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The Process of Developing a Disease Activity Index in Microscopic Colitis.
Lesnovska, Katarina Pihl; Münch, Andreas; Bonderup, Ole; Magro, Fernando; Kupcinskas, Juozas; Zabana, Yamile; Tontini, Gian Eugenio; Munck, Lars Kristian; Guagnozzi, Danila; Latella, Giovanni; Fernandez-Banares, Fernando; Miehlke, Stephan; Madisch, Ahmed; Wildt, Signe; Hjortswang, Henrik.
Afiliación
  • Lesnovska KP; Department of Gastroenterology and Hepatology in Linköping, and Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden.
  • Münch A; Department of Gastroenterology and Hepatology in Linköping, and Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden.
  • Bonderup O; Diagnostik Center, Hospitalenhed Midt, Regionhospitalet Silkeborg, Silkeborg, Denmark.
  • Magro F; Department of Pharmacology, Hospital de Sao Joao, Porto, Portugal.
  • Kupcinskas J; Department of Gastroenterology and Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • Zabana Y; Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Barcelona, Spain.
  • Tontini GE; Department of Gastroenterology, Hospital Universitari Mutua de Terrassa, University of Barcelona, Barcelona, Spain.
  • Munck LK; Department of Pathophysiology and Organ Transplantation, University of Milan and Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Guagnozzi D; Department of Gastroenterology, Zealand University Hospital, Koege, Denmark.
  • Latella G; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
  • Fernandez-Banares F; Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Barcelona, Spain.
  • Miehlke S; Neuro-Immuno-Gastroenterology Group, Digestive Physiology and Pathophysiology Unit, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.
  • Madisch A; Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
  • Wildt S; Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Barcelona, Spain.
  • Hjortswang H; Department of Gastroenterology, Hospital Universitari Mutua de Terrassa, University of Barcelona, Barcelona, Spain.
J Crohns Colitis ; 16(3): 452-459, 2022 Mar 14.
Article en En | MEDLINE | ID: mdl-34562005
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-MCAI] 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Colitis Microscópica / Medición de Resultados Informados por el Paciente Tipo de estudio: Diagnostic_studies / Observational_studies / Prevalence_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Humans Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Suecia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Colitis Microscópica / Medición de Resultados Informados por el Paciente Tipo de estudio: Diagnostic_studies / Observational_studies / Prevalence_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Humans Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Suecia Pais de publicación: Reino Unido