Circulation, Volume 150, Issue Suppl_1, Page A4144167-A4144167, November 12, 2024. Background:Myocardial ischemia remains a significant global health concern for cardiovascular morbidity and mortality. In addition to the traditional treatment modalities, stem cell transplantation is emerging as a promising therapeutic intervention for cardiac regeneration and functional recovery. Our study evaluated the efficacy and clinical impact of SCT by reducing infarct scar size and improving cardiac function. The secondary objectives are to compare stem cell types, identify optimal transplantation strategies, and address safety and feasibility.Method:Randomized controlled trials from January 2000 to July 2023 were collected from PubMed, Cochrane, Google Scholar, and Elsevier. Based on criteria and evidence quality, screening and selection were done. A RevMan analysis was done. Infarct size, LVEF, LVESV, LVEDV, and mortality were measured. Comparator variables included placebo, medical therapy, CABG, and other types of stem cells. Randomization, allocation concealment, blinding, and therapeutic interventions differed among trials. Heterogeneity and publication bias were assessed using random-effects model and funnel plots. Sensitivity analysis and meta-regression identified outcome variability.Results:Seventeen studies (n = 1022 patients) met the inclusion criteria, encompassing various cell types, doses, and administration routes. Compared to controls, SCT greatly enhanced LVEF (MD: 3.39, 95% CI: 1.05 to 5.73, p = 0.005) and reduced infarct size (MD: 14.23, 95% CI: 7.12 to 21.35, p
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Abstract 4137169: Artificial Intelligence-Enabled Electrocardiography For The Prediction of Future Type 2 Diabetes Mellitus
Circulation, Volume 150, Issue Suppl_1, Page A4137169-A4137169, November 12, 2024. Background:Undiagnosed diabetes and prediabetes present a significant global health challenge. Artificial Intelligence-enabled electrocardiography (AI-ECG) has shown promise in identifying subtle ECG changes in a wide range of subclinical diseases. Opportunistic ECG screening could identify prediabetic patients, enabling early interventions to prevent T2DM and adverse cardiovascular events.Aims:To develop the AI-ECG Risk Estimator to diagnose prevalent T2DM and predict future T2DM (AIRE-DM)Methods:AIRE-DM was trained on a real-world secondary care cohort from Beth Israel Deaconess Medical Center (BIDMC) of 1,163,401 ECGs and externally validated in the UK Biobank (UKB, N = 65,606). AIRE-DM employs a residual neural network architecture with a discrete-time survival loss function.Results:AIRE-DM accurately identifies prevalent T2DM (AUROC: BIDMC – 0.712 (0.705-0.719), UKB – 0.731 (0.725 – 0.741) and predicts future T2DM (C-index: BIDMC – 0.666 (0.658-0.675), UKB 0.689 (0.663-0.715). In subjects without T2DM, the high-risk quartile shows a markedly increased risk of future T2DM (HR: BIDMC – 4.67 (4.01-5.45), UKB – 10.10 (5.87-17.40), adjusted for age and sex. Adding AIRE-DM to clinical risk factors in BIDMC and to the American Diabetes Association (ADA) score in the UKB significantly enhanced predictive accuracy for future T2DM (C-index improvement: BIDMC – 0.0359 (0.0354-0.0363), UKB: 0.0337 (0.0324-0.0350), continuous net reclassification index: BIDMC – 0.407 (0.360-0.445), UKB – 0.391 (0.259-0.503)).Using phenome- and genome-wide association studies, we identified biologically plausible associations for AIRE-DM, including glucose regulation, cardiac morphology, diastolic dysfunction, arterial stiffness and lipid metabolism. We identified variants adjacent toCASQ2,TBX3,NOS1AP,TKT,VGLL2andPRDM6, which are known regulators of cardiac morphology, arterial stiffness and glucose metabolism.Conclusion:AIRE-DM can predict future T2DM in non-diabetics and enhances T2DM risk prediction when integrated with clinical risk scores. Its application holds promise for early identification of individuals at high risk of T2DM, enabling early lifestyle and pharmacological interventions.
Abstract 4114417: Polygenic Risk in Heart Failure – Evaluating the Ability of a Polygenic Risk Score to Identify Risk of Future Heart Failure Events in 60,000 Patients from 6 TIMI Randomized Trials
Circulation, Volume 150, Issue Suppl_1, Page A4114417-A4114417, November 12, 2024. Background:The ability of polygenic risk scores (PRS) to predict heart failure (HF) beyond classic risk factors is unclear.Aims:To evaluate the risk of a HF PRS with incident hospitalization for HF (HHF) in patients with established cardiovascular disease.Methods:We analyzed a 59 SNP HF PRS (HERMES collaboration, Henry et al) in genotyped patients from six multinational TIMI randomized controlled trials (DECLARE, ENGAGE AF, FOURIER, PEGASUS, SAVOR, SOLID). Patients were stratified to low (quintile, Q1), intermediate (Q2-Q4), or high (Q5) genetic risk. We investigated the association of the HF PRS with incident HHF (median of 2.5 years) i) stratified by prior HF, and ii) across NTproBNP concentrations at baseline, using Cox-proportional hazard models. Results are reported as HR [95% CI], per 1-SD or with Q1 as a reference, and adjusted for ancestry (principal components 1-5), age, sex, trial, BMI, smoking, systolic BP, prior CAD, DM, AF, and eGFR.Results:In 59,906 pts (median age 66 years; 71% male; 26% prior HF), the HF PRS was associated with incident HHF (HRadjper 1-SD 1.08 [1.03, 1.13], p
Abstract 4143814: Utility of Echocardiography to Prognosticate Fetal High Cardiac Output States
Circulation, Volume 150, Issue Suppl_1, Page A4143814-A4143814, November 12, 2024. Background:Fetal anemia can lead to high cardiac output (CO) failure, fetal hydrops and fetal demise. Intrauterine transfusion (IUT) is the standard of care, but carries risks of premature delivery and fetal death; therefore, it is critical to identify the most affected fetuses prior to intervention. Elevation of the peak systolic velocity in the middle cerebral artery (MCA-PSV) is routinely used to indicate intervention; however, the reported false positive rate is as high as 12 to 14%.Aim:Assess whether measured CO by fetal echocardiography (FE) can be used as a complementary screening tool to predict fetal anemia.Methods:We identified all pregnancies referred for FE from 2009-2023 with suspected fetal anemia (n=49). We reviewed FEs (n=88) to measure ventricular function, combined CO (aortic and pulmonary outflows), and measured ventricular dimensions. Percentiles for CO were used based on published normative data. The MCA-PSV was measured and reported as multiples of the median (MoM). Where available, pre-transfusion fetal hemoglobin (Hb) readings were reported as a MoM, with temporally matched FE studies performed prior to IUT included for analysis (n=8).Results:Overall,MCA-PSV was positively associated with left ventricular (LV) CO, but not with right ventricular (RV) or combined (CCO) (LV CO p=0.037, Figure 1A; RV CO p=0.790; CCO p=0.290). The LV CO correlated with z-scores for LV and RV end diastolic dimensions (EDD) (LVEDD p
Abstract 4135476: The Cardiomyocyte Hypertrophy Inhibitor RFN-409, Identified by High Throughput Screening Assay, Suppresses Pressure Overload-induced Systolic Dysfunction in Mice by Suppressing p38 Activity
Circulation, Volume 150, Issue Suppl_1, Page A4135476-A4135476, November 12, 2024. Purpose:When the heart is exposed to stresses such as myocardial infarction or hypertension, it undergoes compensatory hypertrophy in response. However, continuation of the stress causes this compensatory mechanism to fail, and eventually systolic dysfunction or decompensated heart failure occur. As the hypertrophy of individual cardiomyocytes has been observed in this process, controlling cardiomyocyte hypertrophy is a potential target the prevention and treatment of heart failure. In this study, we constructed a high throughput screening (HTS) assay using cardiomyocyte hypertrophy as an index parameter. Compounds that inhibit cardiomyocyte hypertrophy were selected from our low molecular compound library.Methods and Results:In the primary screening, cultured rat primary cardiomyocytes were treated with each compound at a final concentration of 1 µM and then stimulated with 30 µM phenylephrine (PE) for 48 hours. These cells were subjected to fluorescent immunostaining with α-actinin, and cardiomyocyte area was measured using an ArrayScan™ system. The hypertrophy inhibition rate (%) of each compound was calculated as [(PE(+) – compound) / (PE(+) – PE(-))] × 100. The compounds with a hypertrophy inhibition rate greater than 50% and less than 150% were selected as hit compounds. In the secondary screening, these hit compounds were evaluated based on the dose-dependency of cardiomyocyte hypertrophy inhibition and the inhibition of the mRNA levels of the cardiac hypertrophy response genes ANF and BNP using real-time PCR. From the 269 low molecular-weight compounds in the original compound library, eight were selected through the primary and secondary screenings. Among them, we focused on Reference Number 409 (RFN-409). Western blotting indicated that RFN-409 inhibited PE-induced p38 activation. Next, we investigated the effect of RFN-409 on heart failure. Eight-week-old male C57 BL/6J mice were subjected to transverse aortic constriction (TAC) surgery and then randomly assigned to intraperitoneal treatment with RFN-409 (3, 10 mg/kg) or vehicle for eight weeks. RFN-409 at 10 mg/kg significantly prevented TAC-induced increase in left ventricular posterior wall thickness and decrease in left ventricular fractional shortening.Discussion:RFN-409 suppressed TAC-induced development of heart failure, at least partially by inhibiting p38 activity. These findings suggest that RFN-409 may be an effective agent for heart failure therapy.
Abstract 4137945: A Tuscany regional screening program for juvenile sudden cardiac death in high schools: the JUST project
Circulation, Volume 150, Issue Suppl_1, Page A4137945-A4137945, November 12, 2024. Background:Juvenile sudden cardiac death (SCD) has high impact on the family and society of the victim. While SCD screening programmes are effective in athletes, most (70-80%) young non-athletes individuals are not routinely screened.Research question:We hypothesized that a low-cost screening program may early identify subjects at risk of juvenile SCD, even in non-athletes.Goals:To evaluate the prevalence of SCD-related abnormal findings and, ultimately, to test the effectiveness of a screening programme in high schools.Methods:Between April 2023 and June 2024, high school individuals were enrolled in a screening programme in Tuscany (Pisa, Lucca and Livorno), based on a questionnaire investigating family history of juvenile SCD or diseases predisposing to SCD and symptoms (syncope, palpitations, chest pain), and digitally recorded electrocardiograms (ECGs). In case of abnormal findings, second-line investigations locally (echocardiography, Holter ECG monitoring and/or exercise testing) or third-line investigations at Fondazione Monasterio, Pisa, Italy (cardiac MRI, genetics or electrophysiological testing) were planned. Only preliminary results of the first-line screening are hereby reported.Results:We have currently enrolled 872 individuals (age 17.1±1.8 years, 481 [55%] males, 288 [33%] smokers, 102 [11.7%] recreational drugs users, and 645 [74%] non-competitive athletes). At questionnaires, 56 individuals (6.4%) had a family history of SCD, 32 (3.7%) a first-degree relative with cardiomyopathy, and 13 (1.5%) with channelopathy. As for symptoms, 21 participants (2.4%) reported chest pain or 26 (3%) syncope during exertion, while 90 (10.3%) paroxysmal palpitations. At ECG, we found 2 cases (0.2%) with a type-2 Brugada pattern, 1 female case (0.1%) with prolonged QTc interval (QTc 480 ms), 20 cases (2.3%) with V1-V3 T wave inversion (age > 16 years), 18 cases (2%) of left ventricular hypertrophy (non-athletes), and 4 cases (0.5%) with atypical ventricular ectopy. After the first-line screening, 61 (7%) and 10 (1.2%) individuals were referred to second and third-line investigations, which are currently ongoing.Conclusions:We hereby propose a screening model in high schools that includes specific health questionnaires and digitally recorded ECGs. From preliminary analyses, this approach seems sensitive enough to be tested as a model to favour the early diagnosis of diseased conditions associated with juvenile SCD in the general population.
Abstract 4139654: Effects of Exercising Sports on Cardiovascular Health among Youth Athletes: Basketball, Baseball, Football and Soccer
Circulation, Volume 150, Issue Suppl_1, Page A4139654-A4139654, November 12, 2024. Introduction:The impact of exercise on the adult heart has been well studied and associated with better cardiovascular health. However, the exercise-induced physiological adaptations of the youth athlete’s heart are not well understood.Research Questions/Hypothesis:Cardiac screening data will differ significantly based on which sport a youth athlete plays.Goals/Aims:To assess the impacts of different sports on youth athletes’ cardiovascular health.Methods:The HeartBytes National Youth Database produced by Simon’s Heart was used for this study. The database contains demographics, exercise-related symptoms, ECG data obtained during Simon’s Heart PPEs, and data on various types of sports that athletes participate in. To investigate the effects of each specific sport, we excluded those playing multiple sports from the data set, and employed a propensity score match method to control the confounding influences of race, sex, and exercise intensity. This study used an odds ratio statistic and p-value of 5% criterion to evaluate associations between specific sports and cardiovascular risk factors.Results:Of the 7425 athletes in the HeartBytes database, the majority were male (60.6%) and White (83.1%). The mean BMI was 21.4 with SD 4.6. The median age was 15.0 years old with an interquartile range 13.5-16.5. There were 279, 120, 179, 552 athletes playing basketball, baseball, football, and soccer only respectively.Athletes playing basketball had higher odds of exertional symptoms of feeling easily tired (p=0.017), ECG abnormalities (p=0.032), and T wave inversion (p=0.017), but lower odds of ADHD (p=0.03).Athletes playing baseball had higher odds of asthma (p=0.02) and T wave inversion (p=0.046) if exercising less than 5 hours/week, and higher odds of murmurs (p=0.023) and exertional syncope (p=0.04) if exercising more than 10 hours/week.Athletes playing football had higher odds of obesity (p
Abstract 4140819: Trends and Racial Disparities in Cardiovascular Deaths in Chronic Kidney Disease in the United States, 1999-2020
Circulation, Volume 150, Issue Suppl_1, Page A4140819-A4140819, November 12, 2024. Background:Previous studies have shown that chronic kidney disease (CKD) is associated with increased cardiovascular disease (CVD) burden, but few studies have investigated trends in CVD deaths in CKD. We evaluated the temporal changes in the CVD-related age-adjusted mortality rate (AAMR) in CKD based on sex, race, rural-urban status, and census region from 1999-2020.Methods:This was a retrospective repeated cross-sectional analysis of national death certificate data from the CDC WONDER from 1999 to 2020. We included persons aged ≥25 years of age with CKD (ICD-10 code N18) as the underlying cause of death. We used ICD-10 codes I10-I178 to identify CVD-related deaths from the multiple cause-of-death dataset. We calculated the CVD-related AAMR in CKD per 100,000 population. The exposure variable was the year of death, and the outcome was the changes over time in CVD- related AAMR in CKD, stratified by sex, race, rural-urban status, and census region. We used the Mann-Whitney test and ANOVA for group comparisons as appropriate. Racial disparities were assessed with the Black-White AAMR ratio. Trends were evaluated with Joinpoint regression and expressed as average annual percentage change (AAPC) with 95% confidence interval (CI). P
Persuasive design principle of social support in digital interventions targeting mental health symptoms: a systematic review and meta-analysis
Objective
This systematic review and meta-analysis evaluates the available evidence on efficacy of social support strategies, as defined by the persuasive system design framework, in internet-based and mobile-based interventions (IMI) targeting mental health.
Design
Systematic review and meta-analysis.
Data sources
PubMed, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials.
Eligibility criteria for selecting studies
Randomised controlled trials comparing IMI implementing a social support strategy for mental health symptoms to various control conditions. Publications up to June 2023 (date of search 6 June 2023) were considered.
Data extraction and synthesis
Two independent reviewers screened and extracted data in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Risk of bias was assessed with the Risk of Bias Tool V.2.0. Data were pooled based on a random-effects model.
Results
After screening 6484 records, a total of 45 studies met our inclusion criteria. At 96%, social support was predominantly implemented through the strategy of social facilitation, by which users recognising others using the intervention (eg, discussion forum). IMI implementing social support strategies showed moderate effect sizes of Hedges’ g=–0.34 (95% CI –0.47 to –0.21, p
Identifying important and feasible primary care structures and processes in the US healthcare system: a modified Delphi study
Objective
To identify primary care structures and processes that have the highest and lowest impact on chronic disease management and screening and prevention outcomes as well as to assess the feasibility of implementing these structures and processes into practice.
Design
A two-round Delphi study was conducted to establish consensus on the impact and feasibility of 258 primary care structures and processes.
Participants
29 primary care providers, health system leaders and health services researchers in the USA.
Outcomes
Primary outcomes were (1) consensus on the impact of each structure and process on chronic disease management and screening and prevention outcomes, separately and (2) consensus on feasibility of implementation by primary care practices.
Results
Consensus on high impact and feasibility of implementation was reached on four items for chronic disease management: ‘Providers use motivational interviewing to help patients set goals’, ‘Practice has designated staff to manage patient panel’, ‘Practice has onsite providers or staff that speak the most dominant, non-English language spoken by patients’ and ‘Practice includes mental health providers and/or behavioural health specialists in care team’ and seven items for screening and prevention: ‘Practice utilizes standing protocols and orders’, ‘Practice generates reports to alert clinicians to missed targets and to identify gaps in care, such as overdue visits, needed vaccinations, screenings or other preventive services’, ‘Practice has designated staff to manage patient panel’, ‘Practice sets performance goals and uses benchmarking to track quality of care’, ‘Practice uses performance feedback to identify practice-specific areas of improvement’, ‘Practice builds quality improvement activities into practice operations’ and ‘Pre-visit planning data are reviewed during daily huddles’. Only ‘Practice has designated staff to manage patient panel’ appeared on both lists.
Conclusion
Findings suggest that practices need to focus on implementing mostly distinct, rather than common, structures and processes to optimise chronic disease and preventive care.
Three-dimensional conformal radiation therapy with concurrent chemotherapy for stage III non-small cell lung cancer: protocol for a systematic review and meta-analysis
Introduction
Lung cancer continues to be a common form of cancer worldwide and a primary contributor to cancer-related fatalities. Non-small cell lung cancer (NSCLC) is the most prevalent form, making up 80% to 85% of newly identified malignant lung tumours, and remains a major concern for worldwide health. Surgical resection is the preferred treatment for localised NSCLC, but more than one-third of patients present with locally advanced, unresectable tumours. Concurrent radiation therapy and chemotherapy are believed to offer the potential for prolonged disease-free and overall survival to those patients. However, the results are inconsistent, and systematic meta-analysis is lacking to evaluate its treatment effect comprehensively. Therefore, we will conduct a meta-analysis to evaluate the efficacy and safety of 3D-CRT concurrent chemotherapy in unresectable stage III NSCLC to provide evidence-based medical support for clinical treatment.
Methods and analysis
This systematic review and meta-analysis will adhere to the guidelines outlined in the PRISMA statement. Based on the predetermined criteria for inclusion, we will conduct a comprehensive search for randomised controlled trials (RCTs) examining the efficacy and safety of three-dimensional conformal radiation therapy (3D-CRT) concurrent chemotherapy in unresectable stage III NSCLC. The search will be performed across multiple databases including PubMed, Embase, Cochrane, Scopus and Web of Science from inception to 1 November 2024 using terms including NSCLC, 3D-CRT concurrent chemotherapy, radiation therapy, RCT and controlled clinical trial. Furthermore, relevant literature citations will be gathered, and relevant journals will be manually searched. The primary outcomes in the study were overall survival; progression-free survival; 1-, 3- and 5-year survival rates; event-free survival; and median survival time. Secondary outcomes included treatment effectiveness, all adverse events (AEs), all treatment-related adverse events (TRAEs), AEs (grade ≥3) and TRAEs (grade ≥3). Two separate reviewers will be responsible for screening, extracting data and evaluating quality. Our reviewers will perform subgroup analysis, sensitivity analysis and publication bias analysis to evaluate the heterogeneity and robustness. Review Manager 5.4 will be used for the analysis and synthesis process. The risk of bias will be assessed using the Cochrane Risk of Bias tool (RoB 2), and the Grading of Recommendations Assessment, Development and Evaluation will be employed to evaluate the study’s overall evidence quality.
Ethics and dissemination
This study is based on a secondary analysis of the literature, so ethical review approval is not required. The final report will be published in a peer-reviewed journal.
Trial registration
The protocol of the systematic review has been registered on Open Science Framework, with a registration DOI https://doi.org/10.17605/OSF.IO/R7WCG.
Updating the critical steps of the quality implementation framework: a protocol for an umbrella review of reviews
Introduction
Implementation science focuses on improving the dissemination, uptake and adoption of evidence into practice. Over the last decade, implementation science research has proliferated, particularly in healthcare and social science. The key synthesis of implementation frameworks conducted by Meyers and colleagues in 2012, and the resulting Quality Implementation Framework, has yet to be updated to incorporate this research. This protocol proposes an umbrella review of reviews (RORs) to synthesise the literature since 2012 on implementation science in the fields of healthcare and social science and provides recommendations for an updated Quality Implementation Framework.
Methods and analysis
This ROR will be conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Four academic databases (PubMed, Scopus, PsycINFO and Web of Science) will be used to identify peer-reviewed meta-analyses, systematic reviews and scoping reviews published in the English language since January 2012 and report on the development, application or update of one or more implementation frameworks in healthcare or social science contexts. Multiple reviewers will be involved in the screening of articles and extraction of data, and the quality of reviews will be assessed using the AMSTAR (A MeaSurement Tool to Assess systematic Reviews) 2. The outcome of interest is the content of implementation science frameworks reported in the included reviews. The content of these frameworks will be synthesised, aggregated and mapped to the four phases and 14 steps outlined in the original Quality Implementation Framework using both deductive and inductive analysis.
Ethics and dissemination
Ethics approval is not required as this ROR protocol and the resulting ROR do not involve primary data collection. The protocol as well as the ROR will be disseminated in peer-reviewed journals.
PROSPERO registration number
CRD42023475994.
Acceptability, barriers and facilitators of using dried blood spots-point-of-care testing for sickle cell disease in Africa: an implementation science protocol for a multinational qualitative study
Background
Sickle cell disease (SCD) is a prevalent inherited blood disorder. Globally, approximately 515 000 babies are born with SCD annually, with 75% of these births occurring in Africa. Integrating newborn screening (NBS) for SCD into primary healthcare structures, such as immunisation programmes, holds significant promise, with dried blood spots (DBS)-point-of-care technologies (POCT) like HaemoTypeSC offering cost-effective screening solutions. However, scaling up DBS-POCT for NBS of SCD in Africa remains challenging.
Objective
This study aims to explore individual, organisational and external factors that may influence the reliability, feasibility, acceptability, adoption and sustainability of using DBS-POCT with HaemoTypeSC for NBS of SCD at primary healthcare centres in African countries.
Method
This qualitative study will be conducted in seven African countries that are part of the SickleInAfrica consortium sites. The study design is informed by the Consolidated Framework for Implementation Research (CFIR) and the Implementation Outcome Model. Participants will be mothers whose babies have been diagnosed with SCD, healthcare professionals and policy-makers. In-depth interviews and focus group discussions will be used for data collection. Data analysis will be through thematic analysis.
Ethics and dissemination
Research ethics approvals have been obtained from the seven countries. Written informed consent will be obtained from all participants. The study results will be disseminated in peer-reviewed scientific journals, scientific conferences, reports to national ministries of public health and webinars.
Exploring accessibility, user experience and engagement of digital media among older patients with depression: a pilot and observational screening study protocol of the DiGA4Aged study
Introduction
The prevalence of mental health problems is increasing worldwide, particularly in the vulnerable group of older people. The limited availability of therapists, long wait periods and increasing shortage of healthcare resources limit adequate care. As a result, digital applications are becoming more commonplace as an alternative to human therapists. However, these tend to be used by younger people with higher education, digital health literacy and experience. In Germany, applications that are approved by the health authorities, so-called digital health applications (DiGAs), can be prescribed by physicians and psychotherapists. It remains unclear to the extent older people are experienced with, are willing and can use a DiGA. Therefore, this research aims to identify specific challenges of older people’s accessibility, user experience and engagement with DiGA for depressive disorders. The DiGA4Aged project consists of: (1) a pilot study on usability, (2) a screening study on potential participants for a randomised controlled trial (RCT) evaluating the digital experience of the target population and (3) an RCT to test the effectiveness of a digital nurse as individualised user support in the intervention group. This paper focuses on the pilot study and the screening study.
Methods and analysis
The instrumental components in preparing for the RCT are a mixed-method pilot and observational quantitative screening study, which are described in this manuscript. The pilot study includes questionnaires (covering sociodemographic data, user experience, health literacy, electronic health literacy, media affinity, severity of depression and perceived usability of DiGA), a concurrent think aloud method and a semistructured interview to evaluate two applications with regard to their usability for, acceptance by and needs of older people. The observational screening study collects data of older patients consecutively admitted to an acute care geriatric hospital ward using various questionnaires to identify which clinical and medical factors are associated with the access to, experience with and (non-)use of digital media. Data from the comprehensive geriatric assessment is collected as well as data on their digital media experience and digital health literacy.
Ethics and dissemination
The overall project DiGA4Aged received ethical approval on 17 November 2023 from the ethics committee of the Medical Faculty of Ruhr-University Bochum (registration number 23-7901). Results will be disseminated within the scientific community via publication in peer-reviewed journals as well as presentation at national conferences. The findings from the pilot study and the observational screening study will determine the selection of the DiGA and the recruitment strategy for the subsequent RCT.
Trial registration numbers
The pilot study has been prospectively registered in the German Clinical Trials Register (DRKS00033640, registered on 18 March 2024, available from https://drks.de/search/de/trial/DRKS00033640). Likewise, the observational screening study has been prospectively registered in the German Clinical Trials Register (DRKS00032931, registered on 29 November 2023, available from https://drks.de/search/de/trial/DRKS00032931).
Secondary Hypertension in Young Adults
Patients in their 30s had higher rates of secondary hypertension than did younger adults, which highlights potential gaps in screening recommendations.
Systematic review of child maltreatment screening tools used by different occupational groups: a study protocol
Background
Child maltreatment (CM) encompasses physical, emotional or sexual abuse, physical or emotional/psychological neglect or intimate partner (or domestic) violence and is associated with adverse cognitive, behavioural, physical and social outcomes that often continue shaping adulthood. The early and valid detection of CM is essential to initiate treatment and intervention as well as to avoid continued violence against the child. Various occupational groups, such as healthcare providers, teachers, social workers, psychotherapists and others, encounter maltreated children in their professional settings. Systematic reviews on instruments to assess suspected CM often report on retrospective measurement via caregiver’s or child’s self-report and are frequently limited to the health system as a setting. The purpose of this Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review is to synthesise the evidence on psychometric properties of instruments to assess suspected CM at the presentation to a broad range of different occupational groups who work with children inside and outside the healthcare system.
Method
A systematic search will be performed in Scopus, PsycInfo, Medline and Web of Science with no limit on the earliest publication until January 2022. Eligibility criteria include studies that investigate psychometric properties of instruments to assess suspected CM in children and adolescents under 18 years by a professional proxy. After the independent screening of studies by two reviewers, quality assessment and data extraction will be performed using an adaptation of the COnsensus-based Standards for the selection of health Measurement INstruments Risk of Bias checklist, Strengthening the Reporting of Observational Studies in Epidemiology: Explanation and Elaboration report and Downs and Black checklist for measuring study quality. Screening, quality assessment and data extraction will be done using Covidence. The results will be presented in narrative form and, if adequate, a meta-analysis will be performed.
Discussion
This review aims to give an overview of the psychometric properties of different instruments designed to screen suspected CM by professional proxies. The results will be of interest to different occupational groups who need information about methodological quality and characteristics of instruments to make decisions about the best-suited tool for a specific purpose. Furthermore, the results of this review will support the development of novel instruments and might improve the existing ones.
Ethics and dissemination
Ethics approval will not be required. The results of this systematic review will be submitted for publication in a peer-reviewed journal.
PROSPERO registration number
CRD42022297997.