<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/NCT03011411</url>
  </required_header>
  <id_info>
    <org_study_id>PREPS-13-0071</org_study_id>
    <nct_id>NCT03011411</nct_id>
  </id_info>
  <brief_title>Comparison of Methods to Collect Healthcare Consumption Data of Patients in Clinical Trials With an Economic Evaluation</brief_title>
  <acronym>COMERE</acronym>
  <official_title>Comparison of Methods to Collect Healthcare Consumption Data of Patients in Clinical Trials With an Economic Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pragmatic study comparing historical data from usual collection tools to medical&#xD;
      administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to the&#xD;
      data collection:&#xD;
&#xD;
        1. Collection of hospitalization data from the local PMSI and outpatient data from CRF&#xD;
&#xD;
        2. Collection of hospitalization data in the national PMSI with a probabilistic matching&#xD;
           between local and national PMSI data&#xD;
&#xD;
        3. Collection of outpatient consumption data from SNIIRAM after matching of data from the&#xD;
           national PMSI to the SNIIRAM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In studies assessing therapeutic interventions, an economic evaluation requires the&#xD;
      collection of patients' healthcare consumption. Two methods are primarily used in accordance&#xD;
      with the recommendations of the National Authority for Health (HAS): case report forms (CRF)&#xD;
      for ambulatory care and the local hospital discharge databases (local PMSI) - extracted from&#xD;
      participating centers - for hospital care. However, these conventional methods have limits.&#xD;
      The first is a declarative and mostly retrospective collection, often misinformed and&#xD;
      unverifiable. The second provides high quality data but is far from exhaustive as it only&#xD;
      concerns hospitalizations that occurred in the participating center, not those that occurred&#xD;
      in other hospitals.&#xD;
&#xD;
      In France, medical administrative databases SNIIRAM (all care reimbursed by the statutory&#xD;
      health insurance) and national PMSI (all hospital care) are the &quot;gold standards&quot; for&#xD;
      collecting consumer personal care. However, the administrative difficulties associated with&#xD;
      accessing these databases prevent researchers from extracting routine care consumption data&#xD;
      from these databases for health economic studies, despite the fact that the unreliability of&#xD;
      the conventional methods has been objectified in a small number of studies in the literature.&#xD;
      These studies are few, have been conducted abroad and seek to compare declarative collections&#xD;
      to non-exhaustive medical and administrative data. Moreover, they compare only the number of&#xD;
      events collected and not the implication for economic evaluations using those numbers,&#xD;
      limiting the applicability of their results to economic assessments.&#xD;
&#xD;
      The main objective of this study is to evaluate the performance of usual collection tools&#xD;
      compared to the gold standards (medical and administrative databases) for estimating&#xD;
      consumption of inpatient and outpatient care in health economic evaluations. The secondary&#xD;
      objectives are to evaluate the impact of the potential underestimation of healthcare&#xD;
      consumption on the estimated costs and results of economic assessments by studying the&#xD;
      variation of the calculated incremental cost-effectiveness ratio (ICER) and the conclusion of&#xD;
      evaluation.&#xD;
&#xD;
      The COMERE population comes from studies in which an economic evaluation for an innovative&#xD;
      therapeutic strategy was conducted by the principal investigators's research unity. These&#xD;
      studies include at the minimum a collection of hospital care consumption. This data&#xD;
      collection must be over by the time for the start of the project. The procedure code and&#xD;
      studied pathology alone allow the investigators to identify patients in the national PMSI&#xD;
      with a probability greater than 0.9. When adding other information available in the local&#xD;
      PMSI, this probability reaches 0.99. The principal investigators of the studies agreed on the&#xD;
      use of data from their studies in the context of this research project. Overall, among the&#xD;
      studies carried out in our unit, 12 projects funded by the Ministry of Health's program&#xD;
      supporting funds for expensive innovative technology (STIC) and 1 national registry matched&#xD;
      the study's criteria and were retained. Of these 13 studies: 13 have collected data on&#xD;
      hospital care consumption and 8 collected data on ambulatory care consumption. In total,&#xD;
      these studies included 87 separate centers and 6,928 patients of which 2,661 have an&#xD;
      ambulatory care collection. Their data are completely anonymous.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2008</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the average ratio of the number of hospital stays collected by the usual method / number collected by the gold standard method</measure>
    <time_frame>1 day</time_frame>
    <description>the performance of the hospital care consumption collection by the local PMSI: the average ratio of the number of hospital stays (initial and re-hospitalizations) for a patient during the study follow-up period collected through the local PMSI on the number of hospital stays for this patient over the same period collected with the national PMSI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the average ratio of the number of ambulatory acts performed for a patient collected by the usual method / number collected by the gold standard method.</measure>
    <time_frame>1 day</time_frame>
    <description>the performance of the outpatient care consumption by the CRF: the average ratio of the number of ambulatory acts performed for a patient during the study follow-up period collected by the CRF on the number of acts for the same patient extracted from the SNIIRAM over the same period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ratio of the cost estimated with the conventional method / estimated with the gold standard</measure>
    <time_frame>1 day</time_frame>
    <description>The secondary endpoints are the following:&#xD;
The ratio of the cost associated with hospital care consumption estimated using data collected by the usual method (local PMSI) on the cost of that consumption estimated using the gold standard method (national PMSI);&#xD;
The ratio of the cost associated with outpatient care consumption estimated using data collected by the usual method (CRF) on the cost of that consumption estimated using data collected with the gold standard method (SNIIRAM);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in the ICER with both methods (%)</measure>
    <time_frame>1 day</time_frame>
    <description>The secondary endpoints are the following: The change in the ICER, i.e. the difference between the ICER estimated from the usual method of collection and those estimated using the gold standard method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of studies in which the conclusion would change</measure>
    <time_frame>1day</time_frame>
    <description>The secondary endpoints are the following: The proportion of studies in which there is a change in the conclusion when the performance of the tools used to collect care consumption is taken into account, in particular in probabilistic sensitivity analyses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigation of the &quot;center&quot; effect and/or &quot;study&quot; effect in the data corresponding to the primary endpoint using intraclass coefficient</measure>
    <time_frame>1 day</time_frame>
    <description>The secondary endpoints are the following: The search for an effect of the hierarchical data structure (&quot;study&quot; effect and &quot;center&quot; effect) on the extent of the variations observed in the primary endpoint.</description>
  </secondary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>Healthcare Consumption</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with an initial hospital stay during which the innovative treatment strategy was&#xD;
        implemented&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Among patients of the source population, patients were included if:&#xD;
&#xD;
          -  Their initial hospital stay (the one during which the innovative treatment strategy&#xD;
             was implemented) was found in the local PMSI&#xD;
&#xD;
          -  A probabilistic matching with the national PMSI is possible with a probability equal&#xD;
             to 1 (in order to compare the data from the usual collections to the gold standard&#xD;
             methods).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded patients whose initial hospital stay found in the national PMSI was not&#xD;
             linkable with other admissions due to a coding error.&#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>Karine CHEVREUL, Pr MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital HOTEL DIEU</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>methods, qualitative research</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03011411
org study id: PREPS-13-0071
nct id: NCT03011411
lead sponsor: 
has dmc: No
Pragmatic study comparing historical data from usual collection tools to medical
      administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to the
      data collection:

        1. Collection of hospitalization data from the local PMSI and outpatient data from CRF

        2. Collection of hospitalization data in the national PMSI with a probabilistic matching
           between local and national PMSI data

        3. Collection of outpatient consumption data from SNIIRAM after matching of data from the
           national PMSI to the SNIIRAM.
In studies assessing therapeutic interventions, an economic evaluation requires the
      collection of patients' healthcare consumption. Two methods are primarily used in accordance
      with the recommendations of the National Authority for Health (HAS): case report forms (CRF)
      for ambulatory care and the local hospital discharge databases (local PMSI) - extracted from
      participating centers - for hospital care. However, these conventional methods have limits.
      The first is a declarative and mostly retrospective collection, often misinformed and
      unverifiable. The second provides high quality data but is far from exhaustive as it only
      concerns hospitalizations that occurred in the participating center, not those that occurred
      in other hospitals.

      In France, medical administrative databases SNIIRAM (all care reimbursed by the statutory
      health insurance) and national PMSI (all hospital care) are the "gold standards" for
      collecting consumer personal care. However, the administrative difficulties associated with
      accessing these databases prevent researchers from extracting routine care consumption data
      from these databases for health economic studies, despite the fact that the unreliability of
      the conventional methods has been objectified in a small number of studies in the literature.
      These studies are few, have been conducted abroad and seek to compare declarative collections
      to non-exhaustive medical and administrative data. Moreover, they compare only the number of
      events collected and not the implication for economic evaluations using those numbers,
      limiting the applicability of their results to economic assessments.

      The main objective of this study is to evaluate the performance of usual collection tools
      compared to the gold standards (medical and administrative databases) for estimating
      consumption of inpatient and outpatient care in health economic evaluations. The secondary
      objectives are to evaluate the impact of the potential underestimation of healthcare
      consumption on the estimated costs and results of economic assessments by studying the
      variation of the calculated incremental cost-effectiveness ratio (ICER) and the conclusion of
      evaluation.

      The COMERE population comes from studies in which an economic evaluation for an innovative
      therapeutic strategy was conducted by the principal investigators's research unity. These
      studies include at the minimum a collection of hospital care consumption. This data
      collection must be over by the time for the start of the project. The procedure code and
      studied pathology alone allow the investigators to identify patients in the national PMSI
      with a probability greater than 0.9. When adding other information available in the local
      PMSI, this probability reaches 0.99. The principal investigators of the studies agreed on the
      use of data from their studies in the context of this research project. Overall, among the
      studies carried out in our unit, 12 projects funded by the Ministry of Health's program
      supporting funds for expensive innovative technology (STIC) and 1 national registry matched
      the study's criteria and were retained. Of these 13 studies: 13 have collected data on
      hospital care consumption and 8 collected data on ambulatory care consumption. In total,
      these studies included 87 separate centers and 6,928 patients of which 2,661 have an
      ambulatory care collection. Their data are completely anonymous.
time perspective: Retrospective
measure: the average ratio of the number of hospital stays collected by the usual method / number collected by the gold standard method
time frame: 1 day
description: the performance of the hospital care consumption collection by the local PMSI: the average ratio of the number of hospital stays (initial and re-hospitalizations) for a patient during the study follow-up period collected through the local PMSI on the number of hospital stays for this patient over the same period collected with the national PMSI.
measure: the average ratio of the number of ambulatory acts performed for a patient collected by the usual method / number collected by the gold standard method.
time frame: 1 day
description: the performance of the outpatient care consumption by the CRF: the average ratio of the number of ambulatory acts performed for a patient during the study follow-up period collected by the CRF on the number of acts for the same patient extracted from the SNIIRAM over the same period.
measure: Ratio of the cost estimated with the conventional method / estimated with the gold standard
time frame: 1 day
description: The secondary endpoints are the following:
The ratio of the cost associated with hospital care consumption estimated using data collected by the usual method (local PMSI) on the cost of that consumption estimated using the gold standard method (national PMSI);
The ratio of the cost associated with outpatient care consumption estimated using data collected by the usual method (CRF) on the cost of that consumption estimated using data collected with the gold standard method (SNIIRAM);
measure: Variation in the ICER with both methods (%)
time frame: 1 day
description: The secondary endpoints are the following: The change in the ICER, i.e. the difference between the ICER estimated from the usual method of collection and those estimated using the gold standard method
measure: Proportion of studies in which the conclusion would change
time frame: 1day
description: The secondary endpoints are the following: The proportion of studies in which there is a change in the conclusion when the performance of the tools used to collect care consumption is taken into account, in particular in probabilistic sensitivity analyses
measure: Investigation of the "center" effect and/or "study" effect in the data corresponding to the primary endpoint using intraclass coefficient
time frame: 1 day
description: The secondary endpoints are the following: The search for an effect of the hierarchical data structure ("study" effect and "center" effect) on the extent of the variations observed in the primary endpoint.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karine CHEVREUL, Pr MD PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided