Acute Intermittent Hypoxia in People Living With Chronic Stroke: A Case Series

Stroke, Ahead of Print. BACKGROUND:Acute intermittent hypoxia (AIH) is a novel therapeutic intervention that facilitates recovery of function, but the tolerability and effectiveness have not been tested in people living with chronic stroke. The purpose here was to examine whether AIH is tolerable and effective in this population.METHODS:Ten participants with a unilateral, hemispheric stroke were assessed before and after 4 sessions of AIH separated by ≥48 hours in a case series at Shirley Ryan AbilityLab (Chicago). Physician-assessed signs and symptoms (assessed via: repeated symptom reviews, National Institutes of Health Stroke Scale, cranial nerve assessment, a muscle strength test, the Brunnstrom scale, sensory changes, reflexes, assessment of heart and lung status, Fugl-Meyer test, Chedoke-McMaster Stroke Assessment, Modified Ashworth Scale for Spasticity, and Delis Kaplan Executive Function System Color-Word Interference Test) and bilateral upper limb strength (grip and elbow flexion) were assessed before, ≈15 to 30 minutes, and ≈60 minutes after the intervention.RESULTS:AIH was well-tolerated and there were no adverse events observed. After AIH, grip strength (12.91% and 16.53% improvement at 30 and 60 minutes post-AIH, respectively) and elbow flexion force (5.87% and 7.01% improvement at 30 and 60 minutes post-AIH, respectively) improved in the more-affected limb.CONCLUSIONS:AIH is potentially safe and effective for improving strength in the more-affected limb in people living with hemiparetic stroke. Future work should explore the use of AIH to enhance task-specific training-induced plasticity.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT04019522.

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Left Ventricular Entry to Reduce Brain Lesions During Catheter Ablation: A Randomized Trial

Circulation, Ahead of Print. BACKGROUND:Catheter ablation of ventricular arrhythmias, one of the most rapidly growing procedures in cardiac electrophysiology, is associated with magnetic resonance imaging–detected brain lesions in more than half of cases. Although a retrograde aortic approach is conventional, modern tools enable entry through a transseptal approach that may avoid embolization of debris from the arterial system. We sought to test the hypothesis that a transseptal puncture would mitigate brain injury compared with a retrograde aortic approach.METHODS:The TRAVERSE trial (Transseptal Versus Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli) was a multicenter randomized controlled comparative effectiveness trial. Patients with left ventricular arrhythmias undergoing catheter ablation procedures were randomly assigned to a transseptal puncture approach compared (1:1) with a retrograde aortic approach. The primary outcome was the presence of an acute brain lesion detected by magnetic resonance imaging. Secondary outcomes included clinically manifest complications, procedural efficacy, and 6-month neurocognitive assessments.RESULTS:Among the 62 patients randomly assigned to a retrograde aortic approach with postoperative brain magnetic resonance imaging, 28 (45%) exhibited an acute brain lesion compared with 19 of the 69 (28%) of those randomized to a transseptal puncture (P=0.036). No differences in clinically manifest complications or procedural efficacy were observed. More patients in the retrograde aortic arm were categorized as having a high likelihood of cognitive impairment at 6 months (33% compared with 19% of those in the transseptal arm), but substantial loss to follow-up was present.CONCLUSIONS:Among patients undergoing left ventricular catheter ablation procedures, a transseptal approach reduced the risk of acute brain lesions by nearly half compared with a retrograde aortic approach without sacrificing safety or efficacy. Given a likely embolic pathogenesis, the brain magnetic resonance imaging findings may reflect a propensity to other organ damage; these findings may extend to other procedures requiring left ventricular entry.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03946072

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Temporal changes in blood biomarkers associated with sleep apnoea severity: a retrospective cohort study in Finland

Introduction
Obstructive sleep apnoea (OSA) is a common sleep disorder associated with breathing interruptions during sleep, often leading to oxygen level drops and sleep disturbances. OSA is known to impact various physiological parameters, including haematological and lipid profiles. This study aims to investigate the effect of continuous positive airway pressure (CPAP) therapy on laboratory values in patients with OSA.

Methods
A retrospective study was conducted using data from Finland’s largest hospital district, including 30 722 adult OSA patients treated between 2005 and 2020. A text search algorithm was implemented within the patient chart data to extract the apnoea-hypopnoea index (AHI) and the usage of CPAP therapy, along with identifying patients who had declined treatment. Haematological and metabolic laboratory values were collected 3 years before and after the first OSA diagnosis. Analysis of covariance was employed to compare parameter variations across severity levels, adjusted for age, sex and body mass index (BMI). T-test for repeated measurements was used to analyse the differences between data, 3 years prior and 3 years after the first OSA diagnosis.

Results
The study of 30 722 OSA patients showed varying severity levels: 14.8% mild, 32.6% moderate and 52.6% severe, with an average diagnosis age of 55.0 years and a mean BMI of 32.4. The most clinically significant changes were observed in lipid profile markers, with improvements in cholesterol and low-density lipoprotein (LDL) levels (p value

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Effect of vestibular rehabilitation treatment (VRT) on patients with unsteadiness after intratympanic gentamicin in Menieres disease: protocol for a randomised controlled trial

Introduction
Menière’s disease (MD) is a multifactorial disease characterised by recurring vertigo, tinnitus and fluctuating sensorineural hearing loss as typical clinical symptoms. For patients with MD with poor response to non-invasive treatments, it is recommended to use intratympanic gentamicin treatment. The destruction of vestibular organs by gentamicin may cause residual vestibular symptoms, notably unsteadiness. However, most previous clinical studies paid little attention to this issue. Currently, vestibular rehabilitation treatment (VRT) has been proven to be an effective method for controlling vestibular symptoms and has been applied to patients with various vestibular diseases. The aim of this study is to investigate the efficacy of VRT versus usual care in MD patients who experience persistent unsteadiness for 1 month after intratympanic gentamicin treatment, in order to understand whether VRT has a positive impact on balance maintenance and vertigo control in patients with MD.

Methods and analysis
Randomised, assessor-blinded, controlled clinical trials will be used to compare the efficacy of balance function before and after VRT. Patients with MD who experience chronic unsteadiness for 1 month after intratympanic gentamicin treatment will be recruited and receive VRT, mainly including gaze stability training, gait rehabilitation, vestibular habituation training, etc. The outcomes assessments will be conducted at baseline and at eighth week and sixth month post-randomisation. The primary outcome will be the improvements in vestibular function quantified through the Functional Gait Assessment. The secondary outcomes will include sensory organisation test, vestibular laboratory tests (video head impulse test, caloric test and vestibular evoked myogenic potentials), Menière’s disease outcomes questionnaire, visual vertigo analogue scale and vestibular activities and participation measure.

Ethics and dissemination
This trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2024020). The study results will be disseminated via peer-reviewed journals and conferences.

Trial registration number
NCT06143462.

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Association between clinical and pulmonary function features and diagnosis of cough variant asthma: a case-control study

Objectives
To compare physical information, such as age, sex, height, weight, body mass index (BMI) and pulmonary function test (PFT) results, between cough variant asthma (CVA) and chronic cough (CC) and establish a diagnostic model of CVA.

Design
A case–control study of patients with suspected CVA enrolled at The First Affiliated Hospital of Zhejiang Chinese Medical University.

Setting
One leader unit of the National Key Specialised Pulmonary Disease Cooperation Group in China.

Participants
Enrolled 545 patients who underwent PFT and bronchial provocation tests.

Outcome measures
We obtained physical information and pulmonary test data and established the model using logistic regression analysis. The Hosmer-Lemeshow goodness-of-fit test, area under the receiver operating characteristic curve (AUC), calibration plot and decision curve analysis were used to evaluate this model. All data were analysed using SPSS V.27 and RStudio software.

Results
The CVA group had more female patients (%) (68.12% vs 51.48%, p value

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Time-varying effects of COVID-19 vaccination on symptomatic and asymptomatic infections in a prospective university cohort in the USA

Objectives
Despite widespread vaccination programmes and consensus recommendations, the understanding of the durability of COVID-19 vaccination against ensuing infection and transmission at the individual level is incomplete. The objective of this study was to estimate the effects of time-varying covariates including time since vaccination and symptoms on subsequent positive SARS-CoV-2 test results and assess the stability of these effects between March 2020 and April 2022.

Design
Prospective cohort study.

Setting
Urban university in the USA.

Participants
Drexel University students, faculty, and staff (n=15 527) undergoing mandatory COVID-19 symptom tracking, testing and vaccinations.

Intervention
Systematic symptom tracking and SARS-COV-2 testing starting in September 2020 and mandatory COVID-19 vaccination starting in September 2021.

Main outcomes and measures
COVID-19 vaccine effectiveness modified by time since vaccination and symptoms.

Results
Using fit-for-purpose digitally based symptom and vaccine tracking and mandatory comprehensive testing for SARS-CoV-2 infection, we estimate the time-dependent effects of vaccination, symptoms and covariates on the risk of infection with a Cox proportional hazards model based on calendar time scale. We found a strong protective effect of vaccination against symptomatic infection. However, there was strong evidence of a protective effect against infection only in the first 90 days after completed vaccination, and only against symptomatic versus asymptomatic infection. The overall estimated effect of vaccination within 30 days, including asymptomatic infections, was 37.3% (95% CI 26%, 47%). Vaccine effect modification by reported symptoms and time period was estimated, revealing the protective effect of vaccination within 90 days against symptomatic infection that varied from 90% (95% CI 84%, 94%) to 49%(95% CI –77%, 85%) across time periods.

Conclusions
This study is among the first to prospectively capture complete COVID-19 symptom, testing and vaccination data over a multiyear period. Overall effectiveness of the COVID-19 vaccine against subsequent infection, including transmissible asymptomatic infections, is modest and wanes after 90 days. Vaccination policies may need to take these issues into account.

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Health valuation protocol for dual discrete choice experiment (dual-DCE) surveys to estimate the effects of different scenarios and attributes on main effects

Introduction
A typical health preference study conducts a single discrete choice experiment (DCE). For example, a health valuation study may elicit preferences on an individual’s health-related quality of life along five EQ-5D-5L attributes (Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Using this protocol, researchers can conduct a dual-DCE survey (ie, with two different full-block DCEs completed sequentially). To demonstrate this protocol, we will conduct 12 dual-DCE surveys in two waves and estimate the effects of different scenarios and descriptive systems on main effects (ie, incremental differences in value between levels).

Methods and analysis
Each of the two DCEs in a dual-DCE survey equates to a stand-alone health valuation study. To demonstrate this protocol, each is an EQ-5D-5L valuation study, including d-efficient blocks of 15 kaizen tasks and 5 paired comparisons. In wave 1 (six surveys, 1000 US adults each), the two DCEs will differ by scenario (1-year episodes ending in recovery or death or no duration/ending described). In wave 2 (six surveys, 200 US adults each), the two DCEs will include the same 5 EQ-5D-5L attributes but differ by the number of additional attributes related to cognition: none, one composite attribute (memory/concentration) and two component attributes (memory, concentration). For each DCE, we will estimate a conditional logit model and test for differences in value using cluster bootstrap techniques. We hypothesise that the values will differ by scenarios and systems. As secondary analyses, we assess the effects of sampling, scenario/system order and DCE order.

Ethics and dissemination
The independent review board (IRB) at Advarra determined that this research project (Pro00080475; 11 July 2024) is exempt from IRB oversight based on the Department of Health and Human Services regulations found at 45 CFR 46.104(d)(2). Furthermore, the IRB determined that the project is not subject to requirements for continuing review. To disseminate our findings, we will prepare multiple manuscripts for publication in peer-reviewed journals and present highlights at scientific meetings, such as the EuroQol Plenary Meeting, International Academy of Health Preference Research and ISPOR.

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Feasibility study of a co-designed, evidence-informed and community-based incentive intervention to promote healthy weight and well-being in disadvantaged communities in Scotland

Objectives
To feasibility test a novel community-based financial incentive scheme to promote healthy weight and well-being.

Design
Single-arm, prospective feasibility study using mixed methods.

Setting
Two communities in Scotland experiencing high levels of disadvantage according to the Scottish Index for Multiple Deprivation (SIMD). Community C1 is in a large rural area with a small town centre (population~1.5K) and community C2 is a small and urban community (population~9K), enabling contextual comparison.

Participants
Eligible adult (18 years or over) community members recruited through community outreach.

Intervention
The Enjoy Life LocallY (ELLY) intervention comprised free soup twice weekly (café/delivery/pickup); loyalty card stamped for engagement in community assets (such as local activities, groups and clubs) exchanged for a £25 shopping card when a participant attends a minimum of 9 assets over 12 weeks; goal setting; information resources; self-monitoring of weight and well-being.

Outcomes
Primary outcomes—feasibility of recruitment, retention and engagement. Acceptability of intervention components was assessed by self-reported questionnaires and interviews. Secondary outcomes—feasibility of collecting outcomes prioritised by communities for a future trial: health-related quality of life (EQ-5D-5L), mental well-being (WEMWBS), connectedness (Social Connectedness Scale) and weight-related measures (weight, body mass index (BMI)).

Results
Over 3 months, 75 community citizens (35 citizens in C1, 40 citizens in C2) were recruited (125% of target recruitment of 60 participants (117% of 30 participants C1 target, 133% of 30 participants C2 target), 84% female, baseline weight mean (SD)=84.8 kg (20) and BMI mean (SD)=31.9 kg/m2 (7.3), 65/75 (87%) living in disadvantaged areas (SIMD quintiles 1–3)). Retention at 12 weeks, defined by completion of outcome measures at 12 weeks, was 65 (87%). Participation in at least one asset for a minimum of 9 out of 12 weeks of the intervention was achieved by 55 (73%). All intervention components were acceptable, with the loyalty card being the most popular and the soup cafés the least popular. The mean average cost of the soup ingredients, per participant, over the 12 weeks was £12.02. Outcome data showed a small decrease in weight and BMI and a small increase in health-related quality of life, mental well-being and social connectedness.

Conclusions
The ELLY study recruited and retained participants from two disadvantaged communities in Scotland. The study was acceptable to participants and feasible to deliver. A full trial is warranted to determine effectiveness and cost-effectiveness, with consideration of scalability.

Trial registration number
The ELLY feasibility study was not pre-registered.

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Isokinetic muscle strength training combined with proprioceptive neuromuscular facilitation for rehabilitation of patients after anterior cruciate ligament reconstruction: a protocol for a randomised controlled trial

Introduction
Anterior cruciate ligament injury seriously affects the motor function of patients. Currently, there are numerous rehabilitation methods after anterior cruciate ligament reconstruction (ACLR). The aim of this study was to investigate the rehabilitation effect of isokinetic muscle strength training combined with proprioceptive neuromuscular facilitation (PNF) technique in postoperative patients. A single-blind randomised controlled trial was conducted to compare the difference between this combined therapy and conventional rehabilitation, and to provide a scientific basis for optimising the rehabilitation strategy after ACLR, to promote faster and better recovery of knee joint function in patients.

Methods and analysis
This study is a randomised controlled, assessor-blind trial. A total of 40 patients after ACLR were randomly divided into a control group and a test group. Conventional rehabilitation and isokinetic muscle strength training will be performed in the control group, while the test group will receive PNF techniques in addition to the interventions of the control group. These interventions were performed three times a week for 6 weeks. All interventions will be completed in the Department of Rehabilitation Medicine of the Second Affiliated Hospital of Xi’an Jiaotong University. The primary outcome measure will be assessed by knee proprioception. Secondary outcome measures will include knee isokinetic strength, balance ability and Lysholm knee function score. The above assessments will include a baseline assessment, an assessment after 6 weeks of intervention, and a follow-up visit at week 24.

Ethics and dissemination
This study was approved by the Ethics Committee of the Second Affiliated Hospital of Xi’an Jiaotong University (Number: 2024059). Study results will be published in open access peer-reviewed journals and may be shared at relevant meetings and research meetings.

Trial registration number
ChiCTR2400085897.

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Satisfaction with HIV/AIDS treatment and care services and its associated factors among adult people receiving antiretroviral therapy in Ethiopia: a systematic review and meta-analysis

Objective
To make healthcare programmes more patient-centred and efficient in light of limited resources, it is crucial to ensure patient satisfaction. There is limited information on the overall level of satisfaction with Human Immunodeficiency Virus/ Acquired Immune deficiency syndromes (HIV/AIDS) treatment and care services in Ethiopia. This meta-analysis aimed to generate a nationwide pooled estimate of the level of satisfaction with HIV/AIDS and associated factors by combining data from primary studies to provide a general overview of the effect across the country, aiming to informed policy decisions.

Design
Systematic review and meta-analysis.

Data source
PubMed, Scopus, Hinari, African journals online and Google Scholar were used to locate published studies.

Eligibility criteria
Observational studies assessing the level of satisfaction with HIV/AIDS care and treatment services and its associated factors among adult people living with HIV/AIDS receiving antiretroviral therapy in Ethiopia were included.

Data extraction and synthesis
Two authors extracted the data using a pre-established data extraction format and exported it to Stata V.17 for analysis. The Cochran-Q and I2 test statistics were used to measure the statistical heterogeneity among included studies. A random-effects meta-analysis model with the Der Simonian-Laird method was used to estimate the pooled effect size of satisfaction with HIV/AIDS care and treatment services with its 95% CI. Small study effects were assessed using Egger’s regression test at a 5% level of significance. A meta-regression analysis and a leave-one-out sensitivity analysis were also conducted.

Results
24 studies were included. The pooled level of satisfaction with HIV/AIDS treatment and care services in Ethiopia was 69.7% (95% CI 63.8, 75.5%) with a significant level of heterogeneity (I2=98.0%; p

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Development of a nomogram for predicting depression risk in patients with chronic kidney disease: an analysis of data from the US National Health and Nutrition Examination Survey, 2007-2014

Objectives
Depression frequently occurs among individuals suffering from chronic kidney disease (CKD), diminishing life quality considerably while accelerating the disease course. This study aims to create a predictive model to identify patients with CKD at high risk for depression.

Design
Analysis of cross-sectional data.

Setting
US National Health and Nutrition Examination Survey (2007–2014).

Participants
A total of 2303 patients with CKD (weighted=17 422 083) with complete data were included in the analysis.

Outcome measures
We used the least absolute shrinkage and selection operator regression for variable selection and constructed a weighted logistic regression model through stepwise backward elimination based on minimisation of the Akaike information criterion, visualised with a nomogram. Internal validation was conducted using 1000 bootstrap resamples. Model discrimination was assessed using receiver operating characteristic curves, calibration was evaluated using the Hosmer-Lemeshow test and calibration curves, and net benefits and clinical impact were analysed using decision curve analysis and comparative impact chart curves.

Results
The final model included 10 predictors: age, gender, poverty income ratio, body mass index, smoking, sleep time, sleep disorder, chest pain, diabetes and arthritis. The model achieved an area under the curve of 0.776 (95% CI 0.745 to 0.806) with good fit (Hosmer-Lemeshow p=0.805). Interventions within the 0.1–0.6 probability range showed significant benefits.

Conclusion
We have crafted a predictive model with good discriminative power that could potentially help clinicians identify patients with CKD at high risk for depression, thereby facilitating early intervention and improving the prognosis of these patients.

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