Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set.
Identifieur interne : 000318 ( Main/Exploration ); précédent : 000317; suivant : 000319Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set.
Auteurs : Nicola L. Harman [Royaume-Uni] ; John Wilding [Royaume-Uni] ; Dave Curry [Royaume-Uni] ; James Harris [Royaume-Uni] ; Jennifer Logue [Royaume-Uni] ; R John Pemberton [Royaume-Uni] ; Leigh Perreault [Royaume-Uni, États-Unis] ; Gareth Thompson [Royaume-Uni] ; Sean Tunis [États-Unis] ; Paula R. Williamson [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2018.
Descripteurs français
- KwdFr :
- Conférences de consensus comme sujet (MeSH), Consensus (MeSH), Diabète de type 2 (diagnostic), Diabète de type 2 (sang), Diabète de type 2 (thérapie), Détermination du point final (normes), Essais contrôlés randomisés comme sujet (méthodes), Essais contrôlés randomisés comme sujet (normes), Glycémie (métabolisme), Humains (MeSH), Marqueurs biologiques (sang), Méthode Delphi (MeSH), Plan de recherche (normes), Revues systématiques comme sujet (MeSH), Résultat thérapeutique (MeSH).
- MESH :
- diagnostic : Diabète de type 2.
- métabolisme : Glycémie.
- méthodes : Essais contrôlés randomisés comme sujet.
- normes : Détermination du point final, Essais contrôlés randomisés comme sujet, Plan de recherche.
- sang : Diabète de type 2, Marqueurs biologiques.
- thérapie : Diabète de type 2.
- Conférences de consensus comme sujet, Consensus, Humains, Méthode Delphi, Revues systématiques comme sujet, Résultat thérapeutique.
English descriptors
- KwdEn :
- Biomarkers (blood), Blood Glucose (metabolism), Consensus (MeSH), Consensus Development Conferences as Topic (MeSH), Delphi Technique (MeSH), Diabetes Mellitus, Type 2 (blood), Diabetes Mellitus, Type 2 (diagnosis), Diabetes Mellitus, Type 2 (therapy), Endpoint Determination (standards), Humans (MeSH), Randomized Controlled Trials as Topic (methods), Randomized Controlled Trials as Topic (standards), Research Design (standards), Systematic Reviews as Topic (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , blood : Biomarkers.
- chemical , metabolism : Blood Glucose.
- blood : Diabetes Mellitus, Type 2.
- diagnosis : Diabetes Mellitus, Type 2.
- methods : Randomized Controlled Trials as Topic.
- standards : Endpoint Determination, Randomized Controlled Trials as Topic, Research Design.
- therapy : Diabetes Mellitus, Type 2.
- Consensus, Consensus Development Conferences as Topic, Delphi Technique, Humans, Systematic Reviews as Topic, Treatment Outcome.
Abstract
BACKGROUND
Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes.
METHODS/DESIGN
This study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups.
DISCUSSION
The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly.
TRIAL REGISTRATION
The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956 . Registered January 2017.
DOI: 10.1186/s13063-018-2805-2
PubMed: 30086771
PubMed Central: PMC6081933
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Harman</name><affiliation wicri:level="1"><nlm:affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK. n.harman@liv.ac.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL</wicri:regionArea><wicri:noRegion>L69 3GL</wicri:noRegion></affiliation></author><author><name sortKey="Wilding, John" sort="Wilding, John" uniqKey="Wilding J" first="John" last="Wilding">John Wilding</name><affiliation wicri:level="1"><nlm:affiliation>Obesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Obesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University Hospital Aintree, 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Pemberton</name><affiliation wicri:level="1"><nlm:affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL</wicri:regionArea><wicri:noRegion>L69 3GL</wicri:noRegion></affiliation></author><author><name sortKey="Perreault, Leigh" sort="Perreault, Leigh" uniqKey="Perreault L" first="Leigh" last="Perreault">Leigh Perreault</name><affiliation wicri:level="4"><nlm:affiliation>Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow</wicri:regionArea><orgName type="university">Université de Glasgow</orgName><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Division of Endocrinology, Metabolism and Diabetes, Affiliate Center for Global Health, University of Colorado Anschutz Medical Campus, 13001 E. 17th Pl, Aurora, CO, 80045, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Endocrinology, Metabolism and Diabetes, Affiliate Center for Global Health, University of Colorado Anschutz Medical Campus, 13001 E. 17th Pl, Aurora, CO, 80045</wicri:regionArea><wicri:noRegion>80045</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Colorado School of Public Health, 13001 E. 17th Place, Mail Stop B119, Aurora, CO, 80045, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Colorado School of Public Health, 13001 E. 17th Place, Mail Stop B119, Aurora, CO, 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Medical Technology Policy (CMTP), World Trade Center Baltimore, Baltimore, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Williamson, Paula R" sort="Williamson, Paula R" uniqKey="Williamson P" first="Paula R" last="Williamson">Paula R. Williamson</name><affiliation wicri:level="1"><nlm:affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL</wicri:regionArea><wicri:noRegion>L69 3GL</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Biomarkers (blood)</term><term>Blood Glucose (metabolism)</term><term>Consensus (MeSH)</term><term>Consensus Development Conferences as Topic (MeSH)</term><term>Delphi Technique (MeSH)</term><term>Diabetes Mellitus, Type 2 (blood)</term><term>Diabetes Mellitus, Type 2 (diagnosis)</term><term>Diabetes Mellitus, Type 2 (therapy)</term><term>Endpoint Determination (standards)</term><term>Humans (MeSH)</term><term>Randomized Controlled Trials as Topic (methods)</term><term>Randomized Controlled Trials as Topic (standards)</term><term>Research Design (standards)</term><term>Systematic Reviews as Topic (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Conférences de consensus comme sujet (MeSH)</term><term>Consensus (MeSH)</term><term>Diabète de type 2 (diagnostic)</term><term>Diabète de type 2 (sang)</term><term>Diabète de type 2 (thérapie)</term><term>Détermination du point final (normes)</term><term>Essais contrôlés randomisés comme sujet (méthodes)</term><term>Essais contrôlés randomisés comme sujet (normes)</term><term>Glycémie (métabolisme)</term><term>Humains (MeSH)</term><term>Marqueurs biologiques (sang)</term><term>Méthode Delphi (MeSH)</term><term>Plan de recherche (normes)</term><term>Revues systématiques comme sujet (MeSH)</term><term>Résultat thérapeutique (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Biomarkers</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Blood Glucose</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Diabetes Mellitus, Type 2</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Diabetes Mellitus, Type 2</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Diabète de type 2</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Glycémie</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Détermination du point final</term><term>Essais contrôlés randomisés comme sujet</term><term>Plan de recherche</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Diabète de type 2</term><term>Marqueurs biologiques</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Endpoint Determination</term><term>Randomized Controlled Trials as Topic</term><term>Research Design</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Diabetes Mellitus, Type 2</term></keywords><keywords scheme="MESH" qualifier="thérapie" xml:lang="fr"><term>Diabète de type 2</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Consensus</term><term>Consensus Development Conferences as Topic</term><term>Delphi Technique</term><term>Humans</term><term>Systematic Reviews as Topic</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Conférences de consensus comme sujet</term><term>Consensus</term><term>Humains</term><term>Méthode Delphi</term><term>Revues systématiques comme sujet</term><term>Résultat thérapeutique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS/DESIGN</b></p><p>This study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION</b></p><p>The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956 . Registered January 2017.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30086771</PMID><DateCompleted><Year>2019</Year><Month>03</Month><Day>14</Day></DateCompleted><DateRevised><Year>2019</Year><Month>03</Month><Day>14</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>1</Issue><PubDate><Year>2018</Year><Month>Aug</Month><Day>07</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set.</ArticleTitle><Pagination><MedlinePgn>427</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-018-2805-2</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">This study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956 . Registered January 2017.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Harman</LastName><ForeName>Nicola L</ForeName><Initials>NL</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-6958-6466</Identifier><AffiliationInfo><Affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK. n.harman@liv.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wilding</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Obesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Curry</LastName><ForeName>Dave</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Harris</LastName><ForeName>James</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Logue</LastName><ForeName>Jennifer</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pemberton</LastName><ForeName>R John</ForeName><Initials>RJ</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Perreault</LastName><ForeName>Leigh</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Division of Endocrinology, Metabolism and Diabetes, Affiliate Center for Global Health, University of Colorado Anschutz Medical Campus, 13001 E. 17th Pl, Aurora, CO, 80045, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Colorado School of Public Health, 13001 E. 17th Place, Mail Stop B119, Aurora, CO, 80045, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thompson</LastName><ForeName>Gareth</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tunis</LastName><ForeName>Sean</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Center for Medical Technology Policy (CMTP), World Trade Center Baltimore, Baltimore, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Williamson</LastName><ForeName>Paula R</ForeName><Initials>PR</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>SCORE-IT study team</CollectiveName></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>654248</GrantID><Agency>Horizon 2020</Agency><Country></Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2018</Year><Month>08</Month><Day>07</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015415">Biomarkers</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001786">Blood Glucose</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D015415" MajorTopicYN="N">Biomarkers</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001786" MajorTopicYN="N">Blood Glucose</DescriptorName><QualifierName UI="Q000378" MajorTopicYN="Y">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D032921" MajorTopicYN="N">Consensus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003245" MajorTopicYN="N">Consensus Development Conferences as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003697" MajorTopicYN="N">Delphi Technique</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003924" MajorTopicYN="N">Diabetes Mellitus, Type 2</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D023381" MajorTopicYN="Y">Endpoint Determination</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="Y">Research Design</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000078202" MajorTopicYN="N">Systematic Reviews as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Core outcome set</Keyword><Keyword MajorTopicYN="N">Systematic review</Keyword><Keyword MajorTopicYN="N">Type 2 diabetes</Keyword></KeywordList><InvestigatorList><Investigator ValidYN="Y"><LastName>Battaglia</LastName><ForeName>Serena</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Demotes-Mainard</LastName><ForeName>Jacques</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Gailus-Durner</LastName><ForeName>Valerie</ForeName><Initials>V</Initials></Investigator><Investigator ValidYN="Y"><LastName>Garattini</LastName><ForeName>Silvio</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Prinsen</LastName><ForeName>Cecilia A C</ForeName><Initials>CAC</Initials></Investigator><Investigator ValidYN="Y"><LastName>Raess</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>da Silva-Buttkus</LastName><ForeName>Patricia</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Terwee</LastName><ForeName>Caroline B</ForeName><Initials>CB</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate 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IdType="pubmed">29246177</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Maryland</li><li>Écosse</li></region><settlement><li>Glasgow</li></settlement><orgName><li>Université de Glasgow</li></orgName></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Harman, Nicola L" sort="Harman, Nicola L" uniqKey="Harman N" first="Nicola L" last="Harman">Nicola L. Harman</name></noRegion><name sortKey="Curry, Dave" sort="Curry, Dave" uniqKey="Curry D" first="Dave" last="Curry">Dave Curry</name><name sortKey="Harris, James" sort="Harris, James" uniqKey="Harris J" first="James" last="Harris">James Harris</name><name sortKey="Logue, Jennifer" sort="Logue, Jennifer" uniqKey="Logue J" first="Jennifer" last="Logue">Jennifer Logue</name><name sortKey="Pemberton, R John" sort="Pemberton, R John" uniqKey="Pemberton R" first="R John" last="Pemberton">R John Pemberton</name><name sortKey="Perreault, Leigh" sort="Perreault, Leigh" uniqKey="Perreault L" first="Leigh" last="Perreault">Leigh Perreault</name><name sortKey="Thompson, Gareth" sort="Thompson, Gareth" uniqKey="Thompson G" first="Gareth" last="Thompson">Gareth Thompson</name><name sortKey="Wilding, John" sort="Wilding, John" uniqKey="Wilding J" first="John" last="Wilding">John Wilding</name><name sortKey="Williamson, Paula R" sort="Williamson, Paula R" uniqKey="Williamson P" first="Paula R" last="Williamson">Paula R. 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