Abstract
Background
IBD requires tight monitoring of disease activity. E-health applications are associated with improved clinical outcomes and have a positive impact on healthcare costs. INTERACTION ...(telemedIciNe as parT of an intEgRAted IBD Care paThway @Imelda bONheiden) is a pilot project exploring the feasibility of implementation of teleconsultation in an existing tight monitoring care pathway and potential (dis)advantages for patients, health-care workers and quality-of-care.
Methods
INTERACTION is an ongoing, single-centre feasibility project including patients with moderate-to-severe IBD (UC/CD) treated with immunomodulators, subcutaneous biotherapy or oral small molecules since February 2022. Eligibility criteria include (i) stable treatment and remission, based on physician global assessment, patient-reported outcomes (UC: SCCAI<3; CD: PRO-2 ≤11), and faecal calprotectin (<250 µg/g) or endoscopy (UC: MES ≤1; CD: SES-CD ≤5), and (ii) digital access.. Participants agreed to embark in an adapted care pathway implementing video consultations with the treating physician alternating with in-person consultations. PRO’s and biomarkers were collected on dedicated time points (Figure 1). Patients’ expectations were questioned at the start of the pathway. Outcomes included patients’ experiences (assessed with the adapted Telehealth Usability Questionnaire), socio-economic impact, and clinical evolution (IBD-related flares or hospitalizations).
Results
At the moment of interim analysis (Oct 24th 2022), 37/44 (84%) invited patients wanted to participate. The majority expected that teleconsultations could be equal to in-person consultations (86%) and lead to an increased access to healthcare (92%) and time gain (97%). Seven patients refused participation for various reasons (Table 1). Four patients were screen failures due to lack of remission. Ultimately, 33 patients (baseline characteristics: Table 2) underwent a total of 67 consultations. The majority (92%) experienced the video consultations as (strongly) satisfactory (Figure 2). Patients’ time savings with video consultation compared to an in-person consultation varied between 0-30’ (16%); 30-60’ (36%), 60-120’ (36%) and more than 120’ (12%). The majority (92%) avoided a round trip to the hospital of at least 10 km. Forty percent averted absenteeism. One patient experienced an IBD flare without the need for hospitalisation during the median follow-up of 3 (IQR 3-5.5) months .
Conclusion
Implementing video consultations in the IBD care pathway of the ongoing INTERACTION project seems feasible, well-received and safe in patients with IBD in stable remission. In a second phase, video consultations led by an advanced IBD-nurse warrant further exploration.
Abstract
Background
Although clinical trials led to the registration of subcutaneous (SC) infliximab CT-P13 (IFX) and SC vedolizumab (VDZ) for patients with Crohn’s disease (CD) and ulcerative ...colitis (UC), many practical aspects have not been addressed yet. We explored what strategy Belgian clinicians plan to follow once these formulations become available.
Methods
A 3-round Delphi process was initiated in Jan 2021. A core panel (4 IBD clinicians, 1 PKPD expert, 1 IBD nurse, 1 methodologist) developed a neutral video on the available data, as well as 65 statements and 9 multiple-choice questions related to the practical use of SC IFX and VDZ. The expert panel, consisting of 45 IBD clinicians (median IQR years of practice 19 11-26 years), scored all statements on a 10-point Likert scale. We here present the results of the first Delphi round. The complete report will be available after the final Delphi round in May 2021. A ≥70% consensus level (scores 1-4 for disagreement, scores 7-10 for agreement) is foreseen.
Results
The majority of IBD clinicians expressed the need for more scientific data on switching from intravenous (IV) to SC therapy (Table 1). Furthermore, a minority would consider starting SC therapy after only two IV induction doses (Figure 1).
Most clinicians would restrict switching to patients who achieved both clinical, biological response, and endoscopic response (Figure 2) and this only when receiving standard IV dosing of 5mg/kg IFX (75.5%) or 300mg VDZ every 8 weeks (68.9%). Both for IFX and VDZ, 57.1% of IBD clinicians would administer a first SC dose no later than 6 weeks after the last IV administration.
The IBD clinicians highlighted the role of the IBD nurse in explaining and guiding a potential switch (82.2% IFX, 88.9% VDZ) and supervising the first SC administration (100.0% IFX, 95.5% VDZ). They emphasized the need for a clinical follow-up within 8 weeks (88.6% IFX, 88.9% VDZ).
Although reactive therapeutic drug monitoring under SC therapy was considered helpful by IBD clinicians (77.8% IFX, 68.9% VDZ), they acknowledged the lack of an optimal serum concentration (73.4% IFX, 84.3% VDZ).
Round one did not result in a consensus on using SC formulations in patients with quiescent perianal fistulising disease or a prior episode of acute severe UC. Finally, the optimal strategy in case of an objectified clinical relapse after switching to SC therapy seems is clearly unknown (83.3% IFX, 76.2% VDZ).
Conclusion
Although both SC IFX and SC VDZ will become available soon, the majority of IBD clinicians expressed the need for more scientific data on switching from IV to SC therapy. This Delphi process may indicate pivotal remaining research questions to be answered through post-marketing studies.
Abstract
Background
Subcutaneous (SC) formulations were recently approved for CT-P13 and vedolizumab (VED). No insights in the willingness of patients with Inflammatory Bowel Disease (IBD) to switch ...from intravenous (IV) to SC maintenance therapy with CT-P13 and VED are available. The aims of this study were (1) to evaluate the percentage of patients with IBD in favour of switching to SC formulations, (2) to define the factors influencing this decision, and (3) to explore the role of the IBD nurse in the process of switching.
Methods
This was a monocentric study in patients with IBD on maintenance IV CT-P13 or VED. All patients attending the infusion unit were invited to complete a survey exploring the willingness to switch to SC formulations. Prior to completing the survey, patients were informed on the new SC formulations and the accompanying care pathway. The survey was performed prior to the market introduction of SC CT-P13 and VED. Demographics, patient reported outcomes, willingness to switch and reason for IV vs. SC preferences were captured.
Results
In total, 183 (91%) patients completed the survey (m/f: 84/99; CD/UC/IBD-U: 120/57/6; median age 45 IQR 34–59; remission CD/UC: 67%/75%). The majority of patients preferred switching to SC (56% yes, 12% no, 32% doubt). The main driver to switch was an anticipated decrease in hospital visits (90%); the main reason to continue IV was fear of change (61%). Patients doubting to switch had a lower stool frequency compared with patients making a definite decision (p=0.012). Factors significantly associated with the willingness to switch in the univariate analysis were younger age (p<0.0001), experience with SC therapy (p=0.03), full time work occupancy (p=0.001), younger age at start IV therapy (p=0.001), shorter disease duration (p=0.012), and compliance level (p<0.0001). Multivariate analysis retained younger age as the only independent factor. For patients doubting to switch, an electronic alert (71%), an information brochure (69%), and a personal teaching moment (60%) were recognised as valuable support. An information package should cover patient-focused efficacy and safety data of SC therapy, therapeutic options in case of disease worsening, and practical concerns including information about administrative issues and travelling.
Conclusion
This is the first study exploring the willingness to switch from IV to SC maintenance therapy with CT-P13 and VED in patients with IBD. The majority prefers to switch to a SC formulation, with willingness to switch being most likely in younger patients. Further studies are required to investigate the impact of nurse led interventions on the willingness to switch, patient satisfaction, and treatment compliance.
Abstract
Background
Treating beyond endoscopic remission, aiming for histological remission, has shown to reduce relapse and hospitalization rates in patients with ulcerative colitis (UC). However, ...very little is known on how histological remission associates with patient reported outcomes (PROMs).
Methods
PROMs (Simple clinical colitis activity index SCCAI, IBD disk and Visual Analogue Scales VAS) were prospectively collected through a digital questionnaire in all patients with UC undergoing colonoscopy between July 21st 2020-Jan 21st 2021. Mayo endoscopic sub score and UCEIS were determined, as well as the Nancy histologic index (NHI) of the most affected area. Endoscopic remission was defined as Mayo endoscopic sub score 0 and UCEIS 0; histologic remission as NHI 0, absence of active inflammation as NHI ≤ 1. PRO2 remission was defined as stool frequency ≤ 1 (absolute stool frequency ≤ 3 OR 1–2 stools more than usual) and rectal bleeding score of 0.
Results
Fifty-six paired assessments were collected in 48 unique patients (Table 1), with a histologic, endoscopic and PRO-2 remission rate of 23.2%, 28.6% and 38.2% respectively. Patients with histologic remission or absence of histologic inflammation had a significantly lower overall IBD disability (p=0.007, p=0.003) and disease activity score (p=0.003, p<0.001), as compared to patients without. In line, NHI correlated with the overall IBD disk (r=0.40, p=0.002) and SCCAI score (r=0.50, p<0.001). Many individual components of both scores (abdominal pain, arthralgia, impact on education and work/interpersonal interactions/sexual function, regulation of defecation, blood loss, general wellbeing, joint pain, numbers of stools during night/day, urgency) differed significantly between patients with and without histologic remission. VAS scores assessing general wellbeing (r=0.33, p=0.01), impact on daily activities (r=0.41, p=0.002), UC-related symptoms (r=0.42, p=0.001) and worries (r=0.40, p=0.002) correlated with histology. Quartile analysis of the overall IBD disk and SCCAI scores confirmed the highest likelihood for histologic remission in patients with the lowest scores (Q1-Q2 vs Q3-Q4 39.3% vs 7.1%, p=0.01; 40.0% vs 9.7%, p=0.01) (Figure 1). Nevertheless, the overall accuracy of the IBD disk (0.75) or SCCAI score (0.76) for histologic remission is lower (p<0.05) than the accuracy of the Mayo endoscopic (0.90) or UCEIS (0.90) score.
Table 1: Baseline features
Abstract OP09 – Figure 1: Quartile analysis
Conclusion
In patients with UC, PROMs for disability and clinical disease activity reflect histologic disease activity and should therefore be further explored in (trial) endpoint discussions. However, they cannot fully replace endoscopic and histologic findings, and should be considered complementary.
Abstract
Background
The treatment paradigm for inflammatory bowel disease (IBD) is becoming increasingly diverse and complex. It is suggested that engaging patients through shared decision-making ...optimises treatment selection in line with clinical need and patient preference and expectations. This patient survey aimed to explore patients’ preferences towards attributes of currently available advanced therapies for IBD as well as the impact of IBD on patients’ quality of life (QoL) across 7 countries in Europe. The demographic profile of the study cohort and findings on the patient-rated impact of IBD on QoL are reported here.
Methods
An online, cross-sectional survey (October 2020 to January 2021) enrolling adults aged ≥18 years who self-reported having and being previously/currently treated for Crohn’s disease (CD) or ulcerative colitis (UC) was conducted across Europe (France, the UK, Spain, Italy, Belgium, Switzerland and the Netherlands). Patient perspectives on IBD care and preferences regarding specific attributes of existing treatment options were explored using the Carenity platform and via partnerships with local organisations. This descriptive analysis evaluated the demographic and clinical profile of respondents, treatment management and impact on QoL.
Results
Overall, 686 patients (CD: 360; UC: 326) across 7 countries completed the survey. Among CD and UC patients, respectively, 71.9% and 57.7% were females; mean age (range) was 48.0 (19.0–77.0) and 50.0 (19.0–82.0) years; and mean disease duration (range) was 13.6 (0.2–49.1) and 11.0 (0.1–68.7) years. Overall, 37.5% of CD patients reported fistulising CD, and 9.4% (CD) and 10.1% (UC) of patients had a stoma or pouch; 76.7% (CD) and 78.5% (UC) of patients were being treated for IBD. Approximately 50.0% of patients with IBD were full-time or part-time employed at the time of survey. Abdominal pain, fatigue, and stool frequency were ranked by 83%, 79%, and 73% patients with CD, respectively, as the symptoms most impacting QoL; 79%, 71%, and 61% patients ranked energy status, general well-being and daily activities, respectively, as the most impacted aspects. Abdominal pain, stool frequency and fatigue were ranked by 73%, 72% and 67% patients with UC, respectively, as the symptoms most impacting QoL; the most impacted aspects were similar to those of patients with CD. Patients in both groups prioritised general well-being, energy status and daily activities as aspects for improvement through treatment.
Conclusion
This large European survey highlights the most impactful symptoms and QoL aspects from the patient perspective. These findings can support clinical decision-making and treatment strategies to improve treatment outcomes and patient QoL.
Abstract
Background
Quality of care in inflammatory bowel disease (IBD) depends on multiple factors and is assessed through structure, process and outcome indicators. Structure and process indicators ...are more static and can easily be measured by an audit. Patient-oriented outcome indicators that impact on the quality of life are more difficult to assess.
The aim of the project was to build a platform that automatically captures key outcome quality indicators and provide benchmarking output to improve quality of care in IBD centres.
Methods
Literature was reviewed for relevant quality indicators in IBD. After two non-anonymized Delphi like review and consensus meetings, twelve quality indicators were selected for implementation. The definitions of the outcomes were aligned in consensus with the available International Consortium for Health Outcomes Measurement (ICHOM). A web-based interface was built in three large volume IBD centres in Belgium to collect data on multiple ways: (i) Patients complete patient-reported outcome questionnaires and disease specific questions when attending the outpatient clinic and/or day clinic; (ii) The software automatically extracts data from the electronic medical files including biochemical and endoscopic reports; (iii) The medical baseline characteristics and outcome indicators for each patient are completed by the healthcare professional at inclusion and after this on a yearly basis.
Results
In total 265 patients were included in the participating IBD centres. Three indicators could be directly extracted from the patient-reported outcome questionnaires (clinical remission, fatigue, work productivity). Two items could be retrieved by use of the bot that automatically extracts biochemical and endoscopic reports from the medical files (anaemia, deep remission). The other items were collected throughout yearly confirmation by a health care professional (colorectal cancer, steroid use systemic/topical, severe infections, hospital admission, IBD surgery perianal/abdominal). All items are benchmarked in an anonymous way on a benchmarking dashboard. Each centre can only see his own position in the benchmarking diagram. Additionally, the case mix per centre (type IBD, severity, demographic data) was added to the benchmarking output to provide a balanced evaluation of the outcome indicators.
Conclusion
This is the first partially automated benchmarking initiative for quality of care in IBD. The data collection is feasible and provides an objective assessment and comparison of the IBD related quality of care in different centres. Further prospective evaluation needs to confirm that implementation of benchmarking improves the performance and quality of IBD management.
Abstract
Background
Subcutaneous (SC) formulations of CT-P13 and vedolizumab (VED) are currently available as new treatment option for patients with inflammatory bowel disease (IBD). The decision to ...switch requires a shared decision making based on adequate education of the patient, to avoid negative outcomes due to a nocebo effect. The aims of this study were (1) to evaluate the percentage of patients with IBD in favour of switching to SC formulations and (2) to compare two educational strategies.
Methods
This was a multicentre study in patients with IBD on maintenance intravenous (IV) CT-P13 or VED. Patients attending the infusion unit were invited to complete a survey exploring the willingness to switch to SC formulations. In centre A, all patients were informed on the new SC formulations and the accompanying care pathway by an information leaflet and a face-to-face interaction with the IBD nurse, prior to completing the survey. In centre B, patients on a minimal interval of q8w were digital invited to the same survey via the e-health application of the hospital. Demographics, patient reported outcomes, willingness to switch and reasons for IV vs. SC preferences were captured.
Results
In total, 447 (n=183 Centre A; n=264 Centre B; participation ratio 83.6%) patients completed the survey (m/f: 212/235; CD/UC/IBD-U: 275/161/11; median age 45 IQR 33–57; remission CD/UC: 75%/82%) see table. Most patients were open to SC treatment (47% yes, 33% doubt, 20% no). The main driver to switch was an anticipated decrease in hospital visits (86%) and overall time gain (78%). The main reason to continue IV was fear of change (60%) and uncertainty in case of relapse after switch to a SC formulation (46%). In univariate analysis, the self-estimated compliance rate was associated with the willingness to switch (p<0.0001). To evaluate the impact of the approach in patient education between the two centres, we compared the subgroup of patients on ≥q8w interval with a dosing of 5-10mg/kg CT-P13 or 300 mg VED (n=335). The willingness to switch was higher after a face-to-face approach (centre A) compared to a merely digital approach (centre B; 53.9 % vs. 40.9 % p=0.038), although patients in centre B had a higher educational level (p=0.003), more prior experience with other IBD SC medication (p=<0.001), lived further from the hospital (p<0.001) and had a younger age at diagnosis (p=0.019).
Conclusion
In this multicentre comparative study exploring the willingness to switch from IV to SC maintenance therapy with CT-P13 and VED, the majority is open to switch to a SC formulation. The direct approach and education of the patient by the IBD nurse impacts significantly the willingness to switch. In a follow-up we will investigate the actual switch rates.
Abstract
Background
Therapeutic drug monitoring (TDM) of infliximab (IFX) improves patient outcomes and is cost-effective. The short turnaround time of point-of-care testing (POCT) allows ad hoc dose ...adjustment. We aimed to determine the feasibility and pilot effectiveness of an ultra-proactive TDM algorithm including POCT of IFX in patients with inflammatory bowel disease (IBD).
Methods
All IBD patients with maintenance IFX treatment at our referral IBD clinic were prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm was applied as follows. All patients had an ELISA trough level (TL) measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3–7 μg/ml: continuation at same dose and interval; (B) TL >7 μg/ml: interval prolongation allowed; (C) TL <3 μg/ml: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL <3 μg/ml, dose was optimised ad hoc using a linear dosing formula (Dosen = (TLtarget * Dosen−1) / TLmeasured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3 μg/ml, no additional dose was given and routine TL testing with ELISA was retaken at next visit. Physician’s global assessment, C-reactive protein (CRP), haemoglobin and albumin levels were sequentially evaluated according to standard of care.
Results
In total, 115 patients were included (Crohn’s disease/ulcerative colitis/IBDU n = 80/34/1; median CRP 1.2 mg/l (IQR 0.6–3.8); median TL 4.6 μg/ml (IQR 2.6–7.4)). A median of 3 infusions (IQR 3–4) during follow-up led to a total number of 371 TL measurements. There was a significant drop of low TL (<3 μg/ml) over time (38/115 at baseline vs. 22/256 during follow-up; p = 0.0001). The need for POCT reduced from an initial 28% to 8.7% (p = 0.0001). Additional dosing based on POCT measurement was needed in 7/43 (16.3%) cases. Patients needing ad hoc dose adjustment after interval shortening had significant lower TL at the previous measurement than those who did not (median (IQR) TL 0.9 μg/ml (0.7–1.8) vs. 2.3 μg/ml (1.5–2.6); p = 0.036). An IFX TL cut-off of 1 µg/ml predicted an ad hoc extra dose after interval shortening with an NPV of 96% (90% sens, 75% spec). In patients with elevated CRP at baseline (n = 26), ultra-proactive TDM resulted in a significant reduction of CRP over time, with a median (IQR) of 7.8 (6.5–18.3) mg/l at baseline compared with 6.3 (4–9.9) mg/l during follow-up (p = 0.025).
Conclusions
Ultra-proactive TDM based on a strict algorithm including POCT and ad hoc dose adjustment is feasible and significantly lowers CRP levels in IBD patients treated with maintenance IFX. Less than 10% of patients need POCT over time.
PDF