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Experiences of adolescents using sexual health services on Reunion Island: protocol for a qualitative phenomenological study

Por: Reynaud · D. · Laboureur · E. · Marimoutou · C. · Cartron · E.
Introduction

Adolescence and early adulthood are often critical periods of sexual development. The discovery of sexual intercourse can lead to sexual risk-taking which may impact the incidence of sexually transmitted infections (STIs) and unwanted pregnancies. Despite available sexual health services on Reunion Island, sexual health indicators for adolescents are very poor showing a high number of teenage pregnancies and abortions, low use of contraception and an upsurge of STIs. In contrast, this French region is equipped with many services and resources that enable young adults to make informed sexual health choices. This study protocol describes the methodology to describe adolescent experiences of using sexual health services on Reunion Island.

Methods and analysis

A monocentric descriptive qualitative study using a phenomenological approach will be conducted from December 2022 to August 2023 and will be based on face-to-face semistructured interviews with participants aged 15–19 years and residing on Reunion Island. Recruitment will be distributed at various educational institutions and sexual health centres and will be facilitated by the ‘snowball’ and ‘word-of-mouth’ effect. Data analysis will be independently carried out by three investigators to increase reliability. An interpretative phenomenological analysis will be performed.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Hospital Center University De Bordeaux (CER-BDX-2022-55). Data generated do not fall within the field of biological or medical knowledge nor into the category of Research Involving the Human Person as defined in Articles L. 1121-1 and R. 1121-1 of the Public Health Code in France. All participants will receive information about the study in verbal and written forms and will give their oral consent before enrolment. Results will be published in a peer-reviewed journal as well as presented and disseminated at the Regional Health Agency of Reunion Island, conferences and in meetings with school directors.

Prehospital acute life-threatening cardiovascular disease in elderly: an observational, prospective, multicentre, ambulance-based cohort study

Objective

The aim was to explore the association of demographic and prehospital parameters with short-term and long-term mortality in acute life-threatening cardiovascular disease by using a hazard model, focusing on elderly individuals, by comparing patients under 75 years versus patients over 75 years of age.

Design

Prospective, multicentre, observational study.

Setting

Emergency medical services (EMS) delivery study gathering data from two back-to-back studies between 1 October 2019 and 30 November 2021. Six advanced life support (ALS), 43 basic life support and five hospitals in Spain were considered.

Participants

Adult patients suffering from acute life-threatening cardiovascular disease attended by the EMS.

Primary and secondary outcome measures

The primary outcome was in-hospital mortality from any cause within the first to the 365 days following EMS attendance. The main measures included prehospital demographics, biochemical variables, prehospital ALS techniques used and syndromic suspected conditions.

Results

A total of 1744 patients fulfilled the inclusion criteria. The 365-day cumulative mortality in the elderly amounted to 26.1% (229 cases) versus 11.6% (11.6%) in patients under 75 years old. Elderly patients (≥75 years) presented a twofold risk of mortality compared with patients ≤74 years. Life-threatening interventions (mechanical ventilation, cardioversion and defibrillation) were also related to a twofold increased risk of mortality. Importantly, patients suffering from acute heart failure presented a more than twofold increased risk of mortality.

Conclusions

This study revealed the prehospital variables associated with the long-term mortality of patients suffering from acute cardiovascular disease. Our results provide important insights for the development of specific codes or scores for cardiovascular diseases to facilitate the risk of mortality characterisation.

Early offering transcatheter aortic valve replacement to patients with moderate aortic stenosis: quantifying costs and benefits - a Markov model-based simulation study

Por: Nguyen · D. · Marwick · T. · Moodie · M. · Gao · L.
Objective

Aortic stenosis (AS) is one of the most common acquired cardiac valvular diseases. The success of transcatheter aortic valve implantation (TAVI) for severe AS has led to increasing interest in its use to earlier disease—moderate AS (MAS).

Design

Model-based study using a Markov microsimulation technique to evaluate the long-term costs and benefits associated with ‘early’ TAVI. Key data inputs were sourced from the international literature and costs were obtained from Australian sources.

Setting

Australian health care system perspective.

Participants

10 000 hypothetical MAS patients with or without left ventricular diastolic dysfunction or impaired left ventricular ejection fraction.

Intervention

Comparing early TAVI to medical management over a life time horizon for MAS patients aged >65 years. We evaluated the cost-effectiveness of offering early TAVI in five scenarios (10%, 25%, 50%, 75% and 90% take-up rates).

Primary and secondary outcome measures

The primary outcome measure is quality-adjusted life years (QALY) gained and the incremental cost–utility ratio (ICUR). Secondary outcomes are life-years gained and the number of heart failure case avoided.

Results

Offering early TAVI for MAS patients resulted in both higher healthcare costs and greater benefits (an increase of 3.02 QALYs or 3.99 life-years) per person treated. The ICUR was around $A10 867 and $A11 926 per QALY gained for all five scenarios, with the total cost of early TAVI to the healthcare system being anticipated to be up to $A3.66 billion. Sensitivity analyses indicated a 100% probability of being cost-effective with a willingness to pay threshold of $A50 000/QALY. The benefits remained, even with assumptions of high levels of repeat valve replacement after TAVI.

Conclusion

While ongoing randomised controlled trials will define the benefit of TAVI to MAS patients, these results suggest that this intervention is likely to be cost-effective.

Intrapartum care measures and indicators for monitoring the implementation of WHO recommendations for a positive childbirth experience: a scoping review

Por: Vallely · L. H. · Shalit · A. · Nguyen · R. · Althabe · F. · Pingray · V. · Bonet · M. · Armari · E. · Bohren · M. · Homer · C. · Vogel · J. P.
Objective

We aimed to identify all available studies describing measures or indicators used to monitor 41 intrapartum care practices described in the 2018 WHO intrapartum care recommendations, with a view to informing development of standardised measurement of implementing these recommendations.

Design

Systematic scoping review.

Methods

We conducted a scoping review to identify studies reporting measures of intrapartum care published between 1 January 2000 and 28 June 2021. Primary and secondary outcome measures included study characteristics (publication year, journal, country and World Bank classification) and intrapartum care measure characteristics (definition, numerator, denominator, measurement level and measurement approach). We searched MEDLINE, EMBASE, CINAHL, Cochrane Library, the Maternity and Infant Care Database, Global Index Medicus and grey literature using structured search terms related to included recommendations, focusing on respectful and supportive care, and clinical practices performed throughout labour and birth. The measures identified were classified by the WHO recommendation and their characteristics reported.

Results

We identified 150 studies which described 1331 intrapartum care measures. These measures corresponded to 35 of the 41 included WHO recommendations, and represented all domains of the WHO recommendations (care throughout labour and birth, first stage of labour, second stage of labour, third stage of labour). A total of 40.1% (534 of 1331 measures) of measures were related to respectful maternity care. Most studies used a questionnaire or survey measurement approach (522 of 1331 measures, 39.2%).

Conclusion

This scoping review presents a database of existing intrapartum care measures used to monitor the quality of intrapartum care globally. There is no clear consensus on a core set of measures for evaluating the practice of the WHO’s intrapartum care recommendations. This review provides a foundation to support the development of a core set of internationally standardised intrapartum care measures for the WHO intrapartum care recommendations, highlighting key areas requiring consensus and validation, and measure development.

Exploring the outcomes of research engagement using the observation method in an online setting

Por: Marshall · D. A. · Suryaprakash · N. · Lavallee · D. C. · Barker · K. L. · Mackean · G. · Zelinsky · S. · McCarron · T. L. · Santana · M. J. · Moayyedi · P. · Bryan · S.
Objective

The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.

Design

We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.

Setting

The study was conducted online.

Participants

Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.

Main outcome measures

Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.

Results

Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.

Conclusions

Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

Perceived value and benefits of the Community Paramedicine at Clinic (CP@clinic) programme: a descriptive qualitative study

Por: Marzanek · F. · Nair · K. · Ziesmann · A. · Paramalingam · A. · Pirrie · M. · Angeles · R. · Agarwal · G.
Objectives

Community Paramedicine (CP) is increasingly being used to provide chronic disease management for vulnerable populations in the community. CP@clinic took place in social housing buildings to support cardiovascular health and diabetes management for older adults. The purpose of this study was to examine participant perceptions of their experience with CP@clinic as well as potential ongoing programme benefits.

Design

This descriptive qualitative study used focus groups to understand resident experiences of the CP@clinic programme. Groups were facilitated by experienced moderators using a semistructured guide. An inductive coding approach was used with at least two researchers taking part in each step of the analysis process.

Setting

Community-based social housing buildings in Ontario, Canada.

Participants

Forty-one participants from four CP@clinic sites took part in a focus group. Convenience sampling was used with anyone having taken part in a CP@clinic session being eligible to attend the focus group.

Results

Analysis yielded six themes across two broad areas: timely access to health information and services, support to achieve personal health goals, better understanding of healthcare system (Personal Benefits); and sense of community, comfortable and familiar place to talk about health, facilitated communication between healthcare professionals (Programme Structure). Participants experienced discernible health changes that motivated their participation. CP@clinic was viewed as a programme that created connections within the building and outside of it. Participants were enthusiastic for the continuation of the programme and appreciated the consistent support to meet their health goals.

Conclusions

CP@clinic was successful in creating a supportive and friendly environment to facilitate health behavioural changes. Ongoing implementation of CP@clinic would allow residents to continue to build their chronic disease management knowledge and skills.

Trial registration number

Trial registration number: NCT02152891, Clinicaltrials.gov.

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol

Por: Abdel Shaheed · C. · Ivers · R. · Vizza · L. · McLachlan · A. · Kelly · P. J. · Blyth · F. · Stanaway · F. · Clare · P. J. · Thompson · R. · Lung · T. · Degenhardt · L. · Reid · S. · Martin · B. · Wright · M. · Osman · R. · French · S. · McCaffery · K. · Campbell · G. · Jenkins · H. · Mathie
Introduction

Low back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines.

Methods and analysis

This is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient–participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient–participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned.

Ethics and dissemination

The trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations.

Trial registration number

ACTRN12622001505796.

Angiotensin II in liver transplantation (AngLT-1): protocol of a randomised, double-blind, placebo-controlled trial

Por: Bokoch · M. P. · Tran · A. T. · Brinson · E. L. · Marcus · S. G. · Reddy · M. · Sun · E. · Roll · G. R. · Pardo · M. · Fields · S. · Adelmann · D. · Kothari · R. P. · Legrand · M.
Introduction

Catecholamine vasopressors such as norepinephrine are the standard drugs used to maintain mean arterial pressure during liver transplantation. At high doses, catecholamines may impair organ perfusion. Angiotensin II is a peptide vasoconstrictor that may improve renal perfusion pressure and glomerular filtration rate, a haemodynamic profile that could reduce acute kidney injury. Angiotensin II is approved for vasodilatory shock but has not been rigorously evaluated for treatment of hypotension during liver transplantation. The objective is to assess the efficacy of angiotensin II as a second-line vasopressor infusion during liver transplantation. This trial will establish the efficacy of angiotensin II in decreasing the dose of norepinephrine to maintain adequate blood pressure. Completion of this study will allow design of a follow-up, multicentre trial powered to detect a reduction of organ injury in liver transplantation.

Methods and analysis

This is a double-blind, randomised clinical trial. Eligible subjects are adults with a Model for End-Stage Liver Disease Sodium Score ≥25 undergoing deceased donor liver transplantation. Subjects are randomised 1:1 to receive angiotensin II or saline placebo as the second-line vasopressor infusion. The study drug infusion is initiated on reaching a norepinephrine dose of 0.05 µg kg-1 min-1 and titrated per protocol. The primary outcome is the dose of norepinephrine required to maintain a mean arterial pressure ≥65 mm Hg. Secondary outcomes include vasopressin or epinephrine requirement and duration of hypotension. Safety outcomes include incidence of thromboembolism within 48 hours of the end of surgery and severe hypertension. An intention-to-treat analysis will be performed for all randomised subjects receiving the study drug. The total dose of norepinephrine will be compared between the two arms by a one-tailed Mann-Whitney U test.

Ethics and dissemination

The trial protocol was approved by the local Institutional Review Board (#20–30948). Results will be posted on ClinicalTrials.gov and published in a peer-reviewed journal.

Trial registration number

ClinicalTrials.govNCT04901169

Incidence and predictors of respiratory distress syndrome among low birth weight neonates in the first seven days in Northwest Ethiopia Comprehensive Specialized Hospitals, 2023: A retrospective follow-up study

Por: Wondie · W. T. · Legesse · B. T. · Mekonnen · G. B. · Degaga · G. T. · Zemariam · A. B. · Gedefaw · G. D. · Abebe · D. E. · Kassie · Y. T. · Gonete · A. T. · Belay · A. E. · Wubneh · C. A.
Introduction

Respiratory distress syndrome is a catastrophic respiratory problem among low birth weight neonates. It increases the suffering of neonates and the economic expenditure of the countries. Notably, it is a major public health issue in low-income and middle-income countries such as Ethiopia. Despite this, studies regarding respiratory distress syndrome among low birth weight neonates were limited in Ethiopia.

Objective

To assess the incidence and predictors of respiratory distress syndrome among low birth weight neonates in the first 7 days in Northwest Ethiopia Comprehensive Specialized Hospitals.

Method

Multicentred institution-based retrospective follow-up study was conducted from 19 September 2021 to 1 January 2023, among 423 low birthweight neonates. A simple random sampling technique was used. The data were collected using a data extraction checklist from the medical registry of neonates. The collected data were entered into EPI-DATA V.4.6.0.6. and analysed using STATA V.14. The Kaplan-Meier failure curve and log-rank test were employed. Bivariable and multivariable Weibull regression was carried out to identify predictors of respiratory distress syndrome. Statistical significance was declared at a p≤0.05.

Result

The incidence rate of respiratory distress syndrome was found to be 10.78 (95% CI 9.35 to 12.42) per 100 neonate days. Fifth minute Appearance, Pulse, Grimace, Activity, Respiration (APGAR score)

Conclusion

The incidence of respiratory distress syndrome was higher than other studies conducted on other groups of neonates. Multiple pregnancy, fifth minute APGAR score, caesarean section, prematurity, extremely low birth weight and very low birth weight were predictors of respiratory distress syndrome. However, it needs further prospective study. Therefore, the concerned stakeholders should give due attention and appropriate intervention for these predictors.

Protocol for a cluster randomised trial of a goal-oriented care approach for multimorbidity patients supported by a digital platform

Por: Gil Conde · M. · Peyroteo · M. · Maria · A. · Maia · M. R. · Gregorio · J. · Paulo · M. S. · Alves · M. · Papoila · A. L. · Lapao · L. V. · Heleno · B.
Introduction

Health information systems represent an opportunity to improve the care provided to people with multimorbidity. There is a pressing need to assess their impact on clinical outcomes to validate this intervention. Our study will determine whether using a digital platform (Multimorbidity Management Health Information System, METHIS) to manage multimorbidity improves health-related quality of life (HR-QoL).

Methods and analysis

A superiority, cluster randomised trial will be conducted at primary healthcare practices (1:1 allocation ratio). All public practices in the Lisbon and Tagus Valley (LVT) Region, Portugal, not involved in a previous pilot trial, will be eligible. At the participant level, eligible patients will be people with complex multimorbidity, aged 50 years or older, with access to an internet connection and a communication technology device. Participants who cannot sign/read/write and who do not have access to an email account will not be included in the study. The intervention combines a training programme and a customised information system (METHIS). Both are designed to help clinicians adopt a goal-oriented care model approach and to encourage patients and carers to play a more active role in autonomous healthcare. The primary outcome is HR-QoL, measured at 12 months with the physical component scale of the 12-item Short Form questionnaire (SF-12). Secondary outcomes will also be measured at 12 months and include mental health (mental component Scale SF-12, Hospital Anxiety and Depression Scale). We will also assess serious adverse events during the trial, including hospitalisation and emergency services. Finally, at 18 months, we will ask the general practitioners for any potentially missed diagnoses.

Ethics and dissemination

The Research and Ethics Committee (LVT Region) approved the trial protocol. Clinicians and patients will sign an informed consent. A data management officer will handle all data, and the publication of several scientific papers and presentations at relevant conferences/workshops is envisaged.

Trial registration number

NCT05593835.

Traditional management of female infertility in Africa: a scoping review protocol

Por: Mashaah · T. · Muziringa · M. · Gomo · E. · Chideme-Maradzika · J. · Madziyire · M. G. · January · J.
Introduction

Infertility adversely affects the sexual reproductive health and overall quality of life of people. Recent estimates show that about one in six people (both men and women) experience infertility in their lifetime. This scoping review will, therefore, map the existing evidence on traditional management of female infertility in Africa including the effectiveness of the traditional healthcare systems, to inform policy and practice.

Methods

The scoping review will be guided by the Arksey and O’Malley framework in conjunction with the Joanna Briggs Institute updated methodological guidance for scoping reviews. A search strategy will be developed, which will target the following databases: PubMed, Scopus, Embase, CINAHL, Google Scholar and Africa-Wide Information including grey literature. The screening of titles, abstracts and full text will be done by two independent reviewers. Data will be extracted, analysed numerically and thematically. The reporting of the scoping review will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist.

Ethics and dissemination

This scoping review will not require ethical approval as this is secondary analysis of peer-reviewed articles. The findings of the review will be disseminated on various platforms including conferences, meetings to key stakeholders and in a peer-reviewed journal for wider sharing.

Experience and impact of gender-based violence in Honiara, Solomon Islands: a cross-sectional study recording violence over a 12-month period

Por: Chadwick · V. · Kluckow · H. · Mapstone · K. · Whiffin · V. · Ryder · B. · Rimon · M. · Hebala · H. · Hill · S. · Martiniuk · A. L.
Objective

This study aims to collect data on the experience and impact of gender-based violence experienced by women attending health clinics in Honiara, Solomon Islands.

Method

Any woman over the age of 18 who attended a local health clinic in Honiara, Solomon Islands during the time of recruitment (ten consecutive weekdays in May 2015) was eligible to participate in an interviewer administered, in-person survey, gathering data on gender-based violence over the past 12 months.

Results

A total of 100 women were recruited into this study. Of these women, 47% of women reported experiencing physical or sexual violence in the past 12 months. The most common perpetrators were the woman’s husband or boyfriend. There are low rates of reporting, particularly through formal avenues such as to police or village leaders. Alcohol was involved in more than half the cases of reported violence.

Conclusion

Women in this study report high rates of gender-based violence. To our knowledge, this is the only study examining women’s personal experience of gender-based violence in the Solomon Islands, with self-reported data on the frequency and nature of the violence, and the impact on women, including physical and mental, utilisation of healthcare services, police and legal involvement. Efforts to reduce gender-based violence should aim to reduce intimate partner violence, increase reporting and address wider social attitudes towards gender equality.

REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol

Por: Deane · A. M. · Alhazzani · W. · Guyatt · G. · Finfer · S. · Marshall · J. C. · Myburgh · J. · Zytaruk · N. · Hardie · M. · Saunders · L. · Knowles · S. · Lauzier · F. · Chapman · M. J. · English · S. · Muscedere · J. · Arabi · Y. · Ostermann · M. · Venkatesh · B. · Young · P. · Thabane · L
Introduction

The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.

Methods and analysis

REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.

Ethics and dissemination

All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.

Trial registration number

NCT03374800.

Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial

Por: Molina Hidalgo · C. · Collins · A. M. · Crisafio · M. E. · Grove · G. · Kamarck · T. W. · Kang · C. · Leckie · R. L. · MacDonald · M. · Manuck · S. B. · Marsland · A. L. · Muldoon · M. F. · Rasero · J. · Scudder · M. R. · Velazquez-Diaz · D. · Verstynen · T. · Wan · L. · Gianaros · P. J
Introduction

Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

Methods and analysis

In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethics and dissemination

Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

Trial registration number

NCT03841669.

Relationship between Framingham Cardiovascular Risk Score and cognitive performance among ageing rural Indian participants: a cross-sectional analysis

Por: Mensegere · A. L. · Sundarakumar · J. S. · Diwakar · L. · Issac · T. G. · SANSCOG Study Team · Gangadhar · Rao · Rao · Sivakumar
Objective

The burden of cardiovascular risk factors is increasing in India, which, in turn, can adversely impact cognition. Our objective was to examine the effect of cardiovascular risk factors measured by Framingham Risk Score (FRS) on cognitive performance among a cohort of healthy, ageing individuals (n=3609) aged ≥45 years from rural India.

Design

A cross-sectional analysis.

Setting

A rural community setting in southern India.

Participants

Healthy, ageing, dementia-free participants, aged 45 years and above, belonging to the villages of Srinivaspura (a rural community located around 100 km from Bangalore, India), were recruited.

Primary outcome measures

Using a locally adapted, validated, computerised cognitive test battery, we assessed cognitive performance across multiple cognitive domains: attention, memory, language, executive functioning and visuospatial ability.

Results

The median (IQR) age of the sample was 57 (50.65) and 50.5% were women. Multiple linear regression analysis showed that participants with higher FRS performed poorly in attention (visual attention (β=–0.018, p=0.041)), executive functioning (categorical fluency (β=–0.064, p

Conclusion

Increased cardiovascular risk as evidenced by FRS was associated with poorer cognitive performance in all cognitive domains among dementia-free middle-aged and older rural Indians. It is imperative to design and implement appropriate interventions (pharmacological and lifestyle-based) for cardiovascular risk reduction and thereby, prevent or mitigate accelerated cognitive impairment in ageing individuals.

Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease: protocol for a randomised controlled feasibility study

Por: Schmid · A. S. · Ehrler · M. · Wehrle · F. · Tuura · R. O. · Kretschmar · O. · Landolt · M. · Latal · B.
Introduction

Children with congenital heart disease (CHD) are at risk for executive functions (EF) impairments. To date, interventions have limited effects on EF in children and adolescents with complex CHD. Therefore, we developed a new multimodal and personalised EF intervention (E-Fit). This study aims to test the feasibility of this intervention called ‘E-Fit’ for children with complex CHD and EF impairments.

Methods and analysis

This is a single-centre, single-blinded, randomised controlled feasibility study exploring the E-Fit intervention. We aim to enrol 40 children with CHD aged 10–12 years who underwent infant cardiopulmonary bypass surgery and show clinically relevant EF impairments (T-score ≥60 on any Behaviour Rating Inventory for Executive Function questionnaire summary scale). The multimodal intervention was developed with focus groups and the Delphi method involving children and adolescents with CHD, their parents and teachers, and health professionals. The intervention is composed of three elements: computer-based EF training using CogniFit Inc 2022, performed three times a week at home; weekly EF remote strategy coaching and analogue games. The content of the computer and strategy training is personalised to the child’s EF difficulties. The control group follows their daily routines as before and completes a diary about their everyday activities four times a week. Participants will be randomised in a 1:1 ratio. Feasibility is measured by the participants’ and providers’ ratings of the participants’ adherence and exposure to the intervention, recruitment rates and the evaluation of the intended effects of the programme.

Ethics and dissemination

Local ethics committee approval was obtained for the study (BASEC-Nr: 2021-02413). Parents provide written informed consent. Key outputs from the trial will be disseminated through presentations at conferences, peer-reviewed publications and directly to participating families. Furthermore, these results will inform the decision whether to proceed to a randomised controlled trial to investigate effectiveness.

Trial registration number

NCT05198583.

'The burden of wanting to make it right: thematic analysis of semistructured interviews to explore experiences of planning for crisis standards of care and ventilator allocation during the COVID-19 pandemic in the USA

Por: MacMartin · M. · Zeng · A. · Chelen · J. · Barnato · A. · Chuang · E.
Objectives

The COVID-19 pandemic prompted planning for clinical surges and associated resource shortages, particularly of equipment such as ventilators. We sought to examine the experience of the healthcare professionals who created policies for crisis standards of care, and allocation of ventilators in the event of shortage.

Design

To that end, we conducted semistructured interviews with healthcare professionals in the USA involved in institutional planning for resource shortages in the setting of the COVID-19 pandemic.

Setting

USA.

Participants

We conducted 25 interviews between May and July 2021. Half of the respondents were female (48%), many from Northeastern institutions (52%), and most practised in academic institutions (92%).

Results

Many (64%) respondents reported that their institution had an approved policy to guide ventilator allocation in the event of a shortage. We identified one overarching theme: the work of planning for resource shortages imposed a psychological burden on many planners. We identified four subthemes that influenced that burden: impact of leadership, institutional variation in process and policies, faith in the policies and future directions.

Conclusions

Improved leadership strategies and cross-institutional collaboration can reduce the psychological burden of planning and facilitate updating plans in anticipation of future shortages.

What are effective vaccine distribution approaches for equity-deserving and high-risk populations during COVID-19? Exploring best practices and recommendations in Canada: protocol for a mixed-methods multiple case codesign study

Por: Aggarwal · M. · Katz · A. · Kokorelias · K. M. · Wong · S. T. · Aghajafari · F. · Ivers · N. M. · Martin-Misener · R. · Aubrey-Bassler · K. · Breton · M. · Upshur · R. E. G. · Kwong · J. C.
Introduction

The WHO has stated that vaccine hesitancy is a serious threat to overcoming COVID-19. Vaccine hesitancy among underserved and at-risk communities is an ongoing challenge in Canada. Public confidence in vaccine safety and effectiveness and the principles of equity need to be considered in vaccine distribution. In Canada, governments of each province or territory manage their own healthcare system, providing an opportunity to compare and contrast distribution strategies. The overarching objective of this study is to identify effective vaccine distribution approaches and advance knowledge on how to design and implement various strategies to meet the different needs of underserved communities.

Methods and analysis

Multiple case studies in seven Canadian provinces will be conducted using a mixed-methods design. The study will be informed by Experience-Based CoDesign techniques and theoretically guided by the Socio-Ecological Model and the Vaccine Hesitancy Matrix frameworks. Phase 1 will involve a policy document review to systematically explore the vaccine distribution strategy over time in each jurisdiction. This will inform the second phase, which will involve (2a) semistructured, in-depth interviews with policymakers, public health officials, researchers, providers, groups representing patients, researchers and stakeholders and (2b) an analysis of population-based administrative health data of vaccine administration. Integration of qualitative and quantitative data will inform the identification of effective vaccine distribution approaches for various populations. Informed by this evidence, phase 3 of the study will involve conducting focus groups with multiple stakeholders to codesign recommendations for the design and implementation of effective vaccine delivery strategies for equity-deserving and at-risk populations.

Ethics and dissemination

This study is approved by the University of Toronto’s Health Sciences Research Ethics Board (#42643), University of British Columbia Behavioural Research Ethics Board (#H22-01750-A002), Research Ethics Board of the Nova Scotia Health Authority (#48272), Newfoundland and Labrador Health Research Ethics Board (#2022.126), Conjoint Health Research Ethics Board, University of Calgary (REB22-0207), and University of Manitoba Health Research Board (H2022-239). The outcome of this study will be to produce a series of recommendations for implementing future vaccine distribution approaches from the perspective of various stakeholders, including equity-deserving and at-risk populations.

Child eye health in Ethiopia: a mixed methods analysis of policy and commitment to action

Por: Sherief · S. T. · Tesfaye · S. · Eshetu · Z. · Ali · A. · Dimaras · H.
Background

Child eye health is a serious public health issue in Ethiopia, where children under the age of 15 account for over half of the population. Our aim was to review Ethiopian health policy and practice to reveal approaches and commitment to promotion and delivery of child eye health services.

Methods

We conducted a mixed-methods situational analysis employing documentary analysis and key informant interview methods. Government publications touching on any element of child eye health were included. Key informants were eligible if they were leaders, authorities, researchers or clinicians involved in child health. Data was combined and analysed by narrative synthesis, using an adaptation of the Eye Care Situation Analysis Tool as a framework.

Findings

Eleven documents developed by the Ministries of Health and Education were included and interviews with 14 key informants were conducted. A focus on child eye health was lacking in key health policy documents, demonstrated by limited allocation of funds, a shortage of human resources, and a subpar referral system across all levels of child eye care.

Conclusion

The study identified several gaps and limitations in child eye health in Ethiopia. There is a need for health policies that strengthen ownership, finance and partnerships for improved coordination, and collaboration with line ministries and other stakeholders to improve child eye health services in Ethiopia.

Systematic review of seroprevalence of SARS-CoV-2 antibodies and appraisal of evidence, prior to the widespread introduction of vaccine programmes in the WHO European Region, January-December 2020

Por: Vaughan · A. · Duffell · E. · Freidl · G. S. · Lemos · D. S. · Nardone · A. · Valenciano · M. · Subissi · L. · Bergeri · I. · K Broberg · E. · Penttinen · P. · Pebody · R. · Keramarou · M.
Objectives

Systematic review of SARS-CoV-2 seroprevalence studies undertaken in the WHO European Region to measure pre-existing and cumulative seropositivity prior to the roll out of vaccination programmes.

Design

A systematic review of the literature.

Data sources

We searched MEDLINE, EMBASE and the preprint servers MedRxiv and BioRxiv in the WHO ‘COVID-19 Global literature on coronavirus disease’ database using a predefined search strategy. Articles were supplemented with unpublished WHO-supported Unity-aligned seroprevalence studies and other studies reported directly to WHO Regional Office for Europe and European Centre for Disease Prevention and Control.

Eligibility criteria

Studies published before the widespread implementation of COVID-19 vaccination programmes in January 2021 among the general population and blood donors, at national and regional levels.

Data extraction and synthesis

At least two independent researchers extracted the eligible studies; a third researcher resolved any disagreements. Study risk of bias was assessed using a quality scoring system based on sample size, sampling and testing methodologies.

Results

In total, 111 studies from 26 countries published or conducted between 1 January 2020 and 31 December 2020 across the WHO European Region were included. A significant heterogeneity in implementation was noted across the studies, with a paucity of studies from the east of the Region. Sixty-four (58%) studies were assessed to be of medium to high risk of bias. Overall, SARS-CoV-2 seropositivity prior to widespread community circulation was very low. National seroprevalence estimates after circulation started ranged from 0% to 51.3% (median 2.2% (IQR 0.7–5.2%); n=124), while subnational estimates ranged from 0% to 52% (median 5.8% (IQR 2.3%–12%); n=101), with the highest estimates in areas following widespread local transmission.

Conclusions

The low levels of SARS-CoV-2 antibody in most populations prior to the start of vaccine programmes underlines the critical importance of targeted vaccination of priority groups at risk of severe disease, while maintaining reduced levels of transmission to minimise population morbidity and mortality.

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