ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization Laboratory
2014; Lippincott Williams & Wilkins; Volume: 129; Issue: 24 Linguagem: Inglês
10.1161/cir.0000000000000043
ISSN1524-4539
AutoresTimothy A. Sanborn, James E. Tcheng, H. Vernon Anderson, Charles E. Chambers, John P. Cheatham, Matthew DeCaro, Jeremy C. Durack, Allen D. Everett, John B. Gordon, W. Ed Hammond, Ziyad M. Hijazi, Vikram S. Kashyap, M.L. Knudtson, Michael J. Landzberg, Marco Antonio Martínez‐Ríos, Lisa Riggs, Kui Hian Sim, David J. Slotwiner, Harry C. Solomon, Wilson Y. Szeto, Bonnie H. Weiner, William S. Weintraub, John R. Windle,
Tópico(s)Meta-analysis and systematic reviews
ResumoHomeCirculationVol. 129, No. 24ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization Laboratory Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUBACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization LaboratoryA Report of the American College of Cardiology Clinical Quality Committee Timothy A. Sanborn, MD, MS, FACC, FAHA, FSCAI, Chair, James E. Tcheng, MD, FACC, FSCAI, Vice-Chair, H. Vernon Anderson, MD, FACC, FSCAI, Charles E. Chambers, MD, FACC, FSCAI, Sharon L. Cheatham, PhD, APRN, Matthew V. DeCaro, MD, FACC, Jeremy C. Durack, MD, Allen D. Everett, MD, FACC, John B. Gordon, MD, FACC, William E. Hammond, PhD, Ziyad M. Hijazi, MBBS, MPH, FACC, Vikram S. Kashyap, MD, FACS, Merrill Knudtson, MD, FRCP(C), CM, Michael J. Landzberg, MD, FACC, Marco A. Martinez-Rios, MD, FACC, FIACC, FSCAI, Lisa A. Riggs, CNS, Kui Hian Sim, MBBS, FACC, David J. Slotwiner, MD, FACC, Harry Solomon, Wilson Y. Szeto, MD, Bonnie H. Weiner, MD, FACC, FSCAI, William S. Weintraub, MD, FACC, FAHA and John R. Windle, MD, FACC Timothy A. SanbornTimothy A. Sanborn , James E. TchengJames E. Tcheng , H. Vernon AndersonH. Vernon Anderson , Charles E. ChambersCharles E. Chambers , Sharon L. CheathamSharon L. Cheatham , Matthew V. DeCaroMatthew V. DeCaro , Jeremy C. DurackJeremy C. Durack , Allen D. EverettAllen D. Everett , John B. GordonJohn B. Gordon , William E. HammondWilliam E. Hammond , Ziyad M. HijaziZiyad M. Hijazi , Vikram S. KashyapVikram S. Kashyap , Merrill KnudtsonMerrill Knudtson , Michael J. LandzbergMichael J. Landzberg , Marco A. Martinez-RiosMarco A. Martinez-Rios , Lisa A. RiggsLisa A. Riggs , Kui Hian SimKui Hian Sim , David J. SlotwinerDavid J. Slotwiner , Harry SolomonHarry Solomon , Wilson Y. SzetoWilson Y. Szeto , Bonnie H. WeinerBonnie H. Weiner , William S. WeintraubWilliam S. Weintraub and John R. WindleJohn R. Windle Originally published28 Mar 2014https://doi.org/10.1161/CIR.0000000000000043Circulation. 2014;129:2578–2609Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2014: Previous Version 1 IntroductionTable of ContentsPreamble 2579Executive Summary 25801. Introduction 25801.1. Document Development Process 25801.1.1. Writing Committee Organization 25801.1.2. Document Development and Approval 25811.2. Background and Rationale 25812. Principles of Structured Reporting 25822.1. General Principles 25822.2. Integration of Data Acquisition With Workflow 25832.3. Capture of Information as Data Rather Than Prose 25842.4. Role of the Physician in Authoring the Structured Procedure Report 25852.5. The Best Practice Model 25853. Catheterization Procedure Reporting: Anticipating 2 Different Reports 25863.1. The Procedure Log Report 25863.2. The Physician-Authored Structured Procedure Report 25874. The Prototype Formatted, Tabular, Structured Procedure Report 25874.1. Front Page Summary: Highest Value Information 25884.2. Graphics and Images Section 25884.3. Report Body: Details 25884.3.1. Administrative Information 25894.3.2. History and Risk Factors 25904.3.3. Procedure Details 25904.3.4. Diagnostic Results 25914.3.5. Intervention 25914.3.6. Final Diagnoses 25914.3.7. Operators, Titles, Regulatory Attestation 25944.4. Procedure-Specific Content 25944.4.1. Cardiac Catheterization (Right, Left, Coronary Intervention) 25944.4.2. Peripheral Vascular Catheterization 25954.4.3. Cerebrovascular Catheterization 25964.4.4. Valvular Heart Disease: Transcatheter Aortic Valve Replacement 25964.4.5. Congenital and Structural Heart Catheterization 25974.4.6. Combination Procedures 25974.5. Structured Report Style Guide 25974.6. Data Export 25984.7. Paradigm Expansion 25985. Adoption and Implementation 25986. Extending the Structured Reporting Use Case 2600References 2601Appendix 1. Author Relationships With Industry and Other Entities (Relevant) 2603Appendix 2. Peer Reviewer Relationships With Industry and Other Entities (Relevant) 2605Appendix 3. Abbreviations 2609PreambleThis document has been developed as a health policy statement (HPS) by the American College of Cardiology (ACC). HPSs are intended to promote or advocate a position, be informational in nature, and offer guidance to the stakeholder community regarding the stance of the ACC and other contributing organizations on healthcare policies and programs. HPSs are not intended to offer clinical guidance and do not contradict existing ACC clinical policy. They are overseen by the ACC Clinical Quality Committee (CQC), the group responsible for developing and implementing all HPS policies and procedures related to topic selection, commissioning writing committees, and defining document development methodologies. The CQC brings together various areas of the College such as the Advocacy Committee, the National Cardiovascular Data Registry (NCDR), the ACC/American Heart Association (AHA) Task Forces on Guidelines and Performance Measurement, and the ACC Appropriate Use Criteria (AUC) Task Force.The CQC recommended the development of this HPS to document the ACC's official position on structured reporting of cardiac catheterization procedures. A number of organizations were invited to coauthor this statement with the goal of sharing a unified message on this important topic. Structured reporting is believed to be foundational to the provision of high-quality care for patients undergoing procedures in the cardiac catheterization laboratory. As such, the intended audience for this document includes third-party payers; electronic health record (EHR) and clinical software vendors; accrediting and certifying organizations; and regulators whose areas of responsibility include electronic health data.To avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the writing committee, all members of the writing committee, as well as peer reviewers of the document, are asked to disclose all current healthcare-related relationships, including those existing 12 months before initiation of the writing effort. The CQC reviews these disclosures to determine what companies make products (on market or in development) that pertain to the document under development. On the basis of this information, a writing committee is formed to include a majority of members with no relevant relationships with industry and other entities (RWI), led by a chair with no relevant RWI. Authors with relevant RWI are not permitted to draft initial text or vote on recommendations pertaining to their RWI. RWI is reviewed on all conference calls and updated as changes occur. Author and peer reviewer RWI pertinent to this document are disclosed in Appendices 1 and 2, respectively. In addition, to ensure complete transparency, authors' comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Disclosure information for the ACC CQC is also available online at http://www.cardiosource.org/ACC/About-ACC/Who-We-Are/Leadership/Guidelines-and-Documents-Task-Forces.aspx, as well as the ACC disclosure policy for document development at http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx. The work of the writing committee was supported exclusively by the ACC without commercial support. The writing committee members volunteered their time to this effort. Conference calls of the writing committee were confidential and attended only by committee members.Joseph P. Drozda, Jr., MD, FACCChair, ACC Clinical Quality CommitteeExecutive SummaryThe final report is an essential component of every invasive and operative procedure. This vital document records key data used to assess indications and appropriateness of care, details technical aspects of the procedure, describes findings and observations, lists results and calculations, provides the interpretation of the study, and conveys patient care recommendations. In addition to providing essential information to the entire team of care providers, the final report is utilized in billing and inventory management, process and performance improvement, outcomes analysis, teaching and education, and as a data source for registries.1 The final report is a legal medical record document and should be of the highest quality so as to optimize both patient outcomes and institutional operational efficiencies. A structured report generated by a structured reporting process is the most suitable vehicle for these goals, but this approach is only slowly being adopted despite prior recommendations and endorsements. This HPS is intended to provide a general model for structured reporting for invasive and interventional cardiovascular procedures and thus catalyze and accelerate implementation of structured reporting. Through endorsement of this document, the cardiovascular community recognizes the critical importance of structured reporting and calls for its uniform adoption.The general principles of structured reporting in cardiovascular imaging are well established. Information should be captured as data rather than prose; these data should flow bidirectionally to and from the EHR for subsequent presentation and analysis. The final report should be clear, concise, organized, consistent, reproducible, understandable, and in a format that is flexible to accommodate evolutionary procedural changes and documentation requirements.Key considerations for generating a structured report are discussed in detail, with a structured procedure report prototype included for modeling purposes. The prototype final report is segmented into 3 principal sections. The first section (front page) is a single (physical) page that contains the highest value clinical information. Because angiography is inherently visual, the second section is dedicated to the graphical representations of the findings and (optionally) images imported into the report. The body (third section) contains all of the remaining data presented as a series of structured, formatted tables. Procedure-specific content is outlined for diagnostic cardiac catheterization, percutaneous coronary intervention (PCI), peripheral vascular and cerebral vascular procedures, valvular heart disease including transcatheter aortic valve replacement (TAVR), structural and congenital heart disease (CHD), and combination procedures. The concepts enumerated in this HPS are applicable to nonsurgical endovascular procedures performed in a cardiac catheterization laboratory, hybrid catheterization/operating room suite, and interventional/neuroradiology suite.Universal adoption of structured reporting for invasive cardiovascular imaging procedures requires the acknowledgment of its potential benefits and acceptance of the responsibilities entailed. In order to stimulate structured reporting implementation, key groups including physician operators, catheterization laboratory personnel, the software vendor community, and leadership of registries must be on the forefront of advocating the adoption of structured reporting. The ACC/AHA/Society for Cardiovascular Angiography and Interventions Foundation (SCAI) recognize that the development and deployment of structured reporting will be an ongoing process and, therefore, strongly encourage the view that structured reporting be considered one component of the overall quality improvement imperative for cardiovascular care.1. Introduction1.1. Document Development Process1.1.1. Writing Committee OrganizationThe writing committee consists of a broad range of members from the ACC as well as the following societies: American Association of Critical-Care Nurses (AACN), AHA, Asian Pacific Society of Cardiology (APSC), Canadian Cardiovascular Society (CCS), Digital Imaging and Communications in Medicine (DICOM), Health Level Seven International (HL7), Inter-American Society of Cardiology (IASC), Integrating the Healthcare Enterprise (IHE), International Society for Adult Congenital Heart Disease (ISACHD), SCAI, Society of Interventional Radiology (SIR), Society of Thoracic Surgeons (STS), and Society for Vascular Surgery (SVS). Representatives from these societies included those with expertise in cardiothoracic surgery, interventional cardiology, interventional radiology, general cardiology, echocardiography, and cardiac nursing. Along with these specialties, specific knowledge in the areas of TAVR, carotid and cerebrovascular disease, vascular medicine, structural heart disease, patient outcomes, data interoperability, and catheterization laboratory workflows were also reflected in the workgroup to provide an appropriate balance of perspectives. Geographically, the writing committee included both domestic and international members. Relationships with EHR companies and software vendors active in cardiovascular medicine were deemed relevant to this writing effort. This writing committee met the College's disclosure requirements for RWI as described in the Preamble.1.1.2. Document Development and ApprovalThe writing committee convened by conference call and e-mail to finalize the document outline, develop the initial draft, revise the draft per committee feedback, and ultimately approve the document for external peer review. Each participating organization provided peer reviewers, resulting in 32 reviewers representing 410 comments. To increase its applicability further, the document was posted online for a 3-week public comment period, resulting in 4 people providing 19 additional comments. All comments were reviewed and addressed by the writing committee, resulting in change to the manuscript. A member of the ACC CQC served as lead reviewer to ensure that all comments were addressed adequately. Both the writing committee and CQC approved the version of the final document sent for board review. The ACC Board of Trustees, the AHA Science Advisory and Coordinating Committee, and the Society for Cardiovascular Angiography and Interventions Foundation Board of Trustees reviewed the document, including all peer review comments and writing committee responses, and approved the document in February 2014. The AACN, APSC, CCS, HL7, IASC, IHE, STS, SVS, endorsed the document in March 2014. This document is considered current until the CQC revises or withdraws it from publication.1.2. Background and RationaleA final procedure report is essential and required for all cardiovascular catheterization procedures. The procedure report documents key data used to assess indications and appropriateness of care, details technical aspects of the procedure, describes findings and observations, lists results and calculations, provides the interpretation of the study, and conveys patient care recommendations. It is a vital means of communication between the physician operator and the team of care providers. Additionally, it is utilized in billing and inventory management, process and performance improvement, patient outcomes analysis, teaching and education, and participation in data registries. The final procedure report is a legal medical record document often accessible to patients via internet portals and personal health records. Patient education, enablement, and participation in their health care are augmented by unambiguous information returned to the patient, a movement that is facilitated by better procedure reporting. Accordingly, it is imperative that complete reports of the highest quality are authored. Elements of quality achieved through structured reporting include clarity and completeness of documentation, consistency in the organization and presentation of information, and fulfillment of requirements for quality reporting, regulatory compliance, coding and billing, all while reducing the time devoted to documentation and improving operator efficiency. Furthermore, structured reporting creates the potential for patient-specific risk prediction (eg, bleeding, restenosis, mortality) and other types of clinical decision support at the point of care.The concept of a structured procedure report is not new.2,3 In 2006, a multistakeholder group recommended the use of structured reports as a key component to achieving quality in cardiovascular imaging.4 The subsequent "2008 ACCF/ACR/AHA/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR HPS on Structured Reporting in Cardiovascular Imaging" articulated the framework for structured reporting for cardiovascular imaging procedures.5 Structured reporting was again endorsed in the "2012 ACCF/SCAI Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update" as the instrument for documenting cardiac catheterization laboratory procedures.6 Nonetheless, adoption of structured reporting has been slow, and even today the majority of catheterization reports are dictated and transcribed in unstructured formats. Even when structured reporting is used, there is a lack of consistency from laboratory to laboratory, and from vendor to vendor. This suggests several reasons for the failure to universally adopt structured reporting: insufficient understanding of the specifics of structured reporting; inadequate guidance to both the clinical community and administrative management as to exactly what to demand; and an absence of sufficient economic, professional, and regulatory motivation to adopt structured reporting as a "requirement." This HPS addresses these dimensions, leveraging advances in standards (such as the HL7 Consolidated Clinical Document Architecture [C-CDA]7 and the Integrating the Healthcare Enterprise Cath Report Content [IHE CRC] profile8) to provide explicit technical specifications while articulating the clinical, scientific, social, economic, and regulatory advantages of structured reporting in the cardiovascular catheterization suite.It is critical to differentiate the narrow concept of the "structured report" from the more comprehensive process of "structured reporting." Structured reporting begins with the explicit use of standardized, controlled vocabularies of clinical data elements, integrates workflow and documentation processes, and achieves data interoperability among information technology systems as a natural and intended result. The authoring of formatted, structured catheterization procedure reports in a coherent, consistent, and clinically relevant manner is perhaps the most valuable outcome of a structured reporting environment. However, this HPS purposefully expands beyond the narrow concept of the structured report to include the entire data acquisition and reporting process.Controlled vocabularies are selected lists of words and phrases (standardized data elements) with explicit definitions that convey specific (human interpretable) meaning while achieving computational interoperability. Controlled vocabularies are foundational to structured reporting because they enable the computational assessment of systems, processes, performance, and outcomes. The consistent use of controlled vocabularies among disparate encounters allows organizations to assess procedure appropriateness and determine compliance with practice guidelines of professional societies.9–15 Although standardized data can improve care within an individual organization, the larger impact occurs when the data are shared externally for analysis and reporting. Specifically, this standardization facilitates the extraction, transmission, and analysis of the data via registries such as the ACC NCDR.16 At the clinician level, the use of controlled vocabularies, coupled with report formats that are consistent in key elements, improves understanding of report content critical to direct patient care. Analysis of datasets comprising uniformly defined data elements can be returned to the clinician to identify opportunities for care improvement and, encourage lifelong professional learning activities. For patients, data terminology standards facilitate a better understanding of the documents that describe their process. For society, the capability of aggregating data in a semantically meaningful way enables device and drug surveillance, including comparative effectiveness research that strives to best understand the risks and benefits of treatments and alternatives.On February 17, 2009, the US federal government enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act of the American Recovery and Reinvestment Act of 2009 legislation.17 A key goal of HITECH is to achieve interoperability of standardized, structured data. Interoperability is the capacity of information technology systems and software applications to communicate and exchange data accurately, effectively, and consistently, as well as to use the information that has been exchanged meaningfully.18 Achieving true semantic interoperability, which refers to the interchange of data while retaining the meaning of the contained information, is the ultimate goal. In health care, semantics are represented in controlled vocabularies such as Systemized Nomenclature of Medicine–Clinical Terms (SNOMED CT), with the semantic relationships among terms modeled in the Unified Medical Language System (UMLS).19,20 However, the SNOMED CT vocabulary set is substantially limited by not including many of the detailed findings required for the completion of a typical cardiac catheterization procedure report, signaling the necessary development of additional data standards in the cardiovascular arena. For cardiovascular procedures, the NCDR data dictionary provides a comprehensive list of many of the terms critical to a complete cardiovascular catheterization report,21 as does the CCS.22 In addition, the ACC and AHA both have a methodology23 and ongoing projects to formalize and harmonize the vocabularies of cardiovascular medicine with relevant professional societies and the US Food and Drug Administration, including an imaging lexicon.24 Importantly, the informatics formalisms to achieve semantic interoperability of these terms are still under development—in other words, many of the above efforts are better described as the authoring of clinical dictionaries rather than the development of the specifics required for semantically interoperable controlled vocabularies. Despite the absence of a formal controlled vocabulary for cardiovascular catheterization procedures, it is nonetheless believed that the structured reporting principles (including the structured report format construct described herein) can be adopted by the clinical and vendor communities.In the healthcare environment, data interoperability through controlled vocabularies will ultimately allow us to achieve a "collect once, verify often, use many times" approach to data, rather than the manual, inefficient, repetitive, and potentially inaccurate acquisition of data (and the corresponding entry and re-entry of that data into information systems) that characterizes healthcare operations today. However, the work required to achieve this interoperability is extensive and complex. Data standardization goes beyond simply defining the data elements (the packets); these electronic elements must be delivered, received, and opened across the information technology systems found in our complex healthcare ecosystem. The American Health Information Management Association lists 16 standards development organizations and 45 groups working on structure and content standards, functional EHR standards, technical and interoperability standards, and vocabulary, along with terminology and classification systems.25 This only serves to highlight the complexities of positioning and aligning this structured reporting initiative within the larger context of healthcare information management.This HPS is intended to provide a general model for structured reporting for invasive and interventional cardiovascular procedures. Of note, the principles and practices espoused by this HPS are also applicable to nonsurgical endovascular procedures performed in a cardiac catheterization laboratory, hybrid catheterization/operating room suite, and interventional/neuroradiology suite, given the similarities in workflows. Use of controlled vocabularies coupled with formatted reporting will facilitate quality improvement activities and provide the ability to interact with data registries for data exchange. All healthcare providers will find catheterization reports easier to understand when they are presented in a consistent format using defined and standardized terminologies. Comparisons between studies performed by other operators or at other institutions will be facilitated by following structured reporting principles.Implementation of structured reporting is thus both a clinical practice and healthcare policy imperative. Through the creation and endorsement of this document, the organizations involved recognize the critical importance of structured reporting and call for its uniform adoption. This includes the collection of standardized data via controlled vocabularies in all cardiovascular procedure settings, the use of structured reports for the reporting of these procedures by all physicians, and adherence to standards for data interoperability, transfer, and communications.12. Principles of Structured Reporting2.1. General PrinciplesThe general principles of structured reporting in cardiovascular imaging have been published previously and remain current, relevant, and applicable.5 The key characteristics of a proper structured report are as follows: 1) it must be inclusive of all information relevant to both clinical care and operational administration; 2) it should be clear, concise, organized, and reproducible, as well as straightforward, to cognitively assimilate and comprehend, while being sufficiently flexible to accommodate evolutionary changes in procedures and documentation requirements; 3) it should contain all the required elements for documenting procedure indications and assessing appropriateness per local coverage determination rules and/or published AUC9–11; 4) a consistent minimum dataset should be included in the content of each report, anticipating clinical, operational, regulatory, and financial uses of the data therein; and 5) the report should be devoid of extraneous content and be brief yet thorough.2.2. Integration of Data Acquisition With WorkflowThe processes of structured reporting extend the emphasis from structure and format of the report to the integration of data acquisition with workflow, maximizing the accuracy, completeness, and efficiency of procedure report generation. In this paradigm, complete and accurate documentation occurs at every step of the workflow; the responsibility for data acquisition is shared by the entire healthcare team. Ideally, proper system design will enable this tight coupling, resulting in a final structured procedure report within minutes of procedure completion.Typical steps that comprise a cardiovascular catheterization procedure encounter are depicted in Figure 1. In a structured reporting environment, the opportunity for data gathering begins with the request to the scheduling office. This includes requesting the capture of demographic information and procedures. Additional clinical information such as a basic history, medications, allergies, risk factors, previous procedures, and laboratory data should be available at this juncture. The idealized workflow imports (or otherwise) captures these data before the patient presents for the procedure. Ideally, data should flow bidirectionally to and from the EHR.Download figureDownload PowerPointFigure 1. Sequence Diagram for Cardiovascular Catheterization Procedures. This schematic illustrates the temporal relationships and dependencies among the events, individuals, and actions that occur from the point of requesting/scheduling a catheterization procedure through the data outputs arising from the procedure. The diagram depicts the sequence of the Duke University Hospital Catheterization Laboratory; modification may be needed to represent the sequence of other catheterization laboratories. Time is nonlinear and is oriented along the horizontal axis in this depiction. ACC NCDR indicates American College of Cardiology National Cardiovascular Data Registry; ACTION-GWTG, Acute Coronary Treatment and Intervention Outcomes Network–Get With The Guidelines (registry); Cath Lab, catheterization laboratory; CathPCI, Cardiac Catheterization and Percutaneous Coronary Intervention (registry); H&P, history and physical; Hemo, hemodynamic; HER, electronic health record; HIS, hospital information system; IMPACT, Improving Pediatric and Adult Congenital Treatment (registry); IP, inpatient; IT, information technology; IV, intravenous; MRN, medical record number; NP, nurse practitioner; OP, outpatient; PA, physician assistant; PACS, picture archiving and communication system; RN, registered nurse; STS CT Surgery, Society of Thoracic Surgeons Cardiothoracic Surgery (registry); and Tech, technologist.This basic paradigm—using optimized technology solutions to accomplish data collection by the individuals handling the data when the information becomes available—is then extended to the other steps involved in a catheterization procedure, with the data aggregated and stored for subsequent presentation and analysis (Figure 2). The need to establish specific responsibilities and accountability of the individuals for specific sets of data is an implicit step at every point in the process. No single individ
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