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

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.

Introduction

Ulcerative colitis (UC) is a chronic, idiopathic inflammatory bowel disease (IBD) affecting the large intestine, characterized by mucosal inflammation in the colon.^1,2 Patients with UC experience relapsing and remitting periods of disease activity. Major symptoms of UC include diarrhea, blood in stool, bowel urgency, and abdominal pain.^1,2 These symptoms, among other physical and psychological symptoms, impose substantial disease burdens on patients and can result in considerable reductions in overall quality of life.^3,4 The primary goals of treatment are to induce symptomatic and endoscopic remission, prevent relapse, and improve quality of life.^2,5 Despite advances of multiple therapeutics for treatment of UC, therapy may be suboptimal to achieve these goals leading to ongoing symptoms and quality-of-life impairment.^6,7

As UC is a chronic condition, patients require long-term care and are regularly assessed to monitor both clinical and endoscopic remission. Adherence to treatment is vital to ensure sustained remission.⁸ Good communication between health care professionals (HCPs) and patients optimizes patient health outcomes^9,10 and has been linked with better treatment adherence in IBD.¹¹ Recent studies have reported discrepancies between patients and HCP views on symptom burden and that HCPs often fail to recognize key issues that are important to patients.^12-15 For example, patients identify bowel urgency as a symptom with considerable negative impact on quality of life.^12,16 Notably, patients often feel uncomfortable discussing this symptom with their HCP,¹⁷ and HCPs do not typically prioritize this symptom.^12,16

To date, qualitative studies have shed light on patients’ experiences of UC symptoms, HCPs’ perceptions on the impact and burden of UC symptoms, and gaps in HCP–patient communication^12,13,17-19; however, misalignments continue to exist. Determining whether these misalignments are global is important, as well as assessing the experience and impact of important symptoms of interest (such as bowel urgency) on patients’ daily lives.

The aims of the The Communicating Needs and Features of IBD Experiences (CONFIDE) study aimed to study were to understand the experience and impact of symptoms on patients’ lives and the relevance of these symptoms for treatment-related decisions and to elucidate communication gaps between HCPs and patients. We report CONFIDE study results from patients with moderate-to-severe UC and HCPs in the United States and Europe (France, Germany, Italy, Spain, and the United Kingdom).

Methods

The CONFIDE study comprised 2 online, quantitative, cross-sectional surveys: one for patients with UC or Crohn’s disease (CD) and another for prescribing HCPs managing UC and CD (see Supplementary Appendix A). The surveys were completed by patients and HCPs from the United States, Japan, and 5 European countries (France, Germany, Italy, Spain, and the United Kingdom). This article includes results from patients with UC and prescribing HCPs managing UC from the United States and Europe.

Survey Development, Recruitment, and Participants

The surveys were designed and run by Adelphi Real World, in partnership with Eli Lilly and Company. The surveys were codeveloped with patients with UC and CD and a panel of gastroenterologists, from a range of countries, with expertise in IBD patient-reported outcomes, extensive clinical IBD experience, and/or experience related to IBD surveys. Surveys were piloted with 2 gastroenterologists and 2 patients (1 patient with UC and 1 with CD) in both the United States and United Kingdom. Surveys were locally translated into the native language and culturally adapted to account for country-specific nuances in question wording for each country.

HCPs as well as patients with moderate-to-severe, self-reported, HCP-diagnosed UC were recruited via online patient panels. The surveys were delivered through email links and hosted on a secure website to facilitate data collection. Patients and HCPs received email links to complete the survey, and links remained live until the sample target was reached. No personally identifiable information was directly captured from the respondents; however, extra steps were taken to ensure that respondents could not be identified via linking data points.

Respondents were screened online to ensure that only relevant patients and HCPs completed the survey. Eligible patients were adults (≥18 years of age) with active disease of at least moderate severity (defined as having received anti-tumor necrosis factor [TNF], anti-integrin, JAK inhibitor, anti-interleukin [IL]-12/23, or immunomodulator treatment within the last 12 months, and/or having received steroid treatment for at least 1 month out of the last 12 months, and/or were hospitalized for at least 4 consecutive weeks in the last 5 years). Patients who had a colectomy were excluded. Additionally, patients with a self-reported HCP diagnosis of concomitant irritable bowel syndrome were restricted to no more than 20% of sample size. Eligible HCPs for completion of the survey were gastroenterologists, IBD nurse specialists (United Kingdom only), internal medicine with gastroenterology (GI) focus, nurse practitioners (United States only), or physician assistants (United States only); had responsibility for making prescribing decisions for at least 10 patients with UC (at least 5 of whom must be patients with moderate-to-severe UC or CD in a month); and spent ≥50% of working time actively seeing patients. To reflect prescribing dynamics, recruitment targets in the United States and United Kingdom aimed to include approximately 15% nurse practitioners/specialists and physician assistants and 85% gastroenterologists. This recruitment target was surpassed in the United Kingdom, and as a result, 31% of UK HCPs were nurse specialists. For completion of the survey, all participants were provided with a nominal honorarium.

Patients and HCPs had to answer every question, for which they were eligible, and there was no option to skip a question. If a patient or HCP did not screen in, or elected not to continue, then the survey ended. Only responses from completed surveys were included.

Advanced therapy included adalimumab (including biosimilars), infliximab (including biosimilars), golimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, and tofacitinib.

Survey Content

Data were collected via structured online surveys of approximately 30 minutes in duration. The first section of both the patient and HCP surveys collected demographic information. Additionally, the surveys included questions that examined the experience, impact, and burden of UC-related symptoms on patients’ lives and the perception of symptoms on their quality of life, productivity, and psychological and social health of patients with UC and that identified gaps and barriers in HCP–patient communication (see Supplementary Appendix A).

To identify symptoms experienced by patients in the past month and ever, patients were asked to select from a list of 30 symptoms: (1) which symptoms they currently experienced (that is suffered from in the last month) and (2) which symptoms they ever experienced (ever suffered from). From symptoms reported as ever experienced, patients ranked those with the greatest impact from 1 to 5 (in which 1 was the most impactful, 2 was the second most impactful, etc.). HCPs ranked the most common symptoms reported by patients from 1 to 3 (in which 1 was the most reported, 2 was the second most reported, etc.) and, similar to patients, ranked symptoms with the greatest impact from 1 to 5. Patients who reported experiencing bowel urgency in the past month were asked to rate their severity of urgency over the last 3 days on the Urgency Numeric Rating Scale (NRS) (from 0 to 10, in which 0 indicated no urgency and 10 indicated the worst possible urgency).²⁰ Urgency NRS data were not collected for patients who did not report currently experiencing bowel urgency. Patients rated levels of comfort reporting bowel urgency on a scale of 1 to 7 (in which 1 indicated “not at all comfortable” and 7 indicated “completely comfortable”), and scores ≤4 represent “not feeling comfortable.”

Statistical Analysis

Because this was a descriptive study, formal sample size estimations were not performed. A sample size of approximately 200 patients from the United States (US) and 100 patients from each European country was recruited to allow descriptive analysis at global and regional levels. Similarly for HCPs, a sample size of approximately 200 US HCPs and 100 HCPs from each European country was surveyed.

Data were summarized using descriptive statistics: categorical variables were presented as number of observations (HCPs or patients), frequency, and percentage; ordinal variables as frequencies and percentages; and continuous variables (eg, age, time since diagnosis, and questions with NRS responses) as number of observations (HCPs or patients), means/medians, and standard deviations. Analysis of variance was used to compare severity of urgency between groups (those who needed to get to the bathroom within 5 minutes vs those who were able to defer bowel movements for more than 5 minutes).^16,21 A P value of <.05 was considered significant.

Ethical Considerations

All participants provided informed consent to participate in the study. The protocol and supporting data collection materials were approved by the Western Institutional Review Board. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Pharmacoepidemiology Practices and applicable laws and regulations of the countries where the study is being conducted, as appropriate.

Results

Demographics and Characteristics

Of the 18 002 patients who were contacted, surveys were completed by 200 US and 556 European patients (France: n = 100, Germany: n = 98, Italy: n = 161, Spain: n = 90, United Kingdom: n = 107) between July 1, 2021, and September 9, 2021. The remainder either did not meet the eligibility criteria or did not consent to participate. Key patient demographics and characteristics are reported in Table 1. The mean age of US and European patients was 40.4 and 38.9 years, respectively; and 61.5% and 57.4% of US and European patients, respectively, were male. The most common UC treatments that both US and European patients currently received were anti-TNF biologic therapy (46.5% and 54.1%, respectively) and corticosteroids (40.5% and 62.4%, respectively); 76.5% and 54.1% of US and European patients, respectively, were receiving advanced therapy.

A total of 840 HCPs were contacted, of which, 200 US and 503 European HCPs (France: n = 101, Germany: n = 101, Italy: n = 101, Spain: n = 100, United Kingdom: n = 100) completed the surveys between May 28, 2021, and October 2, 2021. The remainder either did not meet the eligibility criteria or did not consent to participate. Key HCP demographics and characteristics are reported in Table 1. Overall, the majority of US and European HCPs surveyed were male (78.0% and 70.8%) and gastroenterologists (88.0% and 93.2%). US HCPs included nurse practitioners (5.5%) and physician assistants (5.5%), while UK HCPs included IBD nurse specialists (31.0%).

Key demographics and characteristics of patients and HCPs in each European country are reported in Supplementary Table 1.

Patient and HCP Perceptions on UC Symptoms

The symptoms most commonly experienced in the last month (prior to survey completion) by US and European patients were diarrhea (62.5% and 50.2%, respectively), bowel urgency (47.0% and 29.7%, respectively), and increased stool frequency (38.5% and 29.5%, respectively) (Figure 1A). Patients receiving advanced therapy (United States: n = 153; Europe: n = 301) also reported these 3 symptoms as the most commonly experienced in the last month. Similarly, the symptoms most commonly experienced ever were diarrhea (74.0% and 67.1%), bowel urgency (61.5% and 45.0%), and increased stool frequency (57.5% and 46.0%) for US and European patients, respectively. The top symptoms commonly experienced by patients in each European country in the last month are shown in Supplementary Figure 1A.

HCPs ranked the symptoms most reported by patients; both US and European HCPs ranked diarrhea (73.5% and 65.0%, respectively), blood in stool (69.0% and 64.9%, respectively), and increased stool frequency (37.5% and 33.9%, respectively) as the 3 most common symptoms reported by patients (Figure 1B). A total of 24.0% of US HCPs and 29.8% of European HCPs ranked bowel urgency among the top 3 most reported symptoms. The most common symptoms reported by patients according to HCPs in each European country are shown in Supplementary Figure 1B.

According to both US and European patients, respectively, the 5 symptoms with the greatest impact were bowel urgency (78.0% and 74.8%), diarrhea (73.0% and 79.9%), bowel urgency–related accidents (63.3% and 65.1%), increased stool frequency (57.4% and 69.5%), and persistent abdominal pain (53.9% and 66.0%) (Figure 1C). Similar to patients, US and European HCPs, respectively, reported diarrhea (73.5% and 74.0%), bowel urgency (54.0% and 57.6%), increased stool frequency (47.0% and 44.2%), and bowel urgency–related accidents (45.5% and 39.6%) as 4 of the most impactful symptoms (Figure 1D). However, while 76.5% of US and 71.0% of European HCPs ranked blood in stool as having the greatest impact on patients, fewer patients ranked this symptom as having the greatest impact (49.9% and 58.2%, respectively). Furthermore, persistent abdominal pain was ranked more impactful by patients than HCPs. Symptoms with the greatest impact reported by patients and HCPs in each European country are shown in Supplementary Figure 1C, D.

Experience of Bowel Urgency

When asked about deferral time (a measure of the urgency patients experience before bowel movements) in the last 3 days, approximately one-third of all patients reported that they could not defer defecation for more than 5 minutes, while 3.0% and 2.5% of all US and European patients, respectively, reported sometimes not being able to make it to the bathroom in time (Figure 2A). Patients who experienced bowel urgency in the past month were less able to defer their bowel movements (Figure 2B). Most patients experiencing bowel urgency (in the last month) rated its severity as 6 out of 10 or higher using the Urgency NRS; mean Urgency NRS scores were similar among US and European patients (6.9 vs 6.8 out of 10) (Figure 2C). Patients from Spain reported the highest mean Urgency NRS rating from European countries (7.4 out of 10) (Supplementary Table 2). Among patients who experienced bowel urgency in the last month, mean Urgency NRS scores were higher among those that reported shorter defecation deferral times (Figure 2D). Severity of bowel urgency was significantly higher in those who needed to get to the bathroom within 5 minutes than in those who were able to defer bowel movements for more than 5 minutes (United States: 7.9 vs 6.4; P < .001; Europe: 7.2 vs 6.5; P = .02). Among patients who reported ever experiencing bowel urgency (United States: n = 123; Europe: n = 250), 78.9% of US and 70.8% European patients reported doing so at least once a week over the past 3 months (Figure 2E). Among patients receiving advanced therapy and those who had ever experienced bowel urgency (United States: n = 91; Europe: n = 126), the proportion of US and European patients who reported experiencing bowel urgency at least once a week in the past 3 months was similar (80.2% and 73.9%, respectively). Supplementary Table 2 shows deferral of defecation times, Urgency NRS scores, and the frequency of bowel urgency among patients in each European country.

Use of Diaper/Pad/Protection and Avoidance of Activities

Patients were asked if, in the past 3 months, they wore a diaper/pad/other protection due to fear or anticipation of fecal urge incontinence (ie, bowel urgency–related accidents in which patients cannot make it to the bathroom in time). A total of 45.0% of US and 37.0% of European patients reported wearing a diaper/pad/protection at least once a week in the past 3 months due to fear/anticipation of fecal urge incontinence (Figure 3A). Within European countries, weekly use of diaper/pad/protection was highest in France (53.0%) and lowest in Germany (26.6%) (Supplementary Table 3). Among patients receiving advanced therapy (United States: n = 153; Europe: n = 301), 47.1% of US and 38.3% of European patients reported wearing a diaper/pad/protection at least once a week in the past 3 months due to fear or anticipation of fecal urge incontinence.

When asked about the impact of UC on patients’ work/school life, social life, and their ability to participate in sports/physical exercise in the last 3 months, the most common reasons for declining participation in each activity among both US and European patients were bowel urgency and fear of bowel urgency–related accidents (Table 2). Of the patients who had ever experienced bowel urgency, 78.0% of US and 77.2% of European patients reported that it negatively affected work or school (Figure 3B). Supplementary Figure 2 shows the top reasons patients in each European country declined participation in work/school, social events, and sports/physical exercise.

HCP–Patient Communication

Over 30% of US patients and 40% of European patients do not feel comfortable discussing bowel urgency with their HCP (Figure 3C). The most common reason was due to feeling embarrassed to do so (Figure 3D and Supplementary Figure 3). Compared with European patients, a greater proportion of US patients discuss bowel urgency with their HCP at every appointment (Figure 3E). About three-quarters of both US and European patients (of those that do not discuss this symptom with their HCP) said that they would like to discuss it more frequently with their HCP (Figure 3F).

According to US and European HCPs, respectively, the top 4 symptoms proactively discussed by the HCP in routine appointments were blood in stool (92.5% and 93.6%), diarrhea (89.5% and 90.9%), increased stool frequency (81.5% and 81.9%), and bowel urgency (75.5% and 82.1%) (Figure 3G). Among HCPs who did not proactively discuss bowel urgency at a routine appointment, 46.9% of US and 40.0% of European HCPs expect patients to bring this up if it is an issue (Figure 3H).

A higher proportion of patients in Italy were not comfortable discussing bowel urgency with their HCP compared with patients in other European countries; across each European country, the most common reason for not feeling comfortable discussing bowel urgency was due to being embarrassed (Supplementary Figure 3). Supplementary Figure 3E and F shows the HCP-reported most common symptoms proactively discussed at a routine appointment and the reasons that HCPs say that they do not discuss bowel urgency at routine appointments.

Most Impactful Symptoms on Treatment Decisions

HCPs were asked to rank the 3 most impactful symptoms on their treatment decisions. Both US and European HCPs, respectively, ranked blood in stool (73.5% and 77.1%), diarrhea (68.0% and 61.3%), and increased stool frequency (36.0% and 34.5%) as most impactful (Figure 3I). While over half of US and European HCPs (54.0% and 57.6%, respectively) ranked bowel urgency as 1 of the top 5 symptoms affecting patient lives (Figure 1D), only 21.5% and 22.2% of US and European HCPs, respectively, ranked it within the top 3 most impactful symptoms on treatment decisions (Figure 3I). Supplementary Figure 4 shows the most impactful symptoms on treatment decisions according to European HCPs.

Discussion

The CONFIDE study provides insight into the perspectives of patients with moderate-to-severe UC on the experience, impact, and burden of UC symptoms. Most strikingly, 45.0% of US and 37.0% of European patients with moderate-to-severe UC had worn diapers/pads/other protection due to fear or anticipation of fecal urge incontinence at least once a week in the past 3 months. In those being treated with advanced therapies, that figure was 47.1% for US and 38.3% for European patients.

The CONFIDE study also documented the perspectives of prescribing HCPs on UC symptoms, symptom impact on patients, and symptom influence on treatment-related decision making. The study, performed in an era in which multiple therapeutic options are available, uncovered novel findings on the ongoing daily burden of UC symptoms on patients’ lives as well as discrepancies in patient–HCP perceptions on the impact of symptoms.

Patients identified bowel urgency as a particularly bothersome UC symptom, consistent with previous studies.^17,19,22,23 Both US and European patients reported bowel urgency in the top 3 most common symptoms in the last month, along with diarrhea and increased stool frequency. In addition, bowel urgency was one of the top symptoms with greatest impact. Given the high proportion of patients receiving steroids or advanced therapy, these findings highlight the substantial impact of bowel urgency. Bowel urgency–related accidents had a very high impact, as might be expected, but it was the fear of such urgency-related accidents that affected activities. Almost half of US patients and over one-third of European patients reported wearing a diaper/pad/protection at least once a week in the past 3 months due to fear or anticipation of fecal urge incontinence. Studies have shown that fear of fecal urge incontinence has extensive emotional and psychological effects on patients with IBD. The unpredictable and urgent nature of defecation, as well as any uncertainty over access to facilities, may increase the fear of having bowel accidents in public and may be as limiting as actual incontinence.²⁴ The fact that, in the last 3 days, approximately 30% of US and European patients had to get to a bathroom within 5 minutes or were unable to make it to the bathroom in time, further emphasizes the burden of bowel urgency. Taken together, these findings illustrate the extent that bowel urgency and fecal urge incontinence affect patients’ lives. The frequent use of diaper/pad/other protection is particularly disconcerting considering the young mean age of the patient population and the high percentage of patients receiving advanced therapy. This study is one of the first to examine diaper/pad/other protection use among patients with UC. It identifies another disease burden experienced by this population and underlines the need to address bowel urgency in order to improve patients’ quality of life. Additional studies are necessary to investigate HCP–patient communication gaps related to diaper/pad/protection use among patients, as this may help to understand and potentially manage the impact of UC.

According to HCPs, bowel urgency is reported by patients less often and has less impact on both patients and treatment decisions, compared with other symptoms such as blood in stool. These results highlight a gap in HCP–patient perceptions of UC and are consistent with other studies.^12,17

The results show that UC has wide-ranging effects on multiple aspects of patients’ lives. Most patients reported declining participation in work/school, social events, and sports/physical exercise due to their UC, consistent with previous studies.^25-28 The CONFIDE study has shown that bowel urgency and fear of bowel urgency–related accidents were among the top 3 reasons that made patients avoid such activities. Importantly, blood in stool, the symptom with the greatest impact on patients according to HCPs, was not among the top reasons that patients avoided such activities. Furthermore, over three-quarters of patients who had ever experienced bowel urgency reported that bowel urgency negatively affected their work or school lives, supporting the evidence that IBD restricts patients from reaching their full potential.^24,29 It has been shown that bowel urgency increases the risk of social impairment, depression, and anxiety in patients with UC,²⁸ and that absence of bowel urgency in patients is strongly associated with improvement in quality of life.³⁰ Thus, HCPs need to recognize bowel urgency and fear of bowel urgency–related accidents as important factors in UC management.

Of the patients who experienced bowel urgency, fewer than half of US patients and even fewer European patients discuss this symptom with their HCP at every appointment, and most of those who do not discuss this symptom wish to do so. Conversely, over three-quarters of HCPs report discussing bowel urgency during routine appointments. This clearly does not match patient perception. Both US and European patients reported feeling embarrassed as the main reason for not being comfortable discussing bowel urgency, while for HCPs, the main reason for not discussing this symptom was due to the expectation that patients would bring it up themselves if it was an issue. Assessment of bowel urgency is not part of activity indices most commonly used in clinical trials and in the past has been overlooked in relation to treatment goals.³¹ However, recently, there has been increased acknowledgment of the importance of recognizing the impact of bowel urgency as evidenced by its inclusion in UC diagnosis and measures of remission,² in defining severity of disease activity,³² and in UC guidelines.^2,33,34 Nevertheless, it is vital to confront these gaps and barriers in HCP–patient communication and to routinely discuss bowel urgency in addition to symptoms such as blood in stool and stool frequency.

In general, results across US and European patients and HCPs were similar. The impact and frequency of symptoms, in particular a patient’s experience of bowel urgency, were remarkably similar across both populations. However, while marked differences exist, it is important to consider differences in both lifestyle and access to supportive care between US and European patients. Key patient differences from the survey included fewer European patients discussing bowel urgency with their HCP at every appointment and more European patients reporting not feeling comfortable discussing bowel urgency. Furthermore, a larger percentage of European patients reported multiple negative consequences of bowel urgency on work/school. This finding may be influenced by different work and school environments in the United States and in European countries. The survey findings across the 2 regions are generalizable, and both require approaches to address misalignments.

Survey responses from patients and HCPs across European countries were generally comparable, but clear differences exist. First, bowel urgency was among the top 3 most reported symptoms experienced in the past month among patients from Germany, Italy, and the United Kingdom, but it was the fourth most common symptom among patients from France, and fifth among patients from Spain. Interestingly, among HCPs from Italy, the top 3 HCP-perceived most common symptom reported by patients included bowel urgency, indicating greater awareness of this symptom by HCPs in Italy. Results on the experience of bowel urgency among patients in each European country showed that more patients from France, Italy, and Spain reported the need to get to a bathroom within 5 to 15 minutes. Similarly, mean Urgency NRS scores were higher for patients in these countries.

This study had several limitations. First, eligibility of patients, diagnosis of concomitant irritable bowel syndrome, and survey responses were self-reported and consisted primarily of their retrospective assessment, potentially resulting in recall bias and adversely affecting data reliability. Second, because only the patients who completed the survey were included, the results might have been biased to inclusion of patients who are more active in managing their disease and communicating with HCPs. Third, participation was influenced by willingness to complete the survey, so patient participants may not reflect the general population with moderate-to-severe UC. On the other hand, the frequency with which diaper/pads/other protection are used by a large proportion of patients with UC, even those on advanced therapies, has been identified and might become a simple metric for assessing the quality of care. Fourth, the study population included elderly patients (>65 years of age; United States: n = 10 [5%]; Europe: n = 4 [0.7%]). As the elderly patients may experience age-related anal sphincter dysfunction, it may have a confounding effect on the interpretation of results. Fifth, back-translations of the surveys were not performed. However, translations were performed by a translation agency and validated by native speakers with a specialty in the medical field by comparing with the original English version. Last, this study is limited to patients with moderate-to-severe UC; therefore, the results may not represent the full UC population.

Conclusions

Despite the introduction of multiple advanced therapies, many patients are still experiencing symptoms that are significantly affecting their quality of life. This study underscores the impact of bowel urgency on everyday life of patients with moderate-to-severe UC. Bowel urgency and the fears associated with this symptom are not well explored by HCPs. There is an urgent need to enhance patient–HCP communication and to address bowel urgency in order to improve patient outcomes.

Supplementary data

Supplementary data is available at Inflammatory Bowel Diseases online.

Acknowledgments

The authors thank the survey respondents for their participation in this study. The authors also thank Angela O’Sullivan, PhD, and employee of Eli Lilly and Company for medical writing and project management support. Sonal Saxena, PhD, an employee of Eli Lilly Services India Pvt Ltd, helped in addressing the journal’s peer review comments in collaboration with authors.

Author Contributions

A.P.B., C.K., C.S., and T.H.G. contributed to conception, design, and interpretation of data. M.C.D., D.R., E.J.F., R.P., S.T., S.S., and T.H. contributed to design and interpretation of data. CA contributed to design, acquisition, and interpretation of data. A.P.B., T.H., and C.S. were involved in data analyses. All the authors were involved in critical revision of the intellectual content.

Funding

This study was sponsored by Eli Lilly and Company.

Conflict of Interest

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.

References