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Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B.
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

Determinants of iron-rich food deficiency among children under 5 years in sub-Saharan Africa: a comprehensive analysis of Demographic and Health Surveys

Por: Osei Bonsu · E. · Addo · I. Y. · Boadi · C. · Boadu · E. F. · Okeke · S. R.
Background

Iron deficiency is a major public health problem that affects the physical and cognitive development of children under 5 years of age (under-5 children) in sub-Saharan Africa (SSA). However, the factors associated with the limited consumption of iron-rich foods in the region are poorly understood.

Objective

This study examined the prevalence and determinants of iron-rich food deficiency among under-5 children in 26 SSA countries.

Design

This nationally representative quantitative study employed pooled data from Demographic and Health Surveys conducted between 2010 and 2019.

Methods

Representative samples comprising 296 850 under-5 children from the various countries were used. Bivariate and multivariate logistic regression models were used to determine the associations between the lack of iron-rich food uptake and various sociodemographic factors.

Result

The overall prevalence of iron-rich food deficiency among the children in the entire sample was 56.75%. The prevalence of iron-rich food deficiency varied widely across the 26 countries, ranging from 42.76% in Congo Democratic Republic to 77.50% in Guinea. Maternal education, particularly primary education (OR 0.62, 95% CI 0.57 to 0.68) and higher education (OR 0.58, 95% CI 0.52 to 0.64), demonstrated a reduced likelihood of iron-rich food deficiency in the sample. Likewise, paternal education, with both primary education (OR 0.69, 95% CI 0.63 to 0.75) and higher education (OR 0.66, 95% CI 0.60 to 0.73) showed decreased odds of iron-rich food deficiency. Postnatal visits contributed significantly to reducing the odds of iron-rich food deficiency (OR 0.90, 95% CI 0.83 to 0.95), along with antenatal visits, which also had a positive impact (OR 0.84, 95% CI 0.74 to 0.95). Finally, residents in rural areas showed slightly higher odds of iron-rich food deficiency (OR 1.12, 95% CI 1.10 to 1.28).

Conclusion

Based on the findings, interventions targeting iron-food deficiency in the SSA region should take into strong consideration the key determinants highlighted in this study.

Effectiveness of shared medical appointments delivered in primary care for improving health outcomes in patients with long-term conditions: a systematic review of randomised controlled trials

Por: Tang · M. Y. · Graham · F. · O'Donnell · A. · Beyer · F. · Richmond · C. · Dhami · R. · Sniehotta · F. F. · Kaner · E. F. S.
Objectives

To examine the effectiveness of shared medical appointments (SMAs) compared with one-to-one appointments in primary care for improving health outcomes and reducing demand on healthcare services by people with one or more long-term conditions (LTCs).

Design

A systematic review of the published literature.

Data sources

Six databases, including MEDLINE and Web of Science, were searched 2013–2023. Relevant pre-2013 trials identified by forward and backward citation searches of the included trials were included.

Eligibility criteria

Randomised controlled trials of SMAs delivered in a primary care setting involving adults over 18 years with one or more LTCs. Studies were excluded if the SMA did not include one-to-one patient-clinician time. All countries were eligible for inclusion.

Data extraction and synthesis

Data were extracted and outcomes narratively synthesised, meta-analysis was undertaken where possible.

Results

Twenty-nine unique trials were included. SMA models varied in terms of components, mode of delivery and target population. Most trials recruited patients with a single LTC, most commonly diabetes (n=16). There was substantial heterogeneity in outcome measures. Meta-analysis showed that participants in SMA groups had lower diastolic blood pressure than those in usual care (d=–0.086, 95% CI=–0.16 to –0.02, n=10) (p=0.014). No statistically significant differences were found across other outcomes. Compared with usual care, SMAs had no significant effect on healthcare service use. For example, no difference between SMAs and usual care was found for admissions to emergency departments at follow-up (d=–0.094, 95% CI=–0.27 to 0.08, n=6, p=0.289).

Conclusions

There was a little difference in the effectiveness of SMAs compared with usual care in terms of health outcomes or healthcare service use in the short-term (range 12 weeks to 24 months). To strengthen the evidence base, future studies should include a wider array of LTCs, standardised outcome measures and more details on SMA components to help inform economic evaluation.

PROSPERO registration number

CRD42020173084.

Elements of organisation of integrated maternity care and their associations with outcomes: a scoping review protocol

Por: Liebregts · J. · Goodarzi · B. · Valentijn · P. P. · Downe · S. · Erwich · J. J. · Burchell · G. · Batenburg · R. · de Vries · E. F. · de Jonge · A. · Verhoeven · C. J. M. · VOICE study group · Graaf · Heemstra · Rippen · Struijs · Zuidhof · Boesveld · Kaiser · Fransen · Berks · Haga
Introduction

Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes.

Methods and analysis

We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’.

Ethics and dissemination

Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations.

The findings of this scoping review will give insight into the nature and effectiveness of elements of integrated care and will generate hypotheses for further research.

Perceptions of academic staff and students of senior high school in implementing game-based exercises in physical education classes--a research protocol for a qualitative descriptive study

Por: Manlapaz · D. · Vergara · J. A. · Alpuerto · K. M. B. · De Los Santos · I. K. S. · Enriquez · M. U. · Manicio · Z. Z. · Mendres · J. E. F. · Tolosa · C. G. S. · Vilela · Z. G. D. · Zabat · Z. E. G. A.
Background

The COVID-19 pandemic has taken a toll on both physical activity and fitness as several pursuits and activities have been restricted. Coupled with this, increased food intake and sedentary lifestyles have produced poor physical health outcomes. Online physical education classes have been more difficult to conduct given the limitations of the setup. As such, exergaming has been identified as a possible educational tool that could improve students’ motivation, participation and fitness levels and reduce negative behaviours in class while contributing to the current curriculum.

Objectives

The study explores the perspectives of both the physical education academic staff and senior high school students from the University of Santo Tomas on the implementation of exergaming to determine the feasibility of exergaming as an educational tool in the Philippines’ physical education curriculum.

Methodology

A descriptive qualitative design will be used and participants will be selected through criterion sampling. The authors will conduct a process of question development and pilot FGDs beforehand to ensure smooth proceedings. Once done, they will undergo FGDs conducted through Google Meet. Data will be coded and analysed via thematic analysis using manual coding and NVivo V.12 software to summarise central themes and perceptions.

Ethics and dissemination

This study will abide by the Nuremberg Code, Declaration of Helsinki, Belmont Report, Data Privacy Act of 2012 and National Ethical Guidelines (for health-related research) of 2017. The study has received approval from the University of Santo Tomas (UST)-College of Rehabilitation Sciences (CRS) Ethics Review Committee. All participant data will be labelled according to random two-digit computer generated codes to preserve anonymity and stored in password-protected laptops and Google Drive folders to preserve confidentiality. Results will be made available to individual UST physical education academic staff and senior high school students prior to publication in peer-reviewed journal.

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