Standardized Data Elements for Patients With Acute Pulmonary Embolism: A Consensus Report From the Pulmonary Embolism Research Collaborative.

Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams 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 health care, 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 patients with PE 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, >100 international PE thought leaders convened in Washington, DC, in April 2022 to form the Pulmonary Embolism Research Collaborative. Participants included physician experts, key members of the US Food and Drug Administration, patient representatives, and industry leaders. Recognizing the multidisciplinary nature of PE care, the Pulmonary Embolism Research Collaborative 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 the Pulmonary Embolism Research Collaborative, 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.
Competing Interests: Dr Rosenfield reports consulting fees from Abbott Vascular, Boston Scientific, Contego, Imperative Care, Johnson & Johnson, Biosense Webster, Medtronic, Neptune Medical, and Philips; board membership for the PERT (Pulmonary Embolism Response Team) Consortium; and stock or stock options in Access Vascular, Althea Medical, Auxetics, Contego, Endospan, Imperative Care, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Sealonix, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vantis Vascular, Vasorum, Viz.ai, and Vumedi. Dr Bowers reports consulting fees from Truvic, Inc, lecture fees from Janssen and Bristol Myers Squibb (BMS)-Pfizer, payment for expert testimony, and participation on Advisory Board of Truvic, Inc. Dr Barnett reports payment for expert testimony. Dr Davis reports travel support for attending the Pulmonary Embolism Research Collaborative meeting. Dr Giri reports research support from Boston Scientific, Inc, and Inari Medical; consulting fees from Boston Scientific, Inc, Cordis, and Abbott Vascular; support for attending meetings from Inari Medical; participation on an advisory board for Angiodynamics, Inc, and Boston Scientific, Inc; participation in leadership at Society for Cardiac Angiography and Intervention and the PERT Consortium; and stock or stock options in Endovascular Engineering. Dr Horowitz reports research support from Inari Medical; consultation and personal lecture fees from Inari Medical and Penumbra, Inc; and support for attending meetings from Inari Medical. Dr Keeling reports consulting fees from Angiodynamics, Inc, Penumbra, Inc, Viz.ai, and Dexcom. Dr Klok reports institutional research support from Bayer, Bristol Myers Squibb, Actelion, Boston Scientific, Inc, Leo Pharma, the Netherlands Organisation for Health Research and Development, the Dutch Thrombosis Association, the Dutch Heart Foundation, and the Horizon Europe program; service on the Board of the Rembrandt Institute of Cardiovascular Science; Chair of the Board of the Dutch Society of Vascular Medicine; nucleus member of the European Society of Cardiology work group on pulmonary circulation and RV function; nucleus member of ISTH SSC diagnostic and predictive variables; Chair of the Board of the Dutch Thrombosis Network; and medical lead, Anticoagulation Clinic Leiden. Dr Konstantinides reports personal and institutional consulting fees from Bayer AG, Daiichi-Sankyo, and Boston Scientific, Inc, and personal lecture fees from Bayer AG, Daiichi-Sankyo, Pfizer–Bristol Myers Squibb, and Boston Scientific, Inc. Dr Lookstein reports consulting fees from Penumbra, Inc, Boston Scientific, Inc, Medtronic, Cordis, Becton Dickinson, Abbott Vascular, Neptune Medical, Imperative Care, and Aidoc; payment for expert testimony; participation on advisory boards for Magneto, Boston Scientific, Inc, Medtronic, and Trireme; leadership roles at the PERT Consortium, Critical Limb Ischemia Global Society, and Society of Interventional Radiology; and stock or stock options in Imperative Vascular, Thrombolex, Innova Vascular, and Summa Vascular. Dr Moriarty reports research support from Angiodynamics, Inc, and Penumbra, Inc; consulting fees from Angiodynamics, Inc, Penumbra Inc, Inquis Medical, Innova Vascular, Boston Scientific Inc, Auxetics, and Retriever Medical; and participation on the data safety monitoring board for Penumbra, Inc. Dr Ní Áinle reports institutional research support from Sanofi, Daiichi-Sankyo, the Irish Health Research Board, Bayer, and Boston Scientific, Inc; patents pending for European Application No. 20166826.6; past member of World Thrombosis Day International Steering Committee; Director at Large and Member, International Network of Venous ThromboEmbolism Research Networks Council; Co-Director, InVite; Co-Founder and member of Executive Committee of Venous Thromboembolism Ireland; Advisory Committee for Human Medicines; member of “Preventing Venous Thromboembolism in Hospitals” Collaborative Advisory Group; Board Member, Thrombosis Ireland Patient Organization and Charity; and National Lead, Irish Venous Thromboembolism Patient Safety Programme. Dr Rosovsky reports research support from BMS and Janssen; consulting fees from Abbott, BMS, Dova, Inari Medical, Janssen, and Penumbra, Inc; participation on the data safety monitoring board for the Pepper Trial and Harvard Cancer Center; unpaid President-Elect of the PERT Consortium; and unpaid member of ASH Committee on Quality. Dr Secemsky reports research support from NIH/NHLBINIH/NHBLI K23HL150290, Food and Drug Administration, Becton-Dickinson, Boston Scientific, Inc, Cook Medical, Cardiovascular Systems Inc., Laminate Medical, Medtronic, and Philip; consulting fees and personal lecture fees from Abbott, Bayer, Becton-Dickinson, Boston Scientific, Inc, Cook, Cardiovascular Systems Inc., Inari Medical, Medtronic, Philips, Shockwave, and VentureMed; and participation on data safety monitoring boards for LIFE BTK, BIOMIMCS3D, HI-PEITHO, and Transcend. Dr Sharp reports consulting and lecture fees from Medtronic, Boston Scientific, Inc, Philips, Recor Medical, and Penumbra, Inc. Dr Sista reports research support from NIH/NHLBI as principal investigator of U34 and UG3 awards, unpaid participation on data safety monitoring boards for Angiodynamics, Inc, and Thrombolex, Inc; and participation on the Board of Directors for the Society of Interventional Radiology. Dr Wells reports participation on the data safety monitoring board for Anthos. The other authors report no conflicts.