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 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 15170: Prognostic Implication of Left Atrial Reservoir Strain in Severe Mitral Stenosis With Low Transmitral Diastolic Pressure Gradient: Result From Long-Term Follow-Up Registry

Circulation, Volume 148, Issue Suppl_1, Page A15170-A15170, November 6, 2023. Background:Prognosis of severe mitral stenosis (MS) with low transmitral mean diastolic pressure gradient (MDPG) has not been fully understood with lack of long-term follow-up study.Aims:We investigated the prognostic implication in severe MS with low MDPG.Methods:We included patients with severe rheumatic MS (mitral valve area [MVA] < 1.5 cm2) from the Multicenter mitrAl STEnosis with Rheumatic etiology (MASTER) registry. Patients with severe MS were categorized into high (≥ 5 mmHg) or low (< 5 mmHg) MDPG groups. The primary outcome was a composite of all-cause mortality and stroke. Among 1,248 patients with severe MS, 322 (25.8%) had low and 926 (74.2%) had high MDPG.Results:Their mean age was 59±13 years, 25% were men, and 74% had atrial fibrillation. Patients with low MDPG were older and had a higher prevalence of atrial fibrillation. During a mean follow-up of 6.8±5.9 years, 194 patients (15.5%) experienced composite events. Patients with severe MS and low MDPG had a higher risk of experiencing composite events compared to those with high MDPG (hazard ratio [HR]: 1.56, 95% CI: 1.15-2.12; p=0.004). Subgroup analysis with low MDPG revealed that decreased left atrial reservoir strain (LARs) was independently associated with poorer outcome (HR, 2.58, 95% CI: 1.08-6.20; p=0.034).Conclusion:Severe MS patients with low MDPG are at higher risk of adverse events compared to those with high MDPG. The assessment of LARs can be useful in identifying subgroups of low MDPG severe MS patients with poor prognosis.

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Novembre 2023

Abstract 17627: The Relationship Between Physical Activity, Extracellular Vesicles, and Diabetes Risk in African American Women at Risk for Cardiovascular Disease: Data From a Pilot Study of the Step It Up Physical Activity Intervention

Circulation, Volume 148, Issue Suppl_1, Page A17627-A17627, November 6, 2023. Background:Diabetes and cardiovascular disease (CVD) disproportionally affect African American (AA) women. Prior studies suggest extracellular vesicles (EV) are involved in atherogenesis, but little is known about relationships between PA and EVs in AA women. Thus, we examined associations between diabetes risk markers, EV, and PA in a community-based cohort of AA women at risk for CVD from resource-limited Washington, D.C. neighborhoods.Methods:Participants were enrolled in pilot testing of Step It Up, a place-tailored mobile app designed to increase PA. Baseline daily step counts for PA were measured by Fitbit® (Charge 2) and fasting baseline blood samples were cryopreserved. NMR (Nuclear magnetic resonance) spectroscopy was used to measure Lipoprotein Insulin Resistance Index (LP-IR), a diabetes risk marker. EV were isolated from heparinized plasma using size exclusion chromatography with size and numbers determined by nanoparticle tracking analysis. Associations between LP-IR, EVs, and daily step count 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 with overweight/obesity (N=24, Age: 57±12, BMI: 35±6, ASCVD: 9±5). Smaller EV size associated with higher LP-IR (β=-0.45, p=0.04) with EV concentration trending to a positive association with LP-IR (β=0.38, p=0.08). Higher daily step count associated with larger EV particle size (β=0.48, p=0.02) but not with EV concentration. Additionally, higher daily step count associated with lower LP-IR (β=-0.42, p=0.04).Conclusions:Our data show that reduced EV size and increased EV concentration associate with higher LP-IR, a diabetes index among a community-based cohort of AA women. Additionally, our findings suggest that PA might help mitigate these associations. More research is needed to understand the potential impact of PA on EV, diabetes risk and subsequent CVD. Future PA interventions in at-risk patients may reduce existing diabetes and CVD-related health disparities and EVs may emerge as a mechanistic link.

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Novembre 2023

Abstract 17536: Real World Analysis from the “Fast STEMI” Registry on Adherence and Discontinuation of Statin Therapy Within 6 Months After ST-Elevation Myocardial Infarction on First Year Follow-Up: Prognostic Impact and Predictors of Adherence

Circulation, Volume 148, Issue Suppl_1, Page A17536-A17536, November 6, 2023. Background:The impact of statin therapy on cardiovascular outcomes after ST-elevation acute myocardial infarction (STEMI) in real-world patients is understudied.Objectives:to identify predictors of low adherence and discontinuation to statin therapy within 6 months after STEMI and to estimate their impact on cardiovascular outcomes at one year follow-up.Methods:We evaluated real-world adherence to statin therapy by comparing the number of bought tablets to the expected ones at 1 year follow-up through pharmacy registries. A total of 6043 STEMI patients admitted from 2012 to 2017 were enrolled in the FAST STEMI registry and followed up for 4,7±1,6 years; 299 patients with intraprocedural and intrahospital deaths were excluded. The main outcomes evaluated were all-cause death, cardiovascular death, myocardial infarction, major and minor bleeding events, and ischemic stroke. The compliance cut-off chosen was 80% as mainly reported in literature.Results:From a total of 5744 patients, 418 (7,2%) patients interrupted statin therapy within 6 months after STEMI. After univariate and multivariate analysis age over 75 years old, known ischemic cardiopathy and female gender resulted as predictors of therapy discontinuation. Statin discontinuation within 6 months showed an increase of both cardiovascular (5% vs 1.7%; HR 2.23; 95%CI 1.37-3.65; p=0,001) and all-cause mortality (14.8% vs 5.1%, HR 2.32; 95%CI 1.73-3.11; p80%) reduced ischemic stroke incidence (1% vs 2.5%, p=0.001) and both cardiovascular and all-cause death (0.1% vs 4.6%; 0.3% vs 13.4%; p

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Novembre 2023

Abstract 15982: Management and Follow-Up of Inpatients With Cardiac Implantable Electronic Devices and Bacteremia With and Without Electrophysiology Consultation

Circulation, Volume 148, Issue Suppl_1, Page A15982-A15982, November 6, 2023. Introduction:Transvenous cardiac implantable electronic device (CIED) infection is a significant cause of morbidity and mortality. Expert consensus recommends a multidisciplinary approach to bacteremia in the context of CIED incorporating both infectious disease (ID) and electrophysiology (EP) consultation to balance the risks of infection with those of CIED removal.Hypothesis:Not all patients with CIEDs and bacteremia are evaluated with EP consultation, and this difference is associated with variability in management.Methods:Using the EMR, we retrospectively identified inpatients with a CIED and a positive blood culture across three hospitals: one academic, one specialty and one community. True infection versus contaminant was determined by an EP or ID attending at the time of presentation or adjudicated retrospectively by an EP who performs extractions. We examined the rates of EP consultation based on hospital site, CIED removal and appropriate follow-up in those without CIED removal. Fisher’s exact test was used to compare the rates of follow up.Results:We identified 88 inpatients with a CIED and positive blood culture between January 2020 – February 2023. True bacteremia was adjudicated in 48 patients (55%). Of these patients, 24 were seen by EP (50%), 22 were seen by EP and ID (46%), and 14 were seen by neither (29%). Patients admitted to an academic hospital were more likely to be seen by EP (22/38, 57%) than those admitted to a specialty or community hospital (2/10, 20%). CIED removal was performed in 15 of 24 patients seen by EP (63%). Patients seen by EP were significantly more likely to have documented plans, repeat blood cultures after antibiotic completion, and appropriate follow up than those not seen by EP (24/24 100% vs. 3/24, 8%, p

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Novembre 2023