xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015529</url>
    </required_header>
    <id_info>
      <org_study_id>36553108</org_study_id>
      <nct_id>NCT06015529</nct_id>
    </id_info>
    <brief_title>Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS</brief_title>
    <acronym>SPEED&amp;PEPS</acronym>
    <official_title>Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: SPEED&amp;PEPS Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Angers</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Angers</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The increased use of diagnostic imaging and especially computed tomography pulmonary&#xD;
        angiography in patients suspected of pulmonary embolism (PE) is an important point of&#xD;
        concerns.&#xD;
  &#xD;
        The goal of this pragmatic cluster-randomized trial is to compare the diagnostic strategy&#xD;
        based on the four-level pulmonary embolism probability score (4PEPS) and current practices.&#xD;
  &#xD;
        The main questions it aims to answer is: &quot;Does the diagnostic strategy based on 4PEPS&#xD;
        significantly reduce the use of thoracic imaging without increasing the risk of serious&#xD;
        adverse events as compared to current diagnostic practices?&quot; Patients suspected of having PE&#xD;
        in the participating emergency departments will be included and followed for 90 days. In ten&#xD;
        centers, the emergency physicians will apply the 4PEPS strategy and in ten other centers, the&#xD;
        emergency physicians will be free to do as they see fit. Researchers will compare the two&#xD;
        groups of patients to see if the rate of diagnostic thoracic imaging tests and the rate of&#xD;
        adverse events related to diagnostic strategies will differ.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Several strategies have been devised to safely limit the use of thoracic imaging in patients&#xD;
        suspected of pulmonary embolism (PE). However, they are based on different rules for clinical&#xD;
        probability (CP) assessment, rendering their combination difficult. The four-level pulmonary&#xD;
        embolism probability score (4PEPS) allows the combination of all other strategies using a&#xD;
        single CP assessment. Methods and analysis: SPEED&amp;PEPS is a pragmatic cluster-randomized&#xD;
        trial. After a preliminary period aimed to assess the possibility of inclusions and current&#xD;
        practices in 23 Emergency Departments (ED), 20 EDs will be selected to participate to the&#xD;
        active phase and randomization. Half of the centers will be allocated to the control group&#xD;
        where physicians will be free to do as they see fit but they will be given the recommendation&#xD;
        to apply a validated strategy. Half of the centers will be allocated to the interventional&#xD;
        group where the physicians will be given the recommendation to apply the 4PEPS strategy.&#xD;
        Patients with suspected PE will be included and followed for 90 days (anticipated number of&#xD;
        patients to be included: 2560, 1280 in each arm). The primary objective will be to&#xD;
        demonstrate that the application of the 4PEPS strategy by emergency physicians, in comparison&#xD;
        to current practices, (i) does not increase the risk of serious events related to diagnostic&#xD;
        strategies and (ii) significantly reduces the use of thoracic imaging. If successful, the&#xD;
        SPEED&amp;PEPS trial will have an important impact for patients suspected of PE limiting their&#xD;
        irradiation and for public health in substantial savings in terms of the direct cost of&#xD;
        diagnostic investigations and the indirect cost of hospitalizations due to waiting times or&#xD;
        delayed harmful effects. Funding: This work is funded by a French Public Health grant&#xD;
        (PREPS-N 2019). The funding source plays no role in the study design, data collection,&#xD;
        analysis, interpretation or the writing of the manuscript.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Pragmatic cluster-randomized trial</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>blinded adjudication committee assessing endpoints</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of serious clinical events in the 90 days following inclusion</measure>
      <time_frame>90 days</time_frame>
      <description>The primary safety endpoint will be the rate of serious clinical events in the 90 days following inclusion: • Serious adverse events related to diagnostic testing (leading to hospitalization or prolongation of hospitalization, permanent inability or incapacity, and death). • Symptomatic thromboembolic events in patients not diagnosed with PE in the emergency department or new thromboembolic events in patients diagnosed with PE. • Death related to PE (initial or recurrent PE). • Major bleeding related to an anticoagulant treatment prescribed for pulmonary embolism according to ISTH criteria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of diagnostic thoracic imaging</measure>
      <time_frame>up to 72 hours following inclusion</time_frame>
      <description>The primary efficacy endpoint will be the rate of thoracic imaging among all included patients with suspected PE. The following examinations are considered if they are performed at the request of the emergency physician in search of PE: computed tomography pulmonary angiography (CTPA), planar perfusion or perfusion-ventilation scintigraphy, and SPECT scintigraphy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out according to the 4PEPS strategy in the intervention group</measure>
      <time_frame>90 days</time_frame>
      <description>The first secondary objective is to demonstrate, in the intervention group, that the risk of false-negative diagnosis with the 4PEPS strategy is very low in accordance with the International Society of Thrombosis and Hemostasis (ISTH) criteria for validation of rule-out PE diagnostic strategies.&#xD;
  The endpoint will be the false-negative rate defined as the rate of thromboembolic events occurring in the 90 days following inclusion in patients in the intervention group for whom PE was ruled out according to the 4PEPS strategy and who were not treated with anticoagulants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out in both groups</measure>
      <time_frame>90 days</time_frame>
      <description>The second secondary objective is to demonstrate that the 4PEPS strategy (intervention group) is not inferior to current practices (control group) as regards the risk of false-negative diagnosis.&#xD;
  The false-negative rate will be defined as the rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out and who were not treated with anticoagulants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of D-dimer measurement</measure>
      <time_frame>up to 72 hours following inclusion</time_frame>
      <description>The third secondary objective is to to evaluate and compare to usual practice the impact of the 4PEPS strategy as regards the rate of D-dimer measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in ED</measure>
      <time_frame>Up to Emergency Department discharge (assessed up to 48 hours)</time_frame>
      <description>The fourth secondary objective is to evaluate and compare to usual practice the impact of the 4PEPS strategy as regards the length of time spent in the emergency department by patients with suspected PE.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2560</enrollment>
    <condition>Pulmonary Embolism</condition>
    <arm_group>
      <arm_group_label>Control group - current practices</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The investigating physicians of the participating centers in the control group will be free to provide care as they see fit. However, a reminder of national and European guidelines for PE management will be given to them and they will have the recommendation to apply a validated strategy. To make it easier, the different scores will be included in the clinical help-decision support software called SPEED. Investigators will be asked to enter data about the included patients directly into SPEED, which will act as the study's electronic case report form (eCRF). A paper version of the CRF will also be available.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group - 4PEPS strategy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Physicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. To make it easier to apply, the 4PEPS score will be included in SPEED. Investigators will be asked to enter the information relating to patients included in the study directly into SPEED before performing any testing. Entering these data will enable the 4PEPS score to be calculated automatically and specific recommendations to be provided. A paper version of the CRF will also be available</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>4PEPS strategy</intervention_name>
      <description>Physicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. Using 12 variables, 4PEPS defines four levels of CP that rule out a PE, namely&#xD;
  based only on clinical data (very low CP: PEPS &lt; 0),&#xD;
  based on a D-dimer level &lt; 1000 μg/L (low CP: PEPS ≥ 0 and &lt; 5),&#xD;
  based on a D-dimer level with an age-adjusted cut-off value (moderate CP: PEPS ≥ 5 and &lt;12), or&#xD;
  the diagnosis cannot reliably be ruled out based on a D-dimer test (high CP: PEPS ≥ 12)</description>
      <arm_group_label>Intervention group - 4PEPS strategy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Admission to an emergency department participating in the study.&#xD;
  &#xD;
            -  Suspected PE due to thoracic symptoms (dyspnea, chest pain, or hemoptysis) and/or&#xD;
               syncope without any other obvious explanation after clinical examination and possible&#xD;
               additional first-line tests (ECG, chest X-ray, or routine lab work-up not including&#xD;
               D-dimer test).&#xD;
  &#xD;
            -  Free, prior, and informed consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 18 years.&#xD;
  &#xD;
            -  Known result of a specific diagnostic examination for PE (D-dimer test, thoracic CT&#xD;
               angiography, pulmonary scintigraphy, or venous ultrasound of the lower limbs).&#xD;
  &#xD;
            -  Hemodynamic instability (systolic blood pressure &lt; 90 mmHg or more than 40 mmHg lower&#xD;
               than usual for more than 15 min).&#xD;
  &#xD;
            -  Curative dose of anticoagulant in place for more than two days prior to inclusion.&#xD;
  &#xD;
            -  Pregnant or parturient patient.&#xD;
  &#xD;
            -  Patient in detention by judicial or administrative decision.&#xD;
  &#xD;
            -  Patient undergoing compulsory psychiatric treatment.&#xD;
  &#xD;
            -  Patient placed under a legal protection measure.&#xD;
  &#xD;
            -  Patient incapable of giving free and informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pierre-Marie ROY, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Angers</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pierre-Marie ROY, MD, PhD</last_name>
      <phone>+33241353637</phone>
      <email>PMRoy@chu-angers.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anthea LOIEZ</last_name>
      <phone>+33241353637</phone>
      <email>Anthea.Loiez@chu-angers.fr</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Roy PM, Friou E, Germeau B, Douillet D, Kline JA, Righini M, Le Gal G, Moumneh T, Penaloza A. Derivation and Validation of a 4-Level Clinical Pretest Probability Score for Suspected Pulmonary Embolism to Safely Decrease Imaging Testing. JAMA Cardiol. 2021 Jun 1;6(6):669-677. doi: 10.1001/jamacardio.2021.0064.</citation>
      <PMID>33656522</PMID>
    </results_reference>
    <results_reference>
      <citation>Roy PM, Durieux P, Gillaizeau F, Legall C, Armand-Perroux A, Martino L, Hachelaf M, Dubart AE, Schmidt J, Cristiano M, Chretien JM, Perrier A, Meyer G. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):677-86. doi: 10.7326/0003-4819-151-10-200911170-00003.</citation>
      <PMID>19920268</PMID>
    </results_reference>
    <results_reference>
      <citation>Roy PM, Moumneh T, Penaloza A, Schmidt J, Charpentier S, Joly LM, Riou J, Douillet D. Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: Study Protocol of SPEED&amp;PEPS Trial. Diagnostics (Basel). 2022 Dec 9;12(12):3101. doi: 10.3390/diagnostics12123101.</citation>
      <PMID>36553108</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pulmonary Embolism</keyword>
    <keyword>suspected PE</keyword>
    <keyword>diagnostic strategy</keyword>
    <keyword>clinical probability</keyword>
    <keyword>cluster-randomized trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Embolism</mesh_term>
      <mesh_term>Embolism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymized raw data on individual patients constituting the basis of the analysis, results and conclusions will be available to a third-party auditor and to researchers on reasonable and justified request to the main investigator (Prof. Pierre-Marie ROY - PMRoy@chu-angers.fr) after publication and approval by the study steering committee.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>The study protocol is already published and available (doi: 10.3390/diagnostics12123101). The other supporting documents will be available within publication of the results of the trial.</ipd_time_frame>
      <ipd_access_criteria>Request to the main investigator (Prof. Pierre-Marie ROY - PMRoy@chu-angers.fr)</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015529
  org study id: 36553108
  nct id: NCT06015529
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The increased use of diagnostic imaging and especially computed tomography pulmonary
        angiography in patients suspected of pulmonary embolism (PE) is an important point of
        concerns.
  
        The goal of this pragmatic cluster-randomized trial is to compare the diagnostic strategy
        based on the four-level pulmonary embolism probability score (4PEPS) and current practices.
  
        The main questions it aims to answer is: "Does the diagnostic strategy based on 4PEPS
        significantly reduce the use of thoracic imaging without increasing the risk of serious
        adverse events as compared to current diagnostic practices?" Patients suspected of having PE
        in the participating emergency departments will be included and followed for 90 days. In ten
        centers, the emergency physicians will apply the 4PEPS strategy and in ten other centers, the
        emergency physicians will be free to do as they see fit. Researchers will compare the two
        groups of patients to see if the rate of diagnostic thoracic imaging tests and the rate of
        adverse events related to diagnostic strategies will differ.
  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: SPEED&PEPS is a pragmatic cluster-randomized
        trial. After a preliminary period aimed to assess the possibility of inclusions and current
        practices in 23 Emergency Departments (ED), 20 EDs will be selected to participate to the
        active phase and randomization. Half of the 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. Half of the centers will be allocated to the interventional
        group where the physicians will be given the recommendation to apply the 4PEPS strategy.
        Patients with suspected PE will be included and followed for 90 days (anticipated number of
        patients to be included: 2560, 1280 in each arm). The primary objective will be to
        demonstrate that the application of the 4PEPS strategy by 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. 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Pragmatic cluster-randomized trial
  primary purpose: Diagnostic
  masking: None (Open Label)
  masking description: blinded adjudication committee assessing endpoints
  measure: Rate of serious clinical events in the 90 days following inclusion
  time frame: 90 days
  description: The primary safety endpoint will be the rate of serious clinical events in the 90 days following inclusion: • Serious adverse events related to diagnostic testing (leading to hospitalization or prolongation of hospitalization, permanent inability or incapacity, and death). • Symptomatic thromboembolic events in patients not diagnosed with PE in the emergency department or new thromboembolic events in patients diagnosed with PE. • Death related to PE (initial or recurrent PE). • Major bleeding related to an anticoagulant treatment prescribed for pulmonary embolism according to ISTH criteria.
  measure: Rate of diagnostic thoracic imaging
  time frame: up to 72 hours following inclusion
  description: The primary efficacy endpoint will be the rate of thoracic imaging among all included patients with suspected PE. The following examinations are considered if they are performed at the request of the emergency physician in search of PE: computed tomography pulmonary angiography (CTPA), planar perfusion or perfusion-ventilation scintigraphy, and SPECT scintigraphy.
  measure: Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out according to the 4PEPS strategy in the intervention group
  time frame: 90 days
  description: The first secondary objective is to demonstrate, in the intervention group, that the risk of false-negative diagnosis with the 4PEPS strategy is very low in accordance with the International Society of Thrombosis and Hemostasis (ISTH) criteria for validation of rule-out PE diagnostic strategies.
  The endpoint will be the false-negative rate defined as the rate of thromboembolic events occurring in the 90 days following inclusion in patients in the intervention group for whom PE was ruled out according to the 4PEPS strategy and who were not treated with anticoagulants.
  measure: Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out in both groups
  time frame: 90 days
  description: The second secondary objective is to demonstrate that the 4PEPS strategy (intervention group) is not inferior to current practices (control group) as regards the risk of false-negative diagnosis.
  The false-negative rate will be defined as the rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out and who were not treated with anticoagulants.
  measure: Rate of D-dimer measurement
  time frame: up to 72 hours following inclusion
  description: The third secondary objective is to to evaluate and compare to usual practice the impact of the 4PEPS strategy as regards the rate of D-dimer measurement.
  measure: Length of stay in ED
  time frame: Up to Emergency Department discharge (assessed up to 48 hours)
  description: The fourth secondary objective is to evaluate and compare to usual practice the impact of the 4PEPS strategy as regards the length of time spent in the emergency department by patients with suspected PE.
  arm group label: Control group - current practices
  arm group type: No Intervention
  description: The investigating physicians of the participating centers in the control group will be free to provide care as they see fit. However, a reminder of national and European guidelines for PE management will be given to them and they will have the recommendation to apply a validated strategy. To make it easier, the different scores will be included in the clinical help-decision support software called SPEED. Investigators will be asked to enter data about the included patients directly into SPEED, which will act as the study's electronic case report form (eCRF). A paper version of the CRF will also be available.
  arm group label: Intervention group - 4PEPS strategy
  arm group type: Active Comparator
  description: Physicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. To make it easier to apply, the 4PEPS score will be included in SPEED. Investigators will be asked to enter the information relating to patients included in the study directly into SPEED before performing any testing. Entering these data will enable the 4PEPS score to be calculated automatically and specific recommendations to be provided. A paper version of the CRF will also be available
  intervention type: Diagnostic Test
  intervention name: 4PEPS strategy
  description: Physicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. Using 12 variables, 4PEPS defines four levels of CP that rule out a PE, namely
  based only on clinical data (very low CP: PEPS < 0),
  based on a D-dimer level < 1000 μg/L (low CP: PEPS ≥ 0 and < 5),
  based on a D-dimer level with an age-adjusted cut-off value (moderate CP: PEPS ≥ 5 and <12), or
  the diagnosis cannot reliably be ruled out based on a D-dimer test (high CP: PEPS ≥ 12)
  arm group label: Intervention group - 4PEPS strategy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Pierre-Marie ROY, MD, PhD
  role: Principal Investigator
  affiliation: University Hospital, Angers
  last name: Pierre-Marie ROY, MD, PhD
  phone: +33241353637
  email: PMRoy@chu-angers.fr
  last name: Anthea LOIEZ
  phone: +33241353637
  email: Anthea.Loiez@chu-angers.fr
  citation: Roy PM, Friou E, Germeau B, Douillet D, Kline JA, Righini M, Le Gal G, Moumneh T, Penaloza A. Derivation and Validation of a 4-Level Clinical Pretest Probability Score for Suspected Pulmonary Embolism to Safely Decrease Imaging Testing. JAMA Cardiol. 2021 Jun 1;6(6):669-677. doi: 10.1001/jamacardio.2021.0064.
  PMID: 33656522
  citation: Roy PM, Durieux P, Gillaizeau F, Legall C, Armand-Perroux A, Martino L, Hachelaf M, Dubart AE, Schmidt J, Cristiano M, Chretien JM, Perrier A, Meyer G. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):677-86. doi: 10.7326/0003-4819-151-10-200911170-00003.
  PMID: 19920268
  citation: Roy PM, Moumneh T, Penaloza A, Schmidt J, Charpentier S, Joly LM, Riou J, Douillet D. 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. Diagnostics (Basel). 2022 Dec 9;12(12):3101. doi: 10.3390/diagnostics12123101.
  PMID: 36553108
  responsible party type: Sponsor
  mesh term: Pulmonary Embolism
  mesh term: Embolism
  sharing ipd: Yes
  ipd description: Anonymized raw data on individual patients constituting the basis of the analysis, results and conclusions will be available to a third-party auditor and to researchers on reasonable and justified request to the main investigator (Prof. Pierre-Marie ROY - PMRoy@chu-angers.fr) after publication and approval by the study steering committee.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: The study protocol is already published and available (doi: 10.3390/diagnostics12123101). The other supporting documents will be available within publication of the results of the trial.
  ipd access criteria: Request to the main investigator (Prof. Pierre-Marie ROY - PMRoy@chu-angers.fr)