Tag: nevin manimala

Hum Vaccin Immunother. 2023 Dec 15;19(3):2278346. doi: 10.1080/21645515.2023.2278346. Epub 2023 Nov 15.

ABSTRACT

The WHO pre-qualified rotavirus vaccine, ROTAVAC®, is derived naturally from the neonatal 116E rotavirus strain, and stored at -20°C. As refrigerator storage is preferable, immunogenicity and safety of liquid formulations kept at 2-8°C, having excipients to stabilize the rotavirus, with or without buffers, were compared with ROTAVAC® in different clinical studies. Study-1, the pivotal trial for this entire product development work, was a randomized, single-blind trial with two operationally seamless phases: (i) an exploratory phase involving 675 infants in which two formulations, ROTAVAC 5C (LnHRV-1.5 mL and LnHRV-2.0 mL) containing buffer and excipients to stabilize the virus against gastric acidity and temperature, were compared with ROTAVAC®. As the immune response of ROTAVAC 5C (LnHRV-2.0 mL) was non-inferior to ROTAVAC®, it was selected for (ii) confirmatory phase, involving 1,302 infants randomized 1:1:1:1 to receive three lots of LnHRV-2.0 mL, or ROTAVAC®. Primary objectives were the evaluation of non-inferiority and lot-to-lot consistency. The secondary objectives were to assess the safety and interference with the concomitant pentavalent vaccine. As it was separately established that buffers are not required for ROTAVAC®, in Study-2, the safety and immunogenicity of ROTAVAC 5D® (with excipients) were compared with ROTAVAC® and lot-to-lot consistency was assessed in another study. All lots elicited consistent immune responses, did not interfere with UIP vaccines, and had reactogenicity similar to ROTAVAC®. ROTAVAC 5C and ROTAVAC 5D® were immunogenic and well tolerated as ROTAVAC®. ROTAVAC 5D® had comparable immunogenicity and safety profiles with ROTAVAC® and can be stored at 2-8°C, leading to WHO pre-qualification.Clinical Trials Registration: Clinical Trials Registry of India (CTRI): CTRI/2015/02/005577CTRI/2016/11/007481 and CTRI/2019/03/017934.

PMID:37968237 | DOI:10.1080/21645515.2023.2278346

Hum Reprod. 2023 Nov 15:dead236. doi: 10.1093/humrep/dead236. Online ahead of print.

ABSTRACT

STUDY QUESTION: Are there significant associations existing between parental age differences and adverse perinatal outcomes?

SUMMARY ANSWER: Large differences in parental age are associated with adverse perinatal outcomes, particularly with older mothers paired with younger fathers.

WHAT IS KNOWN ALREADY: The association between advanced maternal age and perinatal outcomes is well-documented with women over 35 years showing an increased risk of several adverse outcomes. Other studies have identified potential associations between advanced paternal age and adverse perinatal outcomes.

STUDY DESIGN, SIZE, DURATION: A historical (retrospective) cohort analysis was performed utilizing a multivariable logistic regression model to evaluate the association between varying differences in parental age and adverse perinatal outcomes while controlling for demographic and health-related covariates. Data were compiled from the National Vital Statistics System for 20 613 704 births between 2012 and 2018.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Parental age differences, categorized into eleven 4-year intervals, were stratified by seven maternal age categories and evaluated for their associations with adverse perinatal outcomes. Main outcome measures included low birth weight, very low birth weight, preterm birth, very preterm birth, small size for gestational age, low 5-min appearance, pulse, grimace, activity, and respiration score, congenital defects, and chromosomal anomalies.

MAIN RESULTS AND THE ROLE OF CHANCE: Increased parental age differences, in either direction, were associated with significant risks for all adverse outcomes, aside from congenital defects, even when controlling for maternal age. Restricting maternal age to the reference range of 25-29 years, infants born to fathers aged 9-12 years younger (n = 3773) had 27% (odds ratio (OR) 1.27, 95% CI, 1.17-1.37) higher odds of having any adverse perinatal outcome. Infants born to fathers aged >16 years older (n = 98 555) had 14% (OR 1.14, 95% CI, 1.12-1.16) higher odds of having any adverse perinatal outcome.

LIMITATIONS, REASONS FOR CAUTION: Data extracted from US birth certificates may be compromised by errors in reporting or documentation. Information regarding the mother’s socioeconomic status was estimated using proxy variables and may be susceptible to uncontrolled factors. Use of a pre-compiled dataset may potentially exclude additional maternal comorbidities that could impact perinatal outcomes.

WIDER IMPLICATIONS OF FINDINGS: Older mothers paired with younger fathers demonstrated the highest risk, even when maternal age was below the threshold of 35 years. For the clinical setting, parental age differences should be considered alongside maternal and paternal age when assessing risks of adverse perinatal outcomes for potential parents. This is particularly relevant for older women with younger male partners as this may exacerbate the impact of advanced maternal age.

STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the NIH Research Fellowship T35 Training Grant. There are no competing interests.

TRIAL REGISTRATION NUMBER: N/A.

PMID:37968231 | DOI:10.1093/humrep/dead236

J Cardiothorac Vasc Anesth. 2023 Oct 4:S1053-0770(23)00829-7. doi: 10.1053/j.jvca.2023.09.044. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine the analgesic efficacy of postoperative deep parasternal intercostal plane (DPIP) blocks for patients having cardiac surgery via median sternotomy.

DESIGN: This single-center retrospective study compared patients receiving bilateral DPIP blocks with a matched cohort of patients not receiving DPIP blocks.

SETTING: Large quaternary referral center.

PARTICIPANTS: Adult patients admitted to the authors’ institution from January 1, 2016, to August 14, 2020, for elective cardiac surgery via median sternotomy.

INTERVENTIONS: Patients received ultrasound-guided bilateral DPIP blocks.

MEASUREMENTS AND MAIN RESULTS: A total of 113 patients received a DPIP block; 3,461 patients did not. The estimated multiplicative change in cumulative opioid consumption through 24 hours was 0.42 (95% CI 0.32-0.56; p < 0.001), indicating that patients receiving DPIP blocks required 60% fewer opioids than patients who did not. Proportional odds ratios for the average pain score on postoperative day (POD) 0 was 0.46 (95% CI 0.32-0.65; p < 0.001), and POD 1 was 0.67 (95% CI 0.47-0.94; p = 0.021), indicating lower pain scores for patients receiving blocks. The exploratory analysis identified an inverse correlation between DPIP blocks and atrial fibrillation incidence (2% v 15%; inverse probability of treatment weighting odds ratio 0.088, 95% CI 0.02-0.41; p = 0.002).

CONCLUSIONS: The use of DPIP blocks in patients undergoing cardiac surgery via median sternotomy was associated with less opioid use and improved pain scores in the early postoperative period compared with patients not receiving blocks. Prospective randomized controlled studies should further elucidate the efficacy and risks of DPIP blocks in cardiac surgery.

PMID:37968198 | DOI:10.1053/j.jvca.2023.09.044

Med Clin (Barc). 2023 Nov 13:S0025-7753(23)00604-8. doi: 10.1016/j.medcli.2023.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with chronic diseases such as heart failure (HF) are at risk of hospital admission. We evaluated the impact of living in nursing homes (NH) on readmissions and all-cause mortality of HF patients during a one-year follow up.

METHODS: An observational and multicenter study from the Spanish National Registry of Heart Failure (RICA) was performed. We compared clinical and prognostic characteristics between both groups. Bivariate analyses were performed using Student’s t-test and Tukey’s method and a Kaplan-Meier survival at one-year follow up. A multivariate proportional hazards analysis of [Cox] regression by the conditional backward method was conducted for the variables being statistically significant related to the probability of death in the univariate.

RESULTS: There were 5644 patients included, 462 (8.2%) of whom were nursing home residents. There were 52.7% women and mean age was 79.7±8.8 years. NH residents had lower Barthel (74.07), Charlson (3.27), and Pfeiffer index (2.2), p<0.001). Mean pro-BNP was 6686pg/ml without statistical significance differences between groups. After 1-year follow-up, crude analysis showed no differences in readmissions 74.7% vs. 72.3%, p=0.292, or mortality 63.9% vs. 61.1%, p=0.239 between groups. However, after controlling for confounding variables, NH residents had a higher 1-year all-cause mortality (HR 1.153; 95% CI 1.011-1.317; p=0.034). Kaplan-Meier analysis showed worse survival in nursing home residents (log-rank of 7.12, p=0.008).

CONCLUSIONS: Nursing home residents with heart failure showed higher one-year mortality which could be due to worse functional status, higher comorbidity, and cognitive deterioration.

PMID:37968173 | DOI:10.1016/j.medcli.2023.10.003

Neuromuscul Disord. 2023 Oct 18:S0960-8966(23)00751-4. doi: 10.1016/j.nmd.2023.10.006. Online ahead of print.

ABSTRACT

Central nervous system dysfunction is characteristic of patients with myotonic dystrophy type 1 (DM1). Although no consensus exists regarding the exact cognitive profile of these patients, executive dysfunction has been suggested to play a role. Due to the impact of executive functions on daily performance, this study aimed to describe executive functioning in an ecological manner and to analyze its impact – and that of other clinical variables – on the functional performance of DM1 patients. A Virtual Reality executive functioning test (Nesplora Ice Cream), the Wechsler Adult Intelligence Scale-Fourth Edition, and self-report questionnaires (AES, FSS, ESS and LIFE-H) were administered to 20 patients. Statistical analyses included correlation and multiple regression analyses to analyze the best predictors of daily performance. DM1 patients did not show major difficulties in the executive functioning tasks or in their overall performance on daily habits. However, both cold and hot executive functions still seem necessary for the correct accomplishment of life habits, since planning and level of apathy explained 47.6% of the total variance of daily functioning. This was the first study to assess executive functions in DM1 using Virtual Reality, and our findings open a debate about their actual impairment in this population.

PMID:37968165 | DOI:10.1016/j.nmd.2023.10.006

J Pediatr Surg. 2023 Oct 20:S0022-3468(23)00637-1. doi: 10.1016/j.jpedsurg.2023.10.027. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aims to find out the optimal timing for herniotomy for premature infants with inguinal hernia (IH): early during hospitalisation or delayed after hospital discharge.

METHOD: A retrospective cohort study was conducted on premature infants diagnosed with IH during their initial hospitalization between 2015 and 2020. Demographic data and clinical outcomes were compared between infants undergoing herniotomy before discharge (“early”) and those who were discharged without herniotomy (“delayed”). Student’s t-test or Mann-Whitney U test and Fisher’s exact test were used for statistical analysis.

RESULTS: Of 219 premature infants, 189 (86.3%) underwent early herniotomy, while 30 were discharged with unoperated IH. In the delayed group, 15 (50%) underwent planned delayed herniotomy, and the remaining 15 experienced spontaneous resolution (absence of inguinal bulge over at least 1-year follow-up). The gestational age and birth weight of both groups were similar. At surgery, the delayed group median (interquartile range) was significantly older (42.1[38-49] vs 37.7 [36-40] weeks, p < 0.001) and heavier (3.27 [2.21-4.60] vs 2.22 [2.00-2.70] kg, p < 0.001). Two infants (1%) in the early group presented with incarcerated IH requiring urgent operation. In the delayed group, no infant developed incarcerated IH while awaiting elective operation (time from diagnosis to operation 44 [21-85] days). There was no statistically significant difference in respiratory and surgical complications between the two groups, although the delayed group had lesser surgical complications (0% vs 9.5%).

CONCLUSION: Deferring herniotomy after discharge for premature infants is safe with close monitoring and associated with a chance of spontaneous resolution.

LEVEL OF EVIDENCE: Level III, treatment study.

PMID:37968149 | DOI:10.1016/j.jpedsurg.2023.10.027

Am J Emerg Med. 2023 Oct 29;75:72-78. doi: 10.1016/j.ajem.2023.10.034. Online ahead of print.

ABSTRACT

AIM: The objective of our research is to evaluate and compare the performance of ChatGPT, Google Bard, and medical students in performing START triage during mass casualty situations.

METHOD: We conducted a cross-sectional analysis to compare ChatGPT, Google Bard, and medical students in mass casualty incident (MCI) triage using the Simple Triage And Rapid Treatment (START) method. A validated questionnaire with 15 diverse MCI scenarios was used to assess triage accuracy and content analysis in four categories: “Walking wounded,” “Respiration,” “Perfusion,” and “Mental Status.” Statistical analysis compared the results.

RESULT: Google Bard demonstrated a notably higher accuracy of 60%, while ChatGPT achieved an accuracy of 26.67% (p = 0.002). Comparatively, medical students performed at an accuracy rate of 64.3% in a previous study. However, there was no significant difference observed between Google Bard and medical students (p = 0.211). Qualitative content analysis of ‘walking-wounded’, ‘respiration’, ‘perfusion’, and ‘mental status’ indicated that Google Bard outperformed ChatGPT.

CONCLUSION: Google Bard was found to be superior to ChatGPT in correctly performing mass casualty incident triage. Google Bard achieved an accuracy of 60%, while chatGPT only achieved an accuracy of 26.67%. This difference was statistically significant (p = 0.002).

PMID:37967485 | DOI:10.1016/j.ajem.2023.10.034

Geriatr Nurs. 2023 Nov 13;55:35-43. doi: 10.1016/j.gerinurse.2023.10.017. Online ahead of print.

ABSTRACT

BACKGROUND: Climate change is a global environmental phenomenon that affects human health. It has a negative impact on the health and well-being of older adults. Therefore, educating older adults about coping with climate change and providing psychological interventions could promote successful aging.

AIM: To determine the effectiveness of psycho-educational program on climate change distress and risk perception among older adults.

METHODS: A quasi-experimental research design, “pre-test and post-test was followed. The study used the Climate Change Distress, the Impairment Scale, and the Risk Perception Scale. Data were collected from 80 older adults aged 60 years and above at three elderly clubs in Damanhour City, El-Behaira Governorate, Egypt.

RESULTS: The difference in mean severity of climate change distress, impairment, and risk perception scores between the study and control groups after the psycho-educational program was statistically significant.

CONCLUSION: Psycho-educational interventions can reduce climate change distress and impairment among older adults and increase their risk perception.

PMID:37967480 | DOI:10.1016/j.gerinurse.2023.10.017

Int J STD AIDS. 2023 Nov 15:9564624231214583. doi: 10.1177/09564624231214583. Online ahead of print.

ABSTRACT

INTRODUCTION: We assessed trends in HIV and syphilis prevalence, HIV incidence, related risk factors, and preventive behaviors among men who have sex with men (MSM) in Vietnam from 2015 to 2020.

METHODS: Data originated from the HIV Sentinel Surveillance Plus system, which sampled MSM at venues and hotspots in seven of Vietnam’s 63 provinces in 2015, 2016, 2018, and 2020 (N = 1100-1445 per year; ∼150-300 per province per year).

RESULTS: HIV prevalence estimates increased from 6.6% (95% CI 4.5-9.6) in 2015 to 13.8% (95% CI 10.5-18.2, p = .001 for trend) in 2020 overall, and separately in An Giang, Can Tho, Hai Phong, and Khanh Hoa provinces but not in Ho Chi Minh City, Hanoi, or Kien Giang. Syphilis prevalence increased from 2.7% (95% CI 1.4-5.1) in 2015 to 12.6% (95% CI 8.7-18.0) in 2020 overall (p < .001 for trend), and separately in An Giang, Can Tho, and Hai Phong provinces but not in Ho Chi Minh City or Kien Giang. We calculated time-at-risk from first anal sex to first HIV-positive or last HIV-negative test to estimate HIV incidence. Estimated HIV incidence suggested increasing rates of seroconversion from 1.36 per 100 person-years experienced by participants in 2015 to 2.61 per 100 person-years among participants in 2020 (hazard ratio per year 1.13, 95% CI 1.08-1.18, p < .001). There was a statistically significant increase in HIV testing, STI testing, and receipt of free condoms over the period (p < .05 for trend), and a statistically significant decrease in amphetamine use (p = .043 for trend).

CONCLUSIONS: Despite prevention efforts and improvements in some risk indicators, consecutive cross-sectional sampling results provide evidence of increasing incidence of HIV and syphilis among MSM in Vietnam, especially outside the major cities. Aggressive HIV prevention and treatment services can be expanded while conducting deeper investigations into the causes of these increases.

PMID:37967472 | DOI:10.1177/09564624231214583

J Integr Complement Med. 2023 Nov 15. doi: 10.1089/jicm.2022.0785. Online ahead of print.

ABSTRACT

Introduction: Yoga is a mind-body practice often used to improve health. Systematic reviews (SRs) of randomized controlled trials on yoga for health are foundational to evidence-based yoga interventions and require rigorous and transparent methods, including preparation of a protocol (e.g., PROSPERO) and following SR reporting guidelines (e.g., Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA]). Objective: To evaluate the availability of protocols and the completeness of reporting for SRs on yoga for health. Methods: We used a previously assembled database of SRs focused on the use of yoga for health. The authors independently extracted data on protocol availability, PROSPERO registration, and reporting for each PRISMA 2009 checklist item. Discrepancies were discussed or referred to a third author. We used Stata 10 software to produce descriptive statistics and tests for relationships between registration, reporting, and publication year, country, and journal type. Results: We included 147 reviews published between 2005 and 2019. The most common first author country was the United States or Germany (total 67/147; 46%), and the most common journal type was specialty journals (71/147; 48%). Most reviews (116/147; 79%) made no mention of a protocol or registration, and only 15/147 (10%) reviews were linked to an accessible protocol or registration. Most SRs published in 2010 or later mentioned or cited PRISMA (97/139; 70%), and individual PRISMA items were addressed between 10% and 100% of the time. PRISMA reporting improved; over time, but there was no relationship with country or journal type. Discussion: This study identifies a need for increased SR registration for yoga research. The assessment of PRISMA reporting did not evaluate the comprehensiveness with which each item was reported, and while trends are encouraging, there is likely room for improvement. We recommend registering all yoga SRs and following updated PRISMA and recent yoga-specific guidelines for reporting. This may increase transparency, minimize bias, and produce high-quality data to inform evidence-based yoga practices.

PMID:37967461 | DOI:10.1089/jicm.2022.0785