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 : 000481 ( Main/Exploration ); précédent : 000480; suivant : 000482Selecting 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 ; John Wilding ; Dave Curry ; James Harris ; Jennifer Logue [Royaume-Uni] ; R. John Pemberton ; Leigh Perreault [Royaume-Uni, États-Unis] ; Gareth Thompson ; Sean Tunis [États-Unis] ; Paula R. WilliamsonSource :
- 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
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.
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.
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.
The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database,
The online version of this article (10.1186/s13063-018-2805-2) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-018-2805-2
PubMed: 30086771
PubMed Central: 6081933
Affiliations:
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Le document en format XML
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John" last="Pemberton">R. 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Williamson</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 8470</institution-id><institution-id institution-id-type="GRID">grid.10025.36</institution-id><institution>Department of Biostatistics, Institute of Translational Medicine,</institution><institution>University of Liverpool,</institution></institution-wrap>Liverpool, L69 3GL UK</nlm:aff><wicri:noCountry code="subfield">L69 3GL UK</wicri:noCountry></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2018">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"><sec><title>Background</title><p id="Par1">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></sec><sec><title>Methods/design</title><p id="Par2">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></sec><sec><title>Discussion</title><p id="Par3">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></sec><sec><title>Trial registration</title><p id="Par4">The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, <ext-link ext-link-type="uri" xlink:href="http://www.comet-initiative.org/studies/details/956">http://www.comet-initiative.org/studies/details/956</ext-link>. Registered January 2017.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (10.1186/s13063-018-2805-2) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Holman, N" uniqKey="Holman N">N Holman</name></author><author><name sortKey="Young, B" uniqKey="Young B">B Young</name></author><author><name sortKey="Gadsby, R" uniqKey="Gadsby R">R Gadsby</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bruno, G" uniqKey="Bruno G">G Bruno</name></author><author><name sortKey="Runzo, C" uniqKey="Runzo C">C Runzo</name></author><author><name sortKey="Cavallo Perin, P" uniqKey="Cavallo Perin P">P Cavallo-Perin</name></author><author><name sortKey="Merletti, F" uniqKey="Merletti F">F Merletti</name></author><author><name sortKey="Rivetti, M" uniqKey="Rivetti M">M 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Harman</name><name sortKey="Harris, James" sort="Harris, James" uniqKey="Harris J" first="James" last="Harris">James Harris</name><name sortKey="Pemberton, R John" sort="Pemberton, R John" uniqKey="Pemberton R" first="R. John" last="Pemberton">R. John Pemberton</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. Williamson</name></noCountry><country name="Royaume-Uni"><noRegion><name sortKey="Logue, Jennifer" sort="Logue, Jennifer" uniqKey="Logue J" first="Jennifer" last="Logue">Jennifer Logue</name></noRegion><name sortKey="Perreault, Leigh" sort="Perreault, Leigh" uniqKey="Perreault L" first="Leigh" last="Perreault">Leigh Perreault</name></country><country name="États-Unis"><region name="Colorado"><name sortKey="Perreault, Leigh" sort="Perreault, Leigh" uniqKey="Perreault L" first="Leigh" last="Perreault">Leigh Perreault</name></region><name sortKey="Perreault, Leigh" sort="Perreault, Leigh" uniqKey="Perreault L" first="Leigh" last="Perreault">Leigh Perreault</name><name sortKey="Tunis, Sean" sort="Tunis, Sean" uniqKey="Tunis S" first="Sean" last="Tunis">Sean Tunis</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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