Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation.
Identifieur interne : 001E19 ( PubMed/Curation ); précédent : 001E18; suivant : 001E20Standardized 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 [États-Unis] ; Lorna Marson [Royaume-Uni] ; Timothy L. Pruett [États-Unis] ; Peter P. Reese [États-Unis] ; David Rosenbloom [États-Unis] ; 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 [États-Unis] ; Nicole Evangelidis [Australie] ; Benedicte Sautenet [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.
DOI: 10.1097/TXD.0000000000000593
PubMed: 27500269
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Warrens</name><affiliation wicri:level="1"><nlm:affiliation>School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; 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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; 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:affiliation>Crowe Associates Ltd, Oxford, United Kingdom.</nlm:affiliation><country xml:lang="fr">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:affiliation>PKD International, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">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:affiliation>Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:affiliation><country xml:lang="fr">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:affiliation>Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:affiliation><country xml:lang="fr">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:affiliation>Department of Medicine, University of Ottawa, Ottawa, Canada.</nlm:affiliation><country xml:lang="fr">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:affiliation>Renal Division, Ghent University Hospital, Ghent, Belgium.</nlm:affiliation><country xml:lang="fr">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:affiliation>Centre for Nephrology, University College London, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">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 wicri:level="2"><nlm:affiliation>Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston</wicri:cityArea></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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; 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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; 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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; 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:affiliation>Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Transplant and Renal Research, Westmead Hospital, Sydney</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27500269</idno><idno type="pmid">27500269</idno><idno type="doi">10.1097/TXD.0000000000000593</idno><idno type="wicri:Area/PubMed/Corpus">001E43</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001E43</idno><idno type="wicri:Area/PubMed/Curation">001E19</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001E19</idno></publicationStmt><sourceDesc><biblStruct><analytic><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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; 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:affiliation>Department of Nephrology, Charité-Universitätsmedizin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">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:affiliation>Division of Nephrology, University of British Columbia, Vancouver, Canada.</nlm:affiliation><country xml:lang="fr">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 wicri:level="2"><nlm:affiliation>Department of Medicine, The University of Chicago, Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Department of Medicine, The University of Chicago, Chicago</wicri:cityArea></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:affiliation>Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.</nlm:affiliation><country xml:lang="fr">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 wicri:level="2"><nlm:affiliation>Department of Surgery, University of Minnesota, Minneapolis, MN.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Department of Surgery, University of Minnesota, Minneapolis</wicri:cityArea></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 wicri:level="2"><nlm:affiliation>Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia</wicri:cityArea></affiliation></author><author><name sortKey="Rosenbloom, David" sort="Rosenbloom, David" uniqKey="Rosenbloom D" first="David" last="Rosenbloom">David Rosenbloom</name><affiliation wicri:level="2"><nlm:affiliation>ESRD Network 18, Los Angeles, CA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>ESRD Network 18, Los Angeles</wicri:cityArea></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:affiliation>Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse, France.</nlm:affiliation><country xml:lang="fr">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:affiliation>School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; 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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; 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:affiliation>Crowe Associates Ltd, Oxford, United Kingdom.</nlm:affiliation><country xml:lang="fr">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:affiliation>PKD International, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">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:affiliation>Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:affiliation><country xml:lang="fr">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:affiliation>Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</nlm:affiliation><country xml:lang="fr">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:affiliation>Department of Medicine, University of Ottawa, Ottawa, Canada.</nlm:affiliation><country xml:lang="fr">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:affiliation>Renal Division, Ghent University Hospital, Ghent, Belgium.</nlm:affiliation><country xml:lang="fr">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:affiliation>Centre for Nephrology, University College London, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">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 wicri:level="2"><nlm:affiliation>Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston</wicri:cityArea></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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; 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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; 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:affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; 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:affiliation>Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">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="ISSN">2373-8731</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">27500269</PMID><DateCreated><Year>2016</Year><Month>08</Month><Day>08</Day></DateCreated><DateCompleted><Year>2016</Year><Month>08</Month><Day>08</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">2373-8731</ISSN><JournalIssue CitedMedium="Print"><Volume>2</Volume><Issue>6</Issue><PubDate><Year>2016</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Transplantation direct</Title><ISOAbbreviation>Transplant Direct</ISOAbbreviation></Journal><ArticleTitle>Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation.</ArticleTitle><Pagination><MedlinePgn>e79</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1097/TXD.0000000000000593</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">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.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">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.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Tong</LastName><ForeName>Allison</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Budde</LastName><ForeName>Klemens</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Nephrology, Charité-Universitätsmedizin, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gill</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Division of Nephrology, University of British Columbia, Vancouver, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Josephson</LastName><ForeName>Michelle A</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Department of Medicine, The University of Chicago, Chicago, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marson</LastName><ForeName>Lorna</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pruett</LastName><ForeName>Timothy L</ForeName><Initials>TL</Initials><AffiliationInfo><Affiliation>Department of Surgery, University of Minnesota, Minneapolis, MN.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Reese</LastName><ForeName>Peter P</ForeName><Initials>PP</Initials><AffiliationInfo><Affiliation>Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rosenbloom</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>ESRD Network 18, Los Angeles, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rostaing</LastName><ForeName>Lionel</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Warrens</LastName><ForeName>Anthony N</ForeName><Initials>AN</Initials><AffiliationInfo><Affiliation>School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Germaine</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Craig</LastName><ForeName>Jonathan C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Crowe</LastName><ForeName>Sally</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Crowe Associates Ltd, Oxford, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Harris</LastName><ForeName>Tess</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>PKD International, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hemmelgarn</LastName><ForeName>Brenda</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Manns</LastName><ForeName>Braden</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tugwell</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of Ottawa, Ottawa, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Van Biesen</LastName><ForeName>Wim</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Renal Division, Ghent University Hospital, Ghent, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wheeler</LastName><ForeName>David C</ForeName><Initials>DC</Initials><AffiliationInfo><Affiliation>Centre for Nephrology, University College London, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Winkelmayer</LastName><ForeName>Wolfgang C</ForeName><Initials>WC</Initials><AffiliationInfo><Affiliation>Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Evangelidis</LastName><ForeName>Nicole</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sautenet</LastName><ForeName>Benedicte</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Howell</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chapman</LastName><ForeName>Jeremy R</ForeName><Initials>JR</Initials><AffiliationInfo><Affiliation>Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>05</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Transplant Direct</MedlineTA><NlmUniqueID>101651609</NlmUniqueID><ISSNLinking>2373-8731</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Trials. 2013 Oct 09;14:324</RefSource><PMID Version="1">24103529</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Curr Opin Organ Transplant. 2015 Aug;20(4):476-81</RefSource><PMID Version="1">26107968</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Am J Transplant. 2004 Mar;4(3):378-83</RefSource><PMID 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