Pragmatic monitoring of emerging efficacy data in randomized controlled trials.

Monitoring the conduct of phase III randomized controlled trials is driven by ethical reasons to protect the study integrity and the safety of trial participants. We propose a group sequential, pragmatic approach for monitoring the accumulating efficacy information in randomized controlled trials. The "Population Health Research Institute boundary" is simple to implement and sensible, as it considers the reduction in uncertainty with increasing information as the study progresses.

A UK framework for the assessment and integration of different scientific evidence streams in chemical risk assessment.

Background: Few methods are available for transparently combining different evidence streams for chemical risk assessment to reach an integrated conclusion on the probability of causation. Hence, the UK Committees on Toxicity (COT) and on Carcinogenicity (COC) have reviewed current practice and developed guidance on how to achieve this in a transparent manner, using graphical visualisation.

Methods/approach: All lines of evidence, including toxicological, epidemiological, new approach methodologies, and mode of action should be considered, taking account of their strengths/weaknesses in their relative weighting towards a conclusion on the probability of causation.

Computerized clinical decision support to improve stroke prevention therapy in primary care management of atrial fibrillation: a cluster randomized trial.

Background: Despite guidelines supporting antithrombotic therapy use in atrial fibrillation (AF), under-prescribing persists. We assessed whether computerized clinical decision support (CDS) would enable guideline-based antithrombotic therapy for AF patients in primary care.

Methods: This cluster randomized trial of CDS versus usual care (UC) recruited participants from primary care practices across Nova Scotia, following them for 12 months.

Aspirin for the Primary Prevention of Vascular Ischemic Events: An Updated Systematic Review and Meta-analysis to Support Shared Decision-Making.

Background: Since the publication of the 2010 Canadian antiplatelet guidelines, several large randomized controlled trials (RCTs) have evaluated the role of aspirin (ASA) use in primary prevention. We evaluated the effect of ASA use, compared with no ASA, on ischemic and bleeding events in patients without known atherosclerotic cardiovascular diseases.

Methods: We updated a published systematic review and meta-analysis by searching MEDLINE, Embase, and CENTRAL for the period up to March 2023.

Genome-wide association analysis of cystatin-C kidney function in continental Africa.

Background: Chronic kidney disease is becoming more prevalent in Africa, and its genetic determinants are poorly understood. Creatinine-based estimated glomerular filtration rate (eGFR) is commonly used to estimate kidney function, modelling the excretion of the endogenous biomarker (creatinine). However, eGFR based on creatinine has been shown to inadequately detect individuals with low kidney function in Sub-Saharan Africa, with eGFR based on cystatin-C (eGFRcys) exhibiting significantly superior performance.

Fine-mapping of retinal vascular complexity loci identifies Notch regulation as a shared mechanism with myocardial infarction outcomes.

There is increasing evidence that the complexity of the retinal vasculature measured as fractal dimension, D, might offer earlier insights into the progression of coronary artery disease (CAD) before traditional biomarkers can be detected. This association could be partly explained by a common genetic basis; however, the genetic component of D is poorly understood. We present a genome-wide association study (GWAS) of 38,000 individuals with white British ancestry from the UK Biobank aimed to comprehensively study the genetic component of D and analyse its relationship with CAD.

Prediction of Lung Function Status Using Handgrip Strength and Anthropometry among the Healthy Malay Population in Malaysia.

Lung function depends primarily on the strength of the intercostal muscles and the diaphragm, which is indirectly related to handgrip strength (HGS). This study aims to determine the predictability of lung functions using HGS among healthy adults of Malay ethnicity in Malaysia. This study also aims to compare the equation using HGS with equations without HGS, such as the Global Lung Initiative (GLI).

The Effect of Chronic Kidney Disease or End-stage Kidney Disease on Perioperative Outcomes and Healthcare Utilization in Patients Undergoing Bariatric Surgery.

Background: As chronic kidney disease (CKD) has a higher prevalence in patients with obesity, there is an increasing need to understand the safety of bariatric surgery for patients with advanced CKD. This study determined if short-term bariatric surgical outcomes and healthcare utilization differ in patients with advanced CKD.

Methods: A retrospective analysis of the Healthcare Cost and Utilization Project National Inpatient Sample (NIS) was performed.

Effectiveness and implementation of a lifestyle modification intervention for women with isolated impaired fasting glucose: Study protocol for a hybrid type 2 study in Kerala, India.

Isolated impaired fasting glucose (i-IFG) constitutes a major group in the prediabetic spectrum among Indians, and thus it is imperative to identify effective diabetes prevention strategies. This study aims to evaluate the effects of an intensive community-based lifestyle modification program on regression to normoglycemia among women with i-IFG, compared to a control group at 24 months. The study also aims to evaluate the implementation of the intervention, via both process and implementation outcomes.

New insights of minimum requirement on legumes (Fabaceae sp.) daily intake in Malaysia.

Background: Despite their low energy density and high nutrient content, legumes may be under-recognised as a beneficial food for the prevention and management of obesity and related diseases, such as cardiovascular disease (CVD). This study aims to analyse the moderation effect of legume intake on the relationship between BMI and the prevalence of CVD among the Malaysian adult population.

Methods: This study addressed communities of urban and rural Malaysia, including adults aged between 35 and 70 years old at the baseline recruitment.

Insight into genetic, biological, and environmental determinants of sexual-dimorphism in type 2 diabetes and glucose-related traits.

There is growing evidence that sex and gender differences play an important role in risk and pathophysiology of type 2 diabetes (T2D). Men develop T2D earlier than women, even though there is more obesity in young women than men. This difference in T2D prevalence is attenuated after the menopause.

Commentary: statistical analysis of 2 × 2 tables in biomarker studies 2) study design and statistical tests.

In this article the importance of study design will be emphasized, statistical methods for analysing the data are described and some of the implications of these method are discussed. How these issues relate to the use of SpIN and SnOUT rules are reviewed.

Development of Food Group Tree-Based Analysis and Its Association with Non-Alcoholic Fatty Liver Disease (NAFLD) and Co-Morbidities in a South Indian Population: A Large Case-Control Study.

Background: Non-alcoholic fatty liver disease (NAFLD) is a global problem growing in parallel to the epidemics of obesity and diabetes, with South Asians being particularly susceptible. Nutrition and behaviour are important modifiers of the disease; however, studies to date have only described dietary patterns and nutrients associated with susceptibility to NAFLD.

Methods: This cross-sectional case-control study included 993 NAFLD patients and 973 healthy controls from Trivandrum (India).

Commentary: statistical analysis of 2 × 2 tables in biomarker studies 3) design, interpretation and guidelines.

This article discusses issues associated with the design and interpretation of biomarker studies, points to various guidelines and lists points to look out for in assessing studies.

Commentary: statistical analysis of 2 × 2 tables in biomarker studies 1) the four 'indices of test validity'.

Diagnostic statistics such as sensitivity and specificity are widely used in the assessment of biomarkers. Interpretation of these and other statistics derived from a 2 × 2 table can be complex. The properties of the commonly used statistics are discussed.

Genetic loci implicated in meta-analysis of body shape in Africans.

Background And Aims: Obesity is one of the leading causes of non-communicable diseases (NCD). Thus, NCD risk varies in obese individuals based on the location of their fat depots; while subcutaneous adiposity is protective, visceral adiposity increases NCD risk. Although, previously anthropometric traits have been used to quantify body shape in low-income settings, there is no consensus on how it should be assessed.

The Hospital at Home Model vs Routine Hospitalization for Acute Heart Failure: A Survey of Patients' Preferences.

Background: Patients with heart failure (HF) experience recurrent hospitalizations and may prefer a Hospital at Home (HaH) model over routine hospitalization.

Methods: We administered a 9-item questionnaire on perceived effectiveness, safety, convenience, and acceptability of a HaH model among patients hospitalized for HF at 2 academic hospitals in Ontario. The primary outcome was HaH care acceptability, defined as a preference for or neutrality to HaH care over routine hospitalization.

Rivaroxaban versus aspirin on functional and cognitive outcomes after embolic stroke of undetermined source: NAVIGATE ESUS trial.

Background: The effect of interventions on functional impairment is an important outcome in stroke prevention trials and should be considered as an adjunct to counting discrete events. In the NAVIGATE-ESUS trial, 7213 patients with recent embolic strokes of undetermined source were randomized to rivaroxaban (15 mg once daily) or aspirin (100 mg daily). After 11 months there was no effect on the prevention of recurrent stroke.

Associations between Dietary Patterns and Cardiometabolic Risk Factors-A Longitudinal Analysis among High-Risk Individuals for Diabetes in Kerala, India.

The association between dietary patterns and cardiometabolic risk factors is not well understood among adults in India, particularly among those at high risk for diabetes. For this study, we analyzed the data of 1007 participants (age 30-60 years) from baseline and year one and two follow-ups from the Kerala Diabetes Prevention Program using multi-level mixed effects modelling. Dietary intake was measured using a quantitative food frequency questionnaire, and dietary patterns were identified using principal component analysis.

Undergraduate medical teaching with remote consultations in general practice: a realist evaluation.

Background: Supervisors historically educated students in primary care in face-to-face contexts; as a result of COVID-19, students now experience patient consultations predominantly remotely. There is a paucity of evidence regarding the facilitators and barriers to supervising students for excellent educational impact in the remote consultation environment.

Aim: To understand the facilitators and barriers to educating medical students using remote consultations in primary care, and the consequences for students in terms of educational impact.

Association of Clonal Hematopoiesis of Indeterminate Potential with Worse Kidney Function and Anemia in Two Cohorts of Patients with Advanced Chronic Kidney Disease.

Background: Clonal hematopoiesis of indeterminate potential (CHIP) is an inflammatory premalignant disorder resulting from acquired genetic mutations in hematopoietic stem cells. This condition is common in aging populations and associated with cardiovascular morbidity and overall mortality, but its role in CKD is unknown.

Methods: We performed targeted sequencing to detect CHIP mutations in two independent cohorts of 87 and 85 adults with an eGFR<60 ml/min per 1.