Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis
Adult
Male
Canada
Psychometrics
Reproducibility of Results
Middle Aged
16. Peace & justice
United States
3. Good health
Interviews as Topic
03 medical and health sciences
0302 clinical medicine
Crohn Disease
Surveys and Questionnaires
Outcome Assessment, Health Care
Symptoms and Impacts Questionnaire for Inflammatory Bowel Disease
Humans
Colitis, Ulcerative
Female
Health Impact Assessment
Patient Reported Outcome Measures
DOI:
10.1111/apt.15726
Publication Date:
2020-04-22T03:19:45Z
AUTHORS (10)
ABSTRACT
SummaryBackgroundPatient‐reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies.AimsTo develop PRO tools for use in Crohn's disease (CD) and ulcerative colitis (UC) following guidance issued by the US FDA and the ISPOR (International Society for Pharmacoeconomics and Outcomes Research).MethodsConcept elicitation and cognitive interviews were conducted in adult patients (≥18 years) across the United States and Canada. Semi‐structured interview guides were used to collect data, and interview transcripts were coded and analysed. Concept elicitation results were considered alongside existing literature and clinical expert opinion to identify candidate PRO items. Cognitive interviews evaluated concept relevance, interpretability and structure, and facilitated instrument refinement. Concept elicitation participants, except those with an ostomy, underwent centrally read endoscopy to assess inflammatory status.ResultsIn all, 54 participants (mean age: 46.2 years; 66.7% female) were included in the CD concept elicitation interviews. In total, 80 symptom concepts and 61 impact concepts were identified. After three waves of cognitive interviews, the 31‐item Symptoms and Impacts Questionnaire for CD (SIQ‐CD) was developed. In the UC concept elicitation phase, 53 participants were interviewed (mean age: 41.4 years; 49.1% female). In total, 79 symptoms concepts and 49 impact concepts were identified. Following two waves of cognitive interviews, the 29‐item Symptoms and Impacts Questionnaire for UC (SIQ‐UC) was developed. Both instruments include four symptom and six impact domains.ConclusionsWe developed PROs to support CD and UC drug labelling claims. Psychometric validation studies to evaluate instrument reliability and responsiveness are ongoing.
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