Effect of text messaging on depression in patients with coronary heart disease: A sub study analysis from the TEXT ME randomised controlled trial

Objective: We aimed to evaluate the effects on depression scores of a lifestyle-focused cardiac support program delivered via mobile-phone text messaging among patients with coronary heart disease (CHD). Design: Sub-study and secondary analysis of a parallel group, single-blind randomized controlled trial of patients with CHD Setting: A tertiary hospital in Sydney, Australia Intervention: The TEXT ME comprised 4 text messages per week for 6 months that provided education, motivation and support on diet, physical activity, general cardiac education and smoking, if relevant. The program did not have any specific mental health component. Outcomes: Depression scores at 6 months measured using the Patient Health Questionnaire-9 (PHQ-9). Treatment effect across sub-groups was measured using log-binomial regression model for the binary outcome (depressed/not depressed, where depressed is any score of PHQ-9 ≥5) with treatment, subgroup and treatment by subgroup interaction as fixed effects. Results: Depression scores at 6 months were lower in the intervention group compared to the control group, mean difference 1.9 (95% CI 1.5-2.4, p-value <0.0001). The frequency of mild or greater depressive symptoms (PHQ-9 scores ≥5) at 6 months was 21/333 (6.3%) in the intervention group and 86/350 (24.6%) in the control group (relative risk 0.26, 95% CI 0.16-0.40, p <0.001). This proportional reduction in depressive symptoms was similar across groups defined by age, sex, education, BMI, physical activity, current smoking, current drinking, and history of depression, diabetes, and hypertension. In particular, the rates of PHQ-9 ≥5 among people with a history of depression were 4/44 (9.1%) vs 29/62 (46.8%) in intervention vs control (RR 0.19, 95% CI 0.07 to 0.51, p<0.001), and were 17/289 (5.9%) vs 57/288 (19.8%) among others (RR 0.30, 95% CI 0.18 to 0.50, p<0.001). Conclusions: Among people with CHD a cardiac support program delivered via mobile-phone text messaging was associated with less symptoms of mild-to-moderate depression at 6 months in the treatment group compared to controls. Trial Registration: Australian New Zealand Clinical Trials Registry Number (ANZCTRN): anzctr.org.au Identifier: ACTRN1261100016192

Mobile phone text-messaging interventions aimed to prevent cardiovascular diseases (Text2PreventCVD): systematic review and individual patient data meta-analysis.

Background: A variety of small mobile phone text-messaging interventions have indicated improvement in risk factors for cardiovascular disease (CVD). Yet the extent of this improvement and whether it impacts multiple risk factors together is uncertain. We aimed to conduct a systematic review and individual patient data (IPD) meta-analysis to investigate the effects of text-messaging interventions for CVD prevention. Methods: Electronic databases were searched to identify trials investigating a text-messaging intervention focusing on CVD prevention with the potential to modify at least two CVD risk factors in adults. The main outcome was blood pressure (BP). We conducted standard and IPD meta-analysis on pooled data. We accounted for clustering of patients within studies and the primary analysis used random-effects models. Sensitivity and subgroup analyses were performed. Results: Nine trials were included in the systematic review involving 3779 participants and 5 (n=2612) contributed data to the IPD meta-analysis. Standard meta-analysis showed that the weighted mean differences are as follows: systolic blood pressure (SBP), -4.13 mm Hg (95% CI -11.07 to 2.81, p<0.0001); diastolic blood pressure (DBP), -1.11 mm Hg (-1.91 to -0.31, p=0.002); and body mass index (BMI), -0.32 (-0.49 to -0.16, p=0.000). In the IPD meta-analysis, the mean difference are as follows: SBP, -1.3 mm Hg (-5.4 to 2.7, p=0.5236); DBP, -0.8 mm Hg (-2.5 to 1.0, p=0.3912); and BMI, -0.2 (-0.8 to 0.4, p=0.5200) in the random-effects model. The impact on other risk factors is described, but there were insufficient data to conduct meta-analyses. Conclusion: Mobile phone text-messaging interventions have modest impacts on BP and BMI. Simultaneous but small impacts on multiple risk factors are likely to be clinically relevant and improve outcome, but there are currently insufficient data in pooled analyses to examine the extent to which simultaneous reduction in multiple risk factors occurs. PROSPERO registration number: CRD42016033236

Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care in patients with mild-to-moderate hypertension in Sri Lanka: a within-trial and modelled economic evaluation of the TRIUMPH trial

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: Elevated blood pressure incurs a major health and economic burden, particularly in low-income and middle-income countries. The Triple Pill versus Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial showed a greater reduction in blood pressure in patients using fixed-combination, low-dose, triple-pill antihypertensive therapy (consisting of amlodipine, telmisartan, and chlorthalidone) than in those receiving usual care in Sri Lanka. We aimed to assess the cost-effectiveness of the triple-pill strategy. Methods: We did a within-trial (6-month) and modelled (10-year) economic evaluation of the TRIUMPH trial, using the health system perspective. Health-care costs, reported in 2017 US dollars, were determined from trial records and published literature. A discrete-time simulation model was developed, extrapolating trial findings of reduced systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality. The primary outcomes were the proportion of people reaching blood pressure targets (at 6 months from baseline) and disability-adjusted life-years (DALYs) averted (at 10 years from baseline). Incremental cost-effectiveness ratios were calculated to estimate the cost per additional participant achieving target blood pressure at 6 months and cost per DALY averted over 10 years. Findings: The triple-pill strategy, compared with usual care, cost an additional US$9·63 (95$347·75 (285·55 to 412·54) per person in the modelled analysis. Incremental cost-effectiveness ratios were estimated at $7·93 (95$2842·79 (−28·67 to 5714·24) per DALY averted over a 10-year period. Interpretation: Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension. Scaled up investment in the triple pill for hypertension management in Sri Lanka should be supported to address the high population burden of cardiovascular disease. Funding: Australian National Health and Medical Research Council

Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to dual combinations for the treatment of hypertension: An international, multi-center, randomized, double-blind, active-controlled, parallel-group trial. Statistical Analysis Plan.

Statistical Analysis Plan of the GMRx2 Active tria

Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to placebo for the treatment of hypertension: An international, multi-center, randomized, double-blind, placebo-controlled, parallel-group trial. Statistical Analysis Plan.

Statistical Analysis Plan of the GMRx2 Placebo-controlled trial (Efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension

High Attack Rate of Severe Acute Respiratory Syndrome Coronavirus 2 B.1.1.529 Among 2-Dose Vaccinated Populations in 2 Indoor Entertainment Setting Outbreaks

Abstract We estimated attack rates of severe acute respiratory syndrome coronavirus 2 Omicron (B.1.1.529) infection among people attending a nightclub and a graduation ball where &amp;gt;95% had at least 2 vaccine doses. Attack rates were 295 of 535 (55.1%) and 102 of 189 (54.0%), respectively (mean, 5 days postevent). At the ball, attack rates increased with time since vaccination: 12.5% among those vaccinated 1–2 months previously and 68.0% among those vaccinated ≥3 months previously; such differences were not found at the nightclub. Recent vaccination prevents Omicron infection, but is time and setting dependent, emphasizing the importance of nonpharmaceutical public health measures in addition to vaccine booster doses to maximize protection in high-risk contexts.</jats:p

High attack rate of SARS-CoV-2 B.1.1.529 among two-dose vaccinated populations in two indoor entertainment setting outbreaks

We estimated attack rates of SARS-CoV-2 B.1.1.529 (Omicron) infection among people attending a nightclub and a graduation ball where >95% had at least 2 vaccine doses. Attack rates were 295/535(55.1%) and 102/189(54.0%) respectively (mean: 5 days post-event). At the ball, attack rates increased with time since vaccination: 12.5% among those vaccinated 1-2 months previously; 68.0% among those vaccinated 3 + months previously; such differences were not found at the nightclub. Recent vaccination prevents Omicron infection, but is time and setting-dependent, emphasising the importance of non-pharmaceutical public health measures in addition to vaccine booster doses to maximise protection in high-risk contexts