27 research outputs found
Developing IBD Outcome Effect Size Thresholds to Inform Research, Guidelines, and Clinical Decisions
BackgroundWhen designing clinical trials, interpreting trial outcomes for guideline development or sharing decisions with patients in clinical practice, the clinical outcomes used and the implicit choices on what constitutes a clinically significant finding can vary greatly. This can lead to diversity or even inequity in care offered to patients with inflammatory bowel disease. The GRADE approach to guideline development has proposed a process to address this prospectively to solve these issues, but this has never been used inflammatory bowel disease (IBD). We aimed to develop the first international consensus set of outcome thresholds to establish their use in Crohn’s disease and ulcerative colitis.MethodsA Delphi methodology was used to develop a consensus. An online survey was conducted by inviting stakeholders from the British Society of Gastroenterology (BSG) through a two-phase process. Participants were asked to select important clinically relevant outcomes and were asked about what magnitude of the effect they consider large, moderate, small, or trivial for each clinical trial outcome in line with the GRADE guidance. The results were fedback to all participants to ensure consensus agreement. Then, further surveys were sent to Europe and North America to ensure validity and international triangulation of the data set. Data are presented as mean percentages with standard deviation (SD).Results131 clinical stakeholders participated including clinicians, IBD nurses and a small number of patients with IBD. Clinical remission and serious adverse events were considered the most critical outcomes for Crohn’s disease while clinical remission and endoscopic remission were for ulcerative colitis. The consensus results for thresholds of small, moderate and large outcome effects size were agreed with as follows: clinical remission 11 (SD 6), 20 (8) and 31 (13), endoscopic remission 9 (5), 17 (9) and 28 (14), and serious adverse events 6 (6), 11 (9) and 17 (12) respectively. No significant differences were observed for responses for each condition.ConclusionThis is the first study to develop a consensus on magnitude thresholds for outcomes in IBD. These thresholds have been used in the development of the 2024 BSG guidelines for the management of IBD but can and should also be used by study designers and mostly importantly for clinicians when discussing evidence with patients as part of shared decision making. Future work to validate these findings globally and with other groups, including patients, is neede
Hidden Republic, Black Armband - 10 Days on the Island
Hidden Republic - a celebration in songs of hope and resistance that delves deep into the songbook of contemporary Indigenous music. Alistair Dobson performs here as a soloist andensemble member in this show that combines the Black Armband and the Tasmanian Symphony Orchestra. Featuring Archie Roach, Jimmy Little, Dewayne Everettsmith, Lou Bennet, Shellie Morris, Ursula Yovich, Emma Donovan and Shane Howar
Breaking into the establishment
In the 1960s Frederick Wiseman began a series of documentaries exploring institutions – schools, hospitals, government departments and even the Juvenile Court. For him, the institution was the star and a gauge for the health of our society. Nowadays, the establishment is still fertile terrain for documentarians but the people inside prisons, psychiatric care facilities and domestic violence organisations tend to hold the media at arm’s length. Bureaucracy and ‘duty of care’ also make institutions very difficult to penetrate. \ud
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In Breaking into the Establishment, we explore the balance of ethical and legal responsibilities against practical considerations filmmakers face negotiating access to subjects and their stories.\ud
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Breaking into the Establishment – a panel on how filmmakers got access to various institutions to make ground-breaking documentaries
British Society of Gastroenterology guidelines on inflammatory bowel disease in adults: 2025
In response to recent advancements in inflammatory bowel disease (IBD) management, the British Society of Gastroenterology (BSG) Clinical Services and Standards Committee (CSSC) has commissioned the BSG IBD section to update its guidelines, last revised in 2019. These updated guidelines aim to complement the IBD standards and promote the use of the national primary care diagnostic pathway for lower gastrointestinal symptoms to enhance diagnostic accuracy and timeliness. Formulated through a systematic and transparent process, this document reflects a consensus of best practices based on current evidence. The guideline, while developed primarily for the UK, is structured to support IBD management internationally. It is endorsed by the BSG executive board and CSSC without external commercial funding, with involvement primarily supported through professional roles in public institutions and the National Health Service (NHS). Methodological revisions since the prior guidelines have enhanced rigor in technical review and development, with methodology details published independently following peer review. In developing the recommendations, 89 clinical experts and stakeholders participated in an online survey, identifying primary outcomes, such as clinical and endoscopic remission, as well as adverse event metrics, all stratified by clinically relevant effect sizes. These guidelines are intended to support clinical decision-making but are not prescriptive, recognizing that individual clinical scenarios may warrant tailored approaches. Further research may inform future revisions as new evidence emerges
A splice of life (home, laptop, wi-fi)
Metramorphosis is a process of change on borderlines and thresholds between being and absence,
memory and oblivion, 1 and non-I, a process of transgression and fading away. The metramorphic
consciousness has no centre, cannot hold a fixed gaze -or, if it has a centre, it constantly slides to the
borders, to the margins.1
This paper examines Bracha Lichtenberg Ettinger’s matrixial theory in relation to her concept of
Metramorphosis as “a process of change on borderlines and thresholds” 2 when experienced from the
perspective of living at home during the pandemic. It attempts to do this by addressing the
circumstances of the artist/author of this paper, as a way to (re)produce encounters, firstly lived
through the screen, then later developed upon through a palimpsestic process whereby layers and
layers of ‘artworking’ are applied through interdisciplinary virtual, digital and analogue methods, as a
response to working through the pandemic
Systematic review: The impact of inflammatory bowel disease-related fatigue on health-related quality of life
BACKGROUND: Fatigue is frequently reported in inflammatory bowel disease (IBD) and impacts on health-related quality of life (HRQoL). HRQoL has not been systematically reviewed in IBD fatigue., AIM: To investigate what impact IBD fatigue has on HRQoL in adults with IBD., METHODS: Systematic searches (CINAHL, EMBASE, PsychINFO, Medline) were conducted on 25 September 2018, restricted to 'human', 'adult', 'primary research' and 'English language'. Search terms encompassed concepts of 'fatigue', 'IBD' and 'HRQoL'. A 5-year time limit (2013-2018) was set to include the most relevant publications. Publications were screened, data extracted and quality appraised by two authors. A narrative synthesis was conducted., RESULTS: Eleven studies were included, presenting data from 2823 participants. Fatigue experiences were significantly related to three HRQoL areas: symptom acceptance, psychosocial well-being and physical activity. Patients reporting high fatigue levels had low symptom acceptance. Psychosocial factors were strongly associated with both fatigue and HRQoL. Higher social support levels were associated with higher HRQoL. Physical activity was impaired by higher fatigue levels, lowering HRQoL, but it was also used as a means of reducing fatigue and improving HRQoL. Quality appraisal revealed methodological shortcomings in a number of studies. Notably, use of multiple measures, comparison without statistical adjustment and fatigue and HRQoL assessment using the same tool were some of the methodological shortcomings., CONCLUSION: Psychosocial factors, symptom management and acceptance and physical activity levels have significant impact on HRQoL. Results support application of psychosocial or exercise interventions for fatigue management. Further exploration of HRQoL factors in IBD fatigue is required, using validated fatigue and HRQoL measures., PROSPERO REGISTRATION NUMBER: CRD42018110005. Copyright © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.https://dx.doi.org/10.1136/flgastro-2019-10135
Safety And Efficacy of Dual Biologics for Inflammatory Bowel Disease
In recent years, the management of Crohn's disease and ulcerative colitis has increasingly focused on advancing treatment options to enhance patient outcomes [1]. Our team is embarking on a comprehensive systems review to evaluate the safety and efficacy of dual biologic therapies. While existing research has provided valuable insights into individual biologic treatments, there remains a significant gap in understanding the potential benefits and risks of using dual biologics
Delphi consensus survey: the opinions of patients living with refractory ulcerative proctitis and the health care professionals who care for them
Refractory ulcerative proctitis presents a huge clinical challenge not only for the patients living with this chronic, progressive condition but also for the professionals who care for them. Currently, there is limited research and evidence-based guidance, resulting in many patients living with the symptomatic burden of disease and reduced quality of life. The aim of this study was to establish a consensus on the thoughts and opinions related to refractory proctitis disease burden and best practice for management. A three-round Delphi consensus survey was conducted among patients living with refractory proctitis and the healthcare experts with knowledge on this disease from the UK. A brainstorming stage involving a focus group where the participants came up with an initial list of statements was completed. Following this, there were three rounds of Delphi surveys in which the participants were asked to rank the importance of the statements and provide any additional comments or clarifications. Calculation of mean scores, analysis of comments and revisions were performed to produce a final list of statements. In total, 14 statements were suggested by the focus group at the initial brainstorming stage. Following completion of three Delphi survey rounds, all 14 statements reached consensus following appropriate revision. We established consensus on the thoughts and opinions related to refractory proctitis from both the experts who manage this disease and the patients living with it. This represents the first step towards developing clinical research data and ultimately the evidence needed for best practice management guidance of this condition. [Abstract copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
EFFICACY AND SAFETY OF THERAPIES FOR INDUCTION AND MAINTENANCE OF REMISSION IN CROHN’S DISEASE: PROTOCOL FOR A NETWORK META-ANALYSIS
Crohn’s disease (CD) is a complex immune mediated inflammatory disease of the intestine, affecting approximately 1 in 300 patients in countries with high prevalence such as the United States of USA and the United Kingdom and is expected to increase in future. (1)
Conventional therapies such as corticosteroids, immunomodulators and surgery played a central role in the management of IBD before the development of advanced targeted therapies. The management principles since then have been transforming, since approval of the first biologic therapy targeting tumour necrosis factor (TNF), infliximab, in early 2000s. Since then various classes of biologics namely anti-integrins, anti-IL-12/23p49, anti-IL23p19 and oral small molecules (JAKi) have been developed in the last two decades and many of them have been approved. With the availability of multiple treatment options, the choice of therapy can be challenging in clinical practice. While head-to-head blinded controlled trials are the ideal method for comparing the efficacy of different drugs, practical limitations make it challenging to conduct multiple trials encompassing all available treatment options.
There is a need for NMAs that examines and compares the efficacy and safety of advanced therapies for CD and immunomodulators.
This protocol describes the steps that will be followed to produce an NMA for induction of remission and another for maintenance of remission
Delphi consensus survey: the opinions of patients living with refractory ulcerative proctitis and the health care professionals who care for them
© 2023 The Authors. Published by BMJ Publishing Group. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website: http://dx.doi.org/10.1136/bmjgast-2023-001139Background Refractory ulcerative proctitis presents a huge clinical challenge not only for the patients living with this chronic, progressive condition but also for the professionals who care for them. Currently, there is limited research and evidence-based guidance, resulting in many patients living with the symptomatic burden of disease and reduced quality of life. The aim of this study was to establish a consensus on the thoughts and opinions related to refractory proctitis disease burden and best practice for management.
Methods A three-round Delphi consensus survey was conducted among patients living with refractory proctitis and the healthcare experts with knowledge on this disease from the UK. A brainstorming stage involving a focus group where the participants came up with an initial list of statements was completed. Following this, there were three rounds of Delphi surveys in which the participants were asked to rank the importance of the statements and provide any additional comments or clarifications. Calculation of mean scores, analysis of comments and revisions were performed to produce a final list of statements.
Results In total, 14 statements were suggested by the focus group at the initial brainstorming stage. Following completion of three Delphi survey rounds, all 14 statements reached consensus following appropriate revision.
Conclusions We established consensus on the thoughts and opinions related to refractory proctitis from both the experts who manage this disease and the patients living with it. This represents the first step towards developing clinical research data and ultimately the evidence needed for best practice management guidance of this condition.Published versio
