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Development and validation of the Good Limb Position Management Scale for Stroke Patients with Hemiplegia by Nurses: a cross-sectional study

Por: Leng · M. · Dong · Y. · Liu · B. · Zhang · X. · Ji · X. · Sun · F. · Li · M. · Yang · L. · Chen · X.
Background

A good limb position (GLP) plays an important role in the rehabilitation process of patients who have had a stroke with hemiplegia. However, there remains a lack of effective assessment tools for clinical nurses to evaluate their GLP management practices.

Objective

This study aimed to develop and test the psychometric properties of the Good Limb Position Management Scale for Stroke Patients with Hemiplegia by Nurses (GLPMSSPHN).

Design

A quantitative and cross-sectional design.

Setting

89 hospitals in 16 cities of China.

Participants

A total of 516 participants completed the questionnaire and were finally used for the analyses.

Main outcome measures

An initial scale was developed based on the Capability, Opportunity and Motivation-Behaviour model combined with a comprehensive literature review, semi-structured interviews, Delphi expert consultations and a pilot test. A field survey was then performed using the initial scale to test the reliability and validity of the scale. Reliability analysis was conducted by calculating Cronbach’s α coefficients and test–retest reliability. The results of exploratory factor analysis and confirmatory factor analysis were used as the validity index to further verify the model structure of the scale and develop a formal scale.

Results

The GLPMSSPHN was formulated with 4 dimensions and 35 items. Exploratory factor analysis extracted four factors, with a cumulative variance contribution rate of 81.842%, and confirmatory factor analysis indicated that the scale had good construct validity. The Cronbach’s α coefficient of the scale was 0.978, and the test–retest reliability was 0.863.

Conclusions

The GLPMSSPHN has ideal reliability and validity and provides a valid and reliable tool for clinical nurses to identify and assess the management level of GLP in patients who have had a stroke with hemiplegia.

Navigating a vulnerable transition: a qualitative study of the role of companions and providers in pregnancy and childbirth in Burkina Faso

Por: Wallengren · E. · Ouedraogo · K. · Hanson · C. · Mölsted Alvesson · H. · Bocoum · F. Y. · Kabore · C. P. · Dumont · A. · Betran · A. P. · Cleeve · A.
Objective

To explore women’s expectations and experiences of care and support from pregnancy to childbirth in Burkina Faso, with a focus on the role and impact of companions and providers.

Design

An exploratory qualitative study based on in-depth interviews with purposively sampled participants and employing reflexive thematic analysis.

Setting

Two public hospitals in urban Burkina Faso having implemented the ‘QUALIty DECision-making by women and providers for appropriate use of caesarean section’ intervention.

Participants

24 purposively selected postpartum women with variation in terms of parity, mode of birth, labour companionship experiences, education level and occupation were interviewed before discharge from the hospital.

Results

The two themes generated from the analysis elucidate how women rely on providers and companions to navigate uncertainty and vulnerability experienced during pregnancy and childbirth. Women viewed providers as essential for managing the biomedical risks of childbirth and voiced their need for care at critical moments. They expected companions to enhance the non-clinical aspects of their experiences by providing spiritual support and alleviating feelings of loneliness. However, participants also expressed ambivalence about companions witnessing intimate aspects of their birth experience and valued the ability to choose a companion as means to preserve personal integrity.

Conclusions

Both providers and labour companions play an essential role in enhancing women’s experiences of pregnancy and childbirth in Burkina Faso. Additional research and programmatic efforts are needed to support women’s equitable participation in patient–provider interactions and operationalise the notion of choice of a labour companion in a contextually appropriate manner.

Perinatal challenges for mothers of Haitian origin and their newborns in French Guiana: a historical cohort from 2013 to 2021

Por: Laumonnier · J. · Alcouffe · L. · Vendittelli · F. · Covis · S. · Bernard · S. · Nacher · M. · Elenga · N. · Osei · L.
Objectives

To describe the sociodemographic characteristics of mothers of Haitian origin and the obstetric and neonatal outcomes of their newborns born in French Guiana between 2013 and 2021 in order to identify specific vulnerabilities within this population.

Design

A descriptive, population-based study using data from a comprehensive birth cohort including all deliveries in French Guiana from 2013 to 2021.

Setting

All maternity units in French Guiana, a French overseas territory located in South America.

Participants

A total of 66 485 live births were recorded during the study period, including 14 065 (21.2%) births to mothers of Haitian origin.

Primary and secondary outcome measures

Sociodemographic characteristics, antenatal care indicators and neonatal outcomes were compared between mothers of Haitian origin and mothers of other origins. Adjusted odds ratios (aOR) and 95% CI were calculated for key outcomes.

Results

Compared with mothers of other origins, Haitian mothers had higher odds of delivering a newborn small for gestational age (aOR=1.41, 95% CI 1.32 to 1.50), neonatal hospitalisation at birth (aOR=1.19, 95% CI 1.11 to 1.28), having an insufficient number of antenatal visits (aOR=1.32, 95% CI 1.26 to 1.38) and lacking health insurance coverage (aOR=2.83, 95% CI 2.52 to 3.17). Conversely, they had a lower risk of adolescent pregnancy (

Conclusion

Mothers of Haitian origin in French Guiana experience distinct social and perinatal vulnerabilities. Strengthening equitable access to healthcare and implementing targeted community-based interventions are essential to improve maternal and neonatal health outcomes in this population.

Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS

Por: Trad · G. · Lenglet · T. · Ledoux · I. · Querin · G. · Blancho · S. · Marchand-Pauvert · V. · Hogrel · J.-Y. · Pradat · P.-F.
Introduction

Robotic rehabilitation on locomotion is a new approach in amyotrophic lateral sclerosis (ALS) and previous studies showed its feasibility. In this study, we aim to evaluate safety, patient’s experience and efficacy of a gait training programme with the Atalante exoskeleton, compared with usual care, on walking ability, functional capacity and other symptoms associated with ALS.

Methods and analysis

EXALS is a monocentric, prospective, interventional, open trial. 20 slowly progressing patients with gait deficits will be recruited. The study is conducted in three phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients practise their gait training at a rhythm of three sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment. An evaluation is planned before, in the middle and at the end of each phase. The primary outcome of the study is safety and tolerability of the Atalante exoskeleton. Secondary outcomes include: participants’ subjective impact and experience, attitude and motivation, efficacy and interactivity of the exoskeleton, walking ability, functional capacity, spasticity, balance, postural stability, lower limb muscle strength, quality of life, pain, fatigue, anxiety and depression. Statistical analyses will include descriptive methods for all variables and adverse events. Quantitative outcomes are analysed using repeated-measures ANOVA (analysis of variance) across the seven visits, with post hoc tests applied when appropriate. Nominal outcomes are evaluated using Cochran’s Q test with McNemar pairwise comparisons when significant. Associations between variables are examined using Spearman correlation coefficients. Missing data will be replaced using linear interpolation, and sensitivity analyses will be planned. Qualitative interview data are analysed using thematic analysis.

Ethics and dissemination

This study was approved by the French ethics committee CPP Nord-Ouest I (no. 23.02378.000201). Participant data are anonymised and securely stored in the laboratory’s database, accessible only to the research team. Results will be disseminated through peer-reviewed journals and conferences.

NCT06199284.

Causes of community deaths by verbal autopsy among persons with HIV in 33 districts in Zambia, 2020–2023

by Priscilla Kapombe, Choolwe Jacobs, Mark W. Tenforde, Kashala Kamalonga, Diane Morof, Terrence Lo, Mweene Cheelo, Lloyd Mulenga, Sombo Fwoloshi, Cordilia M. Himwaze, Patrick Musonda, Mpundu Makasa, Jonas Z. Hines

Zambia has achieved improvements in life expectancy among persons living with HIV (PLHIV) because of high antiretroviral therapy (ART) coverage, which should improve survival due to reductions in AIDS-defining conditions. However, recent estimates of the most common causes of death are not widely available. We utilized mortality surveillance data to report on common causes of death among persons with HIV who died in community settings in Zambia. The Zambian Ministry of Health conducted sentinel mortality surveillance of community deaths in 45 hospitals in 33 of 116 districts from January 2020 through December 2023. Verbal autopsies (VA) were conducted through interviews with relatives or close associates of deceased persons using the 2016 World Health Organization tool. HIV status was reported. A probable cause of death was assigned by a validated computer algorithm (InterVA5). We describe the top assigned causes of death stratified by HIV status. Verbal autopsies were conducted for 67,079 community deaths, of which 11,475 (17.1%) were persons with HIV. The mean age at death was 45 years among persons with HIV and 48 years for persons without HIV (T-test p 

Cutaneous anthrax outbreak associated with use of cattle hides and handling carcasses, Amudat District, Uganda, 2023–2024

by Patrick Kwizera, Richard Migisha, Hannington Katumba, Esther Nabatta, Samuel Gidudu, Benon Kwesiga, Job Morukileng, Lilian Bulage, Alex Riolexus Ario

Background

Anthrax is a zoonotic disease that remains endemic in Uganda, particularly in cattle-keeping areas. On December 28, 2023, the first suspected human case of anthrax was detected in Amudat District. We investigated to determine the outbreak’s magnitude, identify risk factors, and recommend prevention and control measures.

Methods

We defined a suspected cutaneous anthrax case as acute onset of ≥2 of the following: skin lesions (papule, vesicle, or eschar) on exposed areas such as the hands, forearms, shoulders, back, thighs or face, localized itching, redness, swelling, or regional lymphadenopathy, in Amudat residents from December 2023–June 2024.A confirmed case was a suspected case with PCR-positive test for Bacillus anthracis. In unmatched case-control study (1:3 ratio), we compared exposures among 40 cases and 120 controls. We identified cases through house-to-house search, medical record reviews, and snowballing among case-persons. Human and animal samples were collected and tested, alongside an environmental assessment. We used multivariable logistic regression to identify associated risk factors.

Results

We identified 102 cutaneous anthrax cases, including 7 confirmed cases; none died. The outbreak lasted 7 months, peaking in March 2024, with an overall attack rate of 169/100,000 (males: 196/100,000; females: 138/100,000). Use of cattle hides as bedding (OR=12; 95% CI:2.7–52) and butchering cattle carcasses (OR=6; 95% CI:1.8–19) were significantly associated with anthrax. The highest infection risk was observed among individuals with multiple exposures: butchered only (OR = 6.9, 95% CI:2.6–18), butchered and carried cattle parts (OR = 11, 95% CI:1.2–96), butchered and skinned (OR = 14, 95% CI:3.5–56), and butchered, carried, and skinned (OR = 17, 95% CI:1.6–219). No livestock had been vaccinated prior to the outbreak.

Conclusion

The outbreak was associated to use of cattle hides as bedding and the butchering of cattle carcasses. We recommended community education, livestock vaccination, and safe carcass handling to prevent future outbreaks.

Real-world efficacy of PD-1 inhibitors in treating oesophageal squamous cell carcinoma (ESCAPE): protocol of a multicentre, real-world, observational, cohort study

Por: Wang · C. · Xie · Q. · Miao · Y. · He · W. · Wang · K. · Liu · G. · Fang · Q. · Peng · L. · Chen · Y. · Zhou · J. · Lv · J. · Qi · Y. · Wang · Q. · Shi · Q. · Han · Y. · Leng · X.
Introduction

Oesophageal cancer (EC) presents a substantial global health challenge, ranking eighth in incidence and sixth in cancer-related mortality. Oesophageal squamous cell carcinoma (ESCC) is the primary subtype and accounts for approximately 90% of cases in Asia. Despite treatment advances, the 5-year survival rate remains modest at 10%–30%. Immune checkpoint inhibitors, exemplified by KEYNOTE-590 and CheckMate 577 trials, have reshaped EC therapeutic landscapes. Our study addresses the critical gap in understanding the real-world impact of PD-1 (Programmed Death-1) inhibitors, conducting a multicentre, real-world, observational cohort analysis focused on ESCC. This research endeavours to provide practical insights into PD-1 treatment for EC, facilitating informed clinical decision-making and optimising patient outcomes in diverse healthcare settings.

Methods and analysis

This multicentre study includes patients diagnosed with histopathologically confirmed ESCC who have consented to treatment with PD-1 inhibitors. It is structured into two distinct segments: Part A, characterised by its retrospective nature, and Part B, representing the prospective arm. Within both parts, four stratified cohorts are delineated, comprising Cohort 1 (preoperative neoadjuvant/conversion therapy), Cohort 2 (postoperative adjuvant therapy), Cohort 3 (first-line therapy for advanced ESCC) and Cohort 4 (≥2 lines of therapy for advanced ESCC). The primary endpoint is the objective response rate in diverse treatment cohorts. Secondary endpoints include pathologic complete response rate, disease-free survival, progression-free survival, overall survival, adverse events, immune-related adverse events, quality of life and the intricacies of immunotherapy patterns and hyperprogression. Furthermore, exploratory endpoints scrutinise potentially predictive biomarkers, as well as the clinical and genomic characteristics inherent to ESCC patients if possible. The study endeavours to enrol 417 participants, subject to a comprehensive 5-year follow-up period.

We will collect and analyse real-world data from Chinese ESCC patients treated with PD-1 inhibitors to observe and describe the efficacy and safety of PD-1 inhibitors in Chinese patients with ESCC at various treatment stages.

Ethics and dissemination

Ethical approval was provided by the Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital, China (Approval No. SCCHEC-02-2023-096). Each participating hospital has applied for research permission from the Institutional Review Board of its unit. We will disseminate the results through peer-reviewed journals and academic conferences.

Trial registration number

ChiCTR2300078657.

Effect of vitamin D supplementation during pregnancy and lactation on the development of infants born to Tanzanian women living with HIV: a secondary analysis of a randomised controlled trial

Por: Shobanke · T. · Muhihi · A. · Perumal · N. · Ulenga · N. · Al-Beity · F. M. A. · Duggan · C. P. · Fawzi · W. W. · Manji · K. P. · Sudfeld · C. R.
Background

Infants born to pregnant women living with HIV (WLHIV) are at greater risk for morbidity and mortality and may also have poorer developmental outcomes as compared with infants who are not exposed to HIV. Nutrition interventions in pregnancy may affect developmental outcomes.

Objectives

This study evaluated the effect of maternal vitamin D supplementation on infant development outcomes.

Design

We conducted a secondary analysis of a randomised, triple-blind, placebo-controlled trial of maternal vitamin D supplementation from June 2015 to October 2019.

Setting

Antenatal care clinics in Dar es Salaam, Tanzania.

Participants

Pregnant WLHIV and their offspring.

Interventions

Daily 3000 IU vitamin D3 or placebo supplements taken during pregnancy and lactation.

Outcome measures

Infants were assessed for cognitive, language and motor development at 1 year of age with the Caregiver Reported Early Development Instruments (CREDI).

Results

A total of 2167 infants were eligible, and 1312 of them completed CREDI assessments at 1 year of age. Vitamin D supplementation had no effect on overall CREDI z-scores (standardised mean difference (SMD) 0.03, 95% CI –0.09, 0.15, p value 0.66). There was also no evidence of a difference between vitamin D and placebo groups in language (SMD 0.06, 95% CI –0.08, 0.21, p value 0.40), motor (SMD 0.02, 95% CI –0.09, 0.14, p value 0.69) or cognitive domain z-scores (SMD 0.05, 95% CI –0.08, 0.17, p 0.48).

Conclusions

Maternal vitamin D supplementation during pregnancy and lactation did not affect infant development outcomes.

Trial registration number

ClinicalTrials.gov identifier: NCT02305927.

Access to maternal health services for young women with disabilities in Sub-Saharan Africa: a scoping review protocol

Por: Pebolo · P. F. · Kimera · E. · Nkulu Kalengayi · F. K. · Namatovu · F.
Introduction

Young women with disabilities (WWDs) face multiple barriers in accessing maternal healthcare services in low-resource settings. Consequently, they are at an increased risk of adverse maternal health outcomes due to young age and having a disability. This review focuses on synthesising evidence regarding the extent of access to maternal healthcare services and the barriers faced by young WWDs in Sub-Saharan Africa.

Methods and analysis

We will conduct a scoping review guided by the updated Joanna Briggs Institute methodology for scoping reviews. A systematic search of MEDLINE, EMBASE, Scopus, CINAHL, Web of Science Core Collection, Global Health, African Journal Online and Women’s Studies International will be performed to identify relevant articles published in English from 2007 to 2025. A team of two reviewers will independently screen the retrieved articles for relevancy based on the inclusion criteria, and a thematic synthesis will be undertaken to develop a descriptive analysis.

Ethics and dissemination

Since this review will only involve the analysis of published data, it does not require ethical approval. The results will be published in a peer-reviewed journal.

Registration

This review has been registered with the Open Science Framework DOI; https://doi.org/10.17605/OSF.IO/Q7Y8S.

Neoadjuvant camrelizumab combined with chemoradiotherapy and watch-and-wait strategy versus neoadjuvant chemoradiotherapy followed by surgery in locally advanced oesophageal squamous cell carcinoma: study protocol of a randomised controlled trial (PALACE-

Por: Wang · X. · Li · C. · Cao · Y. · Kang · X. · Leng · X. · Zheng · Y. · Zheng · B. · Guo · W. · Jing · H. · Han · Y. · Chen · C. · Li · Y. · Li · H.
Introduction

Combining immunotherapy with neoadjuvant chemoradiotherapy (neoCRT) has been shown to be safe, achieving a pathological complete response (pCR) rate of 56% in patients with locally advanced oesophageal squamous cell carcinoma (ESCC) in the PALACE-1 trial. This high pCR rate encourages us to explore the feasibility of postponing surgery after immunotherapy combined with neoCRT under active surveillance. This study aims to assess the efficacy, safety and patient-reported quality of life (QOL) of camrelizumab combined with neoCRT and watch-and-wait strategy versus neoCRT followed by surgery in locally advanced resectable ESCC.

Methods and analysis

The PALACE-3 trial is a multicentre, open-label, randomised non-inferiority trial expected to recruit 356 patients from six high-volume centres in China. The study is planned to start in May 2024 and end in December 2028. Eligible patients will be randomly assigned (1:1 ratio) to either camrelizumab combined with neoCRT and watch-and-wait strategy or neoCRT followed by surgery (standard surgery). In the active surveillance group, patients achieving a clinical complete response (cCR) to camrelizumab combined with neoCRT will undergo active surveillance, while those with residual disease or locoregional recurrence will undergo immediate surgery. Patients in the standard surgery group will proceed to surgery after neoCRT. The primary endpoint is the 3-year overall survival (OS) rate. The secondary endpoints include cCR rate, salvage surgery incidence, objective response rate, adverse events during the neoadjuvant therapy, pCR, tumour regression grade, R0 resection rate, lymph node ratio, perioperative complications, disease-free survival (DFS) and 3-year DFS rate, OS and health-related QOL.

Ethics and dissemination

This study has been approved by the Ethics Committee of Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital (Shanghai, China), as well as the ethics committees of the following participating centres: National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (Beijing, China); Sichuan Cancer Hospital and Institute, Sichuan Cancer Centre, School of Medicine, University of Electronic Science and Technology of China (Chengdu, China); The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital (Zhengzhou, China); Fujian Medical University Union Hospital (Fuzhou, China). Complete information about the study status, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. Written informed consent (Supplemental Material) will be obtained from each participant. All research outputs will be published in peer-reviewed journals and presented at national or international conferences.

Trial registration number

The trial was meticulously registered in advance on 1 April 2024 and can be accessed through the following link: https://www.clinicaltrials.gov/study/NCT06339060. The current protocol version number is V.2.0, and the protocol date is 30 June 2024.

Modified Mediterranean diet effects on Parkinsons disease (MED-PARK): a single-centre randomised controlled trial protocol

Por: Pirovano · E. · Marino · F. · Rossi · E. · Gennari · A. · Rasini · E. · Uslenghi · M. · Figueira · I. · Iacoviello · L. · Ferrari · M. · Cosentino · M.
Introduction

Only symptomatic treatments are available for patients with Parkinson’s disease (PD), the second most common chronic neurodegenerative disease worldwide, and it is therefore imperative to identify disease-modifying interventions that can alter the course of the disease. Epidemiological studies in PD patients suggest that a Mediterranean diet is associated with better motor and non-motor symptoms, slower progression and reduced mortality. Few interventional studies, however, investigated the relationship between diet and PD severity and progression. This study aims to determine whether a Mediterranean nutritional intervention can benefit motor and non-motor symptoms experienced by PD patients. As a secondary aim, the effects of a modified Mediterranean diet on the immune system, metabolomics and microbiome will also be assessed.

Methods and analysis

This is an interventional, non-pharmacological, superiority, randomised, controlled, single-centre, masked study with two parallel groups to evaluate the efficacy and safety of a modified Mediterranean diet on motor and non-motor patient-reported symptoms. PD patients meeting inclusion criteria will be enrolled (44 participants, aged between 40 years and 85 years), block-randomised and split into two parallel arms to either maintain their usual diet (control) or follow a modified Mediterranean diet for 6 months (intervention).

Patient-reported symptomatology is the primary outcome, measured through the Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) I+II score. Secondary outcomes include the immunophenotype of circulating cells of the adaptive immune system, the nasal and faecal microbiome composition, faecal and urinary metabolites and the measurement of inflammatory and metabolic markers. Disease severity (MDS-UPDRS III), non-motor symptomatology (Non-Motor Symptoms Scale), participant’s well-being (36-Item Short Form Health Survey), gastrointestinal symptomatology (Gastrointestinal Symptom Rating Scale and the Patient Assessment of Constipation Quality of Life) and intensity of dopaminergic replacement therapy (levodopa equivalents) will also be assessed. Evaluations will be conducted before the start and at the end of the intervention.

Ethics and dissemination

The Ethical Committee ‘Comitato Etico Territoriale Lombardia 5’ first approved this study on 17 September 2024 Prot. Nr. 420/24. Findings will be disseminated via peer-reviewed research papers and conference presentations.

Trial registration number

NCT06705517.

Mixed methods implementation research of oral antiviral treatment for COVID-19 in low- and middle-income countries: a study protocol

Por: Narayanasamy · S. · Gambanga · F. · Boeke · C. E. · Udayakumar · K. · Brothers · L. · Wolfe · C. R. · Agwuocha · C. · Asamoa-Amoakohene · M. N. · Detleuxay · K. · Griffith · B. C. · Hamza · N. · Joseph · J. · Kimani · P. · Kirungi · R. · Lufesi · N. · Mbewe · N. · McCarthy · E. · Mulenga
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT06360783.

Investigating the eye in Down syndrome as a window to Alzheimers disease: the REVEAL protocol - a clinical cross-sectional study

Por: Hunter · A. M. L. · Atkinson · S. · Murray · E. · Saunders · K. · Peto · T. · Csincsik · L. · Mitchell · J. · Zetterberg · H. · Strydom · A. · Little · J.-A. · Lengyel · I.
Introduction

There is a need for early, non-invasive and inexpensive biomarkers for Alzheimer’s disease (AD), which could serve as a proxy measure in prevention and intervention trials that might eventually be suitable for mass screening. People with Down syndrome (DS) are the largest patient group whose condition is associated with a genetically determined increased risk of AD. The REVEAL study aims to examine changes in the structure and function of the eye in individuals with DS compared with those with mild cognitive impairment (MCI) and cognitively healthy control (HC) individuals. REVEAL will also explore whether these changes are connected to inflammatory markers previously associated with AD.

Methods and analysis

The protocol describes a cross-sectional, non-interventional, single-centre study recruiting three cohorts, including (1) participants with DS (target n=50; age range, 6–60 years), (2) participants with MCI (target n=50; age range, 50–80 years) and (3) HC participants (target n=50; age range, 50–80 years). The primary research objective is to profile retinal, choroidal and lenticular status using a variety of eye imaging modalities and retinal functional testing to determine potential associations with cognitive status. The REVEAL study will also measure and compare established blood markers for AD and proteomic and transcriptomic marker profiles between DS, MCI and HC groups. Between-group differences will be assessed with an independent sample t-test and 2 tests for normally distributed or binary measures, respectively. Multivariate regression analysis will be used to analyse parameters across all three cohorts. Data collection began in October 2023 and is expected to end in October 2025.

Ethics and dissemination

The study gained a favourable opinion from Health and Social Care Research Ethics Committee A (REC reference 22/NI/0158; approved on 2 December 2022; Amendment 22/0064 Amend 1, 5 April 2023; Amendment 22/0064 Amend 2; 23 May 2024; Amendment 22/0064 Amend 3; 25 June 2024; Amendment 22/0064 Amend 4; 16 January 2025; Amendment 22.0064 Amend 5; 9 May 2025; Amendment 22.0064 Amend 6; 9 June 2025). The study has also been reviewed and approved by the School of Biomedical Sciences Research Ethics Filter Committee within Ulster University. Findings from the REVEAL study will be presented to academic audiences at international conferences and peer-reviewed publications in targeted high-impact journals after data collection and analysis are complete. Dissemination activities will also include presentations at public events.

Follow-up observation of eye movements in multiple system atrophy and Parkinsons disease: a cohort study

Por: Leng · Y. · Zhou · H. · Wei · L. · Jiang · Y. · Wang · X. · Sun · Y. · Li · F. · Chen · J. · Sun · W. · Wang · W. · Zhang · L. · Zhao · G. · Wang · Z.
Objectives

We aimed to explore the changes in oculomotor deficiencies during the follow-up of patients with multiple system atrophy (MSA) and Parkinson’s disease (PD), and to investigate the value of dynamic eye movement examination in their differential diagnosis.

Design

This was a cohort study conducted from 2017 to 2023.

Setting

The Movement Disorders Clinic at a tertiary hospital in Beijing, China.

Participants

56 patients with PD and 13 patients with MSA from an initial cohort of over 1100 with parkinsonism were included in the final longitudinal analysis.

Outcome measures

Multisystem evaluations were performed at baseline. Videonystagmography (VNG) was repeated to assess oculomotor dysfunction at baseline and during follow-up. Abnormalities in the fixation and gaze-holding test, without-fixation test, reflexive and memory-guided saccade tests, smooth pursuit test and optokinetic test were qualitatively and quantitatively recorded and statistically analysed.

Results

The median follow-up time of MSA (16 months) was significantly shorter than that of PD (27 months). In MSA, the incidence of abnormalities in fixation and gaze-holding tests (0% vs 30.8%, p=0.030), reflexive saccade tests (46.2% vs 84.6%, p=0.039, with slow saccades increasing from 7.7% to 46.2%, p=0.027) and smooth pursuit tests (38.5% vs 76.9%, p=0.047) increased significantly from baseline to the end of follow-up. In PD, no significant changes were revealed during follow-up.

Conclusions

MSA exhibited more rapid and prominent changes in fixation and gaze-holding tests, reflexive saccades and smooth pursuit tests than PD. Dynamic observation of oculomotor function may aid in the differential diagnosis of Parkinson’s syndrome.

The Impact of Undergraduate Informatics Education on Nurses' Acceptance of Information and Communication Technologies: A Cross-sectional Study

imageThis study aimed to examine if exposure to undergraduate nursing informatics educational modalities (ie, lecture, laboratory, and clinical experiences) made a difference in the acceptance of information and communication technologies among nurses in the practice setting. Also, to examine if there was a relationship between selected demographic characteristics and nurses' acceptance of information and communication technologies, a cross-sectional design was used for this study. The Technology Acceptance Model was the theoretical framework for this study. The modified Nursing Acceptance Survey was used to collect data based on the Technology Acceptance Model. The results indicated that exposure to undergraduate informatics education significantly influenced nurses' acceptance of information and communication technologies. The results identified laboratory and clinical as educational modalities influencing nurses' acceptance of information and communication technologies. Demographic characteristics have no statistically significant relationship to nurses' acceptance of information and communication technologies. The results showed that undergraduate informatics education statistically influences nurses' acceptance of information and communication technologies. Findings provide insight into that undergraduate informatics education is important for accepting information and communication technologies among nurses in the practice setting. Also, the findings recognized laboratory and clinical experiences as effective learning modalities for accepting information and communication technologies.
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