic acid ; bmi : body mass index .
medical chart abstraction for all registered patients , we abstracted detailed information from medical chart of the index hospitalization ( case report form shown in supplementary material 2 and data dictionary shown in supplementary material 3 ) .
site investigators photograph complete hospital medical charts of all eligible patients , with identity information concealed ( name , national i d , and contact information ) .
electronic copies of the charts are sent to the ncc via encrypted flash drives for central abstraction .
following receipt of each chart , research staff at the ncc checks the hospitalization i d and date of hospital admission to verify the correct patient identity .
the data are evaluated to ensure completeness , quality , and concealment of personal identifiers .
incomplete or poorly scanned records are rescanned and retransmitted . per the china peace - retrospective ami study methodology , two contracted vendors abstract details of each patients hospitalization using their medical charts .
one vendor abstracts the part that can be abstracted verbatim without need for interpretation ( face sheet , laboratory test results , and physician orders ) of all medical charts via double entry by separate abstractors to ensure the accuracy .
the other vendor abstracts the other part ( the admission record , discharge record , daily record , and procedure reports ) of all medical charts . to ensure the accuracy of interpretation ,
research staff at the ncc randomly audits 5% of all charts on an ongoing basis .
if the charts are not abstracted with at least 98% accuracy , all medical charts in the audited batch will be considered unqualified and will be re - reviewed .
participant interviews participants were interviewed at baseline ( i.e. , during the index hospitalization for ami ) , and at 1 , 6 , and 12 months following hospital discharge ( questionnaires shown in supplementary material 4 ) . during follow - up period ,
baseline and follow - up questionnaires click here for additional data file . at baseline ,
we collect detailed information on demographics , socioeconomic status , cardiovascular risk factors , medical history , sleep apnea , generic and disease - specific health status , depression , and stress [ table 1 ] .
we collected patient outcomes within 12 months after the index ami , including clinical events and pros .
we collected all hospitalizations during follow - up with the medical record as supporting documents .
clinicians at ncc adjudicate all major vascular events ( defined as cardiac death , nonfatal ami , coronary revascularization , or ischemic stroke ) using standard criteria employed in clinical trials . to provide a complete picture of patients health status
, we collect both generic and disease - specific measures , as well as estimates of patients psychosocial status , and sexual functioning .
the study used the euroqol group 5-dimension instrument as a measure of generic health - related quality of life , which also enables the estimation of utilities , and the seattle angina questionnaire to assess condition - specific functioning and quality of life .
psychosocial status was assessed for depressive symptoms ( 8-item patient health questionnaire ) , stress ( 4-item perceived stress scale ) , cognitive function ( mini - mental state examination ) , and sexual activity / function . during follow - up
, we also asked questions regarding adherence to secondary prevention and assessed the management of cardiovascular risk factors . to assess sexual health and cognitive functioning after ami
, we conducted a sub - study among 6 of the participating hospitals ( 3 tertiary and 3 secondary hospitals , from 3 provinces ) .
sexual activity / function and cognitive function were assessed at baseline , 1 , and 12 months after the index ami [ table 1 ] by trained physicians .
sexual activity / function was assessed using instruments from previous large - scale studies of adult sexuality following ami .
this includes information on partner status , sexual activity ( active or not , frequency ) , attitudes ( importance , motivation ) , function , and physician counseling about sexual activity .
site investigators complete the questionnaires electronically on a tablet computer , which allows real - time logic checks to ensure the accuracy and completeness of data .
site investigators photographed signed consent forms with the tablet camera and upload them to the central server .
the data were transferred to the server for synchronization into the central database at ncc via a customized virtual private network .
the ncc coordinators checked consents of all participants , reviewed missing data and made data queries , and requested reasons for missed follow - up appointments .
in addition , an audio record was automatically made during the patient interview and uploaded to the server along with questionnaire data .
. physical examinations and local laboratory tests blood pressure , height , weight , and waist circumference are measured at baseline as well as each follow - up visit .
at the 1- and 12-month follow - up visits , lipid profiles , glucose , renal function , liver function , blood counts , and urinalysis were analyzed locally , which are consistent with the routine clinical practice .
central laboratory tests and long - term storage of blood and urine samples for the purpose of central lab analysis , separate blood and urine samples are obtained during the index hospitalization ( primarily prior to acute treatments , particularly reperfusion therapies ) , as well as at 1-month ( only in the 18 secondary hospitals ) and 12-month follow - up visits .
this will facilitate the assessment of ami biomarkers and long - term management of risk factors ( supplementary material 5 ) .
samples were processed within 24 h following collection , stored at 40c or 80c , transported with dry ice from local sites within 6 months , and then stored in liquid nitrogen at china nccd for central analysis and long - term storage .
the following will be analyzed at a central laboratory : blood lipid profiles ( total cholesterol , high - density lipid - cholesterol , and low - density lipid - cholesterol ) and metabolic markers ( i.e. , alanine aminotransferase , creatinine , ck , high - sensitivity c - reactive protein , glucose , and hemoglobin a1c ) .
blood and urine collection click here for additional data file . to help investigate the effects of health care system and institutional factors on the treatment and outcomes of patients with ami ,
participating hospitals are surveyed about their treatment capacity and processes , as well as their organizational learning behaviors and cultures ( supplementary material 6 ) .
questions about organizational learning were drawn from previously developed instruments . we invite two respondents from each hospital to complete the survey :
one is the local principal investigator of the china peace - prospective ami study at each hospital ( usually the director of the cardiology department or internal medicine department ) and the other is the coordinator of this study at each hospital ( usually a physician involved in routine clinical practice ) .
our strategy of data collection permits a broad range of analysis and analytic approaches , based upon the primary research question ( supplementary material 7 )
. we will calculate summary statistics for major vascular events , as well as pros within 1 , 6 , and 12 months after ami .
we will report summary statistics for patient demographic , clinical , psychosocial , and behavioral characteristics , use of diagnostic tests , treatments received , and control of cardiovascular risk factors . to help identify factors associated with the major vascular events ,
we will use standard parametric and nonparametric tests for bivariate analyses , including t - test , chi - square test , fisher 's exact test , and wilcoxon rank sum tests .
in addition , appropriate multivariable regression analyses , such as linear , logistic , cox proportional hazard , and poisson models , will be conducted to determine a factor 's association with the outcome measures while adjusting for potential confounders . as patients are clustered within hospitals and there are repeated observations clustered within patients , our analyses will account for clustering in data ( e.g. , generalized estimating equations or random effects models ) . while all efforts are made to obtain high response rates in follow - up pros , some missing data are inevitable .
we will carefully evaluate any potential selection biases introduced by missing data and conduct inverse probability weighting when appropriate , based upon a propensity model for participation in the follow - up assessments , to preferentially weight the experiences of patients who were most like those who did not participate in follow - up .
a sample size of 4000 is determined based on both feasibility and consideration of adequate statistical precision for describing 12-month major vascular events and pros in the overall sample , and secondary or tertiary hospitals separately ( supplementary material 8) .
the china peace - prospective ami study is based on the china peace platform , a collaborative effort among china national center for cardiovascular diseases ( nccd ) , the yale - new haven hospital , center for outcomes research and evaluation , the chinese government , and 208 chinese hospitals to improve cardiovascular disease outcomes in china [ figure 1 ] .
the china peace - prospective ami study recruited 4000 patients treated for ami in 53 hospitals ( 35 tertiary and 18 secondary hospitals ) located in 21 of the 31 provinces in china ( supplementary material 1 ) and followed them prospectively for 12 months .
the first patient was enrolled in december 2012 ; follow - up finished in june 2015 .
data were collected at baseline ( i.e. , index hospitalization for ami ) , as well as at 1 , 6 , and 12 months following hospital discharge .
key partners include the chinese government , collaborating hospitals , the china national center for cardiovascular disease , and the yale - new haven hospital , center for outcomes research and evaluation .
ami : acute myocardial infarction ; pci : percutaneous coronary intervention ; 3vd : revascularization in patients with triple - vessel disease .
the national coordinating center ( ncc ) of this study is based at the nccd / fuwai hospital in beijing , and works in close collaboration with 10 regional coordinating centers in various regions of china .
the nccd / fuwai hospital ethics committee approved this study and , where required , individual hospitals received approval from their local ethics committee .
the chinese government , which provides financial support for the study , has no role in the design or conduct of the study ; in the collection , management , analysis , and interpretation of the data ; or in the preparation or approval of the article or any of the articles that will be derived from the study .
we selected geographically matched hospitals , consisting of one secondary and at least one tertiary hospital in each geographic region ( typically a province ) .
this design was implemented to examine the treatment outcomes and associated risk factors of patients following ami , under different treatment circumstances and patterns with the ability to compare tertiary hospitals ( with the capacity of performing primary percutaneous coronary intervention [ pci ] ) with secondary hospitals ( without the capacity of performing primary pci ) .
although selecting pairs of secondary and tertiary hospitals from the same city was a priority , when this was not feasible , we selected secondary and tertiary hospitals from geographically proximal cities .
eligible patients included those age 18 years or older admitted to a participating hospital for ami within 24 h of symptom onset .
the diagnosis of ami was defined as an increase in cardiac biomarker levels ( troponin or creatine kinase [ ck]-mb ) with at least one value above the 99 percentile of the upper reference limit , and clinical evidence of acute myocardial ischemia ( i.e. , symptoms of ischemia , or electrocardiogram changes indicative of new ischemia ) .
patients were excluded if they have any of the following : ami caused by physical trauma , elevated cardiac biomarkers as a complication of elective coronary revascularization . the diagnosis confirmed by local physicians
all eligible patients were registered and invited to participate in the study by trained / certified investigators at each site .
hospitals with enrollment rates that were lower than expected were provided assistance from the ncc , which shares the best practices and strategies used by more successfully enrolling hospitals .
we established the study cohort for follow - up , which included all enrolled ami patients who were alive at discharge . in order to evaluate potential selection bias by comparing enrolled versus nonenrolled patients , we collected information on baseline characteristics , in - hospital care , and in - hospital outcomes for all eligible patients through medical chart abstraction .
the china patient - centered evaluative assessment of cardiac events prospective study of acute myocardial infarction study flow chart .
ami : acute myocardial infarction ; acs : acute coronary syndrome ; ua : unstable angina .
data are collected via central medical chart abstraction , interviews , and physical examinations by site investigators , local lab tests , and central lab analysis [ table 1 ] .
all data are treated as protected health information and are securely stored in an encrypted and password - protected database at the ncc with frequent local and offsite backup on secure servers .
data collected during the ami index hospitalization and follow - up * only performed in 6 hospitals ( 3 tertiary and 3 secondary hospitals , from 3 provinces ) ; only collected in secondary hospitals .
ami : acute myocardial infarction ; cvd : cardiovascular disease ; saq : seattle angina questionnaire ; eq-5d : euroqol group 5-dimension self - report questionnaire ; phq-8 : patient health questionnaire 8-item depression scale ; pss : perceived stress scale ; essi : enhancing recovery in coronary heart disease ( enrichd ) social support inventory ; mbq : modified berlin questionnaire ; mmse : mini mental state examination ; tcm : traditional chinese medicine ; bun : blood urea nitrogen ; hba1c : hemoglobin a1c ; hs - crp : high - sensitivity c - reactive protein ; dna : deoxyribonucleic acid ; rna : ribonucleic acid ; bmi : body mass index .
medical chart abstraction for all registered patients , we abstracted detailed information from medical chart of the index hospitalization ( case report form shown in supplementary material 2 and data dictionary shown in supplementary material 3 ) .
site investigators photograph complete hospital medical charts of all eligible patients , with identity information concealed ( name , national i d , and contact information ) .
electronic copies of the charts are sent to the ncc via encrypted flash drives for central abstraction .
following receipt of each chart , research staff at the ncc checks the hospitalization i d and date of hospital admission to verify the correct patient identity .
the data are evaluated to ensure completeness , quality , and concealment of personal identifiers .
incomplete or poorly scanned records are rescanned and retransmitted . per the china peace - retrospective ami study methodology ,
one vendor abstracts the part that can be abstracted verbatim without need for interpretation ( face sheet , laboratory test results , and physician orders ) of all medical charts via double entry by separate abstractors to ensure the accuracy .
the other vendor abstracts the other part ( the admission record , discharge record , daily record , and procedure reports ) of all medical charts . to ensure the accuracy of interpretation ,
research staff at the ncc randomly audits 5% of all charts on an ongoing basis .
if the charts are not abstracted with at least 98% accuracy , all medical charts in the audited batch will be considered unqualified and will be re - reviewed .
participant interviews participants were interviewed at baseline ( i.e. , during the index hospitalization for ami ) , and at 1 , 6 , and 12 months following hospital discharge ( questionnaires shown in supplementary material 4 ) . during follow - up period
baseline and follow - up questionnaires click here for additional data file . at baseline ,
we collect detailed information on demographics , socioeconomic status , cardiovascular risk factors , medical history , sleep apnea , generic and disease - specific health status , depression , and stress [ table 1 ] .
we collected patient outcomes within 12 months after the index ami , including clinical events and pros .
we collected all hospitalizations during follow - up with the medical record as supporting documents .
clinicians at ncc adjudicate all major vascular events ( defined as cardiac death , nonfatal ami , coronary revascularization , or ischemic stroke ) using standard criteria employed in clinical trials . to provide a complete picture of patients health status ,
we collect both generic and disease - specific measures , as well as estimates of patients psychosocial status , and sexual functioning .
the study used the euroqol group 5-dimension instrument as a measure of generic health - related quality of life , which also enables the estimation of utilities , and the seattle angina questionnaire to assess condition - specific functioning and quality of life .
psychosocial status was assessed for depressive symptoms ( 8-item patient health questionnaire ) , stress ( 4-item perceived stress scale ) , cognitive function ( mini - mental state examination ) , and sexual activity / function . during follow - up
, we also asked questions regarding adherence to secondary prevention and assessed the management of cardiovascular risk factors . to assess sexual health and cognitive functioning after ami
, we conducted a sub - study among 6 of the participating hospitals ( 3 tertiary and 3 secondary hospitals , from 3 provinces ) .
sexual activity / function and cognitive function were assessed at baseline , 1 , and 12 months after the index ami [ table 1 ] by trained physicians .
sexual activity / function was assessed using instruments from previous large - scale studies of adult sexuality following ami .
this includes information on partner status , sexual activity ( active or not , frequency ) , attitudes ( importance , motivation ) , function , and physician counseling about sexual activity .
site investigators complete the questionnaires electronically on a tablet computer , which allows real - time logic checks to ensure the accuracy and completeness of data .
site investigators photographed signed consent forms with the tablet camera and upload them to the central server .
the data were transferred to the server for synchronization into the central database at ncc via a customized virtual private network .
the ncc coordinators checked consents of all participants , reviewed missing data and made data queries , and requested reasons for missed follow - up appointments .
in addition , an audio record was automatically made during the patient interview and uploaded to the server along with questionnaire data .
physical examinations and local laboratory tests blood pressure , height , weight , and waist circumference are measured at baseline as well as each follow - up visit . at the 1- and 12-month follow - up visits , lipid profiles , glucose , renal function , liver function , blood counts , and urinalysis
central laboratory tests and long - term storage of blood and urine samples for the purpose of central lab analysis , separate blood and urine samples are obtained during the index hospitalization ( primarily prior to acute treatments , particularly reperfusion therapies ) , as well as at 1-month ( only in the 18 secondary hospitals ) and 12-month follow - up visits .
this will facilitate the assessment of ami biomarkers and long - term management of risk factors ( supplementary material 5 ) .
samples were processed within 24 h following collection , stored at 40c or 80c , transported with dry ice from local sites within 6 months , and then stored in liquid nitrogen at china nccd for central analysis and long - term storage .
the following will be analyzed at a central laboratory : blood lipid profiles ( total cholesterol , high - density lipid - cholesterol , and low - density lipid - cholesterol ) and metabolic markers ( i.e. , alanine aminotransferase , creatinine , ck , high - sensitivity c - reactive protein , glucose , and hemoglobin a1c ) .
blood and urine collection click here for additional data file . to help investigate the effects of health care system and institutional factors on the treatment and outcomes of patients with ami ,
participating hospitals are surveyed about their treatment capacity and processes , as well as their organizational learning behaviors and cultures ( supplementary material 6 ) .
we invite two respondents from each hospital to complete the survey : one is the local principal investigator of the china peace - prospective ami study at each hospital ( usually the director of the cardiology department or internal medicine department ) and the other is the coordinator of this study at each hospital ( usually a physician involved in routine clinical practice ) .
our strategy of data collection permits a broad range of analysis and analytic approaches , based upon the primary research question ( supplementary material 7 )
. we will calculate summary statistics for major vascular events , as well as pros within 1 , 6 , and 12 months after ami .
we will report summary statistics for patient demographic , clinical , psychosocial , and behavioral characteristics , use of diagnostic tests , treatments received , and control of cardiovascular risk factors . to help identify factors associated with the major vascular events
, we will use standard parametric and nonparametric tests for bivariate analyses , including t - test , chi - square test , fisher 's exact test , and wilcoxon rank sum tests .
in addition , appropriate multivariable regression analyses , such as linear , logistic , cox proportional hazard , and poisson models , will be conducted to determine a factor 's association with the outcome measures while adjusting for potential confounders . as patients are clustered within hospitals and there are repeated observations clustered within patients , our analyses will account for clustering in data ( e.g. , generalized estimating equations or random effects models ) . while all efforts are made to obtain high response rates in follow - up pros , some missing data are inevitable .
we will carefully evaluate any potential selection biases introduced by missing data and conduct inverse probability weighting when appropriate , based upon a propensity model for participation in the follow - up assessments , to preferentially weight the experiences of patients who were most like those who did not participate in follow - up .
a sample size of 4000 is determined based on both feasibility and consideration of adequate statistical precision for describing 12-month major vascular events and pros in the overall sample , and secondary or tertiary hospitals separately ( supplementary material 8) .
the china peace - prospective ami study is the first national longitudinal study on both clinical events and pros among patients with ami in china .
the goal of the study is to assess a broad range of outcomes of patients recovering from ami to directly address an important knowledge gap and serve as a foundation with which to develop novel interventions to improve the health outcomes of ami patients in china .
several unique features of this study , including the consecutive enrollment of patients , the validation processes to ensure accurate capture of source data , the collection of patient - centered data elements through serial interviews , and the detailed longitudinal follow - up , augment the value of this study .
pro measures will provide critically important and currently unknown information to support quality improvement initiatives for ami patients in china .
traditional clinical methods of measuring health and the effects of treatment are increasingly accompanied by pros , which enable the patients perspectives to be taken into account in key aspects of healthcare . during the past decade ,
the treatment of ami has advanced considerably , resulting in significantly decreased mortality and underscoring the importance of capturing the health outcomes of survivors .
physicians need to take into account the impact of treatments on patients health status including psychosocial outcomes that may influence the patient recovery process .
however , previous large - scale international or national studies lack information about pros . in recent years
, several observational studies have broadened the range of outcomes among patients with ami to include these outcomes .
however , these studies were conducted in western countries and in - hospitals with the capacity for angiography .
findings from the china peace - prospective ami study will provide information about the long - term outcomes of patients with ami , in settings both with and without advanced technical capability , such as pci , and thus inform generalizable strategies to improve care and reduce disparities with a focus on a broad range of outcomes including those that reflect the patient 's experience .
the collection of detailed data describing patient characteristics ( e.g. , demographic , clinical , psychosocial , behavioral factors , and hospital care received ) and hospital attributes will enable investigators to define the prognostic importance of both patient- and hospital - level variables on both short- and long - term outcomes .
risk prediction tools developed in the chinese population can facilitate understanding of patient prognosis , stratification , and personalized treatment according to individual risk .
currently used risk scores ( e.g. , grace , timi , gusto ) were developed based on non - chinese patients , and the performance of these models in chinese populations may differ from that in western patients . accordingly , a risk model tailored to identify high - risk patients with ami in china may be more effective in predicting poor prognosis including major adverse vascular events and/or poor quality of life .
data from this study will be used to assess patient- and hospital - level factors influencing continuation of medications and the control of risk factors to optimize secondary prevention following ami , as well as the association between secondary prevention and patient outcomes .
such studies will address a substantial gap in knowledge regarding long - term adherence to preventive medications , particularly in low- and middle - income countries ( lmics ) .
as most prior studies focused only on in - hospital care and discharge medications , there is a continued need to understand the barriers in adherence to secondary prevention , as well as associated patient characteristics and institutional factors .
for example , identifying patient- or system - level factors associated with nonadherence can support novel strategies for improving treatment after discharge and serve as a foundation for strategies to improve medication adherence and risk factor control in ami patients . besides the clinical and psychosocial patterns examined for optimizing the treatment and prognosis of patients with ami
, the blood and urine samples collected in our study will serve the need of basic science , translational , or clinical research to advance the diagnosis , prevention , or treatment of ami .
the large sample of well - characterized patients will be stored long - term as a bio - repository , enabling identification of novel biomarkers , detecting the association between genetic and phenotype factors , and exploring potential mechanisms of ami onset and recovery .
the strengths of conducting a longitudinal study on clinical outcomes and pros among patients with ami have been well - recognized both in china and other lmics , which are all in need of a better understanding of where the greatest opportunities lie in optimizing patient outcomes in the face of an increasing burden of cardiovascular disease .
in addition , the established organizational infrastructure of our research team , based on partnership with the chinese government , collaboration with international experts in observational studies , and the involvement of local hospitals , ensures a rigorous study design and rapid dissemination of findings .
furthermore , the implementation of the high - quality and cost - effective study is supported by a broad research network as well as a robust management system . during the past decade ,
china nccd has collaborated with world 's leading academic institutions to conduct several of the largest clinical trials in china .
continuous efforts have been made in establishing the research network through in - depth training and rigorous quality control procedures .
we have also established a management system for large multi - center studies , which has internationally - accepted quality standards and accounts for the diverse health care settings in china .
the collaborative research and performance improvement network created by the china peace platform will ultimately improve patient outcomes for a broad range of conditions and may present a model for research and quality improvement in other international settings .
it should be noted that only patients who consented can be enrolled and followed - up .
these patients may differ from those who were eligible but did not consent to participate .
in addition , missing data , particularly follow - up pro data , can introduce biased estimates of outcomes and will require extreme diligence in collecting all follow - up pro data and advanced statistical methods for the planned analyses to account for missing data . in conclusion ,
the china peace - prospective ami study is uniquely positioned to help improve the quality of care and patient outcomes for china and similar lmics by generating novel , high - quality , and comprehensive data about patients experience following hospitalizations for ami .
the partnership among the chinese government , an expert clinical trial group , a large network of hospitals with geographic and capability diversity , and international experts in outcomes research , will be leveraged to create a platform for research on cardiovascular diseases which will facilitate policy - making and inform the development of novel quality improvement tools .
supplementary information is linked to the online version of the paper on the chinese medical journal website .
this study was supported by the research special fund for public welfare industry of health ( no .
hmk is supported by grant u01 hl105270 - 05 ( center for cardiovascular outcomes research at yale university ) from the national heart , lung , and blood institute .
the sponsors had no role in the conduct of the study ; in the collection , management , analysis , and interpretation of the data ; or in the preparation or approval of the manuscript .
krumholz works under contract with the centers for medicare & medicaid services to develop and maintain performance measures , is chair of a cardiac scientific advisory board for unitedhealth , and is the recipient of research grants from medtronic , johnson and johnson ( janssen ) through yale university , to develop methods of clinical trial data sharing .
this study was supported by the research special fund for public welfare industry of health ( no .
hmk is supported by grant u01 hl105270 - 05 ( center for cardiovascular outcomes research at yale university ) from the national heart , lung , and blood institute .
the sponsors had no role in the conduct of the study ; in the collection , management , analysis , and interpretation of the data ; or in the preparation or approval of the manuscript .
krumholz works under contract with the centers for medicare & medicaid services to develop and maintain performance measures , is chair of a cardiac scientific advisory board for unitedhealth , and is the recipient of research grants from medtronic , johnson and johnson ( janssen ) through yale university , to develop methods of clinical trial data sharing .
 background : despite the rapid growth in the incidence of acute myocardial infarction ( ami ) in china , there is limited information about patients experiences after ami hospitalization , especially on long - term adverse events and patient - reported outcomes ( pros).methods : the china patient - centered evaluative assessment of cardiac events ( peace)-prospective ami study will enroll 4000 consecutive ami patients from 53 diverse hospitals across china and follow them longitudinally for 12 months to document their treatment , recovery , and outcomes . details of patients medical history , treatment , and in - hospital outcomes are abstracted from medical charts . 
 comprehensive baseline interviews are being conducted to characterize patient demographics , risk factors , presentation , and healthcare utilization . as part of these interviews , validated instruments are administered to measure pros , including quality of life , symptoms , mood , cognition , and sexual activity . 
 follow - up interviews , measuring pros , medication adherence , risk factor control , and collecting hospitalization events are conducted at 1 , 6 , and 12 months after discharge . supporting documents for potential outcomes are collected for adjudication by clinicians at the national coordinating center . 
 blood and urine samples are also obtained at baseline , 1- and 12-month follow - up . 
 in addition , we are conducting a survey of participating hospitals to characterize their organizational characteristics.conclusion:the china peace - prospective ami study will be uniquely positioned to generate new information regarding patient 's experiences and outcomes after ami in china and serve as a foundation for quality improvement activities . 
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Study overview
Site network
Study population
Data collection
Statistical analysis
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Financial support and sponsorship
Conflicts of interest