BACKGROUND:The impact of inflammatory bowel disease (IBD) on caregivers has rarely been investigated. Our work aims to explore the burden of IBD on the different aspects of caregivers' lives. METHODS:We conducted an online survey via the social network of the French IBD patient organization addressed to patients' caregivers who were asked to fill in a questionnaire covering the impact of the disease on different aspects of their lives. Impacts were measured by a visual analog scale (VAS). A VAS score ≥5 of 10 was considered significantly high. We then performed uni- and multivariate analyses of predictors of higher impact on parents and partners, separately. RESULTS:A total of 853 caregivers participated, predominantly women (77%). The mean age was 48.5 years. Their relationship with the patient was mainly parents in 57.1% and partners in 30.6%. The type of IBD was Crohn's disease in 63% and ulcerative colitis in 35%. The psychological burden was the highest among parents and was mainly correlated with a lack of knowledge about IBD and professional compromise (P < .05). The impact on leisure was the highest among partners and was affected by psychological, sexual, and professional burdens (P < .05). About 50% of partners experienced an absent sexual relationship for weeks/months and decreased libido regardless of IBD type. Professional impact was greater in parents compared with partners, and 36% of caregivers needed work arrangements. CONCLUSIONS:IBD has a high impact on different aspects of life of patients' caregivers. Therefore, interventions to reduce the disease burden in this population are needed.

Participatory research, also referred to as patient and public involvement, is an approach that involves collaborating with patients affected by the focus of the research, on the design, development and delivery of research to improve outcomes. There are two broad justifications for this: first, that it enhances the quality and relevance of research, and second, that it satisfies the ethical argument for patient inclusion in decisions about them. This synergistic and collaborative effort, which bridges the divide between researchers and participants with the lived condition, is now a mainstream activity and widely accepted as best practice. Although there has been a substantial increase in the literature over the past two decades, little has been published on how participatory research has been used in inflammatory bowel disease [IBD] research and little guidance as to how researchers should go about this. With an increasing incidence and prevalence worldwide, combined with declining study enrolment in an era of perennial unmet need, there are a multitude of benefits of participatory research to IBD patients and investigators, including research output that is informed and relevant to the real world. A key example of participatory research in IBD is the I-CARE study, a large-scale, pan-European observational study assessing the safety of advanced therapies, which had significant patient involvement throughout the study. In this review, we provide a comprehensive overview of the benefits and challenges of participatory research and discuss opportunities of building strategic alliances between IBD patients, healthcare providers and academics to strengthen research outcomes.

Background: SB5 is an EMA-approved adalimumab biosimilar, having demonstrated bioequivalence, equivalent efficacy, and similar safety and immunogenicity to the reference product.Aims: Describe patient training and satisfaction using patient-reported outcome measures (PROMs) and assess their impact on 12-month persistence on SB5.Methods: The observational PERFUSE study included 318 Crohn's disease (CD) patients and 88 ulcerative colitis (UC) patients in 27 sites across France between October 2018 and December 2020. PROMs were collected at 1-month post-baseline using an online questionnaire (ePRO) designed with patient associations. Treatment persistence was collected during routine visits (up to 15 months post-initiation). Results are presented by prior experience with subcutaneous biologics and training in proper use of the injection device.Results: 57.1% ( n = 145) and 44.1% ( n = 67) of naive and pre-treated patients, respectively, answered the ePRO. Naive patients were offered training more often (86.9% vs 31.3% respectively, p < 0.05), with disparities between sites. All subgroups' satisfaction scores were high. 12-month persistence on SB5 was significantly higher for respondents than for non-respondents (68.0% [60.9; 74.1] vs 52.3% [44.5; 59.6]; p < 0.05) and in patients with a better perception of their illness (OR= 1.02, [1.0; 1.05]; p < 0.05).Conclusions: Early patient questionnaires may be useful to identify patients at higher risk of treatment discontinuation.(c) 2023 The Authors. Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.

Abstract Background Inflammatory Bowel Disease (IBD) has an important impact on patients’ quality of life (QOL). Data on its impact on patients’ close relatives are limited. This study aims at exploring the effect of IBD on patients’ caregivers (PC). Methods We have conducted an online survey about the impact of IBD on PCs via the social network of the French association of IBD patients (Association François Aupetit) between october 16th and november 23rd 2020. The burden the disease had on their psychological, professional and social life was evaluated through a computerized questionnaire. Results Eight hundred and fifty-three PCs aged > 16 years were interrogated. 77% were females. Their relatives had Crohn’s disease (CD) in 63% and Ulcerative colitis (UC) in 35% of cases. Patient was the child in 57% or the partner in 31% of cases. Fifty four percent of PCs had never heard about IBD before the diagnosis of their relatives, and upon disease announcement, 86% experienced a feeling of worry, sadness or anxiety. They were regularly searching informations about the disease through internet websites, IBD associations or health care professionals in 72, 68 and 53% of cases, respectively. Main concerns included novel therapies (55%), treatment side effects (45%), long term disease consequences (52%) and dietary limitations (47%). Twenty percent considered that they were still not well informed about the disease. The most significant impact on daily PCs’ life was psychological as they were regularly experiencing anxiety and incapacity in 94% of cases. Concerning professional impact, 36% of PCs needed to reduce or to adjust their work time, to work from home or even to change or leave their work. Among partners, the disease impacted their sexual life as 22% reported a decrease in their desire/libido and 14% reported an absence of sexual relation for weeks or months. Sixty four percent have waived many social activities as going out with friends, holidays or cinema. More than 50% wished they had more psychological support as well as more information about the disease and the way they could help their relatives. The main factors associated with a higher psychological impact were the following: Female sex (OR 2.23; 95%CI 1.51–3.28; p<0.0001), parental status (OR 2.29; 95%CI 1.28–4.11; P<0.0001), IBD duration <5 years (OR 1.72; 95%CI 1.11–2.66; P=0.005) and the lack of information about the disease (OR 0.59; 95%CI 0.39–0.88; P=0.01). Conclusion IBD had an important impact on PCs’ QOL at personal and social levels. A psychological support and an appropriate information about the disease and the help they can provide to their relatives are essential to reduce the burden of IBD on their daily life.

BACKGROUND AND AIMS:The use of telemedicine dramatically increased during the COVID-19 pandemic. We collected patients and physicians experience on telemedicine in the field of inflammatory bowel disease (IBD).METHODS:We conducted a nationwide survey between September 2020 and January 2021. A self-administered questionnaire was sent to participants through mailing lists of the national patients' association and IBD expert groups.RESULTS:Overall, 300 patients and 110 gastroenterologists filled out the survey. On a 10 points scale of satisfaction with telemedicine, 60% of patients noted a score ≥8 and 52.7% of physicians ≥7. Patients and gastroenterologists felt that the duration of teleconsultations appeared to be shorter than in-person visits in 57.5 and 55.1% of cases, respectively. All participants agreed that telemedicine is appropriate in dedicated situations and not for flare-up consultations. For 55.1% of patients, quality of care was the same via telemedicine, whereas 51.4% of gastroenterologists believed they managed less well their patients. Lack of clinical examination being pointed out as the main limitation of telemedicine. Three-quarters of patients and gastroenterologists would agree to use telemedicine more often in the future.CONCLUSION:Patients and gastroenterologists were satisfied with telemedicine and would be willing to use it in the future. However, telemedicine does not replace in-person visits and should be discussed on a case-by-case basis.

Background: Messages from an Internet forum are raw material that emerges in a natural setting (i.e., non-induced by a research situation).Aims: The FLARE-IBD project aimed at using an innovative approach consisting of collecting messages posted by patients in an Internet forum and conducting a machine-learning study (data analysis/language processing) for developing a patient-reported outcome measuring flare in inflammatory bowel disease meeting international requirements.Methods: We used web-based and machine learning approaches, in the following steps. 1) Web-scraping to collect all available posts in an Internet forum (23 656 messages) and extracting metadata from the forum. 2) Twenty patients were randomly assigned 50 extracted messages; participants indicated whether the message corresponded or not to the flare phenomenon (labeling). If yes, participants were asked to identify excerpts from the text they considered significant flare markers (annotation). 3) The set of annotated messages underwent a vocabulary analysis.Results: The phenomenon of flare was circumscribed with the identification of 20 surrogate flare markers classified into five dimensions with their frequency within extracted labeled data: impact on life, symptoms, extra-intestinal manifestations, drugs and environmental factors. Web-based and machine-learning approaches met international recommendations to inform the content and structure for the development of patient-reported outcomes. (c) 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

In Crohn's disease, combination therapy with anti-tumor necrosis factor (anti-TNF) agents and azathioprine/mercaptopurine has been shown to be superior to monotherapy with one of these treatments alone.1 This combination has its best success rate when used early in the course of treatment.2 However, because of the significant cost of these drugs and concerns over long-term side effects,3,4 many patients and providers often ask about stopping one or both of these medications.

Introduction Crohn’s disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD), are chronic disabling conditions characterised by flares followed by periods of remission. However, patients with IBD are seen every 3–6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is not captured. To our knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in IBD. This study aimed to use an innovative methodology to collect messages posted by patients in an internet forum for developing and validating a PRO measuring flare in IBD.Methods and analysis The design involves (1) computer engineering sciences for scraping extraction of messages posted in an internet forum and for identification of messages related to flare; (2) qualitative methods for thematic content analyse of the messages posted, for candidate items generation, for items selection (Delphi process) and for items adjustment (‘think-aloud’ interviews) and (3) quantitative methods for psychometric validation of the PRO.Ethics and dissemination Ethical approval was obtained from the Comité de Protection des Personnes (CPP) CPP Nord-Ouest I (19.07.15.44139) in November 2019. The project aims to provide a tool to evaluate IBD flare in current medical practice that is constructed with patients’ perspectives. Items generation from a source corresponding to exchanges in an internet forum is an innovative method in this field and provides a wider coverage of qualitative data. If such a forum can result in interesting material, then this could be a new methodological perspective for generating items for questionnaires. Findings will be reported and disseminated widely through international peer-reviewed journal publications, oral and poster presentations at scientific conferences.Trial registration number NCT04180345.

Background: Inflammatory bowel diseases (IBD) affect working-age patients. Data was lacking concerning the impact on working life. Aims: The French IBD patient association conducted a nationwide survey to assess the burden of IBD at work. Methods: An online survey was performed in 2016, targeting IBD patients working or having worked previously. The results were compared to those observed in the general population. Results: Data from 1410 IBD patients were analyzed (62% Crohn's disease, 35% ulcerative colitis). Four-fifth of respondents were actively employed. Half of them stated that working with IBD was a problem. Compared to the general population, IBD employees had higher rates of permanent contracts, public employment but also of part-time contracts, and highly graduated patients were less likely to reach high qualified jobs. Among the disabling symptoms at work, fatigue was the most frequent (41%) followed by diarrhea (25%) and fecal incontinence (18%). Despite these difficulties, 76% were satisfied with their job. Most patients shared their IBD diagnosis with their colleagues, but 25% of them regretted it. Conclusion: IBD has a strong negative impact on working life. While work satisfaction remains high, IBD affects career plans, highlighting the need for supporting measures to improve patients' work experience. (C) 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

When patients with Crohn’s disease (CD) are in remission on combination therapy including an anti-tumour necrosis factor (TNF) agent and an immunomodulator (IM), a frequent question is whether it is appropriate to stop one of these medications. The aim of this study was to understand patients’ perspectives on stopping therapy for CD when in remission, and to identify differences between French and US patient groups. To develop a questionnaire about stopping therapy, a focus group of patients with CD was conducted in the USA. The questionnaire was then distributed to patients from France and the USA. Patients from France were identified from both the St-Antoine cohort and the Association Francois Aupetit (AFA) database. Patients from the US were identified from the Crohn’s and Colitis Foundation of America (CCFA) Partners cohort. A total of 410 patients with CD from the USA (113) and France (297) completed the questionnaire. Their median age was 37, and 75% of respondents were women. The majority of patients from France and the USA had CD for longer than 10 years. French patients were more likely than those in the USA to consider stopping combination therapy if recommended by their doctor (69% vs. 48%, p < 0.01). When asked which prescription they would prefer to stop, most patients in the USA and France preferred to stop the IM (53% US, 47% France) as opposed to anti-TNF (26% US, 28% France). About a quarter of patients (26%) are unwilling to accept any chance of a disease flare when de-escalating therapy. Additionally, over a quarter of patients (27%) responded that they would be unwilling to de-escalate therapy if there is any risk of not getting back into remission when restarting treatment for a flare. A majority of patients (56%) responded that they are more concerned about their CD than the risk of cancer associated with treatment. Over 90% of USA and French patients would be willing to have blood work every 3 months and over 60% were willing to have an annual MRI to monitor for disease recurrence. Patients in the USA were more willing than those in France to have annual colonoscopy to detect early disease recurrence (p < 0.01). French patients are more willing to de-escalate therapy than US patients, and patients in both the USA and France prefer de-escalating from combination therapy to biologic monotherapy. However, a sizeable minority of patients is not willing to accept any risk of future flares or loss of response to therapy when considering de-escalation. Both patient groups are open to regular testing to assess for disease recurrence after de-escalation.

BACKGROUND:Patient reported-outcomes [PROs] are a major therapeutic goal in inflammatory bowel disease [IBD]. METHODS:Between January and June 2014, patients affiliated with the French national IBD association filled out six self-questionnaires: quality of life 9QoL, according to the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] and the Short-Form-36 Questionnaire [SF-36] v2); fatigue (the Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]); work productivity (the Work Productivity and Activity Impairment [WPAI] questionnaire); disability [the I nflammatory Bowel Disease Disability Index]; and anxiety/depression (the Hospital Anxiety and Depression scale [HADS]). Associated factors were identified by univariate and multivariate logistic regression analyses. RESULTS:Datasets were obtained from 1185 IBD patients. Around half of patients reported poor QoL [SIBDQ <45: 53.3%], severe fatigue [FACIT-F <30: 47.4%] and/or depression [HAD-D >7: 49.4%]. One-third of the patients reported anxiety [HAD-A >7: 30.3%] and/or moderate [22.4%] or severe [11.9%] disability. About half of them reported presenteeism and moderate-to-severe loss of work productivity and loss of activity. Poor QoL, severe fatigue, severe disease-related disability, and/or high WPAI were all associated with female gender, unemployment, and disease activity. Poor QoL, severe fatigue, and high WPAI were also associated with the use of tumour necrosis factor antagonists. A history of surgery was associated with poor QoL, whereas age was associated with severe fatigue. Severe depression was associated with female gender and disease activity. CONCLUSIONS:The disease burden is very high in IBD, with poor QoL, fatigue, work impairment, and depression in half of patients. Marked disability and anxiety were reported by one-third of patients.

The constant development of health technologies, combined with the increase in the cost of treatment, means that States must continually make choices about the introduction of new technologies into their healthcare system and how they are to be funded. In France, the systematic participation of patients in these processes is one of the targets to be met in terms of healthcare democracy. Although, on an international level, patient involvement in these assessments is constantly growing, it is difficult to define due to the presence of unstabilised elements in terms of both terminology and assessment methods. As a result, patient and public involvement in health technology assessments varies considerably from one country to the next, from one field to the next and even from one type of technology to the next. Several types of involvement exist, ranging from studies conducted to collect patient "insight" (experience, perception, needs, preferences, attitudes to treatment and health, etc.) to processes aimed at including patients in assessments (as individuals, as representatives of associations, etc.). Given the scope and complexity of the subject, and the difficulty involved in understanding all the different aspects of health technologies and innovations, the members of the Round Table chose to concentrate on health technology assessments (medicinal products and medical devices) to develop national recommendations on all possible types of patient involvement in the health technology assessment processes conducted by the health authorities in France.

BACKGROUND:Complementary and alternative medicines (CAM) are widely used by patients with inflammatory bowel disease (IBD). Few data have been published on the impact of CAM on the quality of life (QOL). AIMS:The aim of the study was to describe CAM use in French patients with IBD, identify characteristics associated with CAM use, and assess the impact of CAM on the QOL. METHODS:We conducted an internet survey on CAM through the French IBD patient's association website. Patients had to answer a questionnaire (LimeSurvey application) about sociodemography, IBD treatment, CAM type, socioeconomic data, and QOL using the Short IBD Questionnaire (SIBDQ). Patients noted the impact of CAM on their symptoms and on their QOL on a scale of 0-100. CAM users and nonusers were compared by univariate and multivariate analyses. RESULTS:A total of 936 IBD patients responded and 767 (82.4%) filled up the whole questionnaire: 503 reported CAM use and 172 had never used. The types of CAM reported were diet-based (30.7%), body-based (25.1%), homeopathic or traditional medicine (19.6%), naturopathy (15.2%), and mind-body medicine (9.1%). The gastroenterologist was aware of CAM use in only 46% of patients. CAM users were more likely to have ulcerative colitis [odds ratio (OR)=1.78, P=0.018], clinical remission (OR=1.42, P=0.06), high level of education (OR=1.51, P=0.02), poor observance (OR=1.81, P=0.017), or to have terminated conventional treatment (OR=2.03, P=0.003). CAM users tend to have higher rates of SIBDQ scores, greater than 50 (OR=1.57, P=0.06). Improvement in symptoms and QOL was reported with all CAM types except mind medicine. CONCLUSION:CAM use is widespread among IBD patients. CAM users report improvement in symptoms and QOL, but they tend to stop their conventional treatment. Better information about CAM might improve adherence to conventional treatment.