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. 2024 Jun 3;30(6):939-949.
doi: 10.1093/ibd/izad142.

The Communicating Needs and Features of IBD Experiences (CONFIDE) Study: US and European Patient and Health Care Professional Perceptions of the Experience and Impact of Symptoms of Moderate-to-Severe Ulcerative Colitis

Simon Travis  1 , Alison Potts Bleakman  2 , Marla C Dubinsky  3 , Stefan Schreiber  4 , Remo Panaccione  5 , Toshifumi Hibi  6 , Theresa Hunter Gibble  2 , Cem Kayhan  2 , Christian Atkinson  7 , Christophe Sapin  2 , Eoin J Flynn  2 , David T Rubin  8
Affiliations

The Communicating Needs and Features of IBD Experiences (CONFIDE) Study: US and European Patient and Health Care Professional Perceptions of the Experience and Impact of Symptoms of Moderate-to-Severe Ulcerative Colitis

Simon Travis et al. Inflamm Bowel Dis. .

Abstract

Background: The Communicating Needs and Features of IBD Experiences (CONFIDE) study aimed to evaluate the experience and impact of ulcerative colitis (UC) symptoms on patients' lives and elucidate gaps in communication between patients and health care professionals (HCPs).

Methods: Online, quantitative, cross-sectional surveys of patients with moderate-to-severe UC and HCPs responsible for making prescribing decisions were conducted in the United States (US) and Europe. UC disease severity was defined by treatment, steroid use, and/or hospitalization history.

Results: Surveys were completed by 200 US and 556 European patients and 200 US and 503 European HCPs. The most common UC symptoms experienced in the preceding month were diarrhea, bowel urgency, and increased stool frequency. Many patients (45.0% of US patients, 37.0% of European patients) reported wearing diapers/pads/protection at least once a week in the past 3 months due to fear/anticipation of fecal urge incontinence. The top reasons for declining participation in social events, work/school, and sports/exercise were due to bowel urgency and fear of fecal urge incontinence. HCPs ranked diarrhea, blood in stool, and increased stool frequency as the most common symptoms. While over half HCPs ranked bowel urgency as a top symptom affecting patients' lives, less than a quarter ranked it in the top 3 most impactful on treatment decisions.

Conclusions: Similar disparities exist between patient and HCP perceptions in the United States and Europe on the experience and impact of UC symptoms. Bowel urgency has a substantial and similar impact on US and European patients, is underappreciated by HCPs, and should be addressed during routine appointments.

Keywords: quality of life; symptom burden; ulcerative colitis.

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Conflict of interest statement

S.T. has received grants/research support from AbbVie, Buhlmann, Celgene, the European Crohn’s and Colitis Organisation, the Helmsley Trust, the International Organization for the Study of Infammatory Bowel Diseases, Janssen, Lilly, Pfizer, Takeda, UCB, UKIERI, Vifor, and the Norman Collisson Foundation; consulting fees from Abacus, AbbVie, Actial, ai4gi, Alcimed, Allergan, Amgen, Arena, Asahi, Astellas, Atlantic, AstraZeneca, Barco, Biocare, Biogen, BLPharma, Boehringer Ingelheim, Bristol-Myers Squibb, Buhlmann, Calcico, Celgene, Cellerix, Cerimon, ChemoCentryx, Chiesi, CisBio, ComCast, Coronado, Cosmo, Ducentis, Dynavax, Elan, Enterome, EQrX, Equillium, Falk, Ferring, FPRT Bio, Galapagos, Genentech/Roche, Genzyme, Gilead, Glenmark, Grunenthal, GlaxoSmithKline, GW Pharmaceuticals, Immunocore, Immunometabolism, Indigo, Janssen, Lexicon, Lilly, Medarex, Medarex, Medtrix, Merck, Merrimack, Mestag, Millennium, Neovasc, Novartis, Novo Nordisk, NPS-Nycomed, Ocera, Optima, Otsuka, Palau, Pentax, Pfizer, Pharmaventure, Phesi, Philips, Procter & Gamble, Pronota, Proximagen, Resolute, Robarts, Sandoz, Santarus, Satisfai, Sensyne Health, Shire, SigmoidPharma, Sorriso, Souffinez, SynDermix, Synthon, Takeda, Theravance, TiGenix, Tillotts, Topivert, Trino Therapeutics with Wellcome Trust, TxCell, UCB Pharma, Vertex, VHsquared, Vifor, Warner Chilcott, and Zeria; and speaker fees from AbbVie, Amgen, Biogen, BMS, Falk, Ferring, Janssen, Lilly, Pfizer, Shire, Takeda, and UCB. A.P.B., T.H.G., C.K., C.S., and E.J.F. are employees and shareholders of Eli Lilly and Company. M.C.D. has received consulting fees from AbbVie Inc, Arena Pharmaceuticals, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Celgene Corporation, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Genentech, Gilead, Janssen Global Services, Pfizer Inc, Prometheus Biosciences, Takeda Pharmaceuticals USA, and UCB SA; has conducted contracted research for AbbVie Inc, Janssen Global Services, LLC, Pfizer Inc, and Prometheus Biosciences; has ownership interest in Trellus Health Inc; and has licensing fees from Takeda Pharmaceuticals USA, Inc. S.S. has received consulting fees from AbbVie, Arena, BMS, Biogen, IMAB, Lilly, Mylan, Portagonist, Takeda, Celltrion, Fresenius, Galapagos, Gilead, Janssen, MSD, Pfizer, Provention Bio, and Theravance; received payment for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Arena, BMS, Biogen, Celltrion, Falk, Fresenius, Galapagos, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Takeda, and Theravance; and participated on a Data Safety Monitoring Board or advisory board for Novartis. R.P. has received grants from AbbVie, Janssen, Pfizer, and Takeda Pharmaceuticals; received consulting fees from AbbVie, Abbott, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pandion, Pharma, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Satisfai Health, Sandoz, Schering-Plough, Shire, Sublimity Therapeutics, Theravance Biopharma, UCB, and Takeda Pharmaceuticals; received research or educational support from AbbVie, Ferring, Janssen, Pfizer, Takeda; served on advisory boards for AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Sandoz, Shire, Sublimity Therapeutics, Theravance Biopharma, and Takeda Pharmaceuticals; and received speaker fees from AbbVie, Arena Pharmaceuticals, Celgene, Eli Lilly, Ferring, Gilead Sciences, Janssen, Merck, Pfizer, Roche, Sandoz, Shire, and Takeda Pharmaceuticals. T.H. has received grants or contracts from AbbVie GK, JIMRO, Misubishi-TanabePharma, Mochida Pharmaceutical, Takeda Pharmaceutical, Zeria Pharmaceutical, Kyorin, Otuska Holdings, MIYARISAN Pharmaceutical, and Alfresa Pharma Corporation; consulting fees from Apo Puls Station, AbbVie GK, Bristol-Myers Squibb, EA Pharma, Eli Lilly, Gilead Sciences, Janssen, Mitsubishi-TanabePharma, Nichi-IkoPharmaceutical, Pfizer, Takeda Pharmaceutical, and Zeria Pharmaceutical; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Sondoz K.K., AbbVie GK, Gilead Sciences, Janssen, Mitsubishi-TanabePharma, Mochida Pharmaceutical, Pfizer, Takeda Pharmaceutical, Zeria Pharmaceutical, EA Pharma, Kyorin, and JIMRO. CA is an employee of Adelphi Real World. D.T.R. has received grants or contracts from Takeda; has received consulting fees from AbbVie, Alimentiv Inc, Altrubio, Arena Pharmaceuticals, Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim Ltd, Bristol-Myers Squibb, Celgene Corp/Syneos, ClostraBio, Connect BioPharma, Datos Health Ltd, EcoR1, Evinature Ltd, Genentech/Roche, Gilead Sciences, Ironwood Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Kaleido Biosciences, Lilly, Pfizer, Prometheus Biosciences, Reistone Biopharma, Seres Therapeutics, Takeda, Target RWE, Techlab Inc, and Trellus Health; and owns stock options from Altrubio and Datos Health.

Figures

Figure 1.
Figure 1.
Patient and health care professional (HCP) perceptions on ulcerative colitis (UC) symptoms in the United States (US) and Europe (EUR). (A) The top 3 symptoms experienced by patients in the last month. Patients were asked which symptoms they currently experience (that is suffered from in the last month). Symptoms were selected from a list of 30 options. (B) The top 3 HCP-perceived most common symptoms reported by patients. HCPs were asked to rank the top 3 symptoms most reported by patients. (C) Patient-reported symptoms with the greatest impact (of symptoms ever experienced). Patients were asked to rank the 5 symptoms that have the greatest impact. (D) HCP-perceived symptoms with the greatest impact on patients. HCPs were asked to rank the top 5 symptoms with the greatest impact on patients.
Figure 2.
Figure 2.
Patient experience of bowel urgency. (A) Patients’ deferral time in last 3 days. Patients were asked how much urgency they had before bowel movements over the last 3 days. (B) Patients’ deferral time over the last 3 days in patients who experienced or did not experience bowel urgency in the past month among United States (US) and European (EUR) patients. (C) Urgency Numeric Rating Scale (NRS). Patients experiencing bowel urgency in the last month rated their urgency (sudden or immediate need) to have a bowel movement in the last 3 days (from 0 [no urgency] to 10 [worst possible urgency]). (D) Mean severity of urgency before bowel movement by deferral time over the last 3 days among patients experiencing bowel urgency in the past month. (E) Frequency of bowel urgency in the past 3 months among patients that reported ever experiencing bowel urgency.
Figure 3.
Figure 3.
Impacts of bowel urgency on daily lives of patients and health care professional (HCP)–patient communication in the United States (US) and Europe (EUR). (A) Frequency of diaper/pad/other protection use due to fear/anticipation of fecal urge incontinence. (B) The impact of experiencing bowel urgency on work/school (among patients who ever experienced bowel urgency). (C) Percentages of patient not comfortable discussing bowel urgency with their HCP, whereby patients rated how comfortable they are at reporting bowel urgency to their HCP on a scale of 1 (not at all comfortable) to 7 (completely comfortable); patients with scores ≤4 are shown. (D) Reasons for patients feeling uncomfortable reporting bowel urgency to HCPs. (E) Percentages of patients (who have experienced bowel urgency in the past month) that discuss bowel urgency at every appointment. (F) Percentages of patients (who do not discuss bowel urgency at every appointment) who would like to discuss bowel urgency more frequently with their HCP. (G) HCP-reported symptoms proactively discussed at a routine appointment. (H) Reasons for HCPs not proactively discussing bowel urgency in routine appointments. (I) HCP-perceived most impactful symptoms on treatment decisions. HCPs were asked to choose from a list of possible symptoms the top 3 most impactful on treatment decisions.
See this image and copyright information in PMC

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