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Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study

Por: Harvey · S. · Stone · M. · Zingelman · S. · Copland · D. A. · Kilkenny · M. F. · Godecke · E. · Cadilhac · D. A. · Kim · J. · Olaiya · M. T. · Rose · M. L. · Breitenstein · C. · Shrubsole · K. · OHalloran · R. · Hill · A. J. · Hersh · D. · Mainstone · K. · Mainstone · P. · Unsworth · C. A
Introduction

People with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum dataset was developed in partnership with people with lived experience of aphasia, clinicians and researchers to address this gap. It comprises sociodemographic characteristics, quality indicators, treatment descriptors and outcome measurement instruments. We present a protocol to pilot the MEASuRES minimum dataset in clinical practice, describe the factors that hinder or support implementation and determine meaningful thresholds of clinical change for core outcome measurement instruments.

Methods and analysis

This research aims to deliver a comprehensive quality assessment toolkit for poststroke aphasia services in four studies. A multicentre pilot study (study 1) will test the administration of the MEASuRES minimum dataset within five Australian health services. An embedded mixed-methods process evaluation (study 2) will evaluate the performance of the minimum dataset and explore its clinical applicability. A consensus study (study 3) will establish consumer-informed thresholds of meaningful change on core aphasia outcome constructs, which will then be used to establish minimal important change values for corresponding core outcome measurement instruments (study 4).

Ethics and dissemination

Studies 1 and 2 have been registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623001313628). Ethics approval has been obtained from the Royal Brisbane and Women’s Hospital (HREC/2023/MNHB/95293) and The University of Queensland (2022/HE001946 and 2023/HE001175). Study findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant stakeholders including healthcare providers, policy-makers, stroke and rehabilitation audit and clinical quality registry custodians, consumer support organisations, and individuals with aphasia and their families.

SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
Introduction

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

Methods and analysis

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov: NCT05533918 and NCT05533359.

Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia

Por: Longman · J. · Paul · C. · Cashmore · A. · Twyman · L. · Barnes · L. A. J. · Adams · C. · Bonevski · B. · Milat · A. · Passey · M. E.
Introduction

Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.

Methods and analysis

The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.

Ethics and dissemination

The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.

Trial registration number

Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

Cohort profile: BioMD-Y (biopsychosocial factors of major depression in youth) - a biobank study on the molecular genetics and environmental factors of depression in children and adolescents in Munich

Por: Scherff · A. D. · Feldmann · L. · Piechaczek · C. · Pehl · V. · Wagenbüchler · P. · Wermuth · I. · Ghotbi · N. · Allgaier · A.-K. · Freisleder · F. J. · Beins · E. C. · Forstner · A. J. · Nöthen · M. M. · Czamara · D. · Rex-Haffner · M. · Ising · M. · Binder · E. · Greimel · E. · Sch
Purpose

BioMD-Y is a comprehensive biobank study of children and adolescents with major depression (MD) and their healthy peers in Germany, collecting a host of both biological and psychosocial information from the participants and their parents with the aim of exploring genetic and environmental risk and protective factors for MD in children and adolescents.

Participants

Children and adolescents aged 8–18 years are recruited to either the clinical case group (MD, diagnosis of MD disorder) or the typically developing control group (absence of any psychiatric condition).

Findings to date

To date, four publications on both genetic and environmental risk and resilience factors (including FKBP5, glucocorticoid receptor activation, polygenic risk scores, psychosocial and sociodemographic risk and resilience factors) have been published based on the BioMD-Y sample.

Future plans

Data collection is currently scheduled to continue into 2026. Research questions will be further addressed using available measures.

Landscape of Metis health and wellness: protocol for a scoping review

Por: Boutros · H. M. · Koprich · S. · Simms · A. J. · Tsui · N. · Boyle · R.-A. · Harrison · J. · Riddell · M. · Sanftenberg · S. · Cripps · S. · Edwards · S. A. · Metis Nation of Ontario (MNO)
Introduction

In Canada, Métis people are one of three distinct Indigenous peoples whose rights are recognised and affirmed in Section 35 of the federal Constitution Act, 1982. In line with Métis people having a unique culture, history, language and way of life, a distinctions-based approach is critical to understand the current landscape of Métis-specific health. In this paper, we present a scoping review protocol to describe this research landscape in Canada led by the Métis Nation of Ontario (MNO).

Methods and analysis

This scoping review protocol is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews reporting guidelines and follows Arksey and O’Malley’s scoping review methodology. We will search electronic databases (Scopus, MEDLINE, Embase, Web of Science, CINAHL, APA PsycINFO, Anthropology Plus, Bibliography of Indigenous Peoples of North America, Canadian Business and Current Affairs, Indigenous Studies Portal, Informit Indigenous Collection, Collaborative Indigenous Garden, PubMed, ProQuest), grey literature sources and reference lists from selected papers. Two reviewers (HMB and SK) will double-blind screen all titles/abstracts and full-text studies for inclusion. Any health-related study or health report that includes a Métis-specific health, well-being or Métis social determinant of health outcome will be included. Relevant variables will be extracted following an iterative process whereby the data charting will be reviewed and updated.

Ethics and dissemination

Findings from this scoping review will be shared back through the MNO’s existing community-based communication channels. Traditional academic dissemination will also be pursued. Research ethics board approval is not required, since data are from peer-reviewed publications or publicly shared health reports and knowledge translation products.

Students perceptions and experiences of an online well-being programme: a phenomenological study protocol

Por: Escuadra · C. J. · Chiong Maya · A. · Nava · J. B. P. · Vergara · J. A. · Bea · T. C. · Javier · A. M. · Karamihan · F. · Padilla · D. P. · Reyes · A. J. · Samonte · J. · Serrano · S. I.
Background

The pandemic has ensued challenges across all sections of the human population such as livelihood and educational changes, which involve the abrupt shift to online learning, immensely affecting the students’ well-being. Negative health consequences of e-learning among students stem from the increased demand for new technological skills, productivity, information overload and restriction of students to spend time with their peers.

Objective

To explore the experiences of the students from the University of Santo Tomas—College of Rehabilitation Sciences (UST-CRS) who participated in the online well-being programme.

Methodology

A phenomenological design will be used to determine the participants’ perceptions and experiences. Purposive sampling will be used to recruit 8–10 undergraduate students from UST-CRS ages 18–22 years, who participated in the well-being programme, and completed the study’s quantitative counterpart. Semistructured, in-depth questions will be used to conduct a focus group discussion. The transcripts will be analysed using thematic analysis via the NVivo V.12 software.

Ethics and dissemination

The study protocol is approved by the UST-CRS Ethical Review Committee (Protocol Number: SI-2022–034 (V.4)). It will be implemented in accordance with the Declaration of Helsinki and the National Ethical Guidelines for Health and Health-Related Research, and Data Privacy Act. Findings will be published in accredited journals and presented in related scientific fora.

Registration ID

PHRR230214-005419; Philippine Health Research Registry.

NeuroMotion smartphone application for remote General Movements Assessment: a feasibility study in Nepal

Por: Kukka · A. J. · Sundelin · H. E. K. · Basnet · O. · Paudel · P. · Upadhyay Subedi · K. · Svensson · K. · Brown · N. · Litorp · H. · Gurung · R. · Bhattarai · P. · Wrammert · J. · KC · A.
Objectives

To evaluate the feasibility of using the NeuroMotion smartphone application for remote General Movements Assessment for screening infants for cerebral palsy in Kathmandu, Nepal.

Method

Thirty-one term-born infants at risk of cerebral palsy due to birth asphyxia or neonatal seizures were recruited for the follow-up at Paropakar Maternity and Women’s Hospital, 1 October 2021 to 7 January 2022. Parents filmed their children at home using the application at 3 months’ age and the videos were assessed for technical quality using a standardised form and for fidgety movements by Prechtl’s General Movements Assessment. The usability of the application was evaluated through a parental survey.

Results

Twenty families sent in altogether 46 videos out of which 35 had approved technical quality. Sixteen children had at least one video with approved technical quality. Three infants lacked fidgety movements. The level of agreement between assessors was acceptable (Krippendorf alpha 0.781). Parental answers to the usability survey were in general positive.

Interpretation

Engaging parents in screening of cerebral palsy with the help of a smartphone-aided remote General Movements Assessment is possible in the urban area of a South Asian lower middle-income country.

Non-communicable disease care in Sierra Leone: a mixed-methods study of the drivers and barriers to retention in care for hypertension

Por: Dibba · Y. · Kachimanga · C. · Gassimu · J. · Kulinkina · A. V. · Bukhman · G. · Gilbert · H. N. · Adler · A. J. · Mukherjee · J. S.
Objective

To retrospectively analyse routinely collected data on the drivers and barriers to retention in chronic care for patients with hypertension in the Kono District of Sierra Leone.

Design

Convergent mixed-methods study.

Setting

Koidu Government Hospital, a secondary-level hospital in Kono District.

Participants

We conducted a descriptive analysis of key variables for 1628 patients with hypertension attending the non-communicable disease (NCD) clinic between February 2018 and August 2019 and qualitative interviews with 21 patients and 7 staff to assess factors shaping patients’ retention in care at the clinic.

Outcomes

Three mutually exclusive outcomes were defined for the study period: adherence to the treatment protocol (attending >80% of scheduled visits); loss-to-follow-up (LTFU) (consecutive 6 months of missed appointments) and engaged in (but not fully adherent) with treatment (

Results

57% of patients were adherent, 20% were engaged in treatment and 22% were LTFU. At enrolment, in the unadjusted variables, patients with higher systolic and diastolic blood pressures had better adherence than those with lower blood pressures (OR 1.005, 95% CI 1.002 to 1.009, p=0.004 and OR 1.008, 95% CI 1.004 to 1.012, p

Conclusion

Free medications, high-quality services and health education may be effective ways of helping NCD patients stay engaged in care. Facility and socioeconomic factors can pose challenges to retention in care.

Adaptive coping strategies among individuals living with long-term chikungunya disease: a qualitative study in Curacao

Por: Doran · C. · Duits · A. J. · Gerstenbluth · I. · Tami · A. · Bailey · A.
Objective

Long-term chikungunya disease is characterised by persistent rheumatic symptoms following chikungunya virus infection. As there is no specific treatment available, affected individuals need strategies to adapt. However, research on these is scarce. This study aimed to explore which adaptive coping strategies are employed to manage persistent rheumatic symptoms in daily life.

Setting

The study was conducted in Curacao.

Design and participants

An explorative qualitative study was conducted between September and October 2020, among a purposive sample of adults, 19 women and 4 men affected by long-term chikungunya disease. In-depth interviews were semi-structured and transcribed verbatim. The data were analysed using inductive thematic analysis.

Results

The disease duration for all participants ranged between 68 and 74 months (6 years). In narrating their experiences of coping with long-term chikungunya disease, four themes were identified: (1) learning to live with the disease; (2) resilience for dealing with pain; (3) maintaining positive self-image and attitude; and (4) coping through spirituality.

Conclusion

To live with long-term chikungunya disease with dignity in spite of physical pain and discomfort, participants tried to retain a sense of control of oneself and one’s lives, to not let the disease take over, focusing on the positive in their lives, and finding strength and remain hopeful. Interventions such as cognitive–behavioural therapy and mindfulness exercises may be effective in strengthening or regain affected individual’s sense of competence and control by fostering adaptive coping skills and resilience. Subsequently, these interventions may improve health-related quality of life when rheumatic symptoms persist following chikungunya virus infection.

Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Por: Brittain · G. · Petrie · J. · Duffy · K. E. M. · Glover · R. · Hullock · K. · Papaioannou · D. · Roldan · E. · Beecher · C. · Bursnall · M. · Ciccarelli · O. · Coles · A. J. · Cooper · C. · Giovannoni · G. · Gabriel · I. · Kazmi · M. · Kyriakou · C. · Nicholas · R. · Paling · D. · Peniket
Introduction

Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis

StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination

The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number

ISRCTN88667898.

Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN

Por: Greene · L. · Barber · R. · Bingham · A. · Connors · J. · Conroy · S. · Elkhafer · K. · Fox · C. · Goodwin · V. · Gordon · A. · Hall · A. J. · Harwood · R. H. · Hulme · C. · Jackson · T. · Litherland · R. · Morgan-Trimmer · S. · Pankiewicz · S. · Parry · S. W. · Sharma · A. · Ukoumunne · O.
Introduction

Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia.

Method and analysis

This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes.

Ethics and dissemination

The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals.

Trial registration number

ISRCTN16413728.

Priority populations experiences of isolation, quarantine and distancing for COVID-19: protocol for a longitudinal cohort study (Optimise Study)

Por: Pedrana · A. · Bowring · A. · Heath · K. · Thomas · A. J. · Wilkinson · A. · Fletcher-Lartey · S. · Saich · F. · Munari · S. · Oliver · J. · Merner · B. · Altermatt · A. · Nguyen · T. · Nguyen · L. · Young · K. · Kerr · P. · Osborne · D. · Kwong · E. J. L. · Corona · M. V. · Ke · T. · Zhang
Introduction

Longitudinal studies can provide timely and accurate information to evaluate and inform COVID-19 control and mitigation strategies and future pandemic preparedness. The Optimise Study is a multidisciplinary research platform established in the Australian state of Victoria in September 2020 to collect epidemiological, social, psychological and behavioural data from priority populations. It aims to understand changing public attitudes, behaviours and experiences of COVID-19 and inform epidemic modelling and support responsive government policy.

Methods and analysis

This protocol paper describes the data collection procedures for the Optimise Study, an ongoing longitudinal cohort of ~1000 Victorian adults and their social networks. Participants are recruited using snowball sampling with a set of seeds and two waves of snowball recruitment. Seeds are purposively selected from priority groups, including recent COVID-19 cases and close contacts and people at heightened risk of infection and/or adverse outcomes of COVID-19 infection and/or public health measures. Participants complete a schedule of monthly quantitative surveys and daily diaries for up to 24 months, plus additional surveys annually for up to 48 months. Cohort participants are recruited for qualitative interviews at key time points to enable in-depth exploration of people’s lived experiences. Separately, community representatives are invited to participate in community engagement groups, which review and interpret research findings to inform policy and practice recommendations.

Ethics and dissemination

The Optimise longitudinal cohort and qualitative interviews are approved by the Alfred Hospital Human Research Ethics Committee (# 333/20). The Optimise Study CEG is approved by the La Trobe University Human Ethics Committee (# HEC20532). All participants provide informed verbal consent to enter the cohort, with additional consent provided prior to any of the sub studies. Study findings will be disseminated through public website (https://optimisecovid.com.au/study-findings/) and through peer-reviewed publications.

Trial registration number

NCT05323799.

Protocol for the challenge non-typhoidal Salmonella (CHANTS) study: a first-in-human, in-patient, double-blind, randomised, safety and dose-escalation controlled human infection model in the UK

Por: Smith · C. · Smith · E. · Rydlova · A. · Varro · R. · Hinton · J. C. D. · Gordon · M. A. · Choy · R. K. M. · Liu · X. · Pollard · A. J. · Chiu · C. · Cooke · G. S. · Gibani · M. M.
Introduction

Invasive non-typhoidal Salmonella (iNTS) serovars are a major cause of community-acquired bloodstream infections in sub-Saharan Africa (SSA). In this setting, Salmonella enterica serovar Typhimurium accounts for two-thirds of infections and is associated with an estimated case fatality rate of 15%–20%. Several iNTS vaccine candidates are in early-stage assessment which—if found effective—would provide a valuable public health tool to reduce iNTS disease burden. The CHANTS study aims to develop a first-in-human Salmonella Typhimurium controlled human infection model, which can act as a platform for future vaccine evaluation, in addition to providing novel insights into iNTS disease pathogenesis.

Methods and analysis

This double-blind, safety and dose-escalation study will randomise 40–80 healthy UK participants aged 18–50 to receive oral challenge with one of two strains of S. Typhimurium belonging to the ST19 (strain 4/74) or ST313 (strain D23580) lineages. 4/74 is a global strain often associated with diarrhoeal illness predominantly in high-income settings, while D23580 is an archetypal strain representing invasive disease-causing isolates found in SSA. The primary objective is to determine the minimum infectious dose (colony-forming unit) required for 60%–75% of participants to develop clinical or microbiological features of systemic salmonellosis. Secondary endpoints are to describe and compare the clinical, microbiological and immunological responses following challenge. Dose escalation or de-escalation will be undertaken by continual-reassessment methodology and limited within prespecified safety thresholds. Exploratory objectives are to describe mechanisms of iNTS virulence, identify putative immune correlates of protection and describe host–pathogen interactions in response to infection.

Ethics and dissemination

Ethical approval has been obtained from the NHS Health Research Authority (London—Fulham Research Ethics Committee 21/PR/0051; IRAS Project ID 301659). The study findings will be disseminated in international peer-reviewed journals and presented at national/international stakeholder meetings. Study outcome summaries will be provided to both funders and participants.

Trial registration number

NCT05870150

Enhancing emotion regulation with an in situ socially assistive robot among LGBTQ+ youth with self-harm ideation: protocol for a randomised controlled trial

Por: Williams · A. J. · Cleare · S. · Borschmann · R. · Tench · C. R. · Gross · J. · Hollis · C. · Chapman-Nisar · A. · Naeche · N. · Townsend · E. · Slovak · P. · On behalf of Digital Youth · Creswell · Fonagy · Arseneault · Lloyd · Mendes · Holter · Jirotka · Lazar · Patalay · Kelly · Ka
Introduction

Purrble, a socially assistive robot, was codesigned with children to support in situ emotion regulation. Preliminary evidence has found that LGBTQ+ youth are receptive to Purrble and find it to be an acceptable intervention to assist with emotion dysregulation and their experiences of self-harm. The present study is designed to evaluate the impact of access to Purrble among LGBTQ+ youth who have self-harmful thoughts, when compared with waitlist controls.

Methods and analysis

The study is a single-blind, randomised control trial comparing access to the Purrble robot with waitlist control. A total of 168 LGBTQ+ youth aged 16–25 years with current self-harmful ideation will be recruited, all based within the UK. The primary outcome is emotion dysregulation (Difficulties with Emotion Regulation Scale-8) measured weekly across a 13-week period, including three pre-deployment timepoints. Secondary outcomes include self-harm (Self-Harm Questionnaire), anxiety (Generalised Anxiety Disorder-7) and depression (Patient Health Questionnaire-9). We will conduct analyses using linear mixed models to assess primary and secondary hypotheses. Intervention participants will have unlimited access to Purrble over the deployment period, which can be used as much or as little as they like. After all assessments, control participants will receive their Purrble, with all participants keeping the robot after the end of the study. After the study has ended, a subset of participants will be invited to participate in semistructured interviews to explore engagement and appropriation of Purrble, considering the young people’s own views of Purrble as an intervention device.

Ethics and dissemination

Ethical approval was received from King’s College London (RESCM-22/23-34570). Findings will be disseminated in peer review open access journals and at academic conferences.

Trial registration number

NCT06025942.

The economic burden associated with unmet surgical needs in Liberia: a retrospective macroeconomic analysis based on a nationwide enumeration of surgical procedures

Por: Adde · H. A. · Oghogho · M. D. · van Duinen · A. J. · Grimes · C. E. · Hampaye · T. C. · Quaife · M. · Bolkan · H. A.
Objectives

The economic consequences of untreated surgical disease are potentially large. The aim of this study was to estimate the economic burden associated with unmet surgical needs in Liberia.

Design

A nationwide enumeration of surgical procedures and providers was conducted in Liberia in 2018. We estimated the number of disability-adjusted life years (DALYs) saved by operative activities and converted these into economic losses averted using gross national income per capita and value of a statistical life (VSL) approaches. The total, the met and the unmet needs for surgery were determined, and economic losses caused by unmet surgical needs were estimated. Finally, we valued the economic losses avoided by various surgical provider groups.

Results

A total of 55 890 DALYs were averted by surgical activities in 2018; these activities prevented an economic loss of between US$35 and US$141 million. About half of these values were generated by the non-specialist physician workforce. Furthermore, a non-specialist physician working a full-time position for 1 year prevented an economic loss of US$717 069 using the VSL approach, while a specialist resident and a certified specialist saved US$726 606 and US$698 877, respectively. The burden of unmet surgical need was associated with productivity losses of between US$388 million and US$1.6 billion; these losses equate to 11% and 46% of the annual gross domestic product for Liberia.

Conclusion

The economic burden of untreated surgical disease is large in Liberia. There is a need to strengthen the surgical system to reduce ongoing economic losses; a framework where specialist and non-specialist physicians collaborate may result in better economic return than a narrower focus on training specialists alone.

MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study

Por: Heiden · E. · Longstaff · J. · Chauhan · M. J. A. · DeVos · R. · Lanning · E. · Neville · D. · Jones · T. L. · Begum · S. · Amos · M. · Mottershaw · M. · Micklam · J. · Holdsworth · B. · Rupani · H. · Brown · T. · Chauhan · A. J. · Mission ABC Collaborators · Baghammar · Bannell · Domin
Objectives

The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics.

Design

This study used a prospective, longitudinal, participatory action research approach.

Setting

The study was conducted in primary care practices across Hampshire, UK.

Participants

Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included.

Interventions

Participants received care through the multidisciplinary, specialist-led MABC clinics.

Primary and secondary outcome measures

Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness.

Results

A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p

Conclusions

Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings.

Trial registration number

NCT03096509.

Implementation of a Scalable Online Weight Management Programme in Clinical Settings: Protocol for the PROPS 2.0 Programme (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0)

Por: Cho · J. · Noonan · S. H. · Fay · R. · Apovian · C. M. · McCarthy · A. C. · Blood · A. J. · Samal · L. · Fisher · N. · Orav · J. E. · Plutzky · J. · Block · J. P. · Bates · D. W. · Rozenblum · R. · Tucci · M. · McPartlin · M. · Gordon · W. J. · McManus · K. D. · Morrison-Deutsch · C. · Sci
Introduction

There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers.

Methods and analysis

We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women’s Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25–29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation.

Ethics and dissemination

The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future.

Trial registration number

NCT0555925.

Self-reported condom use among Washington State residents prior to and during the COVID-19 pandemic: a cross-sectional analysis of BRFSS data

Por: Jewell · M. · Jampel · S. M. · Casagrande · M. G. · Asbjörnsdottir · K. · Littman · A. J.
Objectives

COVID-19 significantly impacted healthcare access and sexual behaviour, but little is known about how COVID-19 affected condom use. This study aimed to investigate whether self-reported condom use and sex in Washington State changed during pandemic restrictions compared with prepandemic.

Design

Cross-sectional survey data from the Behavioral Risk Factor Surveillance System.

Setting

Washington State.

Participants

11 684 participants aged 18–65.

Primary and secondary outcome measures

The primary outcome was changes in the prevalence of condom use by time of interview pre-COVID-19, before the Washington State lockdown (1 January 2019 to 23 March 2020, n=7708) and during COVID-19, after the first state lockdown (24 March 2020 to 31 December 2020, n=3976). The secondary outcome was changes in the prevalence of reported sex during the same periods. We assessed whether associations differed by rurality and HIV risk behaviour.

Results

Condom use was similar during COVID-19 (37.3%) compared with pre-COVID-19 (37.8%) (adjusted prevalence ratio (PR): 0.98, 95% CI 0.89, 1.01). Associations did not differ by rurality or HIV risk behaviour. Compared with pre-COVID-19 (83.0%), a smaller proportion of respondents reported having sex in the last 12 months during COVID-19 (80.5%), a relative decrease of 3% (PR: 0.97, 95% CI 0.96, 0.99; p

Conclusions

The prevalence of reported sex declined during COVID-19, but condom use remained steady in Washington. As our reproductive health system faces increased challenges, these results may inform future sexual health services.

A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial

Por: Cross · A. J. · Geethadevi · G. M. · Magin · P. · Baker · A. L. · Bonevski · B. · Godbee · K. · Ward · S. A. · Mahal · A. · Versace · V. · Bell · J. S. · Mc Namara · K. · O'Reilly · S. L. · Thomas · D. · Manias · E. · Anstey · K. J. · Varnfield · M. · Jayasena · R. · Elliott · R. A. · Lee
Introduction

Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting.

Methods and analysis

General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45–65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia.

Ethics and dissemination

Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time.

Trial registration number

ACTRN12621001168842.

The Oxford Needle Experience (ONE) scale: a UK-based and US-based online mixed-methods psychometric development and validation study of an instrument to assess needle fear, attitudes and expectations in the general public

Por: Kantor · J. · Vanderslott · S. · Morrison · M. · Pollard · A. J. · Carlisle · R. C.
Objectives

To develop and validate the Oxford Needle Experience (ONE) scale, an instrument to assess needle fear, attitudes and expectations in the general population.

Design

Cross-sectional validation study.

Setting

Internet-based with participants in the UK and USA.

Participants

UK and US representative samples stratified by age, sex, and ethnicity using the Prolific Academic platform.

Main outcome measures

Exploratory factor analysis with categorical variables and a polychoric correlation matrix followed by promax oblique rotation on the UK sample for the ONE scale. Confirmatory factor analysis (CFA) with a Satorra-Bentler scaled test statistic evaluating the root mean squared error of approximation (RMSEA), standardised root mean squared residual (SRMR) and comparative fit index (CFI) on the US sample. Reliability as internal consistency using McDonald’s omega. Convergent validity using the Pearson correlation coefficient. Predictive and discriminant validity using logistic regression ORs of association (OR).

Results

The population included 1000 respondents, 500 in the UK and 500 in the USA. Minimum average partial correlation and a scree plot suggested four factors should be retained: injection hesitancy, blood-related hesitancy, recalled negative experiences and perceived benefits, yielding a 19-question scale. On CFA, the RMSEA was 0.070 (90% CI, 0.064 to 0.077), SRMR 0.053 and CFI 0.925. McDonald’s omega was 0.92 and 0.93 in the UK and US samples, respectively. Convergent validity with the four-item Oxford Coronavirus Explanations, Attitudes and Narratives Survey (OCEANS) needle fear scale demonstrated a strong correlation (r=0.83). Predictive validity with a single-question COVID-19 vaccination status question demonstrated a strong association, OR (95% CI) 0.97 (0.96 to 0.98), p

Conclusions

The ONE scale is a reliable and valid multidimensional scale that may be useful in predicting vaccine hesitancy, designing public health interventions to improve vaccine uptake and exploring alternatives to needles for medical procedures.

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