Assessing narcolepsy with cataplexy in children and adolescents: development of a cataplexy diary and the ESS-CHAD.
Identifieur interne : 001176 ( PubMed/Checkpoint ); précédent : 001175; suivant : 001177Assessing narcolepsy with cataplexy in children and adolescents: development of a cataplexy diary and the ESS-CHAD.
Auteurs : Y Grace Wang [États-Unis] ; Khadra Benmedjahed [France] ; Jérémy Lambert [France] ; Christopher J. Evans [États-Unis] ; Steve Hwang [États-Unis] ; Jed Black [États-Unis] ; Murray W. Johns [Australie]Source :
- Nature and science of sleep [ 1179-1608 ] ; 2017.
Abstract
The aim of this study was to qualitatively evaluate concepts for incorporation into a daily diary to capture cataplexy frequency and to assess the content validity of the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) in pediatric patients with narcolepsy.
DOI: 10.2147/NSS.S140143
PubMed: 28860883
Affiliations:
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Evans</name><affiliation wicri:level="2"><nlm:affiliation>Endpoint Outcomes, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Endpoint Outcomes, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Hwang, Steve" sort="Hwang, Steve" uniqKey="Hwang S" first="Steve" last="Hwang">Steve Hwang</name><affiliation wicri:level="2"><nlm:affiliation>Endpoint Outcomes, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Endpoint Outcomes, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Black, Jed" sort="Black, Jed" uniqKey="Black J" first="Jed" last="Black">Jed Black</name><affiliation wicri:level="2"><nlm:affiliation>Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Johns, Murray W" sort="Johns, Murray W" uniqKey="Johns M" first="Murray W" last="Johns">Murray W. 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Evans</name><affiliation wicri:level="2"><nlm:affiliation>Endpoint Outcomes, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Endpoint Outcomes, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Hwang, Steve" sort="Hwang, Steve" uniqKey="Hwang S" first="Steve" last="Hwang">Steve Hwang</name><affiliation wicri:level="2"><nlm:affiliation>Endpoint Outcomes, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Endpoint Outcomes, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Black, Jed" sort="Black, Jed" uniqKey="Black J" first="Jed" last="Black">Jed Black</name><affiliation wicri:level="2"><nlm:affiliation>Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Johns, Murray W" sort="Johns, Murray W" uniqKey="Johns M" first="Murray W" last="Johns">Murray W. Johns</name><affiliation wicri:level="1"><nlm:affiliation>Epworth Sleep Centre, East Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Epworth Sleep Centre, East Melbourne, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author></analytic><series><title level="j">Nature and science of sleep</title><idno type="ISSN">1179-1608</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The aim of this study was to qualitatively evaluate concepts for incorporation into a daily diary to capture cataplexy frequency and to assess the content validity of the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) in pediatric patients with narcolepsy.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">28860883</PMID><DateCreated><Year>2017</Year><Month>09</Month><Day>01</Day></DateCreated><DateRevised><Year>2017</Year><Month>09</Month><Day>03</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">1179-1608</ISSN><JournalIssue CitedMedium="Print"><Volume>9</Volume><PubDate><Year>2017</Year></PubDate></JournalIssue><Title>Nature and science of sleep</Title><ISOAbbreviation>Nat Sci Sleep</ISOAbbreviation></Journal><ArticleTitle>Assessing narcolepsy with cataplexy in children and adolescents: development of a cataplexy diary and the ESS-CHAD.</ArticleTitle><Pagination><MedlinePgn>201-211</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.2147/NSS.S140143</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">The aim of this study was to qualitatively evaluate concepts for incorporation into a daily diary to capture cataplexy frequency and to assess the content validity of the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) in pediatric patients with narcolepsy.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Face-to-face concept elicitation and cognitive interviews were conducted with children (7-9 years; n=13) and adolescents (10-17 years; n=16) who have narcolepsy with cataplexy, and their parents/caregivers.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Similarities and differences were noted between narcolepsy concepts described by children and their parents/caregivers, suggesting some different but complementary perspectives; parents may not recognize cataplexy symptoms/triggers as well as children, but parents have greater recognition of the circumstances of falling asleep. Cataplexy diary modifications included changes in definitions and examples of cataplexy, using child-friendly terminology, adding a quantitative question to determine daily frequency, and standardizing the questionnaire for evening administration with self-completion by the child. Modifications were made to ESS-CHAD for child-friendly wording and to ensure that items reflect activities (eating, watching TV/video) and environments (school, bus/car transport) in which children are likely to participate. Two ESS-CHAD versions were proposed: one with a 1-month recall period, for general use, and the other with a recall period of "since your last study visit," for research, which could be shorter or longer than 1 month (as short as 1 week).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The cataplexy diary and ESS-CHAD were modified for the assessment of children and adolescents. Further psychometric validation is recommended. These measures are being used in a Phase III, placebo-controlled clinical trial of sodium oxybate in children and adolescents with narcolepsy.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Y Grace</ForeName><Initials>YG</Initials><AffiliationInfo><Affiliation>Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Benmedjahed</LastName><ForeName>Khadra</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Patient-Centered Outcomes, Mapi, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lambert</LastName><ForeName>Jérémy</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Patient-Centered Outcomes, Mapi, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Evans</LastName><ForeName>Christopher J</ForeName><Initials>CJ</Initials><AffiliationInfo><Affiliation>Endpoint Outcomes, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hwang</LastName><ForeName>Steve</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Endpoint Outcomes, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Black</LastName><ForeName>Jed</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Sleep Medicine, Stanford Sleep Medicine Center, Redwood City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Johns</LastName><ForeName>Murray W</ForeName><Initials>MW</Initials><AffiliationInfo><Affiliation>Epworth Sleep Centre, East Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>08</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>New Zealand</Country><MedlineTA>Nat Sci Sleep</MedlineTA><NlmUniqueID>101537767</NlmUniqueID><ISSNLinking>1179-1608</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Sleep Med. 2004 Mar;5(2):119-23</RefSource><PMID Version="1">15033130</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Sleep Med. 2017 May;33:30-35</RefSource><PMID Version="1">28449902</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Public Health. 2006 May 02;6:116</RefSource><PMID Version="1">16670019</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Sleep. 1991 Dec;14(6):540-5</RefSource><PMID Version="1">1798888</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Sleep. 2002 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MajorTopicYN="N">cataplexy</Keyword><Keyword MajorTopicYN="N">children</Keyword><Keyword MajorTopicYN="N">narcolepsy</Keyword><Keyword MajorTopicYN="N">sleepiness</Keyword></KeywordList><CoiStatement>Disclosure Dr Y Grace Wang is an employee of Jazz Pharmaceuticals, who in the course of this employment has received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals. Dr Khadra Benmedjahed and Dr Jérémy Lambert are employees of Mapi, a consulting company commissioned by Jazz Pharmaceuticals for this study. Dr Christopher J Evans and Mr Steve Hwang are employees of Endpoint Outcomes, a consulting company commissioned by Jazz Pharmaceuticals for this study. Dr Jed Black is a part-time employee of Jazz Pharmaceuticals and holds stock in Jazz Pharmaceuticals plc. Dr Murray W Johns owns the copyright to the ESS and has received license fees from corporations and government agencies; the ESS-CHAD was used in this study with permission and cooperation, and without financial considerations, by Jazz Pharmaceuticals. The authors report no other conflicts of interest in this work.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>9</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>9</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>9</Month><Day>2</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28860883</ArticleId><ArticleId IdType="doi">10.2147/NSS.S140143</ArticleId><ArticleId IdType="pii">nss-9-201</ArticleId><ArticleId IdType="pmc">PMC5565379</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>France</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Californie</li><li>Massachusetts</li><li>Rhône-Alpes</li></region><settlement><li>Lyon</li></settlement></list><tree><country name="États-Unis"><region name="Californie"><name sortKey="Wang, Y Grace" sort="Wang, Y Grace" uniqKey="Wang Y" first="Y Grace" last="Wang">Y Grace Wang</name></region><name sortKey="Black, Jed" sort="Black, Jed" uniqKey="Black J" first="Jed" last="Black">Jed Black</name><name sortKey="Evans, Christopher J" sort="Evans, Christopher J" uniqKey="Evans C" first="Christopher J" last="Evans">Christopher J. Evans</name><name sortKey="Hwang, Steve" sort="Hwang, Steve" uniqKey="Hwang S" first="Steve" last="Hwang">Steve Hwang</name></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Benmedjahed, Khadra" sort="Benmedjahed, Khadra" uniqKey="Benmedjahed K" first="Khadra" last="Benmedjahed">Khadra Benmedjahed</name></region><name sortKey="Lambert, Jeremy" sort="Lambert, Jeremy" uniqKey="Lambert J" first="Jérémy" last="Lambert">Jérémy Lambert</name></country><country name="Australie"><noRegion><name sortKey="Johns, Murray W" sort="Johns, Murray W" uniqKey="Johns M" first="Murray W" last="Johns">Murray W. Johns</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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