Significant Reduction In Incidence Research Articles

Effect of Dexamethasone versus Low Dose Ketamine on Post Spinal Hypotension in Caesarian Section

Abstract Background Spinal anesthesia is the preferred method for elective cesarean sections due to considerable risks regarding airway management associated with physiological changes of pregnancy. Cesarean sections normally require an anesthetic block at T4 level, so hypotension is reported in up to 80% of spinal anesthesia cases. Aim of the Work To assess the effect of prophylactic sub-anesthetic dose of ketamine versus the effect of Dexamesathone to prevent maternal hypotension after spinal anaesthesia in cesarean section. Patients and Methods This study is a randomized controlled study this study done in obstetrics and Gynecology Department, Ain Shams hospitals at 3 months and the females undergoing caesarian section under spinal anesthesia. Results The study revealed that ketamine group showed significant lower incidence of postspinal hypotension compared to the control group 5, 10, 15, 20 minutes. Whereas the dexamethasone group showed significant reduction in incidence of postspinal hypotension when compared to the control group only at the first 5 minutes, while comparing both ketamine and dexamethasone groups the incidence of hypotension was not significant. Also, observed that total ephidren dose significantly decreased in ketamine group compared to control group. And sedation scores in the first 30 min were higher in ketamine group. HR wasn’t affected. No changes in APGAR score were noticed between the two groups. No side effects from ketamine except for nystagmus. Conclusion the randomized controlled study conducted in the Obstetrics and Gynecology Department at Ain Shams hospitals investigated the effects of dexamethasone and low-dose ketamine on post-spinal hypotension in caesarean deliveries. The study compared three groups: a ketamine group, a dexamethasone group, and a control group.

Trilaciclib use in extensive-stage small cell lung cancer (ES-SCLC): are clinical benefits seen in the real-world setting?

BackgroundTrilaciclib, in comparison to placebo plus carboplatin, etoposide, ± atezolizumab (PEA), has shown significant reductions in incidence of severe neutropenia (SN) among patients with extensive-stage small cell lung cancer (ES-SCLC). Despite these findings, real-world utility remains limited.MethodsA single-center quasi-experimental study compared trilaciclib + PEA (PEAT) versus PEA in ES-SCLC patients. The study period ranged from April 1, 2021 to July 31, 2022, for the PEAT recipients and February 1, 2020, to February 28, 2021, for PEA recipients. The primary endpoint evaluated was incidence of SN after cycle 1 and during the treatment period. Secondary endpoints included measures related to myelopreservation and patient outcomes.ResultsAmong 34 PEAT and 44 PEA patients, baseline characteristics were similar, except for a higher median age (69 vs 64 years) and more males (64.7% vs 38.6%) in the PEAT cohort. The PEAT cohort exhibited a lower SN rate (3%) versus the PEA cohort (18%), with statistical significance demonstrated on multivariate analysis (p = 0.015). Additionally, the PEAT cohort also demonstrated significant reductions in red blood cell transfusion requirements (3% vs 23%; p = 0.02), grade 3–4 anemia (6% vs 25%; p = 0.03), and grade 3–4 thrombocytopenia (0% vs 11%, p = 0.045).ConclusionTrilaciclib, in combination with PEA, demonstrated an improvement in the safety profile without compromising survival outcomes in ES-SCLC patients. These findings underscore the potential benefits of incorporating trilaciclib in real-world clinical settings for enhanced patient care.

Sleep Quality and Bariatric Surgery-Can We Treat Sleep Disturbances and Insomnia in Patients with Obesity with Laparoscopic Sleeve Gastrectomy?

Introduction: Bariatric surgery is the mainstay of treatment of obesity, with a proven, long-lasting effect on body weight reduction and remission of co-morbidities. Sleep disorders, including insomnia, and deteriorated sleep quality and duration are associated with obesity, and a reduction in body weight can be associated with a reduction in prevalence of sleep disorders. The purpose of this study was to assess the influence of laparoscopic sleeve gastrectomy (LSG) on the prevalence and intensity of different sleep disturbances. Methods: This observational prospective study included 80 patients qualified for bariatric surgery who filled in a questionnaire with a set of structured questions about different sleep disturbances, such as difficulties in falling asleep, night awakenings, early morning awakenings, snoring, and nightmares, as well as eating at night and daytime dysfunction, supplemented with Athens Insomnia Scale (AIS), before and 6 months after bariatric surgery. Results: There was a statistically significant reduction in incidence of night awakenings, with 40.00% of participants reporting night awakenings before surgery and, respectively, 25.00% after surgery. A significant reduction was also observed in the rate of patients who reported snoring, with 60.00% before the surgery and 38.75% after the surgery (p < 0.05). There was a correlation present between estimated weight loss % (EWL%) and reduction in snoring (p < 0.05). The mean total AIS score before surgery was 7.21 and 5.99 after surgery, and the change was statistically significant (p < 0.05). A total AIS score of 8 or more, the cutoff score for insomnia diagnosis according to the Polish validation of the Athens Insomnia Scale, was present in 44.16% of cases before surgery and in 38.00% after surgery (p = 0.52). There was a significant difference in the incidence of awakening during the night score before and after surgery (p < 0.05; CI 0.022-0.341), sleep quality (p < 0.05; CI 0.0105-0.4311), well-being during the day (p < 0.05; CI 0.0273-0.4143), and sleepiness during the day (p < 0.05; CI 0.101-0.444). Conclusions: LSG is observed to have a positive effect on selected sleep disturbances and insomnia remission in patients with obesity, measured by a significant reduction in Athens Insomnia Scale scores in follow-up 6 months after surgery. Additionally, patients after bariatric surgery reported less night awakenings and there was a lower rate of snoring. Therefore, LSG can be considered an effective therapeutic tool for insomnia in patients with obesity.

P-734 Low cost antagonist protocol in ivf-icsi cycles using oral ovulation induction agents in developing countries

Abstract Study question The study aimed at comparing the cost-effectiveness of a low cost antagonist protocol using oral-ovulation-induction agents with a standard long GnRH-Agonist protocol in IVF-ICSI cycles. Summary answer Low cost antagonist protocol using oral-ovulation-induction agents comparing with a standard long GnRH-Agonist protocol in IVF-ICSI cycles is cost-effectiveness in developing countries. What is known already IVF-ICSI had always been proved to be costly treatment. The additional expenditure is mainly due to use of high dose of gonadotrophins in order to get more number of eggs. To cut down the cost,low dose or mild stimulation protocol have been popularized all over the world in last few years. Use of aromatase inhibitors along with low doses of gonadotrophins have been an effective means of mild stimulation protocols for IVF cycles. Oral ovulogens, reduces the total dose of gonadotrophin required for inducing follicular maturation. We evaluated if incorporation of letrozole could be an effective alternative for low-cost IVF. Study design, size, duration A total of 304 patients under 40 years of age were studied between 2018 to 2022 Subsequently, they were randomly divided into two groups. The agonist group underwent standard long GnRH analogue protocol. The antagonist group received oral ovulation inducing drugs (CC/Letrozole) and 0.25mg antagonist injections upto the day of hCG injection, using a flexible start approach. Participants/materials, setting, methods A total of 304 patients under 40 years of age were studied between 2018 to 2022. All patients received low-dose OCP before starting treatment. Subsequently, they were randomly divided into two groups. The agonist-group underwent standard long GnRH analogue protocol. The antagonist group received oral ovulation inducing drugs (CC/Letrozole) and 0.25mg antagonist injections upto the day of hCG injection, using a flexible start approach. Follicular development was monitored by vaginal ultrasound and serum estradiol levels. Main results and the role of chance There was a significant difference in the gonadotropin usage between the two groups. As a result, the cost of the CC/Letrozole-gonadotropin-antagonist cycle was significantly lower than the long GnRH agonist-gonadotropin protocol. Though the mean number of oocytes retrieved was higher in the long protocol group, yet the clinical pregnancy rate per transfer was the same in both groups. While comparing for the primary outcomes pregnancy rate and miscarriage rate were comparable between two groups. It is of particular importance to note that despite 60%reduction of total dose of rFSH in the Let-rFSH group,which entailed significant reduction of the cost of treatment, the outcomes in all major aspects including pregnancy rate were comparable between the groups. However, numbers of matured follicles, retrieved oocytes and transferable embryos were not statistically different between study and control group in this study. This prospective study, designed to evaluate the efficacy of oral-ovulogens -FSH as a low-cost IVF protocol, involved an average number of patients; however, the results have been encouraging. We have been successful in reaching our objective to modify an expensive conventional down regulated IVF protocol into one in which the cost was reduced to a larger extent, without compromising the rate of success in developing countries. Limitations, reasons for caution Since last Cochrane review, GnRH-antagonist protocol was proved to be a short and simple protocol with good clinical outcome with significant reduction in incidence of severe OHSS and amount of gonadotrophins requirement. Although, we need more RCTs to come to a conclusion on regular use of such combined protocol. Wider implications of the findings Usage of GnRH-antagonist in combination with Oral-Ovulogens offers the advantage of a low-cost economical stimulation in IVF, as compared to an agonist-protocol, with similar pregnancy-rate in developing countries. It not only offers a cost-saving stimulation-protocol but also reduces side effects like OHSS and multiple pregnancies yet maintain a descent success-rate. Trial registration number not applicable

Factor Xa inhibitors versus warfarin in patients with non-valvular atrial fibrillation and diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials

Background: Patients with non-valvular atrial fibrillation with diabetes face increased stroke and cardiovascular risks. This study compares factor Xa inhibitors and warfarin using data from randomized controlled trials (RCTs). Methods: MEDLINE, Embase, and Cochrane CENTRAL databases were searched for RCTs comparing the risk of efficacy and safety of any factor Xa inhibitors with dose-adjusted warfarin by diabetes status. Incidence of stroke/systemic embolism, major bleeding, intracranial hemorrhage, ischemic stroke, all-cause mortality, risk of hemorrhagic stroke, and myocardial infarction were among the outcomes of interest. A generic inverse-weighted random-effects model was used to calculate hazard ratios (HRs) with 95 percent confidence intervals (CIs). Results: After applying exclusion criteria, four RCTs containing 19 818 patients were included in the analysis. Compared with warfarin, meta-analysis showed statistically significant reduction in incidence of stroke/systemic embolism (HR 0.80 [95% CI 0.69–0.92]; P=0.002), intracranial hemorrhage (HR 0.49 [95% CI 0.37–0.65]; P&lt;0.001), and risk of hemorrhagic stroke (HR 0.37 [95% CI 0.20–0.66]; P=0.001) in patients on factor Xa inhibitors. However, there was no discernible difference between two treatment arms in incidence of major bleeding (HR 0.93 [95% CI 0.84–1.04]; P=0.19), ischemic stroke (risk ratio (RR) 0.90 [95% CI 0.73–1.12; P=0.34), myocardial infarction (RR 0.88 [95% CI 0.67–1.15]; P=0.35), and all-cause mortality (RR 0.89 [95% CI 0.79–1.01]; P=0.06). Conclusion: Factor Xa inhibitors show a favorable balance between efficacy and safety compared with warfarin, which is consistent across a wide range of patients with atrial fibrillation known to be at high risk for both ischemic and bleeding events.

Invasive cervical cancer incidence following bivalent human papillomavirus vaccination: a population-based observational study of age at immunization, dose, and deprivation.

High-risk human papillomavirus causes cervical cancer. Vaccines have been developed that significantly reduce the incidence of preinvasive and invasive disease. This population-based observational study used linked screening, immunization, and cancer registry data from Scotland to assess the influence of age, number of doses, and deprivation on the incidence of invasive disease following administration of the bivalent vaccine. Data for women born between January 1, 1988, and June 5, 1996, were extracted from the Scottish cervical cancer screening system in July 2020 and linked to cancer registry, immunization, and deprivation data. Incidence of invasive cervical cancer per 100 000 person-years and vaccine effectiveness were correlated with vaccination status, age at vaccination, and deprivation; Kaplan Meier curves were calculated. No cases of invasive cancer were recorded in women immunized at 12 or 13 years of age irrespective of the number of doses. Women vaccinated at 14 to 22 years of age and given 3 doses of the bivalent vaccine showed a significant reduction in incidence compared with all unvaccinated women (3.2/100 000 [95% confidence interval (CI) = 2.1 to 4.6] vs 8.4 [95% CI = 7.2 to 9.6]). Unadjusted incidence was significantly higher in women from most deprived (Scottish Index of Multiple Deprivation 1) than least deprived (Scottish Index of Multiple Deprivation 5) areas (10.1/100 000 [95% CI = 7.8 to 12.8] vs 3.9 [95% CI = 2.6 to 5.7]). Women from the most deprived areas showed a significant reduction in incidence following 3 doses of vaccine (13.1/100 000 [95% CI = 9.95 to 16.9] vs 2.29 [95% CI = 0.62 to 5.86]). Our findings confirm that the bivalent vaccine prevents the development of invasive cervical cancer and that even 1 or 2 doses 1 month apart confer benefit if given at 12-13 years of age. At older ages, 3 doses are required for statistically significant vaccine effectiveness. Women from more deprived areas benefit more from vaccination than those from less deprived areas.

Effectiveness of Lifestyle Interventions during Pregnancy on Preventing Gestational Diabetes Mellitus in High-Risk Women: A Systematic Review and Meta-Analyses of Published RCTs.

Until now, it is uncertain whether lifestyle interventions during pregnancy can prevent gestational diabetes mellites (GDM) in high-risk pregnant women. This study aims at investigating the effectiveness of dietary interventions and/or exercise interventions during pregnancy for preventing GDM in high-risk pregnant women. Eligible randomized controlled trials (RCTs) were selected after a search in CENTRAL, Scopus, and PubMed. Synthesis was performed for the outcome of GDM in women with any identified GDM risk factor. Separate meta-analyses (MA) were performed to assess the efficacy of either nutrition or physical activity (PA) interventions or both combined compared with standard prenatal care for preventing GDM. Subgroup and sensitivity analyses, as well as meta-regressions against OR, were performed to assess potentional heterogeneity. Overall quality, the quality of RCTs, and publication bias were also evaluated. A total of 13,524 participants comprising high-risk pregnant women in 41 eligible RCTs were analyzed for GDM. Women receiving only a nutrition intervention during pregnancy were less likely to experience GDM compared with women following standard prenatal care. Among 3109 high-risk pregnant women undergoing only dietary intervention for preventing GDM, 553 (17.8%) developed GDM; however, the result of the MA was marginally not significant (OR 0.73, 95%CI 0.51, 1.03; p-value 0.07), (Q 21.29, p-value 0.01; I2 58% (95%CI 10, 78%)). Subgroup analyses demonstrated an effect for studies that were conducted in Great Britain (OR 0.65, 95%CI 0.49, 0.81; p-value 0.003), and in Spain (OR 0.50, 95%CI 0.27, 0.94; p-value 0.03), for studies with forms of the Mediterranean diet as the intervention's component (OR 0.61; 95%CI 0.46, 0.81; p-value 0.0005), and for studies including a motivation arm in the intervention (OR 0.71, 95%CI 0.58, 0.87; p-value 0.0008). Among 2742 high-risk pregnant women being analyzed for GDM outcome after receiving only an exercise intervention, 461 (16.8%) were diagnosed with GDM. Women after receiving PA intervention were less likely to develop GDM (OR 0.64, 95%CI 0.51, 0.80; p-value < 0.0001), (Q 11.27, p-value 0.51; I2 0% (95%CI 0, 99%)). Finally, 1308 (17%) cases of GDM were diagnosed among 7673 high-risk pregnant women undergoing both diet and PA intervention. Women in the group of mixed lifestyle intervention had a significant reduction in incidence of GDM (OR 0.70, 95%CI 0.55, 0.90; p-value 0.005), (Q 50.32, p-value < 0.0001, I2 66%, (95% CI 44, 79%)). The results of this study support the efficacy of lifestyle interventions during pregnancy for preventing GDM in high-risk women if an exercise component is included in the intervention arm, either alone, or combined with diet. A combined lifestyle intervention including physical exercise and a Mediterranean diet accompanied by motivation support may be considered the most effective way to prevent GDM among high-risk women during pregnancy. Future research is needed to strengthen these findings.

It can be safe to discontinue oral anticoagulants after successful atrial fibrillation ablation: A systematic review and meta-analysis of cohort studies.

Current guidelines recommended that oral anticoagulants (OACs) should last for a minimum first 2 months after atrial fibrillation (AF) ablation and the long-term decision of anticoagulation after AF ablation should be based on the individual patient's risk of stroke rather than the rhythm status. There is controversy about the safety of discontinuing OACs in patients with atrial fibrillation after the blanking period due to the divergences between consensus recommendations and clinical practice. Electronic bibliographic sources (PubMed, Embase, and Web of Science) were searched until August 2023 to identify cohort studies about the safety of discontinuing OACs in patients with AF after the blanking period. The primary outcome was thromboembolism (TE). The secondary outcome was major bleeding events (MBEs). Two authors extracted articles independently using predefined data fields. The pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated based on a random-effects model. A total of 16 studies (11 prospective cohorts and 5 retrospective cohorts) enrolling 23,942 patients (14,382 OFF-OAC and 9560 ON-OAC) were included in our analysis. No significant difference emerged in the risk of TE between OFF-OAC and ON-OAC patients following AF ablation after the banking period (OR = 0.66; 95%CI, 0.43-1.01). Similar results emerged in the patients with a high risk of TE after stratification by the risk level of TE (OR = 0.72; 95%CI, 0.25-2.08). A significant reduction in incidences of major bleeding was found in the OFF-OAC patients compared with the ON-OAC patients (OR = 0.23; 95%CI, 0.12-0.42). Subgroup analyses for TE found a reduction of incidences in the subgroups who switched to antiplatelet drugs and with a follow-up duration <3 years. Subgroup analyses for MBEs found a significant reduction of incidences in all subgroups. Our study suggests it can be safe to discontinue OACs after successful AF ablation. Discontinuation of OACs may reduce the risk of MBEs while not increasing the risk of TE.

Understanding the importance of spatial correlation in identifying spatio-temporal variation of disease risk, in the case of malaria risk mapping in southern Ethiopia

Malaria remains a major health problem in developing countries despite a significant reduction in incidence in the last few years. Disease mapping thus helps to understand the spatial pattern and identify areas characterized by unusual risks. Several spatial models have been used to analyze the incidence of malaria. We aim to compare the predictive performance of these models and investigate the effect of ignoring spatial correlation. The reported malaria case counts of genus P.falciparum in 149 districts of southern Ethiopia from January 2016 to May 2019 were analyzed using the spatial time series model (STS) that ignores spatial correlation, Spatio-temporal conditional autoregressive model (STCAR), Spatio-temporal geostatistical model (STG) and Spatio-temporal spatial discrete approximation to log Gaussian cox process (STSDALGCP). We assess the predictive performance of the models using root mean square error, mean absolute error, and coverage probability. We found that monthly average rainfall, temperature, humidity, and EVI are significantly associated with malaria risk. The spatial variation of malaria incidence changes with time, in particular, the high incidence was observed from November to December, months after heavy rainfall, and more pronounced in the southwest of the country. STSDALGCP gives a small prediction error in test set and captures the uncertainties better than other models, while the STS model gives a high prediction error. Accounting for spatial correlation is crucial for disease risk mapping and leads to better prediction of disease risk. Since malaria transmission operates in a spatially continuous manner, a spatially continuous model should be considered when it is computationally feasible.

Trends and projection of incidence, mortality, and disability-adjusted life years of HIV in the Middle East and North Africa (1990–2030)

Evidence shows a growing trend of the HIV epidemic in the Middle East and North Africa (MENA). We aimed to project the incidence, mortality, and disability-adjusted life years (DALY) in the region from 1990 to 2019 and assess its trend by 2025, and 2030. We extracted the HIV incidence, mortality, and DALY data from the Global Burden of Disease (GBD) and UNAIDS databases. The joinpoint regression model was used to examine changes in HIV trends. The trend changes were estimated by average annual percent change (AAPC). In most countries, an increasing trend was observed in HIV incidence, mortality, and DALY. Specifically, the highest growth in the annual incidence rate was related to Egypt (AAPC = 14.4, GBD) and Iran (AAPC = 9.6, UNAIDS). Notably, Qatar (AAPC = − 5.6, GBD), Bahrain (AAPC = − 3.3, GBD), and Somalia (AAPC = − 4.2, UNAIDS) demonstrated a significant reduction in incidence. Regarding mortality rates, Djibouti (AAPC = 24.2, GBD) and Iran (AAPC = 16.2, UNAIDS) exhibited a significant increasing pattern. Furthermore, the estimated increase in incidence by 2030 was most marked in Djibouti (985%) and Iran (174%). Iran (422%) and Egypt (339%) showed a prominent rise in mortality rates. GBD data showed 16 countries had an increasing pattern in DALY in both genders. According to age and period effects, there was a significant upward trend in incidence, mortality rates, and DALY. Findings highlighted the urgent need for improved prevention and treatment services, including expanding access to HIV testing, promoting safe practices, increasing antiretroviral therapy coverage, and supporting targeted interventions for high-risk populations.

Early vs late drain removal after pancreatic resection-a systematic review and meta-analysis.

Reducing clinically relevant post-operative pancreatic fistula (CR-POPF) incidence after pancreatic resections has been a topic of great academic interest. Optimizing post-operative drain management is a potential strategy in reducing this major complication. Studies involving pancreatic resections, including both pancreaticoduodenectomy (PD) and distal pancreatic resections (DP), with intra-operative drain placement were screened. Early drain removal was defined as removal before or on the 3rd post-operative day (POD) while late drain removal was defined as after the 3rd POD. The primary outcome was CR-POPF, International Study Group of Pancreatic Surgery (ISGPS) Grade B and above. Secondary outcomes were all complications, severe complications, post-operative haemorrhage, intra-abdominal infections, delayed gastric emptying, reoperation, length of stay, readmission, and mortality. Nine studies met the inclusion criteria and were included for analysis. The studies had a total of 8574 patients, comprising 1946 in the early removal group and 6628 in the late removal group. Early drain removal was associated with a significantly lower risk of CR-POPF (OR: 0.24, p < 0.01). Significant reduction in risk of post-operative haemorrhage (OR: 0.55, p < 0.01), intra-abdominal infection (OR: 0.35, p < 0.01), re-admission (OR: 0.63, p < 0.01), re-operation (OR: 0.70, p = 0.03), presence of any complications (OR: 0.46, p < 0.01), and reduced length of stay (SMD: -0.75, p < 0.01) in the early removal group was also observed. Early drain removal is associated with significant reductions in incidence of CR-POPF and other post-operative complications. Further prospective randomised trials in this area are recommended to validate these findings.

Benchmarking of medication incidents reporting and medication error rates in a JCI accredited university teaching hospital at a GCC country

IntroductionThe benchmarking for medication incidents rate is not regarded as a recognized key performance measure or indicator in national or international organizations. The absence of benchmarking the medication incidents results in the loss of a self-governing perception of how well we performed compared to other peers. Methodology and settingsThis 600-bed tertiary, Joint Commission International (JCI) accredited hospital retrospective analysis looked at all medication management-related events from January-2018 to December-2021. The study design follows descriptive, cross-sectional, retrospective prevalence research. ResultsThe rate of medication incidents that resulted in harm declined from Q3-2019 to Q4-2021. A significant increase in Pharmacy interventions/clarifications was recorded. Additionally, a significant increase in incidents reported with no-harm coupled with a significant reduction in incidences of serious events from 2019 to 2020. Finally, no-harm events were significantly reduced from 2020 to 2021. DiscussionThe Pharmacy's study analyzed every medication incident documented from 2019 to 2021. 99.7% of reported incidents were classified as no-harm (near misses). There was an exponential decrease from Q1-2020 to Q1-202. A significant increase in incidents fell in the category of (near misses) with no-harm and a significant reduction in serious events. Pharmacy interventions/clarifications saw a massive increase and impact from Q3-2018 to Q2-2019, compared to the same period in 2018. By preventing medical incidents, benchmarking, and analyzing incidents and the reporting system, the use of information technology could dramatically reduce the rate of drug incidents. ConclusionThis study found that benchmarking medication incidents is valuable, as it can help identify areas where improvements can be made, implement strategies to improve safety, and track progress over time. The benchmark was recommended to be below 100 incidents for every 10,000 prescriptions/orders processed, and for E-I categories, below one incident for every 10,000 prescriptions/orders processed. This will help develop a worldwide standard with an absolved culture with non-punitive consequences.

Improving delivery room and admission efficiency and outcomes for infants < 32 weeks: ELGAN+ (Extremely Low Gestational Age Neonate).

To evaluate the implementation of a systematic approach to improve the resuscitation, stabilization, and admission of infants < 32 weeks gestation and also to ascertain its effect on organization, efficiency, and clinical outcomes during hospitalization. Retrospective study involving a multidisciplinary team with checklists, role assignment, equipment organization, step by step protocol, and real time documentation for the care of infants < 32 weeks gestation in the delivery room to the neonatal intensive care unit. Pre-data collection (cases) period was from Aug, 2015 to July, 2017, and post-data collection(controls) period was from Aug, 2017 to Aug, 2019. 337 infants were included (179 cases; 158 controls). Increase surfactant use in the resuscitation room (41% vs. 27%, p = 0.007) and reduction in median time to administer surfactant (34 minutes (range, 6-120) vs. 74 minutes (range, 7-120), p = 0.001) observed in control-group. There was a significant reduction in incidence of bronchopulmonary dysplasia (27% vs. 39%), intraventricular hemorrhage (11% vs. 17%), severe retinopathy of prematurity (3% vs. 9%), and necrotizing enterocolitis (4% vs. 6%), however these results were not statistically significant after controlling for severity of illness. A systematic approach to the care of infants < 32 weeks gestation significantly improved mortality rates and reduced rates of comorbidities.

Preoperative Single Dose Intraincisional vs Intravenous Ceftriaxone in Preventing Surgical Site Infection Post-Hernioplasty Conducted at a Tertiary Care Centre at Chengalpattu, Tamil Nadu, India

Introduction: Among the hospital acquired infections, Surgical Site Infection (SSI) still remains as the major problem for surgeons. Inguinal hernia surgeries are considered as clean surgeries, incidence of SSI in posthernioplasty is found to be 3.1%-4.5%. But in tertiary care centres in developing countries like India incidence is found to be high 11-14%. Aim: The aim of the present study was to compare the efficacy of preoperative single dose ceftriaxone infiltration at the incision site and preoperative Intravenous ceftriaxone only in preventing SSI in hernioplasty. Materials and Methods: A prospective interventional study was conducted at SRM Medical College and Research Institute, Chengalpattu, Tamil Nadu, from May 2021 to October 2022 for a duration of 18 months in 100 Patients, who attended the surgical outpatient block or other known cases of inguinal hernia who were referred to the surgery department from other departments. They were divided into group A or group B randomly. Hernioplasty was done on these groups, preoperative, intraoperative and postoperative wound swab was sent for these patients. Postoperatively patients were followed up on 3rd, 7th and 14th day and assessed for development of SSI. The continuous variables were presented as mean and SD. The categorical variables were expressed in percentages. The significance of continuous scale data between two groups were determined using student t-test. The Chi-square/Fischer’s-exact test was used to evaluate the significance of the categorical data analysed. Data analysis was computed using Statistical Package for Social Sciences (SPSS) version 27 and Microsoft excel office 2019. Results: Male preponderance was seen 91% in inguinal hernias. Most of the patients belonged to the age group of 41-60 (54%) years of age. Ten patients (20%) developed SSI who got i.v. antibiotic injection but only three patients (6%) developed SSI who got intraincisional antibiotic injection with a p-value of 0.037 (&lt;0.05) showing significance. One patient developed haematoma for with re-exploration was done on Postoperative Day (POD) #3. Two patients developed wound gapping for which secondary suturing was done on POD #7 and suture removal was done on POD #21. For rest of the all the patient’s suture removal was done on POD #14. Intraopertive and postoperative and organism growth was seen only in the 13 patients who developed SSI. Most common organism isolated was staph, Aureus (38.5%, 5 cases). All 13 patients who developed SSI had some co-morbidity. Out of the 13 patients who developed SSI 11 patients (84%) had surgery for more than 30 minutes. Mean hospital stay was 3-5 days (87%). Conclusion: In the present study, there was significant reduction in incidence of SSI in the group, which received preoperative single dose Intraincisional ceftriaxone than the other group which received only preoperative intravenous ceftriaxone. Preoperative intraincisional antibiotics significantly reduces the rate of SSI because of the higher concentration achieved at the incision site.

Efficacy and Safety of Vancomycin Bayesian-Estimated Area Under the Curve Versus Trough-Based Dosing.

Vancomycin guidelines by the Infectious Diseases Society of America and American Society of Health-System Pharmacists endorse Bayesian-software-assisted area under the curve (AUC24h) in their 2020 update. At this time, there are limited clinical data that support its use. The purpose of this study is to evaluate the safety benefits and efficacy outcomes of using Bayesian-assisted AUC24h dosing compared to trough dosing. Hospitalized patients from before February 1, 2020, (preimplementation of AUC24h dosing) and after August 1, 2020, (postimplementation) were reviewed. Patients with confirmed or suspected methicillin-resistant Staphylococcus aureus (MRSA) infection of the lungs, heart, bones, prosthetic joint, or blood receiving vancomycin for at least 72 hours were included. The primary endpoint was the percentage of patients experiencing an acute kidney injury (AKI) in the trough-based group versus those experiencing AKI in the AUC24h group. The composite of all-cause mortality, 30-day readmission, or change in antibiotic therapy due to clinical worsening in patients with confirmed MRSA infections was included as a secondary endpoint. Data were analyzed with statistical testing methods as appropriate. There was a significant reduction in AKI between the AUC24h dosing and trough dosing groups (3% vs 12%; P < 0.01). The efficacy for MRSA infections was also similar between groups (11% vs 14%; P = 0.72). Bayesian-assisted AUC24h dosing was associated with a significant reduction in incidence of AKI when compared to trough-based dosing. There was no difference in the composite efficacy endpoint for patients with confirmed MRSA infection, although the study was not powered for this analysis. These data may provide evidence for more institutions to adopt the Bayesian software to assist in dosing of vancomycin.

Helicobacter pylori eradication for primary prevention of peptic ulcer bleeding in older patients prescribed aspirin in primary care (HEAT): a randomised, double-blind, placebo-controlled trial

Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding. We conducted a randomised, double-blind, placebo-controlled trial (Helicobacter Eradication Aspirin Trial [HEAT]) at 1208 primary care centres in the UK, using routinely collected clinical data. Eligible patients were aged 60 years or older who were receiving aspirin at a daily dose of 325 mg or less (with four or more 28-day prescriptions in the past year) and had a positive C13 urea breath test for H pylori at screening. Patients receiving ulcerogenic or gastroprotective medication were excluded. Participants were randomly assigned (1:1) to receive either a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (active eradication), or oral placebo (control), twice daily for 1 week. Participants, their general practitioners and health-care providers, and the research nurses, trial team, adjudication committee, and analysis team were all masked to group allocation throughout the trial. Follow-up was by scrutiny of electronic data in primary and secondary care. The primary outcome was time to hospitalisation or death due to definite or probable peptic ulcer bleeding, and was analysed by Cox proportional hazards methods in the intention-to-treat population. This trial is registered with EudraCT, 2011-003425-96. Between Sept 14, 2012, and Nov 22, 2017, 30 166 patients had breath testing for H pylori, 5367 had a positive result, and 5352 were randomly assigned to receive active eradication (n=2677) or placebo (n=2675) and were followed up for a median of 5·0 years (IQR 3·9-6·4). Analysis of the primary outcome showed a significant departure from proportional hazards assumptions (p=0·0068), requiring analysis over separate time periods. There was a significant reduction in incidence of the primary outcome in the active eradication group in the first 2·5 years of follow-up compared with the control group (six episodes adjudicated as definite or probable peptic ulcer bleeds, rate 0·92 [95% CI 0·41-2·04] per 1000 person-years vs 17 episodes, rate 2·61 [1·62-4·19] per 1000 person-years; hazard ratio [HR] 0·35 [95% CI 0·14-0·89]; p=0·028). This advantage remained significant after adjusting for the competing risk of death (p=0·028) but was lost with longer follow-up (HR 1·31 [95% CI 0·55-3·11] in the period after the first 2·5 years; p=0·54). Reports of adverse events were actively solicited; taste disturbance was the most common event (787 patients). H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term. National Institute for Health and Care Research Health Technology Assessment.

Model-based evaluation of the impact of prophylactic vaccination applied to Ebola epidemics in Sierra Leone and Democratic Republic of Congo

BackgroundProtection by preventive Ebola vaccines has been demonstrated in clinical trials, but a complete picture of real-world effectiveness is lacking. Our previous study modeling the impact of preventively vaccinating healthcare workers (HCW) alone or with a proportion of the general population (GP) estimated significant reductions in incidence and mortality. The model assumed 100% vaccine efficacy, which is unlikely in the real world. We enhanced this model to account for lower vaccine efficacy and to factor in reduced infectiousness and lower case fatality rate in vaccinated individuals with breakthrough infections.MethodsThe previous model was enhanced to still permit a risk, although lower, for vaccinated individuals to become infected. The enhanced model, calibrated with data from epidemics in Sierra Leone (SL) and North Kivu, Democratic Republic of the Congo, helped evaluate the impact of preventive Ebola vaccination in different scenarios based on different vaccine efficacy rates (90% and 30% reductions in infection risk in the base and conservative scenarios, respectively; additionally, both scenarios with 50% reductions in infectiousness and mortality) and vaccination coverage among HCWs (30%, 90%) and GP (0%, 5%, and 10%).ResultsThe base scenario estimated that, depending upon the proportions of vaccinated HCWs and GP, 33–85% of cases and 34–87% of deaths during the 2014 SL epidemic and 42–89% of cases and 41–89% of deaths during the 2018 North Kivu epidemic would be averted versus no vaccination. Corresponding estimates for the conservative scenario were: 23–74% of cases and 23–77% of deaths averted during the SL epidemic and 31–80% of both cases and deaths averted during the North Kivu epidemic.ConclusionsPreventive vaccination targeting HCW alone or with GP may significantly reduce the size and mortality of an EVD outbreak, even with modest efficacy and coverage. Vaccines may also confer additional benefits through reduced infectiousness and mortality in breakthrough cases.

Effects of a liquefied petroleum gas cookstove and fuel intervention on fetal and neonatal outcomes: a multi-country randomized controlled trial conducted by the Household Air Pollution Intervention Network (HAPIN) trial

Background and aim Household air pollution (HAP) from cooking with solid fuels used during pregnancy has been associated with adverse pregnancy outcomes. The HAPIN trial is a randomized controlled trial of liquefied petroleum gas (LPG) stoves and fuel distribution in 3200 households conducted across Guatemala, India, Peru, and Rwanda. We describe the effects of the LPG intervention on fetal/infant stillbirth, neonatal mortality and congenital anomalies. Methods Pregnant women (18-35 years of age; gestation confirmed by ultrasound at 9-20 weeks) were randomly assigned to an intervention arm (n=1593) or control arm (n=1607). Participants were monitored for stillbirth (fetal death &amp;#x2265; 20 weeks gestation), neonatal mortality (death of any live-born infant in first 28 completed days of life), and congenital anomalies (any structural/functional anomalies that occur during intrauterine life). Analyses were performed according to intention-to-treat (ITT) analysis, and binary outcomes were compared between the two arms using log binomial models. Results Pregnant women were enrolled in the study and received their LPG stoves at 15.4 (SD 3.1) weeks gestation. We recorded 47 congenital anomalies (23 intervention, 24 control), 56 stillbirths (28 intervention, 28 control), and 41 neonatal deaths (20 intervention, 21 control) between enrollment and 28 days of live of the infant. Compared to the control arm, the relative risk among women randomized to the intervention was 0.96 (95% CI: 0.55, 1.70) for congenital anomaly, 1.01 (95% CI: 0.60, 1.70) for stillbirth and 0.97 (95% CI: 0.53, 1.77) for neonatal mortality. Conclusions We did not find a significant reduction in incidence of stillbirth, neonatal mortality and congenital anomalies. The small number of cases may have contributed to the lack of power and the intervention was introduced after the first trimester, which may be too late to find a protective effect. Keywords: household air pollution; congenital anomalies, stillbirth, neonatal mortality. intention-to-treat, HAPIN trial

Designing a synthetic microbial community devoted to biological control: The case study of Fusarium wilt of banana.

Fusarium oxysporum f. sp. cubense (Foc) tropical race 4 (TR4) is threatening banana production because of its increasing spread. Biological control approaches have been widely studied and constitute interesting complementary measures to integrated disease management strategies. They have been based mainly on the use of single biological control agents (BCAs). In this study, we moved a step forward by designing a synthetic microbial community (SynCom) for the control of Fusarium wilt of banana (FWB). Ninety-six isolates of Pseudomonas spp., Bacillus spp., Streptomyces spp., and Trichoderma spp. were obtained from the banana rhizosphere and selected in vitro for the antagonism against Foc TR4. In pot experiments, a large community such as SynCom 1.0 (44 isolates with moderate to high antagonistic activity) or a small one such as SynCom 1.1 (seven highly effective isolates) provided similar disease control (35% symptom severity reduction). An in vitro study of the interactions among SynCom 1.1 isolates and between them and Foc revealed that beneficial microorganisms not only antagonized the pathogen but also some of the SynCom constituents. Furthermore, Foc defended itself by antagonizing the beneficial microbes. We also demonstrated that fusaric acid, known as one of the secondary metabolites of Fusarium species, might be involved in such an interaction. With this knowledge, SynCom 1.2 was then designed with three isolates: Pseudomonas chlororaphis subsp. piscium PS5, Bacillus velezensis BN8.2, and Trichoderma virens T2C1.4. A non-simultaneous soil application of these isolates (to diminish cross-inhibition) delayed FWB progress over time, with significant reductions in incidence and severity. SynCom 1.2 also performed better than two commercial BCAs, BioPak® and T-Gro. Eventually, SynCom 1.2 isolates were characterized for several biocontrol traits and their genome was sequenced. Our data showed that assembling a SynCom for biocontrol is not an easy task. The mere mixtures of antagonists (e.g., SynCom 1.0 and 1.1) might provide effective biocontrol, but an accurate investigation of the interactions among beneficial microorganisms is needed to improve the results (e.g., SynCom 1.2). SynCom 1.2 is a valuable tool to be further developed for the biological control of FWB.

Burden of pneumococcal disease due to serotypes covered by the 13-valent and new higher-valent pneumococcal conjugate vaccines in the United States

The addition of pneumococcal conjugate vaccines (PCVs) to the United States (US) national immunization program led to significant reductions in incidence, mortality, and associated sequelae caused by pneumococcal disease (PD) in children and adults through direct and indirect protection. However, there remains clinical and economic burden due to PD caused by serotypes not included in the current 13-valent PCV (PCV13) formulation. To address this unmet need, 15-valent PCV (PCV15) and 20-valent PCV (PCV20), containing additional serotypes to PCV13, were recently approved in the US for adults and are anticipated for pediatrics in the near future. The study objective was to estimate the annual number of cases, deaths, and economic burden of PD due to serotypes included in PCV13, PCV15, and PCV20 for both US pediatric and adult populations. An Excel-based model was developed to calculate clinical and economic outcomes using published age-group specific serotype coverage; incidence of invasive PD, community-acquired pneumonia, and acute otitis media; case fatality rates; and disease-related costs. The results showed that across all age groups, the estimated annual PD cases and associated deaths covered by PCV13 serotypes were 914,199 and 4320, respectively. Compared with PCV13 serotypes, the additional 2 and 7 serotypes covered by PCV15 and PCV20 were attributed with 550,475 and 991,220 annual PD cases, as well as 1425 and 3226 annual deaths, respectively. This clinical burden translates into considerable economic costs ranging from $903 to $1,928 million USD that could be potentially addressed by PCV15 and PCV20. The additional serotypes included in PCV20 contribute substantially to the clinical and economic PD burden in the US pediatric and adult populations. Despite the success of the PCV13 pediatric national immunization program and increased adult uptake of PCV13 and 23-valent polysaccharide vaccine, broader PCV serotype coverage is needed across all ages to further reduce pneumococcal disease burden.