@article{4f1e0d5a81df496c8bea165632239ec2,
title = "Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis",
abstract = "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 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). Methods: Concept 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. Results: In 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. Conclusions: We developed PROs to support CD and UC drug labelling claims. Psychometric validation studies to evaluate instrument reliability and responsiveness are ongoing.",
author = "Dulai, {Parambir S.} and Vipul Jairath and Reena Khanna and Christopher Ma and McCarrier, {Kelly P.} and Martin, {Mona L.} and Parker, {Claire E.} and Joan Morris and Feagan, {Brian G.} and Sandborn, {William J.}",
note = "Funding Information: : PD has received consulting fees and research support from Takeda, AbbVie, Janssen, Pfizer, Polymedco and Bulhmann. VJ has received consulting fees from AbbVie, Takeda, Eli Lilly, Pfizer, Janssen, Ferring, Shire, Merck, GSK, Celltrion and Robarts Clinical Trials Inc; serves as an advisory board member for AbbVie, Takeda, Janssen, Arena, GSK, Eli Lilly and Ferring; has received speakers' bureau fees from Takeda, AbbVie, Janssen, Pfizer, Shire and Ferring. RK has received scientific advisory board fees from AbbVie, Janssen, Pfizer and Takeda; consulting fees from AbbVie, Janssen, Takeda and Robarts Clinical Trials Inc; and payments for lectures/speakers' bureau fees from AbbVie, Janssen, Shire and Takeda. CM has received scientific advisory board fees from AbbVie, Janssen, Pfizer and Takeda; consulting fees from Robarts Clinical Trials, Inc; and payment for lectures/speakers' bureau fees from AbbVie, Janssen, Pfizer and Takeda. KPM was an employee of Health Research Associates (HRA) at the time the work was conducted. HRA received contract research funding from Robarts Clinical Trials Inc to conduct the studies detailed in this manuscript. MM was an employee of Health Research Associates (HRA) at the time the work was conducted. HRA received contract research funding from Robarts Clinical Trials Inc to conduct the studies detailed in this manuscript. CEP is an employee of Robarts Clinical Trials, Inc JM is an employee of Robarts Clinical Trials, Inc BGF has received grant/research support from AbbVie Inc, Amgen Inc, AstraZeneca/MedImmune Ltd., Atlantic Pharmaceuticals Ltd., Boehringer‐Ingelheim, Celgene Corporation, Celltech, Genentech Inc/Hoffmann‐La Roche Ltd., Gilead Sciences Inc, GlaxoSmithKline (GSK), Janssen Research & Development LLC., Pfizer Inc, Receptos Inc/Celgene International, Sanofi, Santarus Inc, Takeda Development Center Americas Inc, Tillotts Pharma AG, and UCB; consulting fees from Abbott/AbbVie, Akebia Therapeutics, Allergan, Amgen, Applied Molecular Transport Inc, Aptevo Therapeutics, Astra Zeneca, Atlantic Pharma, Avir Pharma, Biogen Idec, BioMx Israel, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, Galapagos, GiCare Pharma, Gilead, Gossamer Pharma, GSK, Inception IBD Inc, JnJ/Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nestle, Nextbiotix, Novonordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, Receptos, Salix Pharma, Shire, Sienna Biologics, Sigmoid Pharma, Sterna Biologicals, Synergy Pharma Inc, Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Vivelix Pharma, VHsquared Ltd., and Zyngenia; speakers bureau fees from Abbott/AbbVie, JnJ/Janssen, Lilly, Takeda, Tillotts, and UCB Pharma; is a scientific advisory board member for Abbott/AbbVie, Allergan, Amgen, Astra Zeneca, Atlantic Pharma, Avaxia Biologics Inc, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Celgene, Centocor Inc, Elan/Biogen, Galapagos, Genentech/Roche, JnJ/Janssen, Merck, Nestle, Novartis, Novonordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Sterna Biologicals, Takeda, Teva, TiGenix, Tillotts Pharma AG, and UCB Pharma; and is the Senior Scientific Officer of Robarts Clinical Trials Inc WJS has received research grant support from Atlantic Healthcare Limited, Amgen, Genentech, Gilead Sciences, AbbVie, Janssen, Takeda, Lilly and Celgene/Receptos; consulting fees from AbbVie, Allergan, Amgen, Boehringer Ingelheim, Celgene, Conatus, Cosmo, Escalier Biosciences, Ferring, Genentech, Gilead, Gossamer Bio, Janssen, Lilly, Miraca Life Sciences, Nivalis Therapeutics, Novartis Nutrition Science Partners, Oppilan Pharma, Otsuka, Paul Hastings, Pfizer, Precision IBD, Progenity, Prometheus Laboratories, Ritter Pharmaceuticals, Robarts Clinical Trials Inc (owned by Health Academic Research Trust or HART), Salix, Shire, Seres Therapeutics, Sigmoid Biotechnologies, Takeda, TiGenix, Tillotts Pharma, UCB Pharma, and Vivelix; and stock options from Ritter Pharmaceuticals, Oppilan Pharma, Escalier Biosciences, Gossamer Bio, Precision IBD, and Progenity. Declaration of personal interests Publisher Copyright: {\textcopyright} 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd",
year = "2020",
month = jun,
day = "1",
doi = "10.1111/apt.15726",
language = "English (US)",
volume = "51",
pages = "1047--1066",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "11",
}