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Hospitalisations and deaths due to ambulatory care sensitive conditions among adults with and without intellectual disabilities in Scotland: a cohort study

Por: Sosenko · F. · Cairns · D. · Jani · B. · Ward · L. M. · Truesdale · M. · Hughes-McCormack · L. · Henderson · A. · Melville · C.
Objectives

To explore how well the primary care system in Scotland works for adults with intellectual disabilities (ID), using the rate of unplanned hospital admissions for ambulatory care sensitive conditions (ACSC) as a proxy indicator. As part of this, to investigate those rates and rate ratios among adults with ID and without ID, adjusting for the prevalence of a given ACSC in each population. The secondary aim was to explore deaths due to ACSC among the ID and no-ID populations.

Design

A population-based retrospective cohort data linkage study of adult respondents to Scotland’s 2011 Census. Self-reported or proxy-reported ID status from the Census was linked to hospital admissions data and deaths data. The cohort was followed until the end of 2019. The prevalence of ACSCs in each population was calculated from aggregate-level data published by the National Health Service, as it was not possible to use the linked dataset for this purpose.

Setting

Whole population of Scotland.

Participants

People aged 18+ on census day (27 March 2011), including all adults with ID (n=16 840) and a 15% randomly selected comparator sample of adults without ID (n=566 074).

Primary and secondary outcome measures

Crude and age-sex standardised incidence rates and ratios; cumulative incidence; prevalence ratios. The exposure was ID status, and the outcomes were (1) unplanned ACSC hospital admission, (2) death with an ACSC condition listed as the main cause on the death certificate and (3) death with an ACSC condition listed as one of the causes on the death certificate.

Results

Adults with ID under the age of 55 had only a slightly higher risk of an unplanned ACSC hospitalisation than their general population counterparts (standardised incidence ratio 1.11; 95% CI 1.03 to 1.20). After adjusting for different ACSC prevalence in ID and non-ID cohorts, this difference in risk disappeared. These findings contrast with existing evidence from England, where a much higher unadjusted risk of unplanned ACSC hospitalisations was found among people with ID. Adults with ID had a higher risk of dying due to ACSC than adults without ID (standardised mortality ratio 2.54; 95% CI 2.19 to 2.95).

Conclusions

Our findings on unplanned ACSC hospitalisations suggest that the primary care system in Scotland appears to be similarly effective for adults with ID than for adults without ID. However, the higher risk of dying from ACSC among people with ID suggests that this system is less effective for people with ID. Future research should investigate this tension and aim to understand why the operation of the primary healthcare system seems to be worse with regards to ACSC mortality than with regards to unplanned ACSC hospitalisations.

Can provision of near vision glasses as an early intervention improve visual outcomes in infants at risk of perinatal brain insult? The Babies in Glasses (BiG) randomised feasibility trial

Por: Bullaj · R. · Dyet · L. · Mitra · S. · Bunce · C. · Clarke · C. S. · Saunders · K. · Dale · N. · Horwood · A. · Williams · C. · St Clair Tracy · H. · Marlow · N. · Bowman · R.
Objectives

We conducted a feasibility study to evaluate the feasibility of recruiting patients to examine the effect of near vision glasses in young infants at risk of cerebral visual impairment.

Design

A three-arm, parallel-group, open-label randomised feasibility trial.

Setting

Tertiary neonatal intensive care in London, UK.

Participants

We included babies born before 29 weeks of gestation or at full term with hypoxic ischaemic encephalopathy. Babies who needed ongoing inpatient care, with established eye anomalies or with very high refractive errors at baseline (±8.00D) were not included. Infants with retinopathy of prematurity were not excluded.

Interventions

At 8 weeks corrected age, we allocated 18 infants to wear glasses (+3.00D over full cycloplegic refraction) immediately (intervention 1), 18 to wear the same glasses at 16 weeks (intervention 2) and 19 infants were allocated to standard treatment (no glasses).

Outcomes

Recruitment and retention of study participants (primary), compliance wearing glasses, preferential-looking visual acuity (with glasses) and visual function as determined using A Test Battery of Child Development for Examining Functional Vision at 3-month and 6-month age post-term.

Results

Of 70 eligible families, 55 consented and 34 attended baseline assessments, and 28 completed the study. Non-attendance was due mainly to prolonged inpatient stay, infant health and scheduling conflicts. Glasses were worn for similar periods in each group (Intervention 1: median 2 hours/day (95% CI 1 hour to 4 hours); Intervention 2: median 2 hours/day (95% CI 1.5 hours to 3 hours)). Visual acuity improved from baseline to 6 months. Mean (SE) LogMAR (Minimum Angle of Resolution) improvements were standard care: 0.47 (0.45); intervention 1: 0.66 (0.44); intervention 2: 0.37 (0.36). Among the 29 very preterm infants, there were similar findings: standard care: 0.35 (0.35); Intervention 1: 0.67 (0.47); Intervention 2: 0.34 (0.40). As a functional measure, object permanence was present at the following rates by randomised arm: standard care: 29%; whereas intervention 1: 56%; and intervention 2: 44% (OR intervention 1 vs standard care: 3.13 (95% CI 0.38 to 25.57), ie, not statistically significant).

Conclusions

We demonstrate feasibility for a definitive RCT (randomized controlled trial) with good recruitment and retention and observed potential benefits for vision and development following the dispensing of glasses at 8 weeks post-term age compared with untreated controls. We identified methodological modifications to further improve recruitment processes for a future larger study.

Trial registration numbers

ISRCTN14646770; NCT05048550.

Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study

Por: Gunning · S. G. S. · Page · J. · Rossdale · J. · Charters · P. F. P. · Hudson · B. · Lyen · S. · Mackenzie Ross · R. · Seatter · A. · Bartlett · J. W. · Austin · L. · Myring · G. · McLeod · H. · Mitchell · P. · Stimpson · D. · Cookson · A. · Suntharalingam · J. · Rodrigues · J. C. L.
Introduction

Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

Methods and analysis

This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI’s interpretation of CTPA images.

A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI’s influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

Ethics and dissemination

This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

Trial registration number

NCT06093217.

Rapid realist review of organisational supports for youth peer support workers

Por: Hews-Girard · J. · Halsall · T. · Cullen · E. · Bellefeuille · A. · Daley · M. · Evans · C. · Sandoval · V. · Dunning · A. · Lee · J. · Carde · B. · Couturier · J. · Ferrari · M. · Kimber · M. · Patten · S. B. · Iyer · S. · Dimitropoulos · G.
Objectives

Providing peer support can benefit youth peer support workers (peers)et by supporting self-determination, recovery and resilience to self-stigma. There is a need to clarify the role of the organisation in providing benefits for peers. We aimed to identify the organisational contexts and mechanisms that result in the creation of healthy workplaces for peers.

Design

Rapid realist review guided by the Realist and Meta-Narrative Evidence Syntheses–Evolving Standards guidelines and Pawson’s iterative approach.

Data sources

MEDLINE, CINAHL, PsycINFO, ERIC, SocINDEX, Google Scholar and Embase were searched from 1979 to 2025.

Eligibility criteria

We included qualitative and quantitative peer-reviewed studies and grey literature that captured characteristics of organisational practices and employment considerations in youth peer support programmes.

Data extraction and synthesis

Articles were screened independently by multiple reviewers. Inclusion criteria were adjusted to capture literature on organisational practices, and employment considerations for youth peer support programmes. Data were extracted and analysed retroductively to develop Context-Mechanism-Outcome Configurations (CMOCs).

Results

Five employment-related risks to peer well-being were identified: (1) difficulty entering the job market, (2) lack of role clarity, (3) pressure to live up to ideals, (4) retraumatisation and (5) stigma. Six CMOCs were developed; all focused on the creation of equitable employment and supporting peer development and empowerment were developed.

Conclusions

Community-based mental health organisations can facilitate equitable peer employment through strategies that reduce professional stigma, enhance peer resilience and promote professional and personal development. Policy reform that addresses precarious work conditions is needed to support healthy work environments.

Redefining ‘normal’: A Canadian case study of cancer survivors’ experiences remaining and/or returning to work during the COVID-19 pandemic

by Carolyn Tran, Debbie Kane, Dale Rajacich, Kathryn Lafreniere, Caroline Hamm

As cancer survival rates increase in Canada, a growing number of working-age individuals face challenges returning to work after treatment. This study examines the experiences of Canadian cancer survivors who remained in or returned to the workforce during the COVID-19 pandemic. Participants were cancer survivors aged 25−62 who had been employed prior to their diagnosis. They completed a brief online survey about their return-to-work (RTW) experiences and were invited to participate in a semi-structured interview. Seven participants took part in the interviews, which were transcribed and analyzed through inductive thematic analysis. Four overarching themes emerged: (1) The Perfect Storm of Systemic Challenges, highlighting healthcare barriers exacerbated by the pandemic; (2) You Are Not Alone, emphasizing the importance of social support in mitigating isolation; (3) One Size Does Not Fit All – Individual Journeys, reflecting the need for flexible workplace accommodations and patient self-advocacy; and (4) Creating a “New Normal,” illustrating how survivors reassessed priorities, work identities, and personal well-being. Participants described delayed treatments, lack of fertility options, and limited support during appointments due to pandemic restrictions. Workplace accommodations varied, with some survivors feeling supported while others faced inflexibility. Findings emphasized the need for improved healthcare responsiveness, personalized RTW accommodations, and improved employer training to support cancer survivors. The study also reveals how the COVID-19 pandemic exacerbated existing systemic gaps, underscoring the importance of preparing healthcare and employment systems to better support vulnerable populations during times of crisis.

Prophylaxis for venous thromboembolism in traumatic brain injury: protocol for a randomised controlled trial

Por: Pirouzmand · F. · Mathieu · F. · Mansouri · A. · Kavikondala · K. · Alkins · R. · Boyd · J. G. · Christie · S. · Couillard · P. · Cusimano · M. D. · Engels · P. T. · English · S. · Fourney · D. · Fowler · R. · Geerts · W. · Gooderham · P. A. · Griesdale · D. · Hunter · G. · Jabehdar Mara
Introduction

Venous thromboembolism (VTE) is a common complication of traumatic brain injury (TBI) and is associated with increased morbidity and mortality. Low molecular weight heparin (LMWH) is recommended for prophylaxis against VTE after trauma but may increase the risk of progression of intracranial bleeding. Limited evidence exists to guide clinicians regarding the optimal timing of VTE prophylaxis in patients with acute TBI. This randomised controlled trial (RCT) will directly compare the safety and effectiveness of early versus delayed initiation of LMWH in patients with moderate to severe TBI.

Methods and analysis

The study design is a Bayesian adaptive RCT comparing early (within three calendar days of injury) versus delayed (after study Day 7) VTE prophylaxis with the LMWH, dalteparin. All patients receive sequential compression devices until study Day 8. The co-primary effectiveness outcome is the development of clinically important VTE at study Day 8. The co-primary safety outcome is the development of clinically important intracranial bleeding at study Day 8. Secondary outcomes are mortality and functional outcomes (Glasgow Outcome Scale Extended and EQ-5D) measured at study Days 30 and 180; clinically diagnosed VTE to Day 30 and progression of intracranial bleeding to Day 8.

Ethics and dissemination

This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre) and all participating centres. It is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and Health Canada regulatory requirements. We anticipate that the trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of critical care, trauma and neurosurgery. The results of this trial will help guide clinicians aiming to balance the risks and benefits of early anticoagulant prophylaxis after TBI and will inform guideline development.

Trial registration number

NCT03559114.

Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+

Por: Daneman · N. · Johnstone · J. · Lee · T. C. · MacFadden · D. R. · McDonald · E. G. · Morpeth · S. C. · Ong · S. W. X. · Paterson · D. L. · Pinto · R. L. · Rishu · A. · Rogers · B. A. · Yahav · D. · Coburn · B. · Daley · P. · Das · P. · Fiest · K. · Findlater · A. · Fralick · M. · George · M
Objectives

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Design

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Setting

Ten hospitals across four Canadian provinces.

Participants

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

Interventions

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Primary outcome measures

Domain-specific recruitment rates and protocol adherence.

Results

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

Conclusions

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

Trial registration number

NCT05893147.

Behavioural and social drivers of immunisation among zero dose children in pastoralist communities of Ethiopia: a qualitative study

Por: Biadiglgn · M. T. · Gelana · N. · Girma · E. · Abebe · F. · Mon · H. S. · Tadesse · Y. · Ayalew Kokebie · M. · Gedlu · T. · Alemayehu · H. · Bikes · T. · Eshetu · Y. · Kasaye · M. · Endale · A. · Sharma · R. · Getachew · H.
Background

Immunisation is one of the most valuable, impactful and cost-effective public health interventions which delivers positive health, social and economic benefits. Globally, 4 million deaths worldwide are prevented by childhood vaccination every year. In Ethiopia, despite huge progress being made, the routine immunisation coverage has never reached the targeted figures and planned goals. Pastoralist communities are often disproportionately under-vaccinated, and there is often a confluence of interrelated factors that drive this outcome. This study enables us to identify factors affecting immunisation service utilisation in the pastoralist communities of Ethiopia, which helps to design effective and context-specific interventions.

Objective

This study aims to explore the behavioural and social drivers (BeSDs) of routine immunisation among the communities with high numbers of zero-dose and under-immunised children in Afar, Somali and Gambella regions of Ethiopia.

Methods

A qualitative exploratory study was conducted in three selected regions of Ethiopia (Gambella, Somali and Afar) from 9 November 2023 to 30 December 2023. Purposive sampling was used. A total of 33 interviews were conducted in the three regions. Sample size was determined based on idea saturation. Data was collected using interview guides. The interview guide was developed after reviewing relevant literature, desk review and using the journey to health and immunisation framework. A separate interview guide was developed for the journey mapping exercise, in-depth interview, healthcare workers discussion guide, focus group discussion and observation. Data was analysed thematically.

Results

Behavioural (lack of awareness, lack of reminder/forgetting, misperception about vaccines, negative previous experience, lost card and fear of post-vaccination adverse events).

Structural (language barrier, long distance from home to facility, high cost of transportation, long waiting time, limited training of healthcare professionals and incentives, inconvenient service hours, shortage of health professionals, disrespect by the healthcare provider), Socio-cultural (competing priorities, low community engagement, lack of decision-making autonomy, limited husband involvement, workload, rural residence and larger family size were the commonly mentioned barriers to routine immunisation uptake. On the other hand, structural (house to house visit by health extension workers, counselling about adverse events, presence of outreach service, affordability (free of charge)), behavioural and socio-cultural (knowledge of adverse event management, and respect from community) were enablers to routine immunisation service uptake in pastoralist communities.

Conclusions

The study found several individual and contextual factors affecting routine immunisation uptake in pastoralist communities. Context-specific and tailored interventions which address zero dose drivers should be designed so as to enhance vaccine uptake. The findings suggested the need to design context-specific interventions to address the aforementioned barriers to immunisation.

Developing a core outcome set for sciatica: a scoping review of outcome measures

Por: Ridsdale · K. · Woodward · J. · Asad · I. · Ward · B. · Marbu · D. · Moore · R. · Reddington · M.
Objectives

Outcome measures used in sciatica research lack standardisation, making it difficult to combine data for analysis. This scoping review identified and categorised Patient Reported Outcome Measures (PROMs) employed in randomised controlled trials investigating sciatica interventions, providing a foundation for developing a consensus-based core outcome set.

Design

Scoping review.

Data sources

A systematic search was conducted across MEDLINE, Embase and Cochrane Central for research published between 1999 and 2024.

Eligibility criteria

We included randomised controlled trials that involved patients with sciatica and used at least one PROM.

Data extraction and synthesis

Screening and data extraction were performed independently by at least two reviewers. PROMs were categorised using the OMERACT Filter 2.0 framework, inductively sub-categorised into domains, and then the frequency was counted to identify patterns of use. Collection time points and intervention type were also assessed.

Results

187 studies met the inclusion criteria. These studies employed 69 different PROMs, collected 548 times across all papers. The Visual Analogue Scale for pain (n=115), Oswestry Disability Index (n=109) and Numeric Pain Rating Scale (n=74) were most frequently used. PROMs predominantly addressed the pathophysiological (n=274) and life impact (n=262) domains, with minimal attention to resource use/economic impact (n=12). Injection-based interventions were the most studied treatment approach. Follow-up periods using the same PROMs varied considerably between studies, with trends by intervention type.

Conclusions

This review identified and categorised PROMs from numerous research studies, revealing substantial heterogeneity in outcome measurement for sciatica trials. This demonstrates the need for a standardised core outcome set. The predominance of use of non-sciatica-specific pain and disability measures suggests potential gaps in capturing sciatica-specific outcomes. Inconsistent follow-up durations and administration methods further highlight the requirement for standardisation.

New nanofiber glaucoma drainage implant: Effectiveness, safety, first <i>in vivo</i> results, and optimization of surgical technique

by Adela Klezlova, Petr Bulir, Alexandr Stepanov, Andrea Sidova, Magdalena Netukova, Jana Vranova, Katarina Urbaniova, Martina Grajciarova, Lenka Vankova, Zbynek Tonar, Pavel Studeny

Purpose

The purpose of the study is to evaluate the effectiveness, surgical preoperative and postoperative complications, histopathological findings, and optimize surgical technique after implantation of the new nanofiber glaucoma drainage implant (GDI).

Method

Implantation of the GDI, a unique nanofiber drainage device fabricated from polyvinylidene fluoride (PVDF) using the well-established electrospinning technology on the Nanospider™ platform, was first optimized in vitro on cadaver porcine bulbs before the initial in vivo implantations. PVDF was selected due to its favorable properties, including biocompatibility, anti-adhesive behavior, and mechanical stability, which are particularly advantageous in minimizing fibroblast colonization and fibrotic encapsulation. The Nanospider™ technology allows for reproducible, large-scale fabrication of nanofiber materials with controlled fiber morphology, which ensures uniformity and precision of implant dimensions.An in vivo study on 28 normotensive eyes from 14 laboratory New Zealand White rabbits was conducted. There were two groups of animals: the study group (14 eyes) and the control group (14 contralateral eyes). The study group underwent implantation of the new nanofiber GDI; the control group did not undergo any surgical procedure. Intraocular pressure (IOP) was measured preoperatively and at regular times postoperatively (Tono-Pen AVIA®). Preoperative and immediate postoperative complications were monitored. Histological quantification was performed using unbiased sampling and stereological methods to assess leukocyte infiltration, type I and type III collagen fractions, and both absolute and relative levels of inflammation.

Results

Based on the previous results and in vitro surgical experiences, the implant was narrowed to 2.0 mm, a thickness of 100 µm was chosen, and the implant was fixed with two scleral stitches to maintain its position. No serious preoperative complications occurred during in vivo experiments. There was one extrusion of the glaucoma implant noted after surgery, likely due to insufficient conjunctival fixation. This animal was excluded from both the study and the control groups. No serious instances of intraocular hypotension were observed after surgery. All animals tolerated the surgical procedure well, and the postoperative period was without any serious issues. In the study group, the average preoperative IOP was 13.6 mmHg (±4.1, n = 13). The average postoperative IOP on the first day, one, two, and three weeks, and one month after surgery decreased to 8.8 mmHg (±3.3, n = 13), 9.8 mmHg (±2.0, n = 13), 10.3 mmHg (±3.6, n = 13), 10.2 mmHg (±2.6, n = 13), and 9.7 mmHg (±2.0, n = 13), respectively. In the control group of contralateral eyes, the average preoperative IOP was 11.42 mmHg (±4.2, n = 13). The average postoperative IOP was 11.8 mmHg (±5.4, n = 13), 14.2 mmHg (±4.6, n = 13), 14.5 mmHg (±3.4, n = 13), 14.0 mmHg (±3.8, n = 13), and 14.2 mmHg (±2.4, n = 13), respectively, at the same follow-ups. In the study group, the IOP was statistically significantly lower by 29% at the end of the follow-up compared to the preoperative measurements (p = 0.009). Eyes with the implant showed greater leukocyte infiltration and less type I collagen compared to the group without implants. The ratio of type I to type III collagen was lower in the implant group, indicating delayed maturation and weaker connective tissue during early healing.

Conclusion

For easier implantation, minor technical adjustments such as implant narrowing and scleral fixation of the GDI were developed and tested using in vitro experiments. In vivo implantation of unique nanofiber GDI appeared safe and technically well-suited for our study. No serious perioperative or postoperative complications were observed. There was one scleral extrusion of the device, which was, in our opinion, caused by insufficient conjunctival fixation. A statistically significant IOP reduction was achieved at the end of the follow-up in the study group with implanted GDIs. Further studies on the effectiveness of the implant with longer monitoring periods, together with other surgical options such as combined cataract surgery and nanofibers GDI, are needed.

Pursuing Reduction in Fatigue After COVID-19 via Exercise and Rehabilitation (PREFACER): a protocol for a randomised feasibility trial

Por: Billias · N. · Pouliopoulou · D. V. · Lawson · A. · DAlessandro · V. · Bryant · D. M. · Peters · S. · Rushton · A. B. · Miller · E. · Brunton · L. · McGuire · S. · Nicholson · M. · Birmingham · T. B. · MacDermid · J. C. · Quinn · K. L. · Razak · F. · Goulding · S. · Galiatsatos · P. · Sa
Introduction

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

Methods and analysis

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethics and dissemination

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

Trial registration number

NCT06156176

Patient flow and safety after implementing a community paramedicine service: a quasi-experimental study

Por: Elden · O. E. · Brulin · E. · Uleberg · O. · Landstad · B. J. · Dalen · H.
Objective

Community paramedicine services (CPSs) may alleviate the increasing pressure on emergency medical services (EMSs) but lack the capacity for patient transport. The study aims to determine whether a municipality implementing the CPS between periods (CPSREGION) compared with a control municipality (CTRREGION) served by EMS only affected patient flow and safety in a rural Norwegian setting.

Design

A quasi-experimental study evaluating patient flow and safety before and after the introduction of CPS in one of two rural municipalities.

Setting

Two rural Norwegian municipalities that were served by EMS from nearby municipalities before the study started.

Participants

Before and after the introduction of CPS, a total of 604 and 650 patients, respectively, were included in CPSREGION, and 367 and 408 patients, respectively, in CTRREGION.

Interventions

CPS was introduced in CPSREGION between the two data collection periods, whereas CTRREGION continued to be served by EMS.

Outcome measures

The outcome of patient flow was assessed by the number of admissions to nearby hospitals, the number of patient contacts and the location for delivery and treatment. The outcome for safety was assessed as the need for medical recontact within 7 days and 30-day mortality.

Results

Hospital admission rates increased over the two study periods, being insignificant in CPSREGION (+4.7%, p=0.373) and significant in CTRREGION (+23.2%, p

Conclusions

Introducing CPS resulted in fewer hospital admissions, with more patients being treated locally. No safety concerns with respect to medical recontacts and 30-day mortality were observed. We conclude that CPS can alter patient flow towards more local treatment without compromising safety.

Distal Radius Interventions for Fracture Treatment (DRIFT) trial: study protocol for a multicentre randomised clinical trial of completely translated distal radius fractures at paediatric hospitals in North America

Por: Balmert Bonner · L. · Janicki · J. · Georgiadis · A. · Truong · W. · Harris Beauvais · D. · Belthur · M. · Daley · E. L. · Franzone · J. · Howard · A. · May · C. · Rockhold · F. · Schulz · J. · Bailey · M. · Chiswell · K. · DeLaRosa · J. · Brooks · J. T. · Cantanzano · A. A. · Chan · A.
Introduction

Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.

Methods and analysis

Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).

Ethics and dissemination

Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.

Trial registration number

NCT05131685.

Older Adults' Self‐Care and Family Caregiver Contribution in Multiple Chronic Conditions: A Dyadic Qualitative Study

ABSTRACT

Aims

To explore how older adult-family caregiver dyads jointly manage multiple chronic conditions. Specifically, it investigates how dyads (i) prioritise chronic diseases, (ii) make and negotiate decisions related to self-care and (iii) define and distribute self-care tasks and caregiver contributions.

Design

A qualitative descriptive study using dyadic data collection and analysis.

Methods

Semi-structured interviews were conducted separately with chronically ill older adults and their family caregivers between July and December 2024. A hybrid inductive-deductive content analysis was applied. Dyadic analysis compared intra-dyad perspectives to identify patterns of agreement and disagreement.

Results

Thirty-four dyads (n = 68 participants) were interviewed. Older adults had a mean age of 80.09 years (SD = 6.95) and were affected by a median of four chronic conditions. Family caregivers had a mean age of 51.71 years (SD = 14.59), with most being the older adults' children (66.67%) and women (82.35%). Five categories, comprising 25 subcategories, were derived from the data. Disease prioritisation varied within dyads: older adults often focused on conditions with the most disabling symptoms, while caregivers emphasised those with higher risks of complication. Decision-making roles ranged from older adult-led to caregiver-led to shared. Care organisation followed three models: collaborative, older adult-directed, or caregiver-directed. Challenges in managing diseases included treatment adherence, care coordination, emotional burden and addressing multiple symptoms simultaneously. Role distribution in disease management and decision-making was complex and occasionally misaligned, sometimes resulting in conflict. Collaborative dyads reported greater adaptability and balance, while incongruent dyads experienced relational and organisational strain.

Conclusion

Managing multiple chronic conditions in older adults is a relational process shaped by interpersonal dynamics and shared responsibilities with family caregivers. Recognising dyadic relational patterns is essential for designing targeted educational interventions. Nurses should incorporate dyadic assessments into routine care to improve outcomes for older adults and reduce caregiver burden.

Implications for the Profession and/or Patient Care

This study highlights the importance of viewing chronic disease management as a dyadic process, rather than an individual task, involving both the older adult and the family caregiver. Tailored strategies that account for the relational dynamics within dyads, such as decision-making roles and care task distribution, are essential for effective chronic disease management.

Reporting Method

Consolidated criteria for reporting qualitative studies (COREQ).

Patient or Public Contribution

None.

Healthcare utilisation and barriers to healthcare after violence and rape in the Norwegian population: a cross-sectional, multimethod study

Por: Skauge · A. D. · Aakvaag · H. F. · Strom · I. F. · Nissen · A. · Seifert · L. C. · Överlien · C. · Dale · M. T. G.
Objectives

Despite the important role of healthcare services in trauma recovery, many survivors of violence do not seek help. This study aims to examine rates of healthcare utilisation, including differences for physical violence versus rape, gender and physical injury (vs no injury) and obstacles to seeking care within 6 months following incidents of physical violence and rape.

Design and setting

The participants were randomly chosen from the National Population Registry in Norway and invited to participate in a telephone survey on violence exposure and health between June 2021 and June 2022 (N=4299, 49% women).

Participants

The sample included 1768 violence-exposed individuals. Of the women (n=749), 82.1% had experienced physical violence and 40.3% had experienced forcible rape. Of the men, most had experienced physical violence (98.6%) and a small percentage had experienced rape (3.5%).

Outcome measures

Logistic regression models were used to investigate whether healthcare seeking differed by gender, type of violence (rape vs physical violence) and severity (physical injury). Barriers to accessing healthcare were also investigated using descriptive statistics and content analysis.

Results

Healthcare seeking rates were low after rape (16.9%) and physical violence (24.2%), with somewhat higher rates among individuals experiencing both types of violence (39.9%). There were no statistically significant differences in the odds of healthcare utilisation between the three types of violence exposures when we controlled for gender, physical injury, violence characteristics and sociodemographic factors. Men were more likely than women to have sought healthcare (adjusted OR (aOR): 1.37, 95% CI: 1.02 to 1.85, p=0.042). Physical injury was strongly associated with greater healthcare utilisation (aOR: 6.39, 95% CI: 4.85 to 8.41, p

Conclusions

Few victims seek healthcare shortly after experiencing rape or physical violence. Quantitative and qualitative findings indicate that many seek healthcare exclusively for severe physical injury. These results emphasise the need to improve health services’ outreach to victims of violence, who are at heightened risk of mental health issues and chronic illnesses.

The Experience of Self‐Care in People With Osteoporosis: A Qualitative Descriptive Study

ABSTRACT

Introduction

Osteoporosis requires long-term self-care engagement, yet little is known about how individuals experience and manage self-care in everyday life. Understanding these experiences is essential to inform tailored nursing interventions. The objective of the study was to explore and describe the experience of self-care maintenance, monitoring, and management in people with osteoporosis.

Design

A qualitative descriptive study.

Methods

We conducted semi-structured interviews. Data were analyzed using Mayring's qualitative content analysis with a deductive approach based on Riegel's theory of self-care. We reported data in accordance with the Consolidated Criteria for Reporting Qualitative Studies (COREQ) checklist.

Results

Participants (1 Male, 19 Females; Aged 55–80) Identified Four Themes of self-care: maintenance (e.g., Medication Adherence, Physical Activity), monitoring (e.g., Symptom Recognition, Test Interpretation), management (e.g., Lifestyle Reflections, Prevention), and general self-care. Key factors included motivation, trust in healthcare professionals, and integration of health behaviors into daily life. Barriers were low self-efficacy, poor symptom recognition, and inconsistent adherence.

Conclusion

Self-care in osteoporosis is a multidimensional and dynamic process influenced by individual beliefs, contextual factors, and support from healthcare professionals. Recognizing the variability in patients' self-care behaviors is essential to develop personalized education and support. Strengthening general health behaviors may enhance disease-specific self-care. This understanding can guide healthcare professionals in designing more effective, tailored care strategies.

Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID): protocol for a randomised controlled adaptive platform trial of treatments for acute SARS-CoV-2 infection in community settings

Por: Hosseini · B. · Condon · A. · da Costa · B. R. · Daley · P. · Greiver · M. · Jüni · P. · Lee · T. C. · McBrien · K. · McDonald · E. G. · Murthy · S. · Selby · P. · Andrew · M. · Aubrey-Bassler · K. · Barber · D. · Barrett · B. · Butler · C. C. · Crampton · N. · Dahrouge · S. · Damji · A.
Introduction

SARS-CoV-2 is now endemic and expected to remain a health threat, with new variants continuing to emerge and the potential for vaccines to become less effective. While effective vaccines and natural immunity have significantly reduced hospitalisations and the need for critical care, outpatient treatment options remain limited, and real-world evidence on their clinical and cost-effectiveness is lacking. In this paper, we present the design of the Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID). By evaluating multiple treatment options in a pragmatic adaptive platform trial, this study will generate high-quality, generalisable evidence to inform clinical guidelines and healthcare decision-making.

Methods and analysis

CanTreatCOVID is an open-label, individually randomised, multicentre, national adaptive platform trial designed to evaluate the clinical and cost-effectiveness of therapeutics for non-hospitalised SARS-CoV-2 patients across Canada. Eligible participants must present with symptomatic SARS-CoV-2 infection, confirmed by PCR or rapid antigen testing (RAT), within 5 days of symptom onset. The trial targets two groups that are expected to be at higher risk of more severe disease: (1) individuals aged 50 years and older and (2) those aged 18–49 years with one or more comorbidities. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multifaceted public communication strategy and outreach through primary care, outpatient clinics and emergency departments. Participants are randomised to receive either usual care, including supportive and symptom-based management, or an investigational therapeutic selected by the Canadian COVID-19 Outpatient Therapeutics Committee. The first therapeutic arm evaluates nirmatrelvir/ritonavir (Paxlovid), administered two times per day for 5 days. The second therapeutic arm investigates a combination antioxidant therapy (selenium 300 µg, zinc 40 mg, lycopene 45 mg and vitamin C 1.5 g), administered for 10 days. The primary outcome is all-cause hospitalisation or death within 28 days of randomisation.

Ethics and dissemination

The CanTreatCOVID master protocol and subprotocols have been approved by Health Canada and local research ethics boards in the participating provinces across Canada. The results of the study will be disseminated to policy-makers, presented at conferences and published in peer-reviewed journals to ensure that findings are accessible to the broader scientific and medical communities. This study was approved by the Unity Health Toronto Research Ethics Board (#22-179) and Clinical Trials Ontario (Project ID 4133).

Trial registration number

NCT05614349

Implementation of a preoperative exercise programme in lung cancer resection: protocol for a mixed-methods study

Por: King · M. · Roche · N. · Harris · B. · Hibbert · M. · Don · G. · Dale · M. · King · G. G. · Wootton · S.
Introduction

Preoperative exercise training is recommended, when feasible, for people undergoing resection for lung cancer and has been shown to reduce the risk of postoperative pulmonary complications and improve preoperative exercise capacity. However, preoperative exercise training programmes are not commonly available in the Australian clinical practice setting due to a range of factors including resource and time restrictions. We aim to describe the protocol to evaluate the implementation of an existing preoperative exercise training programme in people undergoing lung cancer resection in an Australian setting.

Methods and analysis

This is an evaluation of a secondary objective of a study examining the effect of lung cancer resection on exercise capacity, lung function and symptoms of dyspnoea and quality of life. Participants will be prospectively recruited at the time of lung cancer diagnosis and planned surgical treatment through the lung cancer multidisciplinary team of a metropolitan hospital in Sydney, Australia. All participants will be offered the choice of participating in the preoperative exercise training programme which encompasses a hybrid gym and telerehabilitation programme of up to five sessions/week from baseline until surgical date. The programme will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance Framework including both quantitative and qualitative measures which will be analysed using descriptive statistics and qualitative analysis coded inductively.

Ethics and dissemination

The study has received ethical approval through the Northern Sydney Local Health District reference 2023/ETH01643 and has been registered prospectively. Findings will be disseminated through peer-reviewed publication and scientific conference presentation.

Trial registration number

ACTRN12624000359538.

Readiness to reduce primary care-associated carbon emissions in England: a cross-sectional survey of clinical and non-clinical staff views

Por: Geddes · O. · Twohig · H. · Dahlmann · F. · Eccles · A. · Karaba · F. · Nunes · A. R. · Spencer · R. · Dale · J.
Objectives

To describe current levels of interest and action around decarbonisation in general practice settings, and awareness and use of currently available materials designed to support general practice teams undertake decarbonisation activity.

Design

Cross-sectional, mixed methods, online survey.

Setting

473 general practices in three Integrated Care Board regions in England.

Participants

Multiprofessional general practice staff.

Results

There were 328 responses from 163 (34.5%) practices. Most respondents were general practitioner (GP) partners (98; 29.9%), other clinical staff (93; 28.3%) or managerial staff (76; 23.2%). 229 (69.8%) respondents felt that acting to reduce carbon emissions from primary care is a legitimate part of general practice activity. However, only 44 (13.4%) felt that there is sufficient training and resources to support such activity, and only 59 (18.0%) agreed that there was sufficient leadership from higher levels within the health service to enable this. 58 (35.6%) practices had a lead for sustainability, generally managerial staff (22; 37.9%) or GP partners (17; 29.3%). Compared to other practices, those with a decarbonisation lead reported increased levels of decarbonisation actions currently being undertaken (mean = 5.2 vs 3.1; t(161) = 7.7, p2=31.9, p2=32.3, p

Conclusions

This survey provides insight into how English general practices and their staff regard decarbonisation activities. The findings highlight the importance of leadership, resources and incentives in driving such activities and have implications for initiatives to help achieve wider decarbonisation goals in healthcare.

Definition and key concepts of high-performing health systems: a scoping review

Por: Cho · V. · Trowbridge · J. · Perreira · T. · Sodhi · S. · Karsan · A. · Hassan · H. · Perrier · L. · Prokopy · M. · Dale · A. · Brown · A.
Objectives

To determine how high performing is defined in relation to a health system and chart the literature on the definitions and key concepts of high-performing healthcare systems.

Design

Scoping review.

Data sources

MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials were searched from inception to July 2024. The grey literature was also searched.

Eligibility criteria

Included studies reported on health systems and high performance to identify explicit definitions, research outcomes and knowledge gaps.

Results

Two reviewers independently screened 5721 citations and 507 full-text articles, resulting in the inclusion of 35 primary articles and 47 companion documents in the review. Three independent definitions for a high-performance health system were identified. 24 research studies reported outcomes on the elements of a high-performing health system (58%), system evaluation (32%) and tool development or validation (10%). Knowledge gaps identified were the lack of a common definition, a lack of common indicators, strategies for moving evidence into policy and practice, and difficulties with comparisons across health systems.

Conclusions

We found limited definitions and a lack of empirical evidence on our topic. There is an opportunity for primary research in the area of health systems and high performance.

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