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Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: Study Protocol of SPEED&PEPS Trial.
Roy, Pierre-Marie; Moumneh, Thomas; Penaloza, Andrea; Schmidt, Jeannot; Charpentier, Sandrine; Joly, Luc-Marie; Riou, Jérémie; Douillet, Delphine.
Afiliación
  • Roy PM; Angers University Hospital, Emergency Department, Univ Angers, MitoVasc UMR CNRS 6015-INSERM 1083, FCRIN, INNOVTE, 49000 Angers, France.
  • Moumneh T; Angers University Hospital, Emergency Department, Univ Angers, MitoVasc UMR CNRS 6015-INSERM 1083, FCRIN, INNOVTE, 49000 Angers, France.
  • Penaloza A; Cliniques Universitaires St-Luc, Emergency Department, Université Catholique de Louvain, 1200 Bruxelles, Belgium.
  • Schmidt J; Clermont-Ferrand University Hospital-Gabriel Montpied, Emergency Department, FCRIN, INNOVTE, 63000 Clermont-Ferrand, France.
  • Charpentier S; Toulouse University Hospital, Emergency Department, 31300 Toulouse, France.
  • Joly LM; Rouen University Hospital, Emergency Department, 76031 Rouen, France.
  • Riou J; Angers University Hospital, Methodology and Biostatistics Department, Delegation to Clinical Research and Innovation, Univ Angers, MINT UMR INSERM 1066-CNRS 6021, 49000 Angers, France.
  • Douillet D; Angers University Hospital, Emergency Department, Univ Angers, MitoVasc UMR CNRS 6015-INSERM 1083, FCRIN, INNOVTE, 49000 Angers, France.
Diagnostics (Basel) ; 12(12)2022 Dec 09.
Article en En | MEDLINE | ID: mdl-36553108
ABSTRACT

Introduction:

Several strategies have been devised to safely limit the use of thoracic imaging in patients suspected of pulmonary embolism (PE). However, they are based on different rules for clinical probability (CP) assessment, rendering their combination difficult. The four-level pulmonary embolism probability score (4PEPS) allows the combination of all other strategies using a single CP assessment. Methods and

analysis:

Pragmatic cluster-randomized trial in 20 EDs. Patients with suspected PE will be included and followed for 90 days (number of patients to be included 2560, 1280 in each arm). Ten centers will be allocated to the control group where physicians will be free to do as they see fit but they will be given the recommendation to apply a validated strategy. Ten centers will be allocated to the interventional group where the physicians will be given the recommendation to apply the 4PEPS strategy. The primary objective will be to demonstrate that the application of the 4PEPS strategy by the emergency physicians, in comparison to current practices, (i) does not increase the risk of serious events related to diagnostic strategies and (ii) significantly reduces the use of thoracic imaging. Ethics and dissemination The study will be submitted for approval to an institutional ethics review board for all participating centers. If successful, the SPEED&PEPS trial will have an important impact for patients suspected of PE limiting their irradiation and for public health in substantial savings in terms of the direct cost of diagnostic investigations and the indirect cost of hospitalizations due to waiting times or delayed harmful effects.

Funding:

This work is funded by a French Public Health grant (PREPS-N 2019). The funding source plays no role in the study design, data collection, analysis, interpretation or the writing of the manuscript. Trial registration ongoing. Trial status not started.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Aspecto: Ethics Idioma: En Revista: Diagnostics (Basel) Año: 2022 Tipo del documento: Article País de afiliación: Francia

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Aspecto: Ethics Idioma: En Revista: Diagnostics (Basel) Año: 2022 Tipo del documento: Article País de afiliación: Francia