Effectiveness and cost-effectiveness of an app and rewards-based intervention in type 2 diabetes: A randomised controlled trial.

Aim: Digital health interventions and economic incentives have shown promise in facilitating diabetes self-management, though evidence is limited. Therefore, this study aimed to evaluate the effectiveness and cost-effectiveness of a comprehensive app-based diabetes self-management programme with rewards for healthy behaviours and health outcomes.

Materials And Methods: The TRIal to slow the Progression Of Diabetes (TRIPOD) study was an open-label, parallel-group, randomised controlled trial conducted at Duke-NUS Medical School, Singapore.

The Renewing Intimacy and SExuality Intervention for Female Cancer Survivors: A Feasibility Study.

Purpose: This study examined the feasibility and acceptability of a three-session, psychological-based intervention to improve intimacy and sexuality outcomes among women with breast and gynaecologic cancer in Singapore.

Method: Patients from outpatient oncology clinics completed screeners for marital and sexual distress. Those who endorsed either marital or sexual distress were invited into the study, and were randomized to receive the intervention immediately or be waitlisted.

Inclusion of unexposed clusters improves the precision of fixed effects analysis of stepped-wedge cluster randomized trials with binary and count outcomes.

Background: The fixed effects model is a useful alternative to the mixed effects model for analyzing stepped-wedge cluster randomized trials (SW-CRTs). It controls for all time-invariant cluster-level confounders and has proper control of type I error when the number of clusters is small. While all clusters in a SW-CRT are typically designed to crossover from the control to receive the intervention, some trials can end with unexposed clusters (clusters that never receive the intervention), such as when a trial is terminated early due to safety concerns.

The fixed-effects model for robust analysis of stepped-wedge cluster trials with a small number of clusters and continuous outcomes: a simulation study.

Background: Stepped-wedge cluster trials (SW-CTs) describe a cluster trial design where treatment rollout is staggered over the course of the trial. Clusters are commonly randomized to receive treatment beginning at different time points in this study design (commonly referred to as a Stepped-wedge cluster randomized trial; SW-CRT), but they can also be non-randomized. Trials with this design regularly have a low number of clusters and can be vulnerable to covariate imbalance.

Two assumptions of the prior event rate ratio approach for controlling confounding can be evaluated by self-controlled case series and dynamic random intercept modeling.

Objectives: The prior event rate ratio (PERR) is a recently developed approach for controlling confounding by measured and unmeasured covariates in real-world evidence research and observational studies. Despite its rising popularity in studies of safety and effectiveness of biopharmaceutical products, there is no guidance on how to empirically evaluate its model assumptions. We propose two methods to evaluate two of the assumptions required by the PERR, specifically, the assumptions that occurrence of outcome events does not alter the likelihood of receiving treatment, and that earlier event rate does not affect later event rate.

Memory B cell responses induced by pneumococcal conjugate vaccine schedules with fewer doses: analysis of a randomised-controlled trial in Viet Nam.

The use of pneumococcal conjugate vaccine (PCV) schedules with fewer doses are being considered to reduce costs and improve access, particularly in low- and middle-income countries. While several studies have assessed their immunogenicity, there are limited data on their potential for long-term immune protection, as assessed by pneumococcal serotype-specific memory B cell (B) responses. This current study reports secondary outcome data that aims to compare B responses following reduced-dose (0 + 1 and 1 + 1) schedules of PCV10 and PCV13 in Vietnamese infants from our randomised-controlled trial (trial registration number NCT03098628).

Lung-Protective Ventilation for Pediatric Acute Respiratory Distress Syndrome: A Nonrandomized Controlled Trial.

Objectives: Despite the recommendation for lung-protective mechanical ventilation (LPMV) in pediatric acute respiratory distress syndrome (PARDS), there is a lack of robust supporting data and variable adherence in clinical practice. This study evaluates the impact of an LPMV protocol vs. standard care and adherence to LPMV elements on mortality.

Feasibility of Weekly Integrated Palliative Care Outcome Scale (IPOS) Within a Stepped Care Model.

Context: Patients with advanced cancer may experience symptoms and concerns that are inadequately identified by the healthcare team, leading to calls for patient-reported symptom monitoring.

Objectives: Assess the feasibility of administering weekly patient-reported online Integrated Palliative care Outcome Scale (IPOS) questionnaires within the context of a stepped care model in the outpatient care setting.

Methods: Analysis of intervention group data in a randomized controlled trial to assess the effectiveness of a stepped care model of palliative care for patients with advanced cancer.

Electron transport chain capacity expands yellow fever vaccine immunogenicity.

Vaccination has successfully controlled several infectious diseases although better vaccines remain desirable. Host response to vaccination studies have identified correlates of vaccine immunogenicity that could be useful to guide development and selection of future vaccines. However, it remains unclear whether these findings represent mere statistical correlations or reflect functional associations with vaccine immunogenicity.

Estimation and reduction of bias in self-controlled case series with non-rare event dependent outcomes and heterogeneous populations.

The self-controlled case series (SCCS) is a commonly adopted study design in the assessment of vaccine and drug safety. Recurrent event data collected from SCCS studies are typically analyzed using the conditional Poisson model which assumes event times are independent within-cases. This assumption is violated in the presence of event dependence, where the occurrence of an event influences the probability and timing of subsequent events.

Estimation of trajectory of protective efficacy in infectious disease prevention trials using recurrent event times.

In studies of infectious disease prevention, the level of protective efficacy of medicinal products such as vaccines and prophylactic drugs tends to vary over time. Many products require administration of multiple doses at scheduled times, as opposed to one-off or continual intervention. Accurate information on the trajectory of the level of protective efficacy over time facilitates informed clinical recommendations and implementation strategies, for example, with respect to the timing of administration of the doses.

PRECIOUS demonstrated satisfactory measurement properties for assessing the quality of care for children with serious illnesses.

Objectives: To determine the measurement properties of PaRental Experience with care for Children with serIOUS illnesses (PRECIOUS), a parent-reported measure of Quality of Care for seriously ill children across care settings and illness trajectories.

Study Design And Setting: Parents self-administered baseline and 2-week follow-up surveys online. Exploratory Factor Analysis was used to determine PRECIOUS's factor structure and select items.

ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial.

Background: Specialist palliative care is often provided late in the patient's disease trajectory in response to uncontrolled symptoms. Shifting from this reactionary illness-stress paradigm to a proactive health-wellness approach, the ENABLE (Educate, Nurture, Advise, Before Life Ends) telehealth model aims to enhance the coping, stress and symptom management, self-care, and advance care planning skills of patients with advanced cancers and their caregivers. The ENABLE model has been culturally adapted to Singapore (ENABLE-SG) and pilot-tested.

Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1-11-month-old infants in Mali.

Background: The Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin (LAKANA) trial in Mali aims to evaluate the efficacy and safety of azithromycin (AZI) mass drug administration (MDA) to 1-11-month-old infants as well as the impact of the intervention on antimicrobial resistance (AMR) and mechanisms of action of azithromycin. To improve the transparency and quality of this clinical trial, we prepared this statistical analysis plan (SAP).

Methods/design: LAKANA is a cluster randomized trial that aims to address the mortality and health impacts of biannual and quarterly AZI MDA.

Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized controlled trial.

Background: Type 2 diabetes (T2D), a major risk factor for cardiovascular disease and other adverse health conditions, is on the rise in Singapore. TRIPOD is a randomized controlled trial aimed to determine whether complementing usual care with an evidence-based diabetes management package (DMP) -comprising access to an evidence-based app, health coaching, pedometer, glucometer and weighing scale, with or without a financial rewards scheme (M-POWER rewards), can improve mean HbA levels at months 6 and 12.

Methods: The protocol was published in Trials, accessible via https://trialsjournal.

Cluster randomized trial designs for modeling time-varying intervention effects.

Stepped-wedge cluster randomized trials (SW-CRTs) are typically analyzed assuming a constant intervention effect. In practice, the intervention effect may vary as a function of exposure time, leading to biased results. The estimation of time-on-intervention (TOI) effects specifies separate discrete intervention effects for each elapsed period of exposure time since the intervention was first introduced.

Novel 3-arm wait-list controlled trial designs together with mixed-effects analysis improve precision of treatment effect estimators.

Clinical trialists have long been searching for approaches to increase statistical power without increasing sample size. Conventional wait-list controlled (WLC) trials are limited to two trial arms and two or three repeated measurements per person. These features limit statistical power.

Associations of predominant night-eating with plasma glycemic status and continuous glucose monitoring measures among pregnant women.

Background & Aims: To examine whether predominant night-eating, defined as more than 50% of total daily energy intake consumed between 1900 and 0659 h, is associated with glycemic outcomes in pregnancy.

Methods: This was a prospective cohort study of 277 healthy pregnant women with complete 4-day dietary intake records at 18-24 weeks gestation, recruited from KK Women's and Children's Hospital, Singapore. Primary outcomes were fasting, 1-h, and 2-h plasma glucose after a 75-g oral glucose tolerance test at 24-28 weeks gestation.

Measurement Properties of the 15-Item Singapore Caregiver Quality of Life Scale (SCQOLS-15) in Family Caregivers of Patients with Heart Diseases.

Purpose: To evaluate the measurement properties of the 15-item Singapore Caregiver Quality of Life Scale (SCQOLS-15) in family caregivers of patients with heart diseases.

Methods: The SCQOLS-15 survey was self-administered by family caregivers of patients with chronic heart diseases, at baseline and 1 week later. The criterion validity of SCQOLS-15 and its domain scores was assessed by calculating the Spearman correlation coefficient (ρ) with the Brief Assessment Scale for Caregivers (BASC), Caregiver Reaction Assessment (CRA), and their sub-scores.

The relationship between hope, medical expenditure and survival among advanced cancer patients.

Introduction: Among those with advanced illness, higher levels of hope may offer physiological benefits. Yet, greater levels of hope may also encourage aggressive treatments. Therefore, higher levels of hope may lead to greater healthcare utilization, higher expenditure, and longer survival.

Can an Integrated Palliative and Oncology Co-rounding Model Reduce Aggressive Care at the End of Life? Secondary Analysis of an Open-label Stepped-wedge Cluster-randomized Trial.

Background: Clinical trial evidence on the effect of palliative care models in reducing aggressive end-of-life care is inconclusive. We previously reported on an integrated inpatient palliative care and medical oncology co-rounding model that significantly reduced hospital bed-days and postulate additional effect on reducing care aggressiveness.

Objectives: To compare the effect of a co-rounding model vs usual care in reducing receipt of aggressive treatment at end-of-life.

The Impact of Antenatal Azithromycin and Monthly Sulfadoxine-Pyrimethamine on Maternal Malaria during Pregnancy and Fetal Growth: A Randomized Controlled Trial.

Maternal malaria and infections during pregnancy are risk factors for fetal growth restriction. We assessed the impact of preventive treatment in pregnancy on maternal malaria and fetal growth. Between 2003 and 2006, we enrolled 1,320 pregnant Malawian women, 14-26 gestation weeks, in a randomized trial and treated them with two doses of sulfadoxine-pyrimethamine (SP, control) at enrollment and between 28-34 gestation weeks; with monthly SP from enrollment until 37 gestation weeks; or with monthly SP and azithromycin twice, at enrollment and between 28 and 34 gestation weeks (AZI-SP).