Standardized Data Elements for Patients with Acute Pulmonary Embolism: A Consensus Report from the Pulmonary Embolism Research Collaborative
Abstract
ABSTRACT Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams (PERTs) show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of healthcare, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment. We set out to standardize data collection in PE patients undergoing evaluation and treatment, and thus establish the foundation for an expanding evidence base that will address gaps in evidence and inform future care for acute PE. To do so, over 100 international PE thought leaders convened in Washington, DC in April 2022 to form the Pulmonary Embolism Research Collaborative (PERC™). Participants included physician experts, key members of the United States Food and Drug Administration (FDA), patient representatives, and industry leaders. Recognizing the multi-disciplinary nature of PE care, the Pulmonary Embolism Research Collaborative (PERC™) was created with representative experts from stakeholder medical subspecialties, including cardiology, pulmonology, vascular medicine, critical care, hematology, cardiac surgery, emergency medicine, hospital medicine, and pharmacology. A list of critical evidence gaps was composed with a matching comprehensive set of standardized data elements; these data points will provide a foundation for productive research, knowledge enhancement, and advancement of clinical care within the field of acute PE, and contribute to answering urgent unmet needs in PE management. Evidence produced through PERC™, as it is applied to data collection, promises to provide crucial knowledge that will ultimately produce a robust evidence base that will lead to standardization and harmonization of PE management and improved outcomes. CLINICAL PERSPECTIVE 1) What is new? Recent advances have increased options for treatment of acute pulmonary embolism, yet there remain wide variations in management due to the lack of a reliable evidence base upon which to base therapeutic decisions. The PERT Consortium TM is a strong advocate of evidence based care for PE patients and therefore initiated the Pulmonary Embolism Research Collaborative (PERC TM ) to establish a foundation for advancing high quality research and improving clinical care. A novel comprehensive set of standardized data elements is proposed for collection in patients with acute pulmonary embolism, to provide a foundation for expanding the evidence base and enhancing care. 2) What are the clinical implications? Standardizing collection of data for acute pulmonary embolism will enable analyses that will inform optimal risk stratification, treatment, and follow-up of patients with pulmonary embolism, and provide evidence-based treatment algorithms that will improve outcomes. Registries created using the proposed standardized elements will enable benchmarking and quality assurance for clinicians caring for pulmonary embolism patients. Incorporation of comprehensive standardized data elements into FDA IDE trials will enable the Agency to better assess the safety and effectiveness of investigational devices.
Authors 24
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Kenneth Rosenfield corresponding
Massachusetts General Hospital
Affiliation as printed
Division of Cardiology, Massachusetts General Hospital, Boston, MA Massachusetts
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Affiliation as printed
Corewell Health, Beaumont University Hospital, Division of Cardiovascular Medicine, Royal Oak, MI
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University of California, San Francisco
Affiliation as printed
Division of Cardiology, University of California, San Francisco, CA
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University of Kentucky HealthCare · University of Kentucky
Affiliation as printed
University of Kentucky UK HealthCare; University of Kentucky College of Pharmacy, Lexington, KY
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Affiliation as printed
Cardiovascular Medicine Division, University of Pennsylvania Perelman School of Medicine
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NYU Langone Health · New York University
Affiliation as printed
NYU Langone Health, Department of Medicine, Division of Cardiology, New York, NY
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Leiden University Medical Center
Affiliation as printed
Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands and Dutch Thrombosis Network
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Affiliation as printed
Kings Healthcare Partners, London UK
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Affiliation as printed
Wayne State University School of Medicine, Detroit, MI
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Leiden University Medical Center
Affiliation as printed
Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands and Dutch Thrombosis Network
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Democritus University of Thrace · University Medical Center of the Johannes Gutenberg University Mainz
Affiliation as printed
Center for Thrombosis and Hemostasis, University Medical Center Mainz, Germany; Department of Cardiology, Democritus University of Thrace, Greece
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Affiliation as printed
The PERT Consortium™, Nashua, NH
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Icahn School of Medicine at Mount Sinai
Affiliation as printed
Icahn School of Medicine at Mount Sinai; New York, NY
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University of California, Los Angeles
Affiliation as printed
David Geffen School of Medicine at UCLA, Los Angeles, CA
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University College Dublin · Royal College of Surgeons in Ireland · Mater Misericordiae University Hospital
Affiliation as printed
University College Dublin School of Medicine, Mater Misericordiae University Hospital, Dublin, Ireland, Royal College of Surgeons in Ireland
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Harvard University · Massachusetts General Hospital
Affiliation as printed
Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA
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United States Food and Drug Administration
Affiliation as printed
US Food and Drug Administration, Silver Spring, MD
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Beth Israel Deaconess Medical Center
Affiliation as printed
Beth Israel Deaconess Medical Center, Boston, MA
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University Hospital of Wales · Cardiff University
Affiliation as printed
University Hospital of Wales and Cardiff University
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Affiliation as printed
Weill Cornell Medicine, Department of Radiology, New York, NY
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University of Pittsburgh Medical Center
Affiliation as printed
Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA
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University of Ottawa · Ottawa Hospital
Affiliation as printed
Department of Medicine, The Ottawa Hospital; University of Ottawa, Ottawa, ON
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Harvard University · Massachusetts General Hospital
Affiliation as printed
Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA
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United States Food and Drug Administration
Affiliation as printed
US Food and Drug Administration, Silver Spring, MD
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