Conectar
The Optimising older People’s Transition from acute care Into residential aged care through Multidisciplinary Assessment and Liaison (OPTIMAL) trial is a multisite hybrid type II stepped wedge randomised controlled trial with an embedded process evaluation that aims to evaluate the effectiveness of implementing a bundle of evidence-based interventions to provide systematic support to older adults being discharged from hospital to residential aged care (RAC) homes for the first time. The trial is based on evidence from models of care used internationally to improve the quality of care transitions and addresses a need to provide evidence of transferability and effectiveness of these models in the Australian context. The embedded process evaluation will assess the acceptability, appropriateness, feasibility, adoption and fidelity of the OPTIMAL intervention, as well as the mechanisms of impact.
The OPTIMAL trial will be implemented across the three metropolitan local health networks (LHNs) in South Australia. The process evaluation will be conducted in parallel with the main trial and is theoretically informed by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation framework, which theorises that the implementation success of OPTIMAL is determined by the facilitation of the intervention with the intended recipients in their inner and outer contextual setting. The process evaluation will employ a mixed methods approach. Qualitative and quantitative data will be collected through baseline context mapping of LHNs, interviews with key LHN and RAC stakeholders, online survey of clinical teams, fortnightly check-in forms, and activity logs and field notes maintained by the nurse facilitator in each LHN. Data will be mapped and reported based on the i-PARIHS framework.
Ethical approval for the OPTIMAL trial was obtained from the Southern Adelaide Clinical Human Research Ethics Committee (approval 2023/HRE00111), and the relevant governance approvals were obtained for each participating LHN. Ethical approval includes a waiver of the requirement for consent for routinely collected patient data. Study findings will be disseminated via journal publications, presentations at conferences, stakeholder discussions, consumer forums and advocacy to key decision makers to support knowledge translation.
Australia New Zealand Clinical Trial Registry, ACTRN12624001008516, registered 20 August 2024.
This study investigates the potential of digital health technologies (DHTs), such as wearable devices and smartphones, to complement traditional submaximal functional capacity tests, such as the 6 min walk test (6MWT) and the timed up and go test (TUG). While these traditional tests are widely used due to their simplicity and relevance to daily living activities, they have limitations, including infrequent administration and the need for clinical observation. DHT offers continuous, real-world monitoring, which may accurately reflect patients’ health status and effectively inform clinical decisions. However, there is a need to establish the validity of the data and metrics computed through DHT and understand patient perspectives on using such technology.
This is an observational pilot study (Synergy Digital Health study) that aims at linking wearable data with traditional test outcomes and assessing participants’ acceptance and usage of such DHT. A cohort of 30 cardiovascular patients from Oxford University Hospitals, UK, and 30 community-dwelling elderly people from social centres in Helsingborg, Sweden, will use wearable devices for 2 months in free-living conditions, they will fill out technology acceptance questionnaires (AQs), have baseline assessments and perform physical tests such as the 6MWT and TUG using the Mobistudy smartphone app. Subgroups will participate in codesign workshops to identify experience-based design recommendations for the technology. Quantitative and qualitative methods will be adopted to analyse the collected data.
The study protocol received ethical approval in Sweden from the Etikprövningsmyndigheten (2024-04886-01) and in the UK from the National Health Service (NHS) Research Ethics Committees (Iras project ID: 340870), in accordance with local regulations. All participants are asked for written informed consent. The results of the study will be shared via scientific journals and conferences.
Persistent postsurgical pain (PPSP) affects up to 15% of patients after major surgery, impairing physical function, quality of life and increasing risk for long-term opioid use. Current PPSP prediction models rely on static or retrospective data and fail to incorporate dynamic perioperative factors. The Personalised Prediction of Persistent Postsurgical Pain (P5) study aims to develop individualised, multimodal prediction models by integrating preoperative behavioural, psychophysical and neurocognitive assessments and high-frequency symptom monitoring.
P5 is a prospective, single-centre cohort study enrolling 2500 adults aged 18–75 undergoing major surgery at a tertiary academic hospital. Participants complete baseline surveys, cognitive testing and quantitative sensory testing preoperatively. Ecological momentary assessments (EMAs) are collected via smartphone three times per day through 30 days postoperatively, capturing pain, mood, catastrophising and medication use. Participants are assessed on postoperative day 1 and complete online surveys at 3 and 6 months, evaluating pain persistence, interference, neuropathic symptoms and related outcomes. Clinical and perioperative data are extracted from the electronic health record. The primary outcome is PPSP at 3 months. Predictive models will be developed using supervised machine learning and dynamic structural equation modelling to extract latent features from EMA data. Model performance will be assessed using area under the receiver operating characteristic curve, area under the precision-recall curve and SHapley Additive exPlanations for interpretability.
This study has received ethics approval from the Washington University School of Medicine Institutional Review Board #202101123. Informed consent is required. Results will be submitted for publication in peer-reviewed journals and presented at research conferences.
The carbon footprint of end-to-end healthcare deliveries by the National Health Service in England totalled 25.0 megatons of carbon dioxide equivalent (CO2e) in 2019. Optimal and sustainable healthcare can lead to better health outcomes as well as a lower environmental footprint.
To evaluate the potential impact of prevention and effective management of type 2 diabetes mellitus (T2DM) in adults on both the clinical outcomes and greenhouse gas (GHG) emissions in the UK healthcare setting.
We incorporated an environmental module into the existing IQVIA core diabetes model to estimate the impact of improving clinical outcomes on GHG emissions over a lifetime horizon. We assessed two hypothetical scenarios: (1) preventing progression from pre-diabetes to T2DM through diet and exercise versus no intervention and natural disease progression to T2DM; and (2) well-controlled T2DM using interventions with clinical benefit on glycosylated haemoglobin (HbA1c), and renal and cardiovascular outcomes versus uncontrolled T2DM.
Preventing progression to T2DM led to 6.357 additional undiscounted life years and 67% less kg CO2e emissions compared with subsequent natural progression to T2DM for a person with pre-diabetes over a lifetime (emissions of 9586 kg CO2e over 37.115 years vs 28 716 kg CO2e over 30.758 years, respectively). Well-controlled T2DM led to 1.947 additional undiscounted life years and 21% less kg CO2e emissions per patient over a lifetime compared with uncontrolled T2DM (emissions of 14 545 kg CO2e over 22.772 years vs 18 516 kg CO2e over 20.825 years, respectively). In both scenarios, the GHG emission savings were primarily due to reduced emissions related to avoidance of treating complications of T2DM including cardiovascular, renal and eye diseases.
Effective prevention and management of T2DM through implementation of evidence-based clinical guidelines can improve patient outcomes while reducing the healthcare-related environmental impacts.
To develop and validate decision trees using conditional probabilities to identify the predictors of mortality and morbidity deterioration in trauma patients.
A quasi-experimental longitudinal study conducted at a Level 1 Trauma Center in São Paulo, Brazil.
The study analysed 201 patient records using standardised nursing documentation (NANDA International and Nursing Outcomes Classification). Decision trees were constructed using the chi-squared automatic interaction detection (CHAID) algorithm and validated through K-fold cross-validation to ensure model reliability.
Decision trees identified key predictors of survival and mobility deterioration. Patients who did not require (NOC 0414) Cardiopulmonary Status but required (NOC 0210) Transfer Performance had a 97.4% survival rate. Conversely, those requiring (NOC 0414) Cardiopulmonary Status had a 25% risk of worsening mobility, compared to 9% for those who did not. K-fold cross-validation confirmed the model's predictive accuracy, reinforcing the robustness of the decision tree approach (Value).
Decision trees demonstrated strong predictive capabilities for mobility outcomes and mortality risk, offering a structured, data-driven framework for clinical decision-making. These findings underscore the importance of early mobilisation, tailored rehabilitation interventions and assistive devices in improving patient recovery. This study is among the first to apply decision trees in this context, highlighting its novelty and potential to enhance trauma critical care practices.
This study highlights the potential of decision trees, a supervised machine learning method, in nursing practice by providing clear, evidence-based guidance for clinical decision-making. By enabling early identification of high-risk patients, decision trees facilitate timely interventions, reduce complications and support personalised rehabilitation strategies that enhance patient safety and recovery.
This research addresses the challenge of improving outcomes for critically ill and trauma patients with impaired mobility by identifying effective strategies for early mobilisation and rehabilitation. The integration of artificial intelligence-driven decision trees strengthens evidence-based nursing practice, enhances patient education and informs scalable interventions that reduce trauma-related complications. These findings have implications for healthcare providers, rehabilitation specialists and policymakers seeking to optimise trauma care and improve long-term patient outcomes.
Patients provided authorisation for the collection of their clinical data from medical records during hospitalisation.
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
To explore existing strategies for managing sleep disorders in individuals with vision impairment (VI), identifying interventions, geographical trends and research gaps.
Scoping review.
Medline ALL (Ovid), Embase and Web of Science Core Collection, with supplementary searches in Google Scholar. The final search was completed on 28 November 2025.
Original research studies examining strategies to manage sleep disorders in adults (≥18 years) with VI, published in English. Studies focusing on animal models or unrelated to sleep management were excluded.
Two reviewers independently screened titles, abstracts and full texts using Covidence, extracted data using a predefined form and resolved discrepancies by consensus. A narrative synthesis approach was used to summarise findings by intervention type, study design and outcomes.
Of 4368 records screened, 16 studies met inclusion criteria. Participants ranged from 18 years to 85 years (median 40.5). Most studies included individuals with no light perception, though VI definitions were often inconsistent. Pharmacological interventions dominated (13/16, 81.3%), mainly melatonin or melatonin receptor agonists, with some use of zopiclone, low-dose benzodiazepines and tricyclic antidepressants. Non-pharmacological approaches were under-represented, including bright light exposure (n=1), virtual Hatha yoga (n=1) and caffeine modulation (n=1). Substantial variation existed in sleep assessment methods.
This scoping review highlights the predominant focus on pharmacological treatments, especially melatonin, while non-pharmacological strategies remain underexplored. Future research should explore accessible, non-pharmacological interventions and address sleep health inequities faced by individuals with VI.
10.17605/OSF.IO/7E83R.
Healthcare waste production is a significant contributor to carbon emissions, negatively impacting the environment. Ineffective healthcare waste disposal results in greater measures to manage it which is costly to both the environment and healthcare organizations. This study aimed to improve waste management in a tertiary maternity hospital. Specifically, the impact of a midwife-led intervention to improve waste segregation, staff knowledge and attitudes and waste management-related costs was investigated.
A multi-method study including pre- and post-intervention staff waste management knowledge and attitude surveys and waste audits of bins located on the postnatal ward.
The intervention included education sessions, posters and signage by waste bins and monthly newsletters distributed throughout 2021 to raise staff awareness of correct waste segregation processes. Pre- and post-intervention surveys were distributed in early 2021 and early 2022, respectively. The waste audits occurred on three occasions, January, July and December of 2021. The waste audit included total waste in kilograms (kg), waste in kg by segregation and identification of correct and incorrect segregation. Waste audit and quantitative staff survey data were analysed using descriptive statistics and chi square. Qualitative data from the staff surveys were analysed using content analysis.
Knowledge and attitudes to waste management were similar across pre- and post-intervention staff surveys. Knowledge of accurate allocation of specific items to waste streams was variable with errors identified in both the pre- and post-surveys. Waste audit data showed reductions in clinical waste at each measurement, with a 71.2% decrease in clinical waste from baseline to the final audit. Accuracy of waste segregation also improved from the baseline to final audit, resulting in a 48% reduction in waste management costs.
The midwife-led initiative improved waste segregation and achieved the associated waste management cost reduction.
A midwifery-led initiative to address waste production and segregation on a maternity ward had a positive impact on waste segregation practices and associated waste management costs. The existence of change champions along with in-service sessions, posters and newsletters to raise awareness of correct waste segregation resulted in a 71% reduction of incorrect items being placed in clinical waste bins. Challenges such as COVID-19 pressures and workload made it difficult for midwives to engage in waste management education and effective waste segregation.
No patient or public contribution.
Implementing clinician-led waste management interventions across hospital wards while addressing workload issues are likely to have significant cost benefits for organisations and minimise the environmental impacts of healthcare settings.
Inequities in health status exist in New Zealand across the rural–urban spectrum. In parallel, rural–urban differences in health service utilisation vary by service type. Despite the New Zealand public health system being based on principles of universal access, equity and fairness, levels of health expenditure on rural and urban populations are not well understood. The purpose of the study is to undertake a rural–urban analysis of public health system expenditure, based on individual-level service utilisation and national pricing of health service events.
Individual-level service utilisation and pricing will be collated from national collection databases for all eligible users of publicly funded services. The analysis will include calendar years 2017–2024. Descriptive analysis and a two-part generalised linear regression model will be used to identify if rural–urban differences in expenditure exist, and what the association of rurality is with expenditure (if any). The model will also be used to identify geographic regions with expenditure levels that vary from those predicted using regression model weights. As the specific statistical approach will be determined by data attributes, this protocol outlines the intended approach to construct the analytical model.
Ethics approval was obtained from the University of Otago Human Research Ethics Committee (HD23/052). Māori consultation has been undertaken with the Ngāi Tahu Research Consultation Committee and will continue throughout the research process.
The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.
PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.
The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.
This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.
Cystic fibrosis (CF) is an inherited condition, affecting approximately 150 000 people worldwide. Physical activity (PA) is an integral component in the management of CF. However, it is estimated that only a third of young people (with and without CF) achieve UK Chief Medical Officer guideline recommended levels of activity. The aim of this research was to use the person-based approach to develop an intervention supporting families with young people (aged 6–12 years) with CF to incorporate PA as a sustainable habit in their lives to increase the likelihood of sustained PA levels going into adolescence and adulthood.
Using the person-based approach, intervention content was created and iteratively adapted. This was initially guided by relevant literature; the guiding principles, logic model and preliminary content were developed via co-production with patient and public involvement (PPI) representatives (n=8) with lived experience of CF. The intervention was further refined/optimised using qualitative think-aloud and retrospective interviews, the results of the preliminary evaluation are reported. Think-aloud interviews were rapidly analysed using a table of changes analysis and used to inform adaptations to content. Retrospective interviews were analysed thematically.
Community settings in the UK.
Participants included six families with a child with CF aged between 6 years and 12 years old.
Intervention content consisted of nine sections and was delivered as a printable PDF file. Informed by the Capability, Opportunity, Motivation and Behaviour framework and self-determination theory, content focused on promotion of PA as a family activity that is fun, enjoyable, quick and achievable. It promoted ‘movement to make you feel good"’ and in short bursts of activity. Promotion of PA as medicine was avoided. The final intervention was considered to be engaging and acceptable.
Qualitative methods and PPI facilitated the development of a family-focused intervention supporting the integration of PA into daily life. This was viewed as acceptable and engaging among families of people with CF. Future research now needs to explore the effectiveness of the intervention for increasing PA behaviour.
Chinese-speaking immigrants in Australia have a higher risk of type 2 diabetes and face more barriers to accessing quality healthcare compared to non-culturally and linguistically diverse populations. This study aimed to explore the self-management experiences of Chinese-speaking Australians with self-reported lived experience of prediabetes following immigration.
Qualitative study.
Semi-structured interviews were conducted with 10 purposively selected Australian Chinese-speaking immigrants aged over 40 years. Data collection was undertaken in Perth, Western Australia between April and August 2024. Data were analysed using reflexive thematic analysis.
Three themes are presented in this paper: (1) An acculturation journey: Reshaping cultural identity and social connections in immigrant lives, (2) Embodying prediabetes: Cognitive reconstruction and emotional adaptation in the transition to the patient role and (3) Decision-behaviour dynamics: Mapping agency and adaptiveness in self-management processes. Participants demonstrated dynamic adjustment through the processes of self-awareness, adaptive behaviours, self-reflection and self-attribution of health outcomes.
Chinese-speaking Australians navigating prediabetes following immigration underwent a complex process of reconstruction across cognitive, cultural and psychological domains. Prediabetes self-management was shaped by cultural values, acculturation, dietary preferences, emotional resilience, local and distant social networks and resource availability. These findings underscore the importance of empowering both individuals and communities through evidence-based and culturally appropriate strategies.
Participants experienced profound transformations in their cultural adaptation, prediabetes cognition, social support networks and emotional–psychological landscape. Future interventions must address identified barriers (e.g., cooking burden, comorbidities, stress), facilitators (e.g., leisure travel, family support), motivations (e.g., cultural heritage, health risk perception) and challenges (e.g., knowledge–behaviour gap, digital health information) that shape self-management behaviours. A community empowerment approach, utilising evidence-based content, flexible delivery formats and existing cultural networks, should be adopted to offer promising pathways for prediabetes health education.
The study adhered to the Consolidated Criteria for Reporting Qualitative Research guidelines.
Limited patient and public involvement was incorporated, with two community representatives providing feedback on interview questions and recruitment strategies.
To investigate the prognostic value of the Subgroups for Targeted Treatment (STarT) Screening Tool adapted for concussion (STarT-C) on persistent symptoms and disability at 6–9 months following mild traumatic brain injury (mTBI).
Secondary analysis of two prospective studies: an observational cohort study in New Zealand and usual care control arm of a clinical trial in Canada (ClinicalTrials.gov Registry (NCT04704037)).
Participants in the New Zealand cohort were recruited from concussion clinics (five sites) and those in the Canadian cohort were recruited from emergency departments/urgent care centres (eight sites).
New Zealand participants (n=93, median age 37 years, 60% women) were assessed at median=6 weeks post-injury (T1) and 6 months later (T2). Canadian participants (n=223, median age 38 years, 56% women) were assessed at median=2 weeks (T1) and 6 months later (T2).
Symptoms at T2 were assessed using the validated Rivermead Postconcussion Symptoms Questionnaire (RPQ) and disability using the WHO Disability Assessment Schedule 2.0 12-item Interview.
In linear regression analyses, the STarT-C predicted symptom burden (R2=18–36%) and disability (R2=15–18%) at T2 in both cohorts. While the additional prognostic value over and above baseline variables was substantial (delta R2 8–40%), the additional prognostic value over the RPQ at T1 was variable and generally lower (delta R2=1–9%).
The STarT-C—a brief screening tool—predicted persistent symptoms and disability in adults following mTBI. The incremental prognostic value of the STarT-C over the RPQ may be variable, but regardless, the tool may be useful for identifying those at risk of prolonged recovery who may benefit from early psychological intervention.
Research priorities guide research activities, funding and resources within health services. To ensure that research efforts are meaningful and impactful, it is vital that organisational research agendas reflect the priorities of both healthcare consumers and staff, alongside broader national and international research frameworks. This paper outlines a research priority-setting project conducted across two hospitals in Western Australia, aimed at identifying shared research priorities through a collaborative and inclusive approach.
To identify the top ten nursing and allied health research priorities for two hospitals in Western Australia.
A modified James Lind Alliance Priority Setting Partnership approach was used, involving health services users, nurses, allied health professionals, and community members in a co-design approach across three phases. In phase 1, four community conversations were conducted to elicit an initial set of research topics. This data-informed phase 2, a survey to collect diverse views from a wider participant pool. In phase 3, a pre-selected sample of potential research priorities was discussed in a consensus workshop to reach a group consensus of the top ten research priorities. Qualitative data was analysed using multi-step thematic analysis, and quantitative data was analysed using descriptive statistics.
A total of 67, 151 and 18 people participated across study phases 1, 2 and 3, respectively, comprising nurses, allied health professionals, healthcare users, carers, and interested community members. The top ten research priorities reflected three areas: healthcare systems re/design (streamlining care; access to healthcare; patient journey and quality of care), workforce needs (workforce well-being, retention and adequate staffing; workforce training), and specific health issues and needs (dementia and delirium; mental health; caring for carers; Aboriginal and Torres Strait Islander health; palliative care and elderly people).
The research priorities identified in this study for two hospitals in Western Australia reflect the strong desire of nurses, allied health professionals, healthcare users and community members to improve structural issues in healthcare systems. This includes how healthcare systems are designed and integrated with each other, how workforce needs affect service delivery, and a greater focus on holistic service provision for specific health issues and needs.
Healthcare consumers were an integral part of this study. Healthcare consumers were involved in the design of the study, the conduct of the study, and the review of the data analysis.
Homelessness is a global public health concern which extends to the health and well-being of people working in homelessness, and this mixed-methods systematic review aims to explore their experiences of trauma.
The review protocol followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and a mixed-methods convergent segregated approach, a systematic search for qualitative and quantitative research across seven databases.
CINAHL, MEDLINE, PsychINFO, Psychology Database, Public Health Database, Web of Science and PubMed, searched from inception until May 2023.
A total of 22 articles met the eligibility criteria and were retained for inclusion (12 quantitative, 13 qualitative and 3 mixed methods). The methodological quality was assessed using the Mixed Methods Appraisal Tool, and confidence in the findings was assessed via GRADE-CERQual.
Peer-reviewed empirical research and relevant grey literature, available in English, were considered for inclusion. Data were synthesised per the Joanna Briggs Institute guidance on mixed-methods systematic review synthesis, drawing upon the Substance Abuse and Mental Health Services Administration (SAMHSA) definition of trauma.
The methodological quality of studies varied due to unclear reporting on sample representativeness and confounder control, particularly in quantitative studies. Despite this, a high prevalence of trauma experiences was evidenced, with a significant number of participants across this sector encountering traumatic ‘events’, ‘experiences’ and ‘effects’, as conceptualised by SAMHSA, stressing the urgent need for systemic-level change.
This review provides an important evidence base for future research, policy and practice, and discusses the need for psychologically informed practice, to prevent and alleviate trauma experiences across homelessness, along with nuanced, inclusive and consistent measurements of trauma.
Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.
The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.
This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.
FreshRSS 