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The Process of Deve...
The Process of Developing a Disease Activity Index in Microscopic Colitis
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- Pihl Lesnovska, Katarina (author)
- Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken
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- Münch, Andreas (author)
- Linköpings universitet,Avdelningen för molekylär medicin och virologi,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken
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- Bonderup, Ole (author)
- Regionhosp Silkeborg, Denmark
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- Magro, Fernando (author)
- Hosp Sao Joao, Portugal
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- Kupcinskas, Juozas (author)
- Lithuanian Univ Hlth Sci, Lithuania; Lithuanian Univ Hlth Sci, Lithuania
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- Zabana, Yamile (author)
- Ctr Invest Biomed Red Enfermedades Hepat & Digest, Spain; Univ Barcelona, Spain
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- Tontini, Gian Eugenio (author)
- Univ Milan, Italy; Fdn IRCCS Ca Granda Osped Maggiore Policlin, Italy
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- Munck, Lars Kristian (author)
- Zealand Univ Hosp, Denmark; Univ Copenhagen, Denmark
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- Guagnozzi, Danila (author)
- Ctr Invest Biomed Red Enfermedades Hepat & Digest, Spain; Vall dHebron Res Inst VHIR, Spain
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- Latella, Giovanni (author)
- Univ Aquila, Italy
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- Fernandez-Banares, Fernando (author)
- Ctr Invest Biomed Red Enfermedades Hepat & Digest, Spain; Univ Barcelona, Spain
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- Miehlke, Stephan (author)
- Ctr Digest Dis, Germany; Univ Hosp Eppendorf, Germany
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- Madisch, Ahmed (author)
- CRH Clin Siloah, Germany
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- Wildt, Signe (author)
- Zealand Univ Hosp, Denmark; Univ Copenhagen, Denmark
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- Hjortswang, Henrik (author)
- Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken
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(creator_code:org_t)
- 2021-09-25
- 2022
- English.
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In: Journal of Crohn's & Colitis. - Oxford, United Kingdom : Oxford University Press. - 1873-9946 .- 1876-4479. ; 16:3, s. 452-459
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Omvårdnad (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Nursing (hsv//eng)
Keyword
- Microscopic colitis; PROM; disease activity index; instrument development
Publication and Content Type
- ref (subject category)
- art (subject category)
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Pihl Lesnovska, ...
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Münch, Andreas
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Bonderup, Ole
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Magro, Fernando
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Kupcinskas, Juoz ...
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Zabana, Yamile
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Tontini, Gian Eu ...
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Munck, Lars Kris ...
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Guagnozzi, Danil ...
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Latella, Giovann ...
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Fernandez-Banare ...
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Miehlke, Stephan
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Madisch, Ahmed
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Wildt, Signe
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Hjortswang, Henr ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Nursing
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Journal of Crohn ...
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Linköping University