Explore the vast range of titles available.

Traditionally, half of the direct costs associated with chronic inflammatory bowel diseases (IBD) [Crohn’s disease (CD) and ulcerative colitis (UC)] have related to hospital inpatient treatment for a sub-group of more severely affected, often therapy-resistant individuals. The advent of effective but relatively expensive biological agents has increased the contribution of drugs to overall medical care costs. This has focussed interest on the relative cost effectiveness of rival therapies for IBD and, in particular, on the affordability of long-term biological therapy. The purpose of this article is to review the available literature on this topic and to identify areas for future research. Head-to-head trials of competing treatment options are uncommon and clinical trials have seldom addressed cost effectiveness. In UC, models have explored the cost utility of ‘high-’ versus ‘standard-’ dose 5-aminosalicylic acid (5-ASA) therapy and the theoretical impact of improved adherence with once-daily formulations. In CD, cost-utility models for anti-tumour necrosis factor (TNF) drugs versus standard care have suggested consistently that incremental benefits are achieved at increased overall cost. However, studies of varying design have produced a wide spectrum of incremental cost-effectiveness ra tio estimates, which highlights the challenges and limitations of existing modelling techniques.

Background Patient-reported outcome measures (PROMs) are recommended for assessing patient-centered outcomes in inflammatory bowel disease (IBD). The main aims were to assess the level of participation in an electronic PROM (ePROM) data collection system among patients with IBD, and evaluate reliability and validity of the resulting scores. Methods Patients included in the IBD registry of Maccabi Healthcare Services, a state-mandated healthcare provider for over 2.6 million people in Israel, were invited to complete the IBD-Control measure and a general health item, with follow-up ePROMs at 3 and 6 months including a global rating of change item. Descriptive statistics were used to compare patient characteristics by participation rate, and assess survey completion time. Initial scores were assessed for internal consistency reliability using Cronbach's alpha. Test–retest reliability was assessed using the intraclass correlation coefficient from paired scores of patients identified as unchanged between the initial and first follow-up. Construct validity was assessed by the ability of IBD-control scores to discriminate between patient sub-groups in expected ways. Empirical validity was assessed using ePROM score correlations with laboratory markers of disease activity. Score coverage was also assessed. Results A total of 13,588 patients were invited to participate [Mean age = 49 years (SD = 17); females = 51%]. Participation rate was 31.5%. Participants compared to non-participants were slightly older, were more likely to be female, to have a history of biologic treatment, to have higher socio-economic status, and to be more experienced in the usage of the digital patient portal. Median survey completion time was approximately 1:30 min. Internal consistency and test–retest reliability were 0.86 and 0.98, respectively. Scores discriminated between patient sub-groups in clinically expected ways, with expected correlations to laboratory markers of disease activity. A notable ceiling effect was observed (> 15%) for IBD-Control scores. Conclusions Feasibility, reliability, and validity of the ePROM system was supported for measuring the level of perceived disease control in patients diagnosed with IBD in Israel. Additional research is needed to identify ways to increase patient participation, assess clinical implications of the identified measurement ceiling of the IBD-control, and evaluate the added value of the derived scores in support of clinical decision making.

ObjectivesTo examine time trends in patient characteristics, care processes and case fatality of first emergency admission for alcohol-related liver disease (ARLD) in England.DesignNational population-based, retrospective observational cohort study.SettingClinical Practice Research Datalink population of England, 2008/2009 to 2017/2018. First emergency admissions were identified using the Liverpool ARLD algorithm. We applied survival analyses and binary logistic regression to study prognostic trends.Outcome measuresPatient characteristics; ‘recent’ General Practitioner (GP) consultations and hospital admissions (preceding year); higher level care; deaths in-hospital (including certified cause) and within 365 days. Covariates were age, sex, deprivation status, coding pattern, ARLD stage, non-liver comorbidity, coding for ascites and varices.Results17 575 first admissions (mean age: 53 years; 33% women; 32% from most deprived quintile). Almost half had codes suggesting advanced liver disease. In year before admission, only 47% of GP consulters had alcohol-related problems recorded; alcohol-specific diagnostic codes were absent in 24% of recent admission records. Overall, case fatality rate was 15% in-hospital and 34% at 1 year. Case-mix-adjusted odds of in-hospital death reduced by 6% per year (adjusted OR (aOR): 0.94; 95% CI: 0.93 to 0.96) and 4% per year at 365 days (aOR: 0.96; 95% CI: 0.95 to 0.97). Exploratory analyses suggested the possibility of regional inequalities in outcome.ConclusionsDespite improving prognosis of first admissions, we found missed opportunities for earlier recognition and intervention in primary and secondary care. In 2017/2018, one in seven were still dying during index admission, rising to one-third within a year. Nationwide efforts are needed to promote earlier detection and intervention, and to minimise avoidable mortality after first emergency presentation. Regional variation requires further investigation.

ObjectivesKnowledge of the extent of variation in outcome assessment for inflammatory bowel disease (IBD) in routine practice is limited. We aimed to describe and quantify variation in outcome coverage and to explore patient, clinician and practitioner factors associated with it.DesignProspective exploratory mixed-methods study.SettingIBD clinics at six hospitals in North West England with differing electronic health record (EHR) systems.MethodsMixed-methods study comprising: (a) structured observations of outcomes elicited during consultations (102 patients consulting 24 clinicians); (b) retrospective analysis of outcomes recorded in the EHR (909 consultations; 127 clinicians) and (c) semistructured interviews with the 24 observed clinicians. We determined whether specific outcome ‘sets’ were elicited or recorded, including: (1) a minimum set of symptom pairs (‘PRO-2’); (2) symptom sets from disease activity indices and (3) a reference list of 37 symptoms, signs and impacts. Factors associated with variation were explored in univariate and multivariate binary logistic regression analyses and from clinician interviews.ResultsPRO-2 coverage was not invariable (elicited during 81% of observed consultations; recorded in 56% of EHR) and infrequent for complete activity indices (all domains from Harvey-Bradshaw Index: elicited, 18%; recorded, 5%). The median number of outcomes from the reference list elicited per consultation was 12 (13-fold variation) and recorded in EHR was 7 (>20-fold variation). Symptom quantification (PRO-2) seldom adhered closely to standardised descriptors and an explicit timeframe was defined rarely. PRO-2 recording in EHR was associated with a diagnosis of ulcerative colitis (OR: 2.09 (95% CI 1.15 to 3.80)) and nurse-led consultations (OR: 6.98 (95% CI 3.28 to 14.83)) and a three-way model suggested 26% of total variability lay between clinicians, 17% between patients but the remainder was unexplained. Most clinicians expressed preference for individualised health status evaluations versus standardised outcome assessments.ConclusionsThere was little evidence for standardised assessment and recording of IBD outcomes and substantial intra-clinician and inter-clinician variation from one consultation to another. Nurses demonstrated a greater tendency to standardised practice.

VEST was a multi-centre study of real-world use of vedolizumab in inflammatory bowel disease (IBD) in routine practice in the United Kingdom. To describe real-world indications, effectiveness, patient-reported outcomes and safety. Prospective observational cohort study at 22 centres. Patients receiving vedolizumab as part of standard care were included. Data were collected at infusion visits for activity indices (Harvey-Bradshaw Index (HBI) or partial Mayo Score (PMS)), physician global assessment (PGA), patient-reported quality-of-life and treatment perception (IBD-Control Questionnaire) and adverse events. Clinical response (Wk14) was defined as a reduction in HBI ⩾3 or PMS ⩾2, clinical remission as HBI ⩽4 or PMS ⩽1 and analysed using non-responder imputation. One-year persistence was defined as continuing on vedolizumab after an infusion at ⩾48 weeks. Biomarker and endoscopic data were not available. 364 patients, mean age: 48 years; 132 (36%) with Crohn's disease (CD), 224 (62%) with UC and 8 (2%) with IBD-U; 174 (48%) male; 142 (39%) receiving steroids at baseline (Wk0); 141 (39%) bio-naïve. At baseline, 279 (77%) had \"active\" disease. One-year persistence: 58% overall (54% for active disease). Among persistent cases (  = 212), median (IQR) IBD-Control-8 scores improved from 6 (3-10) at baseline to 14 (10-16) at post-induction (Wk14) and 1 year (  < 0.001 vs baseline). Corresponding scores for IBD-Control-VAS were: 50 (30-70), 80 (65-90) and 85 (70-95), respectively (  < 0.001 vs baseline). Each domain of IBD-Control-8 showed improvement. Baseline and post-induction health status (activity index, PGA or IBD-Control) were associated with 1-year persistence, but no significant associations were observed for disease type, duration, bio-naïve status or baseline steroids. Of those with active disease at Wk0, clinical remission rates were 29%, 30% and 38% for CD, UC and IBD-U, respectively, and steroid-free remission rates were 26%, 27% and 38%. Similar remission rates were observed at 1 year. Possible adverse events leading to treatment cessation were rare (3%). In routine clinical practice in the UK, vedolizumab demonstrated high levels of persistence. Similar rates of clinical response, remission and 1-year persistence were seen in UC and CD patients, and in bio-experienced versus naïve cases. Persistent cases experienced significant and sustained improvements in quality of life and treatment perception. Persistence does not imply anti-inflammatory efficacy, as biomarker data were not available.

ObjectiveDeficiencies have been highlighted in acute hospital care for alcohol-related liver disease (ARLD). Such problems may be worse at weekends (WEs). Increased 30-day mortality for WE admissions has been reported for several acute conditions, but data for ARLD are limited. We aimed to compare patient and pathway characteristics between WE and weekday (WD) admissions and investigate the ‘weekend effect’ on mortality.MethodsRetrospective cohort study (2008–2018) using linked electronic databases (Hospital Episode Statistics-Clinical Practice Research Datalink and death registration) including 17 575 first emergency admissions identified using the Liverpool ARLD algorithm. Exposure: WE admission (Saturday or Sunday). Main outcome: all-cause death within 30 days. Covariates included socio-demographic characteristics, pathway characteristics (pre-admission contacts and admission method) and markers of severity (recorded stage of liver disease, ascites and varices, comorbidity). Alternative risk-adjustment methods were used, including standard regression and propensity-weighted analysis (Inverse Probability of Treatment Weighting).Results3249 admissions (18.5%) were at WE. Unadjusted 30-day mortality was significantly higher for WE versus WD (17.1% vs 15.5%, p=0.018). All models demonstrated increased odds of death for WE admissions with adjusted ORs ranging from 1.15 to 1.23 (relative risk of 1.12–1.19). Causes of death did not vary by admission day and effect was consistent across subgroups. Findings were robust to sensitivity analyses restricting the cohort to patients admitted directly from Accident and Emergency department (A&E), or cirrhosis or ascites but not varices.ConclusionFirst ARLD admissions at the WE experienced a 12–19% increase in 30-day mortality risk compared with WD. Although residual confounding cannot be excluded, this suggests the possibility of avoidable mortality among those hospitalised at WEs. Services should be alert to risks of WE effects when planning care.

Background: Selection of second-line therapy in Crohn’s disease (CD) patients after failure of first-line TNFα-inhibitor (TNFi) therapy to optimise outcomes remains challenging in real-world clinical practice. Objectives: This study aimed to provide real-world outcomes of CD patients who failed first-line TNFi therapy and switched to either another TNFi or to a biologic with a different mechanism of action. Patients were stratified as to whether they switched because of primary non-response or secondary loss of response to initial TNFi. Design: Retrospective cohort study. Methods: CD patients whose first biologic therapy was a TNFi and switched to another biologic therapy between 26 August 2015 and 31 March 2021 were identified in records held by the UK IBD Registry. Patients were enrolled at study sites, and data were validated by clinical teams. Patients were grouped as within-class switchers (WCS) if their second-line (index) biologic therapy was another TNFi, or out-of-class switchers (OCS) if their index therapy was vedolizumab or ustekinumab. Patients were followed up for at least 1 year. Time to drug discontinuation and outcomes at 1 year after index therapy start were analysed using Cox regression and binary logistic regression models, before and after baseline covariate adjustment through inverse probability of treatment weighting. Results: A total of 180 adult CD patients were included in the study. OCS were less likely to discontinue index therapy in both unweighted analysis (hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.42–0.96, p = 0.03) and weighted analysis (HR: 0.58, 95% CI: 0.38–0.90, p = 0.01), and more likely to show index drug persistence at 1 year in both unweighted analysis (adjusted odds ratio (aOR): 3.66, 95% CI: 1.81–7.67, p < 0.001) and weighted analysis (aOR: 3.95, 95% CI: 2.04–7.89, p < 0.001). These findings were consistent across all secondary endpoints of steroid-free and/or surgery-free index drug survival at 1 year. Conclusion: Patients switching from a TNFi to either vedolizumab or ustekinumab exhibited significantly higher rates of drug persistence compared to those switching to another TNFi, particularly among those experiencing primary non-response to the initial TNFi.

Reviews the emerging data on the use of vedolizumab, a monoclonal antibody of the integrin antagonist class of drugs developed for use in inflammatory bowel disease (IBD), in the treatment of ulcerative colitis (UC). Looks at traditional drug treatment, then covers integrin antagonists and the role of the α4β7 integrin in IBD pathogenesis. Discusses vedolizumab efficacy, concomitant therapy, immunogenicity, adverse events, and pharmacokinetics/-dynamics. Source: National Library of New Zealand Te Puna Matauranga o Aotearoa, licensed by the Department of Internal Affairs for re-use under the Creative Commons Attribution 3.0 New Zealand Licence.

Introduction The use of patient reported outcome measures to support routine inflammatory bowel disease (IBD) care is not widespread and suggests that existing questionnaires lack relevance to day-to-day decisions or are too cumbersome to administer. We developed a simple, generic tool for capturing disease control from the patient's perspective to address these barriers. Methods Development based on literature review, patient focus groups/interviews and a steering group, defining a limited set of generic questions. The ‘IBD-Control’ questionnaire comprises 13 items plus a visual analogue scale (VAS) (0–100). Prospective validation involved baseline completion of IBD-Control, quality of life (QoL) questionnaire (UK-IBD-Q), EuroQol (EQ-5D), Hospital Anxiety and Depression Score; and clinician assessment (blinded to questionnaire; recording Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index; Global Clinician Rating; treatment outcome). Results 299 patients returned baseline surveys (Crohn's disease, n=160; ulcerative colitis, n=139) and 138 attended for repeat visits. Completion time (mean; SD): 1 min 15 s; 25 s; Internal consistency: Cronbach's α for all 13 items (0.85); for subgroup of eight questions (‘IBD-Control-8’; 0.86). Strong correlation between IBD-Control-8 and IBD-Control-VAS (r=0.81). Test-retest reliability (2 week repeat): intra-class correlation=0.97 for IBD-Control-8 and 0.96 for IBD-Control-VAS. Construct validity: Moderate-to-strong correlations between IBD-Control-8 and IBD-Control-VAS versus activity indices, UK-IBD-Q and EQ-5D (utility) with r values 0.52–0.86. Discriminant validity (mean instrument scores for remission, mild, moderate or severe): p<0.001 (analysis of variance (ANOVA)). Sensitivity to change: Effect sizes: 0.76–1.44. Conclusions The IBD-Control is a rapid, reliable, valid and sensitive instrument for measuring overall disease control from the patient's perspective. Unlike existing patient reported outcome measures, its simplicity, ease-of-use and generic applicability make it a candidate for supporting routine care.

IntroductionA recent national audit of biological therapies in the UK suggested that the recording of a disease activity index (Harvey-Bradshaw Index or Simple Colitis Activity index) was uncommon in routine settings.1 Our aims were to explore the barriers and facilitators to the use of clinical instruments in hospital-based inflammatory bowel disease (IBD) outpatient services, and the reasons for lack of standardisation in outcome assessment by practitioners.MethodsWe performed structured observations of real-life consultations conducted with 102 patients by 24 clinicians (14 doctors and 10 specialist nurses) at six hospitals across the North West region of England, followed by 24 qualitative semi-structured interviews with observed IBD practitioners. Qualitative data analysis was iterative and drew on thematic approaches to describe observed and self-reported practices, views and preferences.ResultsDuring observed consultations, most clinicians performed personalised assessments of symptoms instead of using a standardised clinical index, and expressed preferences for individualised patient-centred evaluations of health status as opposed to a standardised approach. Practitioners captured indices in only 15% of observed consultations and stated that standardised tools were collected primarily for secondary uses of data and seen as an administrative burden with little relevance to clinical context. The perceived barriers to routine use of indices were 1) lack of application in individual decision making due to weak psychometric properties and poor specificity for inflammation, and 2) practical issues relating to constraints of time and lack of suitable IT infrastructure. Most commonly described facilitators were capture of patient reported outcomes instead of clinician-reported indices, user-friendly data entry tools, administrative support, training and regulatory oversight. Many clinicians, particularly doctors, remained sceptical about the benefits of using standardised assessment tools over clinical judgment.ConclusionsThere are significant technical and human barriers to standardisation of clinical assessments for IBD in routine settings. These findings have several implications for efforts to implement clinical instruments in routine practice. Education and training, evidence-based guidance and better IT capabilities are needed in order to improve the capture of standardised information in busy clinical settings. Direct capture of patient reported outcomes is likely to provide a more feasible approach to capturing standardised outcomes as part of the care delivery process.ReferenceRoyal College of Physicians IBD Programme. National clinical audit of biological therapies. Annual report. 2016. https://www.rcplondon.ac.uk/projects/outputs/national-clinical-audit-biological-therapies-annual-report-2016 (accessed 10 January 2021).