Selective fetal growth restriction (sFGR) is a major cause of perinatal morbidity and mortality in monochorionic diamniotic (MCDA) twin pregnancies. Current management relies on umbilical artery Doppler patterns in the smaller twin. These patterns are, however, inconsistent and do not represent a reliable severity scale, complicating clinical decision-making and parental counselling. This study aims to improve risk stratification by identifying predictors of adverse outcomes, while also evaluating the pathophysiology and multi-organ impact of sFGR in early childhood.
This is a prospective, international, multicentre cohort study conducted in six tertiary fetal medicine centres with expertise in complicated twin pregnancies. Recruitment began in March 2023 and will continue until December 2026, targeting 274 MCDA twin pairs with complete follow-up to develop a prediction model for adverse perinatal outcomes in sFGR at the time of diagnosis. Standardised data collection includes serial ultrasound examinations, advanced fetal imaging (cardiac, cerebral and 3D volumetric), fetal brain MRI and detailed placental phenotyping. Maternal and parental well-being are assessed during pregnancy and after birth. Neurodevelopmental outcome is evaluated up to 2 years after birth using validated tools. The statistical analysis plan includes predictive modelling with internal validation.
The study has been approved by the ethical review boards of all participating centres. Findings will be disseminated through peer-reviewed publications, international conferences and engagement with clinical guideline committees.
This study aims to evaluate relationships between self-reported fine motor ability and quality of life (assessed by life satisfaction and life problems) from people with spinal cord injury (SCI) at T1 and above.
Observational cohort study (current analysis from a cross section)
279 individuals with SCI at T1 or above
Community members sampled from records from two Midwestern hospitals and a speciality hospital in the Southeast United States
Fine motor ability was assessed via the Spinal Cord Injury Functional Index-Short Form 9A, while two facets of quality of life, life satisfaction and life problems, were assessed by the Life Situation Questionnaire-Revised version (LSQ-R). Pearson correlations and multivariate analysis were utilised to identify cross-sectional relationships between fine motor ability, life satisfaction and life problems.
Fine motor ability was positively correlated with total life satisfaction score (r=0.16; p=0.02) and was negatively correlated with the total life problems score (r=–0.18; p=0.01), health problems factor (r=–0.24; pβ=0.25; p=0.02), fewer life problems (β=–0.40; pβ=–0.11; pβ=–0.10; p
The results identified significant, modest associations between self-reported outcomes, as better fine motor ability was related to less social isolation, fewer health problems and higher life satisfaction. Further investigation into the relationship between fine motor ability, life satisfaction and life problems is warranted.
To describe obstacles and ideas for improvement for the delivery of cardiopulmonary resuscitation and basic life support to wheelchair users.
A descriptive qualitative study underpinned by constructivism was conducted.
Semi structured interviews were completed with 26 participants from three cohorts: formal and informal carers, wheelchair users and healthcare professionals. Data were collected via online and in person interviews between February and June 2024. All participants were located in Australia, with the exception of one who was located in the United Kingdom. Data were analysed using thematic analysis.
Two major themes were identified: (1) obstacles to providing cardiopulmonary resuscitation and basic life support to a wheelchair user and (2) aspirations for improving cardiopulmonary resuscitation and basic life support for wheelchair users.
Participants shared ideas for how to improve emergency care for wheelchair users, highlighting a need for further research, testing and development of an education intervention.
Improving knowledge about providing emergency care to a wheelchair user could improve outcomes, save lives and reduce the life expectancy gap experienced by people with disability.
Approximately 2% of the global population use a wheelchair. Wheelchair use complicates the delivery of cardiopulmonary resuscitation and basic life support. There are currently no guidelines informing emergency care for wheelchair users available globally. Recognition of common symptoms of distress exhibited by wheelchair users, and options for the delivery of practical emergency care are required for wheelchair users.
The paper adheres to the EQUATOR reporting guidelines utilising the SRQR checklist.
Patients and the public were the driving force in recognising the gap in knowledge regarding the delivery of CPR to wheelchair users. Questions from patients and the public shaped the aims and methodological choices for this study.
To test the feasibility and acceptability of a newly developed model of neonatal nurse-controlled analgesia to manage pain in the post-operative infant.
The study utilised a single-centre two-arm parallel, unblinded randomised controlled external pilot trial design.
The pilot trial was conducted in a surgical neonatal tertiary intensive care unit in Brisbane, Australia. Eligible infants were randomised to receive either post-operative pain management care via a model of neonatal nurse-controlled analgesia or standard care. Feasibility and acceptability were the primary outcomes. Seven feasibility outcomes were assessed by a traffic light system to delineate progression to a larger trial. Acceptability and clinical utility of the model of care by staff were assessed by feedback from an anonymous questionnaire that was administered at the completion of the trial period. Secondary outcomes included parental attitudes and perceptions of post-operative pain management to help establish primary outcomes for a larger randomised controlled trial.
Overall staff found the formalised model beneficial for managing post-operative pain but found the complexity of the model and ability to titrate analgesia based only on documented pain scores barriers requiring further consideration. Three of the seven feasibility outcomes failed to reach ‘greenlight’ targets to progress to a larger trial with adherence to the model, and the proportion of eligible infants not recruited was allocated a ‘redlight’. Secondary outcomes were comparable and support future study.
This pilot feasibility study has shown that a model of neonatal nurse-controlled analgesia can be safely implemented and utilised in the post-operative care of the surgical neonate. Further exploration of the barriers to model adherence and recruitment is warranted before a future larger trial is undertaken.
Though not all primary outcomes reached an acceptable range for further progression, this pilot feasibility study provided invaluable learning and has provided direction for future research into the provision of a family integrated and responsive model of analgesia.
This study is reported in line with the Consolidated Standards of Reporting Trials (CONSORT): Extension to randomised pilot and feasibility trial and the TIDieR Checklist (Template for Intervention, Description and Replication).
No patient or public contribution was utilised for this study.
Trial Registration: ACTRN12623000643673—the trial was prospectively registered
Outward medical tourism is when people seek medical treatment in a different country to the one they live in. We aimed to identify all studies that describe the impact on the UK National Health Service (NHS) of patients who require treatment due to outward medical tourism for elective surgery and report on complications, costs and benefits.
A rapid literature review. Medical and grey literature databases were searched, limited to literature published between 2012 and 2024.
Studies published in the English language, conducted in any NHS setting, describing complications, costs or benefits due to outward medical tourism for elective surgery were included. We excluded emergency and semi-urgent surgery, dental and transplant surgery, cancer treatment and fertility treatment.
Primary outcomes were costs and savings to the NHS. Secondary outcomes were type and frequency, demographics, procedures, complications, treatment, follow-up care and use of NHS resources. Results were summarised narratively. Study quality was assessed using JBI critical appraisal tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for certainty of evidence for costs.
Some 35 case series and case reports and two surveys of NHS plastic surgeons were identified. Case studies described 655 patients treated in specific NHS hospitals between 2006 and 2024 for postoperative complications due to metabolic/bariatric surgery (n=385), cosmetic (n=265) and ophthalmic (n=5) surgery tourism. No cases relating to other surgical specialities were identified in the literature. Most patients were women (90%), with an average age of 38 (range 14–69) years. The most common destination for surgery was Turkey (61%). Complications were not well described for metabolic/bariatric surgery tourism; but for cosmetic surgery tourism, infection and wound dehiscence were most commonly reported. There was evidence that some patients needed complex treatment involving long hospital stays and multiple surgical interventions. Very low certainty evidence indicated that costs to the NHS from outward medical tourism for elective surgery ranged from £1058 to £19 549 per patient in 2024 prices. We found no studies that reported on the benefits of outward medical tourism.
A systematic approach is needed to collecting information on the number of people who travel abroad for elective surgery and the frequency and impact on the UK NHS of treating complications. Without these data, we cannot fully understand the risk of seeking surgery abroad.
Most patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return to work and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The Work And Vocational advicE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA.
A mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study.
Primary care.
The study included participant follow-up by fortnightly Short Message Service text and 6-week questionnaire. Stop/go criteria focus on recruitment and intervention engagement. The semistructured interviews explored participants’ experiences of recruitment and receipt and engagement with the intervention.
19 participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with ≥50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a vocational support worker. Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable.
This study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement.
We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.
To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.
A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.
Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.
While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.
A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.
The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.
This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.
To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.
Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.
Four prisons for men across England and Wales, UK.
Men leaving prison at risk of homelessness and intervention delivery staff.
CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.
Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.
The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.
This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.
To develop and validate a bilingual experience survey for use in any NHS healthcare setting, to support service improvement.
A prospective mixed-methods study.
Any healthcare setting in NHS Wales including primary, secondary, urgent and planned care.
An opportunistic sample of people with experience of using local healthcare services. Qualitative interviews and focus groups were held to develop a draft survey. These were followed by online data collection from a wide participant sample for statistical validation. The tool was translated and linguistically validated following recognised methods. Patient engagement leads were involved to ensure the tool met their needs.
We conducted and analysed five focus groups and four interviews, consisting of 33 people in total. 12 draft questions were developed related to key aspects of patient experience. A series of online surveys were conducted to test the draft questions, with 769 responses received. Data were analysed to assess completion rates, intra-rater reliability, internal consistency and convergent validity. One question had both sub-par intrarater reliability and poor convergent validity, and despite attempts to improve the wording, it failed to meet minimum requirements of validity and was subsequently removed. The final validated People’s Experience Survey (PES) was subsequently translated into Welsh and validated with service users.
The PES is a reliable and valid tool, suitable for use in any healthcare setting. The robust processes that have been undertaken ensure that the questions included are available bilingually to collect reliable, meaningful data to support service improvement work.
To test a theoretical model examining the impact of the work environment on nurses' physical and mental health issues, job burnout, and healthcare productivity.
This cross-sectional study employed structural equation modelling to test a theoretical model linking work environment, physical and mental health issues, job burnout, and healthcare productivity. Data were collected from 600 staff nurses using validated self-report questionnaires administered at one medical teaching hospital and two regional hospitals in Taiwan.
The work environment was significantly associated with healthcare productivity, nurses' physical and mental health issues, and job burnout. Physical and mental health issues were positively related to job burnout, which, in turn, negatively impacted healthcare productivity.
A supportive work environment plays a critical role in promoting nurses' well-being, reducing burnout, and improving productivity. This study advances the understanding of work environment factors that nurse administrators can target for improvement.
Modifying key organisational and interpersonal aspects of the work environment and cultivating a more supportive culture may enhance nurses' well-being, reduce turnover, and improve workforce productivity.
This study adhered to STROBE guidelines for observational studies as per the Equator network.
No patient or public contribution.
To explore participants’ experiences of potential adverse effects of the Informed Health Choices secondary school intervention across three trial sites and to revise a framework of potential adverse effects of interventions to improve critical thinking about health choices.
This was a qualitative study. We extracted and analysed relevant data from separate process evaluations in each country. Data came from surveying teachers, observing lessons and group and individual interviews with students, teachers and other stakeholders. We modified and applied framework analysis, including five stages: (1) development of an initial framework of potential adverse effects, (2) familiarisation with the data, (3) indexing, (4) abstraction and synthesis and (5) revising the framework. We applied reflexive strategies individually and as a team.
Lower secondary school in five randomly sampled subcounties of Kisumu County in Kenya, districts representing all five provinces in Rwanda, and six districts in the central region of Uganda, between 2022 and 2024.
Students and teachers in the intervention arms of the trials, parents of students in the intervention arms and administrators at intervention schools, as well as curriculum developers and policy-makers.
The intervention involved providing teachers with a 2–3-day training workshop, and digital classroom resources, including lesson plans for 10 lessons to be delivered over the course of one semester.
We generated findings about potential increases in adverse misunderstandings, anxiety related to transfer of learning, adversely experienced cognitive dissonance, work or schoolwork-related stress, inequity, conflicts and waste. The revised framework includes the same categories of potential adverse effects as our initial framework: decision-making harms, psychological harms, equity harms, group and social harms, waste and other harms. We revised other elements of the framework, including definitions of the categories and its structure.
This study provides insight into the potential adverse effects of interventions to improve critical thinking about health choices. The findings complement those of the trials and country-level process evaluations.
Muslim women in Australia encounter substantial reproductive health disparities. Reasons include intersecting barriers, including distinct demographic features, modesty and privacy concerns, recency of migration, stigma, discrimination, distrust of health systems, fatalistic health beliefs and lack of culturally appropriate health services. In published literature, community-based participatory research (CBPR) has been used in health promotion in hardly reached Muslim populations along with culturally and/or religiously tailored health promotion programmes to disseminate health messages in mosque settings. Despite positive evidence internationally, mosque-based reproductive health programmes remain largely unexplored in Australia. The Women’s Awareness in ReproDuctive ‘Aafiya (WARDA) study seeks to address this gap by co-designing reproductive health resources tailored for Muslim women in Australia.
WARDA employs a CBPR methodology, actively involving Muslim women aged 18–45 years, community stakeholders and Muslim health professionals in New South Wales. The study comprises two phases: Phase 1 involves co-designing reproductive health promotion resources through participatory workshops, online surveys and semi-structured interviews, followed by the creation of resources. Phase 2 entails delivering the resources through peer educators, and evaluating the acceptability, usability and perceived benefits of these resources through mosque-based community sessions. Qualitative and quantitative data collected during both phases will undergo thematic analysis and descriptive statistical analysis, respectively, ensuring iterative refinement of interventions based on participant feedback. A sustainable version of the resources will be made available online for continued community use.
Ethics approval has been granted by Western Sydney University Human Research Ethics Committee (approval number H16274). Findings from WARDA will be disseminated through grassroots community organisations involved in the project.
The teaching profession plays a crucial role in society. From educating and forming future generations to fulfilling various administrative tasks and managing expectations and experiences that reach beyond the classroom—teachers face immense demands on their time, energy, and emotional resources. Consequently, they are subject to high work burden. This is reflected in the high prevalence of burnout, anxiety, and depression among teachers. A scoping review of factors associated with these outcomes in teachers is required to inform the further development of preventive occupational medicine strategies. In this scoping review, we aim to (i) identify and (ii) appraise the factors (eg, workplace, environmental, lifestyle, psychological) associated with burnout, anxiety, and depression specific to secondary school teachers and to (iii) synthesise the findings from the perspective of preventive occupational medicine.
The scoping review will be performed following the PRISMA extension for Scoping Reviews guidance. A systematic literature search will be conducted in the Medline, Web of Science Core Collection, PsychInfo, and Cochrane Library databases using search terms pertinent to secondary school teachers as the population of interest and depression, anxiety, and burnout as the outcomes of interest. Returned articles from the database search published pre-2017 will be excluded for the following reasons; namely, (a) that current literature will more closely reflect the current demands of the teachers, (b) the timing fits with recent systematic reviews highlighting burnout, anxiety, and depression as major problems among teachers, and (c) it facilitates feasibility of review in terms of the volume of studies. Remaining records will then be deduplicated and screened against predefined eligibility criteria that also add focus on teachers and these outcomes. Relevant data concerning factors associated with burnout, anxiety, and depression in teachers will be extracted and mapped. A narrative appraisal of included studies will be employed that will be specific to the validity of the results regarding factors (exposures, mediators, effect modifiers) that may affect the outcomes of interest (as opposed to more generic appraisal of the entirety of individual articles). Findings will be narratively synthesised from the perspective of preventive occupational medicine.
Formal ethical approval is not required as primary data will not be collected in this study. The findings of this study will be disseminated through peer-reviewed publication, conference presentation, and condensed summaries for key stakeholders and partners in the field (including teachers, schools, and governing bodies).
The protocol was registered on the Open Science Framework on 26.06.2025 and can be identified using the following link: https://doi.org/10.17605/OSF.IO/BKX56.
To examine the extent of adherence to high-level principles in remote prescribing and investigate how medical and non-medical prescribers comply with these principles.
Scoping Review.
A systematic search of CINAHL, PubMed, Medline, the Cochrane Database of Systematic Reviews, the Web of Science, and the Ovid Emcare databases was performed. A grey literature search was conducted on relevant professional websites and Google Scholar. Literature was searched from January 2007 to March 2025.
Research results were uploaded to Raayan for management and selection of evidence. Two reviewers independently scored and appraised papers using a structured data extraction form. The ‘United Kingdom High-level Principles for Good Practice in Remote Consultations and Prescribing’ served as a coding framework for deductive manifest content analysis.
Searches identified 6870 studies. After screening the title and abstract, 54 full texts were reviewed, and 14 studies were identified for analysis. Adherence to high-level principles was limited and inconsistent. Data categories were developed into 5 themes: (1) Patient privacy and vulnerability, (2) Adequate assessment, (3) Guidelines and evidence-based prescribing, (4) Investigations and safety netting, and (5) Organisational safety and creating safe systems.
This review provided insight into the challenges that medical prescribers face when adhering to governance principles during remote prescribing practice. However, no research about how non-medical prescribers integrate remote prescribing governance into their practice was found.
Remote prescribing has become firmly embedded within the current healthcare system and robust governance is required to safeguard patient outcomes. Further research exploring how non-medical prescribers integrate the high-level principles into practice will inform prescribing governance for this group.
No patient or public contribution was sought as the scoping review focused solely on the existing literature.
Observational studies play a pivotal role in understanding population health trends and informing public health policy. However, many such studies inadequately address dimensions of health inequality, potentially perpetuating existing disparities. There is currently no comprehensive overview of frameworks specifically designed to integrate health-inequality constructs into observational public health research. This protocol outlines the methodology of the scoping review, which aims to identify, describe and critically evaluate existing frameworks that explicitly incorporate health inequalities within observational studies.
We will conduct this scoping review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Six electronic databases (PubMed, Embase, Scopus, Web of Science, Global Health and CINAHL) and eligible grey literature sources will be searched using a combination of keywords and subject headings related to health inequalities, observational study design and frameworks. Two independent reviewers will perform title/abstract screening and full-text eligibility assessment using Rayyan, while discrepancies will be resolved by consultation with a third reviewer. Findings will be synthesised narratively.
As this study involves analysis of publicly available literature, formal ethical approval is not required. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and communication with key stakeholders in public health and equity research. The results will also be shared directly with charities and local organisations which focus on addressing health inequalities. By providing a comprehensive map of existing frameworks, this review will inform researchers on best practices for embedding health-inequality considerations in observational studies and support the development of more equitable research methodologies.
Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.
The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.
This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.
Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.
Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;
Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.
NCT06542315, registered on 6 August 2024.