Nevin Manimala

BMC Infect Dis. 2023 Dec 8;23(1):864. doi: 10.1186/s12879-023-08856-y.

ABSTRACT

IMPORTANCE: Acellular human amniotic fluid (hAF) is an antimicrobial and anti-inflammatory fluid that has been used to treat various pro-inflammatory conditions. In a feasibility study, we have previously demonstrated that hAF could be safely administered to severely ill patients with coronavirus disease-19 (COVID-19). The impact of acellular hAF on markers of systemic inflammation and clinical outcomes during COVID-19 infection remain unknown.

OBJECTIVE: To determine the safety and efficacy of acellular, sterile processed intravenously administered hAF on markers of systemic inflammation during COVID-19.

DESIGN, SETTINGS AND PARTICIPANTS: This single-center Phase I/II randomized, placebo controlled clinical trial enrolled adult (age ≥ 18 years) patients hospitalized for respiratory symptoms of COVID-19, including hypoxemia, tachypnea or dyspnea. The study was powered for outcomes with an anticipated enrollment of 60 patients. From 09/28/2020 to 02/04/2022 we enrolled and randomized 47 (of an anticipated 60) patients hospitalized due to COVID-19. One patient withdrew consent after randomization but prior to treatment. Safety outcomes to 30 days were collected through hospital discharge and were complete by the end of screening on 6/30/2022.

INTERVENTIONS: Intravenous administration of 10 cc sterile processed acellular hAF once daily for up to 5 days vs placebo.

MAIN OUTCOME AND MEASURES: Blood biomarkers of inflammation, including C-Reactive protein (CRP), lactate dehydrogenase, D-dimer, and interleukin-6 (IL-6), as well as safety outcomes.

RESULTS: Patients who were randomized to hAF (n = 23) were no more likely to have improvements in CRP from baseline to Day 6 than patients who were randomized to placebo (n = 24) hAF: -5.9 [IQR -8.2, -0.6] vs placebo: -5.9 [-9.4, -2.05]; p = 0.6077). There were no significant differences in safety outcomes or adverse events. Secondary measures of inflammation including lactate dehydrogenase, D-dimer and IL-6 were not statistically different from baseline to day 6.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial involving hospitalized patients with COVID-19, the intravenous administration of 10 cc of hAF daily for 5 days did not result in statistically significant differences in either safety or markers of systemic inflammation compared to placebo, though we did not achieve our enrollment target of 60 patients.

TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov as #NCT04497389 on 04/08/2020.

PMID:38066442 | DOI:10.1186/s12879-023-08856-y

BMC Surg. 2023 Dec 8;23(1):368. doi: 10.1186/s12893-023-02253-7.

ABSTRACT

BACKGROUND: Textbook outcomes is a composite quality assurance tool assessing the ideal perioperative and postoperative course as a unified measure. Currently, its definition and application in the context of oesophagectomy in Australia is unknown. The aim of this study was to assess the textbook outcomes after oesophagectomy in a single referral centre of Australia and investigate the association between textbook outcomes and patient, tumour, and treatment characteristics.

METHODS: An observational study was retrospectively performed on patients undergoing open, laparoscopic, or hybrid oesophagectomy between January 2010 and December 2019 in a single cancer referral centre. A textbook outcome was defined as the fulfillment of 10 criteria: R0 resection, retrieval of at least 15 lymph nodes, no intraoperative complications, no postoperative complications greater than Clavien-Dindo grade III, no anastomotic leak, no readmission to the ICU, no hospital stay beyond 21 days, no mortality within 90 days, no readmission related to the surgical procedure within 30 days from admission and no reintervention related to the surgical procedure. The proportion of patients who met each criterion for textbook outcome was calculated and compared. Selected patient-related parameters (age, gender, BMI, ASA score, CCI score), tumour-related factors (tumour location, tumour histology, AJCC clinical T and N stage and treatment-related factor [neoadjuvant chemotherapy and surgical approach]) were assessed. Disease recurrence and one year survival were also evaluated.

RESULTS: 110 patients who underwent oesophagectomy were included. The overall textbook outcome rate was 24%. The difference in rates across the years was not statistically significant. The most achieved textbook outcome parameters were ‘no mortality in 90 days’ (96%) and ‘R0 resection’ (89%). The least frequently met textbook outcome parameter was ‘no severe postoperative complications’ (58%), followed by ‘no hospital stays over 21 days’ (61%). No significant association was found between patient, tumour and treatment characteristics and the rate of textbook outcome. Tumour recurrence rate and overall long term survival was similar between textbook outcome and non-textbook outcome groups. Patients with R0 resection, no intraoperative complication and a hospital stay less than 21 days had reduced mortality rates.

CONCLUSIONS: Textbook outcome is a clinically relevant indicator and was achieved in 24% of patients. Severe complications and a prolonged hospital stay were the key criteria that limited the achievement of a textbook outcome. These findings provide meticulous evaluation of oesophagectomy perioperative care and provide a direction for the utilisation of this concept in identifying and improving surgical and oncological care across multiple healthcare levels.

PMID:38066440 | DOI:10.1186/s12893-023-02253-7

BMC Geriatr. 2023 Dec 9;23(1):828. doi: 10.1186/s12877-023-04518-5.

ABSTRACT

PURPOSE: Older individuals are priority coronavirus disease 2019 (COVID-19) vaccine recipients. Our aim was to investigate the prevalence of and factors influencing vaccine hesitancy in older individuals living in nursing homes and communities.

METHODS: A self-administered COVID-19 vaccine hesitancy survey was conducted from September 2021 to December 2021 among people aged ≥ 60 years in eight nursing homes (382 participants) and the community (112 participants) in Taizhou, China. The response rate was 72.1% (382/530) for older adults in nursing homes and 68.7% (112/163) for older adults in the community.

RESULTS: We found that 58.1% of the older individuals in nursing homes and 36.6% of those in the community were hesitant to receive the COVID-19 vaccine and that there was a statistically significant difference (P < 0.001). Multiple logistic regression results indicated that the main factors influencing hesitation among the older individuals in nursing homes were being male (Odds Ratio (OR) = 1.67, 95% Confidence Interval (CI): 1.01-2.76); their cognitive level, including having a high perceived risk of COVID-19 infection (OR = 3.06, 95% CI: 1.73-5.43) or the perception of low vaccine safety (OR = 3.08, 95% CI: 1.545- 6.145); anxiety (OR = 3.43, 95% CI: 1.96-5.99); and no previous influenza vaccination (OR = 1.82, 95% CI: 1.13-2.93); whereas those for older individuals in the community were comorbid chronic diseases (OR = 3.13, 95% CI: 1.11- 8.78) and community workers not recommending the vaccine (OR = 8.223, 95% CI: 1.77-38.27).

CONCLUSION: The proportion of older individuals in nursing homes who were hesitant to receive the COVID-19 vaccine was significantly higher than for older individuals in the community. Targeted measures should be implemented to reduce vaccine hesitancy and improve vaccination rates in response to the special environment of nursing homes and the characteristics of this population.

PMID:38066433 | DOI:10.1186/s12877-023-04518-5

BMC Geriatr. 2023 Dec 8;23(1):822. doi: 10.1186/s12877-023-04515-8.

ABSTRACT

BACKGROUND: Antimicrobial resistance is a serious threat to public health. To reduce antimicrobial resistance, interventions to reduce gram-negative infections, specifically urinary tract infections, are vital. Early evidence suggests increased fluid intake is linked with a reduction in UTIs and subsequently has potential to reduce antibiotic usage. Care homes have a high prevalence of UTIs and provide an opportunity in a closed setting to deliver an intervention focused on increasing fluid intake, where it is supported and monitored by health care workers. The study aimed to evaluate the impact and feasibility of an online staff focused intervention over a 30 day period to increase the hydration of care home residents with a view to reducing the burden of AMR in this setting.

METHODS: The study was a pre and post intervention with a sequential explanatory mixed methods design. The intervention was delivered online in 3 care homes, containing 3 main components underpinned by the COM-B model including hydration training, 7 structured drinks rounds and a hydration champion to change behaviour of care home staff. A pre and post questionnaire assessed the impact of the intervention on staff and data was collected on fluid intake, drinks rounds delivered to residents, UTIs, antibiotic used to treat UTIs, falls and hospitalisation. Descriptive statistics summarised and assessed the impact of the study. Focus groups with care home staff provided qualitative data which was thematically analysed.

RESULTS: Staff increased in self-perceived knowledge across the six components of hydration care. 59% of residents had an increase in median fluid intake post intervention. During the time of the intervention, a 13% decrease in UTIs and antibiotic usage to treat UTIs across the 3 care homes was recorded, however falls and hospitalisations increased. Themes arising from focus groups included the role of information for action, accessibility of online training, online training content.

CONCLUSIONS: This study demonstrates that a brief, low cost, online multi-component intervention focused on care home staff can increase the fluid intake of residents. A reduction in UTIs and antibiotic consumption was observed overall. Empowering care home staff could be a way of reducing the burden of infection in this setting.

PMID:38066418 | DOI:10.1186/s12877-023-04515-8

BMC Med Res Methodol. 2023 Dec 8;23(1):289. doi: 10.1186/s12874-023-02116-y.

ABSTRACT

BACKGROUND: In the past two decades, there has been a growing recognition of the need to establish indigenous standards or reference growth charts, particularly following the WHO multicenter growth study in 2006. The availability of accurate and reliable growth charts is crucial for monitoring child health. The choice of an appropriate model for constructing growth charts depends on various data characteristics, including the distribution’s tails and peak. While Pakistan has reported some reference growth charts, there is a notable absence of indigenous charts for children under two years of age, especially for infants aged 0-6 months who are exclusively breastfed. Additionally, acquiring data poses a significant challenge, particularly for low-income countries, as it demands substantial resources such as finances, time, and expertise. The Multiple Indicator Cluster Survey (MICS) constitutes a large-scale national survey conducted periodically in low-income countries under the auspices of UNICEF. In this study, we propose methods for generating selection variables utilizing the “Novel Case Selection Method,” as previously published. Further our approach enables to select and fit appropriate model to the MICS data, selected, and to develop the standard growth charts.

METHODS: Out of the 11,478 children under 6 months of age included in MICS-6 (Pakistan), 3,655 children (1,831 males and 1,824 females) met the specified criteria and were selected using the “Novel Case Selection Method”. The sample was distributed across provinces as follows: 841 (23.0%) from KPK, 1,464 (40.1%) from Punjab, 819 (22.4%) from Sindh, and 531 (14.5%) from Balochistan. This sample encompassed both rural (76.4%) and urban (23.6%) populations. Following data cleaning and outlier removal, a total of 3,540 records for weight (1,768 males and 1,772 females) and 3,515 records for height (1,759 males and 1,756 females) were ultimately available for the development of standard charts. The Bayesian Information Criterion (BIC) was employed to determine the optimal degrees of freedom for L, M, and S using RefCurv_0.4.2. Three families within the gamlss class-namely, Box Cox Cole and Green (BCCG), Box Cox T (BCT), and Box Cox Power Exponential (BCPE)-were applied, each with three smoothing techniques: penalized splines (ps), cubic splines (cs), and polynomial splines (poly). The best-fitted model was selected from these nine combinations based on the Akaike Information Criteria.

RESULTS: The Novel Case Selection Method yielded 3655 cases as per criteria. After cleaning the data, this method lead to selection of 3540 children for “weight for age” (W/A) and 3515 children for “height for age” (H/A). The “BCPE” family and “ps” as smoothing method proved to be best on AIC for all four curves, i.e. the W/A male, W/A female, H/A male, and H/A female. The optimum selected degrees of freedom for the curve “W/A”, for both genders were (M = 1, L = 0, S = 0). The optimum degrees of freedom for H/A male were again (M = 1, L = 0, S = 0), but for females the selected degrees of freedom were (M = 1, L = 1, S = 1). The indigenous fitted standard curves for Pakistan were on lower trajectory in comparison to WHO standards.

CONCLUSION: This study uses the Novel Case Selection Method with introduced algorithms to construct tailored growth charts for lower and middle-income countries. Leveraging extensive MICS data, the methodology ensures representative national samples. The resulting charts hold practical value and await validation from established data sources, offering valuable tools for policy makers and clinicians in diverse global contexts.

PMID:38066412 | DOI:10.1186/s12874-023-02116-y

J Racial Ethn Health Disparities. 2023 Dec 8. doi: 10.1007/s40615-023-01878-x. Online ahead of print.

ABSTRACT

BACKGROUND: The Southern US is confronting bourgeoning HIV and hepatitis C virus (HCV) epidemics among people who inject drugs (PWID), yet little is known about shared and unique risk factors across the region. We applied an intersectional risk environment framework to understand infectious disease outcomes for sub-groups of PWID that experience multiple axes of social marginalization related to racial and ethnic identity and social and economic vulnerability.

METHODS: HIV and HCV prevalence was estimated from the first iteration of the CDC’s National HIV Behavioral Surveillance respondent driven sample of PWID in Shelby County, Tennessee in 2018. We ran adjusted multinomial models to test main and interaction effects of race/ethnicity and structural factors on the prevalence of a three-level outcome: HIV-only, HCV-only, and no infection.

RESULTS: A total of 564 PWID participated, 558 (99%) completed HIV testing, and 540 (96%) HCV testing. Thirty (5%) were HIV-positive, 224 (40%) HCV-positive, and less than 1% were co-infected. Descriptive differences by race/ethnicity and levels of structural vulnerability for HIV and HCV subpopulations were present; however, there was no evidence for statistical interaction. In the final main effects model, HIV status was positively associated with non-Hispanic Black identity (aRR 4.95, 95% CI 1.19, 20.6), whereas HCV status was associated with non-white identity (aRR 0.11 95% CI 0.07, 0.18). Factors associated with HCV infection were higher scores of structural vulnerability (aRR 2.19 95% CI 1.10, 4.35), and criminal legal involvement (aOR 1.99 95% CI 1.18, 3.37).

CONCLUSION: This is the first study to implement local population-based survey data to evaluate distinctive intersections of ethnic/racial and social factors associated with HIV and HCV status among PWID in the Memphis region. Findings come at an opportune time as harm reduction programs are in development in the South and shed light to the need for socially equitable race conscious resource investment.

PMID:38066407 | DOI:10.1007/s40615-023-01878-x

J Racial Ethn Health Disparities. 2023 Dec 8. doi: 10.1007/s40615-023-01875-0. Online ahead of print.

ABSTRACT

Significant racial/ethnic inequities in the uptake of differentiated influenza vaccines (DIVs) have been previously reported, though less is known about regional disparities. We conducted a retrospective longitudinal study (2014/15-2017/18 influenza seasons) among privately insured adults aged 65 + years in the US. The exposure was the beneficiary’s area of residence (US Census Bureau division) and the outcome was the type of influenza vaccine: differentiated (high-dose [HDV], adjuvanted, recombinant, and cell-based) versus conventional standard-dose egg-based. Multilevel logistic regression modeling, guided by a causal diagram, was used to assess the influence of socio-demographics, medical, healthcare utilization, community, and vaccinator characteristics in confounding or mediating regional disparities. Among those vaccinated in physician offices, beneficiaries in the East North Central region were twice as likely to receive a DIV vs those in the South Atlantic, whereas those in the East and West South Central were least likely. Disparities became more pronounced in models adjusted for individual and community characteristics, suggesting that crude uptake estimates understate the true magnitude of disparities. A vaccinator’s previous HDV use was most influential in explaining regional differences. Similar but less pronounced patterns emerged for vaccinations in pharmacies/facilities. Regional disparities remained even in fully adjusted models, pointing to currently poorly understood factors that may include quality of healthcare, client health literacy and engagement, and other political and cultural factors.

PMID:38066406 | DOI:10.1007/s40615-023-01875-0

J Sep Sci. 2023 Dec 8:e2300608. doi: 10.1002/jssc.202300608. Online ahead of print.

ABSTRACT

The common antihypertensive drugs are B-blockers and diuretics. For the determination of beta-blocker medicines (bisoprolol fumarate and carvedilol) and diuretic drug (Furosemide), new and accurate chromatographic method has been developed. The separation was achieved using a developing system that includes chloroform:methanol:ethyl acetate:ammonia (6:2:2:0.2 by volume) as a mobile phase and the bands were detected at 240 nm. The concentration ranges were 5-25, 1-7, and 1-3.5 μg/band for bisoprolol fumarate, carvedilol, and furosemide, respectively. This chromatographic approach is the first methodology for simultaneously determining bisoprolol fumarate, carvedilol, and furosemide in their pure forms and in their pharmaceutical dosage forms. The advantages of using known analytical procedures are their simplicity, speed, cost effectiveness, lack of laboriousness, and ability to save time as the three tablets are determined in one step and can be used for routine analysis of the investigated combinations in quality control laboratories. According to International Conference of Harmonization guidelines, the established procedures have been validated, and the results were statistically compared to those obtained by the reported reversed-phase-high-performance liquid chromatography methods using Student’s t-test and F-test, with no significant difference between them, indicating that the proposed methods can be used for routine drug quality control analysis.

PMID:38066390 | DOI:10.1002/jssc.202300608

Arch Gynecol Obstet. 2023 Dec 8. doi: 10.1007/s00404-023-07307-y. Online ahead of print.

ABSTRACT

BACKGROUND: The mode of delivery for twins born before 32 weeks of gestation remains controversial. Our purpose is to conduct a meta-analysis of twin pregnancies less than 32 weeks or twin weight less than 1500 g, so as to find a suitable delivery mode.

METHODS: We searched PubMed database, Cochrane Library database, and EMBASE database through December 2022. This protocol was registered with PROSPERO (CRD42023386946) prior to initiation. Studies that compared vaginal delivery to cesarean section for newborns less than 32 weeks of gestation or birthweight under 1500 g were included. The primary result was neonatal mortality rate. Secondary result was neonatal morbidity. The quality of literatures included in the research was evaluated in accordance with Newcastle-Ottawa Scale (NOS) literature quality evaluation scale. We use odds ratio (OR) as the effect index for binary variables. Point estimates and 95% confidence intervals (95% CI) were calculated. P < 0. 05 indicated statistically significant difference.

RESULTS: Our search generated 5310 articles, and a total of 8 articles comprising a total of 14,703 newborns were included in the analysis. The odds ratios of neonatal mortality rate were for twins delivered by vaginal delivery compared to cesarean section were 0.84 (95% CI 0.57-1.24, P = 0.38). The 5-min Apgar score < 7 (95% CI 0.44-1.75, P = 0.72), necrotizing enterocolitis (95% CI 0.81-1.19, P = 0.82), intraventricular hemorrhage (95% CI 0.41-1.86, P = 0.71), periventricular leukomalacia (95% CI 0.16-4.52, P = 0.84), bronchopulmonary dysplasia (95% CI 0.88-1.36, P = 0.42), and respiratory distress syndrome (95% CI 0.23-2.01, P = 0.48) were not statistically significant between the two groups.

CONCLUSION: We have observed that vaginal delivery does not confer an increased risk of neonatal morbidity and mortality in twins born before 32 weeks of gestation. However, the current results are affected by substantial heterogeneity and confounding factors. We still need high-quality randomized-controlled studies require to address this important question.

PMID:38066342 | DOI:10.1007/s00404-023-07307-y

Int J Obes (Lond). 2023 Dec 8. doi: 10.1038/s41366-023-01430-1. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity is a common feature in women with polycystic ovary syndrome (PCOS) and is associated with multiple adverse reproductive outcomes. However, the impact of overweight and obesity on reproductive outcomes of women with PCOS who underwent in vitro fertilization-embryo transfer (IVF-ET) is currently controversial and appropriate body mass index (BMI) levels differ across ethnic groups.

METHODS: This was a retrospective study including 1066 women with PCOS receiving IVF treatment at our institution between January 2018 and June 2021, among whom 960 underwent their first fresh or frozen embryo transfer. Participants were categorized according to BMI cut-off values proposed by the World Health Organization for Asian populations: normal weight (BMI < 23 kg/m²), overweight (BMI: 23-24.9 kg/m²), and obesity (BMI ≥ 25 kg/m²). The effect of BMI on clinical and embryological outcomes was evaluated by descriptive statistics and logistic regression models with confounders adjusted. The dose-response relationship between BMI as a continuous variable and IVF outcomes is also explored.

INTERVENTIONS: no RESULTS: Increasing BMI was associated with significantly lower numbers of total oocytes retrieved, metaphase II oocytes, two pronuclear (2PN) zygotes, and good-quality embryos among women with PCOS. Patients with PCOS with a BMI ≥ 23 kg/m² had significantly lower live birth rates (41.9% vs. 49.1%; adjusted odds ratio [aOR], 0.75; 95% confidence interval [CI], 0.57-0.97) and implantation rates (35.8% vs. 43.9%; aOR, 0.76; 95% CI, 0.61-0.93) than those with normal BMI. Moreover, BMI showed a non-linear relationship (p for nonlinearity <0.001) with the number of 2PN zygotes with the curve becoming steeper as BMI surpassed 22.4 kg/m².

CONCLUSIONS: Patients with PCOS with a BMI ≥ 23 kg/m² have lower live birth rates than those with a BMI < 23 kg/m². Defining obesity and overweight with ethnicity-specific BMI cut-offs may help to improve IVF outcomes among PCOS patients.

PMID:38066333 | DOI:10.1038/s41366-023-01430-1