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14 December 2021

Safety and Efficiency of Diagnostic Strategies for Ruling Out Pulmonary Embolism in Clinically Relevant Patient Subgroups: A Systematic Review and Individual-Patient Data Meta-analysis

Publication: Annals of Internal Medicine
Volume 175, Number 2

Abstract

Background:

How diagnostic strategies for suspected pulmonary embolism (PE) perform in relevant patient subgroups defined by sex, age, cancer, and previous venous thromboembolism (VTE) is unknown.

Purpose:

To evaluate the safety and efficiency of the Wells and revised Geneva scores combined with fixed and adapted D-dimer thresholds, as well as the YEARS algorithm, for ruling out acute PE in these subgroups.

Data Sources:

MEDLINE from 1 January 1995 until 1 January 2021.

Study Selection:

16 studies assessing at least 1 diagnostic strategy.

Data Extraction:

Individual-patient data from 20 553 patients.

Data Synthesis:

Safety was defined as the diagnostic failure rate (the predicted 3-month VTE incidence after exclusion of PE without imaging at baseline). Efficiency was defined as the proportion of individuals classified by the strategy as “PE considered excluded” without imaging tests. Across all strategies, efficiency was highest in patients younger than 40 years (47% to 68%) and lowest in patients aged 80 years or older (6.0% to 23%) or patients with cancer (9.6% to 26%). However, efficiency improved considerably in these subgroups when pretest probability–dependent D-dimer thresholds were applied. Predicted failure rates were highest for strategies with adapted D-dimer thresholds, with failure rates varying between 2% and 4% in the predefined patient subgroups.

Limitations:

Between-study differences in scoring predictor items and D-dimer assays, as well as the presence of differential verification bias, in particular for classifying fatal events and subsegmental PE cases, all of which may have led to an overestimation of the predicted failure rates of adapted D-dimer thresholds.

Conclusion:

Overall, all strategies showed acceptable safety, with pretest probability–dependent D-dimer thresholds having not only the highest efficiency but also the highest predicted failure rate. From an efficiency perspective, this individual-patient data meta-analysis supports application of adapted D-dimer thresholds.

Primary Funding Source:

Dutch Research Council. (PROSPERO: CRD42018089366)

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Supplemental Material

Supplement. Patient-Level Data Collected at Baseline

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Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 175Number 2February 2022
Pages: 244 - 255

History

Published online: 14 December 2021
Published in issue: February 2022

Keywords

Authors

Affiliations

Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.A.M.S., M.V.H., F.A.K.)
Toshihiko Takada, MD, PhD https://orcid.org/0000-0002-8032-6224
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands, and Department of General Medicine, Shirakawa Satellite for Teaching and Research (STAR), Fukushima Medical University, Fukushima, Japan (T.T.)
Noémie Kraaijpoel, MD, PhD https://orcid.org/0000-0002-1124-695X
Department of Vascular Medicine, Amsterdam University Medical Center, location AMC, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands (N.K., N.v.E., H.R.B.)
Department of Vascular Medicine, Amsterdam University Medical Center, location AMC, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands (N.K., N.v.E., H.R.B.)
Harry R. Büller, MD, PhD
Department of Vascular Medicine, Amsterdam University Medical Center, location AMC, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands (N.K., N.v.E., H.R.B.)
D. Mark Courtney, MD, PhD
Department of Emergency Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas (D.M.C.)
Yonathan Freund, MD, PhD
Department of Emergency Medicine, Pitié-Salpêtrière University Hospital, Assistance Publique–Hôpitaux de Paris, Paris, France (Y.F.)
Javier Galipienzo, MD
Service of Anesthesiology, Hospital MD Anderson Cancer Center, Madrid, Spain (J.G.)
Grégoire Le Gal, MD, PhD
Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Thrombosis Research Group, Ottawa, Ontario, Canada (G.L.G., P.S.W.)
Department of Medicine, Østfold Hospital Trust and Institute of Clinical Medicine, University of Oslo, Oslo, Norway (W.G.)
Menno V. Huisman, MD, PhD https://orcid.org/0000-0003-1423-5348
Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.A.M.S., M.V.H., F.A.K.)
Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, Indiana (J.A.K.)
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.G.M.M., M.v.S., G.J.G.)
Sameer Parpia, PhD
Department of Oncology, McMaster University, Hamilton, Ontario, Canada (S.P.)
Division of Angiology and Hemostasis, Department of Medical Specialties, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland (A.P., M.R., H.R.E.)
Division of Angiology and Hemostasis, Department of Medical Specialties, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland (A.P., M.R., H.R.E.)
Division of Angiology and Hemostasis, Department of Medical Specialties, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland (A.P., M.R., H.R.E.)
Pierre-Marie Roy, MD, PhD https://orcid.org/0000-0003-4811-6793
Department of Emergency Medicine, University of Angers, Angers, France (P.M.R.)
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.G.M.M., M.v.S., G.J.G.)
Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Thrombosis Research Group, Ottawa, Ontario, Canada (G.L.G., P.S.W.)
Department of Emergency Medicine, Queen's University, Kingston, and Departments of Medicine and Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Ontario, Canada (K.d.W.).
Geert-Jan Geersing, MD, PhD
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.G.M.M., M.v.S., G.J.G.)
Frederikus A. Klok, MD, PhD https://orcid.org/0000-0001-9961-0754
Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.A.M.S., M.V.H., F.A.K.)
Grant Support: By grant 91616030 from the Dutch Research Council.
Reproducible Research Statement: Study protocol: The study protocol was published previously (19). This project was also preregistered at the PROSPERO database for systematic reviews (CRD42018089366). Statistical code and data set: Not available.
Corresponding Author: Frederikus A. Klok, MD, PhD, Department of Medicine–Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, Leiden, the Netherlands; e-mail, [email protected].
Author Contributions: Conception and design: G.J. Geersing, F.A. Klok, N. Kraaijpoel, N. van Es, G. Le Gal, M.V. Huisman, K.G.M. Moons, M. Righini, M. van Smeden.
Analysis and interpretation of the data: M.A.M. Stals, T. Takada, N. Kraaijpoel, N. van Es, H.R. Büller, G. Le Gal, M.V. Huisman, K.G.M. Moons, M. Righini, M. van Smeden, P.S. Wells, K. de Wit, G.J. Geersing, F.A. Klok.
Drafting of the article: M.A.M. Stals, T. Takada, N. Kraaijpoel, N. van Es, M. van Smeden, G.J. Geersing, F.A. Klok.
Critical revision of the article for important intellectual content: M.A.M. Stals, T. Takada, N. Kraaijpoel, N. van Es, H.R. Büller, D.M. Courtney, Y. Freund, J. Galipienzo, G. Le Gal, W. Ghanima, M.V. Huisman, J.A. Kline, K.G.M. Moons, S. Parpia, A. Perrier, M. Righini, H. Robert-Ebadi, P.M. Roy, M. van Smeden, P.S. Wells, K. de Wit, G.J. Geersing, F.A. Klok.
Final approval of the article: M.A.M. Stals, T. Takada, N. Kraaijpoel, N. van Es, H.R. Büller, D.M. Courtney, Y. Freund, J. Galipienzo, G. Le Gal, W. Ghanima, M.V. Huisman, J.A. Kline, K.G.M. Moons, S. Parpia, A. Perrier, M. Righini, H. Robert-Ebadi, P.M. Roy, M. van Smeden, P.S. Wells, K. de Wit, G.J. Geersing, F.A. Klok.
Provision of study materials or patients: Y. Freund, G. Le Gal, W. Ghanima, S. Parpia, M. Righini, P.M. Roy, P.S. Wells, G.J. Geersing.
Statistical expertise: T. Takada, K.G.M. Moons, M. van Smeden, G.J. Geersing.
Obtaining of funding: M. Righini, G.J. Geersing.
Administrative, technical, or logistic support: G. Le Gal, J.A. Kline, M. Righini, G.J. Geersing, F.A. Klok.
Collection and assembly of data: M.A.M. Stals, T. Takada, N. Kraaijpoel, N. van Es, Y. Freund, J. Galipienzo, G. Le Gal, W. Ghanima, M.V. Huisman, J.A. Kline, A. Perrier, M. Righini, K. de Wit, G.J. Geersing, F.A. Klok.
This article was published at Annals.org on 14 December 2021.

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Milou A.M. Stals, Toshihiko Takada, Noémie Kraaijpoel, et al. Safety and Efficiency of Diagnostic Strategies for Ruling Out Pulmonary Embolism in Clinically Relevant Patient Subgroups: A Systematic Review and Individual-Patient Data Meta-analysis. Ann Intern Med.2022;175:244-255. [Epub 14 December 2021]. doi:10.7326/M21-2625

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