Optimising scale-up for public health impact: a multimethod implementation science research protocol to improve infant health outcomes in Ethiopia

Introduction
Child mortality rates remain high in sub-Saharan Africa, including Ethiopia. We are conducting a cluster randomised control trial in the Gondar zone of the Amhara region to determine the impact of pairing Orthodox priests with community health workers, known locally as the Health Development Army (HDA), on newborns’ nutritional status, early illness identification and treatment, and vaccination completeness.
Ensuring intervention efficacy with scientific rigour is essential, but there are often delays in adopting evidence into policy and programmes. Here, we present a protocol for conducting parallel implementation research alongside an efficacy study to understand intervention implementability and scalability. This will help develop a scale-up strategy for effective elements of the intervention to ensure rapid implementation at scale.

Methods and analysis
We will conduct a stakeholder analysis of key implementation stakeholders and readiness surveys to assess their readiness to scale up the intervention. We will conduct semistructured interviews and focus group discussions with stakeholders, including HDA members, health workers, Orthodox priests, and caregivers, to determine the core intervention elements that need to be scaled, barriers and facilitators to scaling up the intervention in diverse sociocultural settings, as well as the human and technical requirements for national and regional implementation. Finally, to determine the financial resources necessary for sustaining and scaling the intervention, we will conduct activity-based costing to estimate implementation costs from the provider’s perspective.

Ethics and dissemination
The study received approval from the University of Gondar Institutional Review Board (approval no: VP/RTT/05/1030/2022) and the University of Washington Human Subjects Division (approval no: STUDY00015369). Participants will consent to participate. Results will be disseminated through workshops with stakeholders, local community meetings, presentations at local and international conferences, and journal publications. The study will provide evidence for factors to consider in developing a scale-up strategy to integrate the intervention into routine health system practices.

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Novembre 2023

Staff perceptions towards virtual reality-motivated treadmill exercise for care home residents: a qualitative feedback study with key stakeholders and follow-up interview with technology developer

Objectives
Health and care resources are under increasing pressure, partly due to the ageing population. Physical activity supports healthy ageing, but motivating exercise is challenging. We aimed to explore staff perceptions towards a virtual reality (VR) omnidirectional treadmill (MOTUS), aimed at increasing physical activity for older adult care home residents.

Design
Interactive workshops and qualitative evaluation.

Settings
Eight interactive workshops were held at six care homes and two university sites across Cornwall, England, from September to November 2021.

Participants
Forty-four staff participated, including care home, supported living, clinical care and compliance managers, carers, activity coordinators, occupational therapists and physiotherapists.

Interventions
Participants tried the VR treadmill system, followed by focus groups exploring device design, potential usefulness or barriers for care home residents. Focus groups were audio-recorded, transcribed verbatim and thematically analysed. We subsequently conducted a follow-up interview with the technology developer (September 2022) to explore the feedback impact.

Results
The analysis produced seven key themes: anticipated benefits, acceptability, concerns of use, concerns of negative effects, suitability/unsuitability, improvements and current design. Participants were generally positive towards VR to motivate care home residents’ physical activity and noted several potential benefits (increased exercise, stimulation, social interaction and rehabilitation). Despite the reported potential, staff had safety concerns for frail older residents due to their standing position. Participants suggested design improvements to enhance safety, usability and accessibility. Feedback to the designers resulted in the development of a new seated VR treadmill to address concerns about falls while maintaining motivation to exercise. The follow-up developer interview identified significant value in academia–industry collaboration.

Conclusion
The use of VR-motivated exercise holds the potential to increase exercise, encourage reminiscence and promote meaningful activity for care home residents. Staff concerns resulted in a redesigned seated treadmill for those too frail to use the standing version. This novel study demonstrates the importance of stakeholder feedback in product design.

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Novembre 2023

Association between anxiety and depression and all-cause mortality: a 50-year follow-up of the Population Study of Women in Gothenburg, Sweden

Objectives
This study aimed to examine the association between anxiety disorders and/or major depression disorder (ADs/MDD) and all-cause mortality in a 50-year perspective and to examine specific risk and health factors that may influence such an association.

Design
Observational population study, 1968–2019.

Setting
The Population Study of Women in Gothenburg, Sweden (PSWG).

Participants
In 1968–1969, 899 (out of 1462) women from PSWG were selected according to date of birth for a psychiatric investigation, including diagnostic evaluation. Eight hundred (89%) were accepted. Twenty-two women were excluded. Of the 778 included, 135 participants (17.4 %) had solely ADs, 32 (4.1%) had solely MDD and 25 (3.2%) had comorbid AD/MDD.

Primary and secondary outcome measures
Associations between ADs, MDD, comorbid AD/MDD and all-cause mortality with adjustments for potential confounding factors. Differences between the groups concerning health and risk factors and their association with mortality.

Results
In a fully adjusted model, ADs were non-significantly associated with all-cause mortality (HR 1.17, 95% CI 0.98 to 1.41). When examining age during risk time as separate intervals, a significant association between mortality and AD was seen in the group of participants who died at the age of 65–80 years (HR 1.70, 95% CI 1.26 to 2.29). In the younger or older age interval, the association did not reach significance at the 95% level of confidence. Among confounding factors, smoking and physical activity were the strongest contributors. The association between smoking and mortality tended to be further increased in the group with ADs versus the group without such disorders (HR 2.10, 95% CI 1.60 to 2.75 and HR 1.82, 95% CI 1.56 to 2.12, respectively).

Conclusions
This study suggests potential links between ADs, age and mortality among women with 50 years of follow-up, but does not provide definitive conclusions due to the borderline significance of the results.

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Novembre 2023

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

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)

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Novembre 2023

Long-term follow-up study of work status among patients with work-related mental disorders referred to departments of occupational medicine in Denmark

Objectives
To describe the 5 year work status in patients referred for suspected work-related common mental disorders. To develop a prognostic model.

Design
Register-based nationwide longitudinal follow-up study.

Setting
All departments of occupational medicine in Denmark.

Participants
17 822 patients aged 18–67 years, seen for the first time at a Department of Occupational Medicine in Denmark from 2000 to 2013 and diagnosed with stress, depression, post-traumatic stress disorder, anxiety or other mental disorders.

Interventions
All patients were seen for diagnostic assessment and causal evaluation of the work-relatedness of their disorders. Some departments offered patients with stress disorders psychological treatment, which, however, was not organised according to patient selection or type of treatment.

Primary and secondary outcome measures
Register data were collected for 5 year periods before and after the patients’ first assessment at a department. Weekly percentages of patients are presented according to work status. The outcome in the prognostic model was a high Work Participation Score (ie, working >75% of potential work weeks/year) at 5 year follow-up.

Results
For all subgroups of patients, a high proportion were working ( >75%) 1–5 years before assessment, and all experienced a large reduction in work status at time of assessment. At 1 year follow-up, almost 60% of patients with stress were working, whereas in the other patient subgroups, less than 40% were working. In the following years, practically no increase was observed in the percentage of patients working in any of the subgroups. Based on these 5 year follow-up data, we developed a work participation model with only moderate discrimination and calibration.

Conclusions
In Denmark, not all return to previous work status 5 years after a referral due to a suspected work-related common mental disorder. We developed a prognostic model with only moderate discrimination and calibration for long-term work participation after suggested work-related common mental disorders.

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Novembre 2023

COVID-19 Hospitalizations Up Among Older Adults

About 63% of COVID-19-related hospitalizations between January and August 2023 were among people aged 65 years or older, based on data collected by the US Centers for Disease Control and Prevention (CDC). The proportion had been declining through mid-July but increased again by the end of August.

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Novembre 2023

Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial

Introduction
Nearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. This paper presents the study protocol for designing and evaluating an ePRO digital health application combined with proactive follow-up by nurses.

Methods and analysis
We designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. We will conduct a pilot test of the intervention with 50 patients with breast cancer for 6 weeks to assess feasibility and adjust the application. We will conduct a parallel arm randomised controlled trial assigning 205 patients each to intervention and control in one of Mexico’s largest public oncology hospitals. The intervention will be provided for 6 months, with additional 3 months of post-intervention observation. The control group will receive usual healthcare and a list of breast cancer information sources. Women diagnosed with stages I, II or III breast cancer who initiate chemotherapy and/or radiotherapy will be invited to participate. The primary study outcome will be supportive care needs; secondary outcomes include global quality of life and breast symptoms. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6 and 9 months.

Ethics and dissemination
The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants will sign an informed consent form prior to their inclusion. Findings will be disseminated through a policy brief to the local authorities, a webinar for patients, publications in peer-reviewed journals and presentations at national and international conferences.

Trial registration number
NCT05925257.

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Novembre 2023

Abstract 15085: Analysis of the Composite of Death and Stroke at Follow-Up Among Risk Profiles in Trials Comparing Transcatheter and Surgical Aortic Valve Implantation. A Systematic Review and Meta-Analysis

Circulation, Volume 148, Issue Suppl_1, Page A15085-A15085, November 6, 2023. Introduction:To compare the effectiveness of transcatheter vs surgical aortic valve implantation on mid-term composite of death for any cause or stroke within high, intermediate and low-risk profiles.Methods:We performed a systematic review of the literature between 2007 and 2023 including randomized controlled trials comparing a composite of all-cause mortality or stroke of transcatheter vs surgical aortic valve replacement. Hazard ratios (HRs) and restricted mean survival time (RMST) differences within high, intermediate and low-risk profiles were estimated by reconstructing time-to-event data from Kaplan-Meier curves.Results:Seven trials were included (8418 participants). The incidence of composite endpoint increases concordantly with higher risk profiles for both treatments. A time variant effect unites all the risk profiles with transcathteter superior to surgery early and a trend toward HR reversal after 24 months, also supported by an cumulative additional time-to-event of 0.57 months at 3 years driven by high risk (95%CI 0.19 – 0.9) that is reabsorbed at 60 months, The benefit of transcatheter approach increased over time till 5 years in high risk, while intermediate and low risk showed a similar quadratic association (a parameter -0.0004, 95%CI -0.0008 – 0, p-value 0.05; b parameter 0.029, 95%CI 0.012 – 0.046, p-value 0.001), with a smaller increase of the transcatheter that is reabsorbed after a nadir at 36 months.Conclusions:There is a different trend of benefit of transcatheter approach within risks. TAVI maintains a benefit over surgery at 5-years in high risk, while its advantage is smaller and runs out at 5 years in the low-mid risk groups.

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Novembre 2023

Abstract 13999: The Relationship Between Neighborhood Deprivation, Diabetes, and Extracellular Vesicles in African American Women at Risk for CVD: Data From a Pilot Study of the Step It Up Physical Activity Intervention

Circulation, Volume 148, Issue Suppl_1, Page A13999-A13999, November 6, 2023. Background:African American women (AA) are at disproportionally high risk for diabetes and cardiovascular disease (CVD) which is accelerated when residing in resource-limited neighborhoods. Extracellular vesicles (EV) are emerging to be of importance in CVD development and progression, but little is known about a potential impact of neighborhood socioeconomic deprivation (NSD). In this study we examined associations between NSD, plasma EV, and markers of diabetes risk in a community-based cohort of AA women at risk for CVD from resource-limited neighborhoods in Washington, DC.Methods:Participants were enrolled in pilot testing of Step It Up, a community engaged physical activity intervention. Blood samples were drawn to measure clinical labs during participants’ baseline visit to the NIH Clinical Center. EV were isolated from heparinized plasma using size exclusion chromatography with size and numbers determined by nanoparticle tracking analysis. NSD was calculated using 2018 US Census tract data as a measure of neighborhood deprivation. Associations between NSD, EV, and diabetes-related clinical measures were analyzed using multivariable regressions adjusted for BMI and ASCVD 10-year risk score.Results:The study cohort was a convenience sample of AA women at risk for CVD (N=24, Age: 57±12, BMI: 35±6, ASCVD: 9±5). NSD associated with fasting glucose (β=0.54, p=0.007) and Hemoglobin A1c (HA1c) (β=0.51, p=0.007). Additionally, NSD associated with lower EV size (β=-0.42, p=0.03), with no association with EV concentration. Fasting glucose and HA1c associated negatively with EV size (β=-0.48, p=0.03 and β=-0.50, p=0.02, respectively) but no association was found with EV concentration.Conclusions:Thus, our data show that higher neighborhood deprivation is associated with lower EV size which, in turn, is associated with higher diabetes risk markers. More research is needed to understand the role of EV in diabetes and CVD development and progression. While larger studies further evaluating these observations are needed, our data highlight the importance of increased diabetes screening and multi-level interventions in patients residing in under-resourced communities to reduce existing health disparities.

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Novembre 2023

Abstract 18106: Keeping up With the Newest Guideline Directed Medical Therapy for Heart Failure With Reduced Ejection Fraction, Resident-Driven Quality Improvement Project

Circulation, Volume 148, Issue Suppl_1, Page A18106-A18106, November 6, 2023. Introduction:Chronic Heart Failure (CHF) is an epidemic associated with high morbidity and mortality. As per 2022 AHA/ACC/HFSA guidelines, the management of Heart Failure with reduced Ejection Fraction (HFrEF) includes Angiotensin Receptor-Neprilysin Inhibitors (ARNIs), Angiotensin-Converting Enzyme Inhibitors (ACEIs)/Angiotensin Receptor Blockers (ARBs), Beta-Blockers (BB), Mineralocorticoid Receptor Antagonists (MRA) and Sodium-Glucose co-transporter 2 Inhibitors (SGLT2I) as class 1 recommendations. Considering the new guidelines for HFrEF we decided to perform a quality improvement project to improve the GDMT prescription rate in patients with HFrEF.Methods:Our project included: dot phrase creation for all physicians through electronic medical records (EMR) system, educational sessions, monthly emails and weekly EMR chat messages regarding GDMT and CHF order set to physicians, A4 sized posters distributed on all hospital floors. We then performed retrospective review and analysis of patient charts who were admitted to three UPMC Central PA hospitals with diagnosis of HFrEF exacerbation during December 2019 to January 2021 (pre-intervention) and March 2022 to September 2022 (post-intervention).Results:Total 615 patients were included. There were no significant differences in demographics between pre intervention (357) and post intervention (258) groups including age, sex, race. There were no differences in prescription rate and target dose at discharge between BB groups (92.72% vs 91.86%%, p=0.693 and 7.25% vs 7.17%, p=0.978). The intervention helped in increasing prescription of ARNIs from 6.2% to 30.62%, p< 0.0001 and 13.92% were discharged on target dosages. The prescription of MRA was increased (47.62%vs 51.55%). Furthermore, initiation of SGLT2I was achieved in 41.47% in post-intervention from 0% in the pre-intervention group.Conclusions:Despite higher awareness of GDMT and the trend towards having more patients discharged on therapeutic dosages of GDMT, it is evident that GDMT is still underused among patients with HFrEF. Our results indicate that more emphasis should be placed on rapid up-titration of GDMT.

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Novembre 2023

Abstract 18219: J-Shaped Association Between LDL-Cholesterol Level and Cardiovascular Events: A Longitudinal Follow-Up Study Over 2.4 Million Nationwide Primary Prevention Cohort

Circulation, Volume 148, Issue Suppl_1, Page A18219-A18219, November 6, 2023. Introduction:Low-density lipoprotein (LDL)-cholesterol lowering treatment showed benefits in patients with high atherosclerotic cardiovascular disease (ASCVD) risk.Hypothesis:Although high LDL-cholesterol level is known to increase ASCVD risks, prognostic implications of low LDL-cholesterol level remain elusive.Methods:Using the data from a Korean Nationwide Cohort, we included 2,432,471 subjects without previous ASCVD. From 2009, subjects were followed for myocardial infarction (MI) and ischemic stroke until 2018. Subjects were stratified according to 10-year ASCVD risks (

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Novembre 2023

Abstract 15793: Impact of Cardiac Rehabilitation on Cardiovascular Disease Risk Factor Management at 1 and 3 Year Follow-Up

Circulation, Volume 148, Issue Suppl_1, Page A15793-A15793, November 6, 2023. Introduction:Cardiac rehabilitation (CR) is a cornerstone of secondary prevention for cardiovascular disease (CVD). CR participation is associated with improvements in secondary CVD risk factor management. However, it is unclear if CR participation is associated with maintained improvements in CVD risk factor management following CR completion.Purpose:The aim of this study was to assess the impact of CR participation on CVD risk factor management at 1 and 3 years following CR completion.Methods:This retrospective study analyzed 911 patients (73% male) enrolled in the CR program at Mayo Clinic from 2013 to 2020. Patient demographics, clinical characteristics, and CVD risk factor management were examined pre and post CR as part of clinical practice and assessed passively at 1 and 3 years following CR. Secondary prevention CVD risk factor goals included total cholesterol (40 mg/dL), LDL cholesterol (

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Novembre 2023