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AnteayerBMJ Open

Impact of long COVID on diverse Australian populations: a multi-site, longitudinal prospective cohort study protocol

Por: Luo · S. · Zheng · Z. · Karimi · L. · Plebanski · M. · Anderson · K. L. M. · Jovanovski · N. · Lankatillake · C. · Cockshaw · W. · Wollersheim · D. · Sheahan · J. · Seal · E.-L. · Butler-Henderson · K. · Campbell · D. · Clarke · A. · Cleary · S. · Danaher · J. · El-Ansary · D. · Figueire
Background

Long COVID is a complex, multisystem chronic condition that may persist or fluctuate for months to years after SARS-CoV-2 infection. Despite emerging international research, significant gaps remain in understanding the full breadth of long COVID’s impacts in Australia. No study has yet prospectively examined these multidimensional impacts using a culturally appropriate, user-validated toolkit. Our study aims to characterise symptom profiles, functional outcomes and psychological, social, financial and behavioural impacts of long COVID in Australian adults; identify factors associated with recovery trajectories; and validate a set of measures to support research and clinical care.

Methods

This national, multi-site, longitudinal prospective cohort study comprises three phases: (1) survey selection and user-testing; (2) psychometric validation; and (3) a longitudinal cohort study. Survey selection was informed by literature review, Australian parliament inquiry reports and international recommendations, and refined through iterative user-testing and expert review. A total of 1000 participants aged ≥18 years from diverse cultural backgrounds with ongoing symptoms following COVID-19 infection will be divided into three cohorts based on time since infection. Surveys will be administered at seven time points over 24 months, with optional follow-up to 36 months. Data linkage to state and national health datasets will enable an objective assessment of healthcare utilisation and associated costs. Psychometric properties of the tools will be evaluated using baseline responses from the initial 300 participants, including assessments of structural/construct validity, convergent validity, known-groups validity, cross-validity, internal reliability, responsiveness and test–retest reliability. Other data analyses will include descriptive statistics, repeated-measures analysis of variance, linear mixed-effects modelling and multivariable regression models.

Ethics and dissemination

Ethics approval was obtained from The St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) (112108/2024/PID00364) and RMIT University HREC (28124). Research findings will be disseminated at conferences and in peer-reviewed publications.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12625001415493).

Incidence and associated factors of inadequate emergence in elderly patients undergoing elective major abdominal surgery: a prospective cohort study in Northwest Ethiopia

Por: Bayable · S. D. · Debas · S. A. · Aligaz · E. M. · Endeshaw · A. S. · Ale · Y. F. · Amberbir · W. D. · Fetene · M. B. · Yetneberk · T. · Zegeye · S. T.
Background

Inadequate emergence is a common postoperative complication in elderly patients following major abdominal surgery. This study was designed to determine its incidence, identify associated risk factors and characterise its clinical subtypes within this high-risk cohort.

Design and setting

This prospective single-centre cohort study was conducted at a comprehensive specialised tertiary care hospital in Northwest Ethiopia. Consecutive patients aged 65 years and older scheduled for elective major abdominal surgery under general anaesthesia were enrolled.

Primary outcome measure

The primary outcome was the proportion of patients experiencing inadequate emergence.

Results

A total of 388 patients were analysed. Inadequate emergence occurred in 21.9% of participants (95% CI 14.3% to 31.6%), with hypoactive emergence observed in 10.7% and emergence delirium in 11.2%. Multivariable logistic regression identified several independent predictors, including advanced age (adjusted OR (AOR)=1.9; 95% CI 1.5 to 8.2), preoperative anxiety (AOR=2.7; 95% CI 1.2 to 7.2), prolonged preoperative fasting (AOR=2.1; 95% CI 1.8 to 9.1), non-ketofol-based induction (AOR=3.4; 95% CI 1.6 to 6.3), absence of abdominal field block (AOR=4.2; 95% CI 4.0 to 9.6), substantial intraoperative blood loss (>1000 mL; AOR=1.9; 95% CI 1.2 to 7.6), postoperative nausea and vomiting requiring antiemetics (AOR=2.2; 95% CI 2.1 to 7.1) and presence of an indwelling urinary catheter (AOR=2.4; 95% CI 1.8 to 7.9).

Conclusions

Inadequate emergence occurred in approximately one in five elderly patients undergoing elective major abdominal surgery. Independent predictors included advanced age, major intraoperative blood loss, postoperative nausea/vomiting requiring antiemetics, non-ketofol-based induction, preoperative anxiety, absence of abdominal field block, presence of an indwelling urinary catheter and prolonged preoperative fasting.

Exploring medication safety in prisons: a scoping review

Por: Alsuwat · M. · Shaw · J. · Keers · R. N.
Objective

Drug-related problems (DRPs), which encompass medication errors (MEs), adverse drug reactions and adverse drug events (ADEs), represent significant challenges in healthcare settings. While medication safety has been extensively studied in hospitals and primary care settings leading to development of improvement strategies, there is limited understanding of these issues within prison healthcare environments. This knowledge gap is concerning given that prisoners often have complex medication needs due to higher rates of chronic physical and mental ill health and substance use disorders compared with the general population. Time in prison presents an opportunity to provide treatment for this socially disadvantaged group, making it an important setting to optimise medication management. This scoping review aimed to understand the nature and frequency of medication safety incidents, their contributory factors and evaluate strategies for enhancing medication safety within prison healthcare environments, where unique institutional constraints and security requirements may impact safe medication use.

Methods

This study conducted a systematic search across six databases to appraise the published literature from 2000 to 2023 (Embase, Medline, PsycINFO, CINAHL Plus, Cochrane and Web of Science), with reporting according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review guidelines. Data extraction was completed by one author, with validation of a sample by the other authors. The review included quantitative, qualitative and mixed-methods studies examining DRPs in prison healthcare.

Results

The review included 42 studies on medication safety in prison healthcare, comprising epidemiological perspectives (52.4%, n=22/42), aetiological exploration of DRPs (45.2%, n=19/42) and intervention evaluation (11.9%, n=5/42). Studies were predominantly from the USA (30.9%, n=13/42) and the UK (26.1%, n=11/42). Most studies focused on infectious disease management (52.3%, n=22/42), particularly HIV treatments (42.8%, n=18/42), followed by mental health medications (23.8%, n=10/42). Non-adherence emerged as the most commonly studied DRP, reported in both epidemiological (68.1%, n=15/22) and aetiological studies (68.4%, n=13/19). Contributing factors included medication delivery problems, psychosocial factors, accessibility challenges and conflicts between healthcare delivery and security requirements. Five intervention studies were identified, with two from the USA (40%, n=2/5). These interventions included those addressing medication non-adherence (40%, n=2/5) and potentially inappropriate prescribing (20%, n=1/5), and highlighted the potential efficacy of multidisciplinary and pharmacist-led approaches in addressing medication safety challenges within prison healthcare settings.

Conclusions

This represents the first comprehensive study to present a narrative report on the existing evidence regarding the epidemiology, aetiology and interventions for medication safety events in prison healthcare. While intervention studies demonstrate promising findings from multidisciplinary and pharmacist-led initiatives, further evidence is needed to address DRPs beyond medication non-adherence, guided by a deeper understanding of their contributory factors. Future studies should target preventable MEs and ADEs, as well as wider health conditions to broaden our understanding of prison-specific contributory factors to develop targeted interventions for this vulnerable population.

ReFIT study (reversing frailty in transplantation): protocol for a longitudinal study to assess clinical and biomedical changes in frailty through kidney transplantation

Por: Payne · T. · Shaw · A. · Hanjani · L. S. · Homes · R. · Giddens · F. · Ravuri · H. G. · Yap · C. X. · Walsh · J. · Kumar · V. · Garton · F. C. · Rhee · H. · Huang · A. · Francis · R. S. · Reid · N. · McAdams-DeMarco · M. · Gordon · E. · Midwinter · M. · Hubbard · R.
Introduction

Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

Methods and analysis

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

Ethics and dissemination

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

Is intensive behavioural change enhanced with dialectical behavioural therapy feasible for weight management in adolescents living with higher body weight? A protocol for a pilot randomised controlled trial in three centres in Canada

Por: Cameron · E. E. · Morrison · K. M. · Ho · J. · Roos · L. · Katz · L. · Mushquash · A. · Dart · A. · Wicklow · B. A. · Senechal · M. · Jung · M. E. · Strachan · S. M. · Afifi · T. O. · Archibald · M. · Andrade · B. · Hadjiyannakis · S. · Hamilton · J. · Slaght · J. · Penner · K. · Balshaw
Introduction

For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

Methods and analysis

The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

Ethics and dissemination

This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

Trial registration number

NCT05338944.

Implementing a bundle of interventions to support older adults transitioning from hospital to residential aged care: a protocol for the process evaluation of the OPTIMAL stepped wedge cluster randomised controlled trial

Por: Fernando · R. L. · Crotty · M. · Inacio · M. C. · Batta · I. · Bourke · A. · Forward · J. · Furst · C. · Whitehead · C. · Shaw · S. · Shepperd · L. · Harvey · G.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

Australia New Zealand Clinical Trial Registry, ACTRN12624001008516, registered 20 August 2024.

Dementia and Mild Cognitive Impairment in Prison (DECISION) care pathway and training package: protocol for a realist-informed mixed-methods feasibility study

Por: Forsyth · K. · Buck · D. · Stalker · K. · Allgar · V. · Shaw · J. · Cowley-Sharp · R. · Hunter · R. · Lennox · C. · ONeill · A. · Robinson · C. · Ware · S. · Robinson · L.
Introduction

Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package–DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.

Methods

This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention’s outcomes.

Ethics and dissemination

This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.

Sleep quality and associated factors in people with schizophrenia in Northwest Ethiopia: a cross-sectional study

Por: Rtbey · G. · Kelebie · M. · Kibralew · G. · Aderaw · M. · Endeshaw · W. · Fentahun · S. · Nakie · G. · Tadesse · G.
Objective

The aim of this study was to assess the prevalence of poor sleep quality and its determinants in people with schizophrenia in Northwest Ethiopia.

Design

Institutional-based cross-sectional study design.

Setting

University of Gondar, Comprehensive and Specialized Hospital, Gondar, Ethiopia.

Participants

A total of 405 people with schizophrenia attending outpatient treatment at University of Gondar, Comprehensive and Specialized Hospital were recruited in this study employing systematic random sampling technique from 1 April to 30 May 2024.

Measurements

An interviewer-administered questionnaire and chart review were used to collect the data. Pittsburgh Sleep Quality Index, Clinical Global Impression-Schizophrenia Scale, Glasgow Antipsychotic Side-Effects Scale, Medication Adherence Report Scale and Oslo Social Support Scale were used. A binary logistic regression was employed to measure the association of poor sleep quality and its determinants and variables with a p value of

Results

The overall prevalence of poor sleep quality in people with schizophrenia was found to be 58.3% with a 95% CI 53.38 to 63. Age less than 45 years (adjusted OR (AOR)=2.1, 95% CI 1.2 to 3.7), poor and moderate social support (AOR=10, 95% CI 5.7 to 17.8 and AOR=4.7, 95% CI 2.5 to 8.8), poor medication adherence (AOR=1.9, 95% CI 1.8 to 3.1) and a family history of mental illness (AOR=1.9, 95% CI 1.2 to 3.3) were significantly associated with poor sleep quality in this study.

Conclusion

This study revealed that around six in 10 people with schizophrenia experience poor sleep quality. Therefore, healthcare providers should routinely screen people with schizophrenia for sleep and consider targeted interventions to achieve the ultimate goal of treatment process.

Direct-to-consumer commercial virtual care: a scoping review

Por: Spithoff · S. · Arnott · C. A. · Visanji · A. · Bhavsar · P. · Goulem · B. · Lapointe-Shaw · L. · Merriman · K. · Raza · D. · Xie · E. C. · Hedden · L. · Abejirinde · I.-O. O. · Motulsky · A. · Shaw · J.
Objective

The literature examining direct-to-consumer (DTC) commercial virtual care has expanded rapidly over the past decade. Our objective was to synthesise the nature and range of evidence on DTC commercial virtual care.

Design

Scoping review.

Data sources

MEDLINE ALL, EMBASE Classic+Embase, CINAHL, HealthSTAR, PsycINFO, CENTRAL and grey literature sources.

Eligibility criteria

We included original research studies published in English or French between 1 January 2016 and 30 April 2025 that assessed DTC commercial virtual care in all contexts and in all populations.

Data extraction and synthesis

Screening titles and abstracts, and full-text manuscripts, and extracting data was done in duplicate. We analysed quantitative data using descriptive statistics and reported findings in tables. We provided a narrative summary of textual data.

Results

After excluding duplicates, we identified 8055 studies for title and abstract screening; 691 articles for full-text screening; and 103 studies meeting our inclusion criteria. 32 studies (31.1%) reported financial ties to the virtual care industry. 67 (65.0%) studies were conducted in the USA. Studies were largely quantitative (87/103 (84.5%)) or mixed methods (8/103 (7.8%)) studies and used cross-sectional (85/95 (89.5%)) designs. Most quantitative studies were descriptive, reporting on quality of care, health outcomes, platform characteristics and patient views, with only 24 of the 95 quantitative studies (25.3%) including a control or comparison group. 18 of these 24 studies (75.0%) compared the quality of care, costs and/or utilisation to other models of care and reported variable findings. The rest compared patient characteristics. Few studies assessed clinician perspectives or addressed privacy-related ethical concerns.

Conclusions

Despite a large number of studies assessing DTC commercial virtual care, we have little insight into impacts on quality of care, health outcomes, health system utilisation and privacy-related ethical concerns. The financial ties with industry suggest that there may be bias in the body of research literature.

Lower versus standard dose-intensity continuous renal replacement therapy: a protocol for a systematic review and meta-analysis

Por: Lumlertgul · N. · Kusirisin · P. · Kung · J. Y. · Duquette · D. · Fujii · T. · Zarbock · A. · Wald · R. · Bagshaw · S. M.
Introduction

The 2012 Kidney Diseases Improving Global Outcomes clinical practice guideline recommends prescribing continuous renal replacement therapy (CRRT) doses in patients with acute kidney injury (AKI) between 20 and 25 mL/kg/hour, with a need to consider further augmentation to 25–30 mL/kg/hour. Observational data have shown that lower-dose CRRT (

Methods and analysis

Ovid MEDLINE, Ovid Embase, CINAHL and Cochrane Library will be searched for studies from inception to present. We will evaluate the risk of bias using the modified Cochrane tool for randomised controlled trials and the Cochrane Risk of Bias In Non-randomised Studies—of Interventions tool for cohort studies. Two reviewers will independently complete study selection, data extraction and bias assessment. Inclusion criteria will be randomised controlled trials and observational studies (cohort) including patients with AKI receiving CRRT. The exposure will be lower dose-intensity CRRT (

Ethics and dissemination

Ethics approval is not required as primary data will not be collected. Findings of this review will be disseminated through peer-related publication.

PROSPERO registration number

CRD420251135606.

Bridging the gap in the UKs National Health Service integrated care systems: insights from a mixed methods implementation evaluation of UCLP-PRIMROSE, a care innovation to reduce physical health inequalities for people with severe mental illness

Por: Shaw · P. · Khurshid · Z. · Lamb · D. · Stevenson · F. A. · Russell · G. · Hudson · K. · Rehill · N. · Copsey · G. · Kearney · M. · Beveridge · E. · Prenelle · I. · Osborn · D.
Objective

We aimed to determine whether UCLP-PRIMROSE (a care innovation to reduce physical health inequalities for people with severe mental illness) could be set up in the current UK National Health Service (NHS) context and identify the processes, barriers and facilitators to implementation.

Design

We employed a convergent mixed methods approach, combining interviews, ethnographic site visits and the collection of meeting notes and uptake data for core model components. Interview transcripts were analysed using reflexive thematic analysis, and all qualitative data, including interview transcripts, were analysed using the Consolidated Framework for Implementation Research. Qualitative work and insights from implementation uptake frequencies were integrated using Normalisation Process Theory.

Setting

We evaluated implementation in Yorkshire and three London boroughs, mainly within general practices.

Participants

We conducted interviews with 39 staff members who were implementing and/or delivering UCLP-PRIMROSE.

Intervention

UCLP-PRIMROSE is an integrated evidence-based care pathway developed to reduce cardiovascular disease risk and mental health relapse in people with severe mental illness.

Results

Adaptation and delivery varied in completeness and consistency across 24 general practices and their wider care teams. Factors outside the implementation teams’ influence challenged the embedding of UCLP-PRIMROSE. Factors included the impact from the immaturity of NHS integrated care systems, unintended consequences of the incentivised NHS severe mental illness physical health check and limited capacity for implementing in a system facing resourcing challenges. Drivers of successful implementation included staff being aligned with the values of the UCLP-PRIMROSE model and system leaders acting as champions. Supportive foundational processes acted as facilitators: these included protected and prioritised time for reflection, learning and problem solving.

Conclusions

Implementation of UCLP-PRIMROSE was moderately successful in a relatively short period of time. At the end of the research, all teams wanted to sustain delivery. However, further pathway simplification and additional resources are required to spread UCLP-PRIMROSE beyond early pockets of good practice.

Screening for hypertension in the inpatient environment (SHINE): a prospective diagnostic accuracy study among adult hospital patients

Por: Armitage · L. C. · Roman · C. · Lawson · B. K. · Mahdi · A. · Biggs · C. · Young · L. · Edmundson · H. · Fanshawe · T. · Tarassenko · L. · Farmer · A. · Watkinson · P. J.
Background

Hypertension is the leading risk factor for death globally. Undiagnosed hypertension is common, but the incidence in hospitalised patients is unclear. There are calls for universal facility-based screening for hypertension among all attending patients. The hospital inpatient setting, where blood pressure (BP) is measured routinely and repeatedly, presents an ideal opportunity. However, international hypertension guidelines do not include inpatient BP thresholds for diagnostic or treatment purposes. We investigated the performance of current UK community BP thresholds for diagnosing hypertension in the hospital setting.

Objectives

Investigate the diagnostic performance of the current UK ambulatory BP diagnostic thresholds for systolic and diastolic hypertension in the hospital setting against the reference test of community-based ambulatory BP monitoring (ABPM).

Design

A prospective diagnostic accuracy study.

Setting

Hospital inpatients admitted to three UK centres were approached. Follow-up ABPM was delivered in the community.

Participants

Eligible patients were aged between 18 and 80 years, with no prior diagnosis of, or prescription for hypertension, and whose mean cumulative daytime BP was 120 mm Hg to 179 mm Hg systolic and ≤109 mm Hg diastolic from the 24th hour of their hospital admission.

Interventions

Participants received 24-hour ABPM 4–26 weeks post-discharge, as the reference test for hypertension, with UK diagnostic thresholds of an average daytime BP of ≥135 mm Hg systolic and ≥85 mm Hg diastolic applied. Participants found to be severely hypertensive at the ABPM fitting appointment were also considered reference-test positive but did not proceed with ABPM.

Primary and secondary outcome measures

The diagnostic performance of a mean daytime in-hospital BP of ≥135 mm Hg systolic or ≥85 mm Hg diastolic (index test) for the prediction of hypertension diagnosed on ABPM (reference test) was assessed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as primary outcome measures. Additionally, we explored the accuracy of a range of alternative in-hospital systolic and diastolic BP thresholds against the same reference test.

Results

351 participants were enrolled and 206 completed the study protocol. The average age of the 206 participants was 53 years, 55% were male, and 91 (44%) had daytime community hypertension on ABPM reference testing. Of 107 participants with raised in-hospital daytime BP, 59 (55%) had daytime community hypertension. When assessing the performance of the index test for detecting daytime community hypertension, sensitivity was 65% (59/91, 54% to 75%) and specificity was 58% (67/115, 49% to 67%). The PPV was 55% (59/107, 45% to 65%) and NPV was 68% (67/99, 58% to 77%), respectively. A further 45/206 participants (23%) had night-time community hypertension when assessed using European diagnostic thresholds for nocturnal hypertension (120 mm Hg systolic or 70 mm Hg diastolic), while 25/107 of those with raised in-hospital daytime BP (23%) had night-time community hypertension. When assessing the performance of the index test for detecting either day or night-time community hypertension, sensitivity was 62% (84/135, 53% to 70%) and specificity was 68% (48/71, 55% to 78%). The PPV was 79% (84/107, 70% to 86%) and NPV was 48% (48/99, 38% to 59%).

Conclusions

Undiagnosed hypertension is common in hospitalised patients, particularly those with raised in-hospital BP. While in-hospital BP alone is an imperfect predictor and should not be used as a stand-alone diagnostic test, this could serve as a trigger for further assessment of BP in the community after discharge.

Trial registration number

The study protocol was registered with the ISCTRN Registry (ISRCTN80586284).

Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (SPEEDY): study protocol for a cluster randomised controlled trial with included health economic and process evaluations

Por: Shaw · L. · Allen · M. · Day · J. · Ford · G. A. · James · M. · McClelland · G. · McMeekin · P. · Mossop · H. · Pope · C. J. · Simmonds · R. L. · White · P. · Wilson · N. · Price · C. I.
Background

Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.

Methods and analysis

This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.

Ethics and dissemination

This study has ethical, Health Research Authority and participating NHS Trust approvals.

Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

Trial registration number

ISRCTN77453332.

Development of a Standardised stroke risk assessment for patients with MigraAinous symptoms Reviewed as suspected TIA (SMART): study protocol for a mixed methods study

Por: Shaw · L. · Isaac · J. · Scott · J. · Sharp · L. · Smyth · E. · Stuart · L. · Werring · D. J. · Price · C.
Background

Transient ischaemic attack (TIA) and migraine can generate identical symptoms but have very different short-term risks of stroke. Uncertainty about the diagnosis may lead to missed opportunities to prevent stroke if TIA is treated as migraine, or overtreatment if migraine is treated as TIA. This project aims to define the risk of stroke for people with migrainous symptoms reviewed as suspected TIA and develop a risk assessment tool that could promote standardisation of care.

Methods and analysis

The project involves two interlinked studies:

(1) Study A: prospective observational cohort study.

Setting: NHS TIA and stroke services.

Population: adults with migrainous symptoms undergoing review for suspected TIA by a TIA/stroke service and the initial specialist clinician symptom-based diagnosis is either possible migraine or possible TIA with migrainous symptoms.

Data collection: baseline clinical characteristics, investigations and treatments. Stroke, TIA and migraine events within 90 days.

Sample size: 2709 participants.

Main analyses: analysis of stroke risk, development of stroke risk prediction model, preparation of visual tools to represent the risk model.

(2) Study B: qualitative co-design study.

Setting and population: clinicians from NHS TIA and stroke services.

Data collection: focus groups/interviews exploring views about the potential role for a risk assessment tool, the most appropriate visualisation for the risk tool and barriers/facilitators for implementation.

Sample size: approximately 16 clinicians.

Analyses: framework approach using the Implementation Research Logic Model.

Ethics and dissemination

This study has ethical, Health Research Authority and participating NHS Trust approvals. Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

Trial registration number

ISRCTN16775533.

Mixed-methods integration during data analysis in clinical trials of complex healthcare interventions: how is it done, and what can it do? Protocol for a systematic methodological review

Por: Sugg · H. V. R. · Shaw · N. · Vesterlund · E. M. · Woodford · J.
Introduction

The importance of conducting qualitative research alongside clinical trials of complex healthcare interventions is well established. There are various ways in which these two methodologies can be combined in mixed-methods research, including integrating data and/or results from the qualitative and quantitative strands during analysis, using techniques such as joint displays. The potential benefits of integration during data analysis include understanding intervention mechanisms, reasons for variation in outcomes, ways of tailoring interventions to individuals and barriers and facilitators to implementation. However, integration during data analysis may rarely be undertaken in practice, and the extent to which integration can provide valuable insights appears to be underappreciated in the field.

In this review, we aim to summarise current methods of integrating qualitative and quantitative raw data and/or results during analysis in clinical trials of complex healthcare interventions, and the yield of these different methods. Our specific research questions focus on (1) which integration techniques are used; (2) whether the results meet the study authors’ aims and/or answer their research questions; (3) the insights obtained and/or meta-inferences generated from these techniques (classified as either global or specific, and as relational, predictive, causal, comparative or elaborative); (4) any relationship between these insights and/or meta-inferences and the integration technique used and (5) the quality of these studies.

Methods and analysis

We will systematically search MEDLINE, Embase, PsycINFO, CENTRAL, CINAHL, Scopus and Web of Science, and manually search reference lists. We will include studies if they integrate, during data analysis, raw data and/or results from a clinical (randomised, non-randomised or single-arm) trial and an embedded or subsequent associated qualitative study of a complex, non-pharmaceutical healthcare intervention (where the effects on a health outcome were measured). Two independent reviewers will screen titles, abstracts and full texts and perform data extraction. We will develop a descriptive account of the data, including mapping the key characteristics of included studies and narratively reporting our findings in relation to each of our research questions. We will explore how integration was undertaken, what insights were obtained and/or meta-inferences generated, and whether and how these relate to the type of integration technique used.

Ethics and dissemination

This study does not require ethical approval. We intend to publish our findings in a peer-reviewed open-access journal and to present our findings at national and/or international conferences.

Registration

This protocol was registered with Open Science Framework on 22 October 2025 (ref osf.io/yxtb9).

The carbon footprints of single-use and reusable medical devices: a systematic review

Por: Booth · A. · Chowaniec · M. · Goyal · S. · Faulkner · S. · Shaw · S.
Objective

Medical devices account for approximately 6–10% of national health systems’ carbon footprints. The global use of single-use devices has increased, with implications for health systems’ climate impact. This systematic review aimed to synthesise global evidence on medical device carbon footprints, compare single-use and reusable devices and identify lifecycle carbon hotspots to inform policy and practice.

Design

We conducted a systematic review of carbon footprints of medical devices used in clinical settings, reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines.

Data sources

We searched MEDLINE and Scopus, in 2022 and updated in 2025, and used citation tracking.

Eligibility criteria

English-language, primary research involving carbon modelling of medical devices used in clinical settings was included, with no date restrictions.

Data extraction and synthesis

Articles were screened, and data on carbon modelling methods, device footprints and lifecycle hotspots were extracted by two independent reviewers. Findings were synthesised in figures and tables, and narratively in text. The heterogeneity in carbon modelling approaches prevented quantitative synthesis.

Results

Of 5195 articles identified, 59 met inclusion criteria. Life cycle assessment was the main carbon modelling approach, though application and data quality varied. Carbon footprints of 61 devices were assessed, primarily in surgical (16), anaesthetic (8) and endoscopic (8) specialties. Reusable devices consistently had lower lifecycle footprints. Hotspots were production and manufacturing for single-use devices and reprocessing for reusables.

Conclusion

Reusable devices are preferable from a climate perspective, though efforts are needed to reduce reprocessing emissions. Co-ordinated interventions are required: policymakers can enable supportive regulation; manufacturers can improve device design; healthcare facilities can optimise reprocessing; and providers can prioritise reusable device procurement and use.

Sources and consequences of self-doubt in patients with Ehlers-Danlos syndrome: a qualitative study in Europe and North America

Por: Halverson · C. M. E. · Vershaw · S. L. · Francomano · C. A. · Doyle · T.
Objectives

To examine how clinicians’ scepticism regarding patients’ self-reports of subjective symptoms can be internalised, leading to psychosocial and medical harms.

Design

In-depth, semi-structured qualitative interviews with the resulting data analysed using reflexive thematic analysis.

Participants

43 individuals with Ehlers-Danlos syndrome (EDS) from Europe and North America completed a pre-survey, and 39 of those participants completed interviews for this study. Purposive sampling was used to obtain approximately equal numbers of participants with hypermobile EDS and the molecularly defined types of EDS.

Results

Patients with both hypermobile and molecularly defined types of EDS reported high levels of self-doubt, with 73% of survey respondents questioning the extent—and even reality—of their private experiences of pain. Participants attributed much of their self-doubt to repeated dismissal and minimisation of their symptoms in healthcare settings, especially during childhood. Ultimately, self-doubt transformed not merely how they communicated their symptoms but also how they recognised, evaluated and even experienced them at a phenomenological level. While some participants developed coping strategies, others withdrew from the conventional medical system altogether.

Conclusion

These findings have important implications for clinicians, who may inadvertently reinforce self-doubt through discussion of diagnostic uncertainty. Doubt need not be delegitamising. Recognising and mitigating these potential harms requires epistemic humility and attention to the psychosocial dynamics of patient-provider interaction.

Smoking, nicotine and pregnancy 3 (SNAP3) trial: protocol for a randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction in pregnancy

Por: Campbell · K. A. · Clark · M. M. · Montgomery · A. A. · Partlett · C. · Dickinson · A. · Bradshaw · L. · Jones · M. · Huang · Y. · Aveyard · P. · Jiang · Y. · Holmes · C. M. · Coleman · T.
Introduction

Nicotine replacement therapy (NRT) helps pregnant women quit smoking. Usual National Health Service (NHS) cessation care in pregnancy starts only after women stop smoking and comprises behavioural support and NRT. NRT is stopped if women restart smoking. We hypothesised that NRT would have a bigger effect on cessation in pregnancy if used: (1) to reduce smoking before quitting (‘preloading’), (2) during brief smoking lapses after quitting and (3) to help those who cannot stop smoking, to reduce instead.

Methods and analysis

A two-arm parallel group, open-label, multicentre, assessor-blind randomised controlled trial. Participants are recruited at hospital antenatal clinics and other NHS settings throughout England and Wales or via social media advertising. Those enrolled are in antenatal care,

Ethics and dissemination

Ethics approval was granted by the West Midlands—Coventry & Warwickshire Research Ethics Committee (REC reference: 21/WM/0172; Protocol number 21001; IRAS Project ID: 291236). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice and policy representatives and other researchers.

Trial registration number

ISRCTN84798566.

High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure (HONOUR): a protocol for a pilot randomised controlled trial

Por: Angriman · F. · Ferreyro · B. L. · Rochwerg · B. · Sklar · M. · Adhikari · N. · Bagshaw · S. M. · Brochard · L. · Cuthbertson · B. · Del Sorbo · L. · Fowler · R. · Geagea · A. · Granton · J. T. · Mehta · S. · Munshi · L. · Muscedere · J. · Nardi · J. · Parhar · K. · Pinto · R. L. · Piquett
Introduction

Acute hypoxaemic respiratory failure is a common reason for intensive care unit (ICU) admission. Non-invasive respiratory support strategies such as high-flow nasal oxygen (HFNO) and helmet non-invasive ventilation may reduce the need for invasive mechanical ventilation and death. The High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure pilot trial is designed to compare helmet non-invasive ventilation combined with HFNO vs HFNO alone in patients with acute hypoxaemic respiratory failure and to determine the feasibility of a larger randomised controlled trial.

Methods and analysis

This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.

Ethics and dissemination

Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.

Trial registration number

ClinicalTrials.gov Identifier: NCT05078034.

Evaluation of a digital health decision intervention to support management decision-making for adults with hearing loss: protocol for the HearChoice randomised controlled trial

Por: Ferguson · M. A. · Sherman · K. A. · Bothe · E. · Timmer · B. H. · Dawes · P. · Myers · B. · Norman · R. · Mejia · J. · Bennett · R. J. · Mottershaw · A. L. · zu Brickwedde · E. M. · Convery · E. · Gyani · A.
Introduction

Hearing loss is highly prevalent and impacts many aspects of a person’s life, including communication, social engagement, employment, general health and well-being. Yet, many people do not access hearing healthcare and are unaware of the range of hearing healthcare options available. Barriers to hearing healthcare include poor understanding of hearing loss and its impact; poor knowledge of help-seeking for hearing healthcare options; minimal support to help decide which option is best; and stigma related to hearing loss. These barriers lead to many people not receiving the hearing healthcare they need. Guided by theories of behaviour change and implementation science, HearChoice, an online tailored decision support intervention, has been co-developed to empower adults with hearing difficulties by offering them choice and control over their own hearing healthcare. HearChoice aims to facilitate informed decisions, accessibility and uptake of hearing healthcare, including a wide range of interventions, for adults with hearing difficulties. The objectives of the trial are to evaluate the effectiveness, health economics and feasibility of HearChoice.

Methods and analysis

This online randomised controlled trial will recruit participants with hearing difficulties across Australia, with an anticipated sample size of 640. Participants will be randomised to either HearChoice (treatment) or an Australia-specific Hearing Option Grid (active control), both delivered online. Outcomes will be assessed at baseline when the interventions will be offered, at 7 days post-intervention (primary endpoint) and at 3 months post-intervention. An email reminder will be sent at 1-month post-intervention. The primary outcome is decisional conflict. Secondary outcomes include measures of readiness and self-efficacy to take action, hearing-related quality of life and empowerment, assessment of the value and impact of HearChoice, work performance and health, and feasibility measures. Primary analysis will compare outcomes between HearChoice and the active control at the primary endpoint.

Ethics and dissemination

The study was approved by the Curtin University Human Ethics Committee (HRE2023-0024). All participants will provide written informed consent prior to participation. A broad dissemination plan of the study findings includes peer-reviewed publications, scientific conference presentations, articles and presentations for the wider community and public written in lay and accessible language, and social media.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12624001139561).

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