Beyond the guideline: lessons in leadership, limits and legacy from the BSG IBD process

Introduction: the hidden labour behind clinical guidelines The British Society of Gastroenterology’s (BSG) latest 5-year national guideline for inflammatory bowel disease (IBD)1 has recently completed. This adjunct commentary to the guideline contains the reflections of two chairs—one methodological, one clinical—who steered the process. It is not written to seek praise or indulgence but rather to lay bare the pragmatic decisions, structural challenges and emerging questions that surfaced while leading the guideline process. We offer five key insights to inform future BSG guideline work and to contribute to international dialogue on how we produce, update and future-proof clinical guidance in increasingly complex evidence environments. Breadth versus usability: how big is too big? The scope of this guideline is vast—over 100 000 words, 43 recommendations, 114 good practice statements with nearly 800 original manuscripts referenced, prompting peer review to suggest relegating many visual and tabular summaries to supplementary…

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Effects of febuxostat on heart failure patients with asymptomatic hyperuricaemia: a retrospective cohort study

Objectives
To investigate the effects of uric-acid-lowering therapy with febuxostat in asymptomatic hyperuricaemic patients with heart failure.

Methods
In this retrospective cohort analysis, we included consecutive hospitalised patients with heart failure and concomitant asymptomatic hyperuricaemia in Yangzhong People’s Hospital from 1 April 2018 through 1 April 2022. Febuxostat was used to lower serum uric acid. The primary endpoint was defined as a composite of cardiovascular death, recurrent hospitalisation and emergency room visit for cardiovascular (CV) reasons. Additional endpoints included changes in echocardiography measures, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and 6-minute walk test (6MWT) distance from baseline to the most recent clinic visit. Cox analysis was used to determine HR between febuxostat and the control group after adjustment for age, sex, body mass index, serum creatinine, atrial fibrillation and coronary heart disease and the Kaplan-Meier curve was used to describe survival.

Results
979 patients were included in the final analysis (505 in the febuxostat group vs 474 in the control group). In a follow-up duration of 16±9 months, uric acid was significantly lower in the febuxostat group compared with the control group (p

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[Articles] Development of a World Health Organization indicator and corresponding questions to measure effective coverage of rehabilitation

We propose a global tracer indicator for measuring effective coverage of rehabilitation at the population level that is captured through population-based surveys. This global indicator uses chronic primary low back pain as the tracer health condition and World Health Organization Disability Assessment Schedule 2.0 12-item to assess whether quality interventions have been provided that produce the desired health gain.

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What do Australian university staff perceive are the features of high-quality rural health student placements? A sequential explanatory study

Objectives
The aim of this study was to explore the features of high-quality rural health student placements from the perspective of university staff involved in designing, delivering and evaluating these programmes.

Design
A sequential explanatory mixed methods design was employed, integrating quantitative survey data with qualitative interview findings to provide a comprehensive understanding of the research question.

Setting and participants
The study was conducted online and sampled staff from universities across Australia, focusing on rural health student placements. The study involved 121 university staff members who participated in the survey, with 10 of these participants also taking part in follow-up qualitative interviews.

Methods
Quantitative data were collected using an online survey distributed to university staff involved in designing, delivering and evaluating rural health student placements. The survey included Likert scale, open-ended and demographic questions, and a preliminary analysis was used to write the interview questions. Qualitative data were gathered through semi-structured interviews, which were transcribed and analysed using the Framework approach. The quantitative and qualitative results were integrated to produce a narrative summary of findings.

Results
Key features identified as essential for high-quality rural health placements included safe and affordable accommodation, financial support and personal safety. High-quality supervision, cultural awareness training and opportunities for interprofessional education were also highlighted. The qualitative findings provided depth to the quantitative data, emphasising the importance of structuring learning within a continuum of education and fostering connections through co-location and community engagement.

Conclusions
This study identifies fundamental features of high-quality rural health placements in Australia, including accommodation, student safety, supervision and cultural responsiveness training. These findings can inform the design, delivery and evaluation of rural health student placements, contributing to the quality of these programmes as an efficacious learning experience.

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Heated tobacco product use prevalence and temporal trends among the German population: a series of representative cross-sectional household surveys, 2018-2023

Objectives
Heated tobacco products (HTPs) are electronic devices that heat tobacco instead of burning it to produce an inhalable aerosol. This study aimed to investigate usage patterns, sociodemographic and socioeconomic factors, as well as co-use characteristics of people who use HTPs within the German population to inform interventions and preventive measures.

Methods
We conducted analysis with pooled cross-sectional data from the German Study on Tobacco Use (DEBRA) from June 2018 till November 2023. We estimated weighted, descriptive and bimonthly data on current and ever HTP usage and descriptive data on user patterns. To analyse the variance between people who ever versus people who never used HTPs in relation to user characteristics, we performed ² tests and calculated percentages and CIs.

Results
The proportions of both people who currently use and people who ever used HTPs have increased from 2018 (current user: 0.1% [95%CI:

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Bioprinting functional hepatocyte organoids derived from human chemically induced pluripotent stem cells to treat liver failure

Background
To treat liver failure, three-dimensional (3D) bioprinting is a promising technology used to construct hepatic tissue models. However, current research on bioprinting of hepatic tissue models primarily relies on conventional single-cell-based bioprinting, where individual functional hepatocytes are dispersed and isolated within hydrogels, leading to insufficient treatment outcomes due to inadequate cell functionality.

Objective
Here, we aim to bioprint a hepatic tissue model using functional hepatocyte organoids (HOs) and evaluate its liver-specific functions in vitro and in vivo.

Design
Human chemically induced pluripotent stem cells (hCiPSCs) were used as a robust and non-genome-integrative cell source to produce highly viable and functional HOs (hCiPSC-HOs). An oxygen-permeable microwell device was used to enhance oxygen supply, ensuring high cell viability and promoting hCiPSC-HOs maturation. To maintain the long-term biofunction of hCiPSC-HOs, spheroid-based bioprinting was employed to construct hepatic tissue models (3DP-HOs). 3DP-HOs were intraperitoneally implanted in mice with liver failure.

Results
3DP-HOs demonstrated enhanced cell viability when compared with a model fabricated using single-cell-based bioprinting and exhibited gene profiles closely resembling hCiPSC-HOs while maintaining liver-specific functionality. Moreover, 3DP-HOs implantation significantly improved survival in mice with CCl4-induced acute-on-chronic liver failure and also Fah–/– mice with liver failure. 3DP-HOs significantly reduced liver injury, inflammation and fibrosis indices while promoting liver regeneration and biofunction expression.

Conclusion
Our bioprinted hepatic tissue model exhibits remarkable therapeutic efficacy for liver failure and holds great potential for clinical research in the field of liver regenerative medicine.

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Understanding Placebo Mechanisms to Reduce Attrition in Psychiatric Trials

Placebo responses in psychiatric trials are clinically significant and variable. When placebo response is large, the assay sensitivity of a clinical trial can be impacted, meaning that it can potentially result in a failure to detect efficacy for an active treatment. The constituent effects that combine to produce a placebo response are multiple and include both specific placebo mechanisms (eg, expectation effects) and nonspecific effects (eg, regression to the mean). An additional factor that might impact estimates of both treatment and placebo response is missing data.

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Investigating biographical post-bariatric surgery uncertainties in the light of changes in bodily practices: a mixed-method, multicentric and longitudinal research protocol

Introduction
The effects of bariatric surgery have largely been studied from a medical viewpoint, seeking to measure changes in anthropometric, physiological or quality-of-life factors after the operation. Few studies, however, have focused on the dynamics of lifestyle changes. Yet we know that changing lifestyle habits—which are often part of the established social configurations at the origin of morbid obesity—is essential for a sustainable recovery from obesity. We also know that the major bodily transformations that occur in the six to twelve months following surgery produce a high degree of biographical uncertainty and affect social interactions. From a sociological perspective, the authors propose to study the processes of disruption and re-establishment of lifestyle habits in the first 24 months following bariatric surgery.

Methods and analysis
The ChiBarAPS study relies on a mixed-method longitudinal survey, comprising three components: qualitative, quantitative, literature and data review. It aims to document three main dimensions, which must be articulated to understand the dynamics of change: (1) the work undertaken by patients on themselves in order to identify and measure the evolutionary effects of surgery, as well as to adapt to them; (2) the experience of using pre- and post-surgery information and support systems, and evaluating their effects on the agency of the people who have undergone surgery; (3) the evolution of social participation and lifestyle habits. The qualitative component concerns a cohort of 30 patients, interviewed in depth (2 hours) on these three dimensions, 6 months, 12 months and 24 months after the operation. The quantitative part uses questionnaires applied to a second group of 200 patients, following the same timeline.

Ethics and dissemination
This study complies with reference methodology MR004 of the French National Data Protection Authority and was registered by the Data Protection Officer of the University of Montpellier on the activity registry of the institution (24 April 2024). Ethics approval has been obtained from the University of Montpellier ethics research board (n°UM2024-037). Informed consent will be obtained from all participants before data collection. The project has received funding from the French National Research Agency (n°ANR-23-CE41-0020-01) from February 2024 to the end of January 2028. The first results of the research will be disseminated from 2026 onwards to researchers, health professionals and patient support organisations. The results of the study will then be published in peer-reviewed scientific journals, both national and international.

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Learning about Inclusion Health in undergraduate medical education: a scoping review

Objectives
An Inclusion Health movement has gained momentum over the past decade, aiming to address the extreme health inequities faced by socially excluded groups (including people experiencing homelessness, problem substance use, Gypsy, Roma and Traveller communities, vulnerable migrants, sex workers, people in contact with the justice system and victims of modern slavery). Despite this progress, there is a lack of understanding of how the issues are being taught by medical schools. We conducted a scoping review to identify and analyse existing research about Inclusion Health content and pedagogy in undergraduate medical education.

Design
A stepwise scoping review methodology was followed in accordance with the latest manual for evidence synthesis from Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Data sources
A search was undertaken across six bibliographic databases, and additional articles were found through citation and grey literature searching.

Eligibility criteria
Primary research studies and evidence reviews from 2013 onwards were included. There were no restrictions on language.

Data extraction and synthesis
Standardised methods were used to screen possible papers. A charting table was developed to record key information from the 74 papers included. Quantitative steps of the analysis included frequency counts of the extent, nature and distribution of the studies; this was followed by basic qualitative content analysis.

Results
Most educational interventions were optional, or student led, with no longitudinal integration across curricula. There was little evidence of co-production with people with lived experience. Challenges included limited curricula time and faculty expertise, being an emotionally challenging subject, limitations of the biomedical model and informal learning perpetuating stigma. Key enablers included structured reflection, support, positive role models, interaction and co-production with people with lived experience, community partnerships and faculty commitment.

Conclusions
Developments in undergraduate medical education are required to produce doctors equipped to meet the needs of socially excluded groups. We have summarised key aspects of the literature that will be useful to clinicians and educators in this endeavour.

Trial registration number
A review protocol was preregistered in the Open Science Framework on 11 May 2023 and can be accessed at https://osf.io/6c2rk/.

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Ashwagandha (Withania somnifera (L.) Dunal) for promoting recovery in long covid: protocol for a randomised placebo-controlled clinical trial (APRIL Trial)

Background
Long covid describes a syndrome of persistent symptoms following COVID-19 and is responsible for substantial healthcare and economic burden. Currently, no effective treatments have been established. Ashwagandha (Withania somnifera (L.) Dunal) is a medicinal herb traditionally used in India for its immune-strengthening and anti-inflammatory properties. Withanolides, a family of steroid-derived molecules unique to Ashwagandha, have been shown to modulate inflammatory pathways in animal models, and several small randomised trials in humans support its effectiveness for reducing symptoms that are also associated with long covid. Therefore, this study aims to assess whether Ashwagandha is effective and safe for improving functional status and reducing symptom burden in adults living with long covid.

Methods
A randomised double-blind placebo-controlled trial will be performed at participating general practice (GP) surgeries and long covid clinics across the UK. Individuals diagnosed with long covid will be screened for eligibility and then randomised 1:1 to take 1000 mg daily of Ashwagandha root extract tablets (standardised to

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Study protocol for a pre-registered randomised open-label trial of ten-session cognitive behaviour therapy (CBT-T) for eating disorders: does stratified augmented treatment lead to better outcomes?

Introduction
Further improvement of cognitive–behavioural therapy for eating disorders (CBT-ED) is required that can provide better outcomes. Recent work showed that the length of therapy is not critical in improving outcomes. Rather, stratifying the treatment to individual needs is required to produce significant improvements. The current study adopts the approach of evaluating augmentations to ten-session CBT (CBT-T) where initial response to therapy is gradual rather than rapid.

Methods and analysis
Clients aged 15 years and over presenting to the Flinders University Services for Eating Disorders between January 2025 and June 2028 will be randomised to receive either CBT-T as usual or CBT-T augmented with therapy modules (CBT-TA) matched to obstacles to progress for gradual responders. Rapid response, assessed using the Eating Disorder Examination Questionnaire, is defined as ≥1.13 decrease in global ED psychopathology at session 4. In CBT-TA, the therapist and gradual responder will collaboratively choose at least one of nine augmentations to incorporate into therapy. Rapid responders in this group will be given access to the augmentations for use in their own time. Data for the main intent-to-treat analyses will be collected on five occasions: baseline assessment (T1), immediately preceding session 4 (T2), end of treatment (T3) and 3-month and 6-month follow-up (T4 and T5). The primary outcome is ED psychopathology, and secondary outcomes include behavioural indicators of the ED, impairment caused by the ED, general negative emotion, self-harm and hope. Analyses will be undertaken on an intention-to-treat basis and will include all participants in the group to which they were randomised.

Ethics and dissemination
Ethics approval was provided by the Social and Behavioural Research Ethics Committee at Flinders University (7992). This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624001495516). The findings arising from the study protocol will be reported to participants and presented at scientific conferences and disseminated by publications submitted to peer-reviewed journals.

Trial registration number
Australian New Zealand Clinical Trials Registry (ACTRN12624001495516).

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Treatment options for women with heavy menstrual bleeding: a protocol for comprehensive systematic review, network meta-analyses and health economic assessment

Introduction
A quarter of women experience heavy periods in their lifetime, often significantly impairing their well-being, productivity and quality of life.
Several treatment options are offered for heavy menstrual bleeding; however, there is limited evidence on the effectiveness, safety and cost of available treatments. We aim to conduct a comprehensive systematic review, network meta-analyses and health economic evaluation to compare all available treatment options while considering the views and treatment preferences of women with heavy menstrual bleeding.

Methods and analysis
We will systematically search electronic databases (MEDLINE, EMBASE, CENTRAL) as well as the grey literature, conference proceedings and trial registries to identify all relevant randomised trials that evaluated any medical or surgical treatment for women with heavy menstrual bleeding regardless of their cause compared with placebo or other active treatments.
We will perform pairwise and network meta-analyses using standard methods. We will report primarily on changes in menstrual blood loss (using Pictorial blood loss assessment chart scores or the Alkaline-Haematin method), quality-of-life measures, safety in addition to other important clinical outcomes.
We will develop a health economic model to evaluate the cost-effectiveness of available treatments within a healthcare perspective using data inputs from the planned meta-analyses. We will calculate the incremental cost per change in alternative outcomes and present the net monetary benefit for a range of cost-effectiveness thresholds for quality-adjusted life-year gained. We will conduct consultations and a discrete choice experiment involving patient representatives to capture the factors influencing women’s decision-making and treatment preferences in real life.

Ethics and dissemination
The project was approved by the UCL Institute for Women’s Health Low-Risk Research Ethics Committee (reference: 004_2023_24) and UCL Research Ethics Committee (ID 16351/003) for the planned patient involvement and qualitative research. We will produce an evidence-based decision aid toolkit and will publish the findings in peer-reviewed journals, as well as lay media outputs to inform health professionals, policymakers and the patient community.

PROSPERO registration numbers
https://doi.org/10.17605/OSF.IO/4MUSF, CRD42023468055, CRD42024519622, CRD42024520558 and CRD42024520634.

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