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Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study

Por: Alodayni · H. M. · Smith · S. · Poushpas · S. · Swagell · K. · Mandic · D. · Johnson · N. A. · Jaffer · U. · Davies · A. · Normahani · P.
Introduction

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

Methods and analysis

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

Ethics and dissemination

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

Trial registration number

ClinicalTrials.gov, NCT06619223.

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Health economic impact of early versus delayed treatment of herpes simplex virus encephalitis in the UK

Por: Defres · S. · Navvuga · P. · Moore · S. · Hardwick · H. · Easton · A. · Michael · B. D. · Kneen · R. · Griffiths · M. · ENCEPHUK Study Group · Medina-Lara · A. · Solomon · T. · Barlow · Beeching · Blanchard · Body · Boyd · Cebria-Prejan · Chadwick · Cooke · Crawford · Davies · Davies
Objective

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

Design and setting

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Study participants

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Primary and secondary outcome measures

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

Results

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

Conclusions

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

Are we getting better over time? Clinical and patient-reported outcomes for reverse shoulder arthroplasty: a National Joint Registry cohort study

Por: OMalley · O. · Davies · A. · Taghavi Azar Sharabiani · M. · Rangan · A. · Sabharwal · S. · Reilly · P.
Objectives

This study aims to review whether both clinical and Patient Reported Outcome Measures (PROMs) of Reverse Shoulder Arthroplasty have improved over time using the National Joint Registry (NJR).

Design

This study is a population-based cohort study using the NJR and Hospital Episode Statistics for England.

Setting

Publicly funded hospitals and procedures in England from 1 January 2013 to 31 December 2021.

Participants

All patients that received a reverse shoulder arthroplasty (RSA) in the specified time period. Patients were excluded if they had less than 1 year of follow-up.

Main outcome measures

Primary outcome was revision at one year. Secondary outcomes were non-revision re-operation and mortality at one year, length of stay (LOS) and mean change in Oxford Shoulder Score (OSS) from pre-operatively to 6 months post-operatively.

Results

There were 24 411 RSA cases available for analysis. There was no significant improvement in revision rates over time; however, there was a significant reduction in non-revision re-operations (OR 0.93 (0.86–0.99) p=0.03) and mortality (0.96 (0.92–1.00) p=0.04). LOS over time improved with an average reduction of 0.24 days per year, ranging from a mean of 3.94 days in 2013 to 2.44 days in 2021 (p

Conclusion

Over the 9-year period recorded in the NJR, revision rates were low and remained similar. There has, however, been an improvement in other clinical outcomes such as non-revision reoperation and mortality as well as functional outcomes and reduced LOS, which demonstrates progress in the quality of care provided to shoulder replacement patients and is suggestive of advancements in surgical techniques, perioperative management and rehabilitation strategies.

'For the love of God, just refer me: a co-produced qualitative study of the experiences of people with Tourette Syndrome and tic disorders accessing healthcare services in the UK

Por: Babbage · C. M. · Davies · E. B. · Jones · D. P. · Stevenson · P. · Salvage · J. · Anderson · S. · McNally · E. · Groom · M. J.
Objectives

Chronic tic disorders (CTDs)—such as Tourette Syndrome (TS)—are neurodevelopmental disorders affecting at least 1% of the population, causing repetitive involuntary movements and vocalisations known as tics. This study aimed to explore the lived experiences of accessing healthcare for people with CTD or TS and their families in the United Kingdom (UK), as part of a larger programme of work to inform change to healthcare services for this population.

Design

Informed and designed with extensive patient and public involvement, the design utilised qualitative research using focus groups. Reflexive thematic analysis was used to analyse the data.

Setting

Participants were recruited via online support groups, social media and research registers.

Participants

Seven focus groups were held separately with young people with tics (n=2), adults with tics (n=10) and parents/guardians of children with tics (n=11), led by a lived experience expert (coauthor PS) and facilitated by researchers. Discussion focused on three areas: the impact of living with tics, experience accessing healthcare for tics and management of tics.

Results

Five themes were developed highlighting challenges across the healthcare pathway, including gaining a diagnosis, and receiving treatment, resulting in the use of self-support methods to reduce tic expression or the impact of tics. Themes also illustrated perceptions that healthcare provider's knowledge impacted initial interactions with the healthcare system, and how healthcare systems were not felt to be prioritising CTDs.

Conclusions

The findings highlight a lack of prioritisation for tic disorders compounded by a healthcare structure which does not support a complex condition that requires a multidisciplinary approach. This research calls for improvements to UK healthcare services for CTD.

What are the Aboriginal worldviews of disability in the Fitzroy Valley? Aboriginal Participatory Action Research to develop strategies for decolonising disability services

Por: Stubbs · T. · Bedford · M. · Bear · E. · Carter · E. · Pickard · A. · Davies · J. · Thomas · S. · Martiniuk · A. L. C. · Elliott · E. J. · Rice · L. J.
Objectives

Aboriginal and Torres Strait Islander people living with disability have unequal access to health and disability support services. The impacts of colonialism and the deficit-based, Western medical model of disability have been identified as barriers to services in remote Aboriginal communities. This study explored different perceptions of disability and identified strategies to help bridge the gap between Aboriginal community members in the Fitzroy Valley and Western health and disability support services.

Design

Aboriginal Participatory Action Research approach with in-depth interviews. Transcripts were analysed using reflexive thematic analysis. Preliminary results were presented to community representatives for contextualisation, validation and to co-design recommendations.

Setting

Fitzroy Valley in the Kimberley region, Western Australia.

Participants

Aboriginal community members with lived experience of disability (n=7) and health and disability support service providers (n=12).

Results

Eight themes were identified: (1) Aboriginal kinship systems are a community strength and support for people living with disability; (2) Aboriginal people from the Fitzroy Valley perceive disability as a social construct; (3) Western medical model of disability differs from Aboriginal perceptions of disability; (4) Aboriginal people from the Fitzroy Valley perceive different types of disabilities in various ways; (5) good awareness of fetal alcohol spectrum disorder in the Fitzroy Valley, but more education is wanted; (6) focus on functional needs and supports for disability; (7) barriers to disability services and (8) decolonise disability services. Community co-designed recommendations focus on centring the Aboriginal worldviews of disability in the Fitzroy Valley.

Conclusions

Decolonising disability services is needed to improve access for Aboriginal and Torres Strait Islander communities. This should involve adapting the current Western medical model of services to enable strengths-based diagnostic and support services that align with Aboriginal and Torres Strait Islander kinship systems, cultures and ways of being. Community leadership must play a central role in this shift.

Understanding the game experiences and mental health of youth: protocol for the Game-in-Action Quebec cohort study

Por: Paquin · V. · Raugh · I. · Davies · M. · Lepage · M. · Lavigne · K. M. · Dion · J. · Abdel-Baki · A. · Shah · J. L. · Iyer · S. N. · Ferrari · M.
Introduction

Video games have been linked to a range of positive and negative effects on the mental health of adolescents and young adults. However, to better understand how games affect the mental health of young people, their use and experiences must be situated in the sociocultural and personal life contexts of individuals. Drawing from a cultural-ecosocial approach, this study combines cross-sectional and digital phenotyping measures to examine the effects of video games on the mental health of youth.

Methods and analysis

Participants will be young people aged 16–25 years from the community and living in the province of Quebec, Canada. An initial sample of 1000 youth will complete a cross-sectional survey online, including measures of socio-demographic context, gaming practices and experiences, streaming practices and experiences, as well as personality and well-being. Qualitative questions will explore personal views on games and mental health. A subsample of 100 participants will be selected for digital phenotyping, including daily surveys of well-being, gaming, streaming and social experiences, combined with passive mobile sensing (eg, geolocation). Analyses will include regression and mixed models for quantitative data, reflexive thematic analysis for qualitative data, and an integration of quantitative and qualitative results using participatory methods.

Ethics and dissemination

The study received ethical approval from the Institutional Review Board of McGill University (24-02-015). The dissemination of results will be conducted in partnership with a multi-stakeholder advisory committee, including youth who play video games, and will involve peer-reviewed publications, presentations to policymakers in Quebec, and workshops for clinicians and researchers.

Understanding tuberculosis among people with tuberculosis through an educational film: a qualitative study

Por: Economou Lundeberg · E. · Biermann · O. · Kuhlin · J. · Kulane · A. · Annerstedt · K. S. · Davies Forsman · L.
Introduction

Treatment of the two billion people with tuberculosis (TB) infection worldwide is crucial to prevent progression to TB disease and thereby prevent further transmission. However, TB is associated with fear and stigma, and knowledge gaps about TB disease are widespread, complicating adherence to treatment. As increasing knowledge about TB can reduce stigma and increase adherence to treatment, we developed an educational film about TB infection and disease. After showing the film to people with TB, our qualitative study aimed to evaluate the film and to explore perceptions, fears and possible knowledge gaps.

Method

We conducted a qualitative study, with in-depth interviews (n=13), at two Infectious Disease Outpatient Departments in Sweden. Included research participants were adults with TB infection or TB disease. After informed consent, the participants watched the film, available in Swedish, English, Somali and Tigrinya. Subsequently, in-depth interviews, using a topic guide, were conducted, transcribed, and a reflexive thematic analysis was performed.

Results

All participants considered the film to be a valuable addition to the written and oral information they had previously received. Identified themes included the perception of TB infection being a deadly, non-curable disease, and many feared being contagious. However, the film challenged these fears and increased the understanding of TB infection being treatable and non-infectious. Another theme revealed that TB-related stigma was experienced in encounters with healthcare professionals in Sweden.

Conclusion

Our educational film was perceived to increase understanding about TB symptoms, transmission and treatment. Implementing the film in Infectious Disease Departments across Sweden may contribute to decreasing stigma and enhancing awareness of the importance of treatment adherence, an outcome that warrants further investigation post-implementation.

Use of an innovative electronic communications platform (912Rwanda) to improve prehospital transport of injured people in Rwanda: protocol for a type 2 hybrid effectiveness-implementation interrupted time series study

Introduction

Injury is a major cause of death in Rwanda, with many deaths occurring before hospital admission. Timely transport of injured patients to appropriate hospitals is crucial, ideally within an hour for severely injured patients. However, delays in reaching treatment facilities are common, with ambulance services using inefficient mobile phone communication. This project aims to evaluate the effectiveness and implementation of an innovative electronic communication platform (912Rwanda).

Methods and analysis

The study will be conducted through the public ambulance service, Service d’Aide Médicale d’Urgence (SAMU), and receiving health facilities in Kigali city and Musanze district in Rwanda. The 912Rwanda intervention will be rolled out in the two locations at different times. The primary effectiveness outcome is the time from ambulance deployment to patient arrival at the health facility. Secondary effectiveness outcomes include disaggregated times of the primary outcome and clinical outcomes, such as length of stay and requirement for intensive care. These outcomes will be evaluated using an interrupted time series analysis, accounting for non-homogeneous variances, auto-regressive errors and non-linear trends where appropriate. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Qualitative Evaluation for Systematic Translation (QuEST) framework. Cost-effectiveness will be evaluated using a cost-consequence analysis with consequences as determined by the interrupted time series analysis.

Ethics and dissemination

Ethical approval was obtained from the Rwanda National Research Ethics Committee (Ref No: 99/RNEC/2023). Dissemination will occur through open-access peer-reviewed publications, relevant national and international conferences.

Trial registration number

ISRCTN97674565.

Duplex ultrasound after endo revascularisation (DUSTER): protocol for a randomised controlled feasibility trial

Por: Gadi · N. · Moore · C. · Hayden · K. · Zhang · J. · Beetar · G. · Rogers · S. · Smith-Ball · C. · Davies · A. · Thapar · A.
Introduction

Endovascular therapy is the main treatment for chronic limb-threatening ischaemia in the UK. Despite a restenosis risk of 50% over 2 years, reintervention rates are low, potentially resulting in preventable amputations. European guidelines recommend ultrasound surveillance to facilitate early treatment of restenosis. This study will investigate the use of duplex ultrasound after endo revascularisation (DUSTER). The aim is to assess the feasibility, acceptability and impact on clinical decision-making of a 1-year integrated ultrasound surveillance programme after lower limb endovascular therapy.

Methods and analysis

DUSTER is a mixed-methods study. Phase I is a three-site, feasibility, open-label, randomised controlled trial. The standard of care, the control arm, is standard clinical surveillance by a vascular specialist at 1, 6 and 12 months. The intervention arm will receive integrated ultrasound (ankle-brachial pressure index, toe pressure and duplex) plus standard clinical surveillance. Primary outcomes are rates of attendance and completion of ultrasound surveillance tests, as well as the percentage of participants undergoing reintervention for restenosis. Secondary outcomes are limb salvage, amputation-free survival, reasons for amputation, complications, serious adverse events and mortality.

Phase II comprises independent semistructured interviews with intervention arm participants. The interviews will explore barriers and facilitators to ultrasound surveillance and the effect of ultrasound surveillance on patients’ lives.

Phase III has two separate focus groups for participants and clinical stakeholders to identify which outcomes matter most in any subsequent large-scale effectiveness trials.

Ethics and dissemination

This research has been approved by a UK (West Midlands, Black Country) Research Ethics Committee (reference 24/WM/0232) and the Health Research Authority (IRAS 349192). Dissemination of results will be by the DUSTER co-investigators in peer-reviewed journals, to the National Institute for Health and Care Research and to a lay audience via the Mid and South Essex NHS Foundations Trust website.

Trial registration number

NCT06702306.

Health and well-being of children and adolescents living in the Kimberley region of Western Australia: a scoping review protocol

Por: Cannon · L. · Carter · E. · Davies · J. · Thomas · S. · Elliott · E. J. · Rice · L. J.
Introduction

Aboriginal people in the Kimberley are concerned that scientific research, government Inquiries and Royal Commissions are not adequately informing policy and service design. In this protocol paper, we outline our proposed scoping review to identify and provide a broad overview of scientific literature regarding the health, well-being, mental health, disability, education and social outcomes of children and adolescents living in the Kimberley region of Western Australia and the recommendations that came from them.

Methods and analysis

This scoping review is guided by Arksey and O’Malley’s (2005) methodological framework. We will conduct a comprehensive search across multiple databases using several search engines. Inclusion criteria were established to inform the selection of papers to be included in the review. After de-duplication, all titles and abstracts will be reviewed, followed by full-text screening. A second reviewer will independently screen 20% of the titles, abstracts and full texts. Two reviewers will discuss discrepancies, and a third reviewer will resolve any disagreements that may arise. We will use a data extraction template in Covidence to systematically extract relevant data.

Ethics and dissemination

This scoping review does not require ethics approval, as we are investigating the breadth of existing literature regarding the outcomes of children and adolescents in the Kimberley, Western Australia. The scoping review results will be published in peer-reviewed journal(s) and shared with relevant policymakers to help inform future policies and service improvements and designs in the region.

Cross-sectional study of the association between diet and physical inactivity with obesity, diabetes and hypertension among older adults in Sierra Leone

Por: Bockarie · T. · Shanker · A. · Jalloh · M. B. · Kamara · A. M. · Odland · M. L. · Wurie · H. · Ansumana · R. · Lamin · J. · Witham · M. · Oyebode · O. · Davies · J.
Objective

To examine the association between behavioural risk factors and their physiological sequelae among adults aged 40 and above in Bo District, Sierra Leone.

Design

Cross-sectional study.

Setting

Household survey in Bo District, Sierra Leone.

Participants

The study included 1978 randomly sampled adults aged 40 and above (44.4% male and 55.6% female). The majority of participants were aged 40–49 years (34.5%). Data were collected using a household survey based on the validated WHO STEPs questionnaire.

Methods

Multivariable logistic regression analysis was performed to determine associations between behavioural risk factors (diet, physical activity and salt intake) and the presence of hypertension, diabetes and/or obesity, adjusting for sociodemographic variables.

Primary outcome measure

The primary outcomes were the presence of hypertension, diabetes or overweight/obesity. Hypertension was defined as systolic blood pressure of ≥140 mm Hg and/or diastolic blood pressure of ≥90 (measured); diabetes as fasting glucose of ≥7.0 mmol/L, random plasma glucose level of ≥11.1 mmol/L or the use of antidiabetic medications (self-reported) and overweight/obesity as having a body mass index of ≥25 kg/m² (measured).

Results

At least one physiological risk factor for cardiovascular diseases, that is, hypertension, obesity or diabetes, was present in 43.5% of participants. Hypertension was associated with urban living (OR=1.46, 95% CI (1.41 to 1.51)), older age (OR for 80+=3.98, 95% CI (3.70 to 4.28)), insufficient fruit and vegetable intake (OR=1.52, 95% CI (1.46 to 1.60)) and low physical activity (OR=1.35, 95% CI (1.27 to 1.43)). Diabetes was associated with urban residence (OR=1.84, 95% CI (1.66 to 2.05)), older age (OR for 70–79=3.82, 95% CI (3.28 to 4.45)), low fruit and vegetable consumption (OR=1.61, 95% CI (1.36 to 1.90)), high salt intake (OR=1.34, 95% CI (1.21 to 1.49)) and low physical activity (OR=1.47, 95% CI (1.26 to 1.71)). Obesity was associated with urban living (OR=1.66, 95% CI (1.59 to 1.72)), high salt intake from two or more sources (OR=1.21, 95% CI (1.17 to 1.25)) and low physical activity (OR=1.30, 95% CI (1.22 to 1.39)). Male sex (OR=0.37, 95% CI (0.36 to 0.38)) and older age (OR for 80+=0.39, 95% CI (0.35 to 0.43)) were protective factors.

Conclusions

In Bo District, nearly half of adults over 40 face hypertension, diabetes or obesity, especially urban dwellers, older age groups and those eating too few fruits and vegetables, consuming excess salt and getting little exercise. Public health efforts should focus on urban-targeted nutrition education, salt-reduction strategies, community exercise programmes and routine blood pressure and glucose screening, working with local leaders to ensure sustainable lifestyle changes and early disease detection.

Developing and integrating a destination decision support algorithm into an innovative electronic communication platform to improve injury care service coordination in Rwanda: the Rwanda912 study protocol

Introduction

Delays in getting injured patients to the hospital in a timely manner can increase avoidable death and disability. Like many low-income or middle-income countries, Rwanda experiences delays related to a lack of efficient prehospital communication and formal guidelines to triage patients for hospital care. This study describes the protocol to develop, roll-out and evaluate the effectiveness of a destination decision support algorithm (DDSA) integrated in an electronic communication platform, ‘912Rwanda’. The DDSA will facilitate the linkage of patients to health facilities able to treat their condition(s).

Methods and analysis

Work will be conducted in the prehospital emergency service ‘Service d'Aide Médicale Urgente’ and health facilities in Kigali city and Musanze district, which serve predominantly urban and rural populations, respectively. We will develop interfaces to capture facility and patient-relevant data, which feed into a guideline-based electronic DDSA to match patients to hospitals. We will assess existing trauma care processes using qualitative and quantitative methodologies. This will be followed by a series of consensus workshops to develop at-scene triage guidelines and agree on variables to capture in the interfaces. The DDSA will be developed based on outputs from these workshops and will be tested against historical ambulance data and expert opinion until acceptable thresholds of performance are achieved. User interfaces will be developed and tested using human–computer interface design principles.

Discussion

The combined collaborative approach of bringing together experts and software developers, and with deep engagement of Rwandan stakeholders, including leadership of Rwanda Ministry of Health through its technical arm, Rwanda Biomedical Center, should lead to an ambulance communication system which is used, sustained and effective.

Ethics and dissemination

The project was approved by the Rwanda National Research Ethics Committee. Annual reports will be disseminated to relevant stakeholders, followed by the public. Publications will be open access as per the funding policy.

Trial registration number

ISRCTN97674565. Registered on 29 July 2024. https://doi.org/10.1186/ISRCTN97674565.

Short-term and long-term outcomes of hybrid revascularisation procedures in peripheral artery disease: a systematic review protocol

Por: Darwish · M. · Davies · H. O. · Morgan · E. · Meecham · L.
Introduction

Peripheral artery disease (PAD) is a chronic condition causing arterial narrowing or blockage, leading to significant morbidity and mortality. Hybrid revascularisation combines open surgical and endovascular techniques to manage multilevel disease by addressing inflow and outflow obstructions. Despite increasing adoption, evidence on the long-term outcomes of these procedures remains limited.

Objective

To evaluate the long-term outcomes of hybrid revascularisation procedures in PAD, including patency rates, limb salvage, survival, reintervention rates and complications, and to provide evidence-based insights for clinical practice and research.

Methods and analysis

This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. It will include randomised controlled trials, cohort studies, case-control studies and large case series (≥10 patients, with at least 1 year of follow-up) assessing adult patients undergoing hybrid revascularisation for PAD. Primary outcomes are patency rates, limb salvage and survival; secondary outcomes include complication rates, functional improvements and quality of life. Searches will be conducted in PubMed, Embase, Cochrane Library, CINAHL and ClinicalTrials.gov. Study selection, data extraction and quality assessment will be performed independently in duplicate by two reviewers. Meta-analyses with random-effects models will summarise findings where feasible, while narrative synthesis will address instances of insufficient data. Subgroup analyses will explore outcomes by demographics, lesion characteristics and procedural details. Risk of bias will be assessed using Cochrane and Newcastle-Ottawa tools.

Ethics and dissemination

Ethical approval is not required. Findings will be published in peer-reviewed journals and presented at conferences.

PROSPERO registration number

CRD42024615809.

Identification of core outcomes for quality in routine care provided to people living with dementia in Australia: a multilevel modified Delphi consensus study

Por: Kenny · D. · Welch · A. · Dao-Tran · T.-H. · Lendich · K. · Brittain · D. · Thompson · J. · Parkin · B. · Nunn · J. · OKeefe · F. · Semler · R. · Davies · B. · Comans · T. · COM-IC project team · Welch · Kearney · Meyer · Cunningham · Kenny · Trepel · Petrie · Nunn · Quinn · Lowthian · Ng
Objective

To co-design a core outcome set with people living with dementia and other stakeholders that can be used to measure the quality of dementia care in home care and residential settings.

Design

Multilevel modified Delphi consensus study. A priori consensus threshold of 70% was used to include or exclude outcomes.

Setting

Routine dementia care provided through home care and residential aged care facilities in Australia.

Participants

A stakeholder panel comprising people living with dementia, formal and family/informal carers of people living with dementia, advocates, policy experts, allied-health professionals, nurses and professionals working in the aged care industry. Round 1 included 10 panellists; subsequent rounds extended the number of participants to 24.

Results

Seven outcome domains (Death, Physiological and clinical, Functional, Life impact, Resources, Adverse events and Education), encompassing 105 individual outcomes were considered by the panel over four rounds.

The 105 outcomes were distilled to 16 outcomes identified as important in home care and 15 in residential aged care. In both settings, nine outcomes (Dignity, Advanced care planning, Meaningful activities, Feeling safe and secure, Emotional wellbeing, Quality of Life, Resource utilisation, Safety incidents and Dementia-specific qualifications for care staff) were considered important.

Additionally, seven outcomes in the home care setting (Behavioural symptoms of dementia, Diagnosis of dementia, Hygiene, Importance of Relationships, Quality of carer and family lives, Dementia care navigation and Opportunities for unpaid carers) and six outcomes in the residential aged care setting (Neuropsychiatric symptoms of dementia, Pain, Hygiene and comfort, Medication safety, Staff carer morale and Adverse effects) were classified as important.

Conclusions

The outcomes identified during this modified Delphi consensus study provide a promising basis for the development of a meaningful, practical and measurable core outcome set that could be used in dementia care settings to improve the quality of routine care provided to people living with dementia.

Womens perspectives of decision-making for labour and birth: a qualitative antenatal-postnatal paired interview study

Por: White · E. · Davies · A. · Demetri · A. · McGuinness · S. · Clayton · G. · Fraser · A. · Barnfield · S. · Bakhbakhi · D. · Anderson · E. C. · Birchenall · K. · Miller · R. · Burden · C. · Merriel · A. · Kingdon · C.
Objectives

To understand and compare women’s antenatal and postnatal views on: (1) priorities for information provided about labour and delivery and (2) decision-making in labour and delivery.

Design

Qualitative interview study using repeat interviews at two time points: during pregnancy (≥13 weeks gestation); and after birth (≥6 weeks).

Setting

Large maternity hospital in the Southwest of England.

Participants

Pregnant women accessing antenatal care were purposively sampled and recruited antenatally by community midwives to ensure representation from different sociodemographic groups, with diverse experiences of low and high-risk care.

Data collection

Telephone interviews with a single researcher using a semistructured interview topic guide.

Data analysis

Interviews were audio recorded, transcribed verbatim, and qualitative thematic analysis was conducted using Braun and Clarke’s six-stage process.

Results

Twelve women participated (12 antenatal interviews; 10 follow-up postnatal interviews). Overall, women’s postnatal views were consistent with their antenatal views about what they wanted to know and the factors that influence decision-making. Three themes were generated. Theme 1 ‘Sources of information’ presents evidence of how women obtain and use information (sub-themes: ‘social influences’, ‘patient responsibility for information seeking’, ‘NHS vs non-NHS resources’). Theme 2 reports women’s views and experiences of ‘The influence of Healthcare Professionals in decision-making’ (sub-themes ‘patient and professional roles in decision-making’, ‘conflicting advice and preferences’, ‘taking authority in emergency decision-making’). The final theme, theme 3, ‘When, how, and what information women want’ shows women want time to process information (sub-themes ‘when: it’s definitely information and time’, ‘how: presentation of information’, ‘what: information required’). Cross-cutting all themes, we found an unmet need for information to be tailored to the individual.

Conclusions

Women understand decision-making during labour and birth is a dynamic process. Women can struggle with the volume, quality and timing of information available. In busy maternity settings, the challenge is to better equip women with the information they want, and health professionals with the information they need to provide for personalised care and shared decision-making. Antenatal interventions that warrant further research include decision aids, birth plans, and structured counselling using core information sets. Insights from both antenatal and postnatal perspectives will help inform their development.

Efficacy and acceptability of different blood flow restriction training interventions during the rehabilitation of military personnel with lower limb musculoskeletal injuries: protocol for a two-phase randomised controlled trial

Por: Gray · L. · Coppack · R. J. · Barker-Davies · R. · Cassidy · R. P. · Bennett · A. N. · Caplan · N. · Atkinson · G. · Bradshaw · L. · Chauhan · J. · Lunt · K. M. · Hughes · L. · Ladlow · P.
Background

Musculoskeletal injury (MSKI) is the leading cause of medical downgrading and discharge within the UK military, with lower limb MSKI having the greatest incidence, negatively impacting operational readiness. Pain is a primary limiting factor to rehabilitation progress following MSKI. Heavy-load resistance training (RT; ie, loads >70% 1-repetition maximum) is traditionally used but may be contraindicated due to pain, potentially prolonging recovery and leading to failure of essential physical employment standards for UK military personnel. Low-load RT with blood flow restriction (BFR) can promote favourable morphological and physiological adaption, as well as elicit hypoalgesia in healthy and clinical populations (eg, post-operative), and has proven a viable option in military rehabilitation settings. The acceptability and tolerance of higher relative BFR pressures in persistent pain populations are unknown due to the complexity of presentation and the perception of discomfort experienced during BFR exercise. Greater relative pressures (ie, 80% limb occlusion pressure (LOP)) elicit a greater hypoalgesic response in pain-free individuals, but greater perceived discomfort which may not be tolerated in persistent pain populations. However, lower relative pressure (ie, 40% LOP) has elicited hypoalgesia in pain-free individuals, which therefore may be more clinically acceptable and tolerated in persistent pain populations. The primary aim of both randomised controlled trials (RCT) is to investigate the efficacy and acceptability of using high-frequency, low-load BFR-RT in UK military personnel with lower limb MSKI where persistent pain is the primary limiting factor for progression.

Methodology

The presented protocol is a two-phase RCT based within a military rehabilitation setting. Phase One is a 1-week RCT to determine the most efficacious and acceptable BFR-RT protocol (7x BFR-RT sessions over 5 days at 40% or 80% LOP; n=28). Phase Two is a 3-week RCT comparing the most clinically acceptable BFR pressure, determined by Phase One (21x BFR-RT sessions over 15 days; n=26) to usual care within UK Defence Rehabilitation residential rehabilitation practices. Outcomes will be recorded at baseline, daily and following completion of the intervention. The primary outcome will be the brief pain inventory. Secondary outcomes include blood biomarkers for inflammation and pain (Phase Two only), injury-specific outcome measures, lower extremity function scale, objective measures of muscle strength and neuromuscular performance, and pressure pain threshold testing.

Ethics and dissemination

The study is approved by the Ministry of Defence Research Ethics Committee (2318/MODREC/24) and Northumbria University. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number

Registered with Clinical Trials. The registration numbers are as follows: NCT06621914 (Phase One) and NCT06621953 (Phase Two).

Use of 3D printed head and neck models for simulating 10 common ENT emergency procedures: a prospective validation study

Por: Rehman · U. · Colton · D. · Gupta · S. · Kulloo · P. · Vijendren · A. · Howard · J. · Sangwan · P. · Davies-Husband · C. · Rudd · J. · Whittaker · M. · Stephenson · K. · Taylor · C. · Roche · P. · Eynon-Lewis · N. · Bajaj · Y. · Lau · A. · Okhovat · S. · Rollin · M. · Lechner · M.
Objective

This study aims to validate a high-fidelity three-dimensional (3D)-printed head and neck model for training emergency medicine (EM) physicians, primary care physicians and allied health professionals in managing 10 common ear, nose and throat (ENT) emergencies.

Setting

The study was conducted at an ENT Emergencies course in London.

Study design

Prospective validation study.

Participants

All delegates (n=90) were healthcare professionals. Among them, 60% (n=54) were EM residents/trainees, 28% (n=25) were primary care residents/trainees, 4% (n=4) were ENT residents/trainees, 4% (n=4) were emergency nurse practitioners, 2% (n=2) were primary care attending physicians and 1% (n=1) was an EM attending/consultant. All faculty were consultant ENT surgeons (n=11).

Intervention

The 3D models, produced using proprietary 3D printing technology (Fuesetec), were used in a 1-day ENT emergencies course for validating training and confidence of delegates in performing 10 common ENT emergencies.

Results

A total of 86% (n=77) of delegates found the models extremely or very helpful in learning ENT emergencies. Delegates rated the resemblance to real patients as excellent or very good in both haptic feedback (n=58, 64%) and tissue texture (n=67, 74%). Additionally, 74%–96% of delegates felt confident in performing the 10 ENT procedures after using the models.

Conclusions

The 3D models enhanced participant confidence in performing 10 common ENT emergency procedures, demonstrating good face, content and indirect criterion validity. These models could support emergency ENT skill development in local emergency departments.

Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study

Por: Evans · A. · Roy · D. · Davies · M. · Dhanda · S. · Morris · D. · Aurelius · T. · Lane · S. · Fry · C. · Shakir · S.
Objectives

To monitor the safety and utilisation of AZD1222 under real-world use in the UK.

Design

A non-interventional post-authorisation active surveillance study.

Setting

Vaccination sites in the UK.

Participants

A total of 17 945 participants were eligible and provided consent to participate in the study between 1 March 2021 and 6 April 2023. Participants were followed up at weeks 1, 4 and 14 and at months 6, 9, 12 and 18 after the first dose of AZD1222 vaccination and prompted to complete electronic data capture forms. A total of 11 219 participants submitted a Follow-Up 1 form and 5189 participants submitted a Follow-Up 7 form (at 18 months).

Primary and secondary outcome measures

The safety of AZD1222, including the identification, assessment and quantification of serious adverse events (SAEs) and adverse events of special interest (AESI), was examined. The utilisation of AZD1222 was described and characterised, including populations with missing information.

Results

The majority of participants were women (n=10 845; 60.4%) and the median age (IQR) was 50 (43, 62) years. Most participants were from white ethnic groups (n=13 112; 73.1%). Headache and fatigue had the highest reported incidence rate (421.28 cases per 1000 person years and 386.00 cases per 1000 person years, respectively). The most frequently reported AESI was anosmia (6.25 cases per 1000 person years). An increased Observed versus Expected (O:E) ratio was seen for anaphylaxis (O:E 7.38 (95% CI 2.80 to 11.95); based on 10 observed cases (expected cases: 1.36)) and anosmia and/or ageusia (O:E 39.23 (95% CI 29.13 to 49.32), based on 58 observed cases (expected cases: 1.48)).

Conclusions

The most frequent vaccinee-reported adverse events (AEs) were headache and fatigue. An increased O:E ratio was seen for the AEs of anaphylaxis and anosmia and/or ageusia. No safety signals were identified throughout the course of this study.

Trial registration number

This study is registered with the HMA-EMA Catalogue of RWD studies (EUPAS44035).

Qualitative study to inform the design and contents of a patient-reported symptom-based risk stratification system for patients referred from primary care on a suspected head and neck cancer diagnostic pathway

Por: Albutt · A. · McVey · L. · Randell · R. · Hardman · J. C. · Kellar · I. · Odo · C. · Patterson · J. · Bradley · P. T. · Davies · C. · Tikka · T. · Paleri · V. · Rousseau · N.
Objectives

This study aims to inform the development of a patient-reported symptom questionnaire for head and neck cancer and outline the requirements for a patient-reported symptom-based risk stratification system. The study objectives are to explore how clinicians ask questions and decide subsequent steps for patients referred with suspected head and neck cancer; the language patients and clinicians use to describe symptoms; how clinicians reassure and discharge low-risk patients; and identify clinician and patient experiences of the head and neck cancer diagnostic pathway and their views on a novel diagnostic pathway using patient-reported symptom-based risk stratification.

Design

The study employed qualitative methods including observation and recordings of clinic consultations and semistructured interviews with clinicians and patients. Analysis proceeded concurrently with data collection using a rapid qualitative analysis approach.

Setting

Three acute UK National Health Service Trusts with variation in service delivery models. Data collection took place between April and October 2023.

Participants

One hundred and fifty-six adults referred for suspected head and neck cancer, and 21 clinicians from different subspecialties were recruited. A subset of recruited patients (n=16) and clinicians (n=13) were interviewed. One observation of a general head and neck clinic was conducted.

Results

The findings highlight types of symptoms and the language used by patients and clinicians to describe these symptoms in clinic consultations. During interviews, patients described the need for in-person support and human clinical decision-making, an accessible system for reporting their symptoms and reassurance regarding the security of patient data. Clinicians discussed the need for risk scores to be sufficiently validated to be trusted, the potential clinical usefulness of a risk score-based system, for example, to support triage by discriminating symptoms, and accessibility for patients. The observation highlighted inconsistent and sometimes unclear referral information and the limited time clinicians have to read referral information.

Conclusion

The findings have implications for the development of a patient-reported symptom-based risk stratification system. As well as ensuring patients can understand the language used, it will be important to consider how their emotional needs can be met. The findings also have wider implications for understanding the impact of language on emotionally evocative healthcare interactions.

Help-seeking experiences of young people of culturally and/or linguistically diverse (CALD) backgrounds following suicidal thoughts and behaviours in Melbourne, Australia: a qualitative approach

Por: Rajaram · G. · Gibson · K. L. · Kartal · D. · Lamblin · M. · Richards · H. · Davies · P. · Witt · K. · Robinson · J.
Objectives

To understand the help-seeking experiences of young people from culturally and linguistically diverse (CALD) backgrounds who have experienced suicidal thoughts and behaviours (STB).

Design

Qualitative study using semistructured interviews and reflexive thematic analysis.

Setting

A specialist, youth-focused Hospital Outreach Post-suicidal Engagement (HOPE) aftercare service delivered by Orygen in North-West Melbourne, Australia.

Participants

Eight young people aged 16–24 years (mean: 18.7±3.1 years, 50% female) from various CALD backgrounds who had been discharged from the HOPE aftercare service within the past 12 months.

Results

Four themes were identified: (1) cultural taboos and generational differences create challenges in communicating with family; (2) isolation is a barrier to reaching out; (3) it’s hard to disclose and discuss STB with clinicians and (4) not being taken seriously in clinical settings.

Conclusion

These findings highlight social, cultural and organisational barriers that shape the help-seeking journeys of young people from CALD backgrounds experiencing STB. Results suggest a need for culturally sensitive suicide prevention strategies, enhanced cultural competency in healthcare settings and efforts to improve mental health literacy within CALD communities.

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