ICONIC is a prospective, multi-country (n=33) observational study, assessing cumulative burden in adult ulcerative colitis (UC) patients (pts) under routine care. Assessments of healthcare resource utilisation (HCRU), disease severity and impact on quality of life will be captured at 6 month intervals through 2 years. This analysis evaluated baseline (BL) HCRU, work productivity, and quality of life among UC pts with different level of disease severity.
Methods
Pts with early UC (diagnosed ≤36 months) were enrolled irrespective of disease severity or treatment. For this analysis, we evaluated pts stratified by physician assessment of disease severity into severe, moderate, mild and remission groups. BL characteristics described: Simple Clinical Colitis Activity Index (SCCAI), UC-related HCRU measured during the 6 months prior to study enrollment (i.e., visits to treating physicians or other IBD-associated healthcare professionals, emergency room (ER) visits, hospitalizations and hospital admissions for surgeries); Health Related Quality of Life (HRQoL), pt-reported employment/UC-related sick leave status and Work and Productivity Activity Index (WPAI:GH; including work time missed (absenteeism), impairment while working (presenteeism), overall work productivity impairment, and daily activity impairment domains).
Results
A total of 1816 UC pts were enrolled; mean ±SD age was 38.5±14.6 years and 833 (45.9%) were female. At BL, 230 pts (12.7%) were in remission, 672 pts (37.0%) had mild UC, 668 pts (36.8%) had moderate UC, and 234 (12.9%) had severe UC. Compared to pts in remission, pts with moderate to severe UC had 1.8 to 2.6-fold higher rates of hospitalizations and 1.6 to 2.5-fold higher rates of ER visits over the past 6 months. Pt with moderate and severe disease were associated with lower SIBDQ scores and higher WPAI:GH domain scores (i.e., greater impairment on work productivity) than pts with mild disease or those in remission. 172 (9.5%) pts reported to be unemployed at BL. 183 (10.1%) reported sick leave at BL. Sick leave time ranged from <2 months (59.6%), 2–4 months (12.6%),>4 months (22.4%).
Conclusion
The direct and indirect burden of UC is substantial, as measured by healthcare resource utilisation and work-life impact. Pts with moderate and severe UC not only were associated with higher rates of urgent care in hospitalisation and ER visits, but also with poorer quality of life, higher unemployment, sick leave and impaired work productivity than pts with mild UC or in remission. For pts with mild UC, despite comparable HCRU to pts in remission, increased impact on work productivity remains a concern.
Abstract Background and Aims Standardising health outcome measurements supports delivery of care and enables data-driven learning systems and secondary data use for research. As part of the Health Outcomes Observatory [H2O] initiative, and building on existing knowledge, a core outcome set [COS] for inflammatory bowel diseases [IBD] was defined through an international modified Delphi method. Methods Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by ≥80% of the participants, or based on consensus meeting agreement, were included in the final set. Results In total, 136 stakeholders (45 IBD patients [advocates], 74 health care professionals/researchers, 13 industry representatives, and four regulators) from 20 different countries participated. The final set includes 18 case-mix variables, three biomarkers [haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation] for completeness, and 28 outcomes (including 16 patient-reported outcomes [PROs] and one patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form, to collect generic PROs annually. Conclusions A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven, and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide.
iron deficiency anemia is a common and very relevant manifestation of inflammatory bowel disease (IBD). Although clinical practice guidelines have been published and updated on this subject, the management in the daily practice of this complication is far from optimal.to determine the actual management, needs and limitations of anemia in IBD by means of a survey of gastroenterology specialists.a self-administered telematic survey was carried out between April and May 2017 and was sent to SEPD members. The survey included four sections: participant demographics, monitoring, treatment and limitations/needs.a total of 122 evaluable surveys were received from all Spanish autonomous communities. Iron deficiency anemia is considered as a frequent manifestation of IBD and is monitored in all patients via the measurement of hemoglobin and ferritin. In the case of anemia, the survey respondents found it necessary to rule out the presence of IBD activity. However, only 14.8% prescribed intravenous iron when IBD was active. The required dose of intravenous iron is mainly calculated according to patient needs but only 33.1% of clinicians infused doses of 1 g or more.the "Gestiona Hierro EII" survey on the management of anemia in IBD demonstrated a high quality of care, even though some aspects need to be improved. These included the prescription of intravenous iron for patients with disease activity, the use of high-dose intravenous iron and the implementation of algorithms into clinical practice.
Abstract To assess inflammatory bowel disease (IBD) patients’ experience of chronic illness care and the relationship with demographic and healthcare-related characteristics. This cross-sectional survey used the Instrument to Evaluate the EXperience of PAtients with Chronic diseases (IEXPAC) questionnaire to identify parameters associated with a better healthcare experience for IBD patients. IEXPAC questionnaire responses are grouped into 3 factors - productive interactions, new relational model, and patient self-management, scoring from 0 (worst) to 10 (best experience). Scores were analyzed by bivariate comparisons and multiple linear regression models. Surveys were returned by 341 of 575 patients (59.3%, mean age 46.8 (12.9) years, 48.2% women). Mean (SD) IEXPAC score was 5.9 (2.0); scores were higher for the productive interactions (7.7) and patient self-management factors (6.7) and much lower for the new relational model factor (2.2). Follow-up by a nurse, being seen by the same physician, and being treated with a lower number of medicines were associated with higher (better) overall patient experience score, and higher productive interactions and self-management factor scores. A higher productive interactions score was also associated with patients receiving medication subcutaneously or intravenously. Higher new relational model scores were associated with follow-up by a nurse, affiliation to a patients’ association, receiving help from others for healthcare, a lower number of medicines and a higher educational level. In patients with IBD, a better overall patient experience was associated with follow-up by a nurse, being seen by the same physician, and being treated with a lower number of medicines.
Conocer los primeros datos de actividad de la Unidad de Atención Crohn-Colitis (UACC) y su línea virtual, la http://www.ua-cc.org La UACC es un servicio de educación y promoción de la salud que se dirige a los enfermos con enfermedad inflamatoria intestinal y a su entorno. Dispone de un centro de coordinación desde donde se gestionan todas las consultas y las resoluciones gestionadas por un equipo multidisciplinario. El acceso telefónico y la web son las principales vías de contacto. A los 3 años de funcionamiento, la UACC cuenta con 956 usuarios, el 87% de los cuales son pacientes, que han generado más de 4.500 consultas multitemáticas. Destaca la vía de atención telefónica con un 67% y los más de 500 usuarios registrados en el portal. Los primeros datos descriptivos expresan un impacto significativo del proyecto, en el que destacan la atención integral y el acceso virtual como las variables más significativas. To assess the activity of the Crohn-Colitis Care Unit (CCCU) and of its web site: http://www.ua-cc.org The CCCU is a unit for the education and health promotion of patients with inflammatory bowel disease and their immediate circle. It includes a coordination center with a multidisciplinary team that manages patients' requests. The main means of contact is through telephone and the Web. After 3 years, there are 956 users registered in the CCCU, of which 87% are patients who generated more than 4,500 consultations on multiple topics. Telephone consultations account for 67% of all consultations and there are 500 users registered in the Web. The preliminary results suggest that the integral approach of the CCCU and its web site have had a significant impact on patients with inflammatory bowel disease.
In addition to their primary disease, ulcerative colitis (UC) patients may concomitantly suffer from extraintestinal manifestations (EIMs), increasing overall disease-related burden. Impact of EIM-augmented burden to patients is poorly understood. ICONIC is the largest ongoing, prospective, multicountry (n = 33) observational study assessing cumulative UC disease burden in patients receiving routine standard of care. Disease severity, activity, and life impact were captured at 6-month intervals through 2 years. This analysis assessed global and regional EIM-associated burden from 1 year of ICONIC. Adults with early UC (diagnosed ≤36 months) were enrolled irrespective of disease severity or treatment. EIM presence and impact at baseline and over 1 year were assessed, focussing on health-related quality of life (HRQoL) measures: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and anxiety/depression (Patient Health Questionnaire-9 [PHQ9]). Patients were stratified by physician-assessed baseline disease severity (severe, moderate, mild, in remission). Regional differences in EIM burden and associated site services supporting EIM management were also evaluated. Observed data using descriptive statistics are presented; statistical comparison was performed using Fischer’s exact test. Of 1794 patients with evaluable 1-year data, 14.1% (n = 253) presented with ≥1 EIM at baseline. At 1 year, 20.1% (n = 361) patients had EIMs, with 3.5% of patients (62/1794) presenting new-onset EIMs at 6 months and 2.6% (46/1794) at 1 year (42.7% increase from baseline to 1 year). Rheumatoid arthritis, ankylosing spondylitis, and erythema nodosum were the most common EIMs. Japan had the lowest overall EIM rate over 1 year (4.3%; 5/117); Western Europe/Canada had a 5.2-fold higher total EIM rate over the same period (22.2%; 184/830). Patients with moderate or severe baseline disease had a significantly higher total EIM rate over 1 year (24.2% or 28.0%, respectively) vs. those with mild disease (14.8%) or in remission (16.1%) at baseline (p < 0.0001). For total study population or when stratified by region, patients with ≥1 EIM had higher PHQ9 and lower SIBDQ mean scores over 1 year vs. patients with no EIMs. Of 231 global sites, 134 (58%) had established multi-disciplinary teams (MDTs) and 86 (37.2%) psychologist in situ. New-onset EIMs are common in UC, even after 1 year disease course. EIM presence is associated with poorer HRQoL. Despite regional EIM differences, overall EIM impact on HRQoL was similar across the global study population. EIM-augmented patient burden is a concern in UC, and, with >40% sites lacking MDTs and >60% sites lacking in situ psychologists, awareness of EIM impact is essential.