Standardized Data Elements for Patients with Acute Pulmonary Embolism: A Consensus Report from the Pulmonary Embolism Research Collaborative
Authors: Rosenfield Kenneth , Bowers Terry R. , Barnett Christopher F. , Davis George A. , Giri Jay , Horowitz James M. , Huisman Menno V. ,   FESC, Hunt Beverley J. , Keeling Brent , Kline Jeffrey A. , Klok Frederikus A. , Konstantinides Stavros V. , Lanno Michelle T , Lookstein Robert , Moriarty John M. , Ní Áinle Fionnuala , Reed Jamie L. , Rosovsky Rachel P. , Royce Sara M. , Secemsky Eric A. , Sharp Andrew SP , Sista Akhilesh K. , Smith Roy E. , Wells Phil , Yang Joanna , Whatley Eleni M. 
Published: December 2024

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 ConsortiumTMis a strong advocate of evidence based care for PE patients and therefore initiated the Pulmonary Embolism Research Collaborative (PERCTM) 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.