downloaded from on november 11 ...sorana.academicdirect.ro/pages/doc/pc2/protocol-cohorta...received...

Protocol for the China PEACE(Patient-centered Evaluative Assessmentof Cardiac Events) retrospective studyof coronary catheterisation andpercutaneous coronary intervention

Jing Li,1 Kumar Dharmarajan,2,3 Xi Li,1 Zhenqiu Lin,2 Sharon-Lise T Normand,4,5

Harlan M Krumholz,2,6,7 Lixin Jiang,1 for the China PEACE Collaborative Group1,2

To cite: Li J, Dharmarajan K,Li X, et al. Protocol for theChina PEACE(Patient-centered EvaluativeAssessment of CardiacEvents) retrospective studyof coronary catheterisationand percutaneous coronaryintervention. BMJ Open2014;4:e004595.doi:10.1136/bmjopen-2013-004595

▸ Additional material isavailable. To view please visitthe journal (http://dx.doi.org/10.1136/bmjopen-2013-004595).

JL and KD are joint firstauthors. HMK and LJ arejoint senior authors.

Received 2 December 2013Accepted 10 February 2014

For numbered affiliations seeend of article.

Correspondence toDr Lixin Jiang;[email protected]

ABSTRACTIntroduction: During the past decade, the volume ofpercutaneous coronary intervention (PCI) in China hasrisen by more than 20-fold. Yet little is known aboutpatterns of care and outcomes across hospitals,regions and time during this period of risingcardiovascular disease and dynamic change in theChinese healthcare system.Methods and analysis: Using the China PEACE(Patient-centered Evaluative Assessment of CardiacEvents) research network, the Retrospective Study ofCoronary Catheterisation and Percutaneous CoronaryIntervention (China PEACE-Retrospective CathPCIStudy) will examine a nationally representative sampleof 11 900 patients who underwent coronarycatheterisation or PCI at 55 Chinese hospitals during2001, 2006 and 2011. We selected patients and studysites using a two-stage cluster sampling design withsimple random sampling stratified within economical-geographical strata. A central coordinating centrewill monitor data quality at the stages of caseascertainment, medical record abstraction and datamanagement. We will examine patient characteristics,diagnostic testing patterns, procedural treatments andin-hospital outcomes, including death, complications oftreatment and costs of hospitalisation. We willadditionally characterise variation in treatments andoutcomes by patient characteristics, hospital, regionand study year.Ethics and dissemination: The China PEACEcollaboration is designed to translate research intoimproved care for patients. The study protocol wasapproved by the central ethics committee at the ChinaNational Center for Cardiovascular Diseases (NCCD)and collaborating hospitals. Findings will be sharedwith participating hospitals, policymakers and theacademic community to promote qualitymonitoring, quality improvement and the efficientallocation and use of coronary catheterisation and PCIin China.Registration details: http://www.clinicaltrials.gov(NCT01624896).

INTRODUCTIONChina, a country with a rapidly rising preva-lence of cardiovascular disease,1–3 is con-comitantly expanding access to advancedcardiovascular procedures. During the pastdecade, the volume of percutaneous coron-ary intervention (PCI) has increased morethan 20-fold.4 5 This expansion has occurredin the context of rising rates of health insur-ance coverage and healthcare costs.6 7 Theoptimal deployment of advanced care strat-egies in settings of constrained resources is acommon challenge faced by many low-income and middle-income countries.8

Although the overall volume of coronarycatheterisation and PCI procedures per-formed in China is known,9–12 there are gapsin knowledge about the details of their useand associated outcomes. Nationally repre-sentative data are lacking, and studies havegenerally included only a small number of

Strengths and limitations of this study

▪ Hospitalisations were sampled from a nationallyrepresentative hospital network for the years 2001,2006 and 2011 to examine the influence of majorchanges in the Chinese healthcare system and thecreation of percutaneous coronary intervention(PCI) guidelines by Chinese medical societies.

▪ To elevate the quality of abstracted data, thestudy uses data collection techniques regularlyemployed by international clinical trials such asintegrated central and on-site monitoring as wellas source document checking.

▪ Findings will be shared with hospitals and pol-icymakers to improve healthcare quality.

▪ Patient outcomes are limited to in-hospital out-comes, and data collection is limited to informa-tion available in medical records.

Li J, Dharmarajan K, Li X, et al. BMJ Open 2014;4:e004595. doi:10.1136/bmjopen-2013-004595 1

Open Access Protocol

group.bmj.com on November 11, 2014 - Published by http://bmjopen.bmj.com/Downloaded from

http://dx.doi.org/10.1136/bmjopen-2013-004595http://dx.doi.org/10.1136/bmjopen-2013-004595http://dx.doi.org/10.1136/bmjopen-2013-004595http://crossmark.crossref.org/dialog/?doi=10.1136/bmjopen-2013-004595&domain=pdf&date_stamp=2014-3-7http://www.clinicaltrials.govhttp://bmjopen.bmj.com/http://group.bmj.com

hospitals in circumscribed geographical areas or singletime periods.5 13–15 Longitudinal data on coronary cath-eterisation and PCI have largely been derived from asingle centre.16 We therefore know relatively little aboutpatient selection, use of specific procedural technologiesand adjunctive therapies, and patient outcomes, includ-ing their variation over time and by site of care. Weknow even less about the influence of major Chinesehealth reforms and evolving standards for accreditationof physicians and hospitals that perform coronary cath-eterisation and PCI.17

To address these gaps in knowledge and as a prelude tonational quality improvement efforts, we have leveragedthe China PEACE (Patient-centered Evaluative Assessmentof Cardiac Events) research network to perform the ChinaPEACE Retrospective Study of Coronary Catheterisationand Percutaneous Coronary Intervention (ChinaPEACE-Retrospective CathPCI Study). China PEACE is acollaborative effort among the China National Center forCardiovascular Diseases (NCCD); the Yale-New HavenHospital Center for Outcomes Research and Evaluation;the Chinese government; and a national network ofChinese hospitals (figure 1). The goal of the network is togenerate new knowledge relevant to practice and policyand to translate this knowledge into action to improve careand outcomes for patients with cardiovascular disease.The China PEACE-Retrospective CathPCI Study will

examine a nationally representative sample of almost12 000 patients who underwent coronary catheterisation orPCI from 55 Chinese hospitals during 2001, 2006 and 2011.This approach will permit the study of care patterns andoutcomes across hospitals, regions and time during adynamic period of healthcare reform. The study is largely

descriptive, and rather than test a specific hypothesis,seeks to provide a foundation for future quality improve-ment and research. Specific aims of the ChinaPEACE-Retrospective CathPCI Study are: (1) to describethe characteristics of patients undergoing coronary cath-eterisation or PCI in China including their demographic,socioeconomic and clinical attributes; (2) to characterisepatterns of treatment including the use of procedural tech-nologies and adjunctive therapies; (3) to describein-hospital outcomes such as mortality, treatment complica-tions, length of stay and hospital charges; (4) to characterisedifferences in treatment and outcomes by patient character-istics, hospital, region and year of study and (5) to examineadherence to quality measures for PCI. Research findingswill be shared with study hospitals and the Chinese govern-ment to improve the selection of patients for these proce-dures and their associated outcomes. In this paper, wedescribe study methodology, abstracted data elements,planned statistical analyses and initial enrolment of sites.

METHODS AND ANALYSISDesign overviewWe defined our study cohort based only on in-hospitalcoronary catheterisations, as these procedures are notcommonly performed on an outpatient basis in China.We included patients undergoing coronary catheterisa-tion for any indication. We sampled eligible hospitalisa-tions for 2001, 2006 and 2011 from a network ofnationally representative hospitals. We chose these threetime periods to reflect the influence of major changesin the Chinese healthcare system and the creation ofPCI guidelines by Chinese medical societies (figure 2).

Figure 1 The China PEACEinitiative. Key partners include theChinese government,collaborating hospitals, the ChinaNational Center forCardiovascular Diseases and theYale-New Haven Hospital Centerfor Outcomes Research andEvaluation. The ChinaPEACE-Retrospective CathPCIStudy is one of five initial studiesfrom the China PEACE initiative.The topic areas for these fiveprojects concern acutemyocardial infarction, coronarycatheterisation/percutaneouscoronary intervention andmultivessel coronary arterydisease. Future studies will focuson cerebrovascular disease andother cardiovascular conditions.3VD, triple-vessel coronary arterydisease; AMI, acute myocardialinfarction; PCI, percutaneouscoronary intervention.

2 Li J, Dharmarajan K, Li X, et al. BMJ Open 2014;4:e004595. doi:10.1136/bmjopen-2013-004595

Open Access


http://bmjopen.bmj.com/http://group.bmj.com

To study 10-year trends in patient characteristics, treat-ment patterns and outcomes nationally and withinregions of different socioeconomic development, wedrew a representative, stratified sample of patient dis-charges for each year. We intentionally drew a largersample for 2011 to obtain more precise estimates of thecurrent performance and variation in treatment patternsand outcomes among hospitals.The central ethics committee at the China NCCD

approved the China PEACE-Retrospective CathPCI Study.All collaborating hospitals accepted the central ethicsapproval except for five hospitals, which obtained localapproval by internal ethics committees. The study is regis-tered at http://www.clinicaltrials.gov (NCT01624896).The Chinese government, which provided financial

support for the study, had no role in its design orconduct; in the collection, management, analysis andinterpretation of the data; or in the preparation orapproval of the manuscript.

Sampling designWe chose hospitals to reflect the diverse sites of care thatperform coronary catheterisation and PCI. Candidate hos-pitals were limited to urban areas, as catheterisation cap-ability is restricted almost exclusively to these regions. Weidentified urban areas using official administrative divi-sions, in which a region is considered urban if it is part ofa downtown or suburban area within a direct-controlledmunicipality (Beijing, Tianjin, Shanghai and Chongqing)or 1 of 283 prefectural-level cities. In total, MainlandChina is composed of 287 urban regions. As financial andmedical resources are not identical throughout MainlandChina, we separately identified hospitals in each of itsthree official economical-geographical regions, that is,Eastern, Central and Western. As Central and Western

urban regions have similar per capita income and healthservices capacity, we combined Central and Westernregions into one stratum.18 We then identified hospitalsseparately for two study strata: Eastern-urban and Central/Western-urban.We identified cases for study inclusion using a stratified

two-stage cluster sampling design (figure 3). In the firststage, we identified hospitals using a simple random sam-pling procedure in each stratum. The sampling frame-work consisted of the highest-level hospitals in each ofthe predefined urban regions with the potential capabil-ity of performing PCI (833 hospitals in 287 urbanregions). Hospital level is officially defined by theChinese government based on clinical resource capacity,for example, secondary hospitals have at least 100inpatient beds and the capacity to provide acute medicalcare and preventive care services to populations of atleast 100 000, while tertiary hospitals are large referralcentres in provincial capitals and major cities.15 19 Weexcluded military hospitals, prison hospitals, specialisedhospitals without a cardiovascular disease division, andtraditional Chinese medicine hospitals. We selected rep-resentative hospitals from 2011 to reflect current prac-tices and traced this same hospital cohort backwards to2006 and 2001 to describe temporal trends. As hospitalnumbers have grown by approximately 18% over the pastdecade,20 21 the cohort should be most representative ofnational treatment patterns and outcomes in 2011.In the second stage, we drew cases based on the local

hospital database for patients who underwent coronarycatheterisation or PCI at each sampled hospital using sys-tematic random sampling procedures. For each stratum,we determined the sample size required to achieve a1.5% precision for describing the percentage of patientsexperiencing in-hospital complications, which we

Figure 2 Chinese trends in PCIvolume from 2001 to 2011.Figure demonstrates the increasein PCI volume by year and theincrease in the number ofhospitals performing >100 PCIsper year. Notable events pertinentto the expansion in PCI accesswith time are highlighted belowthe graph. In 2003, the RuralCooperative Medical Care Systemexpanded health insurance tolow-income rural residents. Thehealthcare reform of 2007substantially expanded healthspending for the rural and urbanpopulation. We sampled eligiblehospitalisations for 2001, 2006and 2011. PCI, percutaneouscoronary intervention.


Open Access


http://www.clinicaltrials.govhttp://bmjopen.bmj.com/http://group.bmj.com

estimated at 5%.9 22–25 To achieve a precision of 1.5%with an α of 0.05 in each stratum, assuming an intraclasscorrelation of 0.02 and design effect of 2.2, we wouldneed to sample 1750 records among hospitals with anaverage cluster size of 60. This cluster size appeared rea-sonable based on national administrative data26 and ourprevious survey of treatment for acute coronary syn-dromes at more than 1000 hospitals in 2010, whichdemonstrated that the median annual PCI volume wasapproximately 300 cases. Assuming a participation rateof 85% among selected hospitals, we approached 35 hos-pitals for participation in each stratum, for a total of 70hospitals. We doubled cluster sizes for 2011 to improveprecision in the description of hospital-level treatmentpatterns and outcomes. Consequently, the total expectedsample volume with the above assumptions was approxi-mately 3500 cases in 2001, 3500 cases in 2006 and 7000

cases in 2011. A more detailed description of the sam-pling strategy is provided in the supplemental materialwithin the online web appendix.

Data collectionWe trained staff at participating hospitals to identify allhospitalisations with coronary catheterisation or PCI pro-cedures from their respective local hospital databases for2001, 2006 and 2011. After we sampled cases at eachhospital, we assigned each case a unique study ID. Wethen required local investigators to obtain the originalrecord and transmit a scanned copy to the coordinatingcentre. To facilitate this process, the coordinating centreprovided each study site with a high-speed scanner. Toverify compliance with the case-finding strategy, researchstaff from the coordinating centre visited 60% of thesites to repeat the case-finding process, confirm that the

Figure 3 The ChinaPEACE-Retrospective CathPCIStudy flow chart and associatedquality assurance strategies. Theflow chart should be read fromtop to bottom. CRF, case reportform; Q & A, questions andanswers.


Open Access



list of hospitalisations undergoing coronary catheterisa-tion or PCI was complete, and assist in acquiring thesampled cases (figure 3). We chose to visit study sitesthat were expected to contribute a large volume of casesand have potential difficulties in complying with thecase-finding strategy. These sites provided 73% ofsampled cases.Following receipt of the scanned record, research staff at

the China NCCD ensured the completeness and qualitywith which each medical record was copied. We requiredincomplete or poorly scanned records to be rescannedand retransmitted (figure 3). We instructed study sites toinclude all parts of the medical record, including the facesheet, admission note, daily progress notes, procedurenotes, medication administration record, diagnostic pro-cedure reports, laboratory test results, physician orders,nursing notes and discharge summary.The China PEACE-Retrospective CathPCI Study

adhered to rigorous standards for abstraction. Before initi-ating the chart review, each abstractor received 2 weeks oftraining that included an introduction to the study, coron-ary heart disease and its subtypes, components of theinpatient medical record including specialised sectionssuch as catheterisation reports, and the ChinaPEACE-Retrospective CathPCI Study data dictionary. Weprovided all material, including the data dictionary, inChinese. After training, we certified individuals who wereable to abstract five sample medical records with greaterthan 98% accuracy. Inexperienced abstractors began withexclusively typewritten rather than handwritten medicalrecords. In addition, we randomly audited approximately5% of the abstracted records. If the records were notabstracted with 98% accuracy, all medical records in theaudited batch were considered unqualified and werere-reviewed by a different abstractor. Abstractors wererequired to maintain this benchmark of 98% accuracy toretain certification. We used abstractors with formalmedical training to identify data elements requiring moreadvanced medical knowledge, such as the development ofpostprocedural complications including bleeding orcardiac tamponade. A physician was always present in theroom with abstractors or was available online to answerquestions as they arose. We assigned medical recordsbelonging to the same hospital and year to a broad groupof reviewers to avoid potential residual disparities inquality among abstractors.

Data managementWe systematically perform ongoing data cleaning. Datamanagers regularly query data for invalid and illogicalvalues as well as for duplicate record entries. They iden-tify potential invalid values by searching for outliers incontinuous data distributions. Records with identicalstudy identification numbers, hospital identificationnumbers, medical record identification numbers anddates of discharge trigger a search for duplicate records.Once a data query is made, concerns are resolved aftertracing and reviewing the relevant records.

All data have been treated as protected health infor-mation and are thus securely stored in an encrypted andpassword protected database at the main coordinatingcentre.

Data elementsWe examined the English language and Chinese literaturefor relevant studies to create a list of candidate variables.We supplemented these elements with variables used inthe CathPCI Registry of the American College ofCardiology National Cardiovascular Data Registry (NCDR).CathPCI is an outcome-based registry and quality improve-ment programme that focuses on patients who undergocoronary catheterisation and PCI in the USA.Incorporating variables from CathPCI will permit cross-country comparisons in resource utilisation and adherenceto quality metrics. We also incorporated elements from thecase report form used in the China PEACE RetrospectiveStudy of Acute Myocardial Infarction27 (clinicaltrials.govidentifier NCT01624883) to permit comparison of hospita-lisations for acute myocardial infarction between these twoChina PEACE studies. Major categories of data elementsare described in table 1.In table 2, we show data relevant to performance mea-

sures during the first 24 h of hospitalisation and at hos-pital discharge for patients with acute myocardialinfarction and those undergoing PCI for stable coronaryartery disease.Where possible, we collected data that would allow us to

construct the core quality measures for acute myocardialinfarction used and reported by the Centers for Medicare& Medicaid Services in the USA as well as the quality mea-sures for PCI from the NCDR.28 Two physician investiga-tors at each participating hospital also completed a survey,modelled on the annual survey of hospitals performed bythe American Hospital Association, of its major structuraland organisational characteristics during the studyperiod.29 Key variables assessed include bed size, teachingstatus and capability of performing coronary artery bypassgraft surgery.

Statistical analysesWe will report summary statistics for patient character-istics, use of diagnostic tests, treatments received andin-hospital outcomes, including complications of careand hospitalisation costs across study sites. Weighting willreflect the reciprocal of sampling probability. For eachaim, we will use standard parametric and non-parametrictechniques for observational data, including t tests, χ2

tests, Wilcoxon rank sum tests and generalised linearmodels. Because patient characteristics, treatments andoutcomes may be correlated within hospitals, analyseswill account for the effect of clustering. To examine andadjust for differences between comparison groups, wewill use linear, logistic, Cox proportional hazard andPoisson models with a generalised estimating equationapproach and hierarchical models, where appropriate.We will develop models to stratify patients according to


Open Access



their risk of adverse outcomes. We will assess the rela-tionship of candidate variables to in-hospital outcomesusing appropriate statistical techniques for the depend-ent variable. We will further refine the list of candidatevariables based on their clinical relevance.

Progress to dateAs of December 2012, 55 hospitals agreed to participatein the study. Fifteen hospitals did not participatebecause they did not provide inpatient services for cor-onary heart disease (5 hospitals), were incapable of per-forming coronary catheterisation and PCI throughoutthe study period (8 hospitals), or refused to participate(2 hospitals). Of the 55 participating hospitals, 29 werelocated in the Eastern economical-geographical stratumand 26 were located in the Central/Western economical-

geographical stratum. The distribution of sites by prov-ince and region is shown in figure 4.In parallel with national trends, the number of hospi-

tals providing cases increased with each subsequent yearof study. In 2001, 26 of the 55 participating hospitalswere capable of performing PCI, of which 24 submittedmedical records. Of the two hospitals that did notsubmit records, one did not keep records in 2001 andthe other had its records destroyed by a fire. Both ofthese institutions most likely had a very limited capacityfor PCI in 2001, as evidenced by their performance ofonly 16 and 28 respective cases of coronary catheterisa-tion or PCI in 2006. A total of 44 hospitals performedPCI in 2006, all of which submitted records to the study.

Table 2 China PEACE-Retrospective CathPCI Studyperformance measures

First 24 h Discharge

Aspirin Aspirin*Time to primaryPCI

Thienopyridine*

Time tofibrinolysis

β blocker

ACE inhibitor or ARB for LV systolicdysfunctionStatin*Smoking cessation counsellingCardiac rehabilitation referral

All performance measures apply to patients with acute myocardialinfarction. Performance measures with asterisks also apply topatients undergoing PCI for stable coronary artery disease.ARB, angiotensin receptor blocker; LV, left ventricle; PCI,percutaneous coronary intervention.

Table 1 China PEACE-Retrospective CathPCI Study data elements

Category Example elements

Patient demographics Age, sex, ethnicity, postal code, occupation and insurance statusMedical history Diabetes, hypertension, hyperlipidaemia, vascular disease and prior revascularisationInitial cardiac status Heart rate, blood pressure, Killip class, heart failure and cardiac arrestLab values Troponin, CK, CK-MB, BNP, sodium, BUN, creatinine, WBC count and haemoglobinDiagnostic procedures Coronary catheterisation, echocardiogram, CT angiogram, stress testing and chest

radiographMedications including dose Antiplatelet therapy, anticoagulant therapy, beta blocker, ACE inhibitor/ARB, statin, and

traditional Chinese medicinesAuxiliary imaging Intravascular ultrasound and fractionated-flow reserveCoronary flow dynamics Preprocedural TIMI flow and postprocedural TIMI flowRevascularisation Fibrinolysis, PCI (access, coronary anatomy, bypass graft anatomy, stent number, stent

type, stent length, contrast dose and closure device) and CABG surgeryMechanical support Intra-aortic balloon pump, left ventricular assist device and ECMOOutcomes including in-hospitalcomplications

Death, myocardial infarction, heart failure, shock, arrhythmia, stroke, bleeding,transfusion, infection, coronary perforation and coronary dissection

ARB, angiotensin receptor blocker; BNP, brain natriuretic peptide; BUN, blood urea nitrogen; CABG, coronary artery bypass graft; CK,creatine kinase; ECMO, extracorporeal membrane oxygenation; PCI, percutaneous coronary intervention; TIMI, thrombolysis in myocardialinfarction; WBC, white blood cell.

Figure 4 Geographical distribution of participating hospitalsin the China PEACE-Retrospective CathPCI Study. Of the 70sampled hospitals, 15 were unable or unwilling to participateand 55 provided cases for the study.


Open Access



Fifty-four hospitals performed catheterisation and PCI in2011. As with 2006, all hospitals that performed PCI in2011 submitted records.We collected all medical records for abstraction by

December 2012. The examination of census databasesfrom participating hospitals yielded 58 008 hospitalisa-tions for coronary catheterisation and PCI (3270 in 2001,12 875 in 2006 and 41 863 in 2011). Of these 58 008 hos-pitalisations, we sampled 12 477 (22%; 1444 (44%) in2001, 3046 (24%) in 2006 and 7987 (19%) in 2011). Ofthese 12 477 sampled hospitalisations, we acquiredmedical records for 11 900 (95%); 577 (5%) medicalrecords could not be found due to poor archiving. Webegan data abstraction of these medical records in March2013 and expect abstraction to be completed in January2014.

DISCUSSIONThrough the use of a national research network, theChina PEACE-Retrospective CathPCI Study is developinga repository of data that describes the current and formeruse of coronary catheterisation and PCI in China. Thisproject will provide answers to questions about contem-porary practice patterns including variation among insti-tutions and temporal trends in procedure use andadjunctive therapy. To elevate the quality of abstracteddata, the study uses data collection techniques regularlyemployed by international clinical trials such as inte-grated central and on-site monitoring as well as sourcedocument checking. The China PEACE-RetrospectiveCathPCI Study also elicits the active participation of hos-pitals across China to ensure that study results dissemin-ate broadly for the purpose of quality improvement.Findings will be shared with government to help researchfindings inform policy. The study is designed to guide theefficient allocation and high-quality use of advanced car-diovascular interventions in the context of a rapidlygrowing cardiovascular disease burden and dynamicallychanging healthcare system.The China PEACE-Retrospective CathPCI Study falls

under the larger China PEACE effort, which aims tocreate a national research network dedicated to improv-ing cardiovascular outcomes. China PEACE is built on aplatform of collaboration and coordination betweenclinicians, researchers and policymakers. With thisframework in mind, study sites do not merely transmitinformation to the coordinating centre, but are full part-ners and consumers of the knowledge generated. In thisway, China PEACE has similarities to the NCDR CathPCIRegistry of the American College of Cardiology, whichprovides participating hospitals with regular perform-ance reports, including analysis of process measures andin-hospital outcomes.The Chinese government, a partner in China PEACE,

will use study results to develop policies intended tostrengthen the clinical performance of the hospitals.The goal is not simply to identify poor performing

institutions, but to use a shared learning approach toelevate care delivery at all participating hospitals andproduce knowledge that is broadly applicable across sitesof care, including those external to the China PEACEnetwork. In the future, we hope to directly involvepatients and caregivers in designing study questions anddisseminating findings.We anticipate that the results of the China

PEACE-Retrospective CathPCI study will illuminate theeffects of recent healthcare reforms in China on the useof coronary catheterisation and PCI. Although China hasadopted policies to enhance quality of care and dissemin-ation of novel technologies over the past decades,17 theyhave been applied differentially across the country.26

After the first PCI was performed in China in 1985,5

there followed a period of unregulated dissemination.30 31

In 2000, most patients paid for PCI themselves, and therewas widespread variation in access to the technology.6 7

Access was subsequently improved in 2003 with the imple-mentation of the Rural Cooperative Medical CareScheme that expanded insurance access to the low-income rural population. This government initiative wasfollowed by additional healthcare reforms in the latterhalf of the decade that further expanded insurancesupport for rural and urban residents.6 7 In this context,the Ministry of Health established processes for accredit-ation of interventional centres in 2007 to promoteminimal quality standards for PCI.17 Through our nation-ally representative and multiyear sample of catheterisa-tion and PCI, we will have the capacity to evaluate thetemporal influence of these policies on practice patternsand their variability by hospital and region. We may iden-tify signals of potentially inefficient allocation ofresources such as the use of drug-eluting stents in situa-tions where bare-metal stents are similarly efficacious.Results may prove useful to future policymaking andguideline development.We also expect that the knowledge generated from the

China PEACE-Retrospective CathPCI Study will be usefulinternationally. Many low-income and middle-incomecountries are undergoing a similar epidemiological transi-tion and experiencing comparable challenges associatedwith a growing number of persons with chronic cardiovas-cular disease and rapidly rising healthcare costs in thesetting of limited healthcare resources.32 The experiencewith China PEACE may help guide other countries intheir desire to learn about trajectories and variation in theuse of novel health technologies. Developed nations arealso facing common challenges around healthcare reformand the optimal utilisation of advanced interventions.33

The development of novel approaches to care in Chinamay have relevance for more wealthy countries that aregrappling with escalating costs and trying to determinewhether reduction in resource expenditures can beachieved without compromising patient outcomes.The China PEACE-Retrospective CathPCI Study is dis-

tinguished from many retrospective analyses by its use ofdata quality control strategies that are common in the


Open Access



performance of multicentre clinical trials. The study hasdevoted significant attention to data quality at multiplestages, including case ascertainment, data abstractionand data management. For example, research staffvisited study sites to identify all hospitalisations involvingcoronary catheterisation or PCI from local hospital data-bases and physically found all medical records forsampled cases whenever possible. In addition, all abstrac-tors underwent standardised training at the coordinatingcentre and continued to maintain high standards foraccuracy to remain certified. Medical records reviewedby abstractors who fail to meet continuing recertificationrequirements are always reabstracted. These and otherquality control and assurance strategies are the result ofthe NCCD’s previous experience in conducting cardio-vascular clinical trials in China.This study has some limitations, including those inher-

ent to its retrospective design. Findings depend on theaccuracy and completeness of the medical records, andthe abstraction process. However, these limitations wouldapply to all retrospective studies. Moreover, the identifica-tion of poor documentation of key variables is crucial tofuture quality improvement measurements. Our study isnot designed to track outcomes following hospitalisationor the experience of patients. These variables, however,will be collected in the recently launched ProspectiveStudy of PCI from the China PEACE platform. Finally, inour sampled hospital cohort, catheterisation and PCIvolume were smaller than expected for the year 2001, inparticular, as the number of hospitals capable of perform-ing PCI and the PCI volume per centre were relativelylow. However, the sample remains nationally representa-tive in the last year and can still provide acceptable preci-sion in describing 10-year trends (supplemental materialwithin the online web appendix).The China PEACE-Retrospective CathPCI Study, one of

the first studies to be launched from the China PEACEplatform, seeks to assess the characteristics, treatmentsand outcomes of patients who receive diagnostic catheter-isation and PCI in a large, nationally representativesample of hospitals in China. It provides a unique oppor-tunity to compare variation in care and to assess trajector-ies in practice in the context of an era of rapid adoptionof new cardiovascular technologies and constrainedhealthcare resources. Findings are intended to guide themore efficient use of coronary catheterisation and PCI ina manner that improves health outcomes across diversegeographical settings and sites of care within China.

DisseminationThe Chinese government, which provided financialsupport for the study, had no role in its design orconduct; in the collection, management, analysis andinterpretation of the data; or in the preparation orapproval of this manuscript.Study findings will be shared freely with participating

hospitals and the Chinese government. To improvehealthcare quality, data will be presented in the format

of regular performance reports that include analysis ofprocess measures and in-hospital outcomes. Findingswill also be disseminated via peer-reviewed publications.Requests for collaboration will be welcomed.

Author affiliations1National Clinical Research Center of Cardiovascular Diseases, State KeyLaboratory of Cardiovascular Disease, Fuwai Hospital, National Center forCardiovascular Diseases, Chinese Academy of Medical Sciences and PekingUnion Medical College, Beijing, People’s Republic of China2Center for Outcomes Research and Evaluation, Yale-New Haven Hospital,New Haven, Connecticut, USA3Division of Cardiology, Columbia University Medical Center, New York,New York, USA4Department of Biostatistics, Harvard School of Public Health, Boston,Massachusetts, USA5Department of Health Care Policy, Harvard Medical School, Boston,Massachusetts, USA6Section of Cardiovascular Medicine and the Robert Wood Johnson ClinicalScholars Program, Department of Internal Medicine, Yale University School ofMedicine, New Haven, Connecticut, USA7Department of Health Policy and Management, Yale School of Public Health,New Haven, Connecticut, USA

Acknowledgements The authors appreciate the multiple contributions madeby study teams at the China Oxford Centre for International Health Researchand the Yale-New Haven Hospital Center for Outcomes Research andEvaluation in the realms of study design and operations. They are grateful forthe support provided by the Chinese government.

Contributors JL and KD made substantial contributions to study conceptionand design and to the drafting and critical revision of the manuscript forimportant intellectual content. XL, ZL and S-LTN made substantialcontributions to the study conception and design and critical revision of themanuscript for important intellectual content. HMK and LJ made substantialcontributions to study conception and design, drafting and critical revision ofthe manuscript for important intellectual content, and provided administrative,technical and material support, including study supervision.

Funding This project was partly supported by the Research Special Fund forPublic Welfare Industry of Health (201202025) from National Health andFamily Planning Commission of China, and the International Science &Technology Cooperation Program (2010DFB33140) from the Ministry ofScience and Technology of China. At the time this study was initiated, Dr.Dharmarajan was supported by grant HL007854 from the National Heart,Lung, and Blood Institute; he was also supported as a Centers of ExcellenceScholar in Geriatric Medicine at Yale by the John A. Hartford Foundation andthe American Federation for Aging Research. HMK is supported by grant U01HL105270-03 (Center for Cardiovascular Outcomes Research at YaleUniversity) from the National Heart, Lung, and Blood Institute.

Competing interests HMK reports being the recipient of research grants fromMedtronic and from Johnson & Johnson, through Yale University, to developmethods of clinical trial data sharing, and the chair of a cardiac scientificadvisory board for UnitedHealth.

Ethics approval The central ethics committee at the China National Center forCardiovascular Diseases (NCCD) approved the China PEACE-Retrospective-CathPCI Study. All collaborating hospitals accepted the central ethics approvalexcept for five hospitals, which obtained the local approval from internal ethicscommittees. The study is registered at http://www.clinicaltrials.gov(NCT01624896).

Provenance and peer review Not commissioned; externally peer reviewed.

Open Access This is an Open Access article distributed in accordance withthe Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license,which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, providedthe original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/


Open Access


http://www.clinicaltrials.govhttp://creativecommons.org/licenses/by-nc/3.0/http://creativecommons.org/licenses/by-nc/3.0/http://bmjopen.bmj.com/http://group.bmj.com

REFERENCES1. He J, Gu D, Wu X, et al. Major causes of death among men and

women in China. N Engl J Med 2005;353:1124–34.2. Moran A, Gu D, Zhao D, et al. Future cardiovascular disease in

China: Markov model and risk factor scenario projections from thecoronary heart disease policy model-China. Circ Cardiovasc QualOutcomes 2010;3:243–52.

3. Yang G, Kong L, Zhao W, et al. Emergence of chronicnon-communicable diseases in China. Lancet 2008;372:1697–705.

4. Gao R. The development of percutaneous cardiovascularintervention in China. http://www.cmt.com.cn/detail/39179.html(accessed 17 Sep 2013).

5. Gao R. Current status of percutaneous coronary intervention inChina. Heart 2010;96:415–18.

6. Cao Q, Shi L, Wang H, et al. Report from China: health insurance inChina—evolution, current status, and challenges. Int J Health Serv2012;42:177–95.

7. Hu S, Tang S, Liu Y, et al. Reform of how health care is paid for inChina: challenges and opportunities. Lancet 2008;372:1846–53.

8. Lozano R, Naghavi M, Foreman K, et al. Global and regionalmortality from 235 causes of death for 20 age groups in 1990 and2010: a systematic analysis for the Global Burden of Disease Study2010. Lancet 2012;380:2095–128.

9. Section of Interventional Cardiology, Chinese Society of Cardiology.A data analysis of the third national coronary intervention registry.Chin J Cardiol 2002;30:719–23.

10. Lu SZ, Song XT, Chen YD, et al. Findings from registry ofpercutaneous coronary intervention in inland of China. ZhonghuaXin Xue Guan Bing Za Zhi 2009;37:26–9.

11. Lu SZ, Song XT, Chen YD, et al. Beyond the numerals: primaryreports from Registry of PCI In China (ROPIC). Zhonghua Xin XueGuan Bing Za Zhi 2006;34:966–70.

12. Yuan F, Song XT, Lu SZ. Percutaneous coronary intervention inmainland China in 2008: register results. Zhonghua Xin Xue GuanBing Za Zhi 2010;38:629–32.

13. Song XT, Du MY, Yuan F, et al. Cost-utility analysis of percutaneouscoronary intervention in 13 cities of China. Zhonghua Xin Xue GuanBing Za Zhi 2010;38:484–7.

14. Yu LT, Zhu J, Mister R, et al. The Chinese registry on reperfusionstrategies and outcomes in ST-elevation myocardial infarction.Zhonghua Xin Xue Guan Bing Za Zhi 2006;34:593–7.

15. Gao R, Patel A, Gao W, et al. Prospective observational study ofacute coronary syndromes in China: practice patterns and outcomes.Heart 2008;94:554–60.

16. Liu SW, Xu B, Chen J, et al. Trends in in-hospital outcome afterpercutaneous coronary intervention in the drug-eluting stents era.Clin Cardiol 2010;33:516–21.

17. Ministry of Health of the People’s Republic of China. Regulationabout cardiovascular interventional techniques 2007. http://www.moh.gov.cn/mohbgt/pw10712/200804/18725.shtml (accessed 17Sep 2013).

18. National Bureau of Statistics of China. 2010 China statisticalyearbook. http://www.stats.gov.cn/tjsj/ndsj/2010/indexeh.htm(accessed 17 Sep 2013).

19. Ministry of Health of the People’s Republic of China.The performance evaluation standards for general hospitals(revised version). http://www.moh.gov.cn/cmsresources/mohbgt/cmsrsdocument/doc6535.pdf (accessed 17 Sep 2013).

20. Ministry of Health of the People’s Republic of China. China publichealth statistical yearbook 2003. Beijing: Peking Union MedicalCollege Publishing House, 2003.

21. Ministry of Health of the People’s Republic of China. China publichealth statistical yearbook 2012. Beijing: Peking Union MedicalCollege Publishing House, 2012.

22. Venkitachalam L, Kip KE, Selzer F, et al. Twenty-year evolution ofpercutaneous coronary intervention and its impact on clinicaloutcomes: a report from the National Heart, Lung, and BloodInstitute–sponsored, multicenter 1985–1986 PTCA and 1997–2006dynamic registries. Circ Cardiovasc Interv 2009;2:6–13.

23. Li Y, Li CX, Wang HC, et al. Efficacy and safety of Firebirdsirolimus-eluting stent in treatment of complex coronary lesions inChinese patients: one-year clinical and eight-month angiographicoutcomes from the FIREMAN registry. Chin Med J 2011;124:817–24.

24. Koh A, Khin L, Choi L, et al. Percutaneous coronary intervention inAsians- are there differences in clinical outcome? BMC CardiovascDisord 2011;11:22.

25. Chinese PLA Cardiology Society. Analysis of the third (from 2003 to2004) PLA coronary intervention therapy registry. Med J ChinPeople’s Liberation Army 2006;31:60–4.

26. Huo Y. Current status and development of percutaneous coronaryintervention in China. J Zhejiang Univ Sci B 2010;11:631–3.

27. Dharmarajan K, Li J, Li X, et al. The China Patient-CenteredEvaluative Assessment of Cardiac Events (China PEACE)retrospective study of acute myocardial infarction: study design. CircCardiovasc Qual Outcomes 2013;6:732–40.

28. National Cardiovascular Data Registry. NCDR quality metrics andmeasures. https://www.ncdr.com/WebNCDR/home/metrics-and-measures (accessed 17 Sep 2013).

29. American Hospital Association. AHA annual survey database fiscalyear 2011. http://www.ahadataviewer.com/book-cd-products/aha-survey/ (accessed 17 Sep 2013).

30. Chinese Society of Cardiology, Chinese Society of CardiologyEditorial Board. 2002 Chinese guideline for percutaneouscoronary intervention. Zhonghua Xin Xue Guan Bing Za Zhi2002;30:707–18.

31. Chinese Society of Cardiology, Chinese Society of Cardiology EditorialBoard. 2009 Chinese guideline for percutaneous coronary intervention.Zhonghua Xin Xue Guan Bing Za Zhi 2009;37:4–25.

32. Nugent R. Chronic diseases in developing countries: health andeconomic burdens. Ann N Y Acad Sci 2008;1136:70–9.

33. Blumenthal D, Dixon J. Health-care reforms in the USA andEngland: areas for useful learning. Lancet 2012;380:1352–7.


Open Access


http://www.cmt.com.cn/detail/39179.htmlhttp://www.moh.gov.cn/mohbgt/pw10712/200804/18725.shtmlhttp://www.moh.gov.cn/mohbgt/pw10712/200804/18725.shtmlhttp://www.stats.gov.cn/tjsj/ndsj/2010/indexeh.htmhttp://www.moh.gov.cn/cmsresources/mohbgt/cmsrsdocument/doc6535.pdfhttp://www.moh.gov.cn/cmsresources/mohbgt/cmsrsdocument/doc6535.pdfhttps://www.ncdr.com/WebNCDR/home/metrics-and-measureshttps://www.ncdr.com/WebNCDR/home/metrics-and-measureshttps://www.ncdr.com/WebNCDR/home/metrics-and-measureshttp://www.ahadataviewer.com/book-cd-products/aha-survey/http://www.ahadataviewer.com/book-cd-products/aha-survey/http://www.ahadataviewer.com/book-cd-products/aha-survey/http://www.ahadataviewer.com/book-cd-products/aha-survey/http://www.ahadataviewer.com/book-cd-products/aha-survey/http://bmjopen.bmj.com/http://group.bmj.com

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

GroupHarlan M Krumholz, Lixin Jiang and for the China PEACE Collaborative Jing Li, Kumar Dharmarajan, Xi Li, Zhenqiu Lin, Sharon-Lise T Normand,

doi: 10.1136/bmjopen-2013-0045952014 4: BMJ Open

http://bmjopen.bmj.com/content/4/3/e004595Updated information and services can be found at:

MaterialSupplementary

595.DC1.htmlhttp://bmjopen.bmj.com/content/suppl/2014/03/07/bmjopen-2013-004Supplementary material can be found at:

These include:

References #BIBLhttp://bmjopen.bmj.com/content/4/3/e004595

This article cites 25 articles, 5 of which you can access for free at:

Open Access

http://creativecommons.org/licenses/by-nc/3.0/non-commercial. See: provided the original work is properly cited and the use isnon-commercially, and license their derivative works on different terms, permits others to distribute, remix, adapt, build upon this workCommons Attribution Non Commercial (CC BY-NC 3.0) license, which This is an Open Access article distributed in accordance with the Creative

serviceEmail alerting

box at the top right corner of the online article. Receive free email alerts when new articles cite this article. Sign up in the

CollectionsTopic Articles on similar topics can be found in the following collections

(856)Epidemiology (339)Cardiovascular medicine

Notes

http://group.bmj.com/group/rights-licensing/permissionsTo request permissions go to:

http://journals.bmj.com/cgi/reprintformTo order reprints go to:

http://group.bmj.com/subscribe/To subscribe to BMJ go to:


http://bmjopen.bmj.com/content/4/3/e004595http://bmjopen.bmj.com/content/suppl/2014/03/07/bmjopen-2013-004595.DC1.htmlhttp://bmjopen.bmj.com/content/suppl/2014/03/07/bmjopen-2013-004595.DC1.htmlhttp://bmjopen.bmj.com/content/4/3/e004595#BIBLhttp://creativecommons.org/licenses/by-nc/3.0/http://bmjopen.bmj.com//cgi/collection/bmj_open_cardiovascular_medicinehttp://bmjopen.bmj.com//cgi/collection/bmj_open_epidemiologyhttp://group.bmj.com/group/rights-licensing/permissionshttp://journals.bmj.com/cgi/reprintformhttp://group.bmj.com/subscribe/http://bmjopen.bmj.com/http://group.bmj.com

Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary interventionAbstractIntroductionMethods and analysisDesign overviewSampling designData collectionData managementData elementsStatistical analysesProgress to date

DiscussionDissemination

References

downloaded from on november 11 ...sorana.academicdirect.ro/pages/doc/pc2/protocol-cohorta...received...

Documents