Last updated on March 2018

Symptom Score to Assess Abdominal Involvement in Patients With Cystic Fibrosis

Brief description of study

Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis.

Detailed Study Description

Development of a multimodal questionnaire considering the FDA guidelines for patient reported outcome measures (PROM)

  • Evaluation of reliability of the questionnaire by examining internal consistency and construct validity
  • Evaluation of reproducibility of the questionnaire by re-testing of patients
  • Assessment of cross-generational applicability of the questionnaire by sub-scoring of age groups
  • Evaluation of the responsiveness of the score by comparison with age-matched healthy controls
  • Assessment of putative relationships of abdominal symptoms with faecal inflammatory markers
  • Assessment of applicability of the questionnaire in other CF centers
  • Transfer the JenAbdomen Score to other countries and languages

Clinical Study Identifier: NCT03052283

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