To determine the personal, National Health Service and wider societal resource use in relation to caring responsibilities for carers of people living with non-memory led dementias (NMLDs); and to design a resource use measure (RUM) that can be delivered in the Better Living with Non-memory-led Dementia (BELIDE) randomised controlled trial, part of the Rare Dementia (RD) - TALK research programme.

The first stage was to identify and review any existing RUMs that could be used or adapted to the trial population and setting. If no measures were identified, the second stage was initial informal discussions with healthcare professionals (HCPs) and the programme patient and public involvement representatives to inform the perspective, settings of care and main resource items to develop a new RUM. In the third stage, a first draft of the RUM was tested for content and face validity in a modified Delphi study comprising HCPs and carers. The measure was revised and, in the final stage, piloted in the first 3 months of the BELIDE trial to assess acceptability and feasibility of collecting the economic outcomes and the completeness of data collection. The key drivers of resource use and costs were assessed, and appropriate face validity checks were applied to ensure accurate description of the treatment pathways.

Carers and family of people living with NMLD recruited from Rare Dementia Support members in the UK, and a broad range of HCPs with experience of working with people who have NMLD to capture the different dimensions of experience, grade and skill mix.

In total, 20 people participated in the modified Delphi study, 11 HCPs and 9 carers. Rare Dementia Support groups and 1:1 calls were highly rated, as were general practitioner appointments. The greatest consensus was in the productivity and carer tasks; all caring tasks were highly rated. Healthcare practitioners rated healthcare items as higher importance than carers themselves.

Unpaid carers and HCPs are the experts in the resource impact of caring for someone with NMLD and have been underserved in research to date. This research, as part of preparatory stages of the BELIDE trial, has enabled the timely development of a comprehensive and valid RUM for unpaid carers of people with NMLD.

CRD42022356943.

NCT06241287.

Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

Exercise-based interventions are well-established in reducing falls and fall-related injuries, but adherence and accessibility remain key challenges, particularly in rural areas. While conventional in-person training is widely used, digital interventions may offer scalable solutions to enhance engagement and reach. However, pragmatic trials evaluating the real-world effectiveness of conventional and digitally supported fall prevention interventions are lacking, limiting the evidence base for their implementation in routine healthcare settings. The SURE-Footed into the Future Fall Intervention Trial (SURE-FIT) aims to compare the effectiveness of two structured fall prevention interventions—a conventional centre-based exercise programme and a hybrid telemedical programme combining in-person and tablet-supported training—against a wait-list control group in reducing falls and fall-related injuries among community-dwelling older adults.

This study is a pragmatic three-arm, parallel-group, randomised controlled superiority trial with a 1:1:1 allocation ratio. Participants (≥65 years, community-dwelling, planned n=2778) will be randomly assigned to (1) conventional centre-based training supplemented with printed materials for home-based continuation (conventional group), (2) a hybrid model integrating centre-based and tablet-supported training for continuation (tablet group) or (3) a wait-list control group. The intervention includes a 9-week supervised phase followed by 43 weeks of independent home-based training. The primary outcomes are the incidence rate of falls and fall-related injuries over 12 months. Secondary outcomes include physical functioning, physical activity, concerns about falling, loneliness and the risk of low protein intake. A process evaluation will assess intervention feasibility and implementation. Additionally, qualitative interviews will be conducted with participants, course instructors and municipal stakeholders to explore experiences, facilitators and challenges related to programme participation and implementation. A health-economic evaluation will be conducted to assess the cost-effectiveness of the structured fall prevention interventions. Data collection will take place at baseline and every 3 months via standardised questionnaires, with a subgroup undergoing physical performance testing and sensor-based activity monitoring. Analyses will follow an intention-to-treat approach.

Ethical approval has been granted by the Ethics Committee of Ulm University (271/23). Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed publications, scientific conferences and national fall prevention initiatives. Additionally, results will be shared with key municipal representatives, and the German National Association of Senior Citizens’ Organisations (BAGSO). A publicly accessible website will provide ongoing access to study information and findings in plain language.

DRKS00032878, German Clinical Trials Register

Research in people with relapsing remitting multiple sclerosis (PwRRMS) is increasingly focusing on non-motor symptoms like cognitive impairment, fatigue and depression. Due to the high negative impact on quality of life and high socioeconomic costs based on these symptoms, more specific research to improve non-motor symptoms is needed. Transcutaneous auricular vagus nerve stimulation (taVNS) has been found to be a cognitive enhancer in preclinical research and was successfully used for the treatment of psychiatric and neurological disorders to combat dysfunctional cognitive and affective processes. However, the capacity of taVNS to improve cognitive and other non-motor symptoms in PwRRMS has not been tested yet. The aim of this study is to evaluate the therapeutic potential of taVNS on cognitive processing speed. Based on ample evidence demonstrating that taVNS promotes adaptive cognitive and affective processes, we hypothesised that taVNS would alleviate cognitive processing speed in PwRRMS.

This study protocol describes the prospective, single-centre, SHAM-controlled, single-blinded trial with a planned sample size of 60 participants (30 PwRRMS, with a diagnosis of multiple sclerosis according to McDonald criteria and 30 healthy controls; age: 18–50 years). The Symbol Digit Modalities Test (SDMT) will be used to determine cognitive processing speed, Beck Depression Inventory-II to determine depression and Fatigue Scale for Motor and Cognitive Functions to determine fatigue. The severity of multiple sclerosis will be assessed using the Expanded Disability Status Scale. After baseline assessment, a taVNS protocol (duration: 30 min, tolerance threshold, pulse width: 250 μs, stimulation frequency: 25 Hz, 30 s on/30 s off) will be applied, followed by post-intervention assessment.

The study was reviewed and approved by the local ethics committee of the University Medical Centre Greifswald (study reference number: BB137/24). Clinical trial registration: www.drks.de, number: DRKS00034912. Study results will be disseminated through academic conferences as well as peer-reviewed publications.

DRKS00034912.

To examine the longitudinal impact of time-varying factors on US youth’s trajectories of initiation and use of e-cigarettes and cigarettes during the transition from adolescence to young adulthood.

Longitudinal.

Nationally representative US survey, the Population Assessment of Tobacco and Health (PATH) Study.

2682 US youth (aged 16–17) at wave (W)1 of the PATH Study across six waves (2013–2020) into young adulthood (aged 22–23).

Unweighted longitudinal latent class analyses identified trajectory classes of e-cigarette and cigarette use, separately. Nationally representative weighted multinomial logistic regression analyses examined time-varying harm perceptions, substance use problems and tobacco product first tried as predictors of these trajectory classes.

Five e-cigarette classes (2013–2020; 41.5% Persistent Never Use, 12.6% W5 Initiation, 19.9% W3 Initiation, 15.2% Prior Initiation, 10.8% High Frequency Past 30-Day (P30D) Use) and five cigarette classes (2013–2019; 58.6% Persistent Never Use, 11.5% W4 Initiation, 10.9% W2 Initiation, 9.6% Prior Initiation, 9.5% High Frequency P30D Use) were identified. Time-varying harm perceptions and substance use problems were associated with trajectories of initiation and use for both products. Cigarettes, cigarillos, other combustibles and any smokeless tobacco as first product tried were associated with e-cigarette initiation and/or progression to high frequency use. E-cigarettes and hookah as first product tried were associated with later cigarette initiation. High Frequency P30D Cigarette Use was less likely if the first product tried was e-cigarettes, cigarillos, hookah or any smokeless tobacco product.

Results reinforce the need for identification and intervention of early substance use among younger adolescents and targeted public health messaging to address changing harm perceptions and prevent initiation among older adolescents.

Suicide poses a significant global health challenge in low- and middle-income countries and is a leading cause of death worldwide. Although global suicide rates have decreased by 36% between 2000 and 2019, the decline in Africa has not been as substantial. Suicide surveillance data, particularly from pesticide ingestion, is lacking.

This scoping review aimed to identify pesticide suicide surveillance methods currently used in African countries and to assess their viability for improving reporting of pesticide suicide deaths.

A scoping review was conducted using a five-stage methodological framework across several databases.

Peer-reviewed articles published in English that investigated (a) pesticide poisoning and (b) suicide in humans only and specific to the African continent.

MEDLINE (via PubMed), Scopus (with substantial Embase content), Web of Science Core Collection, Biological Abstracts, SciELO (on Web of Science platform), Academic Search Premier, Africa-Wide Information, Biological and Agricultural Index, CINAHL, Health Source Nursing/Academic, APA PsycInfo and General Science (EBSCOhost platform). The search was performed in January 2022, and the review of the results took place from February to May 2022.

All authors developed and tested the data extraction tool. The charting framework remained dynamic, continuously updated as reviewers gained a deeper understanding of the studies included. Four independent reviewers charted the data to ensure inter-rater reliability. To address discrepancies, a sample of eligible articles was cross-rated by the reviewers.

We identified 110 relevant studies describing eight different surveillance systems, conducted in 30 different African countries. Of these studies, 50.1% (56/110) reported on the number of pesticide suicides (totalling 1554); however, 49% (54/110) did not differentiate the cause of death further than either a poisoning death or a suicide, making it difficult to determine if pesticides were involved in the death or if the death was an intentional poisoning case. The surveillance systems identified included health facility records (hospital admissions data), poison control centre (PCC) data, forensic/mortuary data (including police reports), media reports, surveys/interviews with patient/family, case reports, systematic/literature reviews and civil registration and vital statistics (CRVS) data. Hospital admissions data was the most frequently used surveillance system (61/110, 55.5%).

The number of studies and surveillance methods found was higher than anticipated. While this is a positive sign, several areas of improvement were identified for pesticide suicide surveillance in Africa. These included improving reporting of the specific pesticides (including the active ingredient) linked to suicide cases for improving policy (since this is required for pesticide regulation) and making use of more than one surveillance system to enhance surveillance of pesticide suicides, allowing for under-used sources, such as PCCs, to be used more effectively in pesticide suicide surveillance. Finally, although a comparison of these surveillance methods outside of Africa was not directly possible for each surveillance system due to a lack of similar high-quality reviews, we did refer to publications where similar pesticide suicide surveillance systems were discussed.

There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.

This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.

This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.

NCT06360783.

Carers of people with non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) face unique challenges. Yet, little evidence-based support and guidance are available for this population. To address this gap in services, we have developed a novel, web-based educational programme: the Better Living with Non-memory-led Dementia programme (BELIDE). BELIDE was co-designed with people with lived experience of non-memory-led dementia and a previous pilot study confirmed its feasibility as an online intervention. This protocol outlines the randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of BELIDE.

This is a parallel-group, single-blind, RCT of 238 unpaid caregivers of people diagnosed with PCA, PPA or bvFTD recruited internationally among members of the UK-based organisation Rare Dementia Support. The intervention (BELIDE programme) consists of six structured online educational modules tailored to each phenotype, a virtual onboarding session, real-life practice tasks and up to two follow-up facilitation sessions. The group receiving the intervention will be given access to the programme, while the control group will receive treatment as usual and be placed on a wait-list to receive access to the programme once they complete their participation in the trial. The allocation ratio will be 1:1 stratified by dementia diagnosis and gender. The primary outcome is reduction in caregiver depressive symptoms. Secondary outcomes include stress, anxiety, self-efficacy, quality of life and caregiver-patient relationship quality. Data will be collected online via Qualtrics surveys at baseline, 8 weeks and 6 months post-randomisation. A mixed-method process evaluation with a subgroup of intervention participants will explore barriers and facilitators for engagement. A health economics evaluation will also be conducted to assess cost-effectiveness. If effective, this programme could improve access to caregiver support for non-memory-led dementias by providing scalable, tailored education.

Ethical approval has been granted by University College London Research Ethics Committee (8545/007). The results will be disseminated via peer-reviewed publications, conferences, stakeholder events and open-access resources.

This trial has been registered prospectively on the Clinical Trials registry, first posted on 5 February 2024 under registration number NCT06241287.

Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

NCT06678438.