This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug ...Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.
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The overall goal of the Supporting Adolescent Adherence in Vietnam (SAAV) study is to improve understanding of an adherence feedback mHealth intervention designed to help adolescents living with HIV ...(ALHIV) maintain high adherence to antiretroviral therapy (ART), critical to effective treatment. Specifically, we aim to: (1) conduct formative research with Vietnamese ALHIV and their caregivers to better understand adherence challenges and refine the personalized mHealth intervention package; and (2) assess the feasibility, acceptability, and efficacy of the intervention to improve ART adherence by implementing a randomized controlled trial (RCT).
The study will utilize mixed methods. The formative phase will include 40 in-depth interviews (IDIs) with 20 adolescent (12-17 years)/caregiver dyads and eight focus group discussions with adolescents, caregivers, and clinicians at the National Hospital for Pediatrics (NHP) in Hanoi, Vietnam. We will also conduct 20 IDIs with older adolescents (18-21 years) who have transitioned to adult care at outpatient clinics in Hanoi. We will then implement a seven-month RCT at NHP. We will recruit 80 adolescents on ART, monitor their adherence for one month to establish baseline adherence using a wireless pill container (WPC), and then randomize participants to intervention versus control within optimal (≥ 95% on-time doses) versus suboptimal (< 95% on-time doses) baseline adherence strata. Intervention participants will receive a reminder of their choice (cellphone text message/call or bottle-based flash/alarm), triggered when they miss a dose, and engage in monthly counseling informed by their adherence data. Comparison participants will receive usual care and offer of counseling at routine monthly clinic visits. After six months, we will compare ART adherence, CD4 count, and HIV viral suppression between arms, in addition to acceptability and feasibility of the intervention.
Findings will contribute valuable information on perceived barriers and facilitators affecting adolescents' ART adherence, mHealth approaches as adherence support tools for ALHIV, and factors affecting adolescents' ART adherence. This information will be useful to researchers, medical personnel, and policy-makers as they develop and implement adherence programs for ALHIV, with potential relevance to other chronic diseases during transition from adolescent to adult care.
ClinicalTrials.gov, NCT03031197 . Registered on 21 January 2017.
Degradation of tropical forests is a major driver of the global extinction crisis. A key question is understanding the role of evolution history during forest succession in the context of forest ...restoration for maintaining ecosystem function and stability. This study was conducted in a fragmented forest landscape in the central highlands of Vietnam. We sampled living trees with diameters at breast height of ≥6.0 cm in nineteen 0.25 ha plots to evaluate forest community structure changes over two early successional stages (<10 years and 10–20 years old) after abandonment and old-growth. We used both statistically metric and nonmetric analyses to examine correlations of community composition during successional stages and along elevational gradients. We found that (i) significant differences existed in the structural compositions between early successional forests and old-growth forests, but did not exist within early successional forests; (ii) the phylogenetic structure shifted from overdispersion to clustering with increasing successional ages; and (iii) above-ground biomass (AGB), representing ecosystem functioning, significantly increased from early-to-late successional stages, but did not correlate with phylogenetic diversity or elevation. Our results revealed that the forest community structure was strongly affected by degradation, particularly AGB and phylogenetic structure. These findings have clear implications for sustaining biodiversity persistence and ecosystem functioning in human-modified landscapes in the study region.
Background:
Adolescents living with HIV (ALHIV) in Vietnam are known to struggle with adherence to Antiretroviral Therapy (ART).
Objective:
To examine treatment challenges and facilitators ...experienced by ALHIV from the perspective of adolescents, their caregivers, and providers, and to inform an adherence intervention.
Methods:
In-depth Interviews (IDIs) of adolescent/caregiver dyads and Focus Group Discussions (FGDs) with adolescents, caregivers, and clinicians were conducted in Hanoi, Vietnam. We used semi-structured guides to encourage open-ended responses. We queried the challenges adolescents experience taking ART medications and being adherent, their awareness of disease status, and facilitators to support high adherence. Audio-recorded IDIs were translated into English, and coded and analyzed in NVivo using a thematic approach.
Results:
A total of 78 individuals participated in the study. Forty individuals participated in IDIs (20 adolescents and 20 caregivers). All adolescents had acquired HIV perinatally. We conducted six FGDs: four with adolescents, and one each with caregivers and clinicians. We identified major themes regarding awareness of HIV status (most caregivers reported they had disclosed to their child, while few adolescents revealed the knowledge of their status); perceived barriers to adherence (medication-related challenges, stigma, school-associated issues, financial obstacles, system challenges, awareness of HIV status); and adherence facilitators (development of dose-taking habits, reminder systems, social support). Differences between adolescents and caregivers related to key issues were evident.
Conclusion:
Further research is needed to elucidate discrepancies in adolescent-caregiver viewpoints and develop interventions tailored to both ALHIV and their caregivers.
Non-sputum-based triage tests for tuberculosis are a priority for ending tuberculosis. We aimed to evaluate the diagnostic accuracy of the late-prototype Xpert MTB Host Response (Xpert HR) ...blood-based assay.
We conducted a prospective diagnostic accuracy study among outpatients with presumed tuberculosis in outpatient clinics in Viet Nam, India, the Philippines, Uganda, and South Africa. Eligible participants were aged 18 years or older and reported cough lasting at least 2 weeks. We excluded those receiving tuberculosis treatment in the preceding 12 months and those who were unwilling to consent. Xpert HR was performed on capillary or venous blood. Reference standard testing included sputum Xpert MTB/RIF Ultra and mycobacterial culture. We performed receiver operating characteristic (ROC) analysis to identify the optimal cutoff value for the Xpert HR to achieve the target sensitivity of 90% or more while maximising specificity, then calculated diagnostic accuracy using this cutoff value. This study was prospectively registered with ClinicalTrials.gov, NCT04923958.
Between July 13, 2021, and Aug 15, 2022, 2046 adults with at least 2 weeks of cough were identified, of whom 1499 adults (686 45·8% females and 813 54·2% males) had valid Xpert HR and reference standard results. 329 (21·9%) had microbiologically confirmed tuberculosis. Xpert HR had an area under the ROC curve of 0·89 (95% CI 0·86–0·91). The optimal cutoff value was less than or equal to –1·25, giving a sensitivity of 90·3% (95% CI 86·5–93·3; 297 of 329) and a specificity of 62·6% (95% CI 59·7–65·3; 732 of 1170). Sensitivity was similar across countries, by sex, and by subgroups, although specificity was lower in people living with HIV (45·1%, 95% CI 37·8–52·6) than in those not living with HIV (65·9%, 62·8–68·8; difference of 20·8%, 95% CI 13·0–28·6; p<0·0001). Xpert HR had high negative predictive value (95·8%, 95% CI 94·1–97·1), but positive predictive value was only 40·1% (95% CI 36·8–44·1). Using the Xpert HR as a triage test would have reduced confirmatory sputum testing by 57·3% (95% CI 54·2–60·4).
Xpert HR did not meet WHO minimum specificity targets for a non-sputum-based triage test for pulmonary tuberculosis. Despite promise as a rule-out test that could reduce confirmatory sputum testing, further cost-effectiveness modelling and data on acceptability and usability are needed to inform policy recommendations.
National Institute of Allergy and Infectious Diseases of the US National Institutes of Health.
For the Vietnamese and Tagalog translations of the abstract see Supplementary Materials section.
In this paper, we study a cold-start problem in recommendation systems where we have completely new users entered the systems. There is not any interaction or feedback of the new users with the ...systems previoustly, thus no ratings are available. Trivial approaches are to select ramdom items or the most popular ones to recommend to the new users. However, these methods perform poorly in many case. In this research, we provide a new look of this cold-start problem in recommendation systems. In fact, we cast this cold-start problem as a contextual-bandit problem. No additional information on new users and new items is needed. We consider all the past ratings of previous users as contextual information to be integrated into the recommendation framework. To solve this type of the cold-start problems, we propose a new efficient method which is based on the LinUCB algorithm for contextual-bandit problems. The experiments were conducted on three different publicly-available data sets, namely Movielens, Netflix and Yahoo!Music. The new proposed methods were also compared with other state-of-the-art techniques. Experiments showed that our new method significantly improves upon all these methods.
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