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AnteayerInterdisciplinares

Methodological issues in visible LED therapy dermatological research and reporting

by David Robert Grimes

Background

The advent of mass-market Light Emitting Diodes (LEDs) has seen considerable interest in potential dermatological applications of LED light photobiomodulation (PBM) for a range of conditions, with a thriving market for direct-to-consumer LED treatments, including red light, blue light, and yellow light wavelengths. Evidence of efficacy is however mixed, and studies report a wide range of irradiances and wavelengths as well as outcome measures, rendering interpretation, comparison, and even efficacy evaluation prohibitive and impeding evidence synthesis.

Methods

This work establishes a model for comparing patient received doses, applying this to existent studies to ascertain potential inhomogeneity in reported doses and wavelengths employed. Patient doses were contrasted to equivalent solar exposure time needed to achieve fluences reported at specified wavelengths in the red light (RL), blue light (BL), and yellow light (YL) portion of the spectrum, yielding a comparison of reported doses to typical solar irradiance at the Earth’s surface. Methodological aspects including dose validation, blinding, and bias were also analysed.

Results

27 relevant studies for dermatological conditions including acne vulgaris (n=9, 33.3%), wrinkle-reduction (n=5, 18.5%), wound-healing (n=3, 11.1%), psoriasis severity (n=3, 11.1%), and erythemal index (n=7, 25.9%) were assessed. Outcome measures were highly heterogeneous between studies, with total patients ranging from 14 – 105 (median: 26). Fluences and wavelengths used in treatment differed over three orders of magnitude across studies even for the same conditions (0.1 J cm−2−126 J cm−2, median: 40.5 J cm−2). Derived equivalent solar time ranged from 0.01-19.35 hours (median: 3.3 hours), with central wavelengths between 405nm (BL) - 660nm (RL). No studies reported any dose validation, 10 (37.0%) were sponsored by the device manufacturer with a further 3 (11.1%) conducted by commercial dermatology practices offering the therapy under investigation. Assessors were unblinded to the treatment/ control groups in 33.3% (n=9), while a further 9 (33.3%) did not have any non-light control group, leaving only 33.3% (n=9) with both control group and blinded outcome assessment.

Conclusions

Results of this analysis suggest that fluences, wavelengths, and effective dose vary inconsistently between studies with often scant biological justification. This analysis suggests that better dose quantification and understanding of the underlying biophysics as well as plausible biological justifications for various wavelengths and fluences are imperative if LED therapy studies for dermatology are to be informative and research replicability improved.

Treatment and monitoring of a high-density population of bare-nosed wombats for sarcoptic mange

by Tanya N. Leary, Lyn Kaye, Olivia Chin, Kar Yee Phoon, David Phalen

Sarcoptes scabiei causes a fatal disease (mange) in bare-nosed wombats (BNWs) (Vombatus ursinus) across their range and can threaten isolated populations with extinction. Repeated dosing of moxidectin (Cydectin®) at a dosage rate of 0.5 mg/kg is effective at treating individual BNWs but is difficult to administer on a population basis where treatment success has varied. This paper documents the temporary (~20 month) eradication of mange from a semi-isolated population of BNWs using repeated dosing of Cydectin® administered by burrow flaps. Treated BNWs were marked with nontoxic paint and selected burrows were monitored with camera traps demonstrating that 64–96% of wombats in the population were treated with each dosage. Treatment success was attributed to the installation of burrow flaps on all burrows in the treated area. This treatment program shows that isolated high-density populations can be successfully treated for S. scabiei infection with repeated dosages of Cydectin® (0.5 mg/kg) and questions the need for higher dosages that have been advocated. Mange returned to the population of BNWs after 20 months possibly as the result of migration of an infected BNW from a nearby population, suggesting mange affected populations may require periodic retreatment. Monitoring of burrow entrances confirmed that burrows provide habitat used by many species of birds, reptiles, and mammals, and suggest burrows could be occasional sites of mange spillover among species. Camera trap monitoring also showed when BNWs in this population leave and return to their burrows; how many BNWs enter a burrow and explore the burrow entrances each night; and how these parameters are impacted by season and mange status; variables that are valuable to know when treating populations of BNW for mange.

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.

A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

ABSTRACT

A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.

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.

An agent-based model to advance the science of collaborative learning health systems

by Michael Seid, David Bridgeland, Christine L. Schuler, David M. Hartley

Improving the healthcare system is a persistent and pressing challenge. Collaborative Learning Health Systems, or Learning Health Networks (LHNs), are a novel, replicable organizational form in healthcare delivery that show substantial promise for improving health outcomes. To realize that promise requires a scientific understanding that can serve LHNs’ improvement and scaling. We translated social and organizational theories of collaboration to a computational (agent-based) model to develop a computer simulation of an LHN and demonstrate the potential of this new tool for advancing the science of LHNs. Model sensitivity analysis showed a small number of parameters with outsized effect on outcomes. Contour plots of these influential parameters allow exploration of alternative strategies for maximizing model outcomes of interest. A simulated trial of two common health system interventions – pre-visit planning and use of a registry – suggested that the efficacy of these could depend on LHN current state. By translating heuristic theories of LHNs to a specifiable, reproducible, and explicit model, this research advances the scientific study of LHNs using tools available from complex systems science.

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.

Exploring the feasibility and acceptability of DIALOG+ (a structured digital communication tool) in strengthening psychiatric care in India and Pakistan: a qualitative pilot study

Por: Qureshi · O. · Divya · K. · Dawood · M. · Davis · S. · Venkatraman · L. · Baig · M. · Priya · K. · Peppl · R. · Pari · M. · Ramachandran · P. · Pasha · A. · Sajun · S. Z. · Sarwar · H. · Shahab · A. · Bird · V. J.
Objectives

To assess the implementation feasibility and acceptability of a structured digital psychosocial communication tool (DIALOG+) to strengthen the quality of person-centric care in psychiatric settings within Pakistan and India.

Design

A hybrid inductive and thematic qualitative analysis using individual interviews (IDIs) and focus group discussions (FGDs).

Setting

Two psychiatric hospitals (Karwan-e-Hayat and Jinnah Postgraduate Medical Centre) in Karachi, Pakistan and one psychiatric care organisation (Schizophrenia Research Foundation) in Chennai, India

Participants

Interviews were conducted with 8 mental health clinicians and 40 patients who completed the DIALOG+ pilot as well as wider stakeholders, that is, 12 mental health clinical providers, 15 caregivers of people with psychosis and 13 mental health experts.

Intervention

A technology-assisted communication tool (DIALOG+) to structure routine meetings and inform care planning, consisting of monthly sessions over a period of 3 months. The intervention comprises a self-reported assessment of patient satisfaction and quality of life on eight holistic life domains and three treatment domains, followed by a four-step solution-focused approach to address the concerns raised in chosen domains for help.

Outcome measures

Key insights for the implementation feasibility and acceptability of DIALOG+ were assessed qualitatively using inductive thematic analysis of 22 IDIs and 8 FGDs with 54 individuals.

Results

Clinicians and patients ascribed value to the efficiency and structure that DIALOG+ introduced to consultations but agreed it was challenging to adopt in busy outpatient settings. Appointment systems and selective criteria for who is offered DIALOG+ were recommended to better manage workload. Caregiver involvement in DIALOG+ delivery was strongly emphasised by family members, along with pictorial representation and relevant life domains by patients to enhance the acceptability of the DIALOG+ approach.

Conclusion

Findings highlight that the feasibility of implementing DIALOG+ in psychiatric care is closely tied to strategies that address clinician workload. Promoting institutional ownership in strengthening resource allocation is essential to reduce the burden on mental health professionals in order to enable them to provide more patient-centric and holistic care for people with psychosis. Further research is required to explore the appropriateness of including caregivers in DIALOG+ delivery to adapt to communal cultural attitudes in South Asia.

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.

A Review of Chronic Wounds and Their Impact on Negative Affect, Cognition, and Quality of Life

ABSTRACT

Chronic wounds represent a substantial socioeconomic, financial, and psychological burden. We examine preclinical and clinical evidence assessing the impact of chronic wounds on negative affect, cognition, and quality of life and discuss potential mechanisms underlying the link between chronic wounds and negative affect and cognition. There is limited preclinical evidence examining negative affect and wounds, but anxiety-related behaviour has been reported in a rat incisional wound model. The incidence of anxiety and depression in people with chronic wounds varies considerably. Potential mechanisms underlying the link between chronic wounds and negative affect include the immune system, pain, metabolic dysfunction, inflammation, and vascular damage. There is a paucity of both preclinical and clinical studies examining the effect of chronic wounds on cognition, highlighting a need for more studies in this area. Research suggests that there are deficiencies in the management of anxiety, depression, and cognitive impairment in people with chronic wounds, but developing and administering therapies that target these comorbidities may have a positive impact on quality of life and wound healing. Integration of mental health and cognition screening into wound care protocols would provide substantial benefits both socioeconomically and to individuals with chronic wounds.

Spatial epidemiology of tuberculosis diagnostic delays, healthcare access disparities, and socioeconomic inequities in Nairobi County, Kenya

by David Majuch Kunjok, John Gachohi Mwangi, Salome Kairu-Wanyoike, Johnson Kinyua, Susan Mambo

Introduction

Kenya ranks among the top 30 countries with a high tuberculosis (TB) burden globally. With a TB prevalence of 558 per 100,000, only 46% of TB cases are diagnosed and treated, leaving 54% undiagnosed and at risk of spreading the disease. This study analyzed the spatial distribution of tuberculosis diagnostic delays and their association with health care accessibility and socioeconomic inequalities in Nairobi County, Kenya.

Materials and methods

The cross-sectional study included 222 newly diagnosed bacteriologically confirmed Mycobacterium tuberculosis (Mtb) patients from Mbagathi County Hospital (MCH), Mama Lucy Kibaki Hospital (MLKH), and Rhodes Chest Clinic (RCC) in Nairobi County, Kenya. Patients were recruited consecutively through census sampling and categorized into two groups: delayed diagnosis (≥21 days from symptom onset) and non-delayed ( Result

Spatial analyses identified 28 statistically significant clusters of delayed TB diagnoses within Nairobi County. Spatial autocorrelation analysis using Moran’s I revealed a significant clustered distribution (Moran’s Index = 0.471, z-score = 3.370, p 2.58, p Discussion and conclusion

The study revealed significant spatial clustering of delayed TB diagnoses in Nairobi County, particularly in informal settlements. In contrast, timely diagnoses were predominantly clustered in high-income areas like Lang’ata and Karen. These clusters were significantly associated with lower household income and increased travel time to health facilities which underscored the need for targeted implementation of TB diagnostic services and control measures in the wards with the highest delays.

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.

Minimum effective dose of a multicomponent behaviour change intervention to increase the physical activity of individuals on primary statin therapy: an adaptive study using the time-to-event continual reassessment method (TiTE-CRM)

Por: Goodwin · A. M. · Friel · C. · Miller · D. · Vicari · F. · Duer-Hefele · J. · Chandereng · T. · Davidson · K. W. · Alfano · C. M. · Cheung · Y. K. · Butler · M. J.
Objectives

To identify the minimum effective dose of a multi-behaviour change technique (BCT) intervention to increase physical activity among individuals on primary statin therapy using the time-to-event continual reassessment method (TiTE-CRM).

Setting

A large New York metropolitan area healthcare system comprising approximately 85 000 employees and 5.5 million patient encounters annually.

Participants

42 participants enrolled in 13 cohorts of 3 participants, 1 cohort of 2 participants and 1 cohort of 1 participant. The sample was composed of 16.7% individuals aged 66 and older (n=7), 64.3% women (n=27), 69.0% white individuals (n=29) and 7.1% Hispanic individuals (n=3).

Interventions

A variable-duration, four-BCT text message intervention and a 2-week follow-up. Dose assignment relied on TiTE-CRM to adjust the duration of the intervention based on adherence of participants in prior cohorts. Five mechanisms of action (MoAs) were assessed: self-efficacy, intrinsic regulation, discrepancy in behaviour, motivation and barriers to activity.

Primary and secondary outcome measures

The primary outcome measure was the proportion of participants who achieved a 2000 step/day increase between baseline and follow-up. The secondary outcomes were within-participant changes in daily steps (examined as a continuous variable at the daily level) and potential MoAs for increased physical activity.

Results

Of the 40 participants who completed follow-up, 7 (17.5%) achieved the goal of 2000 or more steps per day during their follow-up period. Though participants did increase the number of steps they walked during the intervention (B(SE)=373.1 (154.7) steps; p=0.016), there was no association between increased intervention duration and increased daily average steps. The intervention was also associated with increases in self-efficacy (p=0.002), intrinsic regulation (p=0.037), discrepancy in behaviour (p

Conclusions

The results of this trial did not show a traditional dose-response curve to increasing the length of a multicomponent BCT intervention. Results did show that the intervention successfully increased steps during the intervention period and that the benefit of the intervention dwindled during follow-up. Further, potential MoAs for the intervention were confirmed.

Trial registration number

NCT05273723.

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