Gallaghervedel2171
The final selected eight drivers were categorized into five main domains (1) diagnosis (blood pressure measurement accuracy and CVD risk evaluation); (2) treatment (standardized treatment protocol and treatment intensification); (3) continuity of care and follow-up; (4) delivery system (team-based care, medication refill), and (5) system for performance evaluation. The drivers and recommendations were then translated into process measures, resulting in two interconnected scorecards integrated into the HEARTS in the Americas monitoring and evaluation system.
Focus on these key hypertension drivers and resulting scorecards, will guide the quality improvement process to achieve population control goals at the participating health centers in HEARTS implementing countries.
No funding to declare.
No funding to declare.Cardiovascular disease (CVD) is the leading cause of death in the Americas and raised blood pressure accounts for over 50% of CVD. In the Americas over a quarter of adult women and four in ten adult men have hypertension and the diagnosis, treatment and control are suboptimal. In 2021, the World Health Organization (WHO) released an updated guideline for the pharmacological treatment of hypertension in adults. This policy paper highlights the facilitating role of the WHO Global HEARTS initiative and the HEARTS in the Americas initiative to catalyze the implementation of this guideline, provides specific policy advice for implementation, and emphasizes that an overarching strategic approach for hypertension control is needed. The authors urge health advocates and policymakers to prioritize the prevention and control of hypertension to improve the health and wellbeing of their populations and to reduce CVD health disparities within and between populations of the Americas.
Risk stratification is a cornerstone of cardiovascular disease (CVD) prevention and a main strategy proposed to achieve global goals of reducing premature CVD deaths. There are no cardiovascular risk scores based on data from Latin America and the Caribbean (LAC) and it is unknown how well risk scores based on European and North American cohorts represent true risk among LAC populations.
We developed a CVD (including coronary heart disease and stroke) risk score for fatal/non-fatal events using pooled data from 9 prospective cohorts with 21,378 participants and 1,202 events. We developed laboratory-based (systolic blood pressure, total cholesterol, diabetes, and smoking), and office-based (body mass index replaced total cholesterol and diabetes) models. We used Cox proportional hazards and held back a subset of participants to internally validate our models by estimating Harrell's C-statistic and calibration slopes.
The C-statistic for the laboratory-based model was 72% (70-74%), the calibration slope was 0.994 (0.934-1.055) among men and 0.852 (0.761-0.942) among women; for the office-based model the C-statistic was 71% (69-72%) and the calibration slope was 1.028 (0.980-1.076) among men and 0.811 (0.663-0.958) among women. In the pooled sample, using a 20% risk threshold, the laboratory-based model had sensitivity of 21.9% and specificity of 94.2%. Lowering the threshold to 10% increased sensitivity to 52.3% and reduced specificity to 78.7%.
The cardiovascular risk score herein developed had adequate discrimination and calibration. The Globorisk-LAC would be more appropriate for LAC than the current global or regional risk scores. This work provides a tool to strengthen risk-based cardiovascular prevention in LAC.
Wellcome Trust (214185/Z/18/Z).
Wellcome Trust (214185/Z/18/Z).Meckel's diverticulitis is an extremely rare event during pregnancy. Its diagnosis is often difficult and can result in higher maternal and fetal morbimortality. We describe a case of a 40-year-old healthy pregnant woman at 33 weeks of gestation who presented with abdominal pain and tender abdomen, leukocytosis, and elevated PCR. The imagiological exams were not conclusive. After an urgent caesarean section due to worsening of clinical status and nonreassuring fetal well-being, a laparotomy revealed a distended, necrotic, and perforated Meckel's diverticulum.Adipose-derived stem cells (ASCs) improve the self-renewal and survival of fat grafts in breast reconstruction after oncology surgery. However, ASCs have also been found to enhance breast cancer growth, and its role in tumor proliferation remains largely elusive. Here, we explored a novel mechanism that mediates hTERT reactivation during ASC-induced tumor growth in breast cancer cells. In this study, we found the proliferative ability of breast cancer cells markedly increased with ASC coculture. To explore the molecular mechanism, we treated cells with anibody/inhibitor and found that the activation of MEK-ERK pathway was triggered in breast cancer cells by SCF secreted from ASCs, leading to the nuclear recruitment of CBP. As a coactivator of hTERT, CBP subsequently coordinated with RFPL-3 upregulated hTERT transcription and telomerase activity. buy VX-445 The inhibition of CBP and RFPL-3 abrogated the activation of hTERT transcription and the promotion of proliferation in breast cancer cells with cocultured ASCs in vitro and in vivo. Collectively, our study findings indicated that CBP coordination with RFPL-3 promotes ASC-induced breast cancer cell proliferation by anchoring to the hTERT promoter and upregulating telomerase activity, which is activated by the MAPK/ERK pathway.
More and more literature describes how to overcome challenges in the implementation of adaptive designs for trials for drug approval process. Most adaptive trials were conducted in Western Europe or USA for Phase II or Phase II/III settings; however, examples of non-oncology pivotal adaptive trials used for regulatory approval in Japan are rare. This article elaborates on our experience with designing and implementing a Phase III adaptive confirmatory trial permitting unblinded sample size re-estimation and futility analysis after a single interim analysis in Japanese patients with palmoplantar pustulosis (PPP) receiving guselkumab.
We provide insights into consideration at the design stage of an adaptive study, including design options, development duration, operational risks, and statistical methods. We also share our experience from two aspects of implementation conducting an adaptive clinical trial in Japan and setting up a Japanese domestic independent data monitoring committee.
Final analysis results of this study successfully demonstrated the effectiveness of guselkumab for the treatment of PPP. Based on the interim analysis results, it was recommended to continue the study without sample size adjustment.
We discuss results versus design assumptions and advantages to the conduct of the study with the adaptive design approach. Significant cost savings were gained and development time was reduced compared to the alternative option of a fixed conservative design. Several limitations of our study are also discussed.
We discuss results versus design assumptions and advantages to the conduct of the study with the adaptive design approach. Significant cost savings were gained and development time was reduced compared to the alternative option of a fixed conservative design. Several limitations of our study are also discussed.
The process of trial recruitment is vital, given its impact on resources, statistical power and the validity of findings. A participant information leaflet (PIL) is often the initial and primary source of information engaged by potential participants during recruitment. Research suggests that a variety of manipulations to a PIL can be made during its development to enhance understanding, readability and accessibility. In light of this, PIL-design led by
(PPI) may also yield positive effects in this respect, as well as consent and retention. This study-within-a-trial (SWAT) compared the effects of a PPI-developed PIL with a standard, researcher-developed PIL on rates of consent, retention, decision certainty, understanding, readability, accessibility, likeability and decision to consent.
This SWAT used a double-blind, two-armed randomised design. The SWAT was conducted within a host trial of cognitive rehabilitation in multiple sclerosis.
A total of 234 people expressed interest in the trial, of which 94 were retained at 6-month follow up. Results revealed no effects on levels of consent and retention between the two PIL groups.
These null effects provide interesting points of discussion and important implications for not only future research on PILs, but also for future research that involves recruitment to health-related interventions.
These null effects provide interesting points of discussion and important implications for not only future research on PILs, but also for future research that involves recruitment to health-related interventions.
Accumulating evidence of the effects of dementia caregiving on individuals, society, and health has generated intervention studies to reduce the stress among family caregivers of people with dementia. This study aims to evaluate the effectiveness of a family support program, community-based dementia caregiver intervention (CDCI), among family caregivers of people with dementia compared with a control group (no intervention).
This study is a quasi-experimental, non-randomized controlled trial conducted in six dementia relief centers of a community healthcare center in Korea. Family caregivers of 83 patients with dementia were recruited; of these 78 were included in the final study, with 40 in the intervention group and 38 in the control group. Analysis of covariance (ANCOVA) was used to compare the mean difference in the scores of the total short-form Zarit Burden Interview (SZBI), personal strain, role strain, depression, and attitude between the groups.
Compared with controls, in the intervention group, the adjusted mean score of personal strain (F = 4.353, t = 0.041) and attitude toward dementia (F = 10.284, t = 0.002) differed significantly after the intervention, with a small to moderate effect. There was no significant difference in the total SZBI, role strain, or depression mean score.
The findings suggest that CDCI may be an effective intervention strategy to reduce personal strain and enhance the attitudes of family caregivers of people with dementia.
The findings suggest that CDCI may be an effective intervention strategy to reduce personal strain and enhance the attitudes of family caregivers of people with dementia.
We explore the associations of individual and composite cardiovascular health metrics with all-cause dementia, Alzheimer's disease, and vascular dementia among rural-dwelling older adults and the potential age variations in their associations.
This community-based cross-sectional study included 4980 older adults (age ≥65 years; 57.23% women) from the baseline examination of MIND-China. In March-September 2018, data were collected via face-to-face interviews, clinical examinations, and laboratory test. We defined six cardiovascular health metrics according to the modified American Heart Association's recommendations. We diagnosed dementia and its subtypes following the international criteria. Data were analyzed using logistic regression models.
Of all the participants, 250 were diagnosed with dementia, including 165 with Alzheimer's disease and 75 with vascular dementia. Ideal composite global cardiovascular health metrics (vs poor composite metrics) were associated with a multi-adjusted odds ratio (95% confidence interval) of 0.