1. Início
  2. Publicações
  3. The Process of Developing a Disease Activity Index in Microscopic Colitis

The Process of Developing a Disease Activity Index in Microscopic Colitis

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • Fernando José Magro Dias

    Autor

Participantes de fora da FMUP

  • Lesnovska, Katarina Pihl
  • Munch, Andreas
  • Bonderup, Ole
  • 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

Unidades de investigação

Abstract

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.

Dados da publicação

ISSN/ISSNe:
1873-9946, 1876-4479

JOURNAL OF CROHNS & COLITIS  Oxford University Press

Tipo:
Article
Páginas:
452-459
Link para outro recurso:
www.scopus.com

Citações Recebidas na Web of Science: 5

Citações Recebidas na Scopus: 5

Documentos

  • Não há documentos

Métricas

Filiações mostrar / ocultar

Keywords

  • Microscopic colitis; PROM; disease activity index; instrument development

Campos de estudo

Proyectos asociados

Gut microbiome and IBD therapy: an interplay?

Investigador Principal: Fernando José Magro Dias

Estudo Observacional Académico (GutIBD) . 2021

Iron deficiency and inflammatory bowel disease. Correlation with inflammation and Vitamin D status.

Investigador Principal: Fernando José Magro Dias

Estudo Observacional Académico (IronIBD) . 2021

Looking 4WARD: The role of dipeptidyl peptidase 4 (DPP-4) in inflammatory bowel disease (IBD) as a novel biomarker for predicting disease activity and monitoring response to therapy in IBD patients.

Investigador Principal: Fernando José Magro Dias

Estudo Observacional Académico (4WARD) . 2021

Isolated Ulceration of Crohn’s Anastomosis

Investigador Principal: Fernando José Magro Dias

Estudo Clínico Académico . 2021

Therapeutic Drug Monitoring: An Emergent Approach in Inflammatory Bowel Disease

Investigador Principal: Fernando José Magro Dias

Estudo Clínico Académico . 2021

Contributo da endoscopia, biomarcadores e imagiologia na evolução clinica dos doentes com doença inflamatória intestinal

Investigador Principal: Fernando José Magro Dias

Estudo Clínico Académico . 2019

Citar a publicação

Partilhar a publicação