Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis

• DOI: 10.1111/apt.15726
• Publication Date: 2020-04-22T03:19:45Z
• Authors: Parambir S. Dulai; Vipul Jairath; Reena Khanna; Christopher Ma; Kelly P. McCarrier; Mona L. Martin; Claire E. Parker; Joan Morris; Brian G. Feagan; William J. Sandborn
• Keywords: Cognitive interview; Interpretability; Patient-reported outcome; Pharmacoeconomics

Summary Background Patient‐reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies. Aims To develop PRO tools for use Crohn's (CD) and ulcerative colitis (UC) following guidance issued the US FDA ISPOR (International Society Pharmacoeconomics Outcomes Research). Methods Concept elicitation cognitive interviews were conducted adult patients (≥18 years) across United States Canada. Semi‐structured interview guides collect data, transcripts coded analysed. results alongside existing literature clinical expert opinion identify candidate items. Cognitive evaluated concept relevance, interpretability structure, facilitated instrument refinement. participants, except those with an ostomy, underwent centrally read endoscopy assess status. Results In all, 54 participants (mean age: 46.2 years; 66.7% female) included CD interviews. total, 80 symptom concepts 61 impact identified. After three waves of interviews, 31‐item Symptoms Impacts Questionnaire (SIQ‐CD) was developed. UC phase, 53 interviewed 41.4 49.1% female). 79 symptoms 49 Following two 29‐item (SIQ‐UC) Both instruments include four six domains. Conclusions We developed PROs claims. Psychometric validation studies evaluate reliability responsiveness are ongoing.