bmj open€¦ · research, fuwai hospital, national center for cardiovascular diseases, chinese...

For peer review only

Protocol for the China PEACE (Patient-centered Evaluative

Assessment of Cardiac Events) Retrospective Study of

Coronary Catheterization and Percutaneous Coronary

Intervention

Journal: BMJ Open

Manuscript ID: bmjopen-2013-004595

Article Type: Protocol

Date Submitted by the Author: 02-Dec-2013

Complete List of Authors: Li, Jing; Fuwai Hospital, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease Dharmarajan, Kumar; Yale-New Haven Hospital, Center for Outcomes Research and Evaluation; Columbia University Medical Center, Division of Cardiology Li, Xi; Fuwai Hospital, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease Lin, Zhenqiu; Yale-New Haven Hospital, Center for Outcomes Research and Evaluation Normand, Sharon-Lise; Harvard School of Public Health, Division of

Cardiology; Harvard Medical School, Department of Health Care Policy Krumholz, Harlan; Yale-New Haven Hospital, Center for Outcomes Research and Evaluation; Yale University School of Medicine, Department of Internal Medicine Jiang, Lixin; Fuwai Hospital, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease

<b>Primary Subject Heading</b>:

Cardiovascular medicine

Secondary Subject Heading: Epidemiology

Keywords: catheterization, angiography, angioplasty, Epidemiology < TROPICAL MEDICINE, China

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Protocol for the China PEACE (Patient-centered Evaluative Assessment of

Cardiac Events) Retrospective Study of Coronary Catheterization and

Percutaneous Coronary Intervention

Jing Li*, MD, PhDa; Kumar Dharmarajan*, MD, MBAb,c; Xi Li, MD, PhDa; Zhenqiu Lin, PhDb;

Sharon-Lise T. Normand, PhDd,e; Harlan M. Krumholz†, MD, SMb,f,g; Lixin Jiang†, MD, PhDa

(*joint first authors; †joint senior authors); for the China PEACE Collaborative Groupa,b

aState Key Laboratory of Cardiovascular Disease, China Oxford Centre for International Health

Research, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of

Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China;

bCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven,

Connecticut, United States; cDivision of Cardiology, Columbia University Medical Center, New

York, New York, United States; dDepartment of Biostatistics, Harvard School of Public Health,

Boston, Massachusetts, United States; eDepartment of Health Care Policy, Harvard Medical

School, Boston, Massachusetts, United States; fSection of Cardiovascular Medicine and the

Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale

University School of Medicine, New Haven, Connecticut, United States; gDepartment of Health

Policy and Management, Yale School of Public Health, New Haven, Connecticut, United States

Corresponding author. Professor Lixin Jiang, China Oxford Centre for International Health

Research, Fuwai Hospital, 167 Beilishi Road, Beijing 100037, People’s Republic of China; Tel:

+86 10 8839 6203; Fax: +86 10 8836 5201; Email: [email protected]

Keywords. catheterization, angiography, angioplasty, epidemiology, China

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Word count. 3,845 (main manuscript text excluding title page, abstract, acknowledgments,

contributor statement, competing interests statement, funding statement, ethical approval

statement, transparency statement, data sharing statement, references, figures, and tables)

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ABSTRACT

Introduction. 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 heath care system.

Methods and analysis. Using the China PEACE (Patient-centered Evaluative Assessment of

Cardiac Events) research network, the Retrospective Study of Coronary Catheterization and

Percutaneous Coronary Intervention (China PEACE-Retrospective CathPCI Study) will examine

a nationally representative sample of 11,900 patients who underwent coronary catheterization

or PCI at 55 Chinese hospitals during 2001, 2006, and 2011. We selected patients and study

sites using a 2-stage cluster sampling design with simple random sampling stratified within

economic-geographic strata. A central coordinating center 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 hospitalization. We will

additionally characterize variation in treatments and outcomes by patient characteristics,

hospital, region, and study year.

Ethics and dissemination. 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 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 both coronary catheterization and PCI in China.

Registration details. www.clinicaltrials.gov (NCT01624896).

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ARTICLE SUMMARY

Article focus

1. Study protocol for a retrospective observational study to examine the characteristics,

treatments, and outcomes of patients who receive diagnostic catheterization and

percutaneous coronary intervention (PCI) in China between 2001 and 2011.

Key messages

1. Although the overall volume of coronary catheterization and PCI procedures performed in

China is known, there are gaps in knowledge about the details of their use and associated

outcomes, including their variation over time and by site of care.

2. China PEACE is a collaborative effort of hospitals, academicians, and policy makers to

generate new knowledge relevant to practice and policy and to translate this knowledge into

action to improve care and outcomes for patients with cardiovascular disease in China.

3. The Retrospective Study of Coronary Catheterization and Percutaneous Coronary

Intervention leverages the China PEACE network to examine a nationally representative

sample of almost 12,000 patients who underwent coronary catheterization or PCI from 55

Chinese hospitals during 2001, 2006, and 2011.

Strengths and limitations of this study.

1. Hospitalizations were sampled from a nationally representative hospital network for the

years 2001, 2006, and 2011 to examine the influence of major changes in the Chinese

health care system and the creation of PCI guidelines by Chinese medical societies.

2. To elevate the quality of abstracted data, the study uses data collection techniques regularly

employed by international clinical trials such as integrated central and on-site monitoring as

well as source document checking.

3. Findings will be shared with hospitals and policy makers to improve health care quality.

4. Patient outcomes are limited to in-hospital outcomes, and data collection is limited to

information available in the medical record.

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INTRODUCTION

China, a country with a rapidly rising prevalence of cardiovascular disease,[1-3] is

concomitantly expanding access to advanced cardiovascular procedures. During the past

decade, the volume of percutaneous coronary intervention (PCI) has increased more than 20-

fold.[4, 5] This expansion has occurred in the context of rising rates of both health insurance

coverage and health care costs.[6, 7] The optimal deployment of advanced care strategies in

settings of constrained resources is a common challenge faced by many low- and middle-

income countries.[8]

Although the overall volume of coronary catheterization and PCI procedures performed

in China is known,[9-12] there are gaps in knowledge about the details of their use and

associated outcomes. Nationally representative data are lacking, and studies have generally

included only a small number of hospitals in circumscribed geographic areas or single time

periods.[5, 13-15] Longitudinal data on coronary catheterization and PCI have largely been

derived from a single center.[16] We therefore know relatively little about patient selection, use

of specific procedural technologies and adjunctive therapies, and patient outcomes, including

their variation over time and by site of care. We know even less about the influence of major

Chinese health reforms and evolving standards for accreditation of physicians and hospitals that

perform coronary catheterization and PCI.[17]

To address these gaps in knowledge and as a prelude to national quality improvement

efforts, we have leveraged the China PEACE (Patient-centered Evaluative Assessment of

Cardiac Events) research network to perform the China PEACE Retrospective Study of

Coronary Catheterization and Percutaneous Coronary Intervention (China PEACE-

Retrospective CathPCI Study). China PEACE is a collaborative effort between the China

National Center for Cardiovascular Diseases (NCCD); the Yale-New Haven Hospital Center for

Outcomes Research and Evaluation; the Chinese government; and a national network of

Chinese hospitals (Figure 1). The goal of the network is to generate new knowledge relevant to

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practice and policy and to translate this knowledge into action to improve care and outcomes for

patients with cardiovascular disease.

The China PEACE-Retrospective CathPCI Study will examine a nationally

representative sample of almost 12,000 patients who underwent coronary catheterization or PCI

from 55 Chinese hospitals during 2001, 2006, and 2011. This approach will permit the study of

care patterns and outcomes across hospitals, regions, and time during a dynamic period of

health care reform. The study is largely descriptive and rather than test a specific hypothesis

seeks to provide a foundation for future quality improvement and research. Specific aims of the

China PEACE-Retrospective CathPCI Study are: (1) to describe the characteristics of patients

undergoing coronary catheterization or PCI in China including their demographic,

socioeconomic, and clinical attributes; (2) to characterize patterns of treatment including the use

of procedural technologies and adjunctive therapies; (3) to describe in-hospital outcomes such

as mortality, treatment complications, length of stay, and hospital charges; (4) to characterize

differences in treatment and outcomes by patient characteristics, hospital, region, and year of

study; and (5) to examine adherence to quality measures for PCI. Research findings will be

shared with study hospitals and the Chinese government to improve both the selection of

patients for these procedures and their associated outcomes. In this paper, we describe study

methodology, abstracted data elements, planned statistical analyses, and initial enrollment of

sites.

METHODS AND ANALYSIS

Design Overview

We defined our study cohort based only on in-hospital coronary catheterizations, as

these procedures are not commonly performed on an outpatient basis in China. We included

patients undergoing coronary catheterization for any indication. We sampled eligible

hospitalizations for 2001, 2006, and 2011 from a network of nationally representative hospitals.

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We chose these 3 time periods to reflect the influence of major changes in the Chinese health

care system and the creation of PCI guidelines by Chinese medical societies (Figure 2).

To study 10-year trends in patient characteristics, treatment patterns, and outcomes

nationally and within regions of different socioeconomic development, we drew a representative,

stratified sample of patient discharges for each year. We intentionally drew a larger sample for

2011 to obtain more precise estimates of the current performance and variation in treatment

patterns and outcomes among hospitals.

The central ethics committee at the China NCCD approved the China PEACE-

Retrospective-CathPCI Study. All collaborating hospitals accepted the central ethics approval

except for 5 hospitals, which obtained local approval by internal ethics committees. The study is

registered at www.clinicaltrials.gov (NCT01624896).

The Chinese government, who provided financial support for the study, had no role in its

design or conduct; in the collection, management, analysis, and interpretation of the data; or in

the preparation or approval of the manuscript.

Sampling Design

We chose hospitals to reflect the diverse sites of care that perform coronary

catheterization and PCI. Candidate hospitals were limited to urban areas, as catheterization

capability is restricted almost exclusively to these regions. We identified urban areas using

official administrative divisions, in which a region is considered urban if it is part of a downtown

or suburban area within a direct-controlled municipality (Beijing, Tianjin, Shanghai, Chongqing)

or 1 of 283 prefectural-level cities. In total, Mainland China is composed of 287 urban regions.

As financial and medical resources are not identical throughout Mainland China, we separately

identified hospitals in each of its 3 official economic-geographic regions, i.e. Eastern, Central

and Western. As Central and Western urban regions have similar per capita income and health

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services capacity, we combined Central and Western regions into 1 stratum.[18] We then

identified hospitals separately for 2 study strata: Eastern-urban and Central/Western-urban.

We identified cases for study inclusion using a stratified 2-stage cluster sampling design

(Figure 3). In the first stage, we identified hospitals using a simple random sampling procedure

in each strata. The sampling framework consisted of the highest-level hospitals in each of the

predefined urban regions with the potential capability of performing PCI (833 hospitals in 287

urban regions). Hospital level is officially defined by the Chinese government based on clinical

resource capacity, e.g., secondary hospitals have at least 100 inpatient beds and the capacity to

provide acute medical care and preventive care services to populations of at least 100,000,

while tertiary hospitals are large referral centers in provincial capitals and major cities.[15, 19]

We excluded military hospitals, prison hospitals, specialized hospitals without a cardiovascular

disease division, and traditional Chinese medicine hospitals. We selected representative

hospitals from 2011 to reflect current practices and traced this same hospital cohort backward to

2006 and 2001 to describe temporal trends. As hospital number has grown by approximately

18% over the past decade,[20, 21] the cohort should be most representative of national

treatment patterns and outcomes in 2011.

In the second stage, we drew cases based on the local hospital database for patients

who underwent coronary catheterization or PCI at each sampled hospital using systematic

random sampling procedures. For each strata, we determined the sample size required to

achieve a 1.5% precision for describing the percentage of patients experiencing in-hospital

complications, which we estimated at 5%.[9, 22-25] To achieve a precision of 1.5% with an α of

0.05 in each stratum, assuming an intraclass correlation of 0.02 and design effect of 2.2, we

would need to sample 1,750 records among hospitals with an average cluster size of 60. This

cluster size appeared reasonable based upon national administrative data[26] and our previous

survey of treatment for acute coronary syndromes at more than 1000 hospitals in 2010, which

demonstrated that the median annual PCI volume was approximately 300 cases. Assuming a

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participation rate of 85% among selected hospitals, we approached 35 hospitals for participation

in each stratum for a total for 70 hospitals. We doubled cluster sizes for 2011 to improve

precision in the description of hospital-level treatment patterns and outcomes. Consequently,

the total expected sample volume with the above assumptions was approximately 3,500 cases

in 2001, 3,500 cases in 2006, and 7,000 cases in 2011. A more detailed description of the

sampling strategy is provided in the supplemental material within the online web appendix.

Data Collection

We trained staff at participating hospitals to identify all hospitalizations with coronary

catheterization or PCI procedures from their respective local hospital databases for 2001, 2006,

and 2011. After we sampled cases at each hospital, we assigned each case a unique study ID.

We then required local investigators to obtain the original record and transmit a scanned copy to

the coordinating center. To facilitate this process, the coordinating center provided each study

site with a high-speed scanner. To verify compliance with the case-finding strategy, research

staff from the coordinating center visited 60% of the sites to repeat the case-finding process,

confirm that the list of hospitalizations undergoing coronary catheterization or PCI was

complete, and assist in acquiring the sampled cases (Figure 3). We chose to visit study sites

that were expected to contribute a large volume of cases and have potential difficulties in

complying with the case finding strategy. These sites provided 73% of sampled cases.

Following receipt of the scanned record, research staff at the China NCCD ensured the

completeness and quality with which each medical record was copied. We required incomplete

or poorly scanned records to be rescanned and retransmitted (Figure 3). We instructed study

sites to include all parts of the medical record including the face sheet, admission note, daily

progress notes, procedure notes, medication administration record, diagnostic procedure

reports, laboratory test results, physician orders, nursing notes, and discharge summary.

The China PEACE-Retrospective CathPCI Study adhered to rigorous standards for

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abstraction. Before initiating chart review, each abstractor received 2 weeks of training that

included an introduction to the study, coronary heart disease and its subtypes, components of

the inpatient medical record including specialized sections such as catheterization reports, and

the China PEACE-Retrospective CathPCI Study data dictionary. We provided all material,

including the data dictionary, in Chinese. After training, we certified individuals who were able to

abstract 5 sample medical records with greater than 98% accuracy. Inexperienced abstractors

began with exclusively typewritten rather than hand-written medical records. In addition, we

randomly audited approximately 5% of the abstracted records. If the records were not

abstracted with 98% accuracy, all medical records in the audited batch were considered

unqualified and were re-reviewed by a different abstractor. Abstractors were required to

maintain this benchmark of 98% accuracy to retain certification. We used abstractors with

formal medical training to identify data elements requiring more advanced medical knowledge,

such as the development of post-procedural complications including bleeding or cardiac

tamponade. A physician was always present in the room with abstractors or was available

online to answer questions as they arose. We assigned medical records belonging to the same

hospital and year to a broad group of reviewers to avoid potential residual disparities in quality

among abstractors.

Data Management

We systematically perform ongoing data cleaning. Data managers regularly query data

for invalid and illogical values as well as for duplicate record entries. They identify potential

invalid values by searching for outliers in continuous data distributions. Records with identical

study identification numbers, hospital identification numbers, medical record identification

numbers, and dates of discharge trigger a search for duplicate records. Once a data query is

made, concerns are resolved after tracing and reviewing the relevant records.

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All data has been treated as protected health information and has been securely stored

in an encrypted and password protected database at the main coordinating center.

Data Elements

We examined both the English-language and Chinese literature for relevant studies to

create a list of candidate variables. We supplemented these elements with variables used in the

CathPCI Registry of the American College of Cardiology National Cardiovascular Data Registry

(NCDR). CathPCI is an outcomes-based registry and quality improvement program that focuses

on patients who undergo coronary catheterization and PCI in the United States. Incorporating

variables from CathPCI will permit cross-country comparisons in resource utilization and

adherence to quality metrics. We also incorporated elements from the case report form used in

the China PEACE-Retrospective Study of Acute Myocardial Infarction[27] (clinicaltrials.gov

identifier NCT01624883) to permit comparison of hospitalizations for acute myocardial infarction

between these 2 China PEACE studies. Major categories of data elements are described in

Table 1.

Table 1. China PEACE-Retrospective CathPCI Study Data Elements

Category Example Elements

Patient demographics Age, sex, ethnicity, postal code, occupation, insurance status

Medical history Diabetes, hypertension, hyperlipidemia, vascular disease, prior

revascularization

Initial cardiac status Heart rate, blood pressure, Killip class, heart failure, cardiac arrest

Lab values Troponin, CK, CK-MB, BNP, sodium, BUN, creatinine, WBC

count, hemoglobin

Diagnostic procedures Coronary catheterization, echocardiogram, CT angiogram, stress

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testing, chest radiograph

Medications including dose Anti-platelet therapy, anti-coagulant therapy, beta blocker, ACE

inhibitor/ARB, statin, traditional Chinese medicines

Auxiliary imaging Intravascular ultrasound, fractionated-flow reserve

Coronary flow dynamics Pre-procedural TIMI flow, post-procedural TIMI flow

Revascularization Fibrinolysis, PCI (access, coronary anatomy, bypass graft

anatomy, stent number, stent type, stent length, contrast dose,

closure device), CABG surgery

Mechanical support Intra-aortic balloon pump, left ventricular assist device, ECMO

Outcomes including in-

hospital complications

Death, myocardial infarction, heart failure, shock, arrhythmia,

stroke, bleeding, transfusion, infection, coronary perforation,

coronary dissection

ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; BNP, brain natriuretic

peptide; BUN, blood urea nitrogen; CABG, coronary artery bypass graft; CK, creatine kinase;

CK-MB, creatine kinase-MB; CT, computed tomography; ECMO, extracorporeal membrane

oxygenation; PCI, percutaneous coronary intervention; TIMI, Thrombolysis in Myocardial

Infarction; WBC, white blood cell

In Table 2, we show data relevant to performance measures during the first 24 hours of

hospitalization and at hospital discharge for patients with acute myocardial infarction and those

undergoing PCI for stable coronary artery disease.

Table 2. China PEACE-Retrospective CathPCI Study Performance Measures

First 24 Hours Discharge

Aspirin Aspirin*

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Time to primary PCI Thienopyridine*

Time to fibrinolysis Beta blocker

ACE inhibitor or ARB for LV systolic dysfunction

Statin*

Smoking cessation counseling

Cardiac rehabilitation referral

All performance measures apply to patients with acute myocardial infarction. Performance

measures with asterisks also apply to patients undergoing PCI for stable coronary artery

disease. ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; LV, left

ventricle; PCI, percutaneous coronary intervention

Where possible, we collected data that would allow us to construct the core quality measures for

acute myocardial infarction used and reported by the Centers for Medicare & Medicaid Services

in the United States as well as the quality measures for PCI from the NCDR.[28] Two physician

investigators at each participating hospital also completed a survey, modeled on the annual

survey of hospitals performed by the American Hospital Association, of its major structural and

organizational characteristics during the study period.[29] Key variables assessed include bed

size, teaching status, and capability of performing coronary artery bypass graft surgery.

Statistical Analyses

We will report summary statistics for patient characteristics, use of diagnostic tests,

treatments received, and in-hospital outcomes including complications of care and

hospitalization costs across study sites. Weighting will reflect the reciprocal of sampling

probability. For each aim, we will use standard parametric and non-parametric techniques for

observational data, including t tests, chi-square tests, Wilcoxon rank sum tests, and generalized

linear models. Because patient characteristics, treatments, and outcomes may be correlated

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within hospitals, analyses will account for the effect of clustering. To examine and adjust for

differences between comparison groups, we will use linear, logistic, Cox proportional hazard,

and Poisson models with a generalized estimating equation approach and hierarchical models,

where appropriate. We will develop models to stratify patients according to their risk of adverse

outcomes. We will assess the relationship of candidate variables to in-hospital outcomes using

appropriate statistical techniques for the dependent variable. We will further refine the list of

candidate variables based on their clinical relevance.

Progress to Date

As of December 2012, 55 hospitals agreed to participate in the study. Fifteen hospitals

did not participate because they did not provide inpatient services for coronary heart disease (5

hospitals), were incapable of performing coronary catheterization and PCI throughout the study

period (8 hospitals), or refused to participate (2 hospitals). Of the 55 participating hospitals, 29

were located in the Eastern economic-geographic stratum and 26 were located in the

Central/Western economic-geographic stratum. The distribution of sites by province and region

is shown in Figure 4.

In parallel with national trends, the number of hospitals providing cases increased with

each subsequent year of study. In 2001, 26 of the 55 participating hospitals were capable of

performing PCI, of which 24 submitted medical records. Of the 2 hospitals that did not submit

records, 1 did not keep records in 2001 and the other had its records destroyed by a fire. Both

of these institutions likely had very limited capacity for PCI in 2001, as evidenced by their

performance of only 16 and 28 respective cases of coronary catheterization and PCI in 2006. A

total of 44 hospitals performed PCI in 2006, all of which submitted records to the study. Fifty-

four hospitals performed catheterization and PCI in 2011. As with 2006, all hospitals that

performed PCI in 2011 submitted records.

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We collected all medical records for abstraction by December 2012. The examination of

census databases from participating hospitals yielded 58,008 hospitalizations for coronary

catheterization and PCI (3,270 in 2001, 12,875 in 2006, and 41,863 in 2011). Of these 58,008

hospitalizations, we sampled 12,477 (22%) [1,444 (44%) in 2001, 3,046 (24%) in 2006, and

7,987 (19%) in 2011]. Of these 12,477 sampled hospitalizations, we acquired medical records

for 11,900 (95%); 577 (5%) medical records could not be found due to poor archiving. We

began data abstraction of these medical records in March 2013 and expect abstraction to be

completed in January 2014.

DISCUSSION

Through use of a national research network, the China PEACE-Retrospective CathPCI

Study is developing a repository of data that describes the current and former use of coronary

catheterization and PCI in China. This project will provide answers to questions about

contemporary practice patterns including variation among institutions and temporal trends in

procedure use and adjunctive therapy. To elevate the quality of abstracted data, the study uses

data collection techniques regularly employed by international clinical trials such as integrated

central and on-site monitoring as well as source document checking. The China PEACE-

Retrospective CathPCI Study also elicits the active participation of hospitals across China to

ensure that study results disseminate broadly for the purpose of quality improvement. Findings

will be shared with government to help research findings inform policy. The study is designed to

guide the efficient allocation and high-quality use of advanced cardiovascular interventions in

the context of a rapidly growing cardiovascular disease burden and dynamically changing health

care system.

The China PEACE-Retrospective CathPCI Study falls under the larger China PEACE

effort, which aims to create a national research network dedicated to improving cardiovascular

outcomes. China PEACE is built on a platform of collaboration and coordination between

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clinicians, researchers, and policy makers. With this framework in mind, study sites do not

merely transmit information to the coordinating center, but are full partners and consumers of

the knowledge generated. In this way, China PEACE has similarities to the NCDR CathPCI

Registry of the American College of Cardiology, which provides participating hospitals with

regular performance reports including analysis of process measures and in-hospital outcomes.

The Chinese government, a partner in China PEACE, will use study results to develop

policies intended to strengthen the clinical performance of the hospitals. The goal is not simply

to identify poor performing institutions, but to use a shared learning approach to elevate care

delivery at all participating hospitals and produce knowledge that is broadly applicable across

sites of care, including those external to the China PEACE network. In the future, we hope to

directly involve patients and caregivers in designing study questions and disseminating findings.

We anticipate that the results of the China PEACE-Retrospective CathPCI study will

illuminate the effects of recent health care reforms in China on the use of coronary

catheterization and PCI. Although China has adopted policies to enhance quality of care and

dissemination of novel technologies over the past decades,[17] they have 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 there was widespread variation in access to the technology.[6, 7] Access was

subsequently improved in 2003 with the implementation of the Rural Cooperative Medical Care

Scheme that expanded insurance access to the low-income rural population. This government

initiative was followed by additional health care reforms in the latter half of the decade that

further expanded insurance support for both rural and urban residents.[6, 7] In this context, the

Ministry of Health established processes for accreditation of interventional centers in 2007 to

promote minimal quality standards for PCI.[17] Through our nationally representative and multi-

year sample of catheterization and PCI, we will have the capacity to evaluate the temporal

influence of these polices on practice patterns and its variability by hospital and region. We may

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identify signals of potential inefficient allocation of resources such as the use of drug-eluting

stents in situations where bare-metal stents are similarly efficacious. Results may prove useful

to future policymaking and guideline development.

We also expect that the knowledge generated from the China PEACE-Retrospective

CathPCI Study will be useful internationally. Many low- and middle-income countries are

undergoing a similar epidemiological transition and are experiencing comparable challenges

associated with a growing number of persons with chronic cardiovascular disease and rapidly

rising health care costs in the setting of limited health care resources.[32] The experience with

China PEACE may help guide other countries in their desire to learn about trajectories and

variation in the use of novel health technologies. Developed nations are also facing common

challenges around health care reform and the optimal utilization of advanced interventions.[33]

The development of novel approaches to care in China may have relevance for more wealthy

countries that are grappling with escalating costs and trying to determine whether reduction in

resource expenditures can be achieved without compromising patient outcomes.

The China PEACE-Retrospective CathPCI Study is distinguished from many

retrospective analyses by its use of data quality control strategies that are common in the

performance of multicenter clinical trials. The study has devoted significant attention to data

quality at multiple stages including case ascertainment, data abstraction, and data

management. For example, research staff visited study sites to identify all hospitalizations

involving coronary catheterization or PCI from local hospital databases and physically found all

medical records for sampled cases whenever possible. In addition, all abstractors underwent

standardized training at the coordinating center and continued to maintain high standards for

accuracy to remain certified. Medical records reviewed by abstractors who fail to meet

continuing recertification requirements are always re-abstracted. These and other quality control

and assurance strategies are the result of the NCCD’s previous experience in conducting

cardiovascular clinical trials in China.

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This study has some limitations, including those inherent to its retrospective design.

Findings depend on the accuracy and completeness of the medical records, and the abstraction

process. However, these limitations would apply to all retrospective studies. Moreover, the

identification of poor documentation of key variables is crucial to future quality improvement

measurements. Our study is not designed to track outcomes following hospitalization or the

experience of patients. These variables, however, will be collected in the recently launched

Prospective Study of PCI from the China PEACE platform. Finally, in our sampled hospital

cohort, catheterization and PCI volume was smaller than expected for the year 2001, in

particular, as the number of hospitals capable of performing PCI and the PCI volume per center

were relatively low. However, the sample remains nationally representative in the last year and

can still provide acceptable precision in describing 10-year trends (supplemental material within

online web appendix).

The China PEACE-Retrospective CathPCI Study, one of the first studies to be launched

from the China PEACE platform, seeks to assess the characteristics, treatments, and outcomes

of patients who receive diagnostic catheterization and PCI in a large nationally representative

sample of hospitals in China. It provides a unique opportunity to compare variation in care and

to assess trajectories in practice in the context of an era of rapid adoption of new cardiovascular

technologies and constrained health care resources. Findings are intended guide the more

efficient use of coronary catheterization and PCI in a manner that improves health outcomes

across diverse geographic settings and sites of care within China.

ETHICS AND DISSEMINATION

The central ethics committee at the China NCCD approved the China PEACE-

Retrospective-CathPCI Study. Ethics approval was also obtained from all collaborating

hospitals. The study is registered at www.clinicaltrials.gov (NCT01624896). The Chinese

government, who provided financial support for the study, had no role in its design or conduct; in

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the collection, management, analysis, and interpretation of the data; or in the preparation or

approval of this manuscript.

Study findings will be freely shared with participating hospitals and the Chinese

government. To improve health care quality, data will be presented in the format of regular

performance reports that include analysis of both process measures and in-hospital outcomes.

Findings will also be disseminated via peer-reviewed publications. Requests for collaboration

will be welcomed.

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Acknowledgments: We appreciate the multiple contributions made by study teams at the

China Oxford Centre for International Health Research and the Yale-New Haven Hospital

Center for Outcomes Research and Evaluation in the realms of study design and operations.

We are grateful for the support provided by the Chinese government.

Contributor statement. JL and KD made substantial contributions to study conception and

design, drafting of the manuscript, and critical revision of the manuscript for important

intellectual content. XL, ZL, and SLTN made substantial contributions to study conception and

design and critical revision of the manuscript for important intellectual content. HMK and LJ

made substantial contributions to study conception and design, drafting of the manuscript,

critical revision of the manuscript for important intellectual content, and provided administrative,

technical, and material support, including study supervision.

Competing interests. Dr. Krumholz reports being the recipient of a research grant from

Medtronic, Inc. through Yale University and the chair of a cardiac scientific advisory board for

UnitedHealth. The authors declare no other relevant competing interests.

Funding statement. This project was partly supported by grant 201202025 from the Ministry of

Health 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 Excellence Scholar in Geriatric Medicine at Yale by the John A. Hartford Foundation

and the American Federation for Aging Research. 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.

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Ethical approval. The central ethics committee at the China NCCD approved the China

PEACE-Retrospective-CathPCI Study. All collaborating hospitals accepted the central ethics

approval except for 5 hospitals, which obtained local approval by internal ethics committees.

The study is registered at www.clinicaltrials.gov (NCT01624896).

Transparency declaration. LJ affirms that this manuscript is an honest, accurate, and

transparent account of the study protocol being reported; that no important aspects of the study

protocol have been omitted; and that any discrepancies from the study protocol as planned

(and, if relevant, registered) have been explained.

Data sharing. No additional data is directly available. However, requests for collaboration are

welcome.

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FIGURE LEGEND

Figure 1. The China PEACE Initiative. Key partners include the Chinese government,

collaborating hospitals, the China National Center for Cardiovascular Diseases, and the Yale-

New Haven Hospital Center for Outcomes Research and Evaluation. The China PEACE-

Retrospective CathPCI Study is 1 of 5 initial studies from the China PEACE initiative. The topic

areas for these 5 projects concern acute myocardial infarction, coronary

catheterization/percutaneous coronary intervention, and multi-vessel coronary artery disease.

Future studies will focus on cerebrovascular disease and other cardiovascular conditions.

AMI, acute myocardial infarction; PCI, percutaneous coronary intervention; 3VD, triple-vessel

coronary artery disease

Figure 2. Chinese Trends in PCI Volume from 2001 to 2011. Figure demonstrates the increase

in PCI volume by year and the increase in the number of hospitals performing >100 PCIs per

year. Notable events pertinent to the expansion in PCI access with time are highlighted below

the graph. In 2003, the Rural Cooperative Medical Care System expanded health insurance to

low-income rural residents. The health care reform of 2007 substantially expanded health

spending for both the rural and urban population. We sampled eligible hospitalizations for 2001,

2006, and 2011. PCI, percutaneous coronary intervention.

Figure 3. The China PEACE-Retrospective CathPCI Study Flow Chart and Associated Quality

Assurance Strategies. Flow chart should be read from top to bottom. CRF, case report form; Q

& A, questions and answers.

Figure 4. Geographic Distribution of Participating Hospitals in the China PEACE-Retrospective

CathPCI Study. Of 70 sampled hospitals, 15 were unable or unwilling to participate and 55

provided cases for the study.

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WEB APPENDICES: SUPPLEMENTAL MATERIAL Protocol of the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Retrospective Study of Coronary Catheterization and Percutaneous Coronary Intervention The China PEACE Collaborative Group1, 2

1State Key Laboratory of Cardiovascular Disease, China Oxford Centre for International Health Research, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, People's Republic of China; 2The Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, United States

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TABLE OF CONTENTS Page(s) 2 Table of Contents 3-5 China PEACE-Retrospective CathPCI Study Sampling Design 6 China PEACE-Retrospective CathPCI Study Absolute Precision Achieved for in-

Hospital Complications 7 China PEACE-Retrospective CathPCI Study Quality Assurance and Quality

Control Strategies in Medical Record Sampling 8-9 China PEACE-Retrospective CathPCI Study Quality Assurance and Quality

Control Strategies in Medical Record Abstraction 10-41 China PEACE-Retrospective CathPCI Study Case Report Form, Part 1 42-57 China PEACE-Retrospective CathPCI Study Case Report Form, Part 2 58-172 China PEACE-Retrospective CathPCI Study Data Dictionary 173 China PEACE-Retrospective CathPCI Study Site Investigators by Hospital 174 China PEACE Study Consultants

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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY SAMPLING DESIGN

We intended study hospitals to reflect the diverse sites of care performing coronary catheterization and percutaneous coronary intervention (PCI) in China. We restricted hospitals to those in urban areas, as coronary catheterization and PCI are rarely performed in rural areas. We considered an area urban if it is part of a downtown or suburban area within a direct-controlled municipality (Beijing, Tianjin, Shanghai, Chongqing) or 1 of 283 prefectural-level cities. As financial and medical resources are not identical throughout Mainland China, we separately identified hospitals in each of China’s 3 official economic-geographic regions, i.e. Eastern, Central and Western. As Central and Western urban regions have similar per capita income and health services capacity, as shown below, we combined Central and Western regions into 1 stratum.

Population, Economy, and Hospitals in Urban Areas of Different Geographic Strata of Mainland China

Eastern Central Western

Total Population* 336,364,491 150,467,917 144,803,916

Income per capita (RMB)† 21,547 15,539 15,523

Number of urban areas in strata‡ 121 81 85

Median # of hospitals per urban area (IQR)¶¶¶¶

Tertiary hospitals 3 (2-6) 2 (1-3) 2 (1-4)

Secondary hospitals 5 (3-8) 4 (3-6) 3 (2-6)

*Statistics in 2009 from the National Bureau of Statistics of China (http://www.stats.gov.cn/tjsj/ndsj/2010/indexch.htm) †Statistics (RMB) in 2009 from the National Bureau of Statistics of China

(http://www.stats.gov.cn/tjsj/ndsj/2010/indexch.htm) ‡Administrative divisions code (October 31, 2011) in China (http://www.stats.gov.cn/tjbz/xzqhdm/t20120105_402777427.htm) ¶Median (interquartile range)

We then identified hospitals separately for 2 study strata: Eastern-urban and Central/Western-urban regions.

We identified cases for study inclusion using a stratified 2-stage cluster sampling design. In the first stage, we identified hospitals using a simple random sampling procedure within each of the 2 study strata. The sampling framework consisted of the highest-level hospitals in each of the predefined urban regions (833 hospitals in 287 urban regions). Hospital level is officially defined by the Chinese government based on clinical resource capacity. For example, secondary hospitals have at least 100 inpatient beds and the capacity to provide acute medical care and preventive care services to populations of at least 100,000, while tertiary hospitals are large referral centers in provincial capitals and major cities. We excluded military hospitals, prison hospitals, specialized hospitals without a cardiovascular disease division, and traditional Chinese medicine hospitals. Since the number of hospitals has remained stable over the past decade, we decided to select representative hospitals from 2011 to reflect current practices and trace this hospital cohort backward to 2006 and 2001 to describe temporal trends.

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In the second stage, we drew cases based on the local hospital database for patients who

underwent coronary catheterization at each sampled hospital. We ordered each hospital’s list of eligible cases by date of coronary catheterization and selected cases using systematic random sampling with equal probabilities. We selected a case at random, after which we selected every kth case based on sample size requirements, where k is the sampling interval. In each study stratum, we determined the sample size required to achieve a 1.5% precision for describing the rate of in-hospital complications, which we had estimated to be approximately 5%.

The following Equation 1 can be used to define the sample size required (n) for a given proportion of the primary outcome (P), desired precision (d), and specific choice of α.1 Equation 1:

� ��∝

� ∙ ��1 ��

��

However, because random cases sampled within the same hospital are likely to be more similar to one another than to random cases from another hospital, the effective sample size is reduced. Consequently, a design effect adjustment should be introduced as follows: Equation 2:

� ��∝

� ∙ ��1 ��

��

Where the design effect (deff) is given by

Equation 3:

�� 1 � ��′� 1�

where � is the intraclass correlation for the statistic in question and �′� is the average number of

sampled cases within each hospital. �′� is also known as the cluster size.

With this framework in mind, to achieve a precision of 1.5% with an α of 0.05 in each stratum, assuming an intraclass correlation of 0.02 and design effect of 2.2, we would need to sample 1750 medical records among hospitals with an average cluster size of 60. These cluster sizes in urban settings appeared reasonable based upon our previous survey of treatment for acute coronary syndromes at more than 1000 hospitals in 2010, which demonstrated that the median PCI volume was approximately 300 cases per year. Assuming a participation rate of 85% among selected hospitals, we approached 35 hospitals for participation in each stratum for a total of 70 hospitals. We doubled cluster sizes for 2011 to improve precision in the description of hospital-level treatment patterns and outcomes. Consequently, the total expected sample volume with the above assumptions was

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approximately 3,500 cases in 2001, 3,500 cases in 2006, and 7,000 cases in 2011.

Reference 1. Machin D, Campbell M, Fayers P, Pinol A. Sample size tables for clinical studies, 2nd

edition. Malden, MA: Blackwell Science; 1997.

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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY ABSOLUTE PRECISION ACHIEVED FOR IN-HOSPITAL COMPLICATIONS IN STUDY STRATA

Study Stratum Sample Size Achieved

Average Cluster Size

deff Precision Achieved for Proportion of 0.05

Actual Data*

Central/Western-urban in 2001 519 17 1.3 2.1%

Central/Western-urban in 2006 1,131 36 1.7 1.6%

Central/Western-urban in 2011 3,662 118 3.3 1.3%

Eastern-urban in 2001 925 29 1.6 1.7%

Eastern-urban in 2006 1,915 60 2.2 1.5%

Eastern-urban in 2011 4,325 135 3.7 1.3%

Anticipated Data†

2001 or 2006 1,750 60 2.2 1.4%

2011 3,500 120 3.3 1.3%

* Actual data reflects the absolute precision achieved in describing in-hospital mortality in each stratum during 2001, 2006, and 2011 based upon the actual sample size, actual average cluster size, and associated design effect. † Anticipated data reflects the anticipated absolute precision that would be achieved in describing in-hospital mortality in each stratum during 2001, 2006, and 2011 based upon the anticipated sample size, anticipated average cluster size, and associated design effect.

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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY QUALITY ASSURANCE AND QUALITY CONTROL STRATEGIES IN MEDICAL RECORD SAMPLING As the China PEACE Retrospective Study of Coronary Catheterization and Percutaneous Coronary Intervention was designed to study a nationally representative hospital cohort, we selected hospitals based on random sampling rather than previous collaboration or longstanding experience with retrospective data collection. As we anticipated that many hospitals would have little previous experience with clinical research, we provided participating sites with substantial support to ensure adherence with multiple quality control strategies for identifying all hospitalizations undergoing coronary catheterization and for randomly selecting eligible hospitalizations for the China PEACE-Retrospective CathPCI Study. For all participating hospitals, we first held a local investigator meeting to provide in-depth information on study design and operating procedures. We trained sites on how to identify all hospitalizations undergoing coronary catheterization or percutaneous coronary intervention. The sites identified eligible hospitalizations by searching their electronic database or hard-copy log during the specified time periods. To verify compliance with the search strategy, research staff from the study coordinating center visited 33 study sites to repeat the case finding process and confirm that the list of hospitalizations undergoing coronary catheterization and/or PCI was complete. These 33 sites provided 83%of all hospitalizations undergoing coronary catheterization/PCI from which we sampled cases for the PEACE Retrospective CathPCI Study. After we sampled cases at each hospital using systematic random sampling and assigned each record a unique study ID, we required local investigators to gather the original record, assign it its study ID, scan it, and transmit the scanned copy to the coordinating center. Upon receipt of the scanned record, coordinating center staff verified the consistency of the hospitalization ID and procedure date with the sampled case, and ensured that the record itself was complete and legible. To facilitate this process, the coordinating center provided each study site with a high-speed scanner. In addition, coordinating center staff provided on-site assistance for 33 study sites that provided approximately 73% of sampled cases. To ensure transparency in all sampling performed by the NCCD, we have recorded all sampling procedures including the contents of the sampling framework database that contains all eligible cases for sampling in their predefined sequence and the seeds used in random number generation.

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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY QUALITY ASSURANCE AND QUALITY CONTROL STRATEGIES IN MEDICAL RECORD ABSTRACTION Background Medical record abstraction can be guided by the types of data being abstracted. We have defined as simple data elements those elements that can be abstracted directly from the chart without use of professional judgment. Examples include the date of admission, patient sex, patient age, serum creatinine on hospital day 1, etc. In contrast, complex data elements are those that require more advanced medical knowledge for abstraction. Examples of complex data elements include the presence of comorbidities, evidence of pulmonary edema on hospital presentation, development of post-procedural complications such as bleeding or arrhythmia, and so on. Within the Chinese medical record, simple data elements are found predominantly in the medical record face sheet, section for laboratory testing results and physician orders. Complex elements are found throughout all other sections of the medical record including the admission record, discharge record and diagnostic reports, etc. Training and Qualification of Abstractors The abstractors for simple data elements were clerks with experience in medical record abstraction. The abstractors for complex data elements were undergraduate or post-graduate trainees. Most were medical students. Each abstractor was given a set of training materials about medical record abstraction, including CHINA PEACE: A Brief Introduction, China PEACE: Operation Manual of Medical Record Abstraction, and 5 standard training medical records. Each abstractor also underwent the following training courses: (1) Introduction to the China PEACE protocol; (2) Coronary heart disease and its subtypes; (3) Component parts of the inpatient medical record and their contents; (4) China PEACE Retrospective Study of Coronary Catheterization and Percutaneous Coronary Intervention data dictionary; (5) Frequently asked questions in medical record abstraction; (6) Quality assurance and quality control measures in China PEACE; and (7) Intensive guidance in abstracting 5 standard training medical records followed by group discussion and retraining as needed. Once training was completed, each abstractor reviewed 5 standard training medical records. Supervisors were responsible for evaluating the accuracy of abstraction. Every abstractor needed to achieve greater than 98 percent abstraction accuracy in order to be considered competent. Quality Control in Medical Record Abstraction We randomly audit approximately 5% of the abstracted records. If the records have not been abstracted with 98% accuracy, all records in the audited batch are considered unqualified and are re-reviewed by a different abstractor. Discrepancies in abstraction are resolved by review of the original medical record.

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To minimize abstraction errors, abstractors start by abstracting only printed medical records. After gaining experience, these individuals are allowed to begin abstracting hand-written records. In addition, a physician is always present in the room with abstractors or is available online to answer questions and address areas of concern as they arise. Common problems have led to updates of the data dictionary and database into which data are directly entered. This database has been additionally customized to expedite the identification of medications that may have more than one trade name. Furthermore, medical records belonging to the same hospital and year are assigned to a broad group of reviewers to avoid potential residual disparities in quality among different abstractors Data Management and Cleaning Ongoing data cleaning is performed in a systematic manner. Data is regularly queried for invalid and illogical values as well as for duplicate record entry. Outliers in continuous data distributions are identified as potentially invalid and are further explored. Duplicate records are identified by the presence of identical study identification numbers, hospital identification numbers, medical record identification numbers, and dates of discharge. Once a data query is made, concerns are resolved after tracing and reviewing the relevant records.

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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY CASE REPORT FORM, PART I Contents Face Sheet ............................................................................................................................... 11 Discharge Records ................................................................................................................. 111 Admission Records & History of Diseases .............................................................................. 188 Personal History ........................................................................................................................21 Physical Examination ................................................................................................................21 Auxiliary Examination ................................................................................................................22 Preliminary Diagnosis ............................................................................................................. 255 Daily Records ......................................................................................................................... 266 In-Hospital Device Placement ...................................................................................................30 Coronary Angiography and PCI Report .....................................................................................30 CABG Report ............................................................................................................................36 Imaging Examination.................................................................................................................36 In-Hospital ECG ...................................................................................................................... 377 Temperature Report ..................................................................................................................38 Long-term Physician Orders ......................................................................................................38 Short-term Physician Orders .....................................................................................................39 Discharge Medications ..............................................................................................................40 Note: The case report form parallels common sections of the Chinese medical record. In certain instances, questions within the case report form have been repeated for different sections of the medical record to maximize the sensitivity of abstraction.

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1 Study ID _____【【【【Free Text (F)】】】】

Face Sheet

2.1 Medical Record Number _____【【【【F】】】】

2.2 Hospital Number _____【【【【F】】】】

3 Gender【【【【Single Choice (SC)】】】】 --Male --Female

4 Age _____yrs【【【【F】】】】

5.1 Admission Date _____【【【【Select Date from Calendar (C)】】】】

5.2 Admission Time _____【【【【F】】】】

Discharge Records

6 In-Hospital Death【【【【SC】】】】 --Yes --No

7 In-Hospital Death Date _____【【【【C】】】】

8 Admission Diagnosis (Related to Coronary Heart Disease)

【【【【Multiple Choices Permitted (MC)】】】】 --Coronary Heart Disease --Acute Coronary Syndrome --Acute Extensive Anterior Myocardial Infarction --Acute Myocardial Infarction --Acute Anterior Myocardial Infarction --Acute Septal Myocardial Infarction --Acute Inferior Myocardial Infarction --Acute Lateral Myocardial Infarction --Acute Posterior Myocardial Infarction --Acute Right Ventricular Myocardial Infarction --Acute Non ST-Elevation Myocardial Infarction --Acute ST-Elevation Myocardial Infarction --Subendocardial Myocardial Infarction --Acute Myocardial Infarction Suspected --Previous (Q-wave) Myocardial Infarction --Unstable Angina Pectoris --Stable Angina Pectoris --Prinzmetal's Angina --Angina (Unrecorded Subtype)

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--None of the Above Is Recorded

9 Admission Diagnosis (Unrelated to Coronary Heart Disease)【【【【MC】】】】 --Cardiac Arrest --Cardiogenic Shock --Ventricular Fibrillation/Ventricular Tachycardia --Atrial Fibrillation --Acute Heart Failure --Chronic Heart Failure --Heart Failure (Unspecified) --Acute Pulmonary Edema --Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage) --Ischemic Stroke (Cerebral Infarction/Cerebral Embolism/Cerebral Thrombosis) --Stroke (Unspecified) --Pneumonia --COPD Exacerbation --Gastrointestinal Bleeding --Acute Renal Failure --Chronic Renal Failure --Dialysis (Hemodialysis/Peritoneal Dialysis) --Dyslipidemia --Hypertension --Diabetes Mellitus --Diabetic Nephropathy --Gastroesophageal Reflux --Oesophagismus --Cholelithiasis --Anemia --None of the Above Is Recorded

10 Summary of In-Hospital Events 【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】

--Repeat/Recurrent Myocardial Infarction --Repeat/Recurrent Angina --Cardiac Rupture --Papillary Muscle Rupture --Ventricular Septal Perforation --Cardiac Tamponade --Pericardial Effusion --Cardiogenic Shock --Cardiac Arrest --Cardiopulmonary Resuscitation (CPR) --Atrial Fibrillation or Flutter --Ventricular Tachycardia/Ventricular Fibrillation --Acute Heart Failure --Exacerbation of Chronic Heart Failure --Infection --Acute Pulmonary Edema --Gastrointestinal Bleeding --Genitourinary Bleeding

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--Intracranial/Subdural Bleeding --Retroperitoneal Bleeding --Access Site Bleeding (Including Hematoma at Access Site) --Pericardial Bleeding --Bleeding (Unspecified) --Hemorrhagic Shock --Venous Thromboembolism --Pulmonary Embolism --Deep Vein Thrombosis --Stent Thrombosis --Significant Dissection --Perforation --Abrupt Vessel Closure in the Catheterization Laboratory --Side Branch Occlusion --Distal Embolization --No Flow/Slow Flow Phenomenon --Access Site Occlusion --Access Site Arteriovenous Fistula --Access Site Hematoma --Access Site Dissection --Ischemic Stroke (Cerebral Infarction/Thrombosis/Cerebral Embolism) --Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage) --Stroke (Unspecified) --Acute Renal Failure --Dialysis (Hemodialysis/Peritoneal Dialysis) --Contrast Reaction (Include Severe Allergic Reaction) --Contrast-Induced Nephropathy (CIN) --Thrombocytopenia

11 In- Hospital Implantation of Intra-Aortic Balloon Pump (IABP)【【【【SC】】】】 --Yes --No

12.1 Date of Implantation of Intra-Aortic Balloon Pump (IABP) _____【【【【C】】】】

12.2 Time of Implantation of Intra-Aortic Balloon Pump (IABP) _____【【【【F】】】】

13 Did the Patient Refuse the Following Treatments?

【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】 --Refused Percutaneous Coronary Intervention (PCI) --Refused Fibrinolysis --Refused CABG

14 Documented Reasons for Non-prescription of Aspirin in the First 24

Hours【【【【SC】】】】 --No --Yes--Allergy

--Yes--Other (Specify) _____【【【【F】

15 Documented Reasons for Non-prescription of Beta-blocker in the First

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24 Hours【【【【SC】】】】 --No --Yes--Allergy

--Yes--Other (Specify) _____【F】

16 Documented Reasons for Non-prescription of Fibrinolysis in the First 24

Hours【【【【SC】】】】 --No --Yes--Allergy


17 Documented Reasons for Non-prescription of GP IIB/IIIA Inhibitors【【【【SC】】】】 --No --Allergy/Intolerance --Patient Refused --Fibrinolytics Given --Active or Recent (In Past 4 Weeks) Bleeding --Warfarin/Coumadin as Pre-Arrival Medication

--Other Reason Documented by Physician, Specify _____【F】

18 Documented Reasons for Non-prescription of Heparins【【【【SC】】】】 --No --Allergy

--Other (Specify) _____【F】

19 Documented Reasons for Non-prescription of Other Anti-Thrombin

Agents (e.g. Bivalirudin/Lepirudin/Argatroban)【【【【SC】】】】 --No --Allergy/Intolerance --Patient Refused --Stroke or Other Cerebrovascular Event in the Past Year --Known Intracranial Neoplasm --Active or Recent (Past 4 Weeks) Internal Bleeding --Suspected Aortic Dissection --Recent Surgery --Severe Uncontrolled Hypertension on Presentation --Pregnancy --Trauma

--Other Reasons (Specify) _____【F】

20 Documented Reasons for Non-prescription of Aspirin at Discharge【【【【SC】】】】 --No --Yes--Allergy


21 Documented Reasons for Non-prescription of ACE Inhibitor at Discharge

【【【【SC】】】】 --No --Yes--Allergy

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22 Documented Reasons for Non-prescription of ARB at Discharge【【【【SC】】】】 --No --Yes--Allergy


23 Documented Reasons for Non-prescription of Beta-blocker at Discharge【【【【SC】】】】

--No --Yes--Allergy


24 Documented Reasons for Non-prescription of Statin at Discharge【【【【SC】】】】 --No --Yes--Allergy


25 Discharge Status【【【【SC】】】】 --Discharge without Transfer to Another Hospital --Physician Recommends Transfer to Another Hospital --Patient or Relatives Demand Transfer to Another Hospital --Patient Left Against Medical Advice --None of the Above Is Recorded

26 Discharge Diagnosis (Related to Coronary Heart Disease)【【【【MC】】】】 --Coronary Heart Disease --Acute Coronary Syndrome --Acute Myocardial Infarction --Acute Extensive Anterior Myocardial Infarction --Acute Anterior Myocardial Infarction --Acute Septal Myocardial Infarction --Acute Inferior Myocardial Infarction --Acute Lateral Myocardial Infarction --Acute Posterior Myocardial Infarction --Acute Right Ventricular Myocardial Infarction --Acute Non ST-Elevation Myocardial Infarction --Acute ST-Elevation Myocardial Infarction --Subendocardial Myocardial Infarction --Acute Myocardial Infarction Suspected --Previous Q-Wave Myocardial Infarction --Unstable Angina Pectoris --Stable Angina Pectoris --Prinzmetal's Angina --Angina (Unrecorded Subtype) --Repeated/Recurrent Myocardial Infarction --Repeated/Recurrent Unstable Angina

27 Discharge Diagnosis of Acute Myocardial Infarction【【【【SC】】】】 --Yes—Answer the Questions Below Marked with an Asterisk (*)

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--No

28 Discharge Diagnosis【【【【MC】】】】 --Cardiac Rupture --Papillary Muscle Rupture --Ventricular Septal Perforation --Cardiac Tamponade --Pericardial Effusion --Cardiogenic Shock --Cardiac Arrest --Atrial Fibrillation --Ventricular Tachycardia/Ventricular Fibrillation --Acute Heart Failure --Chronic Heart Failure --Heart Failure (Unspecified) --Acute Pulmonary Edema --Gastrointestinal Bleeding --Genitourinary Bleeding --Intracranial/Subdural Bleeding --Retroperitoneal Bleeding --Access Site Bleeding (Including Hematoma at Access Site) --Pericardial Bleeding --Bleeding (Unspecified) --Hemorrhagic Shock --Venous Thromboembolism --Pulmonary Embolism --Deep Vein Thrombosis --Ischemic Stroke (Cerebral Infarction/Thrombosis/Cerebral Embolism) --Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage) --Stroke (Unspecified) --Pneumonia --Infection --COPD Exacerbation --Dyslipidemia --Hypertension --Diabetes Mellitus --Diabetic Nephropathy --Acute Renal Failure --Chronic Renal Failure --Dialysis (Hemodialysis/Peritoneal Dialysis) --Contrast Reaction (Include Severe Allergic Reaction) --Contrast-Induced Nephropathy (CIN) --Thrombocytopenia --Gastroesophageal Reflux --Oesophagismus --Cholelithiasis --Anemia --Unrecorded

29 Discharge Suggestions【【【【MC】】】】

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--Dual Anti-Platelet (Aspirin and Clopidogrel) Therapy【F】

--Regular Blood Lipid Assessment --Dietary Improvement --Weight Reduction --Smoking Cessation --Regular Exercise --PCI --CABG --None of the Above Is Recorded

30 Specify the Duration of Dual Anti-Platelet Therapy _____【【【【F】】】】

31 Medications at Discharge _____【【【【Drug Database(D)】】】】

32 Administration【【【【SC】】】】 --P.O. /Undefined --I.V. drip/ I.V. gtt (intravenously guttae) --I.V. --I.H. (Hypodermic Injection) --I.D. (intradermal Injection) --Others

Dose _____【【【【F】】】】

Unit【【【【SC】】】】 --g --mg --ml --u --piece/ # --mg/kg --mg/h --mg/min --mg/kg·h --ml/kg --ml/h --ml/min --ml/kg·min --u/kg --u/min --u/h --u/kg·h --ug --ug/kg --ug/min --ug/kg·min --MU --BU --% --Other

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--Unrecorded

Frequency【【【【SC】】】】 --Qd /QN --Bid/q12h --Tid/q8h --Q6h --As Needed

--Other --Unrecorded

【33-60】】】】Repeat Questions No.31 to 32 for the Other 14 Available Agents

Admission Records & History of Diseases

61.1 *Ischemic Symptoms Onset Date _____Days Ago【【【【F】】】】

61.2 *Ischemic Symptoms Onset Time _____Hours Ago【【【【F】】】】

62.1 *Ischemic Symptoms Onset Date _____【【【【C】】】】

62.2 *Ischemic Symptoms Onset Time _____【【【【F】】】】

63 *Was the Time of Ischemic Symptom Onset Estimated?【【【【SC】】】】 --Yes --No

64 *Did the Patient Have Chest Discomfort (Chest Pain/Chest Discomfort/Chest Pressure/Other Symptoms in Chest)?【【【【SC】】】】 --Yes --No --Unrecorded

65 *Did the Chest Discomfort Last 10 or More Minutes?【【【【SC】】】】 --Yes --No --Unrecorded

66 *Did the Patient Have Other Ischemia Symptoms (Shortness of

Breath/Pain at Non-chest Sites/Nausea/Vomit/Fatigue)?【【【【SC】】】】 --Yes --No --Unrecorded

67 *Did Other Ischemic Symptoms Last 10 or More Minutes?【【【【SC】】】】 --Yes --No --Unrecorded

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68 CAD Presentation【【【【MC】】】】 --No Symptoms, No Angina --Symptoms Unlikely to Be Ischemic --Stable Angina --Unstable Angina --Non-STEMI --STEMI

69 *Was Medical Assistance Provided at Outside Facilities Prior to This

Hospitalization?【【【【SC】】】】

--Yes --No --Unrecorded

70 *Treatment Prior to Arrival 【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】 --Aspirin --Clopidogrel --Ticlopidine --Antiplatelet Therapy --Fibrinolysis (If Yes, Specify: SK, UK, Rt-PA, Other) --External Defibrillation --CPR/Chest Compression --Temporary Cardiac Pacing

71 Time of Arrival at Your Hospital_____【【【【F】】】】

72 Was Time of Arrival at Your Hospital Estimated?【【【【SC】】】】 --Yes --No --Unrecorded

73 Treatment in Emergency Room Prior to Admission 【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】 --Aspirin --Clopidogrel --Ticlopidine --Antiplatelet Therapy --Fibrinolysis (If Yes, Specify: SK, UK, Rt-PA, Other) --External Defibrillation --CPR/Chest Compression --Temporary Cardiac Pacing

74 Cardiogenic Shock at Presentation【【【【SC】】】】 (Sustained (>30 minutes) Episode of Systolic Blood Pressure <90 mm Hg/Cardiac Index <2.2 L/min/m2/Requirement for Parenteral Inotropic or Vasopressor Agents/Mechanical Support [e.g. IABP/Extracorporeal Circulation/Ventricular Assist Devices]) --Yes

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--No --Unrecorded

75 Past Medical History (Related to Heart Disease) 【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】

--Coronary Heart Disease --Angina Pectoris --Myocardial Infarction --Prior PCI --Prior CABG --Ventricular Tachycardia --Atrial Fibrillation/Flutter --Bradycardia --Heart Failure --Valvular Heart Disease

76 If Patient Had a Prior PCI, Most Recent PCI Date【【【【SC】】】】

--＜1 Month Ago

--1-5 Months Ago --6-12 Months Ago -- 1-2 Years Ago

--＞2 Years Ago

--Unrecorded

77 If Patient Had a Prior CABG, Most Recent CABG Date【【【【SC】】】】

--＜1 Month Ago

--1-5 Months Ago --6-12 Months Ago -- 1-2 Years Ago

--＞2 Years Ago

--Unrecorded

78.1 Specify the First Home Medication _____【【【【F】】】】

78.2 Specify the Second Home Medication _____【【【【F】】】】

78.3 Specify the Third Home Medication _____【【【【F】】】】

78.4 Specify the Fourth Home Medication _____【【【【F】】】】

78.5 Specify the Fifth Home Medication _____【【【【F】】】】

79 Features of the Heart Failure 【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】

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--Unusual Dyspnea on Light Exertion --Recurrent Dyspnea Occurring in the Supine Position

80 Past Medical History (Unrelated to Heart Disease) 【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】

--Hypertension --Diabetes Mellitus --Dyslipidemia --Peripheral Vascular Disease (Intermittent Claudication/Lower Limb Arterial Embolism) --Ischemic Stroke (Cerebral Embolism/Cerebral Infarction/Cerebral Thrombosis) --Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage) --Stroke (Unspecified) --Carotid Artery Surgery/Intervention --Chronic Lung Disease (COPD/Chronic Bronchitis/Emphysema/Asbestosis/Mesothelioma/ Black Lung Disease/Pneumoconiosis/Radiation-induced Pneumonitis/Radiation Fibrosis)

--Chronic Renal Failure --Currently on Dialysis --Hepatitis B --Hepatitis C --Cirrhosis --Family History of CAD

81 Drug Allergy _____【【【【F】】】】

Personal History

82 Smoking History【【【【SC】】】】 --Never --Past --Current --Unrecorded

83 If Current, Duration _____Years _____Months【【【【F】】】】

84 If Past, Duration _____Years _____Months【【【【F】】】】

85 Smoking Frequency _____Cigarettes/Day【【【【F】】】】

Physical Examination

86 Vital Signs【【【【F】】】】 --Temperature at Presentation to This Facility _____°C --Heart Rate at Presentation to This Facility _____bpm --Respiratory Rate at Presentation to This Facility _____bpm --Systolic Blood Pressure at Presentation to This Facility _____mmHg --Diastolic Blood Pressure at Presentation to This Facility _____mmHg

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87 Signs of Heart Failure【【【【MC】】】】

【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】 --Jugular Venous Distension --Rales --Pulmonary Edema --Fluid Retention (Lower Extremity Edema)

Auxiliary Examination

88 Was the ECG Performed at Hospital Presentation Available in Medical Record?【【【【

SC】】】】 --Yes --No

89.1 Date of First ECG at Hospital _____【【【【C】】】】

89.2 Time of First ECG at Hospital _____【【【【F】】】】

90 Original Interpretation of ECG【【【【MC】】】】 --Acute MI --Complete LBBB (Unspecified) --ST-Elevation --ST-Depression --Previous MI (Q Wave) --Ventricular Fibrillation --Ventricular Tachycardia --Atrial Fibrillation --2nd Degree Atrioventricular Block Type 1 --2nd Degree Atrioventricular Block Type 2 --3nd Degree Atrioventricular Block

91 Was a Second ECG Performed during Hospitalization Available in

Medical Record?【【【【SC】】】】 --Yes --No

92.1 Date of Second ECG at Hospital _____【【【【C】】】】

92.2 Time of Second ECG at Hospital _____【【【【F】】】】

93 Original Interpretation of ECG【【【【MC】】】】 --Acute MI --Complete LBBB (Unspecified) --ST-Elevation --ST-Depression --Previous MI (Q Wave) --Ventricular Fibrillation --Ventricular Tachycardia

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--Atrial Fibrillation --2nd Degree Atrioventricular Block Type 1 --2nd Degree Atrioventricular Block Type 2 --3nd Degree Atrioventricular Block

94 Was a Third ECG Performed during Hospitalization Available in Medical

Record?【【【【SC】】】】 --Yes --No

95.1 Date of Third ECG at Hospital _____【【【【C】】】】

95.2 Time of Third ECG at Hospital _____【【【【F】】】】

96 Original Interpretation of ECG【【【【MC】】】】 --Acute MI --Complete LBBB (Unspecified) --ST-Elevation --ST-Depression --Previous MI (Q Wave) --Ventricular Fibrillation --Ventricular Tachycardia --Atrial Fibrillation --2nd Degree Atrioventricular Block Type 1 --2nd Degree Atrioventricular Block Type 2 --3nd Degree Atrioventricular Block

97 Was CK Tested at the Prior Hospital or in the Emergency Room of Your

Hospital? 【【【【SC】】】】 --Yes --No

98.1 CK Value _____【【【【F】】】】

98.2 Unit of CK _____【【【【SC】】】】 --IU/L --ng/ml --mg/ml --% --mg/IU --ml/IU

98.3 CK Date _____【【【【C】】】】

98.4 CK Time_____【【【【F】】】】

99 Was CK-MB Tested at the Prior Hospital or in the Emergency Room of Your

Hospital? 【【【【SC】】】】 --Yes --No

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100.1 CK-MB Value _____【【【【F】】】】

100.2 Unit of CK-MB _____【【【【SC】】】】 --IU/L --ng/ml --mg/ml --% --mg/IU --ml/IU

100.3 CK-MB Date_____【【【【C】】】】

100.4 CK-MB Time_____【【【【F】】】】

101 Was Troponin Tested at the Prior Hospital or in the Emergency Room of

Your Hospital?【【【【SC】】】】 --Yes --No

102.1 Troponin Date _____【【【【C】】】】

102.2 Troponin Time_____【【【【F】】】】

103 The Type of Troponin 【【【【MC】】】】 --Troponin T --Troponin I --Troponin (Unspecified)

104 Value for Troponin T? 【【【【SC】】】】 --Positive --Negative --Numerical value

105 Troponin T Value _____ng/ml【【【【F】】】】

106 Value for Troponin I? --Positive --Negative --Numerical value

107 Troponin I Value _____ng/ml【【【【F】】】】

108 Value for Troponin (Unspecified)? --Positive --Negative --Numerical value

109 Troponin (Unspecified) Value _____ng/ml【【【【F】】】】

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110 Was Routine Blood Test Performed at the Prior Hospital or in the

Emergency Room of Your Hospital?【【【【SC】】】】 --Yes --No

111.1 White Blood Cell (WBC) Value _____ X 109【【【【F】】】】

111.2 Neutrophil Ratio _____ %【【【【F】】】】

111.3 Hemoglobin Value _____ g/L【【【【F】】】】

111.4 Platelet Count Value _____ x109【【【【F】】】】

111.5 Routine Blood Test Date _____【【【【C】】】】

112.1 Creatinine Value _____umol/L【【【【F】】】】

112.2 Date of Creatinine Test _____【【【【C】】】】 113 Was Coagulation Test Performed at the Prior Hospital or in the

Emergency Room of Your Hospital?【【【【SC】】】】 --Yes --No

114.1 PT Value _____s【【【【F】】】】

114.2 APTT Value _____s【【【【F】】】】

114.3 INR Value _____【【【【F】】】】

114.4 Coagulation Test Date _____【【【【C】】】】

Preliminary Diagnosis

115 Admission Diagnosis (Related to Coronary Heart Disease)【【【【MC】】】】Same As No.9

116 Admission Diagnosis (Unrelated to Coronary Heart Disease)【【【【MC】】】】Same As No.10

117 Killip Classification【【【【SC】】】】 --I --II --III --IV --Unrecorded

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118 NYHA Classification【【【【SC】】】】

--I --II --III --IV --Unrecorded

Daily Records

119 Are Daily Records Filed into This Medical Record?【【【【SC】】】】

--Yes --No

120 In-Hospital Events【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】

--Repeat/Recurrent Myocardial Infarction --Repeat/Recurrent Angina --Cardiac Rupture --Papillary Muscle Rupture --Ventricular Septal Perforation --Cardiac Tamponade --Pericardial Effusion --Cardiogenic Shock --Cardiac Arrest --Cardiopulmonary Resuscitation (CPR) --Atrial Fibrillation or Flutter --Ventricular Tachycardia/Ventricular Fibrillation --Acute Heart Failure --Exacerbation of Chronic Heart Failure --Infection --Acute Pulmonary Edema --Gastrointestinal Bleeding --Genitourinary Bleeding --Intracranial/Subdural Bleeding --Retroperitoneal Bleeding --Access Site Bleeding (Including Hematoma at Access Site) --Pericardial Bleeding --Bleeding (Unspecified) --Hemorrhagic Shock --Venous Thromboembolism --Pulmonary Embolism --Deep Vein Thrombosis --Stent Thrombosis --Significant Dissection --Perforation --Abrupt Vessel Closure in the Catheterization Laboratory --Side Branch Occlusion --Distal Embolization --No Flow/Slow Flow Phenomenon

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--Access Site Occlusion --Access Site Arteriovenous Fistula --Access Site Hematoma --Access Site Dissection --Ischemic Stroke (Cerebral Infarction/Thrombosis/Cerebral Embolism) --Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage) --Stroke (Unspecified) --Acute Renal Failure --Dialysis (Hemodialysis/Peritoneal Dialysis) --Contrast Reaction (Include Severe Allergic Reaction) --Contrast-Induced Nephropathy (CIN) --Thrombocytopenia

121 Did the Patient Refuse the Following Treatment? 【【【【Every Item Has Three Options—Y/N/Unrecorded】】】】

--Refused Percutaneous Coronary Intervention (PCI) --Refused Fibrinolysis --Refused CABG

122 Cardiac Arrest Date _____【【【【C】】】】

123 Stroke Date _____【【【【C】】】】

124 Bleeding Date _____【【【【C】】】】

125 Interventions for Management of Bleeding【【【【MC】】】】

--Local Compression --Surgery --Endoscopic --Transfusion --Others --None --Unrecorded

126 The Nadir Blood Pressure After Bleeding Event (Lowest Recorded BP On the Day of and the Next Day After Bleeding Onset) _____/_____mm

Hg【【【【F】】】】

127 Hospital-Acquired Infection Site【【【【SC】】】】

--Pulmonary --Genitourinary --Gastrointestinal --Skin --Surgical site/Access site

--Other, Specify _____【F】

--Unrecorded

128 In-Hospital Implantation of Intra-Aortic Balloon Pump (IABP) 【【【【SC】】】】

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--Yes --No --Unrecorded

129.1 Implantation of Intra-Aortic Balloon Pump (IABP) Date _____【【【【C】】】】

129.2 Implantation of Intra-Aortic Balloon Pump (IABP) Time_____【【【【F】】】】

130 The First Coronary Angiography Status【【【【SC】】】】

--Elective --Urgent --Emergency --Salvage --Unrecorded

131 The First PCI Status【【【【SC】】】】


132 The Second Coronary Angiography Status【【【【SC】】】】


133 The Second PCI Status【【【【SC】】】】


134 Reasons for Repeat PCI During Hospitalization【【【【SC】】】】

--No Repeat PCI --Staged Procedure --Ongoing or recurrent ischemia --Other --Unrecorded

135 Documented Reasons for Non-prescription of Aspirin in the First 24 Hour【【【【SC】】】】 --No --Yes--Allergy

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136 Documented Reasons for Non-prescription of Beta-blocker in the First 24 Hours【【【【SC】】】】 --No --Yes--Allergy


137 Documented Reasons for Non-prescription of Fibrinolytics in the First 24 Hours【【【【SC】】】】 --No --Yes--Allergy

--Yes--Other (Specify) ______【F】

138 Documented Reasons for Non-prescription of GP IIB/IIIA Inhibitor【【【【SC】】】】 --No --Allergy/Intolerance --Patient Refused --Fibrinolytics Given --Active or Recent (In Past 4 Weeks) Bleeding --Warfarin/Coumadin as Pre-Arrival Medication

--Other Reason Documented by Physician, Specify _____【【【【F】

139 Documented Reasons for Non-prescription of Heparins【【【【SC】】】】 --No --Allergy

--Other (Specify) _____【【【【F】

140 Documented Reasons for Non-prescription of other Anti-Thrombin Agents (e.g. Bivalirudin/Lepirudin/Argatroban)【【【【SC】】】】 --Allergy/Intolerance --Patient Refused --Stroke or Other Cerebrovascular Event in the Past Year --Known Intracranial Neoplasm --Active or Recent (Past 4 Weeks) Internal Bleeding --Suspected Aortic Dissection --Recent Surgery --Severe Uncontrolled Hypertension on Presentation --Pregnancy --Trauma

--Other Reason (Specify) _____【F】

141 Documented Reasons for Non-prescription of Aspirin at Discharge【【【【SC】】】】 --No --Yes--Allergy


142 Documented Reasons for Non-prescription of ACE Inhibitor at Discharge【【【【SC】】】】

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--No --Yes--Allergy


143 Documented Reasons for Non-prescription of ARB at Discharge【【【【SC】】】】 --No --Yes--Allergy


144 Documented Reasons for Non-prescription of Beta-blocker at Discharge

【【【【SC】】】】

--No --Yes--Allergy


145 Documented Reasons for Non-prescription of Statin at Discharge【【【【SC】】】】 --No --Yes--Allergy


In-Hospital Device Placement

146 ICD【【【【SC】】】】

--Yes --No

147 ICD Date _____【【【【C】】】】

148 IABP【【【【SC】】】】 --Yes --No

149.1 IABP Date _____【【【【C】】】】

149.2 IABP Time _____【【【【F】】】】

Coronary Angiography and PCI Report

150 Diagnostic Catheterization or Diagnostic Coronary Angiography【【【【SC】】】】

--Yes --No

151.1 Procedure Start Date_____【【【【C】】】】

151.2 Procedure Start Time_____【【【【F】】】】

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152 Arterial Access Site【【【【SC】】】】

--Femoral Artery --Radial Artery --Brachial Artery --Other

153 Arterial Dominance【【【【SC】】】】

--Left Coronary Artery --Right Coronary Artery --Co-dominant --Unrecorded

154 If the Patient Has Not Had a CABG, Is Percent Stenosis Available in Each

of the Native Vessels?【【【【MC】】】】 --Left Main Artery (LM) --Proximal LAD --Mid/Distal LAD/Diag Branches --Circ/OMs/LPDA and LPL Branches --Ramus --RCA/RPDA/RPL/AM Branches --None of the Above is Recorded

155 LM Stenosis Percent _____【【【【F】】】】

156 Proximal LAD Stenosis Percent _____【【【【F】】】】

157 Mid/Distal LAD/Diagonal Stenosis Percent _____【【【【F】】】】

158 Circ/OMs/LPDA/LPL Stenosis Percent _____【【【【F】】】】

159 RCA/PRDA/RPL/AM Stenosis Percent _____【【【【F】】】】

160 Ramus Stenosis Percent _____【【【【F】】】】

161 Graft Vessel(s) Used for Previous CABG 【【【【MC】】】】

--LIMA --RIMA --Radial Artery --SVG --Unrecorded --No CABG History

162 Graft Percent Stenosis【【【【F】】】】

--Graft to Proximal LAD --Graft to Mid/Distal LAD/Diag Branches --Graft to Circ/OMs/LPDA and LPL Branches --Graft to RCA/RPDA/RPL/AM Branches

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--Graft to Ramus --LIMA --RIMA --SVG

163 Intravascular Ultrasound (IVUS ) Performed during the Procedure?【【【【SC】】】】

--Yes --No

164 Left Main Stem Protected?【【【【SC】】】】

--Yes --No

165 Mechanical Ventricular Support【【【【SC】】】】

--None --IABP --ECMO --LVAD

166 If Yes, Timing for IABP Implantation【【【【SC】】】】 --In Place at Start of Procedure --Inserted During Procedure and Prior to PCI --Inserted After PCI has Begun

167 If Yes, Timing for ECMO or LVAD Implantation【【【【SC】】】】 --In Place at Start of Procedure --Inserted During Procedure and Prior to PCI --Inserted After PCI has Begun

168 Recommendation (After Diagnostic Cath)【【【【MC】】】】 --None --Medical Therapy/Counseling --PCI without Planned CABG --CABG (Including Planned Hybrid Procedures) --Other Cardiac Therapy without CABG or PCI

169 Was PCI Performed Immediately Following Diagnostic Catheterization

【【【【SC】】】】

--Yes --No

170.1 PCI Date _____【【【【C】】】】

170.2 PCI Start Time _____【【【【F】】】】

171 Arterial Access Site【【【【SC】】】】

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--Femoral Artery --Radial Artery --Brachial Artery --Other

172 Cardiogenic Shock at Start of PCI【【【【SC】】】】

--Yes --No

173.1 Systolic Blood Pressure Prior to PCI _____mmHg【【【【F】】】】

173.2 Dilated Blood Pressure Prior to PCI _____mmHg【【【【F】】】】

173.3 Heart Rate Prior to PCI _____bpm【【【【F】】】】

174 Time of the First Treatment of Lesion (AngioJet/Other Thrombectomy/Aspiration Device/Laser/Rotational Atherectomy)

_____【【【【F】】】】

175 Time of the First Balloon Inflation _____【【【【F】】】】

176 Lesion Counter _____【【【【F】】】】

177 Choose Segments Below in Which Lesion is Located【【【【MC】】】】 --Left Main Artery (LM) --Proximal LAD --Mid/Distal LAD/Diag Branches --Circ/OMs/LPDA and LPL Branches --Ramus --RCA/RPDA/RPL/AM Branches

178 Stenosis Immediately Prior to PCI _____%【【【【F】】】】

179 Fractional Flow Reserve Ratio Measured during the Procedure _____【【【【F】】】】

180 Pre-Procedure TIMI Flow (Lowest TIMI Flow within the Entire Lesion)【【【【SC】】】】 --TIMI-0 --TIMI-1 --TIMI-2 --TIMI-3 --Unrecorded

181 Pre-treated Lesion【【【【SC】】】】

--Yes --No

182 If Yes, Treated with Stent【SC】

--Yes

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--No

183 If Yes, Reasons for PCI at Site of Former Stent【【【【SC】】】】 --In-stent Restenosis --In-stent Thrombosis --Unrecorded

184 Was Lesion in Bypass Graft【【【【SC】】】】

--Not in Graft --Vein --LIMA --Other Artery --Unrecorded

185 If Vein, LIMA, Other, Location in Graft【【【【SC】】】】

--Aortic (Proximal Vessel) --Body (Mid Vessel) --Distal --Unrecorded

186 Lesion Length ______mm【【【【F】】】】

187 The Characteristics of the Lesion【【【【MC】】】】 --Thrombus Present in the Lesion --Bifurcation Lesion --Calcified Lesion --Type A Lesion --Type B Lesion --Type C Lesion --None of the Above Is Recorded

188 Did Guidewire Cross the Lesion?【【【【SC】】】】

--Yes --No

189 Time Guidewire Crossed the Lesion _____【【【【F】】】】

190 Was a Stent Placed【【【【SC】】】】 --Yes --No

191 If Yes, Time Stent Deployment _____【【【【F】】】】

192.1 The First Stent’s Trade Name _____【【【【D】】】】

192.2 The Second Stent’s Trade Name _____【【【【D】】】】

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192.3 The Third Stent’s Trade Name _____【【【【D】】】】

193.1 The First Stent’s Diameter _____【【【【F】】】】

193.2 The First Stent’s Length _____【【【【F】】】】

193.3 The Second Stent’s Diameter _____【【【【F】】】】

193.4 The Second Stent’s Length _____【【【【F】】】】

193.5 The Third Stent’s Diameter _____【【【【F】】】】

193.6 The Third Stent’s Length _____【【【【F】】】】

194 Post-Procedural Percent Stenosis for the Treated Lesion _____%【【【【F】】】】

195 Post-Procedure TIMI Flow (Coded the Lowest TIMI Flow within the Entire Lesion【【【【SC】】】】

--TIMI-0 --TIMI-1 --TIMI-2 --TIMI-3 --Unrecorded

【196-275】Repeat Question 176 to 195 for Another 4 Lesions】

276 Were Any of the Following Devices Used?【【【【SC】】】】

--None --Balloon --Cutting Balloon --Rotablator --Aspiration Catheters --IVUS --Pressure Wire --Flowire --Brachytherapy --Distal/Proximal Embolic Protection --Thrombectomy Device

277 Was Left Ventricular Ejection Fraction Measured during the Procedure

【【【【SC】】】】

--Yes, EF=______% 【F】

--No

278 Type of Contrast Dye Used【【【【SC】】】】

--Lopamidol --Lopromide --Lohexol

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--Lodixanol --Lomeprol --Loversol --Other --Unrecorded

279 Total Volume of Contrast Dye Used _____ml【【【【F】】】】

280 Closure Method【【【【SC】】】】

--Seal (Angioseal/Vasoseal) --Suture --Manual Compression --Other Method --Unrecorded

281 PCI Complications【【【【MC】】】】

--Ventricular Tachycardia (VT) or Ventricular Fibrillation (V-Fib) --Significant Dissection --Perforation --Abrupt Vessel Closure in the Catheterization Laboratory --Side Branch Occlusion --Peripheral Embolization --Distal Embolization --No Flow/Slow Flow Phenomenon --Access Site Occlusion --Access Site Arteriovenous Fistula --Access Site Hematoma --Access Site Dissection --Access Complication Requiring Surgery/Intervention --None of the Above

【【【【282-414】】】】Repeat Question 150 to 281 for a Second Coronary Angiogram and/or PCI

CABG Report

415 CABG during Hospitalization?【【【【SC】】】】

--Yes --No

416 CABG Date _____【【【【C】】】】

Imaging Examination

417 Was Chest X-ray or Other Lung Imaging (Chest CT/MRI) Performed?【【【【SC】】】】

--Yes

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--No

418 Was Echocardiography Performed?【【【【SC】】】】

--Yes --No

419 Echocardiography LVEF Value _____%【【【【F】】】】

420 Was a Stress Test Performed?【【【【SC】】】】 --Yes --No

421.1 Stress Test Type【【【【SC】】】】

--ECG Only --Radionuclide --Echocardiography --Cardiac MRI --Unrecorded

421.2 Method of Stress Test【【【【SC】】】】

--Exercise --Pharmacologic --Unrecorded

422 Results of Stress Test【【【【SC】】】】

--Negative --Positive --Indeterminate --Unrecorded

423 Was a Coronary CT Angiogram Performed?【【【【SC】】】】

--Yes --No

424 Coronary Calcium Score _____【F】

In-Hospital ECG

425 Was the ECG Performed at Hospital Presentation Available in Medical

Record?【【【【SC】】】】 --Yes --No

426 Original Interpretation of ECG【【【【MC】】】】

--Acute MI

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--New Complete LBBB --Old Complete LBBB --Complete LBBB (Unspecified) --ST-Elevation --ST-Depression --Previous MI (Q Wave) --Ventricular Fibrillation --Ventricular Tachycardia --Atrial Fibrillation --2nd Degree Atrioventricular Block Type 1 --2nd Degree Atrioventricular Block Type 2 --3nd Degree Atrioventricular Block

Temperature Report

0.1 Admission Date _____【【【【C】】】】

0.2 Admission Time _____【【【【F】】】】

Discharge Date _____【【【【C】】】】

Height _____cm【【【【F】】】】

Admission Weight _____kg【【【【F】】】】

Long-term Physician Orders

Name of Long-term Medications _____【【【【D】】】】

Start Time _____【【【【F】】】】

Administration【SC】

--P.O. /Undefined --I.V. drip/ I.V. gtt (intravenously guttae) --I.V. --I.H. (Hypodermic Injection) --I.D. (Intradermal Injection) --Others

Dose _____【【【【F】】】】

Unit _____【【【【SC】】】】 --g --mg --ml --U --piece/ # --mg/kg

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--mg/h --mg/min --mg/kg·h --ml/kg --ml/h --ml/min --ml/kg·min --U/kg --U/min --U/h --U/kg·h --ug --ug/kg --ug/min --ug/kg·min --MU --BU --Other --Unrecorded

Frequency【SC】

--Qd /QN --Bid/q12h --Tid/q8h --Q6h --As Needed --Others --Unrecorded

End Date and Time_____【F】

【【【【434-591】】】】Repeat Questions No.432 to 433 for the Other 79 Available Agents

Short-term Physician Orders

592 Name of Short-term Medications ______【【【【D】】】】

593 Start Time______【【【【F】】】】

Administration【SC】

--P.O. /Undefined --I.V. drip/ I.V. gtt (intravenously guttae) --I.V. --I.H. (hypodermic injection) --I.D. (intradermal injection) --Others

Dose _____【【【【F】】】】

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Unit _____【【【【SC】】】】 --g --mg --ml --U --Piece/ # --mg/kg --mg/h --mg/min --mg/kg·h --ml/kg --ml/h --ml/min --ml/kg·min --U/kg --U/min --U/h --U/kg·h --ug --ug/kg --ug/min --ug/kg·min --MU --BU --Other --Unrecorded

Frequency【SC】


【594-791】】】】Repeat Questions No.592 to 593 for the other 99 Available Agents

Discharge Medications

792 Discharge Agent _____【【【【D】】】】

793 Administration【SC】

--I.V. drip/ I.V. gtt (intravenously guttae) --I.V. --I.H. (hypodermic injection) --I.D. (intradermal injection) --Others

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Dose _____【【【【F】】】】

Unit _____【【【【SC】】】】 --g --mg --ml --U --Piece/ # --mg/kg --mg/h --mg/min --mg/kg·h --ml/kg --ml/h --ml/min --ml/kg·min --U/kg --U/min --U/h --U/kg·h --ug --ug/kg --ug/min --ug/kg·min --MU --BU --Other --Unrecorded

Frequency【SC】


【【【【794-821】】】】Repeat Questions No.792 to 793 for the other 79 Available Agents

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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY CASE REPORT FORM, PART 2

Contents The Face Sheet of Medical Records ........................................................................ 43 Lab Test ................................................................................................................... 49

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1 Study ID _____【【【【Free Text (F)】】】】

The Face Sheet of Medical Records

2 Medical Record Number _____【【【【F】】】】

3 Medical Insurance【【【【Single Choice (SC)】】】】

--Payment Out-of-Pocket --Free Medical Care --Urban Residents/Worker Medical Insurance --Comprehensive Arrangement for Serious Disease --New-Type Rural Cooperative Medical System (CMS) --Poverty Assistance Insurance --Commercial Medical Insurance --Other Social Insurance --Unrecorded

4 Gender【【【【SC】】】】

--Male --Female

5 Age _____【F】

6 Marital Status【【【【SC】】】】 --Married --Single --Divorced --Widowed --Unrecorded

7 Occupation【【【【SC】】】】

--Retired --Worker (Industrial/Mining/Construction/Other Similar Type of Work) --Farmer --Office work --Cadre --Teacher --Student --Physician --Businessman --Engineer --Policeman or Soldier --Freelancers --Unemployed --Other --Unrecorded

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8 Ethnicity【【【【SC】】】】

--Han --Zhuang --Man --Hui --Miao --Weiwuer --Tujia --Yi --Menggu --Zang --Buyi --Other --Unrecorded

9 Nationality【【【【SC】】】】

--China --Other --Unrecorded

10 Location of Residence【【【【SC】】】】

--Urban --Rural --Overseas --Unrecorded

11 Postal Code of Residence _____【【【【F】】】】

12 Admission Date _____【【【【C】】】】

13 Admission Time _____【【【【F】】】】

14 Discharge Date _____【【【【C】】】】

15 Department of Admission【【【【SC】】】】 --Cardiovascular Department --Internal Medicine Department --Geriatrics --Cadre's Ward --Intensive Care Unit (ICU) --Coronary Care Unit (CCU) --Other --Unrecorded

16 Was Patient Transferred from One Department to Another?【【【【SC】】】】

--Yes

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--No --Unrecorded

17 Discharge Department【【【【SC】】】】

--Cardiovascular Department --Internal Medicine Department --Geriatrics --Cadre's Ward --Intensive Care Unit (ICU) --Coronary Care Unit (CCU) --Other --Unrecorded

18 Date Diagnosis Was Confirmed _____【【【【C】】】】 19 Admission Diagnoses (Related to Coronary Heart Disease)

【【【【Multiple Choices Permitted (MC)】】】】 --Coronary Heart Disease --Acute Coronary Syndrome --Acute Myocardial Infarction --Acute Extensive Anterior Myocardial Infarction --Acute Anterior Myocardial Infarction --Acute Septal Myocardial Infarction --Acute Inferior Myocardial Infarction --Acute Lateral Myocardial Infarction --Acute Posterior Myocardial Infarction --Acute Right Ventricular Myocardial Infarction --Acute Non ST-Elevation Myocardial Infarction --Acute ST-Elevation Myocardial Infarction --Subendocardial Myocardial Infarction --Acute Myocardial Infarction Suspected --Previous Q-wave Myocardial Infarction --Unstable Angina Pectoris --Stable Angina Pectoris --Prinzmetal's Angina --Angina (Unrecorded Subtype) --None of the Above is Recorded

20 Admission Diagnoses (Unrelated to Coronary Heart Disease)【【【【MC】】】】

--Cardiac Arrest --Cardiogenic Shock --Ventricular Fibrillation/Ventricular Tachycardia --Atrial Fibrillation --Acute Heart Failure --Chronic Heart Failure --Heart Failure (Unspecified) --Acute Pulmonary Edema --Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage) --Ischemic Stroke (Cerebral Infarction/Cerebral Embolism/Cerebral Thrombosis)

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--Stroke (Unspecified) --Pneumonia --COPD Exacerbation --Gastrointestinal Bleeding --Acute Renal Failure --Chronic Renal Failure --Dialysis (Hemodialysis/Peritoneal Dialysis) --Dyslipidemia --Hypertension --Diabetes Mellitus --Gastroesophageal Reflux --Oesophagismus --Cholelithiasis --Anemia

21 Discharge Diagnoses【【【【MC】】】】

--Coronary Heart Disease --Acute Coronary Syndrome --Acute Myocardial Infarction --Acute Extensive Anterior Myocardial Infarction --Acute Anterior Myocardial Infarction --Acute Septal Myocardial Infarction --Acute Inferior Myocardial Infarction --Acute Lateral Myocardial Infarction --Acute Posterior Myocardial Infarction --Acute Right Ventricular Myocardial Infarction --Acute Non ST-Elevation Myocardial Infarction --Acute ST-Elevation Myocardial Infarction --Subendocardial Myocardial Infarction --Acute Myocardial Infarction Suspected --Previous Q-Wave Myocardial Infarction --Unstable Angina Pectoris --Stable Angina Pectoris --Prinzmetal's Angina --Angina (Unrecorded Subtype) --Repeated/Recurrent Myocardial Infarction --Repeated/Recurrent Unstable Angina --Cardiac Rupture --Papillary Muscle Rupture --Ventricular Septum Perforation --Cardiac Tamponade --Pericardial Effusion --Cardiogenic Shock --Cardiac Arrest --Atrial Fibrillation --Ventricular Tachycardia/Ventricular Fibrillation --Acute Heart Failure --Chronic Heart Failure --Heart Failure (Unspecified) --Acute Pulmonary Edema

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--Gastrointestinal Bleeding --Genitourinary Bleeding --Intracranial/Subdural Bleeding --Retroperitoneal Bleeding --Access Site Bleeding (Including Hematoma at Access Site) --Pericardial Bleeding --Bleeding (Unspecified) --Hemorrhagic Shock --Venous Thromboembolism --Pulmonary Embolism --Deep Vein Thrombosis --Ischemic Stroke (Cerebral Infarction/Thrombosis/Cerebral Embolism) --Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage) --Stroke (Unspecified) --Pneumonia --Infection --COPD Exacerbation --Dyslipidemia --Hypertension --Diabetes Mellitus --Diabetic Nephropathy --Acute Renal Failure --Chronic Renal Failure --Dialysis (Hemodialysis/Peritoneal Dialysis) --Contrast Reaction (Include Severe Allergic Reaction) --Contrast-Induced Nephropathy (CIN) --Thrombocytopenia --Gastroesophageal Reflux --Oesophagismus --Cholelithiasis --Anemia

22 ICD (for Every Diagnosis)【【【【SC】】】】

--ICD 9 --ICD 10 --Unrecorded

23 ICD9 (Specify) _____【【【【F】】】】

24 ICD10 (Specify) _____【【【【F】】】】

25 Nosocomial Infection (Specify) _____【【【【F】】】】

26 Drug Allergy (Specify) _____【【【【F】】】】

27 HBs-Ag【【【【SC】】】】 --Untested --Negative --Positive

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28 HCV-Ab【【【【SC】】】】

--Untested --Negative --Positive

29 HIV-Ab【【【【SC】】】】

--Untested --Negative --Positive

30 The First Procedure Date______【【【【F】】】】

31 Procedures Performed During Hospitalization【【【【MC】】】】 --PCI --CAG --PCI+CAG --PTCA --CABG --LVAD --IABP --ICD --Cardiac Resynchronization Therapy --CRT-D --Pacemaker

--Other (Specify) ______【F】

32 The Second Procedure Date _____【【【【F】】】】

33 Procedures Performed during Hospitalization【【【【MC】】】】 --PCI --CAG --PCI+CAG --PTCA --CABG --LVAD --IABP --ICD --Cardiac Resynchronization Therapy --CRT-D --Pacemaker

--Other (Specify) ______【F】

34 Gross Charge _____ Yuan【【【【F】】】】

35 Autopsy【【【【SC】】】】

--Yes

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--No --Unrecorded

36 The Type of Blood Transfusion【【【【MC】】】】

--No Blood Transfusion --Red Blood Cell --Platelet --Blood Plasma --Whole Blood

--Other (Specify)______【F】

Lab Test

37 Unit of Myohemoglobin【【【【SC】】】】

--IU/L --ng/ml --mg/ml --Other

38 Myohemoglobin Upper Limit of Normal (ULN) _____【【【【F】】】】

39 Initial Myohemoglobin Value _____【【【【F】】】】

40 Initial Myohemoglobin Date and Time _____【【【【C】】】】

41 Maximum Myohemoglobin _____【【【【F】】】】

42 Maximum Myohemoglobin Date and Time _____【【【【C】】】】

43 Unit of Creatine Kinase (CK) Level【【【【SC】】】】 --IU/L --ng/ml --mg/ml --% --mg/IU --ml/IU

44 Initial CK Upper Limit of Normal (ULN) _____【【【【F】】】】

45 Initial Creatine Kinase (CK) Value _____【【【【F】】】】

46 Initial Creatine Kinase (CK) Date and Time _____【【【【C】】】】

47 Maximum Creatine Kinase (CK) Value _____【【【【F】】】】

48 Maximum Creatine Kinase (CK) Date and Time _____【【【【C】】】】

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49 Unit of Creatine Kinase (CK-MB) Level【【【【SC】】】】 --IU/L --ng/ml --mg/ml --% --mg/IU --ml/IU

50 Initial CK-MB Upper Limit of Normal (ULN) _____【【【【F】】】】

51 Initial CK-MB Value _____【【【【F】】】】

52 Initial CK-MB Date and Time _____【【【【F】】】】

53 Maximum CK-MB Value _____【【【【F】】】】

54 Maximum CK-MB Date and Time _____【【【【C】】】】

55 Unit of Troponin I【【【【SC】】】】 --ng/ml --IU/L or U /L --Other

56 Initial Troponin I Value【【【【SC】】】】

--Positive --Negative

--Trace（+/-）

--Numerical Value______【F】

57 Initial Troponin I Upper Reference Limit (URL) _____【【【【F】】】】

58 Initial Troponin I Value _____【【【【F】】】】

59 Initial Troponin I Date and Time _____【【【【C】】】】

60 Maximum Troponin I Value _____【【【【F】】】】

61 Maximum Troponin I Date and Time _____【【【【C】】】】

62 Unit of Troponin T【【【【SC】】】】

--ng/ml --IU/L or U /L --Other

63 Initial Troponin T Value【【【【SC】】】】


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--Numerical Value

64 Initial Troponin T Upper Reference Limit (URL) _____【【【【F】】】】

65 Initial Troponin T Value _____【【【【F】】】】

66 Initial Troponin T Date and Time _____【【【【C】】】】

67 Maximum Troponin T Value _____【【【【F】】】】

68 Maximum Troponin T Date and Time _____【【【【C】】】】

69 Unit of Troponin (Unspecified) 【【【【SC】】】】 --ng/ml --IU/L or U /L --Other

70 Initial Troponin (Unspecified) Value【【【【SC】】】】

--Positive --Negative --Numerical Value

71 Initial Troponin (Unspecified) Upper Reference Limit (URL) _____【【【【F】】】】

72 Initial Troponin (Unspecified) Value _____【【【【F】】】】

73 Initial Troponin (Unspecified) Date and Time _____【【【【C】】】】

74 Maximum Troponin (Unspecified) value _____【【【【F】】】】

75 Maximum Troponin (Unspecified) Date and Time _____【【【【C】】】】

76 First White Blood Cell (WBC) Value ______ X109【【【【F】】】】

77 Date and Time ______【【【【C】】】】

78 Initial Neutrophil Ratio _____ %【【【【F】】】】

79 Date and Time _____【【【【C】】】】

80 Initial Hemoglobin Value _____ g/L【【【【F】】】】

81 Date and Time _____【【【【C】】】】

82 Initial Platelet Count Value _____ x109【【【【F】】】】

83 Date and Time _____【【【【C】】】】

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84 Initial HCT Value _____【【【【F】】】】

85 Date and Time_____【【【【C】】】】

86 Minimum Platelet Count Value _____x109【【【【F】】】】

87 Date and Time _____【【【【C】】】】

88 Lowest Recorded Hemoglobin Value _____g/L【【【【F】】】】

89 Date and Time _____【【【【C】】】】

90 Last Hemoglobin Value _____g/L【【【【F】】】】

91 Date and Time _____【【【【C】】】】

92 Minimum HCT Value _____【【【【F】】】】

93 Date and Time _____【【【【C】】】】

94 Last HCT Value _____【【【【F】】】】

95 Date and Time _____【【【【F】】】】

96 Initial Urine Routine Date and Time _____【【【【C】】】】

97 Urine Protein【【【【SC】】】】 --Negative --Positive/+

--Trace（+/-）

--++ --+++ --++++

98 Initial LDH value _____(U/L;IU/L)【【【【F】】】】

99 Date and Time _____【【【【C】】】】 100 Units of Glucose

--mg/ml --mmol/L --Other

101 Initial GLU Value _____【【【【F】】】】

102 Glycosylated Hemoglobin (HbA1c) _____%【【【【F】】】】

103 Initial ALT Value _____U/L【【【【F】】】】

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104 Date and Time _____【【【【C】】】】

105 Initial AST Value _____U/L【【【【F】】】】

106 Date and Time _____【【【【C】】】】

107 Maximum ALT _____U/L【【【【F】】】】

108 Date and Time _____【【【【C】】】】

109 Maximum AST _____U/L【【【【F】】】】

110 Date and Time _____【【【【C】】】】

111 Lowest ALT _____U/L【【【【F】】】】

112 Date and Time _____【【【【C】】】】

113 Lowest AST _____U/L【【【【F】】】】

114 Date and Time_____【【【【C】】】】

115 Initial Total Bilirubin Value _____umol/L【【【【F】】】】

116 Date and Time _____【【【【C】】】】

117 Initial Direct Bilirubin Value _____ umol/L【【【【F】】】】

118 Date and Time _____【【【【C】】】】

119 Units of Creatinine【【【【SC】】】】 --mg/dL --Mmol/L --Other

120 Initial Creatinine Value _____【【【【F】】】】

121 Date and Time _____【【【【C】】】】

122 Maximum Creatinine Value _____【【【【F】】】】

123 Date and Time _____【【【【C】】】】

124 Last Creatinine Value _____【【【【F】】】】

125 Date and Time _____【【【【C】】】】

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126 Units of BUN【【【【SC】】】】 --mg/dL --Mmol/L --Other

127 Initial BUN Value _____【【【【F】】】】

128 Date and Time _____【【【【C】】】】

129 Maximum BUN Value _____【【【【F】】】】

130 Date and Time _____【【【【C】】】】

131 Units of Lipid【【【【SC】】】】

--mg/dl --Mmol/L --Other

132 Initial Lipid Date and Time _____【【【【C】】】】

133 Total Cholesterol Value _____【【【【F】】】】

134 HDL Cholesterol Value _____【【【【F】】】】

135 LDL Cholesterol Value _____【【【【F】】】】

136 Triglycerides Value _____【【【【F】】】】

137 Initial Potassium Value _____ (mEq/L; mmol/L)【【【【F】】】】

138 Date and Time _____【【【【C】】】】

139 Last Potassium Value _____(mEq/L; mmol/L)【【【【F】】】】

140 Date and Time _____【【【【C】】】】

141 Units of BNP/NT-pBNP【【【【SC】】】】 --pg//ml --ug/L --ug//ml --Fmol/L --Other

142 Initial BNP Value _____【【【【F】】】】

143 Date and Time _____【【【【C】】】】

144 Initial NT-pBNP Value _____【【【【F】】】】

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145 Date and Time _____【【【【C】】】】

146 Units of CRP【【【【SC】】】】 --mg/L --pg//ml --Other

147 Initial CRP Value _____【【【【F】】】】

148 Units of HsCRP【【【【SC】】】】 --mg/L --pg//ml --Other

149 Initial HsCRP Value _____【【【【F】】】】

150 Initial Coagulation Examination Date and Time _____【【【【C】】】】

151 INR Value _____【【【【F】】】】

152 APTT Value _____ s【【【【F】】】】

153 PT Value _____s【【【【F】】】】

154 The Second Coagulation Examination Date and Time _____【【【【C】】】】

155 INR Value _____【【【【F】】】】

156 APTT Value _____s【【【【F】】】】

157 PT Value _____s【【【【F】】】】

158 The Third Coagulation Examination Date and Time _____【【【【C】】】】

159 INR Value _____【【【【F】】】】

160 APTT Value _____s【【【【F】】】】

161 PT Value _____s【【【【F】】】】

162 The Fourth Coagulation Examination Date and Time _____【【【【C】】】】

163 INR Value _____【【【【F】】】】

164 APTT Value _____s【【【【F】】】】

165 Initial PT Value _____ s【【【【F】】】】

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166 The Fifth Coagulation Examination Date and Time _____【【【【C】】】】

167 INR Value _____【【【【F】】】】

168 APTT Value _____s【【【【F】】】】

169 Initial PT Value _____ s【【【【F】】】】

170 The Sixth Coagulation Examination Date and Time _____【【【【C】】】】

171 INR Value _____【【【【F】】】】

172 APTT Value _____s【【【【F】】】】

173 Initial PT Value _____s【【【【F】】】】

174 HBsAg【【【【SC】】】】 --Positive --Negative

--Numerical Value _____【【【【F】】】】

175 HBsAg Upper Reference Limit (URL) _____【【【【F】】】】

176 Anti-HBs/HBs-Ab【【【【SC】】】】 --Positive

--Negative


177 Anti-HBs/HBs-Ab Upper Reference Limit (URL) _____【【【【F】】】】

178 HBeAg【【【【SC】】】】 --Positive --Negative


179 HBeAg Upper Reference Limit (URL) _____【【【【F】】】】

180 Anti-HBeAg/HBe-Ab【【【【SC】】】】



181 Anti-HBeAg/HBe-Ab Upper Reference Limit (URL) _____【【【【F】】】】

182 Anti-HBcAg/HBc-Ab【【【【SC】】】】


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183 Anti-HBcAg/HBc-Ab Upper Reference Limit (URL) _____【【【【F】】】】

184 PreS1【【【【SC】】】】



185 PreS1 Upper Reference Limit (URL) _____【【【【F】】】】

186 HCV-Ab (Unspecified)【【【【SC】】】】



187 HCV-Ab (Unspecified) Upper Reference Limit (URL) _____【【【【F】】】】

188 HCV IgG【【【【SC】】】】



189 HCV IgG Upper Reference Limit (URL) _____【【【【F】】】】

190 HCV IgM【【【【SC】】】】



191 HCV IgM Upper Reference Limit (URL) _____【【【【F】】】】

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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY DATA DICTIONARY

Study ID

Coding Instructions: Indicate the identification number for the study.

Medical Record Number

Coding Instructions: Indicate the identification number for this record.

Hospital Number

Coding Instructions: Indicate the identification number for this hospital.

Are Daily Records Included in This Medical Record?

Coding Instructions: Indicate if there are daily records available as a part of this medical record

Target Value: N/A

Selections: (1) No (2) Yes

Supporting Definition: (none)

Source: Definition per CORE team

Gender

Coding Instructions: Indicate the gender of the patient.

Selections: (1) Male (2) Female (3) Unrecorded

Age

Coding Instructions: Indicate the age of the patient in years.

Medical Insurance

Coding Instructions: Indicate the patient’s medical insurance status.

Target Value: N/A

Selections:

Payment Out-of-Pocket

Free Medical Care

Urban Residents/ Worker Medical Insurance

Comprehensive Arrangement for Serious Disease

New-Type Rural Cooperative Medical System (CMS)

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Poverty Assistance Insurance

Commercial Medical Insurance

Other Social Insurance

Unrecorded

Supporting Definitions:

Urban residents/worker medical insurance: the medical insurance provided by the

government for people who live in urban areas; also is the type of insurance provided by

a company or factory for their employees.

Farmer medical insurance: a new medical insurance type funded by the government for

farmers.

Business insurance: Insurance paid for by individuals to insurance companies.

Comprehensive arrangement for serious disease: Insurance for people living in urban

areas who are employed by a company or factory. Also may apply to persons who are

retired. Specifications vary by city. Covered diseases are different than that covered by

urban residents/worker medical insurance.

Poverty assistance insurance: Medical aid provided by the government for poverty-

stricken individuals to cover a portion of expenses

Free medical care: The government provides free medical treatment for a specific group

of people such as for disabled members of the armed forces.

Self-paying medical care: Indicated for those without medical insurance or for whom

certain diseases are not covered by insurance. Patient will pay for these costs.

Patients may have more than one insurance type at a given time. Abstractor should select all

that apply

Source: Definition per China team.

Height

Coding Instructions: Indicate the patient’s height in centimeters

Note(s): Measurement from the transferring facility is acceptable

Target Value: The first value between arrival at this facility and discharge

Selections: (none)

Supporting Definitions: (none)

Source: Adapted from AHA Get with the Guidelines ACTION registry

Admission Weight

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Coding Instructions: Indicate the patient’s weight in kilograms on admission

Note(s): Measurement from the transferring facility is acceptable

Target Value: The first value between first medical contact and discharge

Selections: (none)



Marital Status

Coding Instructions: Indicate the marital status of the patient

Target Value: N/A

Selections:

Married

Single

Divorced

Widowed

Unrecorded


Married – A formal union with a person of the opposite sex, typically as recognized by law, by

which they are considered husband and wife.

Single- Never been married.

Divorced – Previous marriage has been legally dissolved by a court or another legal body.

Widowed- A person who has lost his/her spouse to death and has not remarried.

Source: Definition per CORE team; Oxford English Dictionary

Occupation

Coding Instructions: Indicate the occupation of the patient

Target Value: N/A

Selections:

Retired

Worker (Industrial/Mining/Construction/Other Similar Type of Work)

Farmer

Office work

Cadre

Teacher

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Student

Physician

Businessman

Engineer

Policeman or Soldier

Freelancers

Unemployed

Other

Unrecorded

Supporting Definitions: Documentation of occupation by treating physician

Source: Definition per CORE team; China team

Ethnicity

Coding Instructions: Indicate the ethnicity of the patient

Target Value: N/A

Selections:

Han

Zhuang

Man

Hui

Miao

Weiwuer

Tujia

Yi

Menggu

Zang

Buyi

Other

Unrecorded

Supporting Definitions: The highlighted groups comprise the top 11 ethnicities by population

size among 56 ethnic groups within China.


Nationality

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Coding Instructions: Indicate the nationality of the patient

Target Value: N/A

Selections:

China

Other

Unrecorded

Supporting Definition: Nationality is the status of belonging to a nation by origin, birth, or

naturalization


Location of Residence

Coding Instructions: Indicate the patient’s location of resident based on the supporting definition.

Target Value: The value on arrival to facility

Selections: (1) Urban (2) Rural (3) Overseas (4) Unrecorded


Urban residence includes the areas of a city or municipality or Hong Kong, Macao and Taiwan

regions.

Rural residence includes the areas belonging to the countryside including associated townships

and villages.

Source: Definition per China team

Postal Code of Residence

Coding Instructions: Indicate patient’s postal code of primary residence

Target Value: The value on arrival to facility

Selections: (none)



Date of Arrival at Your Hospital

Coding Instructions: Indicate the date the patient arrived at your facility.

Target Value: N/A

Selections: (none)


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Time of Arrival at Your Hospital

Coding Instructions: Indicate the time the patient arrived at your facility.

Target Value: N/A

Selections: (none)



Was the Time of Arrival at Your Hospital Estimated?

Coding Instructions: Indicate if the time of arrival at your hospital was estimated.

Target Value: N/A



Source: Definition per CORE team.

Did The Patient Receive Medical Assistance at an Outside Facility Prior to Arrival?

Coding Instructions: Indicate if the patient received medical assistance at an outside facility prior

to arrival.

Target Value: N/A




Admission Date

Coding Instructions: Indicate the date the patient was admitted to your facility

Target Value: N/A

Selections: (none)



Admission Time

Coding Instructions: Indicate the time the patient was admitted to your facility

Target Value: N/A

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Selections: (none)



Department of Admission

Coding Instructions: Indicate the department responsible for the patient admission.

Target Value: N/A

Selections: (1) Cardiovascular Department (2) Internal Medicine Department (3) Geriatrics (4)

Cadre’s Ward (5) CCU (6) ICU (7) Other (8) Unrecorded



Patient Transferred from One Department to Another

Coding Instructions: Indicate if the patient was transferred to another department after initial

admission.

Target Value: N/A

Selections: (1) Yes (2) No (3) Unrecorded



Discharge Department

Coding Instructions: Indicate the department responsible for the patient’s discharge.

Target Value: N/A

Selections: (1) Cardiovascular Department (2) Internal Medicine Department (3) Geriatrics (4)

Cadre’s Ward (5) CCU (6) ICU (7) Other (8) Unrecorded



Discharge Date

Coding Instructions: Indicate the date the patient was discharged from your facility.

Target Value: N/A

Selections: (none)



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Date Diagnosis Was Confirmed

Coding Instructions: Indicate the date on which the principal discharge diagnosis was confirmed.

Target Value: N/A

Selections: N/A



Gross Charge of Hospitalization in Yuan

Coding Instructions: Indicate total charge for patient hospitalization

Target Value: N/A

Selections: (none)

Supporting Definitions: The entire charge associated with hospitalization.


Time since Symptom Onset

Coding Instructions: How much time has passed since onset of ischemic symptoms?

Target Value: N/A

Selections: (1) ___ Days (2) ___Hours

Supporting Definitions: For patients undergoing elective angiography or PCI, indicate the time

passed since ischemic symptoms worsened (for patients with previous ischemic symptoms) or

the time since ischemic symptoms began (for patients without previous ischemic symptoms).

For those undergoing primary percutaneous coronary intervention in the setting of acute

coronary syndromes, indicate the time since the most recent ischemic symptoms began.


Time of Symptom Onset (precise)

Coding Instructions: Indicate the time the patient first noted ischemic symptoms that lasted

greater than or equal to 10 minutes.

If an estimated symptom onset time is recorded, code 'symptom onset time estimated'.

Target Value: The first time symptoms lasted greater than 10 minutes on the symptom onset

date

Selections: (none)


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Note: If the symptom onset time is not specified in the medical record, it may be recorded as

0700 for morning; 1200 for lunchtime; 1500 for afternoon; 1800 for dinnertime; 2200 for evening

and 0300 if awakened from sleep.


Was Symptom Onset Time Estimated?

Coding Instructions: Indicate if the symptom onset time was estimated.

Target Value: N/A




Patient Chest Discomfort

Coding Instructions: Did the patient experience chest symptoms including chest pain, chest

discomfort, chest pressure, or other chest symptoms?

Target Value: N/A



Source: Definition per CORE team, adapted from the AHA Get with the Guidelines ACTION

registry

Time of Duration of Chest Discomfort

Coding Instructions: How long did the patient’s chest discomfort last?

Target Value: N/A

Selections: (1) greater than or equal to 10 minutes; (2) less than 10 minutes; (3) unrecorded



Did the Patient Have Ischemic Symptoms Other than Chest Discomfort?

Coding Instructions: Indicate if there is physician documentation of other ischemic symptoms.

Target Value: N/A


Supporting Definitions: Documentation of one or more of these symptoms warrants a “Yes”

answer: shortness of breath, pain at non-chest sites, nausea, vomiting, or fatigue

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Did Other Ischemic Symptoms Last 10 or More Minutes?

Coding Instructions: How long did other ischemic symptoms last?

Target Value: N/A

Selections: (1) No; (2) Yes; (3) unrecorded



Admission Diagnosis (Related to Coronary Heart Disease)

Coding Instructions: Indicate the admission diagnosis related to coronary heart disease

documented in the medical record.

Note(s): Mark as many of the choices that apply.

Selections: Coronary Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction,

Acute Extensive Anterior Myocardial Infarction, Acute Anterior Myocardial Infarction, Acute

Septal Myocardial Infarction, Acute Inferior Myocardial Infarction, Acute Lateral Myocardial

Infarction, Acute Posterior Myocardial Infarction, Acute Right Ventricular Myocardial Infarction,

Acute Non ST-Elevation Myocardial Infarction, Acute ST-Elevation Myocardial Infarction,

Subendocardial Myocardial Infarction, Acute Myocardial Infarction Suspected, Previous (Q-

wave) Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris, Prinzmetal's

Angina, Angina (Unrecorded Subtype), None of the Above Is Recorded.

Supporting Definition: If none of the above options is noted in the chart, mark “None of the

above is recorded”.


Admission Diagnosis (Unrelated to Coronary Heart Disease)

Coding Instructions: Indicate the admission diagnosis unrelated to coronary heart disease

documented in the medical record.


Selections: Cardiac Arrest, Cardiogenic Shock, Ventricular Fibrillation/Ventricular Tachycardia,

Atrial Fibrillation, Acute Heart Failure, Chronic Heart Failure, Heart Failure (unspecified), Acute

Pulmonary Edema, Hemorrhagic Stroke (Cerebral Hemorrhage/Subarachnoid Hemorrhage),

Ischemic Stroke (Cerebral Infarction/Cerebral Embolism/Cerebral Thrombosis), Stroke

(Unspecified), Pneumonia, COPD Exacerbation, Gastrointestinal Bleeding, Acute Renal Failure,

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Chronic Renal Failure, Dialysis (Hemodialysis/Peritoneal Dialysis), Dyslipidemia, Hypertension,

Diabetes Mellitus, Diabetic Nephropathy, Gastroesophageal Reflux, Oesophagismus,

Cholelithiasis, Anemia, None of the Above Is Recorded.


above is recorded”.


Antiplatelet Therapy Prior to Arrival

Coding Instructions: Indicate whether the patient was given aspirin, clopidogrel, ticlopidine or

other antiplatelet therapy by a health provider (EMS, transferring hospital, etc.) prior to arrival at

this hospital or if the patient self-administered aspirin after symptom onset.

Target Value: N/A




Fibrinolysis Prior to Arrival

Coding Instructions: Indicate whether the patient was given a fibrinolytic by a health provider

(EMS, transferring hospital, etc.) prior to arrival at this hospital.

Target Value: N/A

Selections: (1) No (2) Yes. If yes, please specify the name of the fibrinolytic agent that was

used.



CPR/Chest Compressions Prior to Arrival

Coding Instructions: Indicate if cardiopulmonary resuscitation (CPR) in any form, including chest

compression, was performed for the patient, prior to arrival

Target Value: Any occurrence between first medical contact and arrival to this facility


Supporting Definitions: CPR comprises of a series of interventions performed for patients with

sudden cardiac arrest in order to restore the perfusion and oxygenation of vital organs. Chest or

abdominal compression, ascertainment of patent airways, rescue breathing, as well as electrical

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cardioversion and defibrillation are the cornerstones of CPR. Medications (including

epinephrine, lidocaine, amiodarone, and atropine) may or may not be used during CPR.

Source: Definition per CORE team from: Field JM, Hazinski MF, Sayre MR, Chameides L,

Schexnayder SM, Hemphill R, Samson RA, Kattwinkel J, Berg RA, Bhanji F, Cave DM, Jauch

EC, Kudenchuk PJ, Neumar RW, Peberdy MA, Perlman JM, Sinz E, Travers AH, Berg MD, Billi

JE, Eigel B, Hickey RW, Kleinman ME, Link MS, Morrison LJ, O'Connor RE, Shuster M,

Callaway CW, Cucchiara B, Ferguson JD, Rea TD, Vanden Hoek TL. Part 1: executive

summary: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and

Emergency Cardiovascular Care. Circulation. 2010;122(suppl 3):S640–S656.

External Defibrillation Prior to Arrival

Coding Instructions: Indicate if there is documentation of electrical defibrillation by lay

responders or EMS personnel prior to arrival

Target Value: N/A




Temporary Cardiac Pacing Prior to Arrival

Coding Instructions: Indicate if there is documentation of temporary cardiac transcutaneous or

transvenous pacing by EMS personnel prior to arrival

Target Value: N/A




Cardiac Arrest Prior to Admission

Coding Instructions: Indicate if the patient had an episode of cardiac arrest prior to admission to

this facility.

Note(s): Evaluated by ED personnel and either (1) received attempts at external defibrillation or

chest compressions or (2) were pulseless but did not receive attempts to defibrillate or

cardiopulmonary resuscitation (CPR).

Target Value: Any occurrence prior to admission to this facility.


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Supporting Definitions: 'Sudden' cardiac arrest is the sudden cessation of cardiac activity so that

the victim becomes unresponsive, with no normal breathing and no signs of circulation. If

corrective measures are not taken rapidly, this condition progresses to sudden death. Cardiac

arrest should be used to signify an event as described above that is reversed, usually by CPR,

and/or defibrillation or cardioversion, or cardiac pacing. Sudden cardiac arrest is not the same

as sudden cardiac death. Sudden cardiac death describes a fatal event.

Source: ACC/AHA/HRS 2006 Key Data Elements and Definitions for Electrophysiological

Studies and Procedures; adapted from AHA Get with the Guidelines ACTION registry

CPR/Chest Compressions in the Emergency Department Prior to Admission

Coding Instructions: Indicate if cardiopulmonary resuscitation (CPR) in any form, including chest

compression, was performed for the patient in the emergency department prior to admission

Target Value: Any occurrence between arrival to the ED and admission


Supporting Definitions: CPR comprises of a series of interventions performed for patients with

sudden cardiac arrest in order to restore the perfusion and oxygenation of vital organs. Chest or

abdominal compression, ascertainment of patent airways, rescue breathing, as well as electrical

cardioversion and defibrillation are the cornerstones of CPR. Medications (including

epinephrine, lidocaine, amiodarone, and atropine) may or may not be used during CPR.

Source: Definition per CORE team from: Field JM, Hazinski MF, Sayre MR, Chameides L,

Schexnayder SM, Hemphill R, Samson RA, Kattwinkel J, Berg RA, Bhanji F, Cave DM, Jauch

EC, Kudenchuk PJ, Neumar RW, Peberdy MA, Perlman JM, Sinz E, Travers AH, Berg MD, Billi

JE, Eigel B, Hickey RW, Kleinman ME, Link MS, Morrison LJ, O'Connor RE, Shuster M,

Callaway CW, Cucchiara B, Ferguson JD, Rea TD, Vanden Hoek TL. Part 1: executive

summary: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and

Emergency Cardiovascular Care. Circulation. 2010;122(suppl 3):S640–S656.

External Defibrillation in Emergency Department Prior to Admission

Coding Instructions: Indicate if there is documentation of electrical defibrillation in the

emergency department prior to admission

Target Value: N/A




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Temporary Cardiac Pacing In Emergency Department Prior to Admission

Coding Instructions: Indicate if there is documentation of temporary transcutaneous or

transvenous cardiac pacing in the emergency department prior to admission

Target Value: N/A




Fibrinolysis in Emergency Room Prior to Admission

Coding Instructions: Indicate if fibrinolysis was given in the emergency room prior to admission.

Target Value: N/A


Supporting Definitions: If the patient received fibrinolysis, indicate the type of agent used

(streptokinase, urokinase, reteplase, or other).


Antiplatelet Therapy in the Emergency Department Prior to Admission

Coding Instructions: Indicate whether the patient was given aspirin, clopidogrel, ticlopidine or

other antiplatelet therapy by a health provider (EMS, transferring hospital personnel, etc.) in the

emergency department prior to admission.





Fibrinolysis in the Emergency Department Prior to Admission

Coding Instructions: Indicate whether the patient was given a fibrinolytic by a health provider

(EMS, transferring hospital, etc.) in the emergency department prior to admission.


Selections: (1) No (2) Yes. If yes, please specify the name of the fibrinolytic agent that was

used.



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ACUTE COEXISTING CONDITIONS AT PRESENTATION TO THIS FACILITY

Heart Failure on Presentation to This Facility

Coding Instructions: Indicate if there is physician documentation or report of HF on presentation

to this facility

Target Value: Any occurrence between first medical contact and arrival at this facility


Supporting Definitions: Heart failure is defined as physician documentation or report of any of

the following clinical symptoms of heart failure, described as: unusual dyspnea on light exertion,

recurrent dyspnea occurring in the supine position, fluid retention; or the description of rales,

jugular venous distension, pulmonary edema on physical exam, or pulmonary edema on chest

X-ray presumed to be due to cardiac dysfunction. A low ejection fraction without clinical

evidence of heart failure does not qualify as heart failure.

Source: Acute Coronary Syndromes Data Standards (JACC 2001 38: 2114 - 30), The Society of

Thoracic Surgeons; adapted from AHA Get with the Guidelines ACTION registry

Cardiogenic Shock on Presentation to This Facility

Coding Instructions: Indicate if the patient was in a state of cardiogenic shock on presentation to

this facility.

Note(s): Transient episodes of hypotension reversed with IV fluid or atropine do not constitute

cardiogenic shock. The hemodynamic compromise (with or without extraordinary supportive

therapy) must persist for at least 30 minutes.



Supporting Definitions: Cardiogenic shock is defined as a sustained (>30 minutes) episode of

systolic blood pressure <90 mm Hg, and/or cardiac index <2.2 L/min/m2 determined to be

secondary to cardiac dysfunction, and/or the requirement for parenteral inotropic or vasopressor

agents or mechanical support (e.g., IABP, extracorporeal circulation, ventricular assist devices)

to maintain blood pressure and cardiac index above those specified levels.

Source: Acute Coronary Syndromes Data Standards (JACC 2001 38: 2114 - 30); adapted from

AHA Get with the Guidelines ACTION registry

Pneumonia on Presentation to This Facility

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Coding Instructions: Indicate if there is physician documentation or report of pneumonia on

presentation to this facility



Supporting Definitions: Pneumonia is defined as physician documentation of pneumonia plus

the presence of a demonstrable infiltrate by chest radiograph or other imaging.

Source: Infectious Diseases Society of America/American Thoracic Society consensus

guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis.

2007 Mar 1;44 Suppl 2:S27-72; definition per CORE team

COPD Exacerbation on Presentation to This Facility

Coding Instructions: Indicate if there is physician documentation or report of exacerbated

(acute) COPD on presentation to this facility



Supporting Definitions: Exacerbated COPD is defined as physician documentation of

exacerbated COPD. Other clinical signs and radiographic findings are non-specific.


Acute Stroke on Presentation to This Facility

Coding Instructions: Indicate if there is physician documentation or report of an acute stroke on

presentation to this facility.



Supporting Definitions: Acute stroke is defined as physician documentation of an acute stroke


Active Gastrointestinal Bleeding on Presentation to This Facility

Coding Instructions: Indicate if there is physician documentation or report of active

gastrointestinal bleeding on presentation to this facility.



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Supporting Definitions: Active gastrointestinal bleeding is defined as physician documentation of

active hematemesis (upper gastrointestinal bleeding), active hematochezia (lower

gastrointestinal bleeding), or active melena (upper gastrointestinal bleeding).


Acute Renal Failure on Presentation to This Facility

Coding Instructions: Indicate if there is physician documentation or report of acute renal failure

on presentation to this facility



Supporting Definitions: Acute renal failure is defined as physician documentation of acute renal

failure


NYHA Functional Classification on Arrival

Coding Instructions: Indicate the physician documentation of New York Heart Association

functional class on the patient’s arrival to this facility

Target Value: N/A

Selections:

I – No limitation of physical activity. Ordinary physical activity does not cause undue

fatigue, palpitation, or dyspnea (shortness of breath)

II – Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity

results in fatigue, palpitation, or dyspnea.

III – Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity

causes fatigue, palpitation, or dyspnea.

IV – Unable to carry out any physical activity without discomfort. Symptoms of cardiac

insufficiency present at rest. If any physical activity is undertaken, discomfort is increased.

Unrecorded

Supporting Definitions: The NYHA functional classification system relates symptoms to

everyday activities and the patient's quality of life.

Source: Definition per CORE team; The Criteria Committee of the New York Heart Association.

Diseases of the heart and blood vessels. In: Nomenclature and Criteria for Diagnosis. 7th ed.

Boston: Little, Brown, 1973:286.

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Killip Classification on Arrival

Coding Instructions: Indicate the physician documentation of Killip classification on the patient’s

arrival to this facility

Target Value: N/A

Selections:

I - No rales over the lung fields and no S3.

II - Rales 50% or less over the lung fields or presence of an S3. Includes patients

documented as having bibasilar rales.

III - Rales more than 50% of the lung fields/frank pulmonary edema. Includes patients

documented as having rales throughout.

IV - Cardiogenic Shock

Unrecorded

Supporting Definitions: Killip classification is a method of prognostication and risk-stratification in

patients with acute myocardial infarction.

Source: Adapted from VIRGO registry

PAST MEDICAL HISTORY – RELATED TO HEART DISEASE

History of Angina or Coronary Heart Disease

Coding Instructions: Mark “Yes”, if documented history of angina or coronary heart disease is

present

Target Value: Any occurrence between birth and arrival at this faciltiy


Supporting Definitions: Indicate if there is physician documentation of history of angina or

history of coronary artery disease. Coronary heart disease may be abbreviated as CHD.

Presence of at least one of the two warrants a “Yes” answer.


History of Myocardial Infarction

Coding Instructions: Indicate if the patient has had at least one documented previous

myocardial infarction.

Target Value: Any occurrence between birth and arrival at this facility


Supporting Definitions: A myocardial infarction is evidenced by any of the following:

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1. A rise and fall of cardiac biomarkers (preferably troponin) with at least one of the

values in the abnormal range for that laboratory [typically above the 99th percentile of

the upper reference limit (URL) for normal subjects] together with at least one of the

following manifestations of myocardial ischemia:

a. Ischemic symptoms.

b. ECG changes indicative of new ischemia (new ST-T changes, new left bundle

branch block, or loss of R wave voltage).

c. Development of pathological Q- waves in 2 or more contiguous leads in the

ECG (or equivalent findings for true posterior MI).

d. Imaging evidence of new loss of viable myocardium or new regional wall

motion abnormality.

e. Documentation in the medical record of the diagnosis of acute myocardial

infarction based on the cardiac biomarker pattern in the absence of any items

enumerated in a-d due to conditions that may mask their appearance (e.g., peri-

operative infarct when the patient cannot report ischemic symptoms; baseline left

bundle branch block or ventricular pacing).

2. ECG changes associated with prior myocardial infarction can include the following

(with or without prior symptoms):

a. Any Q-wave in leads V2-V3 >=0.02 seconds or QS complex in leads V2 and

V3.

b. Q-wave >=0.03 seconds and >=0.1 mV deep or QS complex in leads I, II, aVL,

aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6;

II, III, and aVF).

c. R-wave >=0.04 seconds in V1-V2 and R/S >=1 with a concordant positive T-

wave in the absence of a conduction defect.

3. Imaging evidence of a region with new loss of viable myocardium at rest in the

absence of a non-ischemic cause. This can be manifest as:

a. Echocardiographic, CT, MR, ventriculographic or nuclear imaging evidence of

left ventricular thinning or scarring and failure to contract appropriately (i.e.,

hypokinesis, akinesis, or dyskinesis).

b. Fixed (non-reversible) perfusion defects on nuclear radioisotope imaging (e.g.,

MIBI, thallium).

4. Medical record documentation of prior myocardial infarction.

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Source: Joint ESC-ACC-AHA-WHF 2007 Task Force Consensus Document "Universal

Definition of Myocardial Infarction"; adapted from AHA Get with the Guidelines ACTION registry

Family History of CAD

Coding Instructions: Indicate if the patient has a family history of coronary artery disease.



Note(s): If the patient is adopted, or the family history is unavailable, code "No".

Supporting Definitions: Family History of Premature CAD Among Direct Relatives:

Family history includes any direct blood relatives (parents, siblings, children) who have had any

of the following diagnosed at age less than 55 years for male relatives or less than 65 years for

female relatives:

a. Angina

b. Acute myocardial infarction

c. Sudden cardiac death without obvious cause

d. Coronary artery bypass graft surgery

e. Percutaneous coronary intervention

Source: Adapted from AHA Get with the Guidelines CATH-PCI registry

History of Heart Failure

Coding Instructions: Indicate if there is a previous history of heart failure.

Note(s): A previous hospital admission with principal diagnosis of heart failure is considered

evidence of heart failure history.


Selection: (1) No (2) Yes


the following clinical symptoms of heart failure described as unusual dyspnea on light exertion,



X-ray presumed to be cardiac dysfunction. A low ejection fraction without clinical evidence of

heart failure does not qualify as heart failure.



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History of Percutaneous Coronary Intervention

Coding Instructions: Indicate if the patient had a previous percutaneous coronary intervention

(PCI) of any type (balloon angioplasty, stent or other).

Note (s): Timeframe does NOT include the current admission.



Supporting Definitions: A percutaneous coronary intervention (PCI) is the placement of an

angioplasty guide wire, balloon, or other device (e.g. stent, atherectomy, brachytherapy, or

thrombectomy catheter) into a native coronary artery or coronary artery bypass graft for the

purpose of mechanical coronary revascularization.


If Patient Had a Prior PCI, Most Recent PCI Date

Coding Instructions: Indicate the date of most recent PCI.

Target Value: N/A


Selections: Choose one of the following:

a. ＜1 Month Ago

b. 1-5 Months Ago

c. 6-12 Months Ago

d. 1-2 Years Ago

e. ＞2 Years Ago

f. Unrecorded

Note(s): If month or day are unknown enter 01.


History of Fibrinolysis

Coding Instructions: Indicate if the patient has previously received intravenous fibrinolysis.

Note(s): Timeframe does NOT include the current admission.





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History of CABG

Coding Instructions: Indicate whether the patient had a coronary artery bypass graft (CABG).

Note(s): Timeframe does NOT include the current admission.





If Patient Had a Prior CABG, Most Recent CABG Date【【【【SC】】】】

Coding Instructions: Indicate the date of most recent CABG.

Target Value: N/A

Selections:

a. ＜1 Month Ago

b. 1-5 Months Ago

c. 6-12 Months Ago

d. 1-2 Years Ago

e. ＞2 Years Ago

f. Unrecorded


Note(s): If month or day are unknown enter 01.


History of Atrial Fibrillation or Flutter

Coding Instructions: Indicate if there is a previous history of atrial fibrillation or flutter

Note(s): Code "No" if patient was first diagnosed with atrial fibrillation or flutter after reperfusion

during this admission. If there is no prior documentation of atrial arrhythmias, it is acceptable to

code "No"





History of Ventricular Tachycardia or Ventricular Fibrillation

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Coding Instructions: Indicate if there is a previous history of ventricular tachycardia or ventricular

fibrillation

Note(s): Code "No" if patient was first diagnosed with ventricular tachycardia or fibrillation after

reperfusion during this admission. If there is no prior documentation of ventricular arrhythmias, it

is acceptable to code "No"





History of Permanent Pacemaker

Coding Instructions: Indicate if the patient has a history of having a permanent pacemaker

Target Value: N/A


Supporting Definitions: Permanent pacemaker includes single-chamber, dual chamber, and

biventricular pacemakers


History of Bradycardia

Coding Instructions: Indicate if there is chart documentation for a previous history bradycardia.

Note(s): Code "No" if patient was first diagnosed with bradycardia during this admission. If there

is no prior documentation of bradycardia, it is acceptable to code "No".

Target Value: Any occurrence between birth and arrival at this facility.




History of Valvular Heart Disease

Coding Instructions: Indicate if there is chart documentation for a previous history of valvular

heart disease.



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Supporting Definitions: Valvular heart diseases include but are not limited to tricuspid stenosis,

tricuspid regurgitation, pulmonic stenosis, pulmonic regurgitation, mitral stenosis, mitral

regurgitation, aortic stenosis, and aortic regurgitation.


GENERAL PAST MEDICAL HISTORY

History of Hypertension

Coding Instructions: Indicate if the patient has been diagnosed previously with hypertension

Note(s): Code "No" if hypertension was first diagnosed after reperfusion during this admission.



Supporting Definitions: Hypertension is defined by any one of the following:

1. History of hypertension diagnosed and treated with medication, diet and/or exercise

2. Prior documentation of blood pressure greater than 140 mm Hg systolic and/or 90 mm

Hg diastolic for patients without diabetes or chronic kidney disease, or prior

documentation of blood pressure greater than 130 mm Hg systolic or 80 mm Hg diastolic

on at least two occasions for patients with diabetes or chronic kidney disease.

3. Currently on pharmacological therapy for the treatment of hypertension.



History of Dyslipidemia

Coding Instructions: Indicate if the patient has a history of dyslipidemia diagnosed and/or

treated by a physician.



Supporting Definitions: Dyslipidemia is defined by the National Cholesterol Education Program

criteria and includes documentation of the following:

1. Total cholesterol greater than 200 mg/dL (5.18 mmol/l); or

2. Low-density lipoprotein (LDL) greater than or equal to 130 mg/dL (3.37 mmol/l); or

3. High-density lipoprotein (HDL) less than 40 mg/dL (1.04 mmol/l).

4. Currently on pharmacologic therapy for the treatment of dyslipidemia.

For patients with known coronary artery disease, treatment is initiated if LDL is greater

than 100 mg/dL (2.59 mmol/l), and this would qualify as hypercholesterolemia.

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History of Chronic Renal Failure

Coding Instructions: Indicate if the patient has a history of chronic renal failure



Supporting Definitions: Chronic renal failure can be coded for any of the following:

1. A documented history of renal failure, and/or

2. A history of creatinine > 2.0 mg/dL, and/or

3. A documented history of chronic renal disease

Prior renal transplant patients are not included unless creatinine has been >2.0 mg/dL

since transplantation


Currently on Dialysis

Coding Instructions: Indicate if the patient is currently undergoing either hemodialysis or

peritoneal dialysis on an ongoing basis as a result of renal failure.

Note(s): Code "No" if patient was not on dialysis until after reperfusion during this admission.

Target Value: The value on arrival at this facility




History of Chronic Lung Disease

Coding Instructions: Indicate if the patient has a history of chronic lung disease.

A history of chronic inhalation reactive disease (asbestosis, mesothelioma, black lung disease

or pneumoconiosis) qualifies as chronic lung disease. Radiation induced pneumonitis or

radiation fibrosis also qualifies as chronic lung disease. A history of atelectasis is a transient

condition and does not qualify.

Notes: Code "No" if patient was first diagnosed with chronic lung disease after reperfusion

during this admission.



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Supporting Definitions: Chronic lung disease can include patients with chronic obstructive

pulmonary disease, chronic bronchitis, or emphysema. It can also include a patient who is

currently being chronically treated with inhaled or oral pharmacological therapy (e.g., beta-

adrenergic agonist, anti-inflammatory agent, leukotriene receptor antagonist, or steroid).

Patients with asthma or seasonal allergies are not considered to have chronic lung disease.


History of Peripheral Vascular Disease

Coding Instructions: Indicate if there is physician documentation of a history of peripheral

vascular disease

Target Value: N/A


Supporting Definitions: Mark “Yes” if there is exact mention of “a history of peripheral vascular

disease,” or extremity claudication, or history of lower extremity percutaneous or surgical

revascularization procedure.


History of Diabetes Mellitus. History and Risk Factors

Coding Instructions: Indicate if the patient has a history of diabetes mellitus, regardless of

duration of disease or need for antidiabetic agents.

Note(s): Code "No" if the patient was first diagnosed with diabetes mellitus after reperfusion

during this admission.



Supporting Definitions: Diabetes mellitus is diagnosed by a physician or can be defined as a

fasting blood sugar greater than 7 mmol/l or 126 mg/dL. It does not include gestational diabetes.

Diabetes mellitus can also be identified by history of pharmacologic treatment for condition.



History of Hepatitis B Infection

Coding Instructions: Mark “Yes”, if documented history of hepatitis B infection

Target Value: N/A


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History of Hepatitis C Infection

Coding Instructions: Mark “Yes”, if documented history of hepatitis C infection

Target Value: N/A




History of Liver Cirrhosis

Coding Instructions: Mark “Yes”, if documented history of liver cirrhosis is present

Target Value: N/A




Prior Carotid Artery Surgery/Intervention

Coding Instructions: Indicate if the patient has a history of prior carotid artery surgery or stenting



Supporting Definitions: Previous carotid artery surgery/ intervention for carotid artery stenosis.

This does not include neurological disease processes such as metabolic and/or anoxic ischemic

encephalopathy.

Source: The Society of Thoracic Surgeons; adapted from AHA Get with the Guidelines ACTION

registry

Prior Ischemic Stroke

Coding Instructions: Indicate if the patient has had an ischemic stroke.



Supporting Definitions: A prior stroke is defined as any confirmed neurological deficit of abrupt

onset caused by a disturbance in cerebral blood supply that did not resolve within 24 hours.


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Prior Hemorrhagic Stroke

Coding Instructions: Indicate if the patient has had a hemorrhagic stroke.






Prior Stroke, Unknown Subtype

Coding Instructions: Indicate if the patient has had a stroke, but subtype (ischemic,

hemorrhagic) is unknown.






PERSONAL HISTORY

Smoking History

Coding Instructions: Indicate the smoking status of the patient

Target Value: N/A

Selections: (1) Never smoked (2) Current Smoker (3) Past Smoker (4) Unrecorded

Supporting Definitions: Past smoker is defined as a person who was a daily smoker in the past

and stopped smoking at least three months prior to admission date, or chart documentation of

“past smoker”

Source: Definition per CORE team, based on: McCabe RE, Chudzik SM, Antony MM, Young L,

Swinson RP, Zolvensky MJ. Smoking behaviors across anxiety disorders. J Anxiety Disord

2004; 18: 7-18.

Smoking Duration among Current Smokers

Coding Instructions: Indicate the duration of time since the patient first started smoking

Target Value: N/A

Selections: (none)

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Supporting Definitions: Provide the duration in months


Smoking Duration for Past Smokers

Coding Instructions: Indicate the duration of time between when the patient first started smoking

and the cessation of smoking

Target Value: N/A

Selections: (none)

Supporting Definitions: Provide the duration in months


Smoking Frequency

Coding Instructions: Indicate the average number of cigarettes smoked per day

Target Value: N/A

Selections: (none)

Supporting Definitions: Provide the information as cigarettes per day


PHYSICAL EXAMINATION

Heart Rate at Presentation to This Facility

Coding Instructions: Indicate the first measurement or earliest record of heart rate (in beats per

minute).

Note(s): Measurement from EMS or the transferring facility is also acceptable.

Target Value: The first value after arrival at this facility

Selections: (none)



Systolic Blood Pressure at Presentation to This Facility

Coding Instructions: Indicate the first measurement or earliest record of systolic blood pressure

(in mm Hg).



Selections: (none)

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Diastolic Blood Pressure at Presentation to This Facility

Coding Instructions: Indicate the first measurement or earliest record of diastolic blood pressure

(in mm Hg).



Selections: (none)



Temperature at Presentation to This Facility

Coding Instructions: Indicate the first measurement or earliest record of temperature (degrees

Celsius).



Selections: (none)



Respiratory Rate at Presentation to This Facility

Coding Instructions: Indicate the first measurement or earliest record of respiratory rate (breaths

per minute).



Selections: (none)



Specify Home Medications

Coding Instructions: Indicate the names of medications been taken by patient routinely at home

prior to this hospitalization

Note(s): "Routinely" refers to the daily use of medications as prescribed, even if the patient

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misses a dose

Target Value: Any occurrence between 2 weeks prior to first medical contact and first medical

contact

Selections: (none)



AUXILIARY EXAMINATION

ECG at Hospital

Coding Instructions: Indicate if an ECG was obtained at the hospital

Target Value: N/A


Supporting Definitions: This will be considered for the first 3 ECGs.


Date of ECG at Hospital

Coding Instructions: Indicate the date ECG was obtained at presentation to the hospital

Target Value: N/A

Selections: (none)



Time of ECG at Hospital

Coding Instructions: Indicate the time ECG was obtained at presentation to the hospital

Target Value: N/A

Selections: (none)



ECG Results

Coding Instructions: Indicate the documented physician interpretation of the ECG


Target Value: N/A

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Selections: (1) acute myocardial infarction (2) left bundle branch block (3) ST-elevation

myocardial infarction (4) ST-Depression (5) Q-wave myocardial infarction (6) ventricular

fibrillation (7) ventricular tachycardia (8) atrial fibrillation (9) 2nd degree atrioventricular block

type 1 (10) 2nd degree atrioventricular block type 2 (11) 3rd degree atrioventricular block


OTHER DIAGNOSTIC TESTS

Chest X-Ray

Coding Instructions: Indicate whether the patient underwent a chest X-ray or not

Target Value: Any occurrence between arrival at admitting hospital and discharge




Echocardiography

Coding Instructions: Indicate whether the patient underwent echocardiography or not





Echocardiography Ejection Fraction (EF) Value

Instructions: Indicate the value of EF in percent documented in the echocardiography report.


Selections: (none)

Supporting Definition: LVEF: The left ventricular ejection fraction is the percentage of the blood

emptied from the left ventricle at the end of the contraction. The left ventricular ejection fraction

can be assessed via invasive (i.e. LV gram) or noninvasive (i.e. Echo, MR, CT or Nuclear)

testing.

Source: ACC Clinical Data Standards, The Society of Thoracic Surgeons; adapted from AHA

Get with the Guidelines ACTION registry

Stress Testing

Coding Instructions: Indicate whether the patient underwent stress testing or not

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Source: Adapted from AHA Get with the Guidelines registry

Type of Stress Test

Coding Instructions: Indicate the type of stress testing performed

Target Value: N/A

Selections:

1. ECG only

2. With imaging

a. Nuclear (SPECT/PET)

b. Echocardiography

c. Cardiac MRI

d. Unrecorded


Source: Modified from AHA Get with the Guidelines ACTION registry

Method of Stress Test

Coding Instructions: Indicate method of performing stress test

Target Value: N/A

Selections: (1) Exercise (2) Pharmacologic (3) Unknown



Stress Test Results

Coding Instructions: Indicate the results of the stress test.

Target Value: N/A

Selections: (1) Negative (2) Positive (3) Indeterminate (4) Unrecorded



Cardiac CT Angiogram

Coding Instructions: Indicate if the patient received a cardiac CT scan (Cardiac Cat Scan)

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Coronary Calcium Score

Coding Instructions: Indicate the reported coronary calcium score from the cardiac CT

angiogram.

Target Value: N/A


Supporting Definition: The score is usually reported in Hounsfield units.


LABORATORY TESTS

Initial Myohemoglobin Date and Time

Coding Instructions: Indicate the date and time when the initial myohemoglobin sample was

collected (not the date results reported).


Selections: (none)



Units of Myohemoglobin

Coding Instructions: Indicate the sample unit of measure of myohemoglobin level.

Target Value: N/A

Selections:

(1) IU/L

(2) ng/ml

(3) mg/mL

(4) Other



Initial Myohemoglobin Value

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Coding Instructions: Indicate myohemoglobin value.


Selections: (none)



Maximum Myohemoglobin Date and Time

Coding Instructions: Indicate the date and time of collection of the maximum myohemoglobin

value.

Target Value: Any occurrence during the entire hospital stay

Selections: N/A



Maximum Myohemoglobin Value

Coding Instructions: Indicate the value of maximum myohemoglobin.


Selections: (none)



Initial Creatine Kinase (CK) Value

Coding Instructions: Indicate the value of the initial CK.

Notes: Initial CK level corresponds to the first sample obtained within the first 24 hours of care.

It may also have been collected at the transferring hospital.

Target Value: Any occurrence between first medical contact and 24 hours after arrival at first

facility

Selections: N/A



Unit of Creatine Kinase (CK) Level

Coding Instructions: Indicate the sample unit of measure of CK level.

Target Value: N/A

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Selections:

(1) IU/L

(2) %

(3) (mg/mL)/IU

(4) ng/mL

(5) mg/IU

(6) MI/IU



Initial CK Upper Limit of Normal (ULN)

Coding Instructions: Indicate the ULN of the initial CK sample.

Note(s): If a range is given for ULN values, record the highest number in the range.

Examples: If the reference range given is 0.0-1.5, record ULN as 1.5. If the reference range

given is < 1.5, record ULN as 1.5 as well.

The initial sample value refers to the first sample obtained within the first 24 hours of care.

Target Value: N/A

Selections: N/A



Initial Creatine Kinase (CK) Date and Time

Coding Instructions: Indicate the date and time of collection of the initial CK.




facility

Selections: N/A



Maximum Creatine Kinase (CK) Level

Coding Instructions: Indicate the maximum CK level recorded during hospital stay.

Target Value: Any occurrence during the entire hospital stay.

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Selections: N/A



Maximum Creatine Kinase (CK) Date and Time

Coding Instructions: Indicate the date and time of collection of the maximum CK.


Selections: N/A



Initial CK-MB Value

Coding Instructions: Indicate the value of the initial CK-MB.

Notes: If a CK-MB value was not calculated at baseline for normal CPK results, record a value

of 0 (zero). Initial CK level corresponds to the first sample obtained within the first 24 hours of

care. It may also have been collected at the transferring hospital.


facility

Selections: N/A



Initial CK-MB Date and Time

Coding Instructions: Indicate the date and time of collection of the initial CK-MB.




facility

Selections: N/A



Unit of CK-MB Level

Coding Instructions: Indicate the sample unit of measure of CK-MB level.

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Target Value: N/A

Selections:

(1) IU/L

(2) %

(3) (mg/mL)/IU

(4) ng/mL



Initial CK-MB Upper Limit of Normal (ULN)

Coding Instructions: Indicate the ULN of the initial CK-MB sample.

Note(s): If a range is given for ULN values, record the highest number in the range.

Examples: If the reference range given is 0.0-1.5, record ULN as 1.5. If the reference range

given is < 1.5, record ULN as 1.5 as well.

The initial sample value refers to the first sample obtained within the first 24 hours of care.

Target Value: N/A

Selections: N/A



Initial Troponin I Value

Coding Instructions: Indicate the value of initial troponin I.

Notes: Initial troponin I level corresponds to the first sample obtained within the first 24 hours of



facility

Selections: (1) Positive (2) Negative (3) Trace (+/-) (4) Numerical value



Unit of Troponin I

Coding Instructions: Indicate the sample unit of measure of troponin I level.

Target Value: N/A

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Selections: (1) ng/mL (2) Other



Initial Troponin I Upper Reference Limit (URL)

Coding Instructions: Indicate the URL of the initial troponin I sample.

Target Value: N/A

Selections: N/A

Supporting Definition: Upper Reference Limit (URL):

Defined as the 99th percentile of troponin levels for a normal reference population.

Source: Joint ESC-ACC-AHA-WHF 2007 Task Force consensus document "Universal Definition

of Myocardial Infarction"; adapted from AHA Get with the Guidelines ACTION registry

Initial Troponin I Date and Time

Coding Instructions: Indicate the date and time of collection of the initial troponin I.

Notes: Initial troponin I level corresponds to the first sample obtained within the first 24 hours of



facility

Selections: N/A



Maximum Troponin I Level

Coding Instructions: Indicate the maximum troponin I level recorded during hospital stay.


Selections: N/A



Maximum Troponin I Date and Time

Coding Instructions: Indicate the date and time of collection of the maximum troponin I.


Selections: N/A

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Initial Troponin T Value

Coding Instructions: Indicate the value of initial troponin T.

Notes: Initial troponin T level corresponds to the first sample obtained within the first 24 hours of



facility

Selections: N/A



Unit of Troponin T

Coding Instructions: Indicate the sample unit of measure of troponin T level.

Target Value: N/A

Selections: (1) ng/mL (2) Other



Initial Troponin Upper Reference Limit (URL)

Coding Instructions: Indicate the URL of the initial troponin T sample.

Target Value: N/A

Selections: N/A




of Myocardial Infarction"


Initial Troponin T Date and Time

Coding Instructions: Indicate the date and time of collection of the initial troponin T.

Notes: Initial troponin level corresponds to the first sample obtained within the first 24 hours of


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facility

Selections: N/A



Maximum Troponin T Level

Coding Instructions: Indicate the maximum troponin T level recorded during hospital stay.


Selections: N/A



Maximum Troponin T Date and Time

Coding Instructions: Indicate the date and time of collection of the maximum troponin T.


Selections: N/A



Unit of Troponin (Unspecified)

Coding Instructions: Indicate the unit for measurement of troponin (unspecified).

Target Value: N/A

Selections: (1) Ng/mL, (2) IU/L or U/L (3) Other



Initial Troponin (Unspecified) Value

Coding Instructions: Indicate if the results for the initial troponin (unspecified) test were positive

or negative

Target Value: the first troponin collected.

Selections: 1) Positive, 2) Negative 3) Numerical Value



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Initial Troponin (Unspecified) Value

Coding Instructions: Indicate the value of initial troponin.




facility

Selections: N/A



Initial Troponin (Unspecified) Upper Reference Limit (URL)

Coding Instructions: Indicate the URL of the initial troponin (unspecified) sample.

Target Value: N/A

Selections: N/A




of Myocardial Infarction"; adapted from AHA Get with the Guidelines ACTION registry

Initial Troponin (Unspecified) Date and Time

Coding Instructions: Indicate the date and time of collection of the initial troponin (unspecified).




facility

Selections: N/A



Maximum Troponin (Unspecified) Level

Coding Instructions: Indicate the maximum troponin level (unspecified) recorded during hospital

stay.


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Selections: N/A



Maximum Troponin (Unspecified) Date and Time

Coding Instructions: Indicate the date and time of collection of the maximum troponin

(unspecified).


Selections: N/A



Initial Hemoglobin Date and Time

Coding Instructions: Indicate the date and time when the initial hemoglobin sample was



Selections: (none)



Initial Hemoglobin Value

Coding Instructions: Indicate hemoglobin value in mg/dL.


Selections: (none)



Lowest Recorded Hemoglobin Date and Time

Coding Instructions: Indicate the date and time when the hemoglobin sample with the lowest

value was collected (not the date results reported).

Target Value: Any occurrence between first medical contact and discharge

Selections: (none)



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Lowest Recorded Hemoglobin Value

Coding Instructions: Indicate the lowest hemoglobin value available in mg/dL.


Selections: (none)



Last Hemoglobin Date and Time

Coding Instructions: Indicate the date and time when the last hemoglobin sample during hospital

stay was collected (not the date results reported).

Target Value: Last value prior to discharge

Selections: (none)



Last Hemoglobin Value

Coding Instructions: Indicate the last hemoglobin value available in mg/dL.

Target Value: Last value prior to discharge

Selections: (none)



Minimum Hematocrit Date and Time

Coding Instructions: Indicate the date and time of the hematocrit sample that yielded the

minimum value (not the date results reported).

Target Value: The minimum value between first medical contact and discharge

Selections: (none)



Minimum Hematocrit Value

Coding Instructions: Indicate minimum hematocrit value in %.

Target Value: The minimum value between first medical contact and discharge

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Selections: (none)



Last Recorded Hematocrit Date and Time

Coding Instructions: Indicate the date and time when the last hematocrit sample was collected

(not the date results reported).

Target Value: Last occurrence between first medical contact and discharge

Selections: (none)



Last Recorded Hematocrit Value

Coding Instructions: Indicate the last hematocrit value available in %.

Target Value: Last occurrence between first medical contact and discharge

Selections: (none)



Initial WBC Date and Time

Coding Instructions: Indicate the date and time when the initial WBC count was collected (not

the date results reported).

Target Value: The first available value between first medical contact and discharge

Selections: (none)



Initial WBC Value

Coding Instructions: Record the first available WBC count (x103/µL)

Target Value: The first available value between first medical contact and discharge.

Selections: (none)



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Initial Neutrophil Count Date and Time

Coding Instructions: Indicate the date and time when the neutrophil count was collected (not the

date results reported).


Selections: (none)



Initial Neutrophil Count Value

Coding Instructions: Record the initial neutrophil count (x103/µL)


Selections: (none)



Initial Neutrophil Ratio

Coding Instructions: Record the initial neutrophil ratio


Selections: (none)

Supporting Definition: This should be derived from the differentials of the complete blood count

(CBC)


Initial Platelet Count Date and Time

Coding Instructions: Indicate the date and time when the platelet count was collected (not the


Target Value: First value between first medical contact and discharge

Selections: (none)



Initial Platelet Count Value

Coding Instructions: Record the first available platelet count (x109/µL)


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Selections: (none)



Minimum Platelet Count Date and Time

Coding Instructions: Indicate the date and time when the platelet count with the minimum value

was collected (not the date results reported).

Target Value: Lowest value between first medical contact and discharge

Selections: (none)



Minimum Platelet Count Value

Coding Instructions: Record the lowest available platelet count (x109/µL)

Target Value: Lowest value between first medical contact and discharge

Selections: (none)



Hemoglobin A1c Value

Coding Instructions: Record the most recent hemoglobin A1c in % obtained in the past 3

months.

Target Value: The most recent value obtained in the past 3 months

Selections: (none)



Initial LDH Date and Time

Coding Instructions: Indicate the date and time when the initial LDH sample was collected (not



Selections: (none)



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Initial LDH Value

Coding Instructions: Record the first available LDH value (mg/dL)


Selections: (none)



Initial Blood Glucose Value

Coding Instructions: Record the first available blood glucose value (mg/dL)


Selections: (none)



Initial AST Level Date and Time

Coding Instructions: Indicate the date and time when the AST levels were collected (not the



Selections: (none)



Initial AST level Value

Coding Instructions: Record the first available AST level. (IU/L)


Selections: (none)



Maximum AST Level Date and Time

Coding Instructions: Indicate the date and time when the maximum AST levels were collected


Target Value: Maximum value between first medical contact and discharge

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Selections: (none)



Maximum AST level Value

Coding Instructions: Record the maximum available AST level (IU/L).


Selections: (none)



Minimum AST Level Date and Time

Coding Instructions: Indicate the date and time when the minimum AST levels were collected


Target Value: Minimum value between first medical contact and discharge

Selections: (none)



Minimum AST level Value

Coding Instructions: Record the minimum available AST level (IU/L).


Selections: (none)



Initial ALT Level Date and Time

Coding Instructions: Indicate the date and time when the initial ALT levels were collected (not



Selections: (none)



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Initial ALT level Value

Coding Instructions: Record the first available ALT level. (IU/L).


Selections: (none)



Maximum ALT Level Date and Time

Coding Instructions: Indicate the date and time when the maximum ALT levels were collected



Selections: (none)



Maximum ALT level Value

Coding Instructions: Record the maximum available ALT level (IU/L).


Selections: (none)



Minimum ALT Level Date and Time

Coding Instructions: Indicate the date and time when the minimum ALT levels were collected



Selections: (none)



Minimum ALT Level Value

Coding Instructions: Record the minimum available ALT level (IU/L).


Selections: (none)

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Initial Total Bilirubin Date and Time

Coding Instructions: Indicate the date and time when the initial total bilirubin levels were

recorded (not the date results reported).


Selections: (none)



Initial Total Bilirubin Value

Coding Instructions: Record the first available total bilirubin level (IU/L).


Selections: (none)



Initial Direct Bilirubin Date and Time

Coding Instructions: Indicate the initial date and time when the direct bilirubin levels were



Selections: (none)



Initial Direct Bilirubin Value

Coding Instructions: Record the first available direct bilirubin level (IU/L).


Selections: (none)



Initial Creatinine Date and Time

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Coding Instructions: Indicate the date and time when the creatinine levels were recorded (not



Selections: (none)



Initial Creatinine Value

Coding Instructions: Record the first available creatinine level (mg/dL).


Selections: (none)



Maximum Creatinine Date and Time

Coding Instructions: Indicate the date and time when the creatinine levels with maximum value

were collected (not the date results reported).

Target Value: Maximum occurrence between first medical contact and discharge

Selections: (none)



Maximum Creatinine Value

Coding Instructions: Record the maximum available creatinine level (mg/dL).

Target Value: Maximum occurrence between first medical contact and discharge

Selections: (none)



Last Creatinine Date and Time

Coding Instructions: Indicate the date and time when the last creatinine levels with last value

were collected (not the date results reported).

Target Value: Last available value between the first medical contact and discharge

Selections: (none)

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Last Creatinine Value

Coding Instructions: Record the last available creatinine level (mg/dL).

Target Value: Last available value between the first medical contact and discharge

Selections: (none)



Unit of BUN

Coding Instructions: indicate the unit of BUN.

Target Value: N/A

Selections: (1) Mgmg/dl (2) mmol/L (3) Other Supporting Definition: (none)


Initial BUN Date and Time

Coding Instructions: Indicate the date and time when the initial BUN levels were recorded (not



Selections: (none)



Initial BUN Value

Coding Instructions: Record the first available BUN level.


Selections: (none)



Maximum BUN Date and Time

Coding Instructions: Indicate the date and time when the maximum BUN levels were collected

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Selections: (none)



Maximum BUN Value

Coding Instructions: Record the maximum BUN value


Selections: (none)



Initial BNP Date and Time

Coding Instructions: Indicate the date and time when the BNP levels were collected (not the



Selections: (none)



Initial BNP Value

Coding Instructions: Record the first available BNP level (pg/ml).


Selections: (none)



Initial NT-BNP Date and Time

Coding Instructions: Indicate the date and time when the initial NT-BNP levels were collected



Selections: (none)


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Initial NT-BNP Value

Coding Instructions: Record the first available NT-BNP level (pg/ml).


Selections: (none)



Unit of BNP/NT-proBNP

Coding Instructions: indicate the unit of BNP or NT-proBNP.

Target Value: N/A

Selections: 1) Pg/mL, 2) Ug/L, 3) Ug/mL, 4) Fmol/L, 5) other



Initial Lipid Panel Date and Time

Coding Instructions: Indicate the date and time the first sample was collected (not the date

results reported).

Selections: (none)



Unit of Lipids

Coding Instructions: indicate the unit of lipids.

Target Value: N/A

Selections: (1) Mg/dl (2) Mmol/L (3)Other



Total Cholesterol Value

Coding Instructions: Indicate the total cholesterol value in mg/dL.

Notes: If multiple total cholesterol samples were collected, the first one should be preferentially

abstracted.

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Selections: (none)



HDL Cholesterol Value

Coding Instructions: Indicate the HDL cholesterol value in mg/dL.

Notes: If multiple HDL samples were collected, the first one should be preferentially abstracted.

Selections: (none)



LDL Cholesterol Value

Coding Instructions: Indicate the LDL cholesterol value in mg/dL.

Notes: If multiple LDL samples were collected, the first one should be preferentially abstracted.

Selections: (none)



Triglycerides Cholesterol Value

Coding Instructions: Indicate the triglycerides cholesterol value in mg/dL.

Notes: If multiple triglyceride samples were collected, the first one should be preferentially

abstracted.

Selections: (none)



Urine Protein Date and Time

Coding Instructions: Indicate the date and time when the urine protein levels were collected


Target Value: Any occurrence between the first medical contact and discharge

Selections: (none)



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Urine Protein Value

Coding Instructions: Indicate the value of urine protein levels.

Target Value: Any occurrence between the first medical contact and discharge

Selections: (1) Positive/ +, (2) Negative, (3) Trace (+/-), (4)++, (5) +++, (6) ++++



Initial INR Date and Time

Coding Instructions: Indicate the date and time when the initial INR levels were collected (not



Selections: (none)



Initial INR Value

Coding Instructions: Record the first available INR value.


Selections: (none)



Initial APTT Date and Time

Coding Instructions: Indicate the date and time when the initial APTT levels were collected (not



Selections: (none)



Initial APTT Value

Coding Instructions: Record the first available APTT value in seconds.


Selections: (none)

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Initial PT Date and Time

Coding Instructions: Indicate the date and time when the initial PT levels were collected (not the



Selections: (none)



Initial PT Value

Coding Instructions: Record the first available PT value in seconds.


Selections: (none)



HBsAg

Coding Instructions: Indicate if the patient was tested for HBsAg antigen or Pre-S1 protein.



If Yes, specify the result:

Negative

Positive

Un collected

Supporting Definition: HBsAg is the surface antigen of the hepatitis B virus (HBV). It indicates

current hepatitis B infection.


HBsAb

Coding Instructions: Indicate if the patient was tested for HBsAb.



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Negative

Positive

Un collected

Note: If the numerical value is given, please report it.

Supporting Definition: HBsAb is the antibody directed against the surface antigen of the

hepatitis B virus (HBV).


HBeAg /Anti HBeAg

Coding Instructions: Indicate if the patient was tested for HBeAg antigen or Anti-HBeAg

antibody.

Target Value: Any occurrence between arrival at admitting hospital and discharge.



Negative

Positive

Un collected

Supporting Definition: HBeAg is an antigen of the hepatitis B virus indicating active replication of

virus in the bloodstream. It indicates current hepatitis B infection.


HCV-Ab

Coding Instructions: Indicate if the patient was tested for HCV antibody.




Negative

Positive

Un collected

Supporting Definition: HCV antibody test helps to detect infection with Hepatitis C virus. If

tested for HCV-IgM, HCV-IgG, or both, the answer is Yes.


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HIV Ab

Coding Instructions: Indicate if the patient was tested for HIV antibody.




Negative

Positive

Un collected

Supporting Definition: HIV antibody test helps to detect infection with Human Immunodeficiency

Virus.


Initial CRP Date and Time

Coding Instructions: Indicate the date and time when the initial CRP levels were collected (not


Target Value: First occurrence between the first medical contact and discharge

Selections: (none)



Initial CRP Value

Coding Instructions: Indicate the result of test for initial CRP.


Selections: (none)



Unit of CRP/hs-CRP

Coding Instructions: indicate the unit of CRP or hs-CRP.

Target Value: N/A

Selections: (1) Mg/dl (2) Pg/mL (3) Other



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Initial hs-CRP Date and Time

Coding Instructions: Indicate the date and time when the initial hs-CRP levels were collected



Selections: (none)



Initial hs-CRP Value

Coding Instructions: Indicate the result of test for initial hs-CRP.


Selections: (none)



MEDICATIONS ADMINISTERED

Note: All the information about medications was entered into a central medication database. For

each medication, we abstracted name, dose, and route of administration. The following

definitions describe specific pre-defined questions pertinent to medication administration for

acute myocardial infarction.

Aspirin in the First 24 Hours

Coding Instructions: Indicate if aspirin was administered in the first 24 hours before or after first

medical contact, regardless of location of care (e.g. transferring facility or EMS).

Target Value: Any occurrence between 24 hours before first medical contact and 24 hours after

first medical contact




Documented Reasons for Non-prescription of Aspirin in the First 24 Hours

Coding Instructions: If the medication was not prescribed, indicate whether the reason was

documented.

Target Value: Any documentation in the chart regarding contraindications for the prescription of

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the medication in the first 24 hours.

Selections:

(1) No

(2) Yes – Allergy

(3) Yes – Other (specify)


Aspirin in the First 24 Hours- Start Date

Coding Instructions: Indicate the date that aspirin was administered in the first 24 hours before

or after first medical contact, regardless of location of care (e.g. transferring facility or EMS). If

administered more than once, code the first date/time it was administered.

Target Value: The first value between 24 hours before first medical contact and 24 hours after

first medical contact.

Selections: (none)



Aspirin in the First 24 Hours- Start Time

Coding Instructions: Indicate the time that aspirin was administered in the first 24 hours before

or after first medical contact, regardless of location of care (e.g. transferring facility or EMS). If




Selections: (none)



Aspirin at Discharge

Coding Instructions: Indicate if aspirin was continued or prescribed.

Note(s): Discharge medications do not need to be recorded for patients who were discharged to

"Other acute care hospital", "Hospice", or "Left against medical advice (AMA)."

Target Value: Any occurrence on discharge



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Aspirin at Discharge–Dose

Coding Instructions: Indicate the dose of aspirin prescribed at discharge.



Target Value: The highest value on discharge

Selections: (none)



Documented Reasons for Non-Prescription of Aspirin at Discharge


documented.


the medication at discharge.

Selections:

(1) No

(2) Yes – Allergy



Warfarin during the First 24 Hours

Coding Instructions: Indicate if warfarin was administered in the first 24 hours before or after first

medical contact, regardless of location of care (e.g. transferring facility or EMS).



Target Value: Any occurrence

between 24 hours before first medical contact and 24 hours after first medical contact




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Warfarin at Discharge

Coding Instructions: Indicate if Warfarin was continued or prescribed.







Clopidogrel in the First 24 Hours

Coding Instructions: Indicate if clopidogrel was administered, regardless of location of care (e.g.

transferring facility or EMS).






Clopidogrel in the First 24 Hours- Start Date

Coding Instructions: Indicate the date the initial dose of clopidogrel was administered,

regardless of location of care (e.g. transferring facility or EMS). If administered more than once,

code the first date/time it was administered.



Selections: (none)



Clopidogrel in the First 24 Hours- Start Time

Coding Instructions: Indicate the time that clopidogrel was administered in the first 24 hours

before or after first medical contact, regardless of location of care (e.g. transferring facility or

EMS). If administered more than once, code the first date/time it was administered.

Target Value: The first value for clopidogrel in First 24 Hours Start Date

Selections: (none)

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Clopidogrel in the First 24 Hours- Dose

Coding Instructions: Indicate the cumulative dose of clopidogrel.

Target Value: The cumulative dose between first medical contact and 24 hours after first

medical contact

Selections: (none)



Clopidogrel at Discharge

Coding Instructions: Indicate if clopidogrel was continued or prescribed at discharge.







Clopidogrel at Discharge–Dose

Coding Instructions: Indicate the dose of clopidogrel prescribed at discharge.




Selections: (none)



Ticlopidine in the First 24 Hours

Coding Instructions: Indicate if ticlopidine was administered, regardless of location of care (e.g.




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Ticlopidine in the First 24 Hours-Start Date

Coding Instructions: Indicate the date the initial dose of ticlopidine was administered, regardless

of location of care (e.g. transferring facility or EMS). If administered more than once, code the

first date/time it was administered.



Selections: (none)



Ticlopidine in the First 24 Hours- Start Time

Coding Instructions: Indicate the time that ticlopidine was administered in the first 24 hours





Selections: (none)



Ticlopidine in the First 24 Hours- Dose

Coding Instructions: Indicate the cumulative dose of ticlopidine.


medical contact

Selections: (none)



Ticlopidine at Discharge

Coding Instructions: Indicate if ticlopidine was continued or prescribed at discharge.

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Ticlopidine at Discharge –Dose

Coding Instructions: Indicate the dose of ticlopidine prescribed at discharge.




Selections: (none)



Prasugrel in the First 24 Hours

Coding Instructions: Indicate if prasugrel was administered, regardless of location of care (e.g.







Prasugrel in the First 24 Hours- Start Date

Coding Instructions: Indicate the date the initial dose of prasugrel was administered, regardless





Selections: (none)



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Prasugrel in the First 24 Hours- Start Time

Coding Instructions: Indicate the time that prasugrel was administered in the first 24 hours





Selections: (none)



Prasugrel in the First 24 Hours- Dose

Coding Instructions: Indicate the cumulative dose of prasugrel.


medical contact

Selections: (none)



Prasugrel at Discharge

Coding Instructions: Indicate if prasugrel was continued or prescribed at discharge.







Prasugrel at Discharge–Dose

Coding Instructions: Indicate the dose of prasugrel prescribed at discharge.




Selections: (none)

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Fibrinolysis in the First 24 Hours

Coding Instructions: Indicate if fibrinolytics were administered, regardless of location of care

(e.g. transferring facility or EMS).




Supporting Definitions: If fibrinolytics are used, please name the fibrinolytic agent, the Bolus

dose (IU), the Second Bolus dose (IU/hour), or Maintenance dose (IU/hour), where applicable,

or mark “Unknown” if doses are not documented.


Refusal of Fibrinolysis

Coding Instructions: Indicate if there is documentation of patient refusal for fibrinolysis

Target Value: Any occurrence from the beginning of hospital stay to discharge




Fibrinolysis in the First 24 Hours –Start Date

Coding Instructions: Indicate the date the initial dose of fibrinolytic administered, regardless of

location of care (e.g. transferring facility or EMS). If administered more than once, code the first

date/time it was administered.



Selections: (none)



Fibrinolysis in the First 24 Hours –Start Time

Coding Instructions: Indicate the time that a fibrinolytic was administered in the first 24 hours


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Selections: (none)



Documented Reasons for Non-prescription of Fibrinolysis in the First 24 Hours


documented.


the medication in the first 24 hours.

Selections: (1) No (2) Yes – Allergy (3) Yes – Other (specify)


Fibrinolysis after the First 24 Hours

Coding Instructions: Indicate if fibrinolytics were administered, regardless of location of care

(e.g. transferring facility or EMS).

Target Value: Any occurrence after the first 24 hours from the first medical contact




Fibrinolysis after the First 24 Hours–Start Date

Coding Instructions: Indicate the date the initial dose of fibrinolytic was administered, regardless



Target Value: The first value after the first 24 hours from the first medical contact

Selections: (none)



Fibrinolysis after the First 24 Hours –Start Time

Coding Instructions: Indicate the time that a fibrinolytic was administered in the first 24 hours

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Target Value: The first value after the first 24 hours from the first medical contact

Selections: (none)



Anticoagulant Use

Coding Instructions: First, please indicate if an anticoagulant is being used or not (YES/ NO).

Next, please specify the type of anticoagulant(s) administered, including: unfractionated

heparin, low molecular weight heparins (enoxaparin, dalteparin, or fondaparinux), direct

thrombin inhibitors (such as lepirudin, bivalirudin, and argatroban), and coumarins. Please

indicate the start date and time of first administration of the anticoagulant medication(s).

For anticoagulants that are used in the first 24 hours from first medical contact, depending on

the type of the anticoagulant, please also specify:

(1) Was a bolus used? If yes, provide the date, time and dose.

(2) Was an infusion used? If yes, provide the date, time and dose.

(3) Was a subcutaneous injection used? If yes, provide the date, time and dose.

(4) Provide the number of daily injections where applicable.


Documented Reasons for Non-prescription of Anticoagulants

Coding Instructions: Indicate if the patient has documented reasons for not being prescribed

anti-coagulant medications as described above.

Target Value: N/A

Selections: (1) Yes allergy (2) Yes other (3) No



Glycoprotein IIb/IIIa Inhibitor Use

Coding Instructions: First, please indicate if glycoprotein IIb/IIIa inhibitors were used (YES/ NO).

Next please specify the data and time of first administration and the name of drug being used:

abciximab, tirofiban or eptifibatide. If used during the first 24 hours from the time of first medical

contact, please indicate the date and time, as well as bolus and maintenance doses.

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Documented Reasons for Non-prescription of GP IIB/IIIA Inhibitors

Coding Instructions: Indicate if the patient has documented reasons for not being prescribed of

GP IIB/IIIA Inhibitors.

Target Value: N/A

Selections: (1) Yes allergy (2) Yes other (3) No



Beta-blockers in the First 24 Hours

Coding Instructions: Indicate if a beta-blocker was administered, regardless of location of care

(e.g., transferring facility or EMS).






Beta-blockers in the First 24 Hours- Start Date

Coding Instructions: Indicate the date the initial dose of beta-blocker was administered,

regardless of location of care (e.g. transferring facility or EMS). If administered more than once,

code the first date/time it was administered.



Selections: (none)



Beta Blockers in the First 24 Hours-Start Time

Coding Instructions: Indicate the time that the beta blocker was administered in the first 24

hours before or after first medical contact, regardless of location of care (e.g., transferring facility

or EMS). If administered more than once, code the first date/time it was administered.


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Selections: (none)



Beta Blockers in the First 24 Hours- Route of Administration

Coding Instructions: Indicate if beta blockers were given intravenous, PO, or both.

Target Value: N/A

Selections: (1) IV (2) PO (3) Both



Documented Reasons for Non-prescription of Beta-blocker in the First 24 Hours

Coding Instructions: Indicate if the patient has documented reasons for not being prescribed

Beta-blocker in the first 24 hours.

Target Value: N/A

Selections: (1)Yes allergy (2)Yes other (3)No


Note(s): Code 'yes' if there is documented reason that the patient was started on an oral form of

a beta-blocker within the first 24 hours.

Code 'no' if a there is no documented reason that the patient was given a sublingual, IV, or short

acting formula of one of these medications within the first 24 hours.


Beta Blockers at Discharge

Coding Instructions: Indicate if a beta blocker was continued or prescribed at discharge.







Beta Blockers at Discharge–Dose

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Coding Instructions: Indicate the dose of beta blockers prescribed at discharge.




Selections: (none)



Documented Reasons for Non-prescription of Beta Blockers at Discharge


documented.





Angiotensin Converting Enzyme Inhibitor in the First 24 Hours

Coding Instructions: Indicate if an angiotensin converting enzyme inhibitor was administered,

regardless of location of care (e.g., transferring facility or EMS).






Angiotensin Converting Enzyme Inhibitors in the First 24 Hours- Start Date

Coding Instructions: Indicate the date the initial dose of angiotensin converting enzyme inhibitor

was administered, regardless of location of care (e.g. transferring facility or EMS). If




Selections: (none)



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Angiotensin Converting Enzyme Inhibitors in the First 24 Hours- Start Time

Coding Instructions: Indicate the time that the angiotensin converting enzyme inhibitor was

administered in the first 24 hours before or after first medical contact, regardless of location of

care (e.g. transferring facility or EMS). If administered more than once, code the first date/time it

was administered.



Selections: (none)



Angiotensin Converting Enzyme Inhibitors in the First 24 Hours- Route of administration

Coding Instructions: Indicate if angiotensin converting enzyme inhibitors were given

intravenous, PO, or both.

Target Value: N/A

Selections: (1) IV (2) PO (3) Both



Angiotensin Converting Enzyme Inhibitors at Discharge

Coding Instructions: Indicate if an angiotensin converting enzyme inhibitor was continued or

prescribed at discharge.







Angiotensin Converting Enzyme Inhibitors at Discharge –Dose

Coding Instructions: Indicate the dose of angiotensin converting enzyme inhibitor prescribed at

discharge. The name of the agent used should also be mentioned.


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Selections: (none)



Documented Reasons for Non-prescription of ACE Inhibitors at Discharge


documented.





Angiotensin Receptor Blocker in the First 24 Hours

Coding Instructions: Indicate if an angiotensin receptor blocker was administered, regardless of

location of care (e.g. transferring facility or EMS).






Angiotensin Receptor Blockers in the First 24 Hours- Start Date

Coding Instructions: Indicate the date the initial dose of angiotensin receptor blocker was

administered, regardless of location of care (e.g. transferring facility or EMS). If administered

more than once, code the first date/time it was administered.



Selections: (none)



Angiotensin Receptor Blockers in the First 24 Hours- Start Time

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Coding Instructions: Indicate the time that the angiotensin receptor blocker was administered in

the first 24 hours before or after first medical contact, regardless of location of care (e.g.,

transferring facility or EMS). If administered more than once, code the first date/time it was

administered.



Selections: (none)



Angiotensin Receptor Blockers at Discharge –Dose

Coding Instructions: Indicate the dose of angiotensin receptor blocker prescribed at discharge.

The name of the agent used should also be mentioned.




Selections: (none)



Angiotensin Receptor Blockers at Discharge

Coding Instructions: Indicate if an angiotensin receptor blocker was continued or prescribed at

discharge.







Documented Reasons for Non-prescription of ARBs at Discharge


documented.


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Statin in the First 24 Hours

Coding Instructions: Indicate if a statin was administered, regardless of location of care (e.g.







Statins in the First 24 Hours- Start Date

Coding Instructions: Indicate the date the initial dose of statin was administered, regardless of

location of care (e.g. transferring facility or EMS). If administered more than once, code the first

date/time it was administered.



Selections: (none)



Statins in the First 24 Hours- Start Time

Coding Instructions: Indicate the time that the statin was administered in the first 24 hours

before or after first medical contact, regardless of location of care (e.g., transferring facility or




Selections: (none)



Statins at Discharge

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Coding Instructions: Indicate if a statin was continued or prescribed at discharge.







Documented Reasons for Non-Prescription of Statin at Discharge


documented.


the medication at Discharge.

Selections:

(1) No

(2) Yes – Allergy



Statin at Discharge –Dose

Coding Instructions: Indicate the dose of statin prescribed at discharge. The agent used should

be named, too.




Selections: (none)



Non-statin Lipid Lowering Agents in the First 24 Hours

Coding Instructions: Indicate if a non-statin lipid-lowering drug was administered, regardless of

location of care (e.g. transferring facility or EMS).



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Non-statin Lipid Lowering Agents at Discharge

Coding Instructions: Indicate if a non-statin lipid-lowering agent was continued or prescribed at

discharge.







Nitrates in the First 24 Hours

Coding Instructions: Indicate if a nitrate was administered, regardless of location of care (e.g.




Selections: (1) No (2) Yes - If yes, name the drug.



Nitrate at Discharge

Coding Instructions: Indicate if a nitrate was continued or prescribed at discharge.




Selections: (1) No (2) Yes - If yes, name the drug and the dose at discharge



Ranolazine at Discharge

Coding Instructions: Indicate if ranolazine was continued or prescribed at discharge.

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Calcium Channel Blockers at Discharge

Coding Instructions: Indicate if a calcium channel blocker was continued or prescribed at

discharge.




Selections: (1) No (2) Yes - If yes, please name the agent being prescribed.



Traditional Chinese Medications (TCM) at Discharge

Coding Instructions: Indicate if a TCM was continued or prescribed at discharge.




Selections: (1) No (2) Yes -If yes, please name the drug.


We will note the following seven categories TCPM (traditional Chinese patent medication)

commonly used for AMI in China based on their main ingredient.

1. Danshen or Ginseng or Red Ginseng 2. Ginkgo 3. Sanqi (Panax notoginseng) 4.

Hirudin 5. Erigeron breviscapus Extract（Dengzhan Hua） 6. Lipid-lowing TCPM

(Xuezhikang and Taizhian) 7. Others（Jiuxinwan and Gegengsu）


Proton Pump Inhibitor Use

Coding Instructions: Indicate if a proton pump inhibitor was administered, regardless of location

of care (e.g. transferring facility or EMS).

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Target Value: Any occurrence the first medical contact and discharge date.

Selections: (1) No (2) Yes - If yes, name the agent being used.



Other Drugs at Discharge

Coding Instructions: Indicate if other drugs continued or prescribed at discharge.



Target Value: Any occurrence on discharge.

Selections: (1) No (2) Yes - If yes, please name the agent.

Supporting Definitions: If multiple “other drugs” are used, please report each, separately


Drug allergy

Coding Instructions: Indicate if the patient has any drug allergy

Target Value: N/A




CARDIAC CATHETERIZATION AND RELATED COMPLICATIONS

Diagnostic Catheterization or Diagnostic Coronary Angiography

Coding Instructions: Indicate if the patient had a diagnostic coronary angiography procedure.

Target Value: Any occurrence between arrival at first facility and discharge


Supporting Definitions: Diagnostic coronary angiography is defined as the passage of a catheter

into the aortic root or other great vessels for the purpose of angiography of the native coronary

arteries or bypass grafts supplying native coronary arteries.

Source: NCDR; adapted from AHA Get with the Guidelines ACTION registry

Reason for Coronary Angiography

Coding Instructions: Indicate the circumstances or leading to coronary angiography

Target Value: N/A

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Selections: (1) Elective (2) Urgent (3) Emergency (4) Salvage (5) Unrecorded

Supporting Definition: This should be performed for 1st 2 occurrences of coronary angiography


Catheterization Laboratory Arrival Date and Time

Coding Instructions: Indicate the date the patient arrived to the cath lab, as documented in the

medical record, as well as the time of arrival


Selections: (none)

Supporting Definitions: Indicate the time (hours: minutes) using the military 24-hour clock,

beginning at midnight (0000 hours). If an arterial sheath is already in place, use the time of the

introduction of a catheter or the time the sheath was exchanged.

Source: Adapted from AHA Get with the Guidelines ACTION registry and from VIRGO registry

Arterial Access Site

Coding Instructions: Indicate the primary location of percutaneous entry. If more than one entry

site was used, choose the site that was used to perform the majority of the procedure.

Target Value: N/A

Selections: Choose one of the following:

a. Femoral; mark “Femoral” if percutaneous puncture of either femoral artery.

b. Radial; mark “Radial” if percutaneous radial approach.

c. Brachial; mark “Brachial” if either a cutdown or percutaneous puncture of either

brachial artery.

d. Other; mark “Other” if percutaneous entry other than femoral, brachial, or radial

approaches to the cardiovascular system.



Arterial Dominance

Coding Instructions: Indicate the dominance of the coronary anatomy (whether the posterior

descending artery comes from the right or left vessel system).

Selections: Selection Text Definition

Left dominance is present when the posterior descending artery (PDA) and

posterolateral artery (PLA) arise from the left circumflex artery.

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Right dominance is present when the posterior descending artery (PDA) and

posterolateral artery (PLA) arises from the right coronary artery.

Co-dominance is present when the right coronary artery supplies the posterior

descending artery (PDA) and the circumflex supplies the posterolateral artery (PLA).

Thus, there is approximately equal contribution to the inferior surface of the left ventricle

from both the left circumflex and right coronary arteries.

If not reported, select “unrecorded”.


Source: NCDR; Adapted from the CathPCI registry

Stenosis Percent

Coding Instructions: Indicate the best estimate of most severe percent stenosis in any coronary

artery.

Target Value: The highest value between arrival at first facility and discharge

Selections: Include:

a. Left Main Artery (LM)

b. Proximal LAD

c. Mid/Distal LAD, Diag Branches

d. CIRC, OMs, LPDA and LPL Branches

e. RCA, RPDA, RPL, AM Branches

f. Ramus

Supporting Definitions: Does not include collateral circulation.

Provide the most severe stenosis for the vessel that is primarily providing perfusion to the

myocardium in that territory. (Ex. If a patient's mid LAD is 100% and a graft provides

revascularization to that territory of the heart, code the % stenosis of the graft. If the same

patient has an open graft, and a 70% stenosis of the 2nd diagonal, code 70% since that is the

most severe stenosis % for that territory of the myocardium.) In instances where multiple lesions

are present, enter the single highest percent stenosis noted. If no stenosis, then enter 0%.

Stenosis: Stenosis represents the percentage diameter reduction, from 0 to 100, associated

with the identified vessels. Percent stenosis at its maximal point is estimated to be the amount

of reduction in the diameter of the "normal" reference vessel proximal to the lesion.

Source: NCDR; Adapted from AHA Get with the Guidelines ACTION registry

Percent stenosis not available

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Coding Instructions: Indicate if best estimate of percent stenosis is not available.

Target Value: as below

Selections: Left Main artery (LM) not available (1) No (2) Yes

a. Proximal LAD not available (1) No (2) Yes

b. Mid/Distal LAD, Diag Branches not available (1) No (2) Yes

c. CIRC, OMs, LPDA and LPL Branches not available (1) No (2) Yes

d. RCA, RPDA, RPL, AM Branches not available (1) No (2) Yes

e. Ramus not available (1) No (2) Yes

Graft Percent Stenosis

Coding Instructions: Indicate if the percent stenosis is available for the bypass grafts


Selections:

a. Graft to Proximal LAD

b. Graft to Mid/Distal LAD, Diag Branches

c. Graft to Circ, OMs, LPDA and LPL Branches

d. Graft to RCA, RPDA, RPL, AM Branches

e. Graft to Ramus

f. None of the Above is Recorded

g. LIMA

h. RIMA

i. SVG

Source: Definition per CORE team modified from NCDR Cath PCI Registry.

Graft Stenosis Percent

Coding Instructions: Indicate the best estimate of most severe percent stenosis in a graft as

determined by angiography. If no stenosis, enter 0%.

Notes: If CABG was performed prior to cardiac catheterization, provide details per each bypass

graft. Leave blank if CABG Date is greater than Procedure Date/Time or Prior CABG is "No".

Target value: N/A

Supporting definition: Stenosis: Stenosis represents the percentage diameter reduction,

ranging from 0 to 100, associated with the identified vessels. Percent stenosis at its maximal

point is estimated to be the amount of reduction in the diameter of the "normal" reference vessel

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proximal to the lesion. In instances where multiple lesions are present, enter the single highest

percent stenosis noted.

Source: Definition per CORE team modified from NCDR Cath PCI Registry.

Graft Stenosis Location

Coding Instructions: Indicate the location of the lesion within the graft.

Target Value: N/A

Selections: (1) Proximal (2) Mid (3) Distal (4) Unrecorded


Proximal graft site indicates the site of anastomosis closest to the aorta.

Mid-graft site indicates the lesion within the body of the graft.

Distal graft site indicates the site of anastomosis closest to the coronary vessel.

Source: CORE Team

Is the Left Main Stem Protected?

Coding Instructions: Indicate if the patient has protected left main stem disease

Target Value: Any occurrence between beginning of procedure and prior to intervention


Supporting Definitions: Protected left main stem disease implies that the patient has at least

one patent graft on the left anterior descending artery

Source: Definition per CORE team. Lee MS, Faxon DP. Revascularization of left main coronary

artery disease. Cardiol Rev. 2011; 19: 177-83.

Lesion Length

Coding Instructions: Indicate the length of the treated lesion in millimeters.

Note(s): Information obtained after the baseline angiogram can be used to help determine lesion

length (e.g. for total occlusions where the distal vessel cannot be visualized).

Target Value: Any occurrence on current procedure

Selections: (none)


Source: Adapted from NCDR CathPCI

Characteristics of the Lesion

Coding Instructions: Indicate the characteristics that apply for the lesion.

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Target Value: N/A

Selections: (1) Thrombus Present in Lesion (2) Bifurcation Lesion (3) Calcified Lesion (4) Type

A Lesion (5) Type B Lesion (6) Type C Lesion (7) None of the Above is Recorded


Bifurcation Lesion - A significant bifurcation or branch point is a division of a vessel into at least

two branches, each of which is >1.5 mm or greater in diameter. In a bifurcation or branch lesion,

the plaque extends from at least one of the limbs to the branch point; it need not progress down

all the proximal and distal branches. Bifurcations or branch point lesions should be considered

one lesion, no matter how many limbs are treated.

Calcified Lesion – Indicate if there is any calcification within the lesion.

Type A lesions include the following characteristics: Discrete (<10 mm length), Concentric,

Readily accessible, Non-angulated segment <45 degrees, Smooth contour, Little or no

calcification, Less than totally occlusive, Not ostial in location, No major branch involvement,

Absence of thrombus

Type B lesions include the following characteristics: Tubular (10-20 mm length), Eccentric,

Moderate tortuosity of proximal segment, Moderately angulated segment, 45-90 degrees,

Irregular contour, Moderate to heavy calcification, Ostial in location, Bifurcation lesions requiring

double guidewires

Some thrombus present, Total occlusion <3 months old

Type C lesions include the following characteristics: Diffuse (length > 2cm), Excessive tortuosity

of proximal segment, Extremely angulated segments > 90 degrees, Total occlusions > 3

months old and/or bridging collaterals, Inability to protect major side branches, Degenerated

vein grafts with friable lesions


Type of Contrast Dye Used

Coding Instructions: Indicate the name of radiographic contrast agent used for angiography.

Target Value: N/A

Selections: Urografin, Iopamidol , Iopromide , Iohexol , Iodixanol , Iomeprol , Ioversol , Other,

Unrecorded.



Total Volume of Contrast Dye Used

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Coding Instructions: Indicate the total volume (ml) of contrast dye used during angiography/PCI.


Selections: (none)



Complication- Contrast Reaction

Coding Instructions: Indicate whether patient experienced a contrast reaction during the cath lab

visit or after the lab visit but before discharge.

Target Value: Any occurrence between PCI and discharge


Supporting Definition: Contrast reaction is defined as at least one of the following:

a. Anaphylaxis-including bronchospasm and/or vascular collapse

b. Urticaria

c. Hypotension-prolonged depression of blood pressure below 70mm Hg.


Fractional Flow Reserve

Coding Instructions: Indicate if fractional flow reserve was performed to confirm the percent

stenosis. Myocardial fractional flow reserve is a lesion-specific index of stenosis severity.


Selections: (none)



Fractional Flow Reserve Ratio

Coding Instructions: indicate the fractional flow reserve ratio.

Target Value: The lowest value between beginning of procedure and prior to intervention

Selections: (none)



Intravascular Ultrasound (IVUS)

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Coding Instructions: Indicate if intravascular ultrasound was performed to confirm the percent

stenosis.




Source: NCDR CathPCI

Left Ventricular Ejection Fraction Measured During Procedure

Coding Instructions: Indicate whether the left ventricular ejection fraction was measured during

the catheterization procedure.

Target Value: N/A

Selections: (1) No (2) Yes, EF = ______%



Recommendation (After Diagnostic Catheterization)

Coding Instructions: Indicate the recommendations after diagnostic catheterization.

Target Value: N/A

Selections: (1) Medical therapy/counseling (2) PCI without planned CABG (3) CABG (including

planned hybrid procedures) (4) Other cardiac therapy without CABG or PCI (5) None.



Was PCI Performed Immediately Following Diagnostic Catheterization?

Coding Instructions: Indicate if PCI was performed immediately after diagnostic catheterization.

Target Value: Any occurrence between beginning of procedure and prior to intervention.




PCI Date and Time

Coding Instructions: Indicate the date and time the procedure(s) was/were initiated.

Note(s): Indicate the date (mm/dd/yyyy) and time (hours: minutes) using the military 24-hour

clock, beginning at midnight (0000 hours).

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If an arterial sheath is already in place, use the time of the introduction of a catheter or the time

the sheath was exchanged.

Target Value: N/A

Selections: (none)

Supporting Definitions: Time of Procedure: The time the procedure started is defined as the time

at which local anesthetic was first administered for vascular access, or the time of the first

attempt at vascular access for the cardiac catheterization (use whichever is earlier).


Blood Pressure Prior to PCI

Coding Instructions: Indicate the blood pressure prior to the PCI procedure.

Target Value: The last available value prior to the start of the PCI procedure.

Selections: (none)



Heart Rate Prior to PCI

Coding Instructions: Indicate the heart rate recorded prior to the PCI procedure.

Target Value: The last available value prior to the start of the PCI procedure.

Selections: (none)



Cardiogenic Shock at the Start of PCI

Coding Instructions: Indicate if cardiogenic shock was documented at the start of PCI.

Target Value: Any occurrence at the start of the PCI procedure.


Supporting Definitions: Physician documentation of cardiogenic shock.


Pre-Procedure TIMI Flow

Coding Instructions: Indicate the pre-procedure TIMI flow value.

Note(s): If a lesion spans multiple segments with different TIMI flows, code the lowest TIMI flow

within the entire lesion.

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Selections:

TIMI - 0 No flow/no perfusion

TIMI - 1 Slow penetration without perfusion

TIMI - 2 Partial flow/partial perfusion (greater than TIMI-1 but less than TIMI-3).

TIMI - 3 Complete and brisk flow/complete perfusion.

Unknown/not reported




Percutaneous Coronary Intervention (PCI)

Coding Instructions: Indicate if the patient had percutaneous coronary intervention

Target Value: Any occurrence between arrival at this facility and discharge


Supporting Definitions: Percutaneous coronary intervention (PCI) is the placement of an

angioplasty guide wire, balloon, or other device (e.g. stent, atherectomy, brachytherapy, or

thrombectomy catheter) into a native coronary artery or coronary artery bypass graft for the

purpose of mechanical coronary revascularization.


Refusal of Percutaneous Coronary Intervention

Coding Instructions: Indicate if there is documentation of patient refusal for percutaneous

coronary intervention





Previously Treated Lesion

Coding Instructions: Indicate if the lesion of interest had been treated before

Target Value: Any occurrence between birth and current procedure.

Selections: (1) No (2) Yes (3) Unknown/not reported



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Treated with Stent

Coding Instructions: Indicate if the previously treated lesion was treated with any type of stent in

the current or prior episode of care.

Target Value: Any occurrence between birth and current procedure

Selections: (1) No (2) Yes (3) Unknown/not reported



Reasons for PCI at the Site of Former Stent

Coding Instructions: Indicate the reasons for performing PCI at a previously treated site.

Target Value: N/A

Selections: (1) In-Stent Restenosis (2) In-Stent Thrombosis (3) Unrecorded


In-stent restenosis is defined as a previously stented lesion that has 50% or greater stenosis.

In-stent thrombosis is defined as presence of thrombus in a stent.

Source: CORE Team

Did Guidewire Cross Lesion?

Coding Instructions: Indicate if the guidewire successfully crossed the lesion.

Target Value: N/A




First Device Activation Date and Time

Coding Instructions: Indicate the date and time the first device was activated regardless of type

of device used.

Note(s): Use the earliest time from the following:

1. Time of the first balloon inflation.

2. Time of the first stent deployment.

3. Time of the first treatment of lesion (AngjoJet or other thrombectomy/aspiration

device, laser, rotational atherectomy).

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4. If the lesion cannot be crossed with a guidewire or device (and thus none of the above

apply), use the time of guidewire introduction.

This is a process measure about the timeliness of treatment. It is NOT a clinical

outcomes measure based on TIMI flow or clinical reperfusion. It does not matter whether

the baseline angiogram showed TIMI 3 flow or if the final post-PCI angiogram showed

TIMI 0 flow. What is being measured is the time of the first mechanical treatment of the

culprit lesion, not the time when TIMI 3 flow was (or was not) restored.

Indicate the time (hours:minutes) using the military 24-hour clock, beginning at midnight

(0000 hours).

This element is referenced in The Joint Commission AMI Core Measures AMI-8, AMI-8a.

Target Value: N/A

Selections: (none)


beginning at midnight (0000 hours).


Time of the First Balloon Inflation

Coding Instructions: Indicate the date and time of the first balloon inflation during percutaneous

coronary intervention

Target Value: N/A

Selections: (none)




Time of the First Stent Deployment

Coding Instructions: Indicate the date and time of the first stent deployment during

percutaneous coronary intervention

Target Value: N/A

Selections: (none)




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Stent(s) Placed

Coding Instructions: Indicate if a stent or stents were placed in the affected coronary artery.





Total Number of Stent(s) Placed

Coding Instructions: Indicate the number of stents placed in the affected coronary artery.


Selections: (none)



Bare Metal Stent Implanted

Coding Instructions: Indicate if one or more bare metal stents were implanted during PCI.





Drug Eluting Stent Implanted

Coding Instructions: Indicate if one or more drug eluting stents were implanted during PCI.





Use of Mechanical Ventricular Support During Catheterization Procedure

Coding Instructions: Indicate if mechanical ventricular support was used during catheterization.


Selections: (1) Intraaortic balloon pump (IABP) (2) extracorporeal membrane oxygenation

(ECMO) (3) Left ventricular assist device (LVAD) (4) None

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Note: if mechanical ventricular support was used, indicate if it was started at the start of the

catheterization, during the catheterization procedure and prior to PCI, or after PCI began.



Post-Procedure TIMI Flow

Coding Instructions: Indicate the post- procedure TIMI flow value.


Note(s): If a lesion spans multiple segments with different TIMI flows, code the lowest TIMI flow

within the entire lesion.

Selections: Selection Text Definition

TIMI - 0 No flow/no perfusion

TIMI - 1 Slow penetration without perfusion

TIMI - 2 Partial flow/partial perfusion (greater than TIMI-1 but less than TIMI-3.

TIMI - 3 Complete and brisk flow/complete perfusion.



Devices Deployed During Catheterization Procedure

Coding Instructions: Indicate if any intracardiac device was deployed.

Target Value: N/A

Selections: (1) None (2) Balloon (3) Cutting Balloon (4) Rotablator (5) Aspiration Catheters (6)

IVUS (7) Pressure Wire (8) Flowire (9) Brachytherapy (10) Distal/Proximal Embolic Protection

(11) Thrombectomy Device



Closure Method

Coding Instructions: Indicate the closure method after percutaneous coronary intervention (PCI).


Selections:

a. Seal (Angioseal, Vasoseal)

b. Suture

c. Manual Compression

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d. Other

e. Unrecorded

Supporting Definition: The closure device is a device used at the arterial access site at the end

of the procedure to facilitate hemostasis without need for manual compression.


PCI Complication-Tamponade

Coding Instructions: Indicate if the patient experienced a cardiac tamponade associated with the

cardiac catheterization/PCI.



Supporting Definition: Mark “Yes” if there was fluid in the pericardial space compromising

cardiac filling and requiring intervention during the cath lab visit or after lab visit until discharge

(or before any subsequent lab visits). This should be documented by either:

a. Echo showing pericardial fluid and signs of tamponade such as right heart

compromise; or

b. Systemic hypotension due to pericardial fluid compromising cardiac function.


PCI Complication-Peripheral Embolization

Coding Instructions: Indicate whether patient experienced peripheral embolization after PCI.



Supporting Definition: Mark “Yes” if a peripheral embolization occurred distal to the arterial

access site during the procedure or after lab visit but before any subsequent lab visits, requiring

therapy. Peripheral embolization is defined as a loss of distal pulse, pain and/or discoloration

(especially the toes). This can include cholesterol emboli.


PCI Complication-Access Site Arteriovenous Fistula

Coding Instructions: Indicate whether patient experienced access site arteriovenous fistula

during the cath lab visit or after lab visit until discharge.



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PCI Complication-Access Complication Requiring Surgery/Intervention

Coding Instructions: Indicate whether patient experienced access site occlusion at the site of

percutaneous entry during the procedure or after lab visit but before any subsequent lab visits.



Supporting Definition: Access site occlusion if defined as: Total obstruction of the artery usually

by thrombus (but may have other causes) usually at the site of access requiring surgical repair.

Occlusions may be accompanied by absence of palpable pulse or Doppler.


PCI Complication-Retroperitoneal Bleeding

Coding Instructions: Indicate whether patient experienced retroperitoneal bleeding after lab visit.



Supporting Definition: Mark “Yes” if retroperitoneal bleeding occurred during or after the cath lab

visit until discharge. The bleeding should require a transfusion and/or prolong the hospital stay,

and/or cause a drop in hemoglobin > 3.0 gm/dl.


Repeat PCI

Coding Instructions: Indicate whether patient had a second PCI during hospital stay

Target Value: Any occurrence after first PCI and before discharge




Stent Thrombosis

Coding Instructions: Indicate whether patient experienced in-stent thrombosis after PCI

Target Value: Any occurrence after the first PCI and before discharge



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Reasons for Repeat PCI

Coding Instructions: Indicate the reasons for the repeat coronary angiography/ PCI during the

hospital stay.

Selections:

1. Staged procedure

2. Ongoing or recurrent ischemia

3. Other

Target Value: Any occurrence after first PCI and discharge

Supporting Definition: Mark “Staged procedure” if second PCI was planned during

hospitalization for residual stenoses. Mark “Ongoing or recurrent ischemia/angina” if the patient

had recurrent symptoms (e.g. angina), signs (e.g. dynamic ECG changes) or biomarker

elevation consistent with ischemia.

Source: Definition per CORE team and Adapted from VIRGO registry

In-Hospital Implantation of a Permanent Pacemaker Device

Coding Instructions: Indicate if the patient had a permanent pacemaker implanted during the

hospital stay.



Supporting Definitions: Permanent pacemaker includes single-chamber, dual chamber, and

biventricular pacemakers. It does not include temporary transcutaneous pacemaker.


Date of In-Hospital Permanent Pacemaker Device Implantation

Coding Instructions: Indicate date that permanent pacemaker device was placed.

Target Value: The first value between arrival at first facility and discharge

Selections: N/A



In-Hospital Implantation of an Automatic Implantable Cardioverter Defibrillator (AICD)

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Coding Instructions: Indicate whether patient received an implantable cardioverter defibrillator at

any time during hospital stay.

Target Value: N/A




Date of In-Hospital Automatic Implantable Cardioverter Defibrillator (AICD) Implantation

Coding Instructions: Indicate date that Automatic Implantable Cardioverter Defibrillator was

placed


Selections: N/A



In-Hospital Implantation of a Left-Ventricular Assist Device (LVAD)

Coding Instructions: Indicate whether the patient received an LVAD at any time during the

hospital stay





Date of In-Hospital LVAD Implantation

Coding Instructions: Indicate date that LVAD was placed


Selections: N/A



Coronary Artery Bypass Grafting (CABG)

Coding Instructions: Indicate if the patient had a CABG



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Selections: (none)



Refusal of Coronary Artery Bypass Grafting

Coding Instructions: Indicate if there is documentation of patient refusal for coronary artery

bypass grafting





CABG Date

Coding Instructions: Indicate the date of the coronary artery bypass graft (CABG) surgery.


Selections: (none)


Source: Definition as per CORE team

SUMMARY OF IN-HOSPITAL EVENTS

In-Hospital Bleeding

Coding Instructions: Indicate if the patient had a bleeding event during hospitalization.

Target Value: Any occurrence mentioned in the chart from arrival to the facility to discharge


Supporting Definitions: If yes, please indicate the time and date.


Location of Bleeding

Coding Instructions: Indicate the location of bleeding.

Target Value: N/A

Selections: (1) Access site (2) Intracranial (3) Intraocular (4) Intraspinal (5) Retroperitoneal (6)

Pericardial (7) Gastrointestinal (8) Genitourinary (9) Other (specify)

Supporting Definitions: Access site bleeding is marked when bleeding happens at the site of

vascular access. Intracranial bleeding includes intracerebral and subdural bleeding. Please

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record each site separately if more than one applies.


Nadir Blood Pressure After Bleeding Event

Coding Instructions: Indicate the value of the lowest recorded blood pressure on the day of or

the next day after bleeding onset.

Target Value: Lowest occurrence of blood pressure between bleeding onset and the next day

Selections: N/A



Hypovolemic/hemorrhagic Shock after Bleeding

Coding Instructions: Indicate if bleeding led to hypovolemic or hemorrhagic shock.

Target Value: Any occurrence during the hospital stay

Selections: (1) No (2) Yes (3) Unknown

Supporting Definitions: In patients who bled during the hospital stay, evidence in the chart may

suggest hypovolemic shock:

A) Physician report of hypovolemic shock in the chart

B) Post-bleeding systolic hypotension (peak systolic pressure<90mmHg) or a

reduction of >40mmHg in systolic blood pressure plus evidence of organ hypoperfusion,

which is not responsive to administration of plasma expanders or packed RBCs.


Interventions for Management of Bleeding

Coding Instructions: Indicate the intervention(s) used to manage bleeding.

Target Value: Any occurrence after the bleeding event.

Selections: (1) whole blood transfusion (2) packed red cell transfusion (3) local compression (4)

surgical intervention, including open surgery, closure or endoscopic interventions (5) other (6)

none (7) unrecorded.

Supporting Definitions: Access site bleeding is marked when bleeding happens at the site of

vascular access. Intracranial bleeding includes intracerebral and subdural bleeding.

Note(s): Please record each intervention separately if more than one was applied.


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Blood Transfusion

Coding Instructions: Indicate if the patient was transfused with whole blood or any of its

components.


Selections: (1) No (2) Yes (3) Unrecorded

If Yes, specify:

Red blood cell

Platelet

Blood plasma

Whole Blood

Other (specify)______



Bleeding Date Hb, HCT, Platelet Count, PT, aPTT, and INR

Coding Instructions: Indicate the bleeding date Hb, HCT, Platelet Count, PT, aPTT, and INR.

Target Value: In two separate time points

A) Last available laboratory tests before the bleeding event happened

B) Nadir of the aforementioned laboratory tests after the bleeding event

Selections: Varies for each, please refer to the definitions in the laboratory tests section.

Supporting Definitions: Such information should only be collected for patients with bleeding


In-Hospital Dialysis

Coding Instructions: Indicate if the patient received dialysis during the hospital stay

Target Value: Any occurrence from the hospital stay to discharge


Supporting Definitions: Yes includes hemodialysis, peritoneal dialysis, or both.


In-Hospital Cardiac Tamponade

Coding Instructions: Indicate if cardiac tamponade occurred during the hospital stay



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Supporting Definitions: A clinical syndrome caused by the accumulation of fluid in the pericardial

space, resulting in reduced ventricular filling and subsequent hemodynamic compromise.


In-Hospital Venous Thromboembolism

Coding Instructions: Indicate if in-hospital venous thromboembolism (VTE) was diagnosed

during the hospital stay

Target Value: Any occurrence from the beginning of the hospital stay to discharge

Selections: (1) No (2) Yes - If yes, please indicate the date

Supporting Definitions: Venous thromboembolism (VTE) is comprised of deep vein thrombosis

([DVT]; i.e. development of blood clots in the deep veins of lower extremity or upper extremity)

and pulmonary embolism ([PE]; i.e. migration of the clots to the pulmonary arteries. The clots

can clog the pulmonary arteries, impairing the gas exchange in the lungs. PE is associated with

symptoms such as dyspnea and chest pain and can be fatal). For any patient that was

diagnosed with DVT, or with PE, or with both during the index admission, please mark “Yes”.


In-Hospital Deep Vein Thrombosis (DVT)

Coding Instructions: Indicate if in-hospital DVT was diagnosed during the hospital stay



Supporting Definitions: DVT refers to development of blood clots in the deep veins of lower

extremity or upper extremity migration of the clots to the pulmonary arteries. The symptoms and

signs include extremity pain, warmness, swelling, a palpable venous cord, and tenderness. The

diagnosis is made by ultrasonography or venography. Mark “Yes” if there is physician

documentation for the diagnosis.


In-Hospital Pulmonary Embolism (PE)

Coding Instructions: Indicate if in-hospital PE was diagnosed during the hospital stay



Supporting Definitions: PE refers to a clinical condition resulting from migration of the clots

(rarely other material) to the pulmonary arteries. The clots can clog the pulmonary arteries,

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impairing the gas exchange in the lungs. PE is associated with symptoms such as dyspnea,

hemoptysis and chest pain and can be fatal. The diagnosis could be made by ventilation-

perfusion (V/Q) scanning, computed tomography pulmonary angiography, or conventional

pulmonary angiography. Mark “Yes” if there is physician documentation for the diagnosis.


In-Hospital Infection

Coding Instructions: Indicate if in-hospital infection occurred during the hospital stay


Selections: (1) No (2) Yes If yes, please indicate the date



In-Hospital Infection –Site

Coding Instructions: Indicate the site of in-hospital infection

Target Value: N/A

Selections: (1) Pulmonary (2) Genitourinary (3) Gastrointestinal (4) Skin (5) Surgical

site/procedure site (6) Other (7) Site unknown



In-Hospital Cardiogenic Shock

Coding Instructions: Indicate if cardiogenic shock occurred during the hospital stay


Selections: (1) No (2) Yes- If yes, please indicate the date and time

Supporting Definitions: Cardiogenic shock is defined as a sustained (>30 minutes) episode of

systolic blood pressure <90 mm Hg, and/or cardiac index <2.2 L/min/m2 determined to be

secondary to cardiac dysfunction, and/or the requirement for parenteral inotropic or vasopressor

agents or mechanical support (e.g., IABP, extracorporeal circulation, ventricular assist devices)

to maintain blood pressure and cardiac index above those specified levels.

Source: Acute Coronary Syndromes Data Standards (JACC 2001 38: 2114 - 30), Adapted from

AHA Get with the Guidelines ACTION registry

In-Hospital Cardiac Rupture

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Coding Instructions: Indicate if there is physician documentation of in-hospital cardiac rupture





In-Hospital Recurrent Angina/Recurrent Myocardial Infarction

Coding Instructions: Indicate if there is physician documentation of in-hospital recurrent angina

or recurrent myocardial infarction



Supporting Definitions: Physician documentation of recurrent angina, or recurrent myocardial

infarction, or both, warrants a “Yes” answer.


In-Hospital Ventricular Tachycardia/Ventricular Fibrillation

Coding Instructions: Indicate if there is physician documentation of in-hospital ventricular

tachycardia or ventricular fibrillation



Supporting Definitions: Physician documentation of ventricular tachycardia or ventricular

fibrillation, or both, warrants a “Yes” answer.


In-Hospital Papillary Muscle Rupture

Coding Instructions: Indicate if there is physician documentation of in-hospital papillary muscle

rupture.





In-Hospital Ventricular Septal Perforation

Coding Instructions: Indicate if there is physician documentation of ventricular septal perforation.

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Significant Coronary Artery Dissection

Coding Instructions: Indicate if a significant coronary artery dissection was observed.

Note(s): Typically, dissections described as type A or B are not considered significant

dissections because there is no impairment of flow. Significant dissections are grade C

dissections in the presence of ischemia, or grade D-F dissections, all of which are further

described as:

Type C: persisting contrast medium extravasations;

Type D: spiral filling defect with delayed but complete distal flow;

Type E: persistent filling defect with delayed antegrade flow;

Type F: filling defect with impaired flow and total occlusion

The intracoronary device counter is reset back to one for each procedure.



Supporting Definitions: Coronary artery dissection is defined as the appearance of contrast

materials outside of the expected luminal dimensions of the target vessel and extending

longitudinally beyond the length of the lesion.


Coronary Artery Perforation

Coding Instructions: Indicate if angiographic or clinical evidence of coronary artery perforation

was observed.

Note(s): This does not include pre-existing AV fistula and other coronary anomalies.



Supporting Definitions: A coronary artery perforation occurs when there is angiographic or

clinical evidence of a dissection or intimal tear that extends through the full thickness of the

arterial wall.


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Abrupt Vessel Closure in the Catheterization Laboratory

Coding Instructions: Indicate whether there was total occlusion (TIMI grade 0 or 1 flow) of the

dilated coronary artery occurring at any time during the catheterization procedure.

Target Value: N/A

Selections: (none)


Source: CORE team; Relation between activated clotting time during angioplasty and abrupt

closure. Circulation. 1996 Feb 15;93(4):667-71.

Side Branch Occlusion

Coding Instructions: Indicate whether reduction in TIMI flow to grade 0 or 1 was observed in the

side branch during the catheterization procedure.

Target Value: N/A

Selections: (none)


Source: CORE team; Frequency and clinical consequences associated with sidebranch

occlusion during stent implantation using zotarolimus-eluting and paclitaxel-eluting coronary

stents. Circ Cardiovasc Interv. 2009 Apr;2(2):133-9. Epub 2009 Apr 1.

Distal Embolization

Coding Instructions: Indicate if angiographic evidence of distal embolization was observed.



Supporting Definitions: Angiographic distal filling defect with an abrupt cutoff in at least one of

distal branches or vessels of the infarct related artery at any point during the procedure.

Source: CORE team; Fokkema ML, Vlaar PJ, Svilaas T, et al. Incidence and clinical

consequences of distal embolization on the coronary angiogram after percutaneous coronary

intervention for ST-elevation myocardial infarction. Eur Heart J. 2009; 30: 908-15, Fukuda D,

Tanaka A, Shimada K, Nishida Y, Kawarabayashi T, Yoshikawa J. Predicting angiographic

distal embolization following percutaneous coronary intervention in patients with acute

myocardial infarction. Am J Cardiol. 2003; 91: 403-7, Henriques JP, Zijlstra F, Ottervanger JP,

et al. Incidence and clinical significance of distal embolization during primary angioplasty for

acute myocardial infarction. Eur Heart J. 2002; 23: 1112-7.

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No Flow/Slow flow phenomenon

Coding Instructions: Indicate if angiographic evidence of no flow/ slow flow was observed.

Note(s): This does not include impaired flow due to dissection or thrombus.



Supporting Definitions: No flow is defined as cessation of blood flow (or thrombolysis in

myocardial infarction grade ≤ 1flow) into the distal coronary artery in the absence of

angiographic explanation for impairment of flow.

Source: CORE team; Yip HK, Chen MC, Chang HW, et al. Angiographic morphologic features

of infarct-related arteries and timely reperfusion in acute myocardial infarction: predictors of

slow-flow and no-reflow phenomenon. Chest 2002 ;122: 1322-32 and Matsuo H, Watanabe S,

Watanabe T, et al. Prevention of no-reflow/slow-flow phenomenon during rotational

atherectomy--a prospective randomized study comparing intracoronary continuous infusion of

verapamil and nicorandil. Am Heart J. 2007; 154: 994.e1-6.

Access Site Occlusion

Coding Instructions: Indicate if access site occlusion was observed.



Supporting Definitions: Total obstruction of the artery used as the access site. This is typically

due to a thrombus (but may have other causes) and usually requires surgical repair.

Source: CORE team; Rao SV, Ou FS, Wang TY, et al. Trends in the prevalence and outcomes

of radial and femoral approaches to percutaneous coronary intervention: a report from the

National Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008; 1: 379-86.

In-Hospital Acute Renal Failure

Coding Instructions: Indicate if there is physician documentation or report of in-hospital acute

renal failure



Supporting Definitions: Acute renal failure is defined as physician documentation of acute renal

failure


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In-Hospital Peripheral Embolization

Coding Instructions: Indicate if there is physician documentation or report of in-hospital

peripheral embolization



Supporting Definitions: Peripheral embolization should not be reflected here.


In-Hospital Death

Coding Instructions: Indicate if the patient died during hospital stay.

Target Value: Any occurence between arrival at this facility and discharge




In-Hospital Death Date

Coding Instructions: Indicate the date of patient’s death.

Target Value: The first value on death date.

Selections: (none)



Autopsy

Coding Instructions: Indicate if an autopsy of patient was performed after death.

Target Value: N/A

Selections: (1) No (2) Yes (3) Unrecorded

Supporting Definition: Autopsy is a postmortem examination to discover the cause of death or

the extent of disease


In-Hospital Cardiac Arrest

Coding Instructions: Indicate if the patient experienced an episode of cardiac arrest in your

facility.


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Supporting Definitions: 'Sudden' cardiac arrest is the sudden cessation of cardiac activity so that

the victim becomes unresponsive, with no normal breathing and no signs of circulation. If

corrective measures are not taken rapidly, this condition progresses to sudden death. Cardiac

arrest should be used to signify an event as described above that is reversed, usually by CPR,

and/or defibrillation or cardioversion, or cardiac pacing. Sudden cardiac arrest is not the same

as sudden cardiac death. Sudden cardiac death describes a fatal event.

Source: ACC/AHA/HRS 2006 Key Data Elements and Definitions for Electrophysiological

Studies and Procedures

In-Hospital Cardiac Arrest Date

Coding Instructions: Indicate the date of the cardiac arrest.


Selections: (none)


In-Hospital Cerebrovascular accident (CVA)/Stroke

Coding Instructions: Indicate if the patient experienced a stroke or (CVA) in your facility.



Supporting Definitions: Stroke: A stroke or Cerebrovascular accident is defined as loss of

neurological function caused by an ischemic or hemorrhagic event with residual symptoms at

least 24 hours after onset or leading to death.

Source: Acute Coronary Syndromes Data Standards (JACC 2001 38: 2114 - 30)

In-Hospital Stroke Date

Coding Instructions: Indicate the date of onset of stroke. If a stroke occurs during sleep, last

awake time may be used.


Selections: (none)



In-Hospital Hemorrhagic Stroke

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Coding Instructions: Indicate if the patient experienced a hemorrhagic stroke with

documentation on imaging.



Supporting Definitions: Hemorrhagic Stroke: A hemorrhagic stroke requires documentation on

imaging (e.g. CT scan or MRI of hemorrhage in the cerebral parenchyma, or a subdural or

subarachnoid hemorrhage). Evidence of hemorrhagic stroke obtained from lumbar puncture,

neurosurgery, or autopsy can also confirm the diagnosis.

Source: Acute Coronary Syndromes Data Standards (JACC 2001 38: 2114 - 30)

In-Hospital Unspecified Stroke

Coding Instructions: Indicate if the patient experienced an unspecified stroke with

documentation on imaging.



Supporting Definitions: An unspecified stroke can be defined as stroke without documentation

on imaging. Evidence of stroke obtained from clinical symptoms.


In-Hospital (New Onset) Heart Failure

Coding Instructions: Indicate if there is physician documentation or report on development of

heart failure during hospital stay.




the following clinical symptoms of heart failure described as unusual dyspnea on light exertion,



X-ray presumed to be cardiac dysfunction. A low ejection fraction without clinical evidence of

heart failure does not qualify as heart failure.


Thoracic Surgeons

In-Hospital Atrial Fibrillation or Flutter

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Coding Instructions: Indicate if patient was diagnosed with atrial fibrillation or flutter during this

admission.



Supporting Definitions: Fibrillation of > 30 seconds, which presents as supraventricular

complexes at an irregular rhythm and no obvious P waves on ECG; or Flutter presents as

identically recurring regular sawtooth flutter waves on ECG and evidence of continual electrical

activity.

Note(s): Code "No" If there is no documentation of atrial arrhythmias during hospitalization, it is

acceptable to code "No"


Smoking Cessation Counseling

Coding Instructions: Indicate if there was documentation in the medical record that smoking

cessation advice or counseling was given during this admission.

Note(s): This element is referenced in The Joint Commission AMI Core Measures AMI-4.





Discharge Suggestions

Coding Instructions: Indicate if there was documentation of the following recommendations at

discharge


Selections:

a. Dual antiplatelet therapy (aspirin and a thienopyridine) (1) No (2) Yes If yes, specify the

duration

b. Regular blood lipid assessment (1) No (2) Yes

c. Dietary improvement (1) No (2) Yes

d. Weight reduction (1) No (2) Yes

e. Smoking cessation (1) No (2) Yes

f. Regular exercise (1) No (2) Yes

g. PCI (1) No (2) Yes

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h. CABG (1) No (2) Yes

i. None of the Above Is Recorded (1) No (2) Yes



Discharge Diagnosis (Related to Coronary Heart Disease)

Coding Instructions: Indicate the discharge diagnosis mentioned in the chart

Note(s): Marks as many of the choices that apply.

Selections: Coronary Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction,

Acute Extensive Anterior Myocardial Infarction, Acute Anterior Myocardial Infarction, Acute

Septal Myocardial Infarction, Acute Inferior Myocardial Infarction, Acute Lateral Myocardial

Infarction, Acute Posterior Myocardial Infarction, Acute Right Ventricular Myocardial Infarction,

Acute Non ST-Elevation Myocardial Infarction, Acute ST-Elevation Myocardial Infarction,

Subendocardial Myocardial Infarction, Acute Myocardial Infarction Suspected, Previous Q-Wave

Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris, Prinzmetal's Angina,

Angina (Unrecorded Subtype), Repeated/Recurrent Myocardial Infarction, Repeated/Recurrent

Unstable Angina, Cardiac Rupture, Papillary Muscle Rupture, Ventricular Septal Perforation,

Cardiac Tamponade, Pericardial Effusion, Cardiogenic Shock, Cardiac Arrest, Atrial Fibrillation,

Ventricular Tachycardia/Ventricular Fibrillation, Acute Heart Failure, Chronic Heart Failure,

Heart Failure (Unspecified), Acute Pulmonary Edema, Gastrointestinal Bleeding, Genitourinary

Bleeding, Intracranial/Subdural Bleeding, Retroperitoneal Bleeding, Access Site Bleeding

(Including Hematoma at Access Site), Pericardial Bleeding , Bleeding (Unspecified),

Hemorrhagic Shock, Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis,

Ischemic Stroke (Cerebral Infarction/Thrombosis/Cerebral Embolism), Hemorrhagic Stroke

(Cerebral Hemorrhage/Subarachnoid Hemorrhage), Stroke (Unspecified), Pneumonia, Infection,

COPD Exacerbation, Dyslipidemia, Hypertension, Diabetes Mellitus, Diabetic Nephropathy,

Acute Renal Failure, Chronic Renal Failure, Dialysis (Hemodialysis/Peritoneal Dialysis),

Contrast Reaction (Include Severe Allergic Reaction), Contrast-Induced Nephropathy (CIN),

Thrombocytopenia, Gastroesophageal Reflux, Esophagismus, --Cholelithiasis, Anemia,

Unrecorded.


above Is Recorded”.


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Discharge Diagnosis (Unrelated to Coronary Heart Disease)

Coding Instructions: Indicate the discharge diagnosis mentioned in the chart

Note(s): Marks as many of the choices that apply.

Selections: Cardiac rupture, papillary muscle rupture, ventricular septal perforation, cardiac

tamponade, cardiogenic shock, cardiac arrest, atrial fibrillation/flutter, ventricular

tachycardia/fibrillation, heart failure, gastrointestinal bleeding, genitourinary bleeding,

intracranial/subdural bleeding, retroperitoneal bleeding, access site bleeding, pericardial

bleeding, bleeding (unspecified), hemorrhagic shock, venous thromboembolism, pulmonary

embolism, deep vein thrombosis, peripheral embolization, access site arteriovenous fistula,

ischemic stroke, hemorrhagic stroke, stroke (unspecified), pneumonia, COPD exacerbation,

acute renal failure, chronic renal failure, dialysis, infection, septicemia, contrast reaction,

dyslipidemia, hypertension, diabetes mellitus, diabetic nephropathy, trauma, hepatitis, cirrhosis,

anemia.


above Is Recorded”.


International Classification of Diseases (ICD) Discharge Codes

Coding Instructions: For every diagnosis, record the associated ICD code

Target Value: This should be performed for every diagnosis

Selections: (1) ICD 9; specify value (2) ICD 10; specify value (3) Unrecorded



Date of Hospital Discharge

Coding Instructions: Indicate the date on which the patient was discharged from the hospital

Selections: (none)



Transferred to Outside Facility

Coding Instructions: Indicate if the patient was transferred to an outside facility after initial

presentation to your hospital.

Target Value: N/A

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Discharge Status (or Disposition)

Coding Instructions: Indicate the documented nature of the patient’s discharge from the hospital.

Target Value: Any value at discharge

Selections: (1) Discharge without Transfer to Another Hospital

(2) Physician Recommends Transfer to Another Hospital

(3) Patient or Relatives Demand Transfer to Another Hospital

(4) Patient Left Against Medical Advice

(5) None of the Above Is Recorded



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CHINA PEACE-RETROSPECTIVE CATHPCI STUDY SITE INVESTIGATORS BY HOSPITAL Affiliated Hospital of Guiyang Medical College, Lirong Wu, Jiulin Chen; Affiliated Hospital of Hainan Medical College, Tianfa Li, Jun Wang; Affiliated Zhongshan Hospital of Dalian University, Qin Yu, Xiaofei Liu; Changda Hospital Of Anshan City, Xiang Jin, Ting Cai; Dalian Municipal Central Hospital, Yongchao Zhi, Lili Sun; Fourth Hospital of Baotou City, Hongbao Zhang, Yonghou Yin, Bin Tian; Fourth People's Hospital of Zigong City, Yong Yi, Chaoyong Wu; Fujian Provincial Hospital, Yansong Guo, Xinjing Chen; Fuling Center Hospital of Chongqing City, Liquan Xiang, Lin Ning; General Hospital of the Yangtze River Shipping, Xiuqi Li, Xing’an Wu; Guilin People's Hospital, Wei Zhang, Yanni Zhuang, Hua Lu; Haerbin 242 Hospital, Yin Zhou, Qiuling Hu; Henan Provincial People's Hospital, Chuanyu Gao, Jianghong Zhang, You Zhang; Heze Municipal Hospital, Wentang Niu, Xiaolei Ma, Yong Wang; HGKY Group Company General Hospital, Xiaowen Pan, Yanlong Yan; Hua Xin Hospital, First Hospital of Tsinghua University, Lifu Miao, Yanping Yin, Zhiying Zhang; Huizhou Municipal Central Hospital, Yuansheng Shen, Zhiming Li, Lizhen He; Hunan Province Mawangdui Hospital, Zhiyi Rong, Wei Luo; Ji'an Municipal Central People's Hospital, Xueqiao Wang; Jiangxi Provincial People's Hospital, Qing Huang, Xiaohe Wu; Jilin Integrated Traditional Chinese & Western Medicine Hospital, Jilin Province, Jiangping Shi; Jilin Province People's Hospital, Hui Dai, Yuming Du, Wei Guo; Jingzhou Central Hospital, Xin Li, Qin Xu; Jiuquan City People's Hospital, Yuanfeng Yuan, Zhirong Li; Jixi People's Hospital of The Jixi Municipal People's Hospital Medical Group, Jinbo Gao; Liaoyang Central Hospital, Rihui Liu, Peng Guo; Liaoyuan Central Hospital, Chaoyang Guo, Xiangjun Liu, Rujun Zhao, Zeyong Yu; Longyan First Hospital, Kaihong Chen, Yong Fang, Ying Liao; Nanjing First Hospital, Shaoliang Chen, Haibo Jia, Hongjuan Peng; Nantong Third People's Hospital, Song Chen, Dongya Zhang, Ying Wang; Nanyang Central Hospital, Yudong Li, Jianbu Gao, Shouzhong Yang; Peking University People's Hospital, Chenyang Shen, Yunfeng Liu; Peking University Shenzhen Hospital, Chun Wu, Huan Qu, Saiyong Chen; Qinghai Red Cross Hos, Jianqing Zhang, Chunmei Wei, Yanmei Shen; Quzhou People's Hospital, Xiaoming Tu, Zhenyan Gao; Shangluo Central Hospital, Yingmin Guan, Wenfeng Wang, Ting Xiao; Shangqiu Changzheng People's Hospital, Qian Wang; Shenyang Weikang Hospital, Xujie Fu, Shu Zhang; Shougang Shuicheng Iron & Steel (Group) Co.,Ltd. General Hospital, Min Zhang, Kai Fu, Xiaojing Duan; Shuangshan Hospital Of Anshan, Rui Xiao, Ruixia Wu, Bin Li; The Affiliated Hospital of Beihua University, Feng Sun, Qi Zhang; The Fifth People's Hospital of Dalian, Jing Zhang, Yang Zhong; The First Affiliated Hospital of Hebei Northern Institute, Fangjiang Fang, Xiaoyuan Wang; The First Affiliated Hospital of Henan University of Science & Technology, Pingshuan Dong, Laijing Du, Wei Liu; The First Affiliated Hospital Of Jia Mu Si University, Zhaofa He, Meihua Jin; The First Hospital of Fuzhou City, Ting Jiang, Zhuoyan Chen; The First Hospital of Xi’an, Manli Cheng, Yuqiang Ji; The First People's Hospital of Guangyuan, Yizhi Pan, Jian Liu; The First People's Hospital of Guangyuan, Tianxun Wang, Ping Yang; The Fourth people's hospital Of Shang qiu shi, Guiyu Huang, Jianjun Pan, Zhiyong Zhang; The General Hospital of Yongzhou, Mingli Lv; The Second Affiliated Hospital of Harbin Medical University, Bo Yu, Yousheng Xu, Zhengqiu Wang; The Second Affiliated Hospital of Kunming Medical University, Jun Shu, Ge Zhang, Kai Li; The Second People's Hospital of Liaoyuan City, Aimin Zhang, Yongfen Kang; Tianjin Medical University General Hospital, Zheng Wan, Bo Bian; Tibet Autonomous Region People's Hospital, Xuejun Hu, Dawa Ciren; Tongchuan Mining Bureau Central Hospital, Guojiong Jia, Lijie Pan; Tongliao City Horqin District First People's Hospital, Junping Fang, Xinli Yu; Ulanqab Central Hospital, Dacheng Wang, Dajun Liu, Xinhong Cao; Wuhai People's Hospital, Zhaohai Zhou, Lei Shi; Wuhu Second People's Hospital, Wuwang Fang, Manxin Chen; Yuanzhou District People's Hospital of Guyuan City, Xiaoping Gao, Meiying Cai, Lining You; Yuncheng Central Hospital, Xuexin Li, Shuqin Li, Yingjia Li.

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CHINA PEACE STUDY CONSULTANTS Study Consultants: Paul S. Chan, MD, MSc, Jersey Chen, MD, MPH, David J. Cohen, MD, MSc, Nihar R. Desai, MD, MPH, Kumar Dharmarajan MD, MBA, Mikhail N. Kosiborod, MD, Jing Li, MD, PhD, Xi Li, MD, PhD, Zhenqiu Lin, PhD, Frederick A. Masoudi, MD, MSPH, Jennifer Mattera, DrPH, MPH, Brahmajee K. Nallamothu, MD, MPH, Khurram Nasir, MD, MPH, Sharon-Lise T. Normand, PhD, Joseph S. Ross, MD MHS, John A. Spertus, MD, MPH, Henry H. Ting, MD, Yun Wang, PhD, Xiao Xu, PhD St. Luke’s Mid America Heart Institute/University of Missouri Kansas City (PSC, DJC, MNK, JAS), Kansas City, Missouri, United States; Kaiser Permanente (JC), Mid-Atlantic Permanente Research Institute, Rockville, Maryland, United States; Center for Outcomes Research and Evaluation (NRD, KD, ZL, JM, JSR, YW, XX), Yale-New Haven Hospital, New Haven, Connecticut, United States; Division of Cardiology (KD), Department of Internal Medicine, Columbia University Medical Center, New York, New York, United States; State Key Laboratory of Cardiovascular Disease (JL, XL), China Oxford Centre for International Health Research, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China; Division of Cardiology (FAM), University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States; Veterans Affairs Health Services Research and Development Center of Excellence (BKN), Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, United States; Department of Internal Medicine (BKN) and Center for Healthcare Outcomes and Policy (BKN), University of Michigan, Ann Arbor, Michigan, United States; Research Director, Center for Prevention and Wellness (KN), Baptist Health South Florida, Miami, Florida, United States; Section of General Internal Medicine and the Robert Wood Johnson Clinical Scholars Program (JSR), Department of Internal Medicine, Yale University School of Medicine, Connecticut, United States; Division of Cardiovascular Diseases (HHT) and Knowledge and Evaluation Research Unit (HHT), Mayo Clinic College of Medicine, Rochester, Minnesota. United States; Department of Obstetrics, Gynecology, and Reproductive Sciences (XX), Yale School of Medicine, New Haven, Connecticut, United States

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STROBE Statement Checklist of items that should be included in reports of cohort studies

Item No Recommendation

Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the

title or the abstract – DONE (retrospective)

(b) Provide in the abstract an informative and balanced summary

of what was done and what was found – DONE (what was done)

Introduction

Background/rationale 2 Explain the scientific background and rationale for the

investigation being reported - DONE

Objectives 3 State specific objectives, including any prespecified hypotheses -

DONE

Methods

Study design 4 Present key elements of study design early in the paper – DONE

Setting 5 Describe the setting, locations, and relevant dates, including

periods of recruitment, exposure, follow-up, and data collection –

DONE

Participants 6 (a) Give the eligibility criteria, and the sources and methods of

selection of participants. Describe methods of follow-up – DONE

(b) For matched studies, give matching criteria and number of

exposed and unexposed – N/A

Variables 7 Clearly define all outcomes, exposures, predictors, potential

confounders, and effect modifiers. Give diagnostic criteria, if

applicable – DONE (key variables, approach to statistical

analysis, and key outcomes presented in manuscript)

Data sources/

measurement

8* For each variable of interest, give sources of data and details of

methods of assessment (measurement). Describe comparability of

assessment methods if there is more than one group – DONE (in

manuscript and supplement)

Bias 9 Describe any efforts to address potential sources of bias – DONE

(demonstrated how nationally representative data set was

acquired)

Study size 10 Explain how the study size was arrived at – DONE

Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If

applicable, describe which groupings were chosen and why – N/A

(no statistical analyses performed)

Statistical methods 12 (a) Describe all statistical methods, including those used to control

for confounding – DONE (approach to statistical analysis

presented)

(b) Describe any methods used to examine subgroups and

interactions – N/A (no statistical analyses performed)

(c) Explain how missing data were addressed – N/A (no

statistical analyses performed)

(d) If applicable, explain how loss to follow-up was addressed –

N/A (no post-discharge follow-up)

(e) Describe any sensitivity analyses – N/A

Results

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Participants 13* (a) Report numbers of individuals at each stage of study—eg

numbers potentially eligible, examined for eligibility, confirmed

eligible, included in the study, completing follow-up, and analysed

– DONE (total numbers presented)

(b) Give reasons for non-participation at each stage – DONE

(reasons for missing data provided)

(c) Consider use of a flow diagram – N/A for protocol paper; will

include with each study based on database

Descriptive data 14* (a) Give characteristics of study participants (eg demographic,

clinical, social) and information on exposures and potential

confounders – Not possible until data has been analyzed

(b) Indicate number of participants with missing data for each

variable of interest – Not possible until data has been analyzed

(c) Summarise follow-up time (eg, average and total amount) –

N/A (all observations restricted to in-hospital follow-up)

Outcome data 15* Report numbers of outcome events or summary measures over

time – Not possible until data has been analyzed

Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-

adjusted estimates and their precision (eg, 95% confidence

interval). Make clear which confounders were adjusted for and

why they were included – DONE (expected precision

calculations provided in appendix)

(b) Report category boundaries when continuous variables were

categorized – Not possible until data has been analyzed

(c) If relevant, consider translating estimates of relative risk into

absolute risk for a meaningful time period – Not possible until

data has been analyzed

Other analyses 17 Report other analyses done—eg analyses of subgroups and

interactions, and sensitivity analyses – Not possible until data

has been analyzed

Discussion

Key results 18 Summarise key results with reference to study objectives – Not

possible until data has been analyzed

Limitations 19 Discuss limitations of the study, taking into account sources of

potential bias or imprecision. Discuss both direction and

magnitude of any potential bias – DONE

Interpretation 20 Give a cautious overall interpretation of results considering

objectives, limitations, multiplicity of analyses, results from similar

studies, and other relevant evidence – Not possible until data

has been analyzed

Generalisability 21 Discuss the generalisability (external validity) of the study results –

DONE (reported generalizability of data set in general)

Other information

Funding 22 Give the source of funding and the role of the funders for the

present study and, if applicable, for the original study on which the

present article is based - DONE

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