Infectious complications of endoarterial interventional radiology: protocol for an observational study of a longitudinal national cohort of patients assessed in the French hospital discharge database (MOEVA study)
Identifieur interne : 000118 ( Pmc/Curation ); précédent : 000117; suivant : 000119Infectious complications of endoarterial interventional radiology: protocol for an observational study of a longitudinal national cohort of patients assessed in the French hospital discharge database (MOEVA study)
Auteurs : Kaoutar Aid Mellouk [Maroc] ; Abdelmajid Soulaymani [Maroc] ; Fei Gao [France] ; Pascal Astagneau [France] ; Benoit Misset [France]Source :
- BMJ Open [ 2044-6055 ] ; 2019.
Abstract
Around seven million patients undergo endoarterial interventional radiology procedures (EAIRP) annually worldwide. These procedures have become part of the standard repertoire of vascular surgery. However, the healthcare-associated infections related to these procedures are relatively unknown. Prevalence and adverse outcome of infectious complication (IC) post-EAIRP may be underestimated. We aim to provide national trend estimation of EAIRP incidence and outcome in France.
From the French Common Classification of Medical Acts, we will define four categories of EAIRP. We will collect procedures via the French nationwide hospital discharge database, called Programme de Médicalisation des Systèmes d’Information (PMSI) and derived from the Diagnosis Related Group system. Various combinations to identify the numerator will be employed according to a pre-established algorithm. Technical data wrangling tools facilitating the use of PMSI will be developed to obtain a clean and well-structured database ready for statistical analysis. This protocol will require competences in medicine, epidemiology, statistics, data processing and techniques through various stages of the study. The cohort will contain the denominator (the first act of the first stay of each patient) and the corresponding numerator (the IC which will occur during the first stay).
No nominative, sensitive or personal data on patients have been collected. The study of the MOrtality and infectious complications of therapeutic EndoVAscular interventional radiology (MOEVA) study does not involve humans, and falls within the scope of the French Reference Methodology MR-004 according to 2016–41 law dated 26 January 2016 on the modernisation of the French health system. Our study involves the reuse of already recorded data, which require neither information or non-opposition of the included individuals. Access to linked ANOnymous (ANO) file in the PMSI databases was approved by the French National Commission for Data Protection and Liberties (CNIL number 1564135). The results will be disseminated through a peer-reviewed publication.
Url:
DOI: 10.1136/bmjopen-2018-024181
PubMed: 31164361
PubMed Central: 6561437
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<front><div type="abstract" xml:lang="en"><p>Around seven million patients undergo endoarterial interventional radiology procedures (EAIRP) annually worldwide. These procedures have become part of the standard repertoire of vascular surgery. However, the healthcare-associated infections related to these procedures are relatively unknown. Prevalence and adverse outcome of infectious complication (IC) post-EAIRP may be underestimated. We aim to provide national trend estimation of EAIRP incidence and outcome in France.</p>
<sec><title>Methods and analysis</title>
<p>From the French Common Classification of Medical Acts, we will define four categories of EAIRP. We will collect procedures via the French nationwide hospital discharge database, called Programme de Médicalisation des Systèmes d’Information (PMSI) and derived from the Diagnosis Related Group system. Various combinations to identify the numerator will be employed according to a pre-established algorithm. Technical data wrangling tools facilitating the use of PMSI will be developed to obtain a clean and well-structured database ready for statistical analysis. This protocol will require competences in medicine, epidemiology, statistics, data processing and techniques through various stages of the study. The cohort will contain the denominator (the first act of the first stay of each patient) and the corresponding numerator (the IC which will occur during the first stay).</p>
</sec>
<sec><title>Ethics and dissemination</title>
<p>No nominative, sensitive or personal data on patients have been collected. The study of the MOrtality and infectious complications of therapeutic EndoVAscular interventional radiology (MOEVA) study does not involve humans, and falls within the scope of the French Reference Methodology MR-004 according to 2016–41 law dated 26 January 2016 on the modernisation of the French health system. Our study involves the reuse of already recorded data, which require neither information or non-opposition of the included individuals. Access to linked ANOnymous (ANO) file in the PMSI databases was approved by the French National Commission for Data Protection and Liberties (CNIL number 1564135). The results will be disseminated through a peer-reviewed publication.</p>
</sec>
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<pmc article-type="protocol"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">BMJ Open</journal-id>
<journal-id journal-id-type="iso-abbrev">BMJ Open</journal-id>
<journal-id journal-id-type="hwp">bmjopen</journal-id>
<journal-id journal-id-type="publisher-id">bmjopen</journal-id>
<journal-title-group><journal-title>BMJ Open</journal-title>
</journal-title-group>
<issn pub-type="epub">2044-6055</issn>
<publisher><publisher-name>BMJ Publishing Group</publisher-name>
<publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">31164361</article-id>
<article-id pub-id-type="pmc">6561437</article-id>
<article-id pub-id-type="publisher-id">bmjopen-2018-024181</article-id>
<article-id pub-id-type="doi">10.1136/bmjopen-2018-024181</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Radiology and Imaging</subject>
<subj-group><subject>Protocol</subject>
</subj-group>
</subj-group>
<subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject>
<subject>1726</subject>
</subj-group>
</article-categories>
<title-group><article-title>Infectious complications of endoarterial interventional radiology: protocol for an observational study of a longitudinal national cohort of patients assessed in the French hospital discharge database (MOEVA study)</article-title>
</title-group>
<contrib-group><contrib id="author-59494491" contrib-type="author"><name><surname>Aid Mellouk</surname>
<given-names>Kaoutar</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib id="author-61085619" contrib-type="author"><name><surname>Soulaymani</surname>
<given-names>Abdelmajid</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib id="author-61085685" contrib-type="author"><name><surname>Gao</surname>
<given-names>Fei</given-names>
</name>
<xref ref-type="aff" rid="aff2">2</xref>
</contrib>
<contrib id="author-61085709" contrib-type="author"><name><surname>Astagneau</surname>
<given-names>Pascal</given-names>
</name>
<xref ref-type="aff" rid="aff3">3</xref>
<xref ref-type="aff" rid="aff4">4</xref>
</contrib>
<contrib id="author-62535710" contrib-type="author"><name><surname>Misset</surname>
<given-names>Benoit</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
<xref ref-type="aff" rid="aff6">6</xref>
</contrib>
</contrib-group>
<aff id="aff1"><label>1</label>
<institution content-type="department">Center of Doctoral Studies</institution>
,<institution>Universite Ibn Tofail Kenitra Faculte des Sciences</institution>
,<addr-line content-type="city">Kenitra</addr-line>
,<country>Morocco</country>
</aff>
<aff id="aff2"><label>2</label>
<institution content-type="department">Public Health</institution>
,<institution>French School for Advanced Studies in Public Health (EHESP)</institution>
,<addr-line content-type="city">Rennes</addr-line>
,<country>France</country>
</aff>
<aff id="aff3"><label>3</label>
<institution content-type="department">CPias</institution>
,<institution>Center of Support for the Prevention of the Infections Associated with Care Paris 14</institution>
,<addr-line content-type="city">Paris 14</addr-line>
,<addr-line content-type="state">Île-de-France</addr-line>
,<country>France</country>
</aff>
<aff id="aff4"><label>4</label>
<institution content-type="department">Public Health</institution>
,<institution>Pierre & Marie Curie faculty of medicine, Sorbonne universities</institution>
,<addr-line content-type="city">Paris</addr-line>
,<addr-line content-type="state">Île-de-France</addr-line>
,<country>France</country>
</aff>
<aff id="aff5"><label>5</label>
<institution content-type="department">Department of Intensive Care</institution>
,<institution>Rouen University Hospital</institution>
,<addr-line content-type="city">Rouen</addr-line>
,<country>France</country>
</aff>
<aff id="aff6"><label>6</label>
<institution content-type="department">Rouen University</institution>
,<institution>Faculty of medecine and Pharmacy</institution>
,<addr-line content-type="city">Rouen</addr-line>
,<country>France</country>
</aff>
<author-notes><corresp><label>Correspondence to</label>
Kaoutar Aid Mellouk; <email>kaoutarmellouk92@gmail.com</email>
</corresp>
</author-notes>
<pub-date pub-type="collection"><year>2019</year>
</pub-date>
<pub-date pub-type="epub"><day>3</day>
<month>6</month>
<year>2019</year>
</pub-date>
<volume>9</volume>
<issue>6</issue>
<elocation-id>e024181</elocation-id>
<history><date date-type="received"><day>14</day>
<month>5</month>
<year>2018</year>
</date>
<date date-type="rev-recd"><day>02</day>
<month>1</month>
<year>2019</year>
</date>
<date date-type="accepted"><day>16</day>
<month>1</month>
<year>2019</year>
</date>
</history>
<permissions><copyright-statement>© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</copyright-statement>
<copyright-year>2019</copyright-year>
<license license-type="open-access"><license-p>This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">http://creativecommons.org/licenses/by-nc/4.0/</ext-link>
.</license-p>
</license>
</permissions>
<self-uri xlink:title="pdf" xlink:href="bmjopen-2018-024181.pdf"></self-uri>
<self-uri content-type="reviewers-comments-pdf" xlink:href="bmjopen-2018-024181.reviewer_comments.pdf"></self-uri>
<self-uri content-type="draft-revisions-pdf" xlink:href="bmjopen-2018-024181.draft_revisions.pdf"></self-uri>
<abstract><p>Around seven million patients undergo endoarterial interventional radiology procedures (EAIRP) annually worldwide. These procedures have become part of the standard repertoire of vascular surgery. However, the healthcare-associated infections related to these procedures are relatively unknown. Prevalence and adverse outcome of infectious complication (IC) post-EAIRP may be underestimated. We aim to provide national trend estimation of EAIRP incidence and outcome in France.</p>
<sec><title>Methods and analysis</title>
<p>From the French Common Classification of Medical Acts, we will define four categories of EAIRP. We will collect procedures via the French nationwide hospital discharge database, called Programme de Médicalisation des Systèmes d’Information (PMSI) and derived from the Diagnosis Related Group system. Various combinations to identify the numerator will be employed according to a pre-established algorithm. Technical data wrangling tools facilitating the use of PMSI will be developed to obtain a clean and well-structured database ready for statistical analysis. This protocol will require competences in medicine, epidemiology, statistics, data processing and techniques through various stages of the study. The cohort will contain the denominator (the first act of the first stay of each patient) and the corresponding numerator (the IC which will occur during the first stay).</p>
</sec>
<sec><title>Ethics and dissemination</title>
<p>No nominative, sensitive or personal data on patients have been collected. The study of the MOrtality and infectious complications of therapeutic EndoVAscular interventional radiology (MOEVA) study does not involve humans, and falls within the scope of the French Reference Methodology MR-004 according to 2016–41 law dated 26 January 2016 on the modernisation of the French health system. Our study involves the reuse of already recorded data, which require neither information or non-opposition of the included individuals. Access to linked ANOnymous (ANO) file in the PMSI databases was approved by the French National Commission for Data Protection and Liberties (CNIL number 1564135). The results will be disseminated through a peer-reviewed publication.</p>
</sec>
</abstract>
<kwd-group><kwd>endo-arterial</kwd>
<kwd>interventional</kwd>
<kwd>radiology</kwd>
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</front>
</pmc>
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