Search

• Evidence regarding effectiveness of BNT162b2 mRNA COVID-19 vaccine against Omicron in Latin America is limited. • This test-negative study assessed BNT162b2 effectiveness against symptomatic COVID-19 in Brazil when Omicron was predominant. • Two doses of BNT162b2 conferred meaningful but short-lived protection against Omicron infection in a young population. Evidence regarding effectiveness of BNT162b2 mRNA COVID-19 vaccine against Omicron in Latin America is limited. We estimated BNT162b2 effectiveness against symptomatic COVID-19 in Brazil when Omicron was predominant. This prospective test-negative, case-control study was conducted in Toledo, Brazil, following a mass COVID-19 vaccination with BNT162b2. Patients were included if they were aged ≥12 years, sought care for acute respiratory symptoms in the public health system between November 3, 2021 and June 20, 2022, and were tested for SARS-CoV-2 using RT-PCR. In the primary analysis, we determined the effectiveness of two doses of BNT162b2 against symptomatic COVID-19. A total of 4,574 were enrolled; of these, 1,758 patients (586 cases and 1,172 controls) were included in the primary analysis. Mean age was 27.7 years, 53.8 % were women, and 90.1 % had a Charlson comorbidity index of zero. Omicron accounted for >97 % of all identified SARS-CoV-2 variants, with BA.1 and BA.2 accounting for 84.3 % and 12.6 %, respectively. Overall adjusted estimate of two-dose vaccine effectiveness against symptomatic COVID-19 was 46.7 % (95 %CI, 19.9 %–64.6 %) after a median time between the second dose and the beginning of COVID-19 symptoms of 94 days (IQR, 60–139 days). Effectiveness waned from 77.7 % at 7–29 days after receipt of a second dose to <30 % (non-significant) after ≥120 days. In a relatively young and healthy Brazilian population, two doses of BNT162b2 provided protection against symptomatic Omicron infection. However, this protection waned significantly over time, underscoring the need for boosting with variant-adapted vaccines in this population prior to waves of disease activity. Trial registration number: ClinicalTrials.gov number, NCT05052307 (https://clinicaltrials.gov/ct2/show/NCT05052307). [ABSTRACT FROM AUTHOR]

Abstract: The World Health Organization (WHO) has recently released updated recommendations on Diagnostic Criteria and Classification of Hyperglycaemia First Detected in Pregnancy which are likely to increase the prevalence of gestational diabetes mellitus (GDM). Any increase in the number of women with GDM has implications for health services since these women will require treatment and regular surveillance during the pregnancy. Some health services throughout the world may have difficulty meeting these demands since country resources for addressing the diabetes burden are finite and resource allocation must be prioritised by balancing the need to improve care of people with diabetes and finding those with undiagnosed diabetes, including GDM. Consequently each health service will need to assess their burden of hyperglycaemia in pregnancy and decide if and how it will implement programmes to test for and treat such women. This paper discusses some considerations and options to assist countries, health services and health professionals in these deliberations. [Copyright &y& Elsevier]

Abstract: Aims: To evaluate the impact on perinatal outcomes of universal gestational diabetes (GDM) screening based on 1999 WHO and IADPSG diagnostic criteria; to assess the quality of the evidence (GRADE) to support GDM screening. Methods: Simulation of a hypothetical cohort of community-based pregnant women with 10% GDM prevalence (1999 WHO). Most parameters were obtained from recent systematic reviews. Results: Compared to no screening, screening based on 1999 WHO criteria (followed by treatment) reduced the incidence of large for gestational age (LGA) neonates by 0.53% (95% CI 0.37–0.74%; NNS=189) and of preeclampsia by 0.27% (0.10–0.45%; NNS=376). Screening based on IADPSG criteria reduced incidences by 0.85% (0.54–1.29%; NNS=117) and by 0.39% (0.15–0.65%; NNS=257), respectively. Compared to screening based on 1999 WHO criteria, screening with IADPSG criteria reduced the incidence of LGA by 0.32% (0.09–0.63%; NNS=309) and of preeclampsia by 0.12% (0.01–0.25; NNS=808). The quality of evidence for both screening approaches is very low. Conclusions: Universal screening for GDM has only a modest impact on pregnancy outcomes. The impact of screening based on IADPSG (vs. WHO, 1999) criteria is slightly larger. However, costs and resources should also be considered in local selection of a screening approach. [Copyright &y& Elsevier]

Abstract: Aims: To evaluate the effectiveness of gestational diabetes (GDM) treatment compared to usual antenatal care, in the prevention of adverse pregnancy outcomes. Additionally, to assess the quality of the evidence to support GDM treatment according to GRADE guidelines. Methods: Fourteen electronic databases and reference lists of relevant literature were searched for articles published from inception to February, 2012. Controlled clinical trials comparing GDM treatment to usual antenatal care were included. Independent extraction of articles was done by two authors using predefined data fields. Results: Seven trials involving 3157 women were included. We found high quality evidence that treatment of GDM reduces macrosomia (RR=0.47; 95% CI, 0.34–0.65; NNT=11.4) and large for gestational age birth (RR=0.57; 95% CI, 0.47–0.71; NNT=12.2); moderate quality evidence that treatment reduces preeclampsia (RR=0.61; 95% CI, 0.46–0.81; NNT=21.0) and hypertensive disorders in pregnancy (RR=0.64; 95% CI, 0.51–0.81; NNT=18.1); and low quality evidence that treatment reduces shoulder dystocia (RR=0.41; 95% CI, 0.22–0.76; NNT=48.8). No statistically significant reduction was seen for caesarean section. No increase in small for gestational age or preterm birth was found. Conclusions: Treatment of GDM is effective in reducing macrosomia (high quality evidence), preeclampsia and shoulder dystocia. [Copyright &y& Elsevier]

Background: Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers worldwide. Recent studies have shown that 4-20% of patients with PDAC have a germline BReast CAncer (gBRCA) genes 1 and 2 mutation (m). Because homologous recombination is impaired in patients with gBRCAm, some reports suggested that these tumors may be more sensitive to platinum compounds. Therefore, this systematic review and meta-analysis focused on benefit of patients with gBRCAm receiving a platinum-based chemotherapy (PtCh) compared with those treated with a non-platinum-based chemotherapy (NPtCh).Material and Methods: The following electronic databases were searched from inception to May 12, 2018: PubMed (MEDLINE), EMBASE, and Cochrane Library. Abstracts from conferences were also reviewed for inclusion. Cohort, case-control and randomized studies of patients with PDAC and gBRCAm were eligible for inclusion if they provided data to compare patients receiving PtCh vs NPtCh. The primary endpoint was overall survival (OS) in the PtCh group vs the NPtCh group in patients with clinical stage III (locally advanced) or IV (metastatic) (CS III-IV) PDAC.Results: Of 112 studies identified, 6 were included (total of 108 patients); of these, 4 provided sufficient data for meta-analysis. Half of the patients were males, with a mean age ranging from 58 to 63 years. The OS in the 85 patients with CS III-IV PDAC was higher in the PtCh group (23.7 vs 12.2 months; mean difference of 10.21 months, 95% confidence interval [CI] 5.05-15.37; P < 0.001; very low quality of evidence). PtCh was associated with a lower mortality (62.3 vs 87.5%; relative risk of 0.80, 95%CI 0.66-0.97; P = 0.021; very low quality of evidence).Conclusion: Our study confirmed the hypothesis that patients with CS III-IV gBRCAm preferably benefit from a PtCh compared with NPtCh. However the very low quality of evidence should induce to be careful about the risk of potential biases. The generated hypothesis should be prospectively investigated in homogenous clinical settings. [ABSTRACT FROM AUTHOR]

Background: Monochromatic infrared energy (MIRE) or phototherapy has been used to improve plantar sensitivity and pain in lower limbs of patients with diabetic sensorimotor peripheral neuropathy (DSPN), but the available primary results are inconsistent. Objective: To review systematically the effects of MIRE on plantar sensitivity and neuropathic pain in patients with DSPN. Methods: Medline, EMBASE, Cochrane CENTRAL, and Google Scholar were searched up to September 2016. Randomized controlled trials addressing the effects of MIRE on plantar sensitivity and neuropathic pain in patients with DSPN were selected. Study inclusion, risk of bias and quality assessment, and data extraction were completed by two independent reviewers. Results: Of 2549 records identified, six studies met the selection criteria, with 304 patients (594 feet) randomized. MIRE was not associated with improvement in plantar tactile sensitivity (SMD = 0.22, 95%CI -0.07 to 0.51, low quality of evidence). Subgroups of studies with short-term (up to 2 weeks) follow-up showed significant improvement in plantar sensitivity (SMD = 0.41, 95% CI 0.18-0.64). Neuropathic pain increased significantly in patients who received MIRE (MD = 0.49, 95% CI 0.30-0.68, low quality of evidence). Conclusions: There was limited evidence that MIRE results in short-term improvement of tactile sensitivity probably not sustained over time. Limited evidence also suggested that MIRE does not provide relief for neuropathic pain. As quality of evidence is low, further studies are likely to change the estimated effect. [ABSTRACT FROM AUTHOR]

Aims To evaluate the diagnostic criteria of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and alternative criteria in terms of resultant prevalence of gestational diabetes mellitus (GDM) and measures of diagnostic impact. Methods The Brazilian Gestational Diabetes Study (EBDG) is a cohort of pregnant women enrolled consecutively in prenatal care clinics of the Brazilian National Health Service from 1991 to 1995, a time and setting in which those with lesser than diabetes hyperglycemia rarely received drug treatment. Eligibility criteria were age ≥20 years, gestational age 20–28 weeks and no history of diabetes outside pregnancy. After interview and anthropometric measurements, a standardized 2 h 75 g OGTT was scheduled. Women were followed through early postpartum. Results Prevalence of GDM defined by IADPSG criteria was 18.0% (95% CI 16.9–19.0), ranging from 2.7 to 17.0% with the alternative criteria. Relative risks for large for gestational age (LGA) and preeclampsia were generally small. The diagnostic impact assessed by pre- to post-test gain in the probability of an outcome was also small (3.6% for LGA and 0.5% for preeclampsia). Alternative criteria reached maximum gains of 9.7% and 5.3%, respectively. The fractions of LGA births and preeclampsia attributable to GDM by the IADPSG criteria were small, 6.7% and 3.5%, respectively. Conclusions The IADPSG criteria identify more women as having GDM but their diagnostic and population impacts with respect to adverse outcomes are small. Alternative definitions, although also presenting small diagnostic and population impacts, showed advantages which may be useful in specific settings. [ABSTRACT FROM AUTHOR]