Clinical service delivery implications of the COVID-19 pandemic on people with Inflammatory bowel disease: a qualitative study.

BACKGROUND: During the COVID-19 pandemic, clinical services were severely disrupted, restricted, or withdrawn across the country. People living with Inflammatory Bowel Disease (IBD) - an auto-immune disorder for which medical treatment often results in immunosuppression, thus requiring regular monitoring-may have struggled to access clinical support. As part of a larger qualitative study, we investigated experiences of access to clinical services during the pandemic, and patient concerns about and preferences for services in the future. METHODS: This exploratory qualitative study used semi-structured interviews to explore participants' experiences of clinical services across the UK during the pandemic. All data were collected remotely (March - May 2021) using online video-calling platforms or by telephone. Audio files were transcribed professionally and anonymised for analysis. Data were analysed using thematic analysis. RESULTS: Of the eight themes found across all data, four related specifically to accessing GP, local (district) hospital, and specialist (tertiary) referral services for IBD: 1) The Risk of Attending Hospital; 2) Missing Routine Monitoring or Treatment; 3) Accessing Care as Needed, and 4) Remote Access and The Future. CONCLUSIONS: Our findings support other studies reporting changes in use of health services, and concerns about future remote access methods. Maintenance of IBD services in some form is essential throughout crisis periods; newly diagnosed patients need additional support; future dependence on IBD services could be reduced through use of treatment / self-management plans. As the NHS digitalises it's future services, the mode of appointment-remote (telephone, video call), or in-person - needs to be flexible and suit the patient.

Systematic review: advice lines for patients with inflammatory bowel disease.

OBJECTIVE: Advice lines for patients with inflammatory bowel diseases (IBD) have been introduced internationally. However, only a few publications have described the advice line service and evaluated the efficiency of it with many results presented as conference posters. A systematic synthesis of evidence is needed and the aim of this article was to systematically review the evidence of IBD advice lines. MATERIALS AND METHODS: A broad systematic literature search was performed to identify relevant studies addressing the effect of advice lines. The process of selection of the retrieved studies was undertaken in two phases. In phase one, all abstracts were review by two independent reviewers. In phase two, the full text of all included studies were independently reviewed by two reviewers. The included studies underwent quality assessment and data synthesis. RESULTS: Ten published studies and 10 congress abstracts were included in the review. The studies were heterogeneous both in scientific quality and in the focus of the study. No rigorous evidence was found to support that advice lines improve disease activity in IBD and correspondingly no studies reported worsening in disease activity. Advice lines were found to be health economically beneficial with clear indications of the positive impact of advice lines from the patient perspective. CONCLUSION: The levels of evidence of the effect of advice lines in IBD are low. However, the use of advice lines was found to be safe, and cost-effective. Where investigated, patients with IBD overwhelmingly welcome an advice line with high levels of patient satisfaction reported.

Using a geographic information system to enhance patient access to point-of-care diagnostics in a limited-resource setting.

BACKGROUND: Rapid and accurate diagnosis drives evidence-based care in health. Point-of-care testing (POCT) aids diagnosis by bringing advanced technologies closer to patients. Health small-world networks are constrained by natural connectivity in the interactions between geography of resources and social forces. Using a geographic information system (GIS) we can understand how populations utilize their health networks, visualize their inefficiencies, and compare alternatives. METHODS: This project focuses on cardiac care resource in rural Isaan, Thailand. A health care access analysis was created using ArcGIS Network Analyst 10.1 from data representing aggregated population, roads, health resource facilities, and diagnostic technologies. The analysis quantified cardiac health care access and identified ways to improve it using both widespread and resource-limited strategies. RESULTS: Results indicated that having diagnostic technologies closer to populations streamlines critical care paths. GIS allowed us to compare the effectiveness of the implementation strategies and put into perspective the benefits of adopting rapid POCT within health networks. CONCLUSIONS: Geospatial analyses derive high impact by improving alternative diagnostic placement strategies in limited-resource settings and by revealing deficiencies in health care access pathways. Additionally, the GIS provides a platform for comparing relative costs, assessing benefits, and improving outcomes. This approach can be implemented effectively by health ministries seeking to enhance cardiac care despite limited resources.

Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ).

PURPOSE: Despite the significant impact of Crohn's disease (CD) on patients' physical and emotional well-being, no CD-specific patient-reported outcome (PRO) measure is available for determining the efficacy of interventions. The objective of the study was to develop and validate the Crohn's Life Impact Scale (CLIQ), the first such measure. METHODS: Questionnaire content was derived from qualitative interviews with CD patients and face and content validity assessed by cognitive debriefing interviews (CDIs) with patients. A postal survey was conducted to identify the final scale, confirm its unidimensionality and determine reproducibility and construct validity. A subset of the respondents was sent a second questionnaire package 2 weeks after the first. The survey included the CLIQ, Nottingham Health Profile (NHP) and Unidimensional Fatigue Impact Scale (U-FIS). RESULTS: Content analysis was conducted on the 30 interview transcripts and a draft scale produced. The CDIs indicated that the draft scale was relevant, clear and easy to use. The questionnaire package was completed by 273 CD patients (65.6 % male; aged 16-79 (mean 43.9; SD 15.1) years). Of these, 104 also completed the second package. Rasch analysis confirmed a 27-item unidimensional QoL scale (p < 0.05). Both internal consistency and test-retest reliability were high (0.91). Scores on the CLIQ were related to both physical and emotional impairments (NHP) and to fatigue (U-FIS). CONCLUSION: The CLIQ, the first CD-specific PRO, is unidimensional and has excellent psychometric properties. It should prove to be a valuable tool for evaluating the impact of CD and its treatment from the patients' perspective.

Six-month outcomes from a randomized controlled trial to prevent perinatal depression in low-income home visiting clients.

Perinatal depression (PD) has negative consequences for mothers and children and is more prevalent among women of low socioeconomic status. Home visitation programs serve low-income pregnant women at risk for PD. This study tested the efficacy of a group-based cognitive behavioral intervention (Mothers and Babies Course; MB) in reducing depressive symptoms and preventing the onset of perinatal depression among low-income women enrolled in home visitation. A randomized controlled trial was conducted. Seventy-eight women who were pregnant or had a child less than 6 months of age and who were assessed as at risk for PD were randomized to the MB intervention or usual home visiting services. Depressive symptoms were assessed at baseline and 1-week, 3- and 6-months post-intervention; depressive episodes were assessed with a clinical interview at the 6-month follow-up. Depressive symptoms declined at a significantly greater rate for intervention participants than usual care participants between baseline and 1-week, 3 and 6 months post-intervention. At the 6-month follow-up, 15 % of women who received the MB intervention had experienced a major depressive episode as compared with 32 % of women receiving usual care. Integrating mental health interventions into home visitation appears to be a promising approach for preventing PD. Cognitive behavioral techniques can be effective in preventing depression in perinatal populations and treating it.

Significance and structure of clinical research in the UK: an introduction for gastroenterology and hepatology nurses.

This is the first of two articles from the joint British Society of Gastroenterology Nurses association and Research Committee working group. The group is dedicated to signposting and improving access to research for specialist nurses working in gastroenterology and hepatology. This article is an introduction to the significance and structure of the National Institute for Health Research clinical research landscape in the UK and the importance of encouraging nurse engagement in research. This paper describes and 'demystifies' the clinical trials infrastructure in the UK, which is one of the most organised in the world. Going forwards this working group will organise and conduct educational events encouraging specialist nurses to become more aware of and engage in clinical research in their area of practice.

Stepping into nursing research: an introduction for gastroenterology and hepatology nurses.

In this second part of an introduction to research for gastroenterology and hepatology nurses, we aim to build on the first article that introduced the significance and structure of the National Institute for Health and Care Research clinical research landscape in the UK and the importance of nurse engagement. This article introduces possible career pathways available in the profession and specialty. Practical information on how to start research is provided, including an overview of the education, training and support required for a career in research delivery and academic research. Some of the potential barriers to nursing research careers are highlighted, and solutions to navigate a successful career in nursing research are proposed.

A competency framework for inflammatory bowel disease nurses.

More needs to be done to address the professional issues that arise from inflammatory bowel disease (IBD) specialist nurse practice. The lack of regulation of advanced nurse practitioner (ANP) roles in the UK raises questions in relation to inconsistencies of benchmark standards, scope of practice and qualification processes. A review of the literature supports the view that a competency framework for ANP roles would demonstrate knowledge and skills in the absence of UK regulation. The benefits of such a framework have already been recognised in different areas of gastroenterology and other specialties. A specific competency framework is required for IBD specialist nurses to provide transparency and governance in this area of practice.

Scoping review with textual narrative synthesis of the literature reporting stress and burn-out in specialist nurses: making the case for inflammatory bowel disease nurse specialists.

OBJECTIVE: Inflammatory bowel disease clinical nurse specialists (IBD-CNSs) face increasing pressures due to rising clinical and patient demands, advanced complexity of work role, and minimal specialist management training and support. Stress and burn-out could undermine the stability of this workforce, disrupting clinical provision. We reviewed the literature on stress and burn-out to demonstrate the lack of evidence pertinent to IBD-CNSs and make the case for further research. DESIGN: Following Levac et al's scoping review framework, relevant databases were searched for publications reporting work-related stress and burn-out among specialist nurses. Following screening and consensus on selection of the final articles for review, all authors contributed to data charting. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review extension guided reporting of the review. RESULTS: Of 194 retrieved articles, eight were eligible for review. None focused on IBD-CNSs, were qualitative, or UK-based. Three core themes were identified: Rates of Burn-out, Mitigating and Alleviating Factors, and Preventing and Resolving Burn-out. Risk of burn-out is greatest in novice and mid-career CNSs. Age and duration in role appear protective. Personal achievement is also protective and can mitigate earlier episodes of burn-out; opportunities for career progression are limited. Promoting personal well-being is beneficial. Senior managers have poor understanding of the role and provide inadequate support. Commitment to patients remains high. CONCLUSION: Burn-out arises in CNSs across clinical specialisms in the international literature and has a significant negative effect on the workforce. Further research is needed to address the dearth of evidence on burn-out in IBD-CNSs in the UK.

A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn's disease. The Cross Pennine study II.

BACKGROUND: The optimal choice of biological agents after failure of anti-tumour-necrosis-factor-(TNF)α agent in Crohn's disease (CD) is yet to be defined. AIMS: To assess the effectiveness and safety of ustekinumab compared to vedolizumab as second-line treatment in CD patients who failed anti-TNFα therapy. METHODS: Retrospective analysis of clinical response and remission at 14 and 52 weeks to ustekinumab by physician global assessment (PGA). A propensity score-matched analysis with a cohort treated with vedolizumab was performed. RESULTS: Of 282 patients (mean age 40 ± 15, F:M ratio 1.7:1) treated with ustekinumab, clinical response or remission was reached by 200/282 patients (70.9%) at 14 weeks, and 162/259 patients (62.5%) at 52 weeks. Overall, 74 adverse events occurred, of which 26 were labelled as serious (8.3 per 100 person-year). After exclusion of patients without prior anti-TNFα exposure and patients previously exposed to vedolizumab or ustekinumab, we analysed 275/282 patients (97.5%) on ustekinumab and 118/135 patients (87.4%) on vedolizumab. Propensity score analysis revealed that at 14 weeks, patients treated with ustekinumab were 38% (95% CI 25%-50%; P < 0.001) more likely to achieve clinical remission, while at 52 weeks, the difference of 9% (95% CI -15% to 33%; P = 0.462) was not significant. CONCLUSIONS: Ustekinumab was effective and well tolerated in this real-world cohort. While ustekinumab proved more effective at 14-weeks, we found no statistically significant differences at 52 weeks compared to vedolizumab.

A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease: The Cross Pennine study.

BACKGROUND: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest. AIMS: To assess clinical outcome and safety in IBD patients treated with vedolizumab. METHODS: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014-January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined. RESULTS: Two hundred and three IBD patients (mean treatment 16 ±â€¯8 months) were included. Of these, 135 patients (mean age 40.6 ±â€¯16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ±â€¯18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5%) CD and 62/68 (91.2%) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9%) CD and 52/63 (82.5%) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97%). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years. CONCLUSION: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.

A qualitative study of the impact of Crohn's disease from a patient's perspective.

OBJECTIVE: To understand how the lives of people with Crohn's disease (CD) are affected. Most research in CD has focused on symptoms and functioning rather than on how these outcomes influence quality of life (QoL). DESIGN: As part of a study to develop a CD-specific patient-reported outcome measure, qualitative interviews were conducted with patients from Manchester Royal Infirmary to determine how CD affects QoL. The needs-based model was adopted for the study. The interviews, which took the form of focused conversations covering all aspects of the impact of CD and its treatment, were audio-recorded. Theoretical thematic analysis of the transcripts identified needs affected by CD. RESULTS: Thirty patients (60% female) aged 25-68 years were interviewed. Participants had experienced CD for between 2 and 40 years. Nearly 1300 statements relating to the impact of CD were identified. Thirteen main need themes were identified: nutrition, hygiene, continence, freedom from infection, security, self-esteem, role, attractiveness, relationships, intimacy, clear-mindedness, pleasure and autonomy. CONCLUSIONS: The findings from the interviews indicate that CD has a major impact on need-fulfilment. Such issues should be addressed in CD audit, clinical trials and when evaluating clinical practice.

What Are the Top 10 Research Questions in the Treatment of Inflammatory Bowel Disease? A Priority Setting Partnership with the James Lind Alliance.

BACKGROUND AND AIMS: Many uncertainties remain regarding optimal therapies and strategies for the treatment of inflammatory bowel disease. Setting research priorities addressing therapies requires a partnership between health care professionals, patients and organisations supporting patients. We aimed to use the structure of the James Lind Alliance Priority Setting Partnership, which has been used in other disease areas, to identify and prioritise unanswered questions about treatments for inflammatory bowel disease. METHODS: The James Lind Priority Setting Partnership uses methods agreed and adopted in other disease areas to work with patients and clinicians: to identify uncertainties about treatments; to agree by consensus a prioritised list of uncertainties for research; then to translate these uncertainties into research questions which are amenable to hypothesis testing; and finally to take results to research commissioning bodies to be considered for funding. RESULTS: A total of 1636 uncertainties were collected in the initial survey from 531 respondents, which included 22% health care professionals and 78% patients and carers. Using the rigorously applied processes of the priority setting partnership, this list was distilled down to the top 10 research priorities for inflammatory bowel disease. The top priorities were: identifying treatment strategies to optimise efficacy, safety and cost-effectiveness; and stratifying patients with regard to their disease course and treatment response. Diet and symptom control [pain, incontinence and fatigue] were also topics which were prioritised. CONCLUSIONS: A partnership involving multidisciplinary clinicians, patients and organisations supporting patients has identified the top 10 research priorities in the treatment of patients with inflammatory bowel disease.

Identification of Research Priorities for Inflammatory Bowel Disease Nursing in Europe: a Nurses-European Crohn's and Colitis Organisation Delphi Survey.

BACKGROUND: Robust research evidence should inform clinical practice of inflammatory bowel disease [IBD] specialist nurses, but such research is currently very limited. With no current agreement on research priorities for IBD nursing, this survey aimed to establish topics to guide future IBD nursing research across Europe. METHODS: An online modified Delphi survey with nurse and allied health professional members of the Nurses European Crohn's and Colitis Organisation [n = 303] was conducted. In Round One, participants proposed topics for research. In Round Two, research topics were rated on a 1-9 scale and subsequently synthesised to create composite research questions. In Round Three, participants selected their top five research questions, rating these on a 1-5 scale. RESULTS: Representing 13 European countries, 88, 90 and 58 non-medical professionals, predominantly nurses, responded to Rounds One, Two and Three, respectively. In Round One, 173 potential research topics were suggested. In Rounds Two And Three, responders voted for and prioritised 125 and 44 questions, respectively. Round Three votes were weighted [rank of 1 = score of 5], reflecting rank order. The top five research priorities were: interventions to improve self-management of IBD; interventions for symptoms of frequency, urgency and incontinence; the role of the IBD nurse in improving patient outcomes and quality of life; interventions to improve IBD fatigue; and care pathways to optimise clinical outcomes and patient satisfaction. CONCLUSIONS: The prioritised list of topics gives clear direction for future IBD nursing research. Conducting this research has potential to improve clinical practice and patient-reported outcomes.

An evaluation study of a pilot group education programme for inflammatory bowel disease.

BACKGROUND AND AIMS: The emphasis for healthcare clinicians to provide adequate disease-related education is increasing. Yet little is known about the effect of providing disease-related education within inflammatory bowel disease (IBD). Previous studies have demonstrated increased levels of knowledge and satisfaction, but failed to capture any positive effects on the psychosocial elements of living with IBD. The aim of this qualitative study was to evaluate the impact of providing a group patient education programme on the psychosocial elements of living with IBD. METHODS: The data were obtained through eight semistructured qualitative interviews. Participants were recruited at the education programme using purposive sampling. All the interviews were digital recorded and transcribed. Thematic analysis was used by two independent researchers to analyse the transcripts and agreed emerging themes. RESULTS: A global theme of 'mastery' was evident within the transcripts. This was underpinned with two core themes of enablement and cooperative learning. The education programme 'enabled' the participants in a variety of ways: increased confidence, control, courage and power over their disease. An unexpected core theme of cooperative learning was also identified, with participants describing the overwhelming benefit of interaction with other people who also had IBD. CONCLUSIONS: This is the first qualitative study to report on the effects of providing a group patient education within IBD. The results identify new and interesting psychosocial elements that existing quantitative studies have failed to identify.

Aligning oral mesalazine treatment to health service priorities: guidance for nurses.

Oral mesalazine represents a crucial front-line agent for the treatment of active ulcerative colitis (UC) and the maintenance of remission. Clinical aspects of mesalazine therapy are guided by robust evidence-based guidelines, although there is a relative paucity of guidance examining the specific administrative and professional issues faced by inflammatory bowel disease (IBD) nurses. As IBD nurses frequently influence treatment decisions in UC, this article was written to provide a practical review of the key evidence and issues affecting mesalazine treatment. Therefore, it may act as an additional resource for IBD nurses, to enhance prescribing decisions. Using the UK's Quality, Innovation, Productivity and Prevention (QIPP) agenda as a framework, it considers clinical and health service priorities affecting treatment decisions. The quality of care perspective naturally focuses on efficacy; recent interest in specific aspects of efficacy, such as the speed of symptom resolution allows targeting of mesalazine treatment to individual needs. Furthermore, innovative adherence programmes build on the latest evidence to develop robust, integrated patient support approaches. In terms of productivity, nurse-led activities and more sophisticated management strategies may offer the best routes towards reducing the costs of care. Key opportunities for preventing ill health include improving adherence to maintenance therapy and achieving mucosal healing. The principles and approaches highlighted by the QIPP agenda emphasise that prescribing decisions for mesalazine in UC must take account of the full spectrum of clinical and health service needs, and cannot focus on any one element in isolation.

N-ECCO survey results of nursing practice in caring for patients with Crohn's disease or ulcerative colitis in Europe.

BACKGROUND AND AIMS: The difference in nursing roles when caring for patients with inflammatory bowel disease varies across Europe with different levels of responsibility. This might vary widely from country to country and even hospital to hospital depending on the local requirements of the patients and the gastroenterology team. This survey was developed to assess the current nursing practice across Europe. METHODS: A total of 220 nursing delegates who attended the N-ECCO Meeting and School in 2012 were invited to complete a survey. The survey consisted of 11 questions about the role and responsibility of nurses in the care of patients with inflammatory bowel disease. RESULTS: Of the 220 European nurses, 192 responded (87%). A majority (61%) came from 5 European countries, most were between 30 and 50 years old, 73% worked in public hospitals and 68% were involved in adult care. The level of education varied equally between certificate level, degree level, diploma level and masters' level. The nurses' level of experience, above that of the level of education, was the main factor in determining whether to offer advice or not to the patient, independent of a doctor (p<0.01). CONCLUSION: This survey has provided an understanding of the nursing role in the care of patients with IBD across Europe as well as Australia, Canada and Israel. It demonstrates that the role of nurses in IBD exists in various settings within hospital care, providing complex management and autonomous nursing care in a range of services to a significant number of patients with IBD.

An exploration of the follow-up up needs of patients with inflammatory bowel disease.

BACKGROUND AND AIMS: The rising incidence of inflammatory bowel disease (IBD) in adults and children has implications for the lifelong burden of disease and the provision of specialist services. Patients with IBD should have access to specialist care which is delivered according to their values and needs. Few studies have examined patients' views of follow-up care. The aim of this qualitative study was to explore patients' needs, preferences and views of follow-up care. METHODS: IBD patients were selected from a gastroenterology clinic in a UK Hospital and invited to participate in interviews which focused on needs, preferences and role of follow-up, their experience of follow-up, service delivery, and other models of follow-up care. RESULTS: 24 patients were recruited, 18 patients had Crohn's Disease, and 6 ulcerative colitis. Median age was 48.5 years (range was 27-72 years) and median disease duration 11.5 years (range 2-40 years). Four main themes emerged: (1) experiences of current follow-up care; (2) attitudes to new models of care, including self-management, role of general practitioner, patient-initiated consultations and 'virtual' follow-up; (3) the personal value of follow-up care; and (4) the 'ideal' consultation. CONCLUSION: The main finding was that patients prefer a more flexible follow-up care system. 'Virtual' care as an adjunct to patient-initiated consultations and self-management, was identified as optimal approaches to meet the patients' needs of follow-up care. New models of follow-up care could improve the patients' experience of care, offer potential cost savings with reduction in face-to-face consultations and allow targeted care to those who need it.

Understanding the health and social care needs of people living with IBD: a meta-synthesis of the evidence.

AIM: To undertake a metasynthesis of qualitative studies to understand the health and social needs of people living with inflammatory bowel disease (IBD). METHODS: A systematic search strategy identified qualitative studies exploring the phenomenon of living with inflammatory bowel disease. Databases included MEDLINE, PsychInfo, EMBASE, CINAHL and the British Nursing Index via the OVID platform. Qualitative search filters were adapted from Hedges database (http://www.urmc.rochester.edu/hslt/miner/digital_library/tip_sheets/Cinahl_eb_filters.pdf). Qualitative empirical studies exploring the health and social needs of people living with inflammatory bowel disease were selected. Study eligibility and data extraction were independently completed using the Critical Appraisal Skills Programme for qualitative studies. The studies were analysed and synthesised using metasynthesis methodology. The themes from the studies allowed for common translations into a new interpretation of the impact of living with inflammatory bowel disease. RESULTS: Of 1395 studies, six published studies and one unpublished thesis fulfilled the inclusion criteria. First iteration of synthesis identified 16 themes, 2nd iteration synthesised these into three main 2nd order constructs: "detained by the disease"; "living in a world of disease" and "wrestling with life". "Detained by the disease" is the fear of incontinence, the behaviour the patients display due to the fear, and the impact this has on the individual, such as social isolation and missing out on life events. All of these serve to "pull" the patient back from normal living. "Living in a world of disease" is the long term effects of living with a long term condition and the fear of these effects. "Wrestling with life" is the continued fight to thrive, the "push" to continue normal living. CONCLUSION: The metasynthesis provides a comprehensive representation of living with IBD. The unmistakeable burden of incontinence is exposed and its ongoing effects are demonstrated. The combined overall impact of living with IBD is the tension these patients live with: "Pushed and pulled: a compromised life", people living with IBD experience a constant conflict throughout their lives, they push to be normal but IBD pulls them back. The impact of the fear of incontinence and behaviour of the individual as a result, requires further qualitative enquiry.