The International development of PROQOL-HCV: An instrument to assess the health-related quality of life of patients treated for Hepatitis C virus
Identifieur interne : 000558 ( Pmc/Checkpoint ); précédent : 000557; suivant : 000559The International development of PROQOL-HCV: An instrument to assess the health-related quality of life of patients treated for Hepatitis C virus
Auteurs : Andrew Richard Armstrong [France, Australie] ; Susan Elizabeth Herrmann ; Olivier Chassany [France] ; Christophe Lalanne [France] ; Mariliza Henrique Da Silva [Brésil] ; Eliana Galano [Brésil] ; Patrizia M. Carrieri [France] ; Vincent Estellon [France] ; Philippe Sogni [France] ; Martin Duracinsky [France]Source :
- BMC Infectious Diseases [ 1471-2334 ] ; 2016.
Abstract
Hepatitis C virus (HCV) compromises Health-related Quality of Life (HRQL) with detriments to Physical, Mental and Social health domains. Treatment with interferon and ribavirin is associated with side effects which further impair HRQL. New treatments appear potent, effective and tolerable. However, Patient Reported Outcomes instruments that capture the impact on HRQL for people with hepatitis C are largely non-specific and will be needed in the new treatment era. Therefore, we developed a conceptually valid multidimensional model of HCV-specific quality of life and pilot survey instrument, the Patient Reported Outcome Quality of Life survey for HCV (PROQOL-HCV).
HCV patients from France (
Fifteen content dimensions were derived from the qualitative analysis, refined and fitted to four domains: (1) Physical Health included: fatigue, pain, sleep, sexual impairment and physical activity; (2) Mental Health: psychological distress, psychosocial impact, and cognition; (3) Social Health: support, stigma, social activity, substance use; (4) Treatment: management, side effects, and fear of treatment failure. The impact of some dimensions extended beyond their primary domain including: physical activity, cognition, sleep, sexual impairment, and the three treatment dimensions. A bank of 300 items was constructed to reflect patient reports and, following expert review, reduced to a 72-item pilot questionnaire.
We present a conceptually valid multidimensional model of HCV-specific quality of life and the pilot survey instrument, PROQOL-HCV. The model is widely inclusive of the experience of hepatitis C and the first to include the treatment dimension.
Url:
DOI: 10.1186/s12879-016-1771-0
PubMed: 27553866
PubMed Central: 4994204
Affiliations:
- Australie, Brésil, France
- Provence-Alpes-Côte d'Azur, Victoria (État), État de São Paulo, Île-de-France
- Marseille, Melbourne, Paris, São Paulo
- Université Paris-Descartes
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PMC:4994204Le document en format XML
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<author><name sortKey="Armstrong, Andrew Richard" sort="Armstrong, Andrew Richard" uniqKey="Armstrong A" first="Andrew Richard" last="Armstrong">Andrew Richard Armstrong</name>
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<author><name sortKey="Chassany, Olivier" sort="Chassany, Olivier" uniqKey="Chassany O" first="Olivier" last="Chassany">Olivier Chassany</name>
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<author><name sortKey="Lalanne, Christophe" sort="Lalanne, Christophe" uniqKey="Lalanne C" first="Christophe" last="Lalanne">Christophe Lalanne</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
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</affiliation>
</author>
<author><name sortKey="Da Silva, Mariliza Henrique" sort="Da Silva, Mariliza Henrique" uniqKey="Da Silva M" first="Mariliza Henrique" last="Da Silva">Mariliza Henrique Da Silva</name>
<affiliation wicri:level="3"><nlm:aff id="Aff5">Centro de Referência e Treinamento DST/Aids, Rue santa Cruz, Sao Paulo, Brazil</nlm:aff>
<country xml:lang="fr">Brésil</country>
<wicri:regionArea>Centro de Referência e Treinamento DST/Aids, Rue santa Cruz, Sao Paulo</wicri:regionArea>
<placeName><settlement type="city">São Paulo</settlement>
<region type="state">État de São Paulo</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Galano, Eliana" sort="Galano, Eliana" uniqKey="Galano E" first="Eliana" last="Galano">Eliana Galano</name>
<affiliation wicri:level="3"><nlm:aff id="Aff5">Centro de Referência e Treinamento DST/Aids, Rue santa Cruz, Sao Paulo, Brazil</nlm:aff>
<country xml:lang="fr">Brésil</country>
<wicri:regionArea>Centro de Referência e Treinamento DST/Aids, Rue santa Cruz, Sao Paulo</wicri:regionArea>
<placeName><settlement type="city">São Paulo</settlement>
<region type="state">État de São Paulo</region>
</placeName>
</affiliation>
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<author><name sortKey="Carrieri, Patrizia M" sort="Carrieri, Patrizia M" uniqKey="Carrieri P" first="Patrizia M." last="Carrieri">Patrizia M. Carrieri</name>
<affiliation wicri:level="3"><nlm:aff id="Aff6">U912 (SE4S), INSERM, Marseille, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>U912 (SE4S), INSERM, Marseille</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
</placeName>
</affiliation>
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<author><name sortKey="Estellon, Vincent" sort="Estellon, Vincent" uniqKey="Estellon V" first="Vincent" last="Estellon">Vincent Estellon</name>
<affiliation wicri:level="4"><nlm:aff id="Aff7">Université Paris Descartes, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Paris Descartes, Paris</wicri:regionArea>
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<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
<settlement type="city">Paris</settlement>
</placeName>
<orgName type="university">Université Paris-Descartes</orgName>
</affiliation>
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<author><name sortKey="Sogni, Philippe" sort="Sogni, Philippe" uniqKey="Sogni P" first="Philippe" last="Sogni">Philippe Sogni</name>
<affiliation wicri:level="3"><nlm:aff id="Aff8">Service d’Hépatologie, Hopital Cochin, AP-HP, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d’Hépatologie, Hopital Cochin, AP-HP, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Duracinsky, Martin" sort="Duracinsky, Martin" uniqKey="Duracinsky M" first="Martin" last="Duracinsky">Martin Duracinsky</name>
<affiliation wicri:level="3"><nlm:aff id="Aff1">EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="Aff4">URC-ECO, Hopital Hotel-Dieu, AP-HP, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>URC-ECO, Hopital Hotel-Dieu, AP-HP, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff9">Service de Médecine Interne et d’Immunologie Clinique, Hopital Bicetre, AP-HP, Kremlin-Bicetre, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service de Médecine Interne et d’Immunologie Clinique, Hopital Bicetre, AP-HP, Kremlin-Bicetre</wicri:regionArea>
<wicri:noRegion>Kremlin-Bicetre</wicri:noRegion>
<wicri:noRegion>Kremlin-Bicetre</wicri:noRegion>
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<series><title level="j">BMC Infectious Diseases</title>
<idno type="eISSN">1471-2334</idno>
<imprint><date when="2016">2016</date>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Hepatitis C virus (HCV) compromises Health-related Quality of Life (HRQL) with detriments to Physical, Mental and Social health domains. Treatment with interferon and ribavirin is associated with side effects which further impair HRQL. New treatments appear potent, effective and tolerable. However, Patient Reported Outcomes instruments that capture the impact on HRQL for people with hepatitis C are largely non-specific and will be needed in the new treatment era. Therefore, we developed a conceptually valid multidimensional model of HCV-specific quality of life and pilot survey instrument, the Patient Reported Outcome Quality of Life survey for HCV (PROQOL-HCV).</p>
</sec>
<sec><title>Methods</title>
<p>HCV patients from France (<italic>n</italic>
= 30), Brazil (<italic>n</italic>
= 20) and Australia (<italic>n</italic>
= 20) were interviewed to investigate HCV-HRQL issues raised in the scientific literature and by treatment specialists. Interviews were recorded, transcribed and translated into English and French.</p>
</sec>
<sec><title>Results</title>
<p>Fifteen content dimensions were derived from the qualitative analysis, refined and fitted to four domains: (1) Physical Health included: fatigue, pain, sleep, sexual impairment and physical activity; (2) Mental Health: psychological distress, psychosocial impact, and cognition; (3) Social Health: support, stigma, social activity, substance use; (4) Treatment: management, side effects, and fear of treatment failure. The impact of some dimensions extended beyond their primary domain including: physical activity, cognition, sleep, sexual impairment, and the three treatment dimensions. A bank of 300 items was constructed to reflect patient reports and, following expert review, reduced to a 72-item pilot questionnaire.</p>
</sec>
<sec><title>Conclusion</title>
<p>We present a conceptually valid multidimensional model of HCV-specific quality of life and the pilot survey instrument, PROQOL-HCV. The model is widely inclusive of the experience of hepatitis C and the first to include the treatment dimension.</p>
</sec>
</div>
</front>
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<author><name sortKey="Teutsch, S" uniqKey="Teutsch S">S Teutsch</name>
</author>
<author><name sortKey="Scheuer, N" uniqKey="Scheuer N">N Scheuer</name>
</author>
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</author>
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</author>
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</author>
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</author>
<author><name sortKey="Weber, R" uniqKey="Weber R">R Weber</name>
</author>
<author><name sortKey="Hirschel, B" uniqKey="Hirschel B">B Hirschel</name>
</author>
<author><name sortKey="Tarr, Pe" uniqKey="Tarr P">PE Tarr</name>
</author>
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<biblStruct><analytic><author><name sortKey="Dore, Gj" uniqKey="Dore G">GJ Dore</name>
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</author>
<author><name sortKey="Hezode, C" uniqKey="Hezode C">C Hezode</name>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Infect Dis</journal-id>
<journal-id journal-id-type="iso-abbrev">BMC Infect. Dis</journal-id>
<journal-title-group><journal-title>BMC Infectious Diseases</journal-title>
</journal-title-group>
<issn pub-type="epub">1471-2334</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
<publisher-loc>London</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">27553866</article-id>
<article-id pub-id-type="pmc">4994204</article-id>
<article-id pub-id-type="publisher-id">1771</article-id>
<article-id pub-id-type="doi">10.1186/s12879-016-1771-0</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>The International development of PROQOL-HCV: An instrument to assess the health-related quality of life of patients treated for Hepatitis C virus</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Armstrong</surname>
<given-names>Andrew Richard</given-names>
</name>
<address><email>Andrew74.psy@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Herrmann</surname>
<given-names>Susan Elizabeth</given-names>
</name>
<address><email>s.herrmann@iiid.murdoch.edu.au</email>
</address>
<xref ref-type="aff" rid="Aff3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Chassany</surname>
<given-names>Olivier</given-names>
</name>
<address><email>chassany.o@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lalanne</surname>
<given-names>Christophe</given-names>
</name>
<address><email>ch.lalanne@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Da Silva</surname>
<given-names>Mariliza Henrique</given-names>
</name>
<address><email>mariliza@crt.saude.sp.gov.br</email>
</address>
<xref ref-type="aff" rid="Aff5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Galano</surname>
<given-names>Eliana</given-names>
</name>
<address><email>elianagalano@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Carrieri</surname>
<given-names>Patrizia M.</given-names>
</name>
<address><email>pmcarrieri@aol.com</email>
</address>
<xref ref-type="aff" rid="Aff6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Estellon</surname>
<given-names>Vincent</given-names>
</name>
<address><email>vincentestellonparis5@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Sogni</surname>
<given-names>Philippe</given-names>
</name>
<address><email>philippe.sogni@aphp.fr</email>
</address>
<xref ref-type="aff" rid="Aff8">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Duracinsky</surname>
<given-names>Martin</given-names>
</name>
<address><email>duracinsky.m@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff4">4</xref>
<xref ref-type="aff" rid="Aff9">9</xref>
</contrib>
<aff id="Aff1"><label>1</label>
EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris, France</aff>
<aff id="Aff2"><label>2</label>
Australian Institute of Family Studies, Melbourne, Australia</aff>
<aff id="Aff3"><label>3</label>
Institute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia Australia</aff>
<aff id="Aff4"><label>4</label>
URC-ECO, Hopital Hotel-Dieu, AP-HP, Paris, France</aff>
<aff id="Aff5"><label>5</label>
Centro de Referência e Treinamento DST/Aids, Rue santa Cruz, Sao Paulo, Brazil</aff>
<aff id="Aff6"><label>6</label>
U912 (SE4S), INSERM, Marseille, France</aff>
<aff id="Aff7"><label>7</label>
Université Paris Descartes, Paris, France</aff>
<aff id="Aff8"><label>8</label>
Service d’Hépatologie, Hopital Cochin, AP-HP, Paris, France</aff>
<aff id="Aff9"><label>9</label>
Service de Médecine Interne et d’Immunologie Clinique, Hopital Bicetre, AP-HP, Kremlin-Bicetre, France</aff>
</contrib-group>
<pub-date pub-type="epub"><day>23</day>
<month>8</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>23</day>
<month>8</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="collection"><year>2016</year>
</pub-date>
<volume>16</volume>
<issue>1</issue>
<elocation-id>443</elocation-id>
<history><date date-type="received"><day>1</day>
<month>12</month>
<year>2015</year>
</date>
<date date-type="accepted"><day>10</day>
<month>8</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>© The Author(s). 2016</copyright-statement>
<license license-type="OpenAccess"><license-p><bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>
) applies to the data made available in this article, unless otherwise stated.</license-p>
</license>
</permissions>
<abstract id="Abs1"><sec><title>Background</title>
<p>Hepatitis C virus (HCV) compromises Health-related Quality of Life (HRQL) with detriments to Physical, Mental and Social health domains. Treatment with interferon and ribavirin is associated with side effects which further impair HRQL. New treatments appear potent, effective and tolerable. However, Patient Reported Outcomes instruments that capture the impact on HRQL for people with hepatitis C are largely non-specific and will be needed in the new treatment era. Therefore, we developed a conceptually valid multidimensional model of HCV-specific quality of life and pilot survey instrument, the Patient Reported Outcome Quality of Life survey for HCV (PROQOL-HCV).</p>
</sec>
<sec><title>Methods</title>
<p>HCV patients from France (<italic>n</italic>
= 30), Brazil (<italic>n</italic>
= 20) and Australia (<italic>n</italic>
= 20) were interviewed to investigate HCV-HRQL issues raised in the scientific literature and by treatment specialists. Interviews were recorded, transcribed and translated into English and French.</p>
</sec>
<sec><title>Results</title>
<p>Fifteen content dimensions were derived from the qualitative analysis, refined and fitted to four domains: (1) Physical Health included: fatigue, pain, sleep, sexual impairment and physical activity; (2) Mental Health: psychological distress, psychosocial impact, and cognition; (3) Social Health: support, stigma, social activity, substance use; (4) Treatment: management, side effects, and fear of treatment failure. The impact of some dimensions extended beyond their primary domain including: physical activity, cognition, sleep, sexual impairment, and the three treatment dimensions. A bank of 300 items was constructed to reflect patient reports and, following expert review, reduced to a 72-item pilot questionnaire.</p>
</sec>
<sec><title>Conclusion</title>
<p>We present a conceptually valid multidimensional model of HCV-specific quality of life and the pilot survey instrument, PROQOL-HCV. The model is widely inclusive of the experience of hepatitis C and the first to include the treatment dimension.</p>
</sec>
</abstract>
<kwd-group xml:lang="en"><title>Keywords</title>
<kwd>Questionnaires</kwd>
<kwd>Quality of life</kwd>
<kwd>Hepatitis c</kwd>
<kwd>Health status</kwd>
<kwd>Research methods</kwd>
</kwd-group>
<funding-group><award-group><funding-source><institution>Agence Nationale de Recherches sur le Sida et les Hepatites Virales (FR)</institution>
</funding-source>
<award-id>871</award-id>
<principal-award-recipient><name><surname>Armstrong</surname>
<given-names>Andrew Richard</given-names>
</name>
</principal-award-recipient>
</award-group>
</funding-group>
<custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name>
<meta-value>© The Author(s) 2016</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>Australie</li>
<li>Brésil</li>
<li>France</li>
</country>
<region><li>Provence-Alpes-Côte d'Azur</li>
<li>Victoria (État)</li>
<li>État de São Paulo</li>
<li>Île-de-France</li>
</region>
<settlement><li>Marseille</li>
<li>Melbourne</li>
<li>Paris</li>
<li>São Paulo</li>
</settlement>
<orgName><li>Université Paris-Descartes</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Herrmann, Susan Elizabeth" sort="Herrmann, Susan Elizabeth" uniqKey="Herrmann S" first="Susan Elizabeth" last="Herrmann">Susan Elizabeth Herrmann</name>
</noCountry>
<country name="France"><region name="Île-de-France"><name sortKey="Armstrong, Andrew Richard" sort="Armstrong, Andrew Richard" uniqKey="Armstrong A" first="Andrew Richard" last="Armstrong">Andrew Richard Armstrong</name>
</region>
<name sortKey="Carrieri, Patrizia M" sort="Carrieri, Patrizia M" uniqKey="Carrieri P" first="Patrizia M." last="Carrieri">Patrizia M. Carrieri</name>
<name sortKey="Chassany, Olivier" sort="Chassany, Olivier" uniqKey="Chassany O" first="Olivier" last="Chassany">Olivier Chassany</name>
<name sortKey="Chassany, Olivier" sort="Chassany, Olivier" uniqKey="Chassany O" first="Olivier" last="Chassany">Olivier Chassany</name>
<name sortKey="Duracinsky, Martin" sort="Duracinsky, Martin" uniqKey="Duracinsky M" first="Martin" last="Duracinsky">Martin Duracinsky</name>
<name sortKey="Duracinsky, Martin" sort="Duracinsky, Martin" uniqKey="Duracinsky M" first="Martin" last="Duracinsky">Martin Duracinsky</name>
<name sortKey="Duracinsky, Martin" sort="Duracinsky, Martin" uniqKey="Duracinsky M" first="Martin" last="Duracinsky">Martin Duracinsky</name>
<name sortKey="Estellon, Vincent" sort="Estellon, Vincent" uniqKey="Estellon V" first="Vincent" last="Estellon">Vincent Estellon</name>
<name sortKey="Lalanne, Christophe" sort="Lalanne, Christophe" uniqKey="Lalanne C" first="Christophe" last="Lalanne">Christophe Lalanne</name>
<name sortKey="Sogni, Philippe" sort="Sogni, Philippe" uniqKey="Sogni P" first="Philippe" last="Sogni">Philippe Sogni</name>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Armstrong, Andrew Richard" sort="Armstrong, Andrew Richard" uniqKey="Armstrong A" first="Andrew Richard" last="Armstrong">Andrew Richard Armstrong</name>
</region>
</country>
<country name="Brésil"><region name="État de São Paulo"><name sortKey="Da Silva, Mariliza Henrique" sort="Da Silva, Mariliza Henrique" uniqKey="Da Silva M" first="Mariliza Henrique" last="Da Silva">Mariliza Henrique Da Silva</name>
</region>
<name sortKey="Galano, Eliana" sort="Galano, Eliana" uniqKey="Galano E" first="Eliana" last="Galano">Eliana Galano</name>
</country>
</tree>
</affiliations>
</record>
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