Assessing narcolepsy with cataplexy in children and adolescents: development of a cataplexy diary and the ESS-CHAD
Identifieur interne : 004D77 ( Ncbi/Checkpoint ); précédent : 004D76; suivant : 004D78Assessing 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.
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.
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).
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.
Url:
DOI: 10.2147/NSS.S140143
PubMed: 28860883
PubMed Central: 5565379
Affiliations:
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Evans</name><affiliation wicri:level="2"><nlm:aff id="af3-nss-9-201">Endpoint Outcomes, Boston, MA, USA</nlm:aff><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:aff id="af3-nss-9-201">Endpoint Outcomes, Boston, MA, USA</nlm:aff><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:aff id="af1-nss-9-201">Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA</nlm:aff><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><affiliation wicri:level="2"><nlm:aff id="af4-nss-9-201">Sleep Medicine, Stanford Sleep Medicine Center, Redwood City, CA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Sleep Medicine, Stanford Sleep Medicine Center, Redwood City, 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:aff id="af5-nss-9-201">Epworth Sleep Centre, East Melbourne, VIC, Australia</nlm:aff><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="eISSN">1179-1608</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objective</title><p>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.</p></sec><sec><title>Patients and methods</title><p>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.</p></sec><sec><title>Results</title><p>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).</p></sec><sec><title>Conclusion</title><p>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.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Ohayon, Mm" uniqKey="Ohayon M">MM Ohayon</name></author><author><name sortKey="Ferini Strambi, L" uniqKey="Ferini Strambi L">L Ferini-Strambi</name></author><author><name sortKey="Plazzi, G" uniqKey="Plazzi G">G Plazzi</name></author><author><name sortKey="Smirne, S" uniqKey="Smirne S">S Smirne</name></author><author><name sortKey="Castronovo, V" uniqKey="Castronovo V">V Castronovo</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Okun, Ml" uniqKey="Okun M">ML Okun</name></author><author><name sortKey="Lin, L" uniqKey="Lin L">L Lin</name></author><author><name sortKey="Pelin, Z" uniqKey="Pelin Z">Z Pelin</name></author><author><name sortKey="Hong, S" uniqKey="Hong S">S Hong</name></author><author><name 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Mw" uniqKey="Johns M">MW Johns</name></author></analytic></biblStruct></listBibl></div1></back></TEI><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="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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