Evaluation of School Readiness Outcomes in Preterm and SGA Infant

The early preterm and SGA children show lower scores then term infants: high and medium scores were seen 84,8% in I Group; 47,1% in II group; and 48,1% in III group and 79,6% in Control group accordingly. Elementary school readiness scores was i

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial

Background: Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole) with that of guideline-based antiplatelet therapy. Methods: We did an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants with ischaemic stroke or transient ischaemic attack (TIA) within 48 h of onset. Participants were assigned in a 1:1 ratio using computer randomisation to receive loading doses and then 30 days of intensive antiplatelet therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice daily) or guideline-based therapy (comprising either clopidogrel alone or combined aspirin and dipyridamole). Randomisation was stratified by country and index event, and minimised with prognostic baseline factors, medication use, time to randomisation, stroke-related factors, and thrombolysis. The ordinal primary outcome was the combined incidence and severity of any recurrent stroke (ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days, as assessed by central telephone follow-up with masking to treatment assignment, and analysed by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN47823388. Findings: 3096 participants (1556 in the intensive antiplatelet therapy group, 1540 in the guideline antiplatelet therapy group) were recruited from 106 hospitals in four countries between April 7, 2009, and March 18, 2016. The trial was stopped early on the recommendation of the data monitoring committee. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio [cOR] 0·90, 95% CI 0·67–1·20, p=0·47). By contrast, intensive antiplatelet therapy was associated with more, and more severe, bleeding (adjusted cOR 2·54, 95% CI 2·05–3·16, p<0·0001). Interpretation: Among patients with recent cerebral ischaemia, intensive antiplatelet therapy did not reduce the incidence and severity of recurrent stroke or TIA, but did significantly increase the risk of major bleeding. Triple antiplatelet therapy should not be used in routine clinical practice

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial

Background: Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole) with that of guideline-based antiplatelet therapy.Methods: We did an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants with ischaemic stroke or transient ischaemic attack (TIA) within 48 h of onset. Participants were assigned in a 1:1 ratio using computer randomisation to receive loading doses and then 30 days of intensive antiplatelet therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice daily) or guideline-based therapy (comprising either clopidogrel alone or combined aspirin and dipyridamole). Randomisation was stratified by country and index event, and minimised with prognostic baseline factors, medication use, time to randomisation, stroke-related factors, and thrombolysis. The ordinal primary outcome was the combined incidence and severity of any recurrent stroke (ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days, as assessed by central telephone follow-up with masking to treatment assignment, and analysed by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN47823388.Findings: 3096 participants (1556 in the intensive antiplatelet therapy group, 1540 in the guideline antiplatelet therapy group) were recruited from 106 hospitals in four countries between April 7, 2009, and March 18, 2016. The trial was stopped early on the recommendation of the data monitoring committee. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio [cOR] 0·90, 95% CI 0·67–1·20, p=0·47). By contrast, intensive antiplatelet therapy was associated with more, and more severe, bleeding (adjusted cOR 2·54, 95% CI 2·05–3·16,

Cost-effectiveness of pneumococcal conjugate vaccination in Georgia.

OBJECTIVE: Financial support from the Global Alliance for Vaccines and Immunization (GAVI) to introduce the 10-valent pneumococcal conjugate vaccine (PCV10) into the routine childhood immunization schedule in Georgia is ending in 2015. As a result, the Interagency Coordination Committee (ICC) decided to carry out a cost-effectiveness analysis to gather additional evidence to advocate for an appropriate evidence-based decision after GAVI support is over. The study also aimed to strengthen national capacity to conduct cost-effectiveness studies, and to introduce economic evaluations into Georgia's decision-making process. METHODOLOGY: A multidisciplinary team of national experts led by a member of the ICC carried out the analysis that compared two scenarios: introducing PCV10 vs no vaccination. The TRIVAC model was used to evaluate 10 cohorts of children over the period 2014-2023. National data was used to inform demographics, disease burden, vaccine coverage, health service utilization, and costs. Evidence from clinical trials and the scientific literature was used to estimate the impact of the vaccine. A 3+0 schedule and a vaccine price increasing to US$3.50 per dose was assumed for the base-case scenario. Alternative univariate and multivariate scenarios were evaluated. RESULTS: Over the 10-year period, PCV10 was estimated to prevent 7170 (8288 undiscounted) outpatient visits due to all-cause acute otitis media, 5325 (6154 undiscounted) admissions due to all-cause pneumonia, 87 (100 undiscounted) admissions due to pneumococcal meningitis, and 508 (588 undiscounted) admissions due to pneumococcal non-pneumonia and non-meningitis (NPNM). In addition, the vaccine was estimated to prevent 41 (48 undiscounted) deaths. This is equivalent to approximately 5 deaths and 700 admissions prevented each year in Georgia. Over the 10-year period, PCV10 would cost the government approximately US$ 4.4 million ($440,000 per year). However, about half of this would be offset by the treatment costs prevented. The discounted cost-effectiveness ratio was estimated to be US$ 1599 per DALY averted with scenarios ranging from US$286 to US$ 7787. DISCUSSION: This study led to better multi-sectoral collaboration and improved national capacity to perform economic evaluations. Routine infant vaccination against Streptococcus pneumoniae would be highly cost-effective in Georgia. The decision to introduce PCV10 was already made some time before the study was initiated but it provided important economic evidence in support of that decision. There are several uncertainties around many of the parameters used, but a multivariate scenario analysis with several conservative assumptions (including no herd effect in older individuals) shows that this recommendation is robust. This study supports the decision to introduce PCV10 in Georgia

Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial: Rationale, design and progress

Background: Patients who suffer intracerebral hemorrhage (ICH) are at very high risk of recurrent ICH and other serious cardiovascular events. A single-pill combination (SPC) of blood pressure (BP) lowering drugs offers a potentially powerful but simple strategy to optimize secondary prevention. Objectives: The Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) aims to determine the effects of a novel SPC “Triple Pill,” three generic antihypertensive drugs with demonstrated efficacy and complementary mechanisms of action at half standard dose (telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg), with placebo for the prevention of recurrent stroke, cardiovascular events, and cognitive impairment after ICH. Design: An international, double-blind, placebo-controlled, randomized trial in adults with ICH and mild-moderate hypertension (systolic BP: 130–160 mmHg), who are not taking any Triple Pill component drug at greater than half-dose. A total of 1500 randomized patients provide 90% power to detect a hazard ratio of 0.5, over an average follow-up of 3 years, according to a total primary event rate (any stroke) of 12% in the control arm and other assumptions. Secondary outcomes include recurrent ICH, cardiovascular events, and safety. Results: Recruitment started 28 September 2017. Up to 31 October 2021, 821 patients were randomized at 54 active sites in 10 countries. Triple Pill adherence after 30 months is 86%. The required sample size should be achieved by 2024. Conclusion: Low-dose Triple Pill BP lowering could improve long-term outcome from ICH