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☐ ☆ ✇ BMJ Open

Point-of-choice kilocalorie labelling practices in large, out-of-home food businesses: a preobservational versus post observational study of labelling practices following implementation of The Calorie Labelling (Out of Home Sector) (England) Regulations 2

Por: Polden · M. · Jones · A. · Essman · M. · Adams · J. · Bishop · T. · Burgoine · T. · Donohue · A. · Sharp · S. · White · M. · Smith · R. · Robinson · E. — Abril 11th 2024 at 17:57
Background and objectives

On 6 April 2022, the UK government implemented mandatory kilocalorie (kcal) labelling regulations for food and drink products sold in the out-of-home food sector (OHFS) in England. Previous assessments of kcal labelling practices in the UK OHFS found a low prevalence of voluntary implementation and poor compliance with labelling recommendations. This study aimed to examine changes in labelling practices preimplementation versus post implementation of mandatory labelling regulations in 2022.

Methods

In August–December 2021 (preimplementation) and August–November 2022 (post implementation), large OHFS businesses (250 or more employees) subject to labelling regulations were visited. At two time points, a researcher visited the same 117 food outlets (belonging to 90 unique businesses) across four local authorities in England. Outlets were rated for compliance with government regulations for whether kcal labelling was provided at any or all point of choice, provided for all eligible food and drink items, provided per portion for sharing items, if labelling was clear and legible and if kcal reference information was displayed.

Results

There was a significant increase (21% preimplementation vs 80% post implementation, OR=40.98 (95% CI 8.08 to 207.74), p

Conclusion

The number of large businesses in the OHFS providing kcal labelling increased following the implementation of mandatory labelling regulations. However, around one-fifth of eligible outlets sampled were not providing kcal labelling 4–8 months after the regulations came into force, and the majority of businesses only partially complied with government guidance. More effective enforcement may be required to further improve kcal labelling practices in the OHFS in England.

Preregistration

Study protocol and analysis strategy preregistered on Open Science Framework (https://osf.io/pfnm6/).

☐ ☆ ✇ BMJ Open

Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

Por: Law · L. · Heerey · J. L. · Devlin · B. L. · Brukner · P. · Kemp · J. L. · Attanayake · A. · Hulett · M. D. · De Livera · A. · Mosler · A. B. · Morris · H. G. · White · N. P. · Culvenor · A. G. — Abril 3rd 2024 at 04:16
Introduction

Chronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.

Methods and analysis

The eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.

Ethics and dissemination

The study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number

ACTRN12622000440729.

☐ ☆ ✇ BMJ Open

REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial

Por: Bertram · W. · Penfold · C. · Glynn · J. · Johnson · E. · Burston · A. · Rayment · D. · Howells · N. · White · S. · Wylde · V. · Gooberman-Hill · R. · Blom · A. · Whale · K. — Marzo 20th 2024 at 16:56
Objectives

To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.

Design

Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.

Setting

Two National Health Service (NHS) secondary care hospitals in England and Wales.

Participants

Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.

Intervention

The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.

Outcome measures

The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.

Results

Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.

Conclusions

This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.

Trial registration number

ISRCTN14233189.

☐ ☆ ✇ CIN: Computers, Informatics, Nursing

A Systematic Review of Nurses' Perceptions of Electronic Health Record Usability Based on the Human Factor Goals of Satisfaction, Performance, and Safety

imageThe poor usability of electronic health records contributes to increased nurses' workload, workarounds, and potential threats to patient safety. Understanding nurses' perceptions of electronic health record usability and incorporating human factors engineering principles are essential for improving electronic health records and aligning them with nursing workflows. This review aimed to synthesize studies focused on nurses' perceived electronic health record usability and categorize the findings in alignment with three human factor goals: satisfaction, performance, and safety. This systematic review was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Five hundred forty-nine studies were identified from January 2009 to June 2023. Twenty-one studies were included in this review. The majority of the studies utilized reliable and validated questionnaires (n = 15) to capture the viewpoints of hospital-based nurses (n = 20). When categorizing usability-related findings according to the goals of good human factor design, namely, improving satisfaction, performance, and safety, studies used performance-related measures most. Only four studies measured safety-related aspects of electronic health record usability. Electronic health record redesign is necessary to improve nurses' perceptions of electronic health record usability, but future efforts should systematically address all three goals of good human factor design.
☐ ☆ ✇ Journal of Advanced Nursing

Medical and surgical nurses' experiences of modifying and implementing contextually suitable Safewards interventions into medical and surgical hospital wards

Por: Lauretta Luck · Kellie Kaczorowski · Melissa White · Geoffrey Dickens · Fiona McDermid — Febrero 28th 2024 at 05:38

Abstract

Aim

To explore general nurses' experiences of modifying and implementing contextually suitable Safewards interventions into medical and surgical hospital wards.

Design

Qualitative action research was used working with nurses as co-researchers.

Methods

Pre-implementation focus groups were conducted in April 2022 to understand and explore the current strategies nurses utilized to avert, respond to or decrease violence. Following this, two Safewards interventions were modified by the nurses on the wards. Post-implementation focus groups were conducted in October 2022, to explore the nurses' experience of implementing Safewards interventions and the effect on their nursing practice. Data were analysed using Braun and Clarke's framework for thematic analysis.

Results

Three themes emerged from the analysis of the pre-implementation focus groups that reflected the type of violence experienced by these nurses and the context within which they occurred: ‘the space is hectic’; ‘it can feel like a battlefield’; and ‘the aftermath’. These themes encompass the nurses' experience of violence from patients and their visitors. Following the implementation of two modified Safewards interventions, the analysis of the focus groups reflected a change in nursing skills to avert or respond to violence: ‘Safewards in action’; ‘empathy and self-reflection’; and ‘moving forward’.

Conclusion

Safewards interventions can be successfully modified and used in general hospital wards and influence nursing practice to manage patient and visitor violence.

Implications for the Profession

In the interests of safety, successful interventions to reduce violence towards general hospital nurses should be a priority for managers and healthcare organizations. Averting, mitigating and managing violence can decrease the negative professional and personal effect on nurses and ultimately improve well-being, job satisfaction and retention rates. Furthermore, decreasing violence or aggressive incidents leads to a safer patient experience and decreased number of nursing errors ultimately improving patient experiences and outcomes.

Understanding nurses' experiences of violence and working with them to explore and develop contextually relevant solutions increases their capacity to respond to and avert violent incidents. Contextually modified Safewards interventions offer one such solution and potentially has wider implications for healthcare settings beyond the specific wards studied.

Impact

This study addressed the implementation of modified Safewards strategies in medical and surgical wards to prevent violence. Three themes emerged from the analysis of the pre-implementation focus groups that reflected the type of violence experienced by these nurses and the context within which they occurred. Following the implementation of two modified Safewards interventions, the post-implementation focus groups reported positive changes to their practices using the modified resources to prevent violence from patients and their visitors. Mental health interventions, such as those used in the Safewards model can be modified and provide a tool kit of interventions that can be used by medical and surgical nurses.

Reporting Method

This paper has adhered to the COREQ guidelines.

Patient or Public Contribution

No patient or public contribution.

What Does this Paper Contribute to the wider Global Clinical Community?

This paper outlines and discusses the action research approach undertaken to work with general hospital nurses to modify mental health nurses' Safewards interventions into their clinical practice. This paper provides evidence of the ‘real world’ application of Safewards interventions by medical and surgical nurses in general hospital wards. This paper presents qualitative findings based on focus group methods to highlight the narratives of general nurses and their experiences of violence.

☐ ☆ ✇ BMJ Open

Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV,

Por: Young · A. M. · Havens · J. R. · Cooper · H. L. F. · Fallin-Bennett · A. · Fanucchi · L. · Freeman · P. R. · Knudsen · H. · Livingston · M. D. · McCollister · K. E. · Stone · J. · Vickerman · P. · Freeman · E. · Jahangir · T. · Larimore · E. · White · C. R. · Cheatom · C. · Community S — Marzo 2nd 2024 at 04:33
Introduction

Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia.

Methods and analysis

KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness.

Ethics and dissemination

The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings.

Trial registration number

NCT05657106.

☐ ☆ ✇ BMJ Open

A Digitally Enabled, Pharmacist service to detecT medicine harms in residential aged care (nursing home) (ADEPT): protocol for a feasibility study

Por: Boord · M. S. · Brown · P. · Soriano · J. · Meola · T. · Dumuid · D. · Milte · R. · Roughead · E. E. · Lovell · N. H. · Stone · H. · Whitehouse · J. · Janetzki · J. L. · Gebreyohannes · E. A. · Lim · R. — Febrero 10th 2024 at 11:42
Introduction

This feasibility study aims to develop and test a new model of practice in Australia using digital technologies to enable pharmacists to monitor early signs and symptoms of medicine-induced harms in residential aged care.

Methods and analysis

Thirty residents will be recruited from an aged care facility in South Australia. The study will be conducted in two phases. In phase I, the study team will work with aged care software providers and developers of digital technologies (a wearable activity tracker and a sleep tracking sensor) to gather physical activity and sleep data, as well as medication and clinical data from the electronic medication management system and aged care clinical software. Data will be centralised into a cloud-based monitoring platform (TeleClinical Care (TCC)). The TCC will be used to create dashboards that will include longitudinal visualisations of changes in residents’ health, function and medicine use over time. In phase II, the on-site pharmacist will use the centralised TCC platform to monitor each resident’s medicine, clinical, physical activity and sleep data to identify signs of medicine-induced harms over a 12-week period.

A mixed methods process evaluation applying the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework will be used to assess the feasibility of the service. Outcome measures include service reach, changes in resident symptom scores (measured using the Edmonton Symptom Assessment System), number of medication adverse events detected, changes in physical activity and sleep, number of pharmacist recommendations provided, cost analysis and proportion of all pharmacists’ recommendations implemented at 4-week, 8-week and 12-week postbaseline period.

Ethics and dissemination

Ethical approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205098). Findings will be disseminated through published manuscripts, conference presentations and reporting to the study funder.

Trial registration number

ACTRN12623000506695.

☐ ☆ ✇ PLOS ONE Medicine&Health

Characterization and comparison of human and mouse milk cells

by Rose Doerfler, Saigopalakrishna Yerneni, Alexandra Newby, Namit Chaudhary, Ashley Shu, Katherine Fein, Juliana Hofstatter Azambuja, Kathryn A. Whitehead

Recent data has characterized human milk cells with unprecedented detail and provided insight into cell populations. While such analysis of freshly expressed human milk has been possible, studies of cell functionality within the infant have been limited to animal models. One commonly used animal model for milk research is the mouse; however, limited data are available describing the composition of mouse milk. In particular, the maternal cells of mouse milk have not been previously characterized in detail, in part due to the difficulty in collecting sufficient volumes of mouse milk. In this study, we have established a method to collect high volumes of mouse milk, isolate cells, and compare the cell counts and types to human milk. Surprisingly, we found that mouse milk cell density is three orders of magnitude higher than human milk. The cell types present in the milk of mice and humans are similar, broadly consisting of mammary epithelial cells and immune cells. These results provide a basis of comparison for mouse and human milk cells and will inform the most appropriate uses of mouse models for the study of human phenomena.
☐ ☆ ✇ Journal of Clinical Nursing

Prevalence and clustering of NANDA‐I nursing diagnoses in the pre‐hospital emergency care setting: A retrospective records review study

Abstract

Aim

To determine the prevalence and clustering of NANDA-International nursing diagnoses in patients assisted by pre-hospital emergency teams.

Design

Retrospective descriptive study of electronic record review.

Methods

Episodes recorded during 2019, including at least a nursing diagnosis, were recovered from the electronic health records of a Spanish public emergency agency (N = 28,847). Descriptive statistics were used to characterize the sample and determine prevalence. A two-step cluster analysis was used to group nursing diagnoses. A comparison between clusters in sociodemographic and medical problems was performed. Data were accessed in November 2020.

Results

Risk for falls (00155) (27.3%), Anxiety (00146) (23.2%), Acute pain (00132), Fear (00148) and Ineffective breathing pattern (00032) represented 96.1% of all recorded diagnoses. A six-cluster solution (n = 26.788) was found. Five clusters had a single high-prevalence diagnosis predominance: Risk for falls (00155) in cluster 1, Anxiety (00146) in cluster 2, Fear (00148) in cluster 3, Acute pain (00132) in cluster 4 and Ineffective breathing pattern (00032) in cluster 6. Cluster 5 had several high prevalence diagnoses which co-occurred: Risk for unstable blood glucose level (00179), Ineffective coping (00069), Ineffective health management (00078), Impaired comfort (00214) and Impaired verbal communication (00051).

Conclusion

Five nursing diagnoses accounted for almost the entire prevalence. The identified clusters showed that pre-hospital patients present six patterns of nursing diagnoses. Five clusters were predominated by a predominant nursing diagnosis related to patient safety, coping, comfort, and activity/rest, respectively. The sixth cluster grouped several nursing diagnoses applicable to exacerbations of chronic diseases.

Implications for the profession and/or patient care

Knowing the prevalence and clustering of nursing diagnoses allows a better understanding of the human responses of patients attended by pre-hospital emergency teams and increases the evidence of individualized/standardized care plans in the pre-hospital clinical setting.

Impact

What problem did the study address? There are different models of pre-hospital emergency care services. The use of standardized nursing languages in the pre-hospital setting is not homogeneous. Studies on NANDA-I nursing diagnoses in the pre-hospital context are scarce, and those available are conducted on small samples.

What were the main findings? This paper reports the study with the largest sample among the few published on NANDA-I nursing diagnoses in the pre-hospital care setting. Five nursing diagnoses represented 96.1% of all recorded. These diagnoses were related to patients' safety/protection and coping/stress tolerance. Patients attended by pre-hospital care teams are grouped into six clusters based on the nursing diagnoses, and this classification is independent of the medical conditions the patient suffers.

Where and on whom will the research have an impact?

Knowing the prevalence of nursing diagnoses allows a better understanding of the human responses of patients treated in the pre-hospital setting, increasing the evidence of individualized and standardized care plans for pre-hospital care.

Reporting method

STROBE checklist has been used as a reporting method.

No Patient or Public Contribution

Only patients' records were reviewed without further involvement.

☐ ☆ ✇ BMJ Open

IMPAACT: IMproving the PArticipAtion of older people in policy decision-making on common health CondiTions - a study protocol

Por: Ambagtsheer · R. C. · Hurley · C. J. · Lawless · M. · Braunack-Mayer · A. · Visvanathan · R. · Beilby · J. · Stewart · S. · Cornell · V. · Leach · M. J. · Taylor · D. · Thompson · M. · Dent · E. · Whiteway · L. · Archibald · M. · O'Rourke · H. M. · Williams · K. · Chudecka · A. — Enero 12th 2024 at 16:58
Introduction

Rapid population ageing is a demographic trend being experienced and documented worldwide. While increased health screening and assessment may help mitigate the burden of illness in older people, issues such as misdiagnosis may affect access to interventions. This study aims to elicit the values and preferences of evidence-informed older people living in the community on early screening for common health conditions (cardiovascular disease, diabetes, dementia and frailty). The study will proceed in three Phases: (1) generating recommendations of older people through a series of Citizens’ Juries; (2) obtaining feedback from a diverse range of stakeholder groups on the jury findings; and (3) co-designing a set of Knowledge Translation resources to facilitate implementation into research, policy and practice. Conditions were chosen to reflect common health conditions characterised by increasing prevalence with age, but which have been underexamined through a Citizens’ Jury methodology.

Methods and analysis

This study will be conducted in three Phases—(1) Citizens’ Juries, (2) Policy Roundtables and (3) Production of Knowledge Translation resources. First, older people aged 50+ (n=80), including those from traditionally hard-to-reach and diverse groups, will be purposively recruited to four Citizen Juries. Second, representatives from a range of key stakeholder groups, including consumers and carers, health and aged care policymakers, general practitioners, practice nurses, geriatricians, allied health practitioners, pharmaceutical companies, private health insurers and community and aged care providers (n=40) will be purposively recruited for two Policy Roundtables. Finally, two researchers and six purposively recruited consumers will co-design Knowledge Translation resources. Thematic analysis will be performed on documentation and transcripts.

Ethics and dissemination

Ethical approval has been obtained through the Torrens University Human Research Ethics Committee. Participants will give written informed consent. Findings will be disseminated through development of a policy brief and lay summary, peer-reviewed publications, conference presentations and seminars.

☐ ☆ ✇ BMJ Open

Have interventions aimed at assisting general practitioners in facilitating earlier diagnosis of type 1 diabetes in children been successful? A systematic review protocol

Por: Beccia · C. · Hunter · B. · Birkic · V. · White · M. · Manski-Nankervis · J.-A. — Diciembre 30th 2023 at 13:21
Background

Early diagnosis of type 1 diabetes in children is critical to prevent deterioration to diabetic ketoacidosis (DKA), a state where the body’s insulin levels are critically low resulting in the use of fat for fuel and the accumulation of ketones. DKA is a life-threatening emergency where dehydration and cerebral oedema can quickly develop and lead to death. Despite treatment, DKA also has harmful impacts on cognition and brain development. Most children admitted to a hospital with DKA see their general practitioner in the week leading up to their admission. A delay in referral from general practice can result in delays in commencing lifesaving insulin therapy. Prior systematic reviews have explored publicity campaign interventions aimed at recognising type 1 diabetes earlier; however, no reviews have explored these interventions targeted at reducing the delay after presentation to the general practitioner. This systematic review aims to summarise interventions that target the diagnostic delay emerging from general practice and to evaluate their effectiveness in reducing DKA admissions.

Methods

Six databases (Ovid (MEDLINE), Web of Science, EMBASE, CINAHL, Evidence-Based Medicine Reviews (EBMR) and Google Scholar) will be searched to identify studies exploring interventions to reduce diagnostic delay in children with type 1 diabetes, and hence DKA, in general practice. The primary outcome will be the number of DKA admissions to a hospital following a delay in general practice. The secondary outcome will be the behaviour of general practitioners with respect to urgent referral of children with type 1 diabetes. Title, abstract and full-text screening for exclusion and inclusion of publications will be completed by two independent reviewers. Any risks of bias within individual studies will be assessed by two independent reviewers, using the Risk Of Bias In Non-Randomized Studies of Interventions tool. Our confidence in the overall body of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation.

Ethics and dissemination

The systematic review will be disseminated via publication and potentially in conference presentations. Ethics is not required for a systematic review of secondary data.

PROSPERO registration number

CRD42023412504

☐ ☆ ✇ BMJ Open

Development and application of simulation modelling for orthopaedic elective resource planning in England

Por: Harper · A. · Monks · T. · Wilson · R. · Redaniel · M. T. · Eyles · E. · Jones · T. · Penfold · C. · Elliott · A. · Keen · T. · Pitt · M. · Blom · A. · Whitehouse · M. R. · Judge · A. — Diciembre 22nd 2023 at 17:32
Objectives

This study aimed to develop a simulation model to support orthopaedic elective capacity planning.

Methods

An open-source, generalisable discrete-event simulation was developed, including a web-based application. The model used anonymised patient records between 2016 and 2019 of elective orthopaedic procedures from a National Health Service (NHS) Trust in England. In this paper, it is used to investigate scenarios including resourcing (beds and theatres) and productivity (lengths of stay, delayed discharges and theatre activity) to support planning for meeting new NHS targets aimed at reducing elective orthopaedic surgical backlogs in a proposed ring-fenced orthopaedic surgical facility. The simulation is interactive and intended for use by health service planners and clinicians.

Results

A higher number of beds (65–70) than the proposed number (40 beds) will be required if lengths of stay and delayed discharge rates remain unchanged. Reducing lengths of stay in line with national benchmarks reduces bed utilisation to an estimated 60%, allowing for additional theatre activity such as weekend working. Further, reducing the proportion of patients with a delayed discharge by 75% reduces bed utilisation to below 40%, even with weekend working. A range of other scenarios can also be investigated directly by NHS planners using the interactive web app.

Conclusions

The simulation model is intended to support capacity planning of orthopaedic elective services by identifying a balance of capacity across theatres and beds and predicting the impact of productivity measures on capacity requirements. It is applicable beyond the study site and can be adapted for other specialties.

☐ ☆ ✇ BMJ Open

Changes in soft drinks purchased by British households associated with the UK soft drinks industry levy: a controlled interrupted time series analysis

Por: Rogers · N. T. · Pell · D. · Mytton · O. T. · Penney · T. L. · Briggs · A. · Cummins · S. · Jones · C. · Rayner · M. · Rutter · H. · Scarborough · P. · Sharp · S. · Smith · R. · White · M. · Adams · J. — Diciembre 5th 2023 at 10:15
Objective

To determine changes in household purchases of drinks 1 year after implementation of the UK soft drinks industry levy (SDIL).

Design

Controlled interrupted time series.

Participants

Households reporting their purchasing to a market research company (average weekly n=22 091), March 2014 to March 2019.

Intervention

A two-tiered tax levied on soft drinks manufacturers, announced in March 2016 and implemented in April 2018. Drinks with ≥8 g sugar/100 mL (high tier) are taxed at £0.24/L, drinks with ≥5 to

Main outcome measures

Absolute and relative differences in the volume of, and amount of sugar in, soft drinks categories, all soft drinks combined, alcohol and confectionery purchased per household per week 1 year after implementation.

Results

In March 2019, compared with the counterfactual, purchased volume of high tier drinks decreased by 140.8 mL (95% CI 104.3 to 177.3 mL) per household per week, equivalent to 37.8% (28.0% to 47.6%), and sugar purchased in these drinks decreased by 16.2 g (13.5 to 18.8 g), or 42.6% (35.6% to 49.6%). Purchases of low tier drinks decreased by 170.5 mL (154.5 to 186.5 mL) or 85.8% (77.8% to 93.9%), with an 11.5 g (9.1 to 13.9 g) reduction in sugar in these drinks, equivalent to 87.8% (69.2% to 106.4%). When all soft drinks were combined irrespective of levy tier or eligibility, the volume of drinks purchased increased by 188.8 mL (30.7 to 346.9 mL) per household per week, or 2.6% (0.4% to 4.7%), but sugar decreased by 8.0 g (2.4 to 13.6 g), or 2.7% (0.8% to 4.5%). Purchases of confectionery and alcoholic drinks did not increase.

Conclusions

Compared with trends before the SDIL was announced, 1 year after implementation, volume of all soft drinks purchased combined increased by 189 mL, or 2.6% per household per week. The amount of sugar in those drinks was 8 g, or 2.7%, lower per household per week. Further studies should determine whether and how apparently small effect sizes translate into health outcomes.

Trial registration number

ISRCTN18042742.

☐ ☆ ✇ BMJ Open

Protocol for the EACH trial: a multicentre phase II study evaluating the safety and antitumour activity of the combination of avelumab, an anti-PD-L1 agent, and cetuximab, as any line treatment for patients with recurrent/metastatic head and neck squamous

Por: Ng · K. · Metcalf · R. · Sacco · J. · Kong · A. · Wheeler · G. · Forsyth · S. · Bhat · R. · Ward · J. · Ensell · L. · Lowe · H. · Spanswick · V. · Hartley · J. · White · L. · Lloyd-Dehler · E. · Forster · M. — Noviembre 27th 2023 at 17:08
Introduction

Head and neck cancer is the eighth most common cancer in the UK. Current standard of care treatment for patients with recurrent/metastatic squamous cell head and neck carcinoma (HNSCC) is platinum-based chemotherapy combined with the anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, cetuximab. However, most patients will have poor median overall survival (OS) of 6–9 months despite treatment. HNSCC tumours exhibit an immune landscape poised to respond to immunotherapeutic approaches, with most tumours expressing the immunosuppressive receptor programmed death-ligand 1 (PD-L1). We undertook the current study to determine the safety and efficacy of avelumab, a monoclonal antibody targeting the interaction between PD-L1 and its receptor on cytotoxic T-cells, in combination with cetuximab.

Methods and analysis

This is a multi-centre, single-arm dose de-escalation phase II safety and efficacy study of avelumab combined with cetuximab; the study was to progress to a randomised phase II trial, however, the study will now complete after the safety run-in component. Up to 16 participants with histologically/cytologically recurrent/metastatic squamous cell carcinoma (including HNSCC) who have not received cetuximab previously will be recruited. All patients will receive 10 mg/kg avelumab and cetuximab (500, 400 or 300 mg/m2 depending on the cohort open at time of registration) on days 1 and 15 of 4-week cycles for up to 1 year, (avelumab not given cycle 1 day 1). A modified continual reassessment method will be used to determine dose de-escalation. The primary objective is to establish the safety of the combination and to determine the optimum dose of cetuximab. Secondary objectives include assessing evidence of antitumour activity by evaluating response rates and disease control rates at 6 and 12 months as well as progression-free and OS.

Ethics and dissemination

Approval granted by City and East REC (18/LO/0021). Findings will be published in peer-reviewed journals and disseminated at conferences.

Trial registration number

NCT03494322.

☐ ☆ ✇ BMJ Open

Feasibility of linking universal child and family healthcare and financial counselling: findings from the Australian Healthier Wealthier Families (HWF) mixed-methods study

Por: Price · A. M. H. · White · N. · Burley · J. · Zhu · A. · Contreras-Suarez · D. · Wang · S. · Stone · M. · Trotter · K. · Mrad · M. · Caldwell · J. · Bishop · R. · Chota · S. · Bui · L. · Sanger · D. · Roles · R. · Watts · A. · Samir · N. · Grace · R. · Raman · S. · Kemp · L. · Lingam · R. · Eape — Noviembre 22nd 2023 at 17:12
Objectives

‘Healthier Wealthier Families’ (HWF) seeks to reduce financial hardship in the early years by embedding a referral pathway between Australia’s universal child and family health (CFH) services and financial counselling. This pilot study investigated the feasibility and short-term impacts of HWF, adapted from a successful Scottish initiative.

Methods

Setting: CFH services in five sites across two states, coinciding with the COVID-19 pandemic. Participants: Caregivers of children aged 0–5 years experiencing financial hardship (study-designed screen). Design: Mixed methods. With limited progress using a randomised trial (RCT) design in sites 1–3 (March 2020–November 2021), qualitative interviews with service providers identified implementation barriers including stigma, lack of knowledge of financial counselling, low financial literacy, research burden and pandemic disruption. This informed a simplified RCT protocol (site 4) and direct referral model (no randomisation, pre–post evaluation, site 5) (June 2021–May 2022). Intervention: financial counselling; comparator: usual care (sites 1–4). Feasibility measures: proportions of caregivers screened, enrolled, followed up and who accessed financial counselling. Impact measures: finances (quantitative) and other (qualitative) to 6 months post-enrolment.

Results

355/434 caregivers completed the screen (60%–100% across sites). In RCT sites (1–4), 79/365 (19%–41%) reported hardship but less than one-quarter enrolled. In site 5, n=66/69 (96%) caregivers reported hardship and 44/66 (67%) engaged with financial counselling; common issues were utility debts (73%), and obtaining entitlements (43%) or material aid/emergency relief (27%). Per family, financial counselling increased income from government entitlements by an average $A6504 annually plus $A784 from concessions, grants, brokerage and debt waivers. Caregivers described benefits (qualitative) including reduced stress, practical help, increased knowledge and empowerment.

Conclusions

Financial hardship screening via CFH was acceptable to caregivers, direct referral was feasible, but individual randomisation was infeasible. Larger-scale implementation will require careful, staged adaptations where CFH populations and the intervention are well matched and low burden evaluation.

Trial registration number

ACTRN12620000154909.

☐ ☆ ✇ BMJ Open

Salmonella Vaccine Study in Oxford (SALVO) trial: protocol for an observer-participant blind randomised placebo-controlled trial of the iNTS-GMMA vaccine within a European cohort

Por: Hanumunthadu · B. · Kanji · N. · Owino · N. · Ferreira Da Silva · C. · Robinson · H. · White · R. · Ferruzzi · P. · Nakakana · U. · Canals · R. · Pollard · A. J. · Ramasamy · M. · Vacc-iNTS Consortium · Agyapong · Breghi · Crump · Fiorino · Gordon · Jacobs · Kariuki · Malvolti · Mante — Noviembre 14th 2023 at 16:45
Introduction

Invasive non-typhoidal Salmonellosis (iNTS) is mainly caused by Salmonella enterica serovars Typhimurium and Enteritidis and is estimated to result in 77 500 deaths per year, disproportionately affecting children under 5 years of age in sub-Saharan Africa. Invasive non-typhoidal Salmonellae serovars are increasingly acquiring resistance to first-line antibiotics, thus an effective vaccine would be a valuable tool in reducing morbidity and mortality from infection. While NTS livestock vaccines are in wide use, no licensed vaccines exist for use in humans. Here, a first-in-human study of a novel vaccine (iNTS-GMMA) containing S. Typhimurium and S. Enteritidis Generalised Modules for Membrane Antigens (GMMA) outer membrane vesicles is presented.

Method and analysis

The Salmonella Vaccine Study in Oxford is a randomised placebo-controlled participant-observer blind phase I study of the iNTS-GMMA vaccine. Healthy adult volunteers will be randomised to receive three intramuscular injections of the iNTS-GMMA vaccine, containing equal quantities of S. Typhimurium and S. Enteritidis GMMA particles adsorbed on Alhydrogel, or an Alhydrogel placebo at 0, 2 and 6 months. Participants will be sequentially enrolled into three groups: group 1, 1:1 randomisation to low dose iNTS-GMMA vaccine or placebo; group 2, 1:1 randomisation to full dose iNTS-GMMA vaccine or placebo; group 3, 2:1 randomisation to full dose or lower dose (dependant on DSMC reviews of groups 1 and 2) iNTS-GMMA vaccine or placebo.

The primary objective is safety and tolerability of the vaccine. The secondary objective is immunogenicity as measured by O-antigen based ELISA. Further exploratory objectives will characterise the expanded human immune profile.

Ethics and dissemination

Ethical approval for this study has been obtained from the South Central—Oxford A Research Ethics Committee (Ethics REF:22/SC/0059). Appropriate documentation and regulatory approvals have been acquired. Results will be disseminated via peer-reviewed articles and conferences.

Trial registration number

EudraCT Number: 2020-000510-14.

☐ ☆ ✇ BMJ Open

Investigating the associations of age of initiation and other psychosocial factors of singular alcohol, tobacco and marijuana usage on polysubstance use: analysis of a population-based survey in Jamaica

Por: Lalwani · K. · Whitehorne-Smith · P. · McLeary · J.-G. · Albarus · N. · Abel · W. — Noviembre 14th 2023 at 16:45
Objectives

This study aimed to examine concurrent polysubstance use of alcohol, tobacco and marijuana and determine correlations with access to marijuana, friend and familial drug use habits, risk perception and the age of initiation associated with the singular use of these substances.

Design

A secondary data analysis.

Setting

Used the Jamaica National Drug Prevalence Survey 2016 dataset.

Participants

Involved the entire dataset comprising 4623 randomly selected respondents between 12 and 65 years old.

Outcome measures

Primary outcome: concurrent polysubstance use recorded as using two or more of alcohol, tobacco and marijuana. Predictor variables include risk perception and age of initiation of singular alcohol, tobacco and marijuana use, ease of marijuana access and family and friend alcohol and illegal drug use.

Results

Approximately 58%–66% of respondents commenced singular alcohol, tobacco or marijuana use under 17. Participants commencing marijuana use at 11 years and under and between 12 and 17 were 3.346 and 4.560 times more likely to report past month concurrent polysubstance use (p=0.030 and p

Conclusions

Decreased perceived risk, childhood and adolescent age of initiation and easy access to marijuana were significantly associated with polysubstance use among Jamaicans. The influence of friends and family members’ drug and alcohol use behaviours on individuals developing polysubstance use habits further endorses the need for interventions.

☐ ☆ ✇ BMJ Open

Evaluation of the priority primary care centre program to reduce emergency department burden in regional Victoria, Australia: a mixed-method study

Por: Frith · M. · Randall · S. · Savira · F. · Swann · J. · White · N. · Giddy · A. · McLean · K. · Peeters · A. · Robinson · S. — Noviembre 9th 2023 at 15:07
Introduction

In Australia, the Victorian State Government has established a number of priority primary care centres (PPCCs) across the state to address the increasing demand for emergency departments (EDs). PPCCs are general practitioner-led, free-of-charge services that aim to provide care for conditions that require urgent attention but do not require the high-acuity care of an ED. This study aims to evaluate the implementation processes, outcomes and the impact of the PPCC on reducing ED demand within Barwon, Warrnambool and Grampians Health Services in the Western region of Victoria, Australia.

Methods and analysis

This is a convergent mixed-method study. Qualitative data collection will be undertaken through semistructured interviews to understand the experiences of PPCC patients, PPCC clinical staff, PPCC managerial and administrative staff and ED clinical staff. A documentary analysis will be conducted on the materials relating to the implementation of the PPCC. The quantitative component will involve interrupted time series analysis of de-identified administrative data, comprising ED presentation records and PPCC clinical records. Implementation science frameworks will be integrated throughout the study. The RE-AIM framework is a guide used for the planning and evaluation of programmes through five outcomes: reach, effectiveness, adoption, implementation and maintenance. The Consolidated Framework for Implementation Research will be integrated.

Ethics and dissemination

This study has received ethical approval from Deakin University HREC (Ref No. 2023-046) and Barwon Health HREC (Ref No. 94374). Findings will be disseminated as reports, presentations and peer-reviewed journal articles.

☐ ☆ ✇ International Wound Journal

The role community‐based healthcare providers play in managing hard‐to‐heal wounds

Abstract

It is common for community-based healthcare providers (CHPs)—many of whom have not received specialised training in wound care—to deliver initial and ongoing management for various wound types and diverse populations. Wounds in any setting can rapidly transition to a stalled, hard-to-heal wound (HTHW) that is not following a normal healing trajectory. Failure to recognise or address issues that cause delayed healing can lead to increased costs, healthcare utilisation and suffering. To encourage early intervention by CHPs, a panel of wound care experts developed actionable evidence-based recommendations for CHPs delineating characteristics and appropriate care in identifying and treating HTHWs. A HTHW is a wound that fails to progress towards healing with standard therapy in an orderly and timely manner and should be referred to a qualified wound care provider (QWCP) for advanced assessment and diagnosis if not healed or reduced in size by 40%–50% within 4 weeks. HTHWs occur in patients with multiple comorbidities, and display increases in exudate, infection, devitalised tissue, maceration or pain, or no change in wound size. CHPs can play an important initial role by seeing the individual's HTHW risk, addressing local infection and providing an optimal wound environment. An easy-to-follow one-page table was developed for the CHP to systematically identify, evaluate and treat HTHWs, incorporating a basic toolkit with items easily obtainable in common office/clinic practice settings. A flow chart using visual HTHW clinical cues is also presented to address CHPs with different learning styles. These tools encourage delivery of appropriate early interventions that can improve overall healthcare efficiency and cost.

☐ ☆ ✇ Journal of Advanced Nursing

Family caregiver readiness to adopt smart home technology to monitor care—Dependent older adults: A qualitative exploratory study

Por: Gordana Dermody · Roschelle Fritz · Courtney Glass · Melissa Dunham · Lisa Whitehead — Agosto 24th 2023 at 07:10

Abstract

Aims

The aim of this study was to explore factors that influence family caregiver readiness to adopt health smart home technology for their care-dependent older adult family member. Health smart homes are designed to remotely monitor the health and wellness of community-dwelling older adults supporting independent living for as long as possible. Accordingly, if the health smart home is deployed into the home of a care-depended older adult, it can potentially support family caregivers by facilitating workforce participation and give piece of mind to the family caregiver who may not live close to the older adult. However, wider adoption of health smart home technologies into the homes of community-older adults is low, and little is known about the factors that influence the readiness of family caregivers to adopt smart home technologies for their care-dependent older adults.

Design

A qualitative Descriptive study design was utilized.

Methods

Qualitative data were collected between 2019 and 2020 via semi-structured interviews. Thematic analysis of interviews was completed, and data were organized into themes.

Results

Study findings show that caregiver readiness (N = 10) to adopt smart home technology to monitor older adult family members were influenced by five primary themes including a ‘big brother effect’, ‘framing for acceptance’, ‘data privacy’, ‘burden’ and ‘cost.’

Conclusion

Family caregivers were open to adopting smart home technology to support the independent living of their older adult family members. However, the readiness of family caregivers was inextricably linked to the older adults' readiness for smart home adoption. The family caregiver's primary concern was on how they could frame the idea of the smart home to overcome what they viewed as hesitancy to adopt in the older adult. The findings suggest that family caregivers endeavour to balance the hesitancy in their older adult family members with the potential benefits of smart home technology.

Impact

Family caregivers could benefit if their care-dependent older adults adopt smart home technology. Recognizing the role of caregivers and their perspectives on using smart home technologies with their care-dependents is critical to the meaningful design, use and adoption.

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