Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.
A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.
This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.
While almost half of older adults admitted to hospital are prescribed potentially inappropriate medicines, less than 1% have a medicine proactively deprescribed during admission in the UK. The CompreHensive geriAtRician-led MEdication Review (CHARMER) intervention is designed to address geriatricians’ and pharmacists’ barriers and enablers to deprescribing. The CHARMER definitive trial will evaluate effectiveness, cost-effectiveness and safety.
A stepped-wedge cluster randomised controlled trial will be conducted in 20 hospitals in England, with four hospitals in reserve. All hospitals will collect baseline data. Every 3 months, five hospitals will be randomised to receive the intervention. The intervention, implemented by a local project manager, comprises a hospital action plan to set deprescribing as an organisational goal; workshops for pharmacists and geriatricians to change beliefs about deprescribing; weekly briefings between geriatricians and pharmacists to discuss opportunities for deprescribing; benchmarking reports to compare deprescribing performance across participating hospitals. With an average of 200 patients admitted and discharged during each step, the study will have 89.5% power at 5% significance level and intra-class correlation coefficient of 0.05 to detect a 3% difference in 90-day re-admission rate from 16.7% versus 13.7%. Anonymised routinely collected data, including readmissions, will be obtained for all patients admitted during the study period. Enhanced data collection periods of 1 month during control and intervention periods will be used to recruit patients and data for secondary outcomes and process evaluation.
A stepped-wedge design enabled a smaller number of hospitals and patients to be included than a traditional cluster-randomised design. The complexity of intervention implementation necessitated a project manager in addition to the principal investigator responsible for trial conduct. Using routinely collected data for the primary outcome measure should ensure that the trial has sufficient power on completion. Planned enhanced data collection for short periods of time improves trial efficiency.
To explore the feasibility and acceptability of acoustic monitoring and real-time recommendations for stress detection and management (i.e., smarthealth intervention).
This qualitative study used a framework of acceptability for healthcare interventions.
From January 2021 to December 2023 in the U.S.A., we interviewed 10 family caregivers who had completed the 4-month smarthealth intervention. The caregivers shared their user experiences and feedback on the system's feasibility and acceptability. Data were analysed using abductive thematic analysis, incorporating the framework of acceptability for healthcare interventions and the collected data.
Seven themes and 19 categories emerged: attitudes, burden, ethicality, intervention adherence, intervention coherence, perceived effectiveness and suggestions. Feedback on the smarthealth intervention was mixed. Some found it beneficial, citing accuracy, ease of use and increased awareness. However, others felt burdened during its use, primarily due to time constraints.
The smarthealth intervention can potentially improve caregivers' awareness of themselves and caregiving situations.
Future directions should involve adapting the smarthealth intervention to consider diverse caregiving scenarios and incorporating a larger sample of caregivers.
This is the first study to offer a voice detection system and real-time stress management recommendations to caregivers of people living with dementia. An individualised approach should be considered to improve the system's effectiveness. This includes providing personalised intervention components, considering caregivers' time and establishing a user-friendly system with high accessibility. The findings can be a cornerstone for smarthealth interventions influencing dementia caregivers' self-care and emotional regulation.
Standards for Reporting Qualitative Research.
Members of the public and service users from a memory clinic and social media platforms contributed to the study by reviewing recruitment materials.
Trial Registration: This trial's study protocol was registered with ClinicalTrials.gov (ID No. NCT04536701) on 3 September 2020 (https://classic.clinicaltrials.gov/ct2/show/NCT04536701)
To examine factors, including symptom burden profiles and self-care, associated with quality of life among individuals with heart failure and multimorbidity.
A cross-sectional design.
353 adults aged 50 years or older with heart failure and at least one additional chronic condition were recruited from a university-affiliated hospital. Three symptom burden groups were identified (low, moderate, and high) through latent profile analysis of the Edmonton Symptom Assessment Scale scores. The Heart Failure Self-care Index and EuroQoL-5D-5L measured self-care behaviours and quality of life. This study examined group differences and associations overall and stratified by symptom burden groups via multivariable linear regression.
A higher disease burden and the high symptom burden group compared to the low symptom burden group were associated with lower quality of life. Self-care maintenance was positively associated with a higher quality of life, but not in the high-burden group. Among individual symptoms, pain and depression were associated with lower quality of life. In the high-burden group, older age was positively associated with quality of life. Higher symptom burden groups included a greater proportion of women and middle-aged adults.
Symptom burden and self-care maintenance show significant associations with quality of life in multimorbidity. Symptom burden profiles identified through latent profile analysis may complement conventional approaches by targeting high-risk individuals, such as middle-aged individuals and women with high symptom burden, for follow-up and integrated multimorbidity management.
For healthcare providers, including nurses, these findings underscore the importance of holistic, symptom-based care approaches combined with routine support for self-care maintenance. Adopting a life-course approach, through early identification and management of high-risk individuals, may help promote aging in place with a better quality of life for those with heart failure and multimorbidity.
STROBE checklist.
No patient or public contribution.
Compression therapy is the cornerstone, first-line effective evidence-based treatment for healing and managing venous leg ulcers. However, compression therapy is inconsistently applied in hospitals. This paper explores the experiences of a diverse group of clinicians and senior managers applying compression therapy in hospitals across the United Kingdom. A semi-structured qualitative interview study was conducted with 19 participants, drawn from a larger study, who confirmed that their respective hospitals apply compression therapy to inpatients with venous leg ulcers. The interviews were analysed using reflexive thematic analysis. Analysis generated four key themes: Patients ‘slip through the net’, Prioritisation in Hospital Care, A ‘blind Spot’ within Healthcare System and Motivation to Deliver Care. Patients ‘slip through the net’ refers to inpatients with venous leg ulcers face unequal access to compression therapy both within and between hospitals. Prioritisation in Hospital Care indicates how certain diseases are given greater emphasis within healthcare systems. A ‘blind Spot’ in Healthcare System described failing to implement compression therapy has created a critical underlying ‘blind spot’ within the NHS healthcare systems. Motivation to Deliver Care refers to a deep commitment to providing compression therapy, driven by clinicians' inherent dedication and ethical obligation towards improving patient quality of care. The study identified key challenges influencing the application of compression therapy in acute hospitals despite its routine use. These include the lottery of care, systemic inequities, unclear ownership, interprofessional disputes and organisational priorities. It also demonstrated the significant role of passion, motivation and moral responsibility encouraging clinicians to implement compression therapy despite these systemic barriers.
Statins are a cornerstone of cardiovascular disease prevention yet remain underused among eligible patients. Clinical decision support systems embedded in electronic health records (EHRs) are commonly used to encourage guideline-concordant prescribing. Interruptive reminders (eg, pop-ups) may be effective but interfere with clinical workflows and contribute to alert fatigue. Non-interruptive alerts are less intrusive, but their effectiveness remains unclear. The Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC) trial is designed to evaluate the comparative effectiveness of interruptive and non-interruptive reminders on statin-prescribing rates.
INIRSHA-PC is a single-centre, pragmatic, three-arm, parallel-group randomised controlled trial embedded in the EHR at Vanderbilt University Medical Center. The trial will enrol adults aged 18–74 seen in primary care who are eligible for, but not currently prescribed, statin therapy. The planned sample size is 3000 patients (1000 per arm). Enrolled patients will be randomised 1:1:1 to (1) interruptive reminder, (2) non-interruptive reminder or (3) no reminder (usual care). The primary outcome is statin prescription within 24 hours of enrolment. Secondary outcomes are statin prescribing within 12 months and low-density lipoprotein cholesterol levels measured between 30 days and 12 months after enrolment. Enrolment began on 14 August 2024. The study is expected to be completed on 19 November 2025.
The trial has been approved by the Vanderbilt University Medical Center Institutional Review Board with waiver of patient informed consent (IRB number: 240419). Results will be disseminated through peer-reviewed publication and presentation at scientific conferences.
Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO2) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO2 90%–96%) compared with usual care.
The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO2 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO22 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.
The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.
Medication non-adherence in older adults with long-term conditions contributes to significant morbidity, mortality and healthcare costs. While adherence support tools exist, many interventions fail to reach those most at risk. Automated medication dispensers (AMDs) show promise in improving adherence and health outcomes, but their integration into routine community pharmacy practice remains underexplored. This study aims to assess the effectiveness of an AMD intervention with SMS reminders in enhancing medication adherence among older adults and to evaluate how this technology can be integrated into community pharmacy workflows.
This randomised controlled trial involves 144 participants recruited from eight community pharmacies who will be randomised to receive either the AMD intervention or usual care. Primary outcomes include medication adherence, measured through pharmacy records and self-report at baseline, 3 and 6 months. Secondary outcomes include Morisky Medication Adherence Scale, health-related quality of life (SF-12), and healthcare resource use. A nested mixed methods process evaluation will explore uptake, acceptability and implementation.
The study protocol has been approved by the University of Bedfordshire Institute for Health Research Ethics Committee (IHREC1039), the NHS and the local authority Research Governance and Research Ethics Committee (NHS REC reference: 25/EE/0026). The findings will be disseminated via a final report, peer-reviewed journal publications and presentations at relevant conferences.
The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.
ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.
Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.
by Elizabeth Baguley, Madelyn Knaub, Jessica VanDyke, Gideon Hirschfield, Mark G. Swain, Gail Wright, Deirdre McCaughey, Abdel Aziz Shaheen
Pandemic restrictions impacted healthcare, particularly during the first year. We evaluated the impact of the pandemic on quality of life and clinical care among patients with primary biliary cholangitis (PBC). This mixed-methods study administered quality of life surveys (Fear of COVID-19 Scale [FCV-19S], EuroQol 5-dimension 3-level [EQ-5D-3L], 29-item Patient-Reported Outcomes Measurement Instrument Survey [PROMIS-29]) and a PBC Care Delivery questionnaire to 348 Canadian PBC patients, followed by two focus groups with patients (n = 14) and stakeholders (n = 3). Quality of life scores were compared among sub-groups (i.e., care delays and pandemic appointment type) and with various reference populations. Most participants were female (94.0%) and Caucasian (88.2%), with a median age of 63.0 years (IQR: 55.9–71.2). During the pandemic, 75.8% had the majority (≥ 50%) of their hepatologist appointments virtually, but only 22.4% preferred to continue with virtual care post-pandemic. Participants with care delays had worse scores on the FCV-19S (p = 0.014), EQ-5D-3L (p = 0.009), and PROMIS-29 (i.e., fatigue, anxiety, sleep disturbance, ability to participate in social roles and activities, p pTo identify stakeholder perceived challenges and facilitators for implementing a clean fuel and clean stove intervention to reduce household air pollution and hypertension in Lagos, Nigeria.
Qualitative study guided by the Exploration and Preparation phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, using focus group discussions and in-depth semi-structured interviews with inductive and deductive thematic analysis.
Peri-urban communities across the five administrative divisions of Lagos State, Nigeria.
128 stakeholders from 32 communities, including community, religious, market and youth leaders, primary healthcare staff, and household decision makers. Approximately half were female.
This was a pre-implementation needs assessment that included demonstrations of the clean stove and fuel.
Thematic domains describing barriers and enablers to adoption and implementation, mapped to EPIS inner, outer, and bridging factors.
Stakeholders reported barriers that included stove stacking, upfront stove cost, concerns about long-term fuel price and availability, equipment durability and maintenance, safety, mistrust of new technology, and uncertainty about stove performance for dishes requiring high heat and long cooking times. Reported facilitators included payment flexibility and subsidies, opportunities to test the stove, perceived benefits of cleaner and faster cooking with less soot, endorsement by community leaders, and interest in local retail and distribution to improve access.
Implementation planning for clean fuel and clean stove programmes should address affordability, reliable fuel supply chains, durability and service, culturally relevant cooking needs, and trust building through community leadership. These findings inform adaptation strategies for scale-up in similar low-resource settings.
Self-harm and suicidal thoughts and behaviours are a significant public health concern. While individual risk factors have been widely studied, the role of social determinants in shaping these outcomes remains underexplored within policy contexts. This Rapid Realist Policy Review aims to investigate how macro level (national) policies in England address the impact of social determinants of self-harm and suicidal thoughts and behaviours.
This Rapid Realist Policy Review adapts the rapid realist review method to place policy documents at the centre of analysis. It will identify and extract relevant English policy documents (2002–2023) related to suicide, self-harm and mental health, using government and archival databases.
Policy documents will be mapped and categorised based on their pertinence to proximal and distal outcomes and social determinants. A predefined template will be used to extract and appraise data based on relevance, richness and rigour. Context-mechanism-outcome configurations will be developed, validated by content experts and synthesised into an initial programme theory. The review will follow Realist And Meta-narrative Evidence Syntheses: Evolving Standards for realist syntheses.
This review does not require ethical approval due to the use of secondary sources. Findings will be disseminated via an open-access, peer-reviewed journal article. A summary of key recommendations will be produced with the expert stakeholder group to inform policy and practice.
CRD420251057759.
To report how person-centred care principles are applied to care planning and to explore the contextual factors affecting their implementation in older adult care homes in England.
A combined framework analysis and quantitative content analysis study.
Using a semi-structured questionnaire, we interviewed 22 care home managers in England, exploring topics around care planning processes. Audio recordings were transcribed verbatim. Transcripts were analysed through a combined framework approach and content analysis.
Most care home managers discussed person-centred care planning in terms of understanding residents' values and preferences and their engagement in decision-making. Factors facilitating person-centred planning implementation included accessible planning tools, supportive care home leadership, effective communication and collaborative partnerships. Inhibiting factors included regulatory and care practice misalignment, time constraints and adverse staffing conditions.
Differences between care home practitioners' understanding and practice of person-centred care planning require further examination to improve understanding of the sector's complexity and to develop suitable care planning instruments.
Findings demonstrate a need for improved staff access to specialised person-centred care training and an opportunity for care home nursing practitioners to lead the co-development of digital person-centred care planning tools that reflect the reality of long-term care settings.
Identifying factors influencing the implementation of holistic approaches to care planning makes clear the need for modernising long-term care policy and practice to adapt to the contemporary challenges of the care home sector.
Study reporting was guided by the Standards for Reporting Qualitative Research.
Two public involvement advisors with lived experience of caring for a relative living in a care home contributed to the development of the interview guide, advised on care home engagement, guided the interpretation of the findings and commented on the drafted manuscript.
The National Health Service Cervical Screening Programme (NHSCSP) currently involves a healthcare professional collecting a cervical sample in a healthcare setting. This method of screening has barriers associated with access to screening appointments and the poor acceptability of the speculum examination. Primary screening through HPV testing has led to the development of self-sampling screening methods including vaginal and urine self-sampling, with many UK studies comparing these screening methods with the current NHSCSP. It is not known what features of self-sampling influence individuals’ preferences and cervical screening uptake. To understand these preferences, we plan to undertake a discrete choice experiment (DCE). This protocol aims to describe the steps taken to design the DCE and the proposed approach to fielding the DCE to identify preferences for different sampling approaches in cervical screening.
An online survey comprising a DCE was designed to understand preferences of individuals for self-sampling methods within the NHSCSP. Attributes and levels for the DCE were generated through an iterative process including a literature review of qualitative studies about self-sampling cervical screening methods, input from cervical screening clinical experts and a patient and public involvement group (n=6). A D-efficient design was used to create choice sets for the DCE survey. Regression-based analysis will be used to estimate the impact of each attribute and level on individual choices.
This study has been approved by The University of Manchester Proportionate Research Ethics Committee (2024-20767-37669). The results of the DCE will be submitted for publication in a relevant peer review journal and the results will be presented at national and international conferences.
There are no data associated with this protocol. The data produced by this study and analysis scripts will be made available in a public repository following publication of the study.
Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.
Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.
This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).
To identify whether nurse practitioners (NPs) in New Zealand (NZ) have the organisational opportunities to make decisions related to performing their role.
A cross-sectional study of self-reported decision-making, social support, psychosocial demands and identification with role in a representative population of NPs employed in a range of practice settings in NZ.
This study utilised the internationally validated Job Content Questionnaire. Reliability and construct validity were assessed using co-efficient α and confirmatory factor analysis. Linear regression analyses were conducted to understand the strength and direction of the relationships between the constructs.
All scales demonstrated acceptable levels of internal reliability. Factor analysis supported a five-factor model, with decision latitude, psychological job demands, co-worker support, supervisor support and job insecurity as the main factors fitting the theoretical model. Regression models suggested that NPs (n = 169) have more control over their decision-making when supported by their colleagues rather than supervisors. NPs perceive improved relationships with healthcare consumers if they feel an increase in support from their colleagues; this relationship is mediated by the freedom to make decisions. NPs in rural settings had more job security when they felt valued and appreciated at work.
The presence of collegial support significantly influences the freedom and autonomy of NPs in making decisions. Workforce policy, the organisation of practice and vocational training may be effective ways of helping NPs expand access to healthcare services.
Collegial and supervisory support are critical for NPs to work to their full scope. A funded, first-year-in-practice vocational training program designed to support role transition, foster collegial support and build a community of practice for newly qualified NPs.
For the first time, nurse practitioner decision-making and autonomy determinants have been described in NZ. These findings should be considered within the context of international evidence and in global nursing workforce policies that seek to create opportunities for NPs to work to the limit of their scope.
The authors have adhered to relevant EQUATOR guidelines—STROBE checklist.
No patient or public contribution.
In the last 60 years, newborn bloodspot screening (NBS) has expanded as a public health intervention from a single severe childhood genetic disease (SCGD) to up to as many as 80 SCGD and testing of ~40 million newborns/year worldwide. However, the gap between current NBS and its potential to increase the efficiency, effectiveness and global equity of healthcare delivery for SCGD is large and rapidly growing. There are now effective therapeutic interventions—drugs, diets, devices and surgeries—for up to 2000 SCGD. Since almost all SCGD can be identified by bloodspot genome sequencing, it has been a longstanding goal to supplement current NBS with genome sequencing-based NBS (gNBS) for all eligible SCGD. We recently described a novel gNBS platform (named Begin Newborn Genome Sequencing (BeginNGS)) with the potential to overcome several major challenges to gNBS (cost, scalability, false positives and an unprepared healthcare workforce). A pilot clinical trial of BeginNGS for 412 SCGD in a level IV neonatal intensive care unit (NICU) had a true positive rate of 4.2%, sensitivity of 83%, positive predictive value of 100% and clinical utility rate of 4.2%, indicating readiness of the platform for use in a powered, multicentre study.
The BeginNGS study is a single group, international, multicentre, adaptive clinical trial to compare utility, acceptability, feasibility and cost-effectiveness of BeginNGS gNBS (experimental intervention) with standard NBS (control). A minimum of 10 000 neonates (aged 50 000 US children per year.
This study was approved by the WCG Clinical institutional review board on 14 February 2024, and the most recent amendment approved on 7 October 2025 (approval number 20235517). Study findings will be shared through research consortium workshops, national and international conferences, community presentations and peer-reviewed journals.
Adolescence is a key period of development for mental health; however, little is known about how (cumulative) daily life experiences impact long-term mental health development in this period, and vice versa. ‘Mental health in the moment’ (MHIM) is an accelerated cohort measurement burst study designed to illuminate these links.
The current protocol describes the rationale and design for MHIM, which aims to recruit and follow up approximately 500 adolescents across five age cohorts (in secondary school years S1–S5, aged 11–16 at baseline) and follow them over a 5-year data collection period. Data collection will include online surveys and ecological momentary assessments bursts every 6 months, annual caregiver surveys, the collection of stress biomarker data at three key measurement points and continuous radar-based sleep measurement for a subsample of participants. The study is informed by a young person advisory group input throughout its lifecycle. Data will be analysed using techniques such as dynamic structural equation modelling. The study can provide insights into mental health development from a multitimeframe developmental perspective, including insights into ‘daily life’ intervention targets for improving adolescent mental health.
The study received ethical approval from the philosophy, psychology and language science ethics committee at the University of Edinburgh (404-2425/3) and the findings will be published in a series of peer-reviewed publications.
Poor indoor air quality and heat, individually and together, cause serious health impacts on children. Thus, there is a growing interest in creating school classroom environments that reduce health risks associated with these indoor environmental conditions. However, it is unclear if the existing evidence provides effective, practical and reliable interventions or strategies that can be implemented in classrooms. Additionally, the pertinence of these strategies for low-income communities needs to be elucidated. This scoping review will, therefore, document the findings of studies that have analysed interventions and strategies to improve school classroom conditions by reducing heat exposure and poor air quality to protect the health and well-being of children. This scoping review will consider: (1) interventions or adaptation strategies that have reduced heat exposure in classrooms; (2) interventions or adaptation strategies that have reduced air pollutant exposure in classrooms; (3) classroom building modifications that reduce exposure to heat and poor air quality and (4) improved health outcomes in children due to reduced heat and air pollutants. Studies that report reductions in heat or air pollutant exposure and show significant improvements in learner health outcomes will be prioritised for deeper analysis and considered particularly valuable for informing evidence-based recommendations.
We will explore original and review articles from both high-income and low-income settings that evaluate interventions and strategies for preventing or reducing heat exposure and poor air quality, to safeguard the health and well-being of children in classrooms. A comprehensive literature search will be conducted on Ovid MEDLINE, Ovid Global Health, PubMed, Scopus, ScienceDirect and Web of Science. Searches will be limited to literature published in the last 10 years (2015–2025). Results will be exported to EndNote for deduplication and to Abstrackr software for screening. Four reviewers will do abstract screening to ensure consistency. Data from included papers will be presented in tables with a narrative commentary.
No ethical approval is required for this study as primary data collection will not be conducted. A manuscript detailing the findings from this review will be published in a peer-reviewed journal.
Families offer promising targets for mental health interventions. Existing evidence investigates parent-child dyads or partners; we use an innovative approach to look at triads of parents and their children. This gives us more detail on mental health dimensions and individuals central to mental health transmission in families.
Both cross-sectional and longitudinal network models
We identified triads of children (under age 16), mothers and fathers from the UK Household Longitudinal Study, between 2009 and 2022.
Cross-sectional networks captured independent associations between family members’ mental health (n=8795 families). Longitudinal networks examined directional temporal associations among family members’ emotional symptoms (n=3757 families).
Children’s and parents’ mental health dimensions were assessed using the Strengths and Difficulties Questionnaire and the General Health Questionnaire, respectively.
Mothers’ mental health, particularly emotional symptoms, was linked to children’s mental health, while fathers’ symptoms showed no independent association. In the longitudinal network, maternal feelings of being overwhelmed were associated with children’s future worry, affecting symptoms of nervousness and unhappiness, which then fed back into worsening maternal emotional symptoms.
Investigating family mental health using network models highlights mothers’ central role. The longitudinal relationship between maternal feelings of being overwhelmed and children’s anxiety, and the subsequent feedback into maternal anxiety, indicates a promising target for intervention.