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The Process of Deve...
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Pihl Lesnovska, KatarinaLinköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken
(author)
The Process of Developing a Disease Activity Index in Microscopic Colitis
- Article/chapterEnglish2022
Publisher, publication year, extent ...
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2021-09-25
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Oxford, United Kingdom :Oxford University Press,2022
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:liu-183268
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-183268URI
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https://doi.org/10.1093/ecco-jcc/jjab170DOI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Funding Agencies: Tillotts Pharma; N-ECCO research grants
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Background and Aims: Patient-reported outcome measures [PROMs] aim to measure patients perception of how their disorder influences everyday functioning. The objective of this study was to develop a PROM to assess disease activity in microscopic colitis [MC] fulfilling the requirements of the Food and Drug Administration [FDA].Methods: The European Microscopic Colitis Activity Index [E-MCAT] was developed in four steps. [1] A list of symptoms associated with active MC was created by a group of experts in the field. [2] Content validity of the symptoms was performed by experts [n= 14] and patients [n = 79] using the Content Validity Index. [3] Questions and response alternatives were created for each symptom, and validity of the E-MCAI was evaluated with cognitive interviews with patients [n= 7] and by the experts. [4] A pilot postal survey was performed to ensure usability.Results: Seven of the symptoms related to active MC fulfilled the criteria for content validity and were included in the E-MCAI: stool consistency, stool frequency, stools at night, feel a need to pass more stools shortly after a bowel movement, urgent need to empty the bowel, leakage of stool and abdominal pain.The development and validation process resulted in the current version of the E-MCAI consisting of six questions related to MC. Conclusions: The E-MCAI was developed using the methods advocated by the FDA.The evaluation indicates good content validity. Further evaluation will be performed to achieve construct validity, reliability and responsiveness in future cross-sectional and longitudinal studies.
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Münch, AndreasLinköpings universitet,Avdelningen för molekylär medicin och virologi,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken(Swepub:liu)andsa76
(author)
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Bonderup, OleRegionhosp Silkeborg, Denmark
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Magro, FernandoHosp Sao Joao, Portugal
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Kupcinskas, JuozasLithuanian Univ Hlth Sci, Lithuania; Lithuanian Univ Hlth Sci, Lithuania
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Zabana, YamileCtr Invest Biomed Red Enfermedades Hepat & Digest, Spain; Univ Barcelona, Spain
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Tontini, Gian EugenioUniv Milan, Italy; Fdn IRCCS Ca Granda Osped Maggiore Policlin, Italy
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Munck, Lars KristianZealand Univ Hosp, Denmark; Univ Copenhagen, Denmark
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Guagnozzi, DanilaCtr Invest Biomed Red Enfermedades Hepat & Digest, Spain; Vall dHebron Res Inst VHIR, Spain
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Latella, GiovanniUniv Aquila, Italy
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Fernandez-Banares, FernandoCtr Invest Biomed Red Enfermedades Hepat & Digest, Spain; Univ Barcelona, Spain
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Miehlke, StephanCtr Digest Dis, Germany; Univ Hosp Eppendorf, Germany
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Madisch, AhmedCRH Clin Siloah, Germany
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Wildt, SigneZealand Univ Hosp, Denmark; Univ Copenhagen, Denmark
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Hjortswang, HenrikLinköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken(Swepub:liu)henhj44
(author)
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Linköpings universitetAvdelningen för diagnostik och specialistmedicin
(creator_code:org_t)
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In:Journal of Crohn's & ColitisOxford, United Kingdom : Oxford University Press16:3, s. 452-4591873-99461876-4479
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