Target hemoglobin trials in chronic kidney disease: design and interpretation issues.
Identifieur interne : 000198 ( Main/Exploration ); précédent : 000197; suivant : 000199Target hemoglobin trials in chronic kidney disease: design and interpretation issues.
Auteurs : Robert N. FoleySource :
- Pediatric nephrology (Berlin, Germany) [ 1432-198X ] ; 2009.
Descripteurs français
- KwdFr :
- Antianémiques (usage thérapeutique), Anémie (traitement médicamenteux), Défaillance rénale chronique (complications), Défaillance rénale chronique (traitement médicamenteux), Essais cliniques comme sujet (effets indésirables), Essais cliniques comme sujet (méthodes), Humains (MeSH), Hémoglobines (usage thérapeutique), Interprétation statistique de données (MeSH), Protéines recombinantes (MeSH), Résultat thérapeutique (MeSH), Érythropoïétine (usage thérapeutique).
- MESH :
- effets indésirables : Défaillance rénale chronique, Essais cliniques comme sujet.
- méthodes : Essais cliniques comme sujet.
- traitement médicamenteux : Anémie, Défaillance rénale chronique.
- usage thérapeutique : Antianémiques, Hémoglobines, Érythropoïétine.
- Humains, Interprétation statistique de données, Protéines recombinantes, Résultat thérapeutique.
English descriptors
- KwdEn :
- Anemia (drug therapy), Clinical Trials as Topic (adverse effects), Clinical Trials as Topic (methods), Data Interpretation, Statistical (MeSH), Erythropoietin (therapeutic use), Hematinics (therapeutic use), Hemoglobins (therapeutic use), Humans (MeSH), Kidney Failure, Chronic (complications), Kidney Failure, Chronic (drug therapy), Recombinant Proteins (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , therapeutic use : Erythropoietin, Hematinics, Hemoglobins.
- adverse effects : Clinical Trials as Topic.
- complications : Kidney Failure, Chronic.
- drug therapy : Anemia, Kidney Failure, Chronic.
- methods : Clinical Trials as Topic.
- Data Interpretation, Statistical, Humans, Recombinant Proteins, Treatment Outcome.
Abstract
Optimal management of anemia in patients with chronic kidney disease remains a divisive issue within the nephrology community. Because the evidence provided by successive randomized controlled trials has often proven to be incongruent, it is natural to consider whether methodological issues may be responsible. Using four large trials [US Normal Hematocrit, Canadian European Normalization of Hemoglobin, Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta (CREATE) and Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)], this review article highlights several methodological issues that may be important when trial evidence is translated into clinical practice. Issues discussed include heterogeneity of enrollment criteria, failure to conceal treatment allocation, generalizability of study interventions, systematic use of imbalanced co-interventions [especially dose of erythropoietin stimulating agent (ESA), confusion regarding stopping rules and interim analyses and failure to account for imbalances in important patient characteristics generated at randomization.
DOI: 10.1007/s00467-009-1123-z
PubMed: 19221807
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Foley</name></author></analytic><series><title level="j">Pediatric nephrology (Berlin, Germany)</title><idno type="eISSN">1432-198X</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anemia (drug therapy)</term><term>Clinical Trials as Topic (adverse effects)</term><term>Clinical Trials as Topic (methods)</term><term>Data Interpretation, Statistical (MeSH)</term><term>Erythropoietin (therapeutic use)</term><term>Hematinics (therapeutic use)</term><term>Hemoglobins (therapeutic use)</term><term>Humans (MeSH)</term><term>Kidney Failure, Chronic (complications)</term><term>Kidney Failure, Chronic (drug therapy)</term><term>Recombinant Proteins (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Antianémiques (usage thérapeutique)</term><term>Anémie (traitement médicamenteux)</term><term>Défaillance rénale chronique (complications)</term><term>Défaillance rénale chronique (traitement médicamenteux)</term><term>Essais cliniques comme sujet (effets indésirables)</term><term>Essais cliniques comme sujet (méthodes)</term><term>Humains (MeSH)</term><term>Hémoglobines (usage thérapeutique)</term><term>Interprétation statistique de données (MeSH)</term><term>Protéines recombinantes (MeSH)</term><term>Résultat thérapeutique (MeSH)</term><term>Érythropoïétine (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Erythropoietin</term><term>Hematinics</term><term>Hemoglobins</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Kidney Failure, Chronic</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Anemia</term><term>Kidney Failure, Chronic</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Défaillance rénale chronique</term><term>Essais cliniques comme sujet</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Essais cliniques comme sujet</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Anémie</term><term>Défaillance rénale chronique</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antianémiques</term><term>Hémoglobines</term><term>Érythropoïétine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Data Interpretation, Statistical</term><term>Humans</term><term>Recombinant Proteins</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Humains</term><term>Interprétation statistique de données</term><term>Protéines recombinantes</term><term>Résultat thérapeutique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Optimal management of anemia in patients with chronic kidney disease remains a divisive issue within the nephrology community. Because the evidence provided by successive randomized controlled trials has often proven to be incongruent, it is natural to consider whether methodological issues may be responsible. Using four large trials [US Normal Hematocrit, Canadian European Normalization of Hemoglobin, Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta (CREATE) and Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)], this review article highlights several methodological issues that may be important when trial evidence is translated into clinical practice. Issues discussed include heterogeneity of enrollment criteria, failure to conceal treatment allocation, generalizability of study interventions, systematic use of imbalanced co-interventions [especially dose of erythropoietin stimulating agent (ESA), confusion regarding stopping rules and interim analyses and failure to account for imbalances in important patient characteristics generated at randomization.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">19221807</PMID><DateCompleted><Year>2010</Year><Month>01</Month><Day>05</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1432-198X</ISSN><JournalIssue CitedMedium="Internet"><Volume>24</Volume><Issue>12</Issue><PubDate><Year>2009</Year><Month>Dec</Month></PubDate></JournalIssue><Title>Pediatric nephrology (Berlin, Germany)</Title></Journal><ArticleTitle>Target hemoglobin trials in chronic kidney disease: design and interpretation issues.</ArticleTitle><Pagination><MedlinePgn>2279-85</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s00467-009-1123-z</ELocationID><Abstract><AbstractText>Optimal management of anemia in patients with chronic kidney disease remains a divisive issue within the nephrology community. Because the evidence provided by successive randomized controlled trials has often proven to be incongruent, it is natural to consider whether methodological issues may be responsible. Using four large trials [US Normal Hematocrit, Canadian European Normalization of Hemoglobin, Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta (CREATE) and Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)], this review article highlights several methodological issues that may be important when trial evidence is translated into clinical practice. Issues discussed include heterogeneity of enrollment criteria, failure to conceal treatment allocation, generalizability of study interventions, systematic use of imbalanced co-interventions [especially dose of erythropoietin stimulating agent (ESA), confusion regarding stopping rules and interim analyses and failure to account for imbalances in important patient characteristics generated at randomization.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Foley</LastName><ForeName>Robert N</ForeName><Initials>RN</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016421">Editorial</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2009</Year><Month>02</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>Germany</Country><MedlineTA>Pediatr 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MajorTopicYN="N">Clinical Trials as Topic</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003627" MajorTopicYN="N">Data Interpretation, Statistical</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004921" MajorTopicYN="N">Erythropoietin</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006397" MajorTopicYN="N">Hematinics</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006454" MajorTopicYN="N">Hemoglobins</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007676" MajorTopicYN="N">Kidney Failure, Chronic</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011994" MajorTopicYN="N">Recombinant Proteins</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><NumberOfReferences>10</NumberOfReferences></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2008</Year><Month>07</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2008</Year><Month>12</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2008</Year><Month>10</Month><Day>31</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2009</Year><Month>2</Month><Day>18</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2009</Year><Month>2</Month><Day>18</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2010</Year><Month>1</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">19221807</ArticleId><ArticleId IdType="doi">10.1007/s00467-009-1123-z</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Biometrics. 1979 Sep;35(3):549-56</Citation><ArticleIdList><ArticleId IdType="pubmed">497341</ArticleId></ArticleIdList></Reference><Reference><Citation>Pediatr Nephrol. 2009 Mar;24(3):435-7</Citation><ArticleIdList><ArticleId IdType="pubmed">18696118</ArticleId></ArticleIdList></Reference><Reference><Citation>Pediatr Nephrol. 2009 Mar;24(3):571-9</Citation><ArticleIdList><ArticleId IdType="pubmed">18800231</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2006 Nov 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