Rationale for and design of the Idiopathic Pulmonary Fibrosis–PRospective Outcomes (IPF-PRO) registry
Identifieur interne : 000020 ( Main/Exploration ); précédent : 000019; suivant : 000021Rationale for and design of the Idiopathic Pulmonary Fibrosis–PRospective Outcomes (IPF-PRO) registry
Auteurs : Emily C. O'Brien [États-Unis] ; Michael T. Durheim [États-Unis] ; Victoria Gamerman [États-Unis] ; Sandy Garfinkel [États-Unis] ; Kevin J. Anstrom [États-Unis] ; Scott M. Palmer [États-Unis] ; Craig S. Conoscenti [États-Unis]Source :
- BMJ Open Respiratory Research [ 2052-4439 ] ; 2016.
Abstract
Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease characterised by progressive loss of lung function. Its clinical course is variable but ultimately fatal. There is a need for a multicentre patient registry incorporating longitudinal clinical data and biological samples to improve understanding of the natural history of IPF and contemporary practice patterns.
The Idiopathic Pulmonary Fibrosis–PRospective Outcomes (IPF-PRO) registry is a national IPF registry in the USA. This registry will enrol approximately 300 patients with newly diagnosed IPF over 2 years at approximately 14 tertiary pulmonary care sites. Participants will be followed for 3–5 years and will receive usual care, as defined by their physician. Clinical data from the year prior to diagnosis will be collected from medical record review on enrolment. Subsequently, data on diagnostic evaluations, pulmonary function tests, physical examinations, laboratory data and clinical events will be collected at routine clinical visits and via a call centre. Participants will complete patient-reported outcome questionnaires at enrolment and then at approximately 6-month intervals. Blood samples for cellular, genetic and transcriptomic analyses will be collected at the same intervals.
The first results from the IPF-PRO registry will be presented in 2015.
The IPF-PRO registry will improve understanding of the natural history of IPF, its impact on patients and current practice in the diagnosis and care of patients with IPF. The registry will establish a repository of biological samples from a well-characterised patient population for future research.
NCT01915511.
Url:
DOI: 10.1136/bmjresp-2015-000108
PubMed: 26835134
PubMed Central: 4716211
Affiliations:
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Durheim</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Medicine</addr-line>,<institution>Duke University, Duke Clinical Research Institute</institution>,<addr-line>Durham, North Carolina</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gamerman, Victoria" sort="Gamerman, Victoria" uniqKey="Gamerman V" first="Victoria" last="Gamerman">Victoria Gamerman</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Biometrics and Data Management</addr-line>,<institution>Boehringer Ingelheim Pharmaceuticals Inc.</institution>,<addr-line>Ridgefield, Connecticut</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Garfinkel, Sandy" sort="Garfinkel, Sandy" uniqKey="Garfinkel S" first="Sandy" last="Garfinkel">Sandy Garfinkel</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Clinical Operations</addr-line>,<institution>Boehringer Ingelheim Pharmaceuticals Inc.</institution>,<addr-line>Ridgefield, Connecticut</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Anstrom, Kevin J" sort="Anstrom, Kevin J" uniqKey="Anstrom K" first="Kevin J" last="Anstrom">Kevin J. Anstrom</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Department of Biostatistics and Bioinformatics</addr-line>,<institution>Duke Clinical Research Institute</institution>,<addr-line>Durham, North Carolina</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Palmer, Scott M" sort="Palmer, Scott M" uniqKey="Palmer S" first="Scott M" last="Palmer">Scott M. 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O'Brien</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Medicine</addr-line>,<institution>Duke University, Duke Clinical Research Institute</institution>,<addr-line>Durham, North Carolina</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Durheim, Michael T" sort="Durheim, Michael T" uniqKey="Durheim M" first="Michael T" last="Durheim">Michael T. Durheim</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Medicine</addr-line>,<institution>Duke University, Duke Clinical Research Institute</institution>,<addr-line>Durham, North Carolina</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gamerman, Victoria" sort="Gamerman, Victoria" uniqKey="Gamerman V" first="Victoria" last="Gamerman">Victoria Gamerman</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Biometrics and Data Management</addr-line>,<institution>Boehringer Ingelheim Pharmaceuticals Inc.</institution>,<addr-line>Ridgefield, Connecticut</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Garfinkel, Sandy" sort="Garfinkel, Sandy" uniqKey="Garfinkel S" first="Sandy" last="Garfinkel">Sandy Garfinkel</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Clinical Operations</addr-line>,<institution>Boehringer Ingelheim Pharmaceuticals Inc.</institution>,<addr-line>Ridgefield, Connecticut</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Anstrom, Kevin J" sort="Anstrom, Kevin J" uniqKey="Anstrom K" first="Kevin J" last="Anstrom">Kevin J. Anstrom</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Department of Biostatistics and Bioinformatics</addr-line>,<institution>Duke Clinical Research Institute</institution>,<addr-line>Durham, North Carolina</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Palmer, Scott M" sort="Palmer, Scott M" uniqKey="Palmer S" first="Scott M" last="Palmer">Scott M. Palmer</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Medicine</addr-line>,<institution>Duke University, Duke Clinical Research Institute</institution>,<addr-line>Durham, North Carolina</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Conoscenti, Craig S" sort="Conoscenti, Craig S" uniqKey="Conoscenti C" first="Craig S" last="Conoscenti">Craig S. Conoscenti</name><affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Clinical Development and Medical Affairs</addr-line>,<institution>Boehringer Ingelheim Pharmaceuticals Inc.</institution>,<addr-line>Ridgefield, Connecticut</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMJ Open Respiratory Research</title><idno type="eISSN">2052-4439</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease characterised by progressive loss of lung function. Its clinical course is variable but ultimately fatal. There is a need for a multicentre patient registry incorporating longitudinal clinical data and biological samples to improve understanding of the natural history of IPF and contemporary practice patterns.</p></sec><sec><title>Methods/design</title><p>The Idiopathic Pulmonary Fibrosis–PRospective Outcomes (IPF-PRO) registry is a national IPF registry in the USA. This registry will enrol approximately 300 patients with newly diagnosed IPF over 2 years at approximately 14 tertiary pulmonary care sites. Participants will be followed for 3–5 years and will receive usual care, as defined by their physician. Clinical data from the year prior to diagnosis will be collected from medical record review on enrolment. Subsequently, data on diagnostic evaluations, pulmonary function tests, physical examinations, laboratory data and clinical events will be collected at routine clinical visits and via a call centre. Participants will complete patient-reported outcome questionnaires at enrolment and then at approximately 6-month intervals. Blood samples for cellular, genetic and transcriptomic analyses will be collected at the same intervals.</p></sec><sec><title>Results</title><p>The first results from the IPF-PRO registry will be presented in 2015.</p></sec><sec><title>Conclusions</title><p>The IPF-PRO registry will improve understanding of the natural history of IPF, its impact on patients and current practice in the diagnosis and care of patients with IPF. The registry will establish a repository of biological samples from a well-characterised patient population for future research.</p></sec><sec><title>Clinical trial number</title><p>NCT01915511.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Raghu, G" uniqKey="Raghu G">G Raghu</name></author><author><name sortKey="Collard, Hr" uniqKey="Collard H">HR Collard</name></author><author><name sortKey="Egan, Jj" uniqKey="Egan J">JJ Egan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nalysnyk, L" uniqKey="Nalysnyk L">L Nalysnyk</name></author><author><name sortKey="Cid Ruzafa, J" uniqKey="Cid Ruzafa J">J Cid-Ruzafa</name></author><author><name sortKey="Rotella, P" uniqKey="Rotella P">P Rotella</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Raghu, G" uniqKey="Raghu G">G Raghu</name></author><author><name sortKey="Chen, Sy" uniqKey="Chen S">SY 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Selman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Daniels, Ce" uniqKey="Daniels C">CE Daniels</name></author><author><name sortKey="Yi, Es" uniqKey="Yi E">ES Yi</name></author><author><name sortKey="Ryu, Jh" uniqKey="Ryu J">JH Ryu</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="White, Es" uniqKey="White E">ES White</name></author><author><name sortKey="Brown, Kk" uniqKey="Brown K">KK Brown</name></author><author><name sortKey="Collard, Hr" uniqKey="Collard H">HR Collard</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lindell, Ko" uniqKey="Lindell K">KO Lindell</name></author><author><name sortKey="Black, Tr" uniqKey="Black T">TR Black</name></author><author><name sortKey="Hoffmann, K" uniqKey="Hoffmann K">K Hoffmann</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Moodley, Y" uniqKey="Moodley Y">Y Moodley</name></author><author><name sortKey="Goh, N" uniqKey="Goh N">N Goh</name></author><author><name sortKey="Glaspole, I" uniqKey="Glaspole I">I Glaspole</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Behr, J" uniqKey="Behr J">J Behr</name></author><author><name sortKey="Hoeper, Mm" uniqKey="Hoeper M">MM Hoeper</name></author><author><name sortKey="Kreuter, M" uniqKey="Kreuter M">M Kreuter</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wuyts, W" uniqKey="Wuyts W">W Wuyts</name></author><author><name sortKey="Dahlqvist, C" uniqKey="Dahlqvist C">C Dahlqvist</name></author><author><name sortKey="Schlesser, M" uniqKey="Schlesser M">M Schlesser</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ryerson, Cj" uniqKey="Ryerson C">CJ Ryerson</name></author><author><name sortKey="Tan, B" uniqKey="Tan B">B Tan</name></author><author><name sortKey="Fell, Cd" uniqKey="Fell C">CD Fell</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Guenther, A" uniqKey="Guenther A">A Guenther</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="O Brien, Emily C" sort="O Brien, Emily C" uniqKey="O Brien E" first="Emily C" last="O'Brien">Emily C. O'Brien</name></noRegion><name sortKey="Anstrom, Kevin J" sort="Anstrom, Kevin J" uniqKey="Anstrom K" first="Kevin J" last="Anstrom">Kevin J. Anstrom</name><name sortKey="Conoscenti, Craig S" sort="Conoscenti, Craig S" uniqKey="Conoscenti C" first="Craig S" last="Conoscenti">Craig S. Conoscenti</name><name sortKey="Durheim, Michael T" sort="Durheim, Michael T" uniqKey="Durheim M" first="Michael T" last="Durheim">Michael T. Durheim</name><name sortKey="Gamerman, Victoria" sort="Gamerman, Victoria" uniqKey="Gamerman V" first="Victoria" last="Gamerman">Victoria Gamerman</name><name sortKey="Garfinkel, Sandy" sort="Garfinkel, Sandy" uniqKey="Garfinkel S" first="Sandy" last="Garfinkel">Sandy Garfinkel</name><name sortKey="Palmer, Scott M" sort="Palmer, Scott M" uniqKey="Palmer S" first="Scott M" last="Palmer">Scott M. Palmer</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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