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AnteayerBMJ Open

Protocol for a construct and clinical validation study of MyCog Mobile: a remote smartphone-based cognitive screener for older adults

Por: Young · S. R. · McManus Dworak · E. · Byrne · G. J. · Jones · C. M. · Yoshino Benavente · J. · Yao · L. · Curtis · L. M. · Varela Diaz · M. · Gershon · R. · Wolf · M. · Nowinski · C.
Introduction

Annual cognitive screening in older adults is essential for early detection of cognitive impairment, yet primary care settings face time constraints that present barriers to routine screening. A remote cognitive screener completed on a patient’s personal smartphone before a visit has the potential to save primary care clinics time, encourage broader screening practices and increase early detection of cognitive decline. MyCog Mobile is a promising new remote smartphone-based cognitive screening app for primary care settings. We propose a combined construct and clinical validation study of MyCog Mobile.

Methods and analysis

We will recruit a total sample of 300 adult participants aged 65 years and older. A subsample of 200 healthy adult participants and a subsample of 100 adults with a cognitive impairment diagnosis (ie, dementia, mild cognitive impairment, cognitive deficits or other memory loss) will be recruited from the general population and specialty memory care centres, respectively. To evaluate the construct validity of MyCog Mobile, the healthy control sample will self-administer MyCog Mobile on study-provided smartphones and be administered a battery of gold-standard neuropsychological assessments. We will compare correlations between performance on MyCog Mobile and measures of similar and dissimilar constructs to evaluate convergent and discriminant validity. To assess clinical validity, participants in the clinical sample will self-administer MyCog Mobile on a smartphone and be administered a Mini-Cog screener and these data will be combined with the healthy control sample. We will then apply several supervised model types to determine the best predictors of cognitive impairment within the sample. Area under the receiver operating characteristic curve, accuracy, sensitivity and specificity will be the primary performance metrics for clinical validity.

Ethics and dissemination

The Institutional Review Board at Northwestern University (STU00214921) approved this study protocol. Results will be published in peer-reviewed journals and summaries provided to the study’s funders.

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial

Por: Moreno · M. · Barry · A. · Gmeiner · M. · Yaro · J. B. · Serme · S. S. · Byrne · I. · Ramjith · J. · Ouedraogo · A. · Soulama · I. · Grignard · L. · Soremekun · S. · Koele · S. · ter Heine · R. · Ouedraogo · A. Z. · Sawadogo · J. · Sanogo · E. · Ouedraogo · I. N. · Hien · D. · Sirima · S. B
Introduction

Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing Plasmodium falciparum malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population.

Methods and analysis

We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.

Ethics and dissemination

The London School of Hygiene & Tropical Medicine’s Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results.

Trial registration number

NCT05878366.

Effectiveness of an online intervention for parents/guardians of children aged 4-7 years who are concerned about their childs emotional and behavioural development: protocol for an online randomised controlled trial (EMERGENT study)

Por: Frings · D. · Reavey · P. · Chew · J. · Leahy · M. · Allabyrne · C. · Herteliu · C.
Introduction

The demand for resources to support emotional and behavioural development in early childhood is ever increasing. However, conventional interventions are lacking in resources and have significant barriers. The Embers the Dragon programme helps address the growing unmet need of children requiring support. The delivery of the current project seeks to help support parents, reduce the burden placed on pressed services (eg, Child and Adolescent Mental Health Services) and to help improve the emotional and behavioural development of children.

Methods and analysis

This project aims to investigate the efficacy and acceptability of Embers on parenting and children’s psychosocial outcomes. 364 parents/guardians of children aged between 4 and 7 will be recruited via the internet, schools and general practitioners (GPs). This is an online waitlist-controlled trial with three arms: (1) control arm, (2) access to Embers arm and (3) access to Embers+school. Participants will be randomised (1:1) into (1) or (2) to evaluate the use of Embers at home. To evaluate scalability in schools, (3) will be compared with (2), and (1) to test efficacy against treatment as usual (not receiving the intervention). Qualitative interviews will also be conducted. Primary outcomes are the Parental Self-efficacy Scale, Strengths and Difficulties Questionnaire and qualitative interviews. Outcomes will be compared between the three groups at baseline, 8, 16 and 24 weeks.

Ethics and dissemination

Ethical approval has been granted by the London South Bank University ethics panel (ETH2324-0004). To recruit via GPs, NHS ethical approval has been applied for, and the IRAS (331410) application is under consideration by the Central Bristol REC. The results of the project will be submitted for publication in a peer-reviewed journal. Parents/guardians will provide informed consent online prior to taking part in the study. For the interviews, assent will be taken from children by the researchers on the day.

Trial registration number

ISRCTN58327872

Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study

Objectives

Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.

Design

Prospective observational cohort study.

Setting

12 National Health Service centres in England.

Participants

Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.

Primary and secondary outcome measures

Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.

Results

In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (–9.5%, 95% CI –14.3% to -4.8% p

Conclusions

Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.

Trial registration number

NCT02841527 and ISRCTN00786323.

What is the current global health participation and future interest of healthcare students and National Health Service (NHS) staff? A cross-sectional research study of healthcare students and NHS staff in England

Por: Goldstone · R. · Hinds · R. · McCarthy · R. · Byrne · G. · Keen · D.
Objectives

This research aimed to understand the prior and current global health participation, current availability of and future interest in participating in global health activities healthcare students and National Health Service (NHS) staff.

Design

An online survey was conducted on NHS staff and healthcare students in England between July and November 2021. The survey was disseminated to all secondary care providers in the English NHS and universities in England. A volunteer sample of 3955 respondents, including 2936 NHS staff, 683 healthcare students, 172 individuals combining NHS working and study and 164 respondents classified as other.

Results

Most (80%) respondents had not participated in a global health activity before, with 6% having previously participated, a further 3% currently participating and 11% unsure. Among those who had participated, the most common types of activity were attending global health events (75%). The most common reason for not participating was a limited knowledge of opportunities (78%). When asked about their future interest in global health participation, more than half of respondents (53%) indicated an interest and 8% were not interested. There was an significant proportion (39%) answering unsure, indicating a possible lack of understanding about global health participation.

Conclusions

Global health has gathered increasing significance in recent years, both in policy and in education and training for healthcare professionals. Despite recognition of the role global learning plays in knowledge enhancement, skill development and knowledge exchange, this study suggests that global health participation remains low among NHS staff and healthcare students.

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