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FoodCHOMP (Food Challenge--at HOme or in Medical Practice): a pilot multicentre randomised controlled trial evaluating home versus clinic-based food allergy challenges in low-risk adults-study protocol

Por: Godsell · J. · Vogrin · S. · Chan · S. · Henri · M. · Ng · I. · Andrews · E. · Spriggs · K. · Perrett · K. P. · Trubiano · J.
Introduction

Approximately 6%–10% of adults carry food allergy labels. Many such labels are unverified and may be incorrect, contributing to delays in appropriate care, significant dietary restriction, anxiety and unnecessary use of emergency medications. Oral food challenges (OFCs) are the gold standard for confirming or excluding food allergy, but the current model of clinic-based challenges often has long wait times and logistical barriers. This study aims to investigate the feasibility and safety of home-based OFCs compared with standard in-clinic challenges in adults with negative skin-prick testing.

Methods and analysis

Food Challenge at HOme or in Medical Practice is a pilot multicentre randomised controlled trial enrolling 120 adults with reported food allergy labels and negative skin prick testing to the implicated food. Participants will be randomised 1:1 to undergo an OFC either at home or in-clinic. The study is designed to generate feasibility and preliminary safety data for home-based OFC, measured by the proportion of participants experiencing immune-mediated adverse events (AEs), compared with clinic-based OFC. Feasibility metrics (screening to recruitment ratio, protocol completion), non-immune AEs, protocol adherence and quality of life assessed using the Food Allergy Quality of Life Questionnaire-12 at baseline prior to OFC and 6 months post OFC will also be collected. Statistical analysis will include descriptive statistics, with comparisons between arms using risk differences and relative risks with 95% CIs.

Ethics and dissemination

The trial has received ethics approval from the Austin Health Human Research Ethics Committee (HREC/111750/Austin-2024). Findings will be disseminated through peer-reviewed publications and scientific meetings. Data will be presented in aggregated, de-identified form.

Trial registration number

NCT06916819.

Uncovering age-related differences in communication by people with persistent pain when interacting with a pain history assessment chatbot in Australia: an exploratory mixed-methods study using a comparative analysis

Por: Hay · E. · Ireland · D. · Claus · A. · Rose · T. · Strong · J. · Westerman · D. · Schlumpf · M. · Vijayakumar · P. · Burvill · L. · Andrews · N.
Objectives

There is limited research exploring the age-related difference in communication when describing pain experiences. This project aimed to identify key differences between adolescents’, young adults’ and adults’ (i) preferred communication method, (ii) language content and (iii) lexical amount and variety when discussing their persistent pain experience using chatbot technology.

Design

An exploratory concurrent nested mixed-methods design using a comparative analysis.

Setting

Participants were recruited through a convenience sampling strategy from two tertiary multidisciplinary pain centres in Australia.

Participants

20 adolescents, 20 young adults and 20 adults completed a pain history assessment using the Dolores application. The inclusion criteria for this study were (i) persistent non-cancer pain for at least 3 months, (ii) 10 years of age and over and (iii) adequate expressive and receptive language skills to complete the required tasks in English, as determined by clinicians in the treating team.

Results

Drawn, voice and typed responses provided by participants during the chatbot interaction were analysed using content analysis. Fisher’s exact tests and 2 tests were used to examine differences between age groups. Strong effect size estimates generated from comparative analyses suggested that adolescents were the most likely age group to utilise drawing (p=0.153, Cramer’s V=0.268), preferred typing over speaking (p==0.007, Cramer’s V=0.433). Young adults used the greatest number and variety of words in response to chatbot questions including evaluative language (p=0.097, Cramer’s V=0.296). Adults tended to use more metaphors (p=0.085, Cramer’s V=0.305) and had a strong preference for speaking over typing (p=

Conclusions

The results of this study provide insights into age-related differences in communication and preferences when using technology to communicate about persistent pain. Future research exploring individualised age-related approaches to pain assessment, supported by the findings of this study, in comparison to current standardised assessments administered by clinicians are warranted.

Mixed-methods non-randomised single-arm feasibility study assessing delivery of a remote vocational rehabilitation intervention for patients with serious injury: the ROWTATE study

Por: Kellezi · B. · Holmes · J. · Kettlewell · J. · Lindley · R. · Radford · K. · Patel · P. · Bridger · K. · Lannin · N. A. · Andrews · I. · Blackburn · L. · Brooks · A. · das Nair · R. · Fallon · S. · Farrin · A. · Hoffman · K. · Jones · T. · Morriss · R. · Timmons · S. · Kendrick · D.
Objectives

This study aimed to evaluate the feasibility of delivering a vocational rehabilitation intervention (Return to Work After Trauma—ROWTATE), remotely to individuals recovering from traumatic injuries. The primary objectives were to assess therapists’ training and competence, adapt the intervention and training for remote delivery and assess the feasibility and fidelity of remote delivery to inform a definitive randomised controlled trial.

Design

A mixed-methods feasibility study incorporating (1) telerehabilitation qualitative literature review, (2) qualitative interviews preintervention and postintervention with therapists and patients, (3) a team objective structured clinical examination to assess competency, (4) usefulness of training, attitudes towards (15-item Evidence-Based Practice Attitude Scale) and confidence in (4-item Evidence Based Practice Confidence Scale) evidence-based practice, intervention delivery confidence (8-bespoke questions) and intervention behaviour determinants (51-items Theoretical Domains Framework) and (5) single-arm intervention delivery feasibility study.

Setting

The study was conducted in two UK Major Trauma Centres. The intervention and training were adapted for remote delivery due to the COVID-19 pandemic.

Participants

Therapists: Seven occupational therapists (OTs) and clinical psychologists (CPs) were trained, and six participated in competency assessment. Seven OTs and CPs participated in preintervention interviews and surveys; six completed post-intervention interviews and four completed post-training surveys. Patients: 10 patients were enrolled in the single-arm feasibility study and 4 of these participated in postintervention qualitative interviews. Inclusion criteria included therapists involved in vocational rehabilitation delivery and patients admitted to major trauma centres. Exclusion criteria included participation in other vocational rehabilitation trials or those who had returned to work or education for at least 80% of preinjury hours. Intervention: The ROWTATE vocational rehabilitation intervention was delivered remotely by trained OTs and CPs. Training included competency assessments, mentoring and adaptation for telerehabilitation. The intervention was delivered over multiple sessions, with content tailored to individual patient needs.

Results

Therapists found the training useful, reported positive attitudes (Evidence-Based Practice Attitude Scale mean=2.9 (SD 0.9)) and high levels of confidence in delivering evidence-based practice (range 75%–100%) and the ROWTATE intervention (range 80%–100%). Intervention barriers identified pretraining became facilitators post-training. Half the therapists needed additional support post-training through mentoring or additional training. The intervention and training were successfully adapted for remote delivery. High levels of fidelity (intervention components delivered: OTs=84.5%, CPs=92.9%) and session attendance rates were found (median: OT=97%, CP=100%). Virtually all sessions were delivered remotely (OT=98%, CP=100%). The intervention was acceptable to patients and therapists; both considered face-to-face delivery where necessary was important.

Conclusions

The ROWTATE intervention was delivered remotely with high fidelity and attendance and was acceptable to patients and therapists. Definitive trial key changes include modifying therapist training, competency assessment, face-to-face intervention delivery where necessary and addressing lower fidelity intervention components.

Trial registration number

ISRCTN74668529.

Online randomised e-hypnotherapy for chronic pelvic pain study (REST): comparing e-hypnotherapy with relaxation and waitlist to improve pain, cost-effectiveness and biopsychosocial outcomes

Por: Evans · S. · Naude · C. · Coitinho Biurra · Y. · Bowring · J. · Knowles · S. · Brooks · T. · Skvarc · D. · Esterman · A. · Fuller-Tyszkiewicz · M. · Klas · A. · Van Niekerk · L. · McCaffrey · N. · Stanley · K. · Druitt · M. · Andrews · J. · Vancaillie · T. · Cheah · S. · Ciccia · D. · Blak
Background

Chronic pelvic pain, defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.

Methods

A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised relaxation control (n=44) or waitlist control (n=44). The primary outcome will be self-reported pain level, and secondary outcomes will include psychological distress, QoL, pain catastrophising, self-efficacy, central sensitisation, somatic symptoms, fatigue and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n=20) and relaxation (n=20) groups to understand meaningful change and barriers/facilitators for ongoing use.

Ethics and dissemination

This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind–body interventions.

Trial registration number

Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.

Key elements of home care workforce capability to provide integrated home care to older people: scoping review

Por: Kumar · S. · Siddiqui · N. · Andrews · S. · Agaliotis · M.
Objectives

The demand for home care services has increased with the growth of the older population. Currently, home care workers (HCWs) are experiencing challenges such as poor working conditions, high turnover, fragmented services and dissatisfied clients, which are indicative of limitations on HCWs’ ability to provide quality integrated home care to older people. Therefore, we conducted a scoping review to identify the key elements that affect the capabilities of the HCWs in providing quality integrated care to older people in their homes.

Design

Scoping review.

Data sources

PubMed, PsycINFO, Scopus, CINAHL, Cochrane, Analysis & Policy Observatory, Australian Association of Gerontology (Australia), WHO, Trove (Australia), Social Care Online (UK) and Google between January 2014 and August 2025.

Eligibility criteria for selecting studies

Studies were included if they focused on the analysis of HCWs’ experience in providing care to older people within home settings and were published in the English language between January 2014 and August 2025.

Results

19 studies met the inclusion criteria out of 2844 retrieved articles. Most studies were conducted in North America (n=8). Qualitative studies were the most commonly reported (n=16). The findings of the studies were combined and categorised into four themes using a narrative synthesis approach. The four themes identified were HCWs’ capability through (1) collaborative practice, (2) education and training, (3) structural conditions at work and (4) personal attributes.

Conclusion

This scoping review on home care for older people highlights four interconnected pillars that shape HCWs’ capabilities. This review provides valuable insights to inform the standards and policies to strengthen HCWs’ capabilities across these domains. Future study is needed to explore the measures taken by agencies to understand and address key elements of HCWs’ capability.

A grounded theory of clinical nurses’ process of coping during COVID‐19

Abstract

Aims and Objectives

To explore clinical nurses’ process of coping during COVID-19 and develop a grounded theory that can be used by leaders to support clinical nurses during a disaster.

Background

The COVID-19 pandemic has provoked widespread disruption to clinical nurses’ work. It is important to understand clinical nurses’ processes of coping during disasters to support the nursing workforce during events such as global pandemics.

Design

We employed the Corbin and Strauss variant of grounded theory methodology, informed by symbolic interactionism, and applied the EQUATOR guidelines for qualitative research publication (COREQ).

Methods

Data collection entailed semi-structured interviews with experienced clinical nurses (n =20) across diverse settings. We analysed data by identifying key points in the nurses’ coping processes inductively building concepts around these points.

Results

The predictor of nurses’ outcomes in this grounded theory was their confidence in their ability to cope during the pandemic. When nurses lacked confidence, they experienced working in the context of acute COVID—a state of chaos and anxiety, with negative consequences for nurses. However, when nurses were confident in their abilities to cope with the pandemic, they experienced working in the context of chronic COVID, a calmer state of acceptance. There were many workplace factors that influenced nurses’ confidence, including adequacy of personal protective equipment, clear information and guidance, supportive leadership, teamwork and adequate staffing.

Conclusions

Understanding clinical nurses’ experience of coping during COVID-19 is essential to maintain the nursing workforce during similar disasters.

Relevance to clinical practice

Nurse leaders can target areas that support nurses’ confidence, such as adequate PPE and staffing. In turn, increased confidence enables clinical nurses to cope during disasters such as a global pandemic.

Perceived Social Risk Scale: development and validation in relation to social status and depression in the UK

Por: Newton · J. · Andrews · J. L.
Objective

To develop and validate the Perceived Social Risk Scale (PSRS) for assessing perceptions of socially risky behaviours, and to validate it against existing psychological measures such as perceived social status and depressive symptoms in a UK sample of older adolescents and adults.

Design

A cross-sectional study involving exploratory and confirmatory factor analyses.

Setting

Participants were recruited from the Cardiff University’s Department of Psychology participant pool (students completing studies for course credit) and Prolific Academic (a crowdsourcing platform for research volunteers). Data collection occurred between 17 February and 6 May 2024.

Participants

A total of 640 UK participants, including both men and women, aged 18-65.

Main outcome measures

We measured the internal consistency of the PSRS, test-retest reliability and validity against measures including rejection sensitivity, perceived social status, depressive symptoms and resistance to peer influence. Moderation analyses examined the role of perceived social status, age and a sense of belonging in the relationship between PSRS scores and depressive symptoms.

Results

The PSRS showed excellent internal consistency (α=0.96) and good test-retest reliability (Intraclass Correlation Coefficient (ICC)=0.70). Perceptions of social risks significantly declined with age (r=–0.20, p) and factor analyses confirmed that the PSRS differentiates among four distinct but related social risk constructs: authenticity and integrity (α=0.91), social assertiveness (α=0.72), reservedness (α=0.83) and social non-conformity (α=0.72). For evidence of convergent validity, higher PSRS scores were associated with increased sensitivity to social rejection (r=0.23, p elevated depressive symptoms (r=0.13, p=0.012) and negatively correlated with resistance to peer influence (r=–0.13, p=0.013). Local perceived social status significantly moderated the relationship between PSRS scores and depressive symptoms (β=0.005, SE=0.002, t=2.36, p=0.019). A general sense of belonging did not moderate this relationship.

Conclusions

Our results confirm that social risk is not a uniform construct but is instead multidimensional. The PSRS offers a reliable and valid tool for assessing multidimensional social risk-taking, with strong internal consistency and test–retest reliability. The interaction between depression and local perceived social status highlights the importance of perceived status on social risk perception.

Australian research priorities for inherited retinal diseases: a James Lind Alliance priority setting partnership

Por: Robertson · E. G. · Hetherington · K. · Prain · M. · Ma · A. · Ayton · L. N. · Jamieson · R. V. · Shepard · E. · Boyd · L. · Hall · J. · Boyd · R. · Karandrews · S. · Feller · H. · Simunovic · M. P. · Grigg · J. R. · Yamamoto · K. · Wakefield · C. E. · Gonzalez-Cordero · A.
Objectives

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

Design

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Setting

Australia-wide.

Participants

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

Outcome measure

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

Results

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

Conclusion

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

Protocol for development of a checklist and guideline for transparent reporting of cluster analyses (TRoCA)

Por: Lisik · D. · Shah · S. A. · Basna · R. · Dinh · T. · Browne · R. P. · Andrews · J. L. · Wallace · M. · Ezugwu · A. · Marusic · A. · Tran · D. · Torres-Sospedra · J. · Dam · H.-C. · Fournier-Viger · P. · Hennig · C. · Timmerman · M. · Warrens · M. J. · Ceulemans · E. · Nwaru · B. I. · Herna
Introduction

Cluster analysis, a machine learning-based and data-driven technique for identifying groups in data, has demonstrated its potential in a wide range of contexts. However, critical appraisal and reproducibility are often limited by insufficient reporting, ultimately hampering the interpretation and trust of key stakeholders. The present paper describes the protocol that will guide the development of a reporting guideline and checklist for studies incorporating cluster analyses—Transparent Reporting of Cluster Analyses.

Methods and analysis

Following the recommended steps for developing reporting guidelines outlined by the Enhancing the QUAlity and Transparency Of health Research Network, the work will be divided into six stages. Stage 1: literature review to guide development of initial checklist. Stage 2: drafting of the initial checklist. Stage 3: internal revision of checklist. Stage 4: Delphi study in a global sample of researchers from varying fields (n=) to derive consensus regarding items in the checklist and piloting of the checklist. Stage 5: consensus meeting to consolidate checklist. Stage 6: production of statement paper and explanation and elaboration paper. Stage 7: dissemination via journals, conferences, social media and a dedicated web platform.

Ethics and dissemination

Due to local regulations, the planned study is exempt from the requirement of ethical review. The findings will be disseminated through peer-reviewed publications. The checklist with explanations will also be made available freely on a dedicated web platform (troca-statement.org) and in a repository.

Core outcome set and measures of chest health in children and young people with cerebral palsy in the community setting: the CHESTI study protocol

Por: Knight Lozano · R. · Morris · C. · Shannon · H. · Bell · K. · Malyon · H. · Melluish · J. · Latour · J. · CHESTI-study steering group · Andrews · Crombie · Gibson · Grace · Goddard · Kolawole · Lowndes · McNamara · Pilbury · Rapson · Scivier · Sellers · Weighton · Winston
Introduction

Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.

Methods and analysis

A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.

Ethics and dissemination

Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.

Study registration

COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)

PROSPERO registration number

CRD42024562735.

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