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dc.contributor.authorPaller, Amy S
dc.contributor.authorGuttman-Yassky, Emma
dc.contributor.authorIrvine, Alan D
dc.contributor.authorBaselga, Eulalia
dc.contributor.authorde Bruin-Weller, Marjolein
dc.contributor.authorJayawardena, Shyamalie
dc.contributor.authorZhang, Annie
dc.contributor.authorMina-Osorio, Paola
dc.contributor.authorRizova, Elena
dc.contributor.authorOzturk, Zafer E
dc.date.accessioned2021-08-13T15:55:48Z
dc.date.available2021-08-13T15:55:48Z
dc.date.issued2020-03-24
dc.identifier.pmid32209624
dc.identifier.doi10.1136/bmjopen-2019-033507
dc.identifier.urihttp://hdl.handle.net/10147/630064
dc.description.abstractIntroduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease often associated with atopic comorbidities and has significant impact on children and their families. There is a lack of robust and longitudinal long-term data on disease characteristics and typical clinical practice with currently available treatments in children with moderate-to-severe AD. Hence, an observational study is needed to evaluate AD characteristics and progression in paediatric patients with moderate-to-severe AD. Methods and analysis: Pediatric Study in Atopic Dermatitis (PEDISTAD) is a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe AD who are currently receiving systemic or topical treatment and whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not medically advisable. 1300 children at 100-150 sites in approximately 20 countries worldwide will be enrolled and followed for 5 years. AD therapy is at the discretion of the investigator. Data collected will include: AD disease characteristics and comorbidities; current therapy for AD and initiation of new treatments/changes in current treatment; patient-reported/caregiver-reported outcomes; days missed from school/work for the patient/caregiver; healthcare professional visits; safety and biomarkers. Ethics and dissemination: This study is conducted in accordance with the principles established by the 18th World Medical Assembly and all subsequent amendments and the guidelines for Good Epidemiology Practice. Each individual country assures that ethics approval has been received and local regulatory requirements are met. Ethics approval has been obtained in all countries currently participating in PEDISTAD. Study data will be disseminated in manuscripts submitted to peer-reviewed medical journals as well as in abstracts submitted to congresses and in the resulting posters and presentations.en_US
dc.language.isoenen_US
dc.rights© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
dc.subjectatopic dermatitisen_US
dc.subjectobservationalen_US
dc.subjectpaediatricen_US
dc.subjectsystemic treatmenten_US
dc.titleProtocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology.en_US
dc.typeArticleen_US
dc.typeOtheren_US
dc.identifier.eissn2044-6055
dc.identifier.journalBMJ openen_US
dc.description.peer-reviewpeer-reviewen_US
dc.source.journaltitleBMJ open
dc.source.volume10
dc.source.issue3
dc.source.beginpagee033507
dc.source.endpage
refterms.dateFOA2021-08-13T15:55:49Z
dc.source.countryEngland


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