Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation
Identifieur interne : 000640 ( Pmc/Curation ); précédent : 000639; suivant : 000641Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation
Auteurs : Allison Tong [Australie] ; Klemens Budde [Allemagne] ; John Gill [Canada] ; Michelle A. Josephson ; Lorna Marson [Royaume-Uni] ; Timothy L. Pruett ; Peter P. Reese ; David Rosenbloom ; Lionel Rostaing [France] ; Anthony N. Warrens [Royaume-Uni] ; Germaine Wong [Australie] ; Jonathan C. Craig [Australie] ; Sally Crowe [Royaume-Uni] ; Tess Harris [Royaume-Uni] ; Brenda Hemmelgarn [Canada] ; Braden Manns [Canada] ; Peter Tugwell [Canada] ; Wim Van Biesen [Belgique] ; David C. Wheeler [Royaume-Uni] ; Wolfgang C. Winkelmayer ; Nicole Evangelidis [Australie] ; Benedicte Sautenet [Australie, France] ; Martin Howell [Australie] ; Jeremy R. Chapman [Australie]Source :
- Transplantation Direct [ 2373-8731 ] ; 2016.
Abstract
Although advances in treatment have dramatically improved short-term graft survival and acute rejection in kidney transplant recipients, long-term graft outcomes have not substantially improved. Transplant recipients also have a considerably increased risk of cancer, cardiovascular disease, diabetes, and infection, which all contribute to appreciable morbidity and premature mortality. Many trials in kidney transplantation are short-term, frequently use unvalidated surrogate endpoints, outcomes of uncertain relevance to patients and clinicians, and do not consistently measure and report key outcomes like death, graft loss, graft function, and adverse effects of therapy. This diminishes the value of trials in supporting treatment decisions that require individual-level multiple tradeoffs between graft survival and the risk of side effects, adverse events, and mortality. The Standardized Outcomes in Nephrology-Transplantation initiative aims to develop a core outcome set for trials in kidney transplantation that is based on the shared priorities of all stakeholders.
This will include a systematic review to identify outcomes reported in randomized trials, a Delphi survey with an international multistakeholder panel (patients, caregivers, clinicians, researchers, policy makers, members from industry) to develop a consensus-based prioritized list of outcome domains and a consensus workshop to review and finalize the core outcome set for trials in kidney transplantation.
Developing and implementing a core outcome set to be reported, at a minimum, in all kidney transplantation trials will improve the transparency, quality, and relevance of research; to enable kidney transplant recipients and their clinicians to make better-informed treatment decisions for improved patient outcomes.
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DOI: 10.1097/TXD.0000000000000593
PubMed: 27500269
PubMed Central: 4946524
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Michelle A. Josephson<affiliation><nlm:aff id="aff5"> Department of Medicine, The University of Chicago, Chicago, IL.</nlm:aff><wicri:noCountry code="subfield">IL.</wicri:noCountry></affiliation><affiliation><nlm:aff id="aff7"> Department of Surgery, University of Minnesota, Minneapolis, MN.</nlm:aff><wicri:noCountry code="subfield">MN.</wicri:noCountry></affiliation><affiliation><nlm:aff id="aff8"> Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation><affiliation><nlm:aff id="aff9"> ESRD Network 18, Los Angeles, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation><affiliation><nlm:aff id="aff19"> Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.</nlm:aff><wicri:noCountry code="subfield">TX.</wicri:noCountry></affiliation>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation</title><author><name sortKey="Tong, Allison" sort="Tong, Allison" uniqKey="Tong A" first="Allison" last="Tong">Allison Tong</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Budde, Klemens" sort="Budde, Klemens" uniqKey="Budde K" first="Klemens" last="Budde">Klemens Budde</name><affiliation wicri:level="1"><nlm:aff id="aff3"> Department of Nephrology, Charité-Universitätsmedizin, Berlin, Germany.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea> Department of Nephrology, Charité-Universitätsmedizin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Gill, John" sort="Gill, John" uniqKey="Gill J" first="John" last="Gill">John Gill</name><affiliation wicri:level="1"><nlm:aff id="aff4"> Division of Nephrology, University of British Columbia, Vancouver, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Division of Nephrology, University of British Columbia, Vancouver</wicri:regionArea></affiliation></author><author><name sortKey="Josephson, Michelle A" sort="Josephson, Michelle A" uniqKey="Josephson M" first="Michelle A." last="Josephson">Michelle A. Josephson</name><affiliation><nlm:aff id="aff5"> Department of Medicine, The University of Chicago, Chicago, IL.</nlm:aff><wicri:noCountry code="subfield">IL.</wicri:noCountry></affiliation></author><author><name sortKey="Marson, Lorna" sort="Marson, Lorna" uniqKey="Marson L" first="Lorna" last="Marson">Lorna Marson</name><affiliation wicri:level="1"><nlm:aff id="aff6"> Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> Transplant Unit, University of Edinburgh, Edinburgh</wicri:regionArea></affiliation></author><author><name sortKey="Pruett, Timothy L" sort="Pruett, Timothy L" uniqKey="Pruett T" first="Timothy L." last="Pruett">Timothy L. Pruett</name><affiliation><nlm:aff id="aff7"> Department of Surgery, University of Minnesota, Minneapolis, MN.</nlm:aff><wicri:noCountry code="subfield">MN.</wicri:noCountry></affiliation></author><author><name sortKey="Reese, Peter P" sort="Reese, Peter P" uniqKey="Reese P" first="Peter P." last="Reese">Peter P. Reese</name><affiliation><nlm:aff id="aff8"> Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Rosenbloom, David" sort="Rosenbloom, David" uniqKey="Rosenbloom D" first="David" last="Rosenbloom">David Rosenbloom</name><affiliation><nlm:aff id="aff9"> ESRD Network 18, Los Angeles, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name><affiliation wicri:level="1"><nlm:aff id="aff10"> Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse, France.</nlm:aff><country xml:lang="fr" wicri:curation="lc">France</country><wicri:regionArea> Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse</wicri:regionArea></affiliation></author><author><name sortKey="Warrens, Anthony N" sort="Warrens, Anthony N" uniqKey="Warrens A" first="Anthony N." last="Warrens">Anthony N. Warrens</name><affiliation wicri:level="1"><nlm:aff id="aff11"> School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> School of Medicine and Dentistry, Queen Mary University of London, London</wicri:regionArea></affiliation></author><author><name sortKey="Wong, Germaine" sort="Wong, Germaine" uniqKey="Wong G" first="Germaine" last="Wong">Germaine Wong</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff12"> Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Transplant and Renal Research, Westmead Hospital, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Craig, Jonathan C" sort="Craig, Jonathan C" uniqKey="Craig J" first="Jonathan C." last="Craig">Jonathan C. Craig</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Crowe, Sally" sort="Crowe, Sally" uniqKey="Crowe S" first="Sally" last="Crowe">Sally Crowe</name><affiliation wicri:level="1"><nlm:aff id="aff13"> Crowe Associates Ltd, Oxford, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> Crowe Associates Ltd, Oxford</wicri:regionArea></affiliation></author><author><name sortKey="Harris, Tess" sort="Harris, Tess" uniqKey="Harris T" first="Tess" last="Harris">Tess Harris</name><affiliation wicri:level="1"><nlm:aff id="aff14">PKD International, London, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea>PKD International, London</wicri:regionArea></affiliation></author><author><name sortKey="Hemmelgarn, Brenda" sort="Hemmelgarn, Brenda" uniqKey="Hemmelgarn B" first="Brenda" last="Hemmelgarn">Brenda Hemmelgarn</name><affiliation wicri:level="1"><nlm:aff id="aff15"> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary</wicri:regionArea></affiliation></author><author><name sortKey="Manns, Braden" sort="Manns, Braden" uniqKey="Manns B" first="Braden" last="Manns">Braden Manns</name><affiliation wicri:level="1"><nlm:aff id="aff15"> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary</wicri:regionArea></affiliation></author><author><name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name><affiliation wicri:level="1"><nlm:aff id="aff16"> Department of Medicine, University of Ottawa, Ottawa, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Department of Medicine, University of Ottawa, Ottawa</wicri:regionArea></affiliation></author><author><name sortKey="Van Biesen, Wim" sort="Van Biesen, Wim" uniqKey="Van Biesen W" first="Wim" last="Van Biesen">Wim Van Biesen</name><affiliation wicri:level="1"><nlm:aff id="aff17"> Renal Division, Ghent University Hospital, Ghent, Belgium.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea> Renal Division, Ghent University Hospital, Ghent</wicri:regionArea></affiliation></author><author><name sortKey="Wheeler, David C" sort="Wheeler, David C" uniqKey="Wheeler D" first="David C." last="Wheeler">David C. Wheeler</name><affiliation wicri:level="1"><nlm:aff id="aff18"> Centre for Nephrology, University College London, London, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> Centre for Nephrology, University College London, London</wicri:regionArea></affiliation></author><author><name sortKey="Winkelmayer, Wolfgang C" sort="Winkelmayer, Wolfgang C" uniqKey="Winkelmayer W" first="Wolfgang C." last="Winkelmayer">Wolfgang C. Winkelmayer</name><affiliation><nlm:aff id="aff19"> Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.</nlm:aff><wicri:noCountry code="subfield">TX.</wicri:noCountry></affiliation></author><author><name sortKey="Evangelidis, Nicole" sort="Evangelidis, Nicole" uniqKey="Evangelidis N" first="Nicole" last="Evangelidis">Nicole Evangelidis</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Sautenet, Benedicte" sort="Sautenet, Benedicte" uniqKey="Sautenet B" first="Benedicte" last="Sautenet">Benedicte Sautenet</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff20"> Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.</nlm:aff><country xml:lang="fr" wicri:curation="lc">France</country><wicri:regionArea> Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours</wicri:regionArea></affiliation></author><author><name sortKey="Howell, Martin" sort="Howell, Martin" uniqKey="Howell M" first="Martin" last="Howell">Martin Howell</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Chapman, Jeremy R" sort="Chapman, Jeremy R" uniqKey="Chapman J" first="Jeremy R." last="Chapman">Jeremy R. Chapman</name><affiliation wicri:level="1"><nlm:aff id="aff12"> Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Transplant and Renal Research, Westmead Hospital, Sydney</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27500269</idno><idno type="pmc">4946524</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4946524</idno><idno type="RBID">PMC:4946524</idno><idno type="doi">10.1097/TXD.0000000000000593</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000641</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000641</idno><idno type="wicri:Area/Pmc/Curation">000640</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000640</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation</title><author><name sortKey="Tong, Allison" sort="Tong, Allison" uniqKey="Tong A" first="Allison" last="Tong">Allison Tong</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Budde, Klemens" sort="Budde, Klemens" uniqKey="Budde K" first="Klemens" last="Budde">Klemens Budde</name><affiliation wicri:level="1"><nlm:aff id="aff3"> Department of Nephrology, Charité-Universitätsmedizin, Berlin, Germany.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea> Department of Nephrology, Charité-Universitätsmedizin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Gill, John" sort="Gill, John" uniqKey="Gill J" first="John" last="Gill">John Gill</name><affiliation wicri:level="1"><nlm:aff id="aff4"> Division of Nephrology, University of British Columbia, Vancouver, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Division of Nephrology, University of British Columbia, Vancouver</wicri:regionArea></affiliation></author><author><name sortKey="Josephson, Michelle A" sort="Josephson, Michelle A" uniqKey="Josephson M" first="Michelle A." last="Josephson">Michelle A. Josephson</name><affiliation><nlm:aff id="aff5"> Department of Medicine, The University of Chicago, Chicago, IL.</nlm:aff><wicri:noCountry code="subfield">IL.</wicri:noCountry></affiliation></author><author><name sortKey="Marson, Lorna" sort="Marson, Lorna" uniqKey="Marson L" first="Lorna" last="Marson">Lorna Marson</name><affiliation wicri:level="1"><nlm:aff id="aff6"> Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> Transplant Unit, University of Edinburgh, Edinburgh</wicri:regionArea></affiliation></author><author><name sortKey="Pruett, Timothy L" sort="Pruett, Timothy L" uniqKey="Pruett T" first="Timothy L." last="Pruett">Timothy L. Pruett</name><affiliation><nlm:aff id="aff7"> Department of Surgery, University of Minnesota, Minneapolis, MN.</nlm:aff><wicri:noCountry code="subfield">MN.</wicri:noCountry></affiliation></author><author><name sortKey="Reese, Peter P" sort="Reese, Peter P" uniqKey="Reese P" first="Peter P." last="Reese">Peter P. Reese</name><affiliation><nlm:aff id="aff8"> Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Rosenbloom, David" sort="Rosenbloom, David" uniqKey="Rosenbloom D" first="David" last="Rosenbloom">David Rosenbloom</name><affiliation><nlm:aff id="aff9"> ESRD Network 18, Los Angeles, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name><affiliation wicri:level="1"><nlm:aff id="aff10"> Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse, France.</nlm:aff><country xml:lang="fr" wicri:curation="lc">France</country><wicri:regionArea> Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse</wicri:regionArea></affiliation></author><author><name sortKey="Warrens, Anthony N" sort="Warrens, Anthony N" uniqKey="Warrens A" first="Anthony N." last="Warrens">Anthony N. Warrens</name><affiliation wicri:level="1"><nlm:aff id="aff11"> School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> School of Medicine and Dentistry, Queen Mary University of London, London</wicri:regionArea></affiliation></author><author><name sortKey="Wong, Germaine" sort="Wong, Germaine" uniqKey="Wong G" first="Germaine" last="Wong">Germaine Wong</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff12"> Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Transplant and Renal Research, Westmead Hospital, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Craig, Jonathan C" sort="Craig, Jonathan C" uniqKey="Craig J" first="Jonathan C." last="Craig">Jonathan C. Craig</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Crowe, Sally" sort="Crowe, Sally" uniqKey="Crowe S" first="Sally" last="Crowe">Sally Crowe</name><affiliation wicri:level="1"><nlm:aff id="aff13"> Crowe Associates Ltd, Oxford, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> Crowe Associates Ltd, Oxford</wicri:regionArea></affiliation></author><author><name sortKey="Harris, Tess" sort="Harris, Tess" uniqKey="Harris T" first="Tess" last="Harris">Tess Harris</name><affiliation wicri:level="1"><nlm:aff id="aff14">PKD International, London, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea>PKD International, London</wicri:regionArea></affiliation></author><author><name sortKey="Hemmelgarn, Brenda" sort="Hemmelgarn, Brenda" uniqKey="Hemmelgarn B" first="Brenda" last="Hemmelgarn">Brenda Hemmelgarn</name><affiliation wicri:level="1"><nlm:aff id="aff15"> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary</wicri:regionArea></affiliation></author><author><name sortKey="Manns, Braden" sort="Manns, Braden" uniqKey="Manns B" first="Braden" last="Manns">Braden Manns</name><affiliation wicri:level="1"><nlm:aff id="aff15"> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary</wicri:regionArea></affiliation></author><author><name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name><affiliation wicri:level="1"><nlm:aff id="aff16"> Department of Medicine, University of Ottawa, Ottawa, Canada.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Canada</country><wicri:regionArea> Department of Medicine, University of Ottawa, Ottawa</wicri:regionArea></affiliation></author><author><name sortKey="Van Biesen, Wim" sort="Van Biesen, Wim" uniqKey="Van Biesen W" first="Wim" last="Van Biesen">Wim Van Biesen</name><affiliation wicri:level="1"><nlm:aff id="aff17"> Renal Division, Ghent University Hospital, Ghent, Belgium.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea> Renal Division, Ghent University Hospital, Ghent</wicri:regionArea></affiliation></author><author><name sortKey="Wheeler, David C" sort="Wheeler, David C" uniqKey="Wheeler D" first="David C." last="Wheeler">David C. Wheeler</name><affiliation wicri:level="1"><nlm:aff id="aff18"> Centre for Nephrology, University College London, London, United Kingdom.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea> Centre for Nephrology, University College London, London</wicri:regionArea></affiliation></author><author><name sortKey="Winkelmayer, Wolfgang C" sort="Winkelmayer, Wolfgang C" uniqKey="Winkelmayer W" first="Wolfgang C." last="Winkelmayer">Wolfgang C. Winkelmayer</name><affiliation><nlm:aff id="aff19"> Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.</nlm:aff><wicri:noCountry code="subfield">TX.</wicri:noCountry></affiliation></author><author><name sortKey="Evangelidis, Nicole" sort="Evangelidis, Nicole" uniqKey="Evangelidis N" first="Nicole" last="Evangelidis">Nicole Evangelidis</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Sautenet, Benedicte" sort="Sautenet, Benedicte" uniqKey="Sautenet B" first="Benedicte" last="Sautenet">Benedicte Sautenet</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff20"> Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.</nlm:aff><country xml:lang="fr" wicri:curation="lc">France</country><wicri:regionArea> Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours</wicri:regionArea></affiliation></author><author><name sortKey="Howell, Martin" sort="Howell, Martin" uniqKey="Howell M" first="Martin" last="Howell">Martin Howell</name><affiliation wicri:level="1"><nlm:aff id="aff1"> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Sydney School of Public Health, The University of Sydney, Sydney</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Chapman, Jeremy R" sort="Chapman, Jeremy R" uniqKey="Chapman J" first="Jeremy R." last="Chapman">Jeremy R. Chapman</name><affiliation wicri:level="1"><nlm:aff id="aff12"> Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Australie</country><wicri:regionArea> Centre for Transplant and Renal Research, Westmead Hospital, Sydney</wicri:regionArea></affiliation></author></analytic><series><title level="j">Transplantation Direct</title><idno type="eISSN">2373-8731</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>Although advances in treatment have dramatically improved short-term graft survival and acute rejection in kidney transplant recipients, long-term graft outcomes have not substantially improved. Transplant recipients also have a considerably increased risk of cancer, cardiovascular disease, diabetes, and infection, which all contribute to appreciable morbidity and premature mortality. Many trials in kidney transplantation are short-term, frequently use unvalidated surrogate endpoints, outcomes of uncertain relevance to patients and clinicians, and do not consistently measure and report key outcomes like death, graft loss, graft function, and adverse effects of therapy. This diminishes the value of trials in supporting treatment decisions that require individual-level multiple tradeoffs between graft survival and the risk of side effects, adverse events, and mortality. The Standardized Outcomes in Nephrology-Transplantation initiative aims to develop a core outcome set for trials in kidney transplantation that is based on the shared priorities of all stakeholders.</p></sec><sec><title>Methods</title><p>This will include a systematic review to identify outcomes reported in randomized trials, a Delphi survey with an international multistakeholder panel (patients, caregivers, clinicians, researchers, policy makers, members from industry) to develop a consensus-based prioritized list of outcome domains and a consensus workshop to review and finalize the core outcome set for trials in kidney transplantation.</p></sec><sec><title>Conclusions</title><p>Developing and implementing a core outcome set to be reported, at a minimum, in all kidney transplantation trials will improve the transparency, quality, and relevance of research; to enable kidney transplant recipients and their clinicians to make better-informed treatment decisions for improved patient 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Transplant Direct</journal-id><journal-id journal-id-type="iso-abbrev">Transplant Direct</journal-id><journal-id journal-id-type="publisher-id">TXD</journal-id><journal-title-group><journal-title>Transplantation Direct</journal-title></journal-title-group><issn pub-type="epub">2373-8731</issn><publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27500269</article-id><article-id pub-id-type="pmc">4946524</article-id><article-id pub-id-type="publisher-id">TXD50069</article-id><article-id pub-id-type="doi">10.1097/TXD.0000000000000593</article-id><article-id pub-id-type="art-access-id">00010</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Tong</surname><given-names>Allison</given-names></name><degrees>MPH, PhD</degrees><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Budde</surname><given-names>Klemens</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Gill</surname><given-names>John</given-names></name><degrees>MD, MSc</degrees><xref ref-type="aff" rid="aff4"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Josephson</surname><given-names>Michelle A.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="aff5"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Marson</surname><given-names>Lorna</given-names></name><degrees>MBBS, FRCS, MD, FRCPEd</degrees><xref ref-type="aff" rid="aff6"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pruett</surname><given-names>Timothy L.</given-names></name><degrees>MD (Hons)</degrees><xref ref-type="aff" rid="aff7"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Reese</surname><given-names>Peter P.</given-names></name><degrees>MD, MSCE</degrees><xref ref-type="aff" rid="aff8"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Rosenbloom</surname><given-names>David</given-names></name><xref ref-type="aff" rid="aff9"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Rostaing</surname><given-names>Lionel</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="aff10"><sup>10</sup></xref></contrib><contrib contrib-type="author"><name><surname>Warrens</surname><given-names>Anthony N.</given-names></name><degrees>BM, ChB, DM, PhD</degrees><xref ref-type="aff" rid="aff11"><sup>11</sup></xref></contrib><contrib contrib-type="author"><name><surname>Wong</surname><given-names>Germaine</given-names></name><degrees>MBBS, PhD</degrees><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff12"><sup>12</sup></xref></contrib><contrib contrib-type="author"><name><surname>Craig</surname><given-names>Jonathan C.</given-names></name><degrees>BMChB, MMed, PhD</degrees><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Crowe</surname><given-names>Sally</given-names></name><degrees>PG Dip</degrees><xref ref-type="aff" rid="aff13"><sup>13</sup></xref></contrib><contrib contrib-type="author"><name><surname>Harris</surname><given-names>Tess</given-names></name><xref ref-type="aff" rid="aff14"><sup>14</sup></xref></contrib><contrib contrib-type="author"><name><surname>Hemmelgarn</surname><given-names>Brenda</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="aff15"><sup>15</sup></xref></contrib><contrib contrib-type="author"><name><surname>Manns</surname><given-names>Braden</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="aff15"><sup>15</sup></xref></contrib><contrib contrib-type="author"><name><surname>Tugwell</surname><given-names>Peter</given-names></name><degrees>MBBS, MRCP, LMCC, FRCPC</degrees><xref ref-type="aff" rid="aff16"><sup>16</sup></xref></contrib><contrib contrib-type="author"><name><surname>Van Biesen</surname><given-names>Wim</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="aff17"><sup>17</sup></xref></contrib><contrib contrib-type="author"><name><surname>Wheeler</surname><given-names>David C.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="aff18"><sup>18</sup></xref></contrib><contrib contrib-type="author"><name><surname>Winkelmayer</surname><given-names>Wolfgang C.</given-names></name><degrees>MD, ScD</degrees><xref ref-type="aff" rid="aff19"><sup>19</sup></xref></contrib><contrib contrib-type="author"><name><surname>Evangelidis</surname><given-names>Nicole</given-names></name><degrees>BSocSc</degrees><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Sautenet</surname><given-names>Benedicte</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff20"><sup>20</sup></xref></contrib><contrib contrib-type="author"><name><surname>Howell</surname><given-names>Martin</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Chapman</surname><given-names>Jeremy R.</given-names></name><degrees>MD, FRCP</degrees><xref ref-type="aff" rid="aff12"><sup>12</sup></xref></contrib></contrib-group><contrib-group><contrib contrib-type="collab"><collab collab-type="authors">on behalf of the SONG-Tx Investigators</collab></contrib></contrib-group><aff id="aff1"><sup>1</sup> Sydney School of Public Health, The University of Sydney, Sydney, Australia.</aff><aff id="aff2"><sup>2</sup> Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</aff><aff id="aff3"><sup>3</sup> Department of Nephrology, Charité-Universitätsmedizin, Berlin, Germany.</aff><aff id="aff4"><sup>4</sup> Division of Nephrology, University of British Columbia, Vancouver, Canada.</aff><aff id="aff5"><sup>5</sup> Department of Medicine, The University of Chicago, Chicago, IL.</aff><aff id="aff6"><sup>6</sup> Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.</aff><aff id="aff7"><sup>7</sup> Department of Surgery, University of Minnesota, Minneapolis, MN.</aff><aff id="aff8"><sup>8</sup> Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.</aff><aff id="aff9"><sup>9</sup> ESRD Network 18, Los Angeles, CA.</aff><aff id="aff10"><sup>10</sup> Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse, France.</aff><aff id="aff11"><sup>11</sup> School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.</aff><aff id="aff12"><sup>12</sup> Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</aff><aff id="aff13"><sup>13</sup> Crowe Associates Ltd, Oxford, United Kingdom.</aff><aff id="aff14"><sup>14</sup>PKD International, London, United Kingdom.</aff><aff id="aff15"><sup>15</sup> Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</aff><aff id="aff16"><sup>16</sup> Department of Medicine, University of Ottawa, Ottawa, Canada.</aff><aff id="aff17"><sup>17</sup> Renal Division, Ghent University Hospital, Ghent, Belgium.</aff><aff id="aff18"><sup>18</sup> Centre for Nephrology, University College London, London, United Kingdom.</aff><aff id="aff19"><sup>19</sup> Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.</aff><aff id="aff20"><sup>20</sup> Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.</aff><author-notes><corresp>Correspondence: Allison Tong, PhD, Centre for Kidney Research, The Children's Hospital at Westmead, Westmead NSW 2145, Australia. (<email>allison.tong@sydney.edu.au</email>).</corresp></author-notes><pub-date pub-type="collection"><month>6</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>19</day><month>5</month><year>2016</year></pub-date><volume>2</volume><issue>6</issue><elocation-id>e79</elocation-id><history><date date-type="received"><day>15</day><month>2</month><year>2016</year></date><date date-type="rev-request"><day>6</day><month>4</month><year>2016</year></date><date date-type="accepted"><day>09</day><month>4</month><year>2016</year></date></history><permissions><copyright-statement>Copyright © 2016 The Authors. Transplantation Direct. Published by Wolters Kluwer Health, Inc.</copyright-statement><copyright-year>2016</copyright-year><copyright-holder>The Authors. Transplantation Direct. Published by Wolters Kluwer Health, Inc.</copyright-holder><license><license-p>This is an open-access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND)</ext-link>, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.</license-p></license></permissions><self-uri xlink:type="simple" xlink:href="txd-2-e79.pdf"></self-uri><abstract><sec><title>Background</title><p>Although advances in treatment have dramatically improved short-term graft survival and acute rejection in kidney transplant recipients, long-term graft outcomes have not substantially improved. Transplant recipients also have a considerably increased risk of cancer, cardiovascular disease, diabetes, and infection, which all contribute to appreciable morbidity and premature mortality. Many trials in kidney transplantation are short-term, frequently use unvalidated surrogate endpoints, outcomes of uncertain relevance to patients and clinicians, and do not consistently measure and report key outcomes like death, graft loss, graft function, and adverse effects of therapy. This diminishes the value of trials in supporting treatment decisions that require individual-level multiple tradeoffs between graft survival and the risk of side effects, adverse events, and mortality. The Standardized Outcomes in Nephrology-Transplantation initiative aims to develop a core outcome set for trials in kidney transplantation that is based on the shared priorities of all stakeholders.</p></sec><sec><title>Methods</title><p>This will include a systematic review to identify outcomes reported in randomized trials, a Delphi survey with an international multistakeholder panel (patients, caregivers, clinicians, researchers, policy makers, members from industry) to develop a consensus-based prioritized list of outcome domains and a consensus workshop to review and finalize the core outcome set for trials in kidney transplantation.</p></sec><sec><title>Conclusions</title><p>Developing and implementing a core outcome set to be reported, at a minimum, in all kidney transplantation trials will improve the transparency, quality, and relevance of research; to enable kidney transplant recipients and their clinicians to make better-informed treatment decisions for improved patient outcomes.</p></sec></abstract><counts><page-count count="0"></page-count></counts><custom-meta-group><custom-meta><meta-name>OPEN-ACCESS</meta-name><meta-value>TRUE</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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