Long-Term Outcomes of Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation After Stroke

Stroke, Ahead of Print. BACKGROUND:Persistent upper extremity (UE) impairment is common after stroke. Durable treatment benefits for chronic ischemic stroke are needed. The purpose of this report is to determine the long-term effects of vagus nerve stimulation paired with rehabilitation on impairment, activity, and participation in people with UE impairment after ischemic stroke.METHODS:This is a post hoc analysis of data from the VNS-REHAB (A Pivotal Randomized Study Assessing Vagus Nerve Stimulation [VNS] During Rehabilitation for Improved Upper Limb Motor Function After Stroke) randomized clinical trial. Here, we report unblinded, partial crossover, and pooled 1-year outcomes. Initially, 108 participants across 19 sites with chronic ischemic stroke and moderate-to-severe UE impairment were enrolled in VNS-REHAB. Participants received 18 sessions of in-clinic intensive task-specific rehabilitation and 3 months of self-initiated home-based exercise with either real (active) or sham (control) vagus nerve stimulation. Thereafter, Control participants crossed over to receive in-clinic therapy paired with active stimulation. All participants performed home-based exercises paired with self-initiated active stimulation for 1 year. The Fugl-Meyer Assessment UE, Wolf Motor Function Test, and participation outcomes were assessed through 12 months.RESULTS:Seventy-four participants (69%; 51 male; age, mean±SD, 59.6±8.9) completed 1-year follow-up and provided pooled data through 1 year. At 1 year, compared with baseline, there were improvements in impairment (Fugl-Meyer Assessment UE, 5.23 [95% CI, 4.08–6.39];P

Read More

Female sex workers perceptions, concerns and acceptability of OraQuick HIV self-test in Woldia town, North Wollo, Ethiopia: a qualitative study

Objective
To explore female sex workers’ perception, concern and acceptability of OraQuick HIV self-test (HIVST) in Woldia town, North Wollo, Ethiopia, in 2024.

Design
The study used a phenomenological design and the Integrated Behaviour Model as a theoretical framework.

Setting
Woldia town, Ethiopia, is the capital city of North Wollo Zone.

Participants
Twenty female sex workers and 18 key informants in Woldia town were involved.

Results
Most participants had a positive attitude towards testing with these devices and anticipated positive consequences, such as enhanced privacy, decreased waiting time, reduced transportation costs, increased accessibility for immobile individuals, elevated utility in index case screening and testing programmes and the provision of confidential, trustworthy and reliable test results. Most female sex workers perceived that significant people in their social environment approved and used OraQuick HIVST. The facilitators to uptake of OraQuick HIVST among female sex workers included privacy, ease of use and nonrequierement for trained healthcare providers when testing. Thus, most female sex workers were confident in their ability to test themselves and interpret their test result using OraQuick HIVST.
To optimise uptake of testing using OraQuick, female sex workers proposed supplying kits in an easily accessible manner, increasing awareness about the kit and advocating for and promoting that the kits are strategies to facilitate HIVST uptake and maximise individuals’ self-efficacy. The perceived possible concerns or barriers to the uptake of OraQuick HIVST included a shortage of kits, doubts about reliability prior to education, absence of policies or guidelines for HIVST, lack of post-test counselling and immediate treatment for positive individuals, potential psychological trauma such as suicidal ideation or attempts, lack of linkage to care for those with reactive results and inaccurate reporting of positive results or result concealment.

Conclusion
This finding suggests that OraQuick HIVST was acceptable to female sex workers in the study area, with the majority of female sex workers having a positive attitude, supportive social norms and self-efficacy. Therefore, interventions to increase awareness, advocate for the kit and address perceived concerns or barriers to HIVST are needed to maximise its uptake in the study setting.

Read More

Effect of tibialis anterior focal muscle vibration for gait rehabilitation in hemiplegic individuals during the subacute phase after stroke: the NEUROVIB-AVC study protocol – a multicentric randomised controlled trial

Introduction
Gait recovery remains one of the most determining factors in social participation for poststroke individuals, in whom ankle dorsiflexor function is closely related to gait speed. Focal muscle vibration has shown promising neurophysiological and clinical effects in neuromotor recovery. However, it remains to be determined whether tibialis anterior focal muscle vibration applied to the paretic limb could improve walking speed when implemented in early rehabilitation after stroke occurrence.

Methods and analysis
This study describes a multicentric randomised controlled trial in which 70 participants will be randomly assigned in a 1:1 ratio to the tibialis anterior focal muscle vibration group or the sham group, in addition to their conventional rehabilitation. Participants will receive 100 Hz vibration/sham for 30 min, five times per week, for 8 weeks. The primary outcome will be gait speed, as assessed through a 10 m walking test and will be compared between groups at the end of the intervention. Secondary outcomes will include gait abilities, neuromuscular clinical evaluations and neurophysiological measures. Outcomes will be assessed at baseline and across five visits during and after the intervention, until 16 weeks of follow-up.

Ethics and dissemination
Ethics approval was obtained from the French Ethics Committee ‘Protection des Personnes Nord Ouest III’ in 30 May 2023 (IDRCB: 2023-A00489-36). The results will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
NCT05945212.

Read More

Codevelopment of a complex intervention to reduce inequalities in paediatric diabetes secondary care outcomes for children with type 1 diabetes from underserved groups

Objectives
To codevelop (with children and young people with diabetes (CYPD)) an intervention to improve diabetes control and future health outcomes of CYPD from ‘underserved’ groups, to reduce treatment outcome inequalities between different socioeconomic and ethnic groups. To follow Medical Research Council guidance for complex interventions and the COM-B (Capability, Opportunity, Motivation, Behaviour) model for behaviour change intervention development.

Design
In phase 1 (previously reported), we established the evidence base, conducted literature reviews and analysed data from semistructured interviews with CYPD and their carers. In phase 2 (this report), we applied the COM-B framework to identify intervention components; in phase 3 (this report), we evaluated these components, including focus groups with CYPD, their carers’ and healthcare practitioner (HCP) surveys, using the Acceptability, Practicability, Effectiveness, Affordability, Spill-Over Effects, Equity criteria.

Setting
Secondary care; children, young people and their carers’ were approached from two large paediatric diabetes services in England, both with socioeconomically and ethnically diverse underserved populations; paediatric diabetes HCPs were surveyed across four English regions.

Participants
N=69 underserved CYPD (aged 5–19 years) and/or family members took part in interviews; N=48 paediatric diabetes HCP survey respondents (survey 1); N=34 paediatric diabetes HCP survey respondents (survey 2); N=3 young people’s advisory group participants; N=17 underserved CYPD/carers focus group participants; N=9 wider stakeholder participants.

Results
The codevelopment process and integration of COM-B established four elements for an intervention package: (1) an enhanced peer support/mentoring programme; (2) provision of a health and well-being coach to CYPD/families; (3) family/community support to address social and community issues and (4) training for HCPs, including cultural competence, poverty proofing and to emphasise the need for increased sensitivity and better supported communication in work with CYPD from underserved groups.

Conclusions
The Diversity in Diabetes codevelopment work informed an intervention to improve diabetes care in underserved groups, reflecting sociocultural contexts and plausible support options at the individual, community and clinical levels. The ‘Diversity in Diabetes’ programme will next test feasibility and further refine the intervention package in two more paediatric diabetes centres in England.

Read More

Association between glucose intolerance and fatty liver disease in women with previous gestational diabetes mellitus in urban Thailand: a prospective cohort study

Objectives
To examine the associations between glucose levels from the antepartum 100 g oral glucose tolerance test (OGTT) and the 6-week postpartum 75 g oral glucose tolerance test (OGTT) and fatty liver disease (FLD) at 1 year postpartum in women with a history of gestational diabetes mellitus (GDM).

Design
A prospective cohort study.

Setting
A tertiary hospital centre in Bangkok, Thailand.

Participants
A total of 130 women with a history of GDM who underwent liver fat assessment at 1 year postpartum.

Outcome measures
FLD and metabolic dysfunction-associated steatotic liver disease were assessed at 1 year postpartum, with diagnosis based on transient elastography and specific cardiometabolic criteria. The associations between OGTT glucose values and FLD were evaluated using logistic regression models, adjusted for potential confounders, including age, pre-pregnancy weight, weight and waist circumference at 1 year postpartum and exclusive breastfeeding. Receiver operating characteristic analyses were also conducted to assess the predictive performance of glucose parameters from antepartum and postpartum OGTTs.

Results
A total of 44 participants (33.8%) were diagnosed with FLD, with 97.7% meeting metabolic dysfunction-associated steatotic liver disease criteria. Elevated fasting plasma glucose levels during pregnancy (adjusted odds ratio (aOR): 1.49; 95% CI: 0.93 to 3.57), in the early postpartum period (aOR: 1.77; 95% CI: 0.92 to 5.05), or across both periods combined (aOR: 2.16; 95% CI: 0.93 to 7.41) were not independently associated with FLD. In contrast, four abnormal glucose values during pregnancy (aOR: 2.53; 95% CI: 1.03 to 7.87) and two abnormal values on the 6-week postpartum 75 g OGTT (aOR: 2.95; 95% CI: 1.06 to 11.20) were independently associated with FLD. The combined presence of abnormal OGTT values from both periods showed the strongest association with FLD (aOR: 3.04; 95% CI: 1.03 to 13.99), demonstrating high specificity (95.3%) but low sensitivity (13.6%).

Conclusions
Elevated glucose levels from the antepartum 100 g OGTT and the 6 week postpartum 75 g OGTT were associated with FLD at 1 year postpartum in women with a history of GDM. Comprehensive glucose monitoring during and after pregnancy may aid early identification of individuals at higher risk.

Trial registration number
Thai Clinical Trials Registry: Registration no. TCTR20211027007. Date of registration: 27 October 2021. Date of initial participant enrolment: 1 November 2021.

Read More

Effects of an extended therapeutic strategy versus standard-of-care therapy on persistent acute kidney injury in high-risk patients after major surgery: study protocol for the randomised controlled single-centre PrevProgAKI trial

Introduction
Persistent acute kidney injury (AKI) is associated with an increased morbidity and mortality. In patients with an already established AKI, the new urinary biomarker C-C motif chemokine ligand 14 (CCL14) can predict a persistent AKI. However, it is still unknown whether the implementation of nephroprotective measures in patients with an already established moderate/severe AKI can positively influence the trajectory of AKI and patients’ outcome.

Methods and analysis
The PrevProgAKI trial is a randomised, controlled, single-centre trial designed to evaluate the effectiveness of nephroprotective measures in patients with established moderate/severe AKI. We aim to enrol 480 patients with moderate or severe AKI (Kidney Disease: Imroving Global Outcomes, KDIGO, stage 2 or 3) within 72 hours of major surgery. Eligible patients will be randomised to receive either standard of care (control group) or an extended therapeutic strategy that consists of different supportive measures (intervention group). The randomisation will be stratified by urinary CCL14 results (CCL14

Read More

Optimising colorectal cancer screening strategies and target populations in budget-constrained regions through cost-effectiveness analysis: a case from eastern China

Objectives
The primary aim of this study was to optimise colorectal cancer (CRC) screening strategies and target populations in resource-limited areas through cost-effectiveness analysis, evaluating the best screening methods and appropriate screening ages.

Design
A prospective microsimulation model was used for cost-effectiveness analysis, calibrated with real-world data.

Setting
The study was conducted in Huzhou City, Zhejiang Province, China, focusing on primary and secondary healthcare levels. Data were obtained from the Huzhou Center for Disease Control and Prevention.

Participants
The study included 418 805 local residents who participated in the Huzhou screening programme between 2020 and 2022. Inclusion criteria were individuals aged 45–100 years and residing in the local area.

Interventions
Four initial screening methods were evaluated: single-sample immunochemical faecal occult blood test (iFOBT), double-sample iFOBT, single-sample iFOBT combined with a risk assessment questionnaire and double-sample iFOBT combined with a risk assessment questionnaire. Screening frequencies included annual and biennial intervals.

Primary outcome measures
The primary outcome measure was the cost per incremental quality-adjusted life year (QALY) for different screening strategies. Also, the impact on CRC incidence, related deaths, life years saved (LYS) and QALYs was considered.

Results
The primary data were sourced from the Huzhou screening programme, which included 418 805 individuals from 2020 to 2022. All screening strategies were found to be effective, with the cost per incremental QALY being less than $1036, which is below the minimum standard for middle-income countries. The most effective screening strategy was the annual combined two-sample iFOBT and risk evaluation questionnaires. This approach led to a reduction in CRC incidence and related deaths by 2435 and 1174 cases per 100 000 individuals, respectively, and an increase in LYS by 13 903 years and QALYs by 35 564 years. The recommended ages to begin and end screening were 48 and 72 years, respectively.

Conclusions
All CRC screening strategies demonstrated effectiveness compared with non-screening, with the annual combined two-sample iFOBT and risk evaluation questionnaires emerging as the optimal approach. For additional regions, the best screening strategy can be selected based on the health outcomes and costs we have provided.

Read More

Point-of-care troponin tests to rule out acute myocardial infarction in the prehospital environment: a protocol for a systematic review and meta-analysis

Background
Chest pain is a major cause of emergency ambulance calls, often linked to acute myocardial infarction (AMI), a critical condition requiring immediate hospitalisation. Current diagnostic methods, such as history taking and ECG, have limitations, especially for non-ST-elevation myocardial infarction. High-sensitivity cardiac troponin (cTn) assays are more diagnostically sensitive, but the downside is that it needs hospital-based testing, which can delay diagnosis and the necessary treatment protocol. Point-of-care cTn testing, on the other hand, is much faster and done nearer to the patient; hence, it may fundamentally change the prehospital care pathway in terms of diagnostic accuracy, clinical utility and related safety.

Objective
To present a protocol for a systematic review and meta-analysis that will assess the diagnostic accuracy, clinical utility and safety of point of care (POC) troponin tests, with or without clinical decision aids, for ruling out AMI in adults presenting with cardiac chest pain to emergency ambulance services in prehospital settings.

Methods
This protocol follows BMJ guidelines and adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 reporting standards. It is registered with PROSPERO (ID: CRD42024533117). A comprehensive search strategy will identify relevant studies in MEDLINE, EMBASE and CINAHL, focusing on literature from 2000 onwards. Eligibility criteria include adults with chest pain suspected of AMI, excluding those with ST-elevation myocardial infarction. The primary target is type 1 AMI, with secondary outcomes including major adverse cardiac events at 30 days. Risk of bias assessment will be performed using tools such as Quality Assessment of Diagnostic Accuracy Studies version 2, Risk of Bias 2, and Risk of Bias in Non-randomised Studies of Interventions, while the quality of the economic evaluations will be appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Data items extracted will include patient demographics, test characteristics and outcomes. Where possible, meta-analyses will be conducted by fitting hierarchical models for diagnostic accuracy and random effects models for clinical and cost-effectiveness estimates. Subgroup analyses are proposed to quantify the effect of variables such as gender, ethnicity and type of troponin assay on the estimated parameters.

Ethics and dissemination
Ethical approval is not required. The results will be published in a peer-reviewed journal and presented at international conferences.

PROSPERO registration number
This protocol is registered with PROSPERO, the International Prospective Register of Systematic Reviews, under the ID CRD42024533117. Any future amendments will be updated in the PROSPERO record.

Read More

Infection in Childhood Arterial Ischemic Stroke: Metagenomic Next-Generation Sequencing Results of the VIPS II Study

Stroke, Ahead of Print. BACKGROUND:Acute respiratory infection transiently increases risk for childhood arterial ischemic stroke (AIS). We hypothesize that this paradox of a common exposure linked to a rare outcome could be explained by either (1) the infection hypothesis: unusual or multiple pathogens or (2) the host response hypothesis: heterogeneity in the inflammatory response to infection. We leverage metagenomic next-generation sequencing (mNGS), a comprehensive microbial detection tool, to test the first hypothesis.METHODS:The VIPS II study (Vascular Effects of Infection in Pediatric Stroke II) prospectively enrolled children with AIS at 22 international sites over 5 years (December 2016 to January 2022). Sites measured prestroke clinical infection via standardized parental interviews and chart abstraction. To assess more broadly the background spectrum of pathogens, a central research laboratory performed mNGS on plasma and oropharyngeal swabs collected within 72 hours of stroke. mNGS was also performed on biological samples from stroke-free children (June 2017 to January 2022), both without (well) and with (ill) documentation of clinical infection.RESULTS:VIPS II enrolled 205 patients with AIS, 95 stroke-free well children, and 47 stroke-free ill children. Clinical infection, most commonly upper respiratory tract infection, was detected in 81 of 205 (40%) of patients. Both plasma and oropharyngeal swab mNGS data were available for 190 of 205 patients with AIS, 91 of 95 stroke-free well children, and 27 of 47 stroke-free ill children. mNGS detected viruses in 27 of 190 (14%) patients with AIS, 9 of 91 stroke-free well children (10%), and 9 of 27 (33%) stroke-free ill children. Most were common upper respiratory viruses. Coinfections were rare. Similar viruses were found in patients with AIS and stroke-free children.CONCLUSIONS:mNGS detected a variety of common childhood viruses in both patients with AIS and stroke-free children, suggesting that the type of infection does not explain AIS susceptibility. Rather, the alternative hypothesis regarding an unusual host immune response to common infections in the pathogenicity of AIS should be further explored.

Read More

Implementation of sleep apnoea testing and treatment services into a cardiometabolic clinic for people living with severe mental illness: a prospective evaluation of a translational programme

Background
Medical care for sleep-disordered breathing (SDB) in severe mental illness (SMI) is often ignored or poorly delivered. Here we describe an oximetry screening and management pathway for obstructive sleep apnoea (OSA) and assess the night-to-night reliability in a specialist cardiometabolic disease management clinic for patients with SMI.

Objective
The implementation and evaluation of a sleep service for patients living with SMI.

Design
Prospective evaluation of a translational programme.

Setting
A multidisciplinary outpatient clinic for patients with SMI.

Methods
The clinic was prospectively evaluated between May 2019 and December 2020. We used questionnaires and three nights of oximetry to screen patients for OSA. A project coordinator managed the testing-treatment pathway while liaising with health care providers. We also evaluated the agreement between two nights of oximetry.

Results
It is feasible to integrate sleep service into a cardiometabolic clinic for patients with SMI. Oximetry data were collected from 140/153 patients and 129/140 had at least adequate oximetry data for one night, and 107 (82%) had two nights. Oximetry indicated likely moderate-to-severe OSA in 33 patients and severe OSA in 22 patients. A total of 96/140 patients were referred to the SMI sleep clinic, and 40 (42%) recommended polysomnography (PSG) and 31 (78%) completed PSG. Of the 44 patients recommended continuous positive airway pressure (CPAP) therapy, 38 initiated CPAP and 20 (51.3%) demonstrated adherence ( >4 hours 70% of nights over 30 days). Bland-Altman analysis of two nights of oxygen desaturation events greater than 4% per hour found a mean difference of –0.2 (95% CI –14.0 to 14.0). Misclassification of OSA severity was seen in 12 patients (18.7%).

Conclusions
Our recount shows the feasibility and effectiveness of implementing a sleep service in a cardiometabolic clinic for patients with SMI, and using oximetry is an effective diagnostic test of SDB. Having a dedicated project coordinator to oversee the clinical pathway avoids fragmentation of clinical services.

Read More