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Thromb Haemost 2023; 123(06): 649-662
DOI: 10.1055/a-2039-3222
Trial Protocol Design Paper

Developing Validated Tools to Identify Pulmonary Embolism in Electronic Databases: Rationale and Design of the PE-EHR+ Study

Behnood Bikdeli 
1   Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
2   Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
4   Cardiovascular Research Foundation (CRF), New York, New York, United States
,
Ying-Chih Lo
5   Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Candrika D. Khairani
2   Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Antoine Bejjani
2   Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
David Jimenez 
6   Respiratory Department, Hospital Ramón y Cajal and Medicine Department, Universidad de Alcalá (Instituto de Ramón y Cajal de Investigación Sanitaria), Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
,
Stefano Barco 
7   Department of Angiology, University Hospital Zurich, Zurich, Switzerland
8   Center for Thrombosis and Hemostasis, Johannes Gutenberg University Mainz, Mainz, Germany
,
Shiwani Mahajan
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
9   Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, United States
,
César Caraballo
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
,
Eric A. Secemsky
10   Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
11   Harvard Medical School, Boston, Massachusetts, United States
12   Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
,
Frederikus A. Klok
13   Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Centre, Leiden, The Netherlands
,
Andetta R. Hunsaker
14   Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Ayaz Aghayev
14   Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Alfonso Muriel
15   Clinical Biostatistics Unit. Hospital Universitario Ramón y Cajal. IRYCIS, CIBERESP: Universidad de Alcalá. Madrid, Spain
,
Yun Wang
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
10   Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
,
Mohamad A. Hussain
16   Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
17   Centre for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Abena Appah-Sampong
18   Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, United States
,
Yuan Lu
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
,
Zhenqiu Lin
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
,
Sanjay Aneja
19   Department of Therapeutic Radiology, Yale School of Medicine, New Haven, Connecticut, United States
,
Rohan Khera
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
20   Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, United States
,
Samuel Z. Goldhaber
1   Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
2   Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Li Zhou
5   Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Manuel Monreal
21   Cátedra de Enfermedad Tromboembólica, Universidad Católica de Murcia, Murcia, Spain
,
Harlan M. Krumholz
3   YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, Connecticut, United States
20   Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, United States
22   Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut, United States
,
Gregory Piazza
1   Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
2   Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States
› Author Affiliations Funding Dr. Bikdeli is supported by a Career Development Award from the American Heart Association and VIVA Physicians (#938814) for the PE-EHR+ study. Outside the submitted work, Dr. Bikdeli is supported by the Scott Schoen and Nancy Adams IGNITE Award, as well as by the Mary Ann Tynan Research Scientist award from the Mary Horrigan Connors Center for Women's Health and Gender Biology at BWH, and the Heart and Vascular Center Junior Faculty Award from BWH. Dr. Hussain is funded by a Heart and Vascular Center Junior Faculty Award from BWH.
› Further Information
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Abstract

Background Contemporary pulmonary embolism (PE) research, in many cases, relies on data from electronic health records (EHRs) and administrative databases that use International Classification of Diseases (ICD) codes. Natural language processing (NLP) tools can be used for automated chart review and patient identification. However, there remains uncertainty with the validity of ICD-10 codes or NLP algorithms for patient identification.

Methods The PE-EHR+ study has been designed to validate ICD-10 codes as Principal Discharge Diagnosis, or Secondary Discharge Diagnoses, as well as NLP tools set out in prior studies to identify patients with PE within EHRs. Manual chart review by two independent abstractors by predefined criteria will be the reference standard. Sensitivity, specificity, and positive and negative predictive values will be determined. We will assess the discriminatory function of code subgroups for intermediate- and high-risk PE. In addition, accuracy of NLP algorithms to identify PE from radiology reports will be assessed.

Results A total of 1,734 patients from the Mass General Brigham health system have been identified. These include 578 with ICD-10 Principal Discharge Diagnosis codes for PE, 578 with codes in the secondary position, and 578 without PE codes during the index hospitalization. Patients within each group were selected randomly from the entire pool of patients at the Mass General Brigham health system. A smaller subset of patients will also be identified from the Yale-New Haven Health System. Data validation and analyses will be forthcoming.

Conclusions The PE-EHR+ study will help validate efficient tools for identification of patients with PE in EHRs, improving the reliability of efficient observational studies or randomized trials of patients with PE using electronic databases.

Keywords

pulmonary embolism - validity - electronic health records - International Classification of Diseases - natural language processing

Supplementary Material



Publication History

Received: 03 December 2022

Accepted: 17 February 2023

Accepted Manuscript online:
21 February 2023

Article published online:
28 March 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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