Conectar
Newborn bloodspot screening (NBS) is freely and universally available to babies born in Australia, with nearly 300 000 newborns screened each year. The NBS programme screens for approximately 30 conditions; however, there are hundreds of childhood conditions that could be treated if identified earlier and asymptomatically. Contemporary screening platforms have relied on mass spectrometry-based technologies, limiting surveillance to conditions with validated biomarkers detectable within the neonatal period. Advancements in metabolic techniques and genomics have expanded the range of conditions that could be detected. The NewbornsInSA research study will develop, validate and evaluate a novel multi-omic model of newborn screening, integrating metabolomic and genomic newborn screening as complementary methodologies.
Parents can opt in to additional NBS through NewbornsInSA during pregnancy or shortly after birth. One thousand prospectively recruited families will be offered genomic NBS by whole-genome sequencing, including analysis of a virtual gene panel of over 600 genes, and concurrent metabolomic screening. Clinically actionable pathogenic or likely pathogenic genetic variants will be reported to parents and whole genome sequencing data will be available on request for diagnostic reanalysis, if required later in life.
Acceptability of the NewbornsInSA programme will be evaluated through stakeholder engagement activities with healthcare professionals, members of the public and patient advocacy groups. Family experiences will be assessed using online surveys. The diagnostic yield, accuracy and the costs and consequences of the multi-omic NBS model will be assessed by comparison to standard-of-care NBS.
NewbornsInSA will investigate the acceptability, feasibility and cost-effectiveness of a multi-omic newborn screening model in a prospectively recruited South Australian population. We hypothesise that this approach will increase the number of conditions identified, reduce the time to diagnosis and facilitate earlier care with better outcomes for newborns with genetic conditions.
This research study has been ethically approved by the Women’s and Children’s Health Network Human Research Ethics Committee (2022/HRE00258 and 2023/HRE00236). Findings will be disseminated through peer-reviewed publication and conferences.
Inadequate production of the essential stress hormone, cortisol, results in adrenal insufficiency (AI), which is associated with significant morbidity and mortality. The current standard diagnostic test for AI is the Short Synacthen Test (SST), but this is both invasive and resource-intensive, involving cannulation and blood sampling. A novel formulation, Nasacthin, has been developed in which the same Active Pharmaceutical Ingredient can be delivered intranasally, with the resultant glucocorticoid levels either measured in serum, or in saliva samples to render the test non-invasive, thus creating a potentially more cost-effective test. The Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide (STARLIT-3) study aims to determine the diagnostic utility of the test in patients with AI.
STARLIT-3 is a randomised 2-way crossover trial which aims to collect data from 32 AI patients allocated to receive both Synacthen and Nasacthin in a random order across two study visits. Paired blood and saliva samples will be collected from participants at baseline, and then at 30 and 60 min after drug administration. Glucocorticoid levels in study samples will be quantified with the aim to determine whether the Nasacthin test is able to correctly diagnose patients with AI by estimating the positive percent agreement with the standard SST using serum cortisol at 30 and 60 min. Data on any reported harms and on the acceptability, usability and tolerability of the Nasacthin test will also be collected.
The study and subsequent amendments have been reviewed and approved by South Central—Hampshire A Research Ethics Committee. Results will be published in peer-reviewed journals and presented at national and international conferences. Plans for dissemination of results to trial participants will be developed in collaboration with patient and public involvement and engagement groups.
Breast screening uptake remains low in parts of the UK, partly due to barriers including limited transport access. Offering free transport to screening appointments may help address this and improve uptake. This general practitioner (GP) cluster-randomised feasibility trial will assess whether offering free door-to-door transport alongside routine screening invitations increases attendance.
Eight general practices in Yorkshire will be randomised to either the intervention (routine invitation plus information about booking free door-to-door transport) or control (routine invitation only) group. Around 8000 women due for routine breast screening will be included. Primary feasibility outcomes include GP recruitment and randomisation, intervention fidelity, proportion of women from the 10% most deprived areas, acceptability and data transfer processes. Secondary outcomes include understanding travel behaviour, cost-effectiveness and screening uptake. Data will be collected from routine National Health Service (NHS) screening records, data linkage with NHS England, travel surveys and qualitative interviews exploring experiences and acceptability. Patient and public involvement is embedded throughout with members contributing to advisory and oversight roles.
The trial has received ethical approval from the London–Harrow Research Ethics Committee, Section 251 approval from the Confidentiality Advisory Group and other relevant regulatory bodies. The University of Hull is the study sponsor. Results will be disseminated through peer-reviewed journal publications, conference presentations and plain English summaries for participants and the public. Findings will inform the feasibility and design of a potential larger trial to improve breast screening uptake via transport support.
To characterise neighbourhood food environments in British Columbia (BC) and determine whether food environment characteristics are associated with fruit and vegetable (FV) intake.
A cross-sectional study using geospatial linkage of food environment measures within 1 km residential buffers, analysed with mixed-effects models
Urban neighbourhoods in BC, Canada.
Approximately 25 000 adults aged 35–69 years from the BC Generations Project cohort.
FV intake as a continuous variable (servings/day) and as a binary measure (
Approximately 50% of participants lived in neighbourhoods without chain grocery stores, fast-food outlets or convenience stores within walking distance. Neighbourhoods in the highest density category for fast-food outlets were associated with lower odds of consuming ≥5 servings of FV per day (OR=0.89, 95% CI 0.80 to 0.98). Associations between chain grocery stores, convenience stores and FV intake were attenuated after adjusting for neighbourhood characteristics including walkability, and material and social deprivation.
The findings suggest limited neighbourhood access to retail food outlets across urban areas in BC. Participants living in neighbourhoods with greater density of fast-food restaurants were less likely to consume
Occupational gender segregation is a contributing factor to gender pay inequity in medicine but has not been thoroughly characterised. We assessed the historical relationship between surgeon sex, type of work and value of procedural payments. We hypothesised that female surgeons perform lower-paying procedures as a group, and that this could be seen both with broad historical overview and with focused analysis of major operative procedures in a specific year.
We conducted repeated cross-sectional studies using public payment data from the Canadian Institute for Health Information. We calculated average payment per service by sex and service category and used linear regression to assess the association between proportion of female surgeons performing a procedure and payment value per procedure for 41 major procedures in 2019–2020.
Surgeons in 10 Canadian jurisdictions from 1996 to 1997 (5459) to 2019–2020 (8069).
The proportion of female surgeons increased over the study period from 10.5% (n=575) in 1996–1997 to 28.7% (n=2314) in 2019–2020. The sex gap in the average payment per service narrowed but persisted. A greater proportion of women’s earnings came from non-procedural work in consultation and visits (43% for women vs 36% for men in 2019–2020) while a greater proportion of men’s earnings was from procedural work in major surgery (23% for women vs 38% for men in 2019–2020). There was an inverse relationship between proportion of women performing a procedure and payment value such that for one percent increase in female proportion, the procedural payment was CAD$1.77 lower.
Our findings suggest that women receive fewer procedural payments than men and tend to perform lower paying procedures. Reforms to referral systems and billing codes can help address root causes for the gender pay gap in surgery.
Cognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.
Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.
Ethical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.
Osteogenesis imperfecta (OI) is the most common inherited cause of bone fragility (approximately 1 in 16 000). People with OI suffer bone fragility causing fractures, pain and deformity; sarcopenia causing fatigue and poor endurance; aortic root dilatation and hearing loss. No drug currently has market authorisation to treat OI in Europe. Current standard-of-care is multidisciplinary, with pharmacological interventions—primarily bisphosphonates—directed at increasing bone mass; however, such interventions are of equivocal efficacy. The structural damage that can accumulate as a result of repeated fractures over time may not be reversible. The lack of a treatment with clearly defined efficacy in terms of reducing fracture frequency or the sarcopenia, that is increasingly recognised in this condition, leads to the consideration of alternatives based on what is known about the molecular pathophysiology of the condition. For reasons that are currently unclear, transforming growth factor beta (TGFβ) pathway signalling is increased in OI, and both studies in mouse models and more recently also in humans suggest that reducing TGFβ pathway signalling could be of benefit in OI. This demonstrator project tests the hypothesis that losartan, an antihypertensive agent known to reduce circulating TGFβ, will reduce bone turnover and bone loss and have a positive effect on muscle function and quality of life in adults and older adolescents with OI.
This is a phase 2/pilot, open-label, dose-escalating study. This study aims to identify the effective dose for losartan in this population to inform the design of a pivotal phase III study. The study aims to recruit 30 adolescents and adults aged 16 years and above with OI across secondary care study sites in the UK and Italy. Participants will be recruited from the patient populations attending for treatment of OI at the participating hospital sites or referred by clinicians at the Participant Identification Centres (PIC sites). Participants will be randomised to one of three ‘final doses’—25, 50 or 75 mg losartan once daily. All participants will start on 25 mg once daily. Those assigned to higher ‘final doses’ will increase in 25 mg once daily increments on day 8 and day 15 following safety assessments. The primary outcome measures are to establish the effective dose of losartan in OI patients, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX) over the 24-week period of the study.
Secondary outcome measures are to determine the changes in proxy efficacy outcomes for bone (turnover, mass, architecture and strength) using blood tests, high-resolution peripheral quantitative CT (HRpQCT), dual-energy X-ray absorptiometry (DXA) and muscle (strength) using the ‘Timed Up and Go’ test. In addition, the changes in quality of life, including pain and fatigue, will be evaluated by using a disease-specific tool (OI-QOL) and a validated generic tool (EQ-5D-5L-VAS).
In the UK, the study protocol and amendments have been approved by the London Bridge Research Ethics Committee (REC reference: 23/LO/015) and by the Medicines and Healthcare products Regulatory Agency (MHRA). In Italy, the study protocol and amendments have been approved by the Italian and European ethics and regulatory authorities (Clinical Trials Information System European Union (CTIS EU) portal according to EU Regulation 536/2014). Final version of study protocol: Version 3.2, 05.03.2025. Final results will be disseminated in peer-reviewed journals through local OI, orthopaedic and other relevant clinical networks and at national and international meetings. Sheffield Children’s National Health Service Foundation Trust (UK) and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli (Italy) are the joint study sponsors.
ISRCTN (ISRCTN13317811).
To investigate the attitudes of physicians towards addressing environmental sustainability in patient conversations, and to identify barriers and facilitators to doing so.
A qualitative, nation-wide study was conducted using semi-structured online focus groups and interviews. Reflexive thematic analysis was used to analyse transcripts, guided by the Theoretical Domains Framework.
Secondary and tertiary healthcare institutions in the Netherlands.
Participants were medical specialists and residents in obstetrics and gynaecology (OB-GYN physicians) in the Netherlands. Participants were purposefully identified to capture diverse demographics and practice settings.
Physicians’ attitudes towards discussing the environmental impact of healthcare and the health effects of environmental pollution with patients. Themes were identified and categorised using the Theoretical Domains Framework.
The study included 28 OB-GYN physicians working across 23 healthcare institutions in the Netherlands. Six themes were developed: (1) strong sense of urgency to reduce healthcare's environmental impact, (2) knowledge gaps impair communication about environmental impact to patients, (3) prioritisation of individual patient health over environmental concerns in decision-making, (4) perceived lack of patient interest in environmental outcomes, (5) system-level support facilitates discussions about environmental sustainability with patients and (6) limited perceived value in discussing the health effects of environmental pollution and climate change with patients.
OB-GYN physicians are supportive of discussing the environmental impact of healthcare services when clinically appropriate. Addressing knowledge gaps, providing evidence-based guidance and embedding sustainability into clinical guidelines and decision aids may facilitate the integration of environmental sustainability into patient-provider interactions.
To compare costs and health consequences and to assess the cost-effectiveness of using low-dose oral long-acting morphine in people with chronic breathlessness.
Within-trial planned cost-consequences and cost-effectiveness analysis of data from a multisite, parallel-group, double-blind, randomised, placebo-controlled trial of low-dose, long-acting morphine.
11 hospital outpatients across the UK.
Consenting adults with chronic breathlessness due to long-term cardiorespiratory conditions.
5–10 mg two times a day oral long-acting morphine with a blinded laxative for 56 days.
Mean and SD of healthcare resource use (HRU) by trial arm; mean differences and 95% CI of costs between trial arms.
Mean differences in 28- and 56-day quality-adjusted life years (QALYs based on EuroQol five-dimension five-level score), Short Form-six dimensional scores and ICEpop CAPability-Supportive Care Measure scores; cost-utility of long-acting morphine for chronic breathlessness.
143 participants (75 morphine and 67 placebo) were randomised; 140 (90% power, males 66%, mean age 70.5 (SD 9.4)) formed the modified intention-to-treat population (participants receiving at least one dose of study medication). There were more inpatient and fewer outpatient services used by the morphine group versus the placebo. In the base-case analysis at 56 days, long-acting morphine was associated with similar mean per-patient costs and QALYs. There was an increase of £24 (95% CI –£395 to £552) and 0.002 (95% CI –0.004 to 0.008) QALYs. Hospitalisations were the main driver of cost differences. The corresponding incremental cost-effectiveness ratio was £12 000/QALY, with a probability of cost-effectiveness of 54% at a £20 000 willingness-to-pay threshold. In the scenario analysis that excluded costs of adverse events considered unrelated to long-acting morphine by site investigators and researchers, the probability of cost-effectiveness increased to 73%.
Oral morphine for chronic breathlessness is likely to be a cost-effective intervention provided adverse events are minimised, but the effect on outcome is small and cautious interpretation is warranted.
Nurses are the frontline healthcare professionals fighting the medical and social effects of the current COVID-19 pandemic. Although they work with diverse populations, there is a lack of literature on culturally competent education during an emergency such as a pandemic.
To examine the effectiveness of an online education programme aimed at increasing cultural competence among rescue teams and healthcare professionals facing the challenges of the COVID-19 pandemic.
Pre–post-web-based intervention study.
Pre–post-intervention surveys were administered to a matched sample of Israeli healthcare and rescue organisation professionals. The initial sample included 303 participants (52% women) who completed the pre-intervention survey. More than half of the sample (56%, n = 170) were paid workers or volunteers in health organisations. Of the initial sample, 154 participants completed the post-intervention survey following the online cultural competence education programme. Descriptive statistics and multivariate analysis were used to evaluate participants’ gains in culturally competent attitudes, knowledge, skills and encounters. This study followed the STROBE guidelines.
Participants found the online programme useful in improving their cultural competence during the COVID-19 pandemic. The highest gains were found in the attitudes domains, whereas the lowest in the knowledge domain. Pre-intervention cultural competence scores and incorporating the programme in the educational curricula predicted increased gains in cultural competence.
Online educational interventions showed potential for increasing professionals’ awareness of cultural biases, differences and attitudes, leading to more open and accepting attitudes towards patients of different backgrounds.
Recognising the need for real-time, low-cost and available training, the World Health Organization recommended using online courses for healthcare professionals struggling in the pandemic frontline. Online education programmes provide a useful platform for training health professionals in times of emergency.
Diabetes mellitus is a significant global health challenge, requiring innovative strategies to improve management and mitigate complications. Digital health technologies offer promising solutions to enhance diabetes self-care by providing real-time feedback, improving communication and supporting data-driven decision-making. Despite the increasing adoption of digital self-care interventions, there is a lack of comprehensive synthesis of evidence on their impact, accessibility and integration into healthcare systems. This scoping review aims to map existing research on digital self-care solutions for diabetes management, identify knowledge gaps and highlight best practices and key factors influencing adoption.
The review will follow Arksey and O’Malley’s framework and adhere to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A systematic search will be conducted in Medline, Scopus, Embase, CINAHL and Google Scholar, focusing on studies published from January 2004 to December 2024 in English, French, Arabic, Portuguese, Spanish, Italian, Czech, Slovak and Chinese. Studies reporting on digital self-care solutions for diabetes management will be included, covering experimental and quasi-experimental study designs. Data extraction will cover study and participant characteristics, digital solution features, and barriers and facilitators to adoption. Ethical and equity considerations will also be analysed using established frameworks. Two reviewers will independently screen studies, with discrepancies resolved by a third reviewer.
This scoping review will provide a comprehensive understanding of digital self-care solutions for diabetes management, offering insights to inform future research and enhance self-care practices globally. Findings will be disseminated through peer-reviewed publications, conferences and interest holder engagements to inform clinical practice and policy development. As this study involves the review of existing literature, ethical approval is not required.
Lymphoma is a haematologic malignancy affecting cells of the immune system. With numerous treatment options available, clinicians and patients frequently face difficulty in selecting the most appropriate therapy. Patient-reported Outcome (PRO) offers valuable patients’ insight that may support treatment differentiation. A PRO measure (PROM) is a questionnaire or survey measuring a PRO. Despite many efforts to guide the selection of PROMs in clinical trials, choosing the appropriate ones remains a challenge. This study aims to develop a pragmatic paradigm for selecting PROMs in clinical trials involving adult patients with lymphoma through the collaboration and communication between clinical investigators involved in trials and Health Economics and Outcomes Research (HEOR) scientists specialised in research methodologies.
A rapid review was conducted to identify existing PROMs for adult patients with lymphoma in clinical trials and guidelines supporting PROM selection.
PubMed, Google Scholar and websites for regulatory and health technology assessment (HTA) bodies in eight countries of interest were searched from 2009 to July 2024.
Publications with PROMs were identified for adult patients in lymphoma trials. The most relevant guidelines supporting the development of the pragmatic paradigm were selected.
The initial search and data extraction were conducted by one author. All authors participated in an in-depth review process.
We categorise 31 applicable PROMs for lymphoma into four distinct groups, streamlining the PROM selection process to facilitate effective communication among clinical investigators, HEOR scientists, patients and others. Additionally, a five-step pragmatic paradigm is developed for identifying appropriate PROM(s).
The pragmatic paradigm presents a practical approach for selecting PROM(s) in lymphoma clinical trials. An appropriate PROM should conceptually align with the treatment goals and be acceptable to regulatory and HTA bodies. Thus, lymphoma clinical trials can generate more patient-focused data, contributing to improving patients’ quality of life and advancing lymphoma care.
To examine the decision-making processes underlying missed nursing care.
A qualitative study using Critical Incident Debriefing interviews.
Fifteen nurses from inpatient wards in a general hospital participated in semi-structured interviews following their morning shifts. Interviews focused on care prioritisation incidents leading to missed nursing care. Data were analysed using thematic analysis.
Analysis revealed a central theme of emotions as crucial determinants in care prioritisation decisions. Two subthemes emerged: emotions as drivers of care prioritisation decisions and emotions as responses to these decisions. Positive emotions motivated nurses to prioritise care for specific patients, while negative emotions sometimes led to care delays. Successful care completion generated professional satisfaction, while care omissions produced complex emotional responses, including guilt, frustration and helplessness.
The dual emotional processes identified in this study—emotions functioning as both drivers and responses in care decisions—challenge purely structural explanations of missed nursing care. This perspective reframes nurses as emotionally engaged decision-makers who actively navigate care priorities rather than passively react to contextual constraints, offering a more comprehensive framework for understanding the complexity of clinical judgement in real-world settings.
This study positions emotions as legitimate components of clinical decision-making rather than cognitive biases. For nursing practice, this necessitates integrating emotional awareness into professional development. For patient care, recognising emotional underpinnings may promote equitable care distribution through interventions that engage with the emotional realities of nursing work.
This study addressed limited understanding of decision-making in missed nursing care, particularly emotions' role. Findings reveal how emotions influence nurses' prioritisation decisions and wellbeing, with implications for nurses, educators and administrators seeking interventions addressing structural and emotional dimensions.
This study adhered to the Standards for Reporting Qualitative Research (SRQR) guidelines (Appendix S1).
No patient or public contribution.
Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.
This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.
Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.
Acknowledging equality, diversity and inclusion (EDI) in research is not only a moral imperative but also an important step in avoiding bias and ensuring generalisability of results. This protocol describes the development of STAndards for ReporTing EDI (START-EDI) in research, which will provide a set of minimum standards to help researchers improve their consistency, completeness and transparency in EDI reporting. We anticipate that these guidelines will benefit authors, reviewers, editors, funding organisations, healthcare providers, patients and the public.
To create START-EDI reporting guidelines, the following five stages are proposed: (i) establish a diverse, multidisciplinary Steering Committee that will lead and coordinate guideline development; (ii) a systematic review to identify the essential principles and methodological approaches for EDI to generate preliminary checklist items; (iii) conduct an international Delphi process to reach a consensus on the checklist items; (iv) finalise the reporting guidelines and create a separate explanation and elaboration document; and (v) broad dissemination and implementation of START-EDI guidelines. We will work with patient and public involvement representatives and under-served groups in research throughout the project stages.
The study has received ethical approval from the Imperial College London Research Ethics Committee (study ID: 7592283). The reporting guidelines will be published in open access peer-reviewed publications and presented in international conferences, and disseminated through community networks and forums.
The project is pre-registered within the Open Science Framework (https://osf.io/8udbq/) and the Enhancing the Quality and Transparency of Health Research Network.
Pain is one of the most bothersome symptoms that affects patients with inflammatory bowel disease (IBD) but is often inadequately treated. Inadequate pain control in the inpatient setting not only impacts patients’ experience but increases opioid use and hospital length of stay. Opioids are often considered first-line treatment for severe pain but are associated with significant morbidity and mortality in IBD. Non-steroidal anti-inflammatory drugs are a non-opioid analgesic option, but concerns regarding their contribution to IBD flares have limited their use. Brain-gut behavioural therapies (BGBT), such as cognitive behavioural therapy, meditation and gut-directed hypnotherapy, are effective for pain management and have a role in the treatment of IBD symptoms. However, the use of BGBT in IBD is challenging, given limited access to behavioural health specialists, especially in the inpatient setting. Virtual reality (VR)-directed BGBT programmes can bridge this gap and enhance pain treatment for inpatients with IBD. Therefore, in this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.
We will recruit 40 patients with IBD who are hospitalised at Michigan Medicine and who endorse IBD-related pain. We will assess patient-reported outcomes (pain rating, IBD-specific symptoms, perceived stress, mood) before and after treatment, cumulative inpatient analgesic requirements and hospital length of stay. Our primary objective will be to establish intervention feasibility defined by the frequency and percentage of enrolled participants that use the VR-directed BGBT inpatient intervention in any capacity. Our secondary objective will be to evaluate intervention acceptability by conducting semistructured interviews with study participants. We will also explore the preliminary effectiveness of VR-directed BGBT on patient-reported outcomes and healthcare utilisation as compared with historic controls.
The study was approved by the institutional review board of the University of Michigan Medical School on 10 October 2023 (HUM00240999). All human subjects will be required to sign an informed consent document prior to study participation. Study findings will be reported through peer-reviewed publication.
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