Categories
Nevin Manimala Statistics

Prenatal Predictors for Pulmonary Balloon Valvuloplasty in the Newborn

Pediatr Cardiol. 2024 Feb 27. doi: 10.1007/s00246-024-03430-y. Online ahead of print.

ABSTRACT

Pulmonary balloon valvuloplasty (PBV) is the treatment of choice for subjects with isolated pulmonary valve stenosis (IPS). The purpose of this study was to define fetal echocardiographic features associated with an inpatient PBV prior to newborn hospital discharge and characterize resource utilization of IPS fetuses among participating centers. Six center, retrospective case series of singleton fetuses identified between 2010 and 2020 with IPS. Third-trimester echocardiogram data was compared with postnatal data, included pulmonary valve Doppler velocities, pulmonary valve insufficiency and ductus arteriosus flow direction. Comparison between subjects who underwent inpatient PBV during their newborn hospital admission versus those infants referred for outpatient PBV after initial hospital discharge. We analyzed data by logistic regression, student t test and Chi-Square testing with a p value of ≤ 0.05 considered statistically significant. Forty-nine IPS fetuses were identified. Thirty-eight (78%) underwent inpatient PBV at 5 (range 1-58) days and 11 (22%) underwent outpatient PBV at 51.8 (11-174) days. Newborns requiring an inpatient PBV were more likely to have one or more characteristics on 3rd-trimester fetal echocardiogram: left to right or bidirectional ductus arteriosus flow (61% vs 0%), and/or a peak pulmonary valve velocity > 3.0 m/s (odds ratio 16.9, 95% confidence interval 3.02-94.17) with a sensitivity of 90.4% and specificity of 97.7%. Ductus arteriosus flow direction and pulmonary valve peak velocity in the 3rd trimester can successfully predict the need for newborn inpatient PBV. We speculate these findings may be useful in choosing delivery site for the pregnancy complicated by fetal IPS.

PMID:38411710 | DOI:10.1007/s00246-024-03430-y

Categories
Nevin Manimala Statistics

Sex Differences in Outcomes of Acute Myocardial Injury After Stroke

J Am Heart Assoc. 2024 Feb 27:e032755. doi: 10.1161/JAHA.123.032755. Online ahead of print.

ABSTRACT

BACKGROUND: Sex differences in presentation, treatment, and prognosis of cardiovascular disorders are well recognized. Although an association between acute myocardial injury and mortality after ischemic stroke has been demonstrated, it is unclear whether prevalence and outcome of poststroke acute myocardial injury differ between women and men.

METHODS AND RESULTS: We prospectively screened consecutive patients with acute ischemic stroke and serial high-sensitivity cardiac troponin T measurements admitted to our center. Acute myocardial injury was defined as at least 1 high-sensitivity cardiac troponin T value above the upper reference limit (14 ng/L) with a rise/fall of >20%. Rates of acute myocardial injury were also calculated using sex-specific high-sensitivity cardiac troponin T cutoffs (women upper reference limit, 9 ng/L; men upper reference limit, 16 ng/L). Logistic regression analyses were performed to evaluate the association between acute myocardial injury and outcomes. Of 1067 patients included, 494 were women (46%). Women were older, had a higher rate of known atrial fibrillation, were more likely to be functionally dependent before admission, had higher stroke severity, and more often had cardioembolic strokes (all P values <0.05). The crude prevalence of acute myocardial injury differed by sex (29% women versus 23% men, P=0.024). Statistically significant associations between acute myocardial injury and outcomes were observed in women (7-day in-hospital mortality: adjusted odds ratio [aOR], 3.2 [95% CI, 1.07-9.3]; in-hospital mortality: aOR, 3.3 [95% CI, 1.4-7.6]; modified Rankin Scale score at discharge: aOR, 1.6 [95% CI, 1.1-2.4]) but not in men. The implementation of sex-specific cutoffs did not increase the prognostic value of acute myocardial injury for unfavorable outcomes.

CONCLUSIONS: The prevalence of acute myocardial injury after ischemic stroke and its association with mortality and greater disability might be sex-dependent.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03892226.

PMID:38410952 | DOI:10.1161/JAHA.123.032755

Categories
Nevin Manimala Statistics

Association of Sex With Cardiovascular Outcomes in Heart Failure Patients With Obstructive or Central Sleep Apnea

J Am Heart Assoc. 2024 Feb 27:e031186. doi: 10.1161/JAHA.123.031186. Online ahead of print.

ABSTRACT

BACKGROUND: This study investigated the association of sex with cardiovascular outcomes in a prospective cohort of patients with heart failure (HF) with obstructive sleep apnea or central sleep apnea.

METHODS AND RESULTS: Patients were screened for sleep apnea on admission using multichannel cardiopulmonary monitoring from May 2015 to July 2018. The primary outcome was a composite of cardiovascular death or unplanned hospitalization for worsening HF. Ultimately, 453 patients with HF with obstructive sleep apnea or central sleep apnea were included; 71 (15.7%) and 382 (84.3%) were women and men, respectively. During a median follow-up of 2.33 years, 248 (54.7%) patients experienced the primary outcome. In the overall population, after adjusting for potential confounders, women had an increased risk of the primary outcome (66.2% versus 52.6%; hazard ratio [HR], 1.47 [95% CI, 1.05-2.04]; P=0.024) and HF rehospitalization (62.0% versus 46.6%; HR, 1.55 [95% CI, 1.10-2.19]; P=0.013) compared with men but a comparable risk of cardiovascular death (21.1% versus 23.3%; HR, 0.78 [95% CI, 0.44-1.37]; P=0.383). Likewise, in patients with HF with obstructive sleep apnea, women had a higher risk of the primary outcome (81.8% versus 46.3%, HR, 2.37 [95% CI, 1.28-4.38]; P=0.006) and HF rehospitalization (81.8% versus 44.7%, HR, 2.46 [95% CI, 1.32-4.56], P=0.004). However, in patients with HF with central sleep apnea, there was no statistically significant difference between women and men.

CONCLUSIONS: In hospitalized patients with HF, female sex was associated with an increased risk of the primary outcome and HF rehospitalization, especially in those with obstructive sleep apnea. Screening for sleep apnea should be emphasized to improve the prognosis.

REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02664818.

PMID:38410942 | DOI:10.1161/JAHA.123.031186

Categories
Nevin Manimala Statistics

Exploring Recent Decreases in First Molar Sealants among US Children

J Dent Res. 2024 Feb 27:220345241231774. doi: 10.1177/00220345241231774. Online ahead of print.

ABSTRACT

Analyses of National Health and Nutrition Examination Survey (NHANES) data suggested a significant decrease in sealant prevalence among children between 2011 to 2014 and 2015 to 2018. We explore whether this decrease could be associated with possible changes in 1) clinical sealant delivery, 2) dental materials (i.e., increased use of glass ionomer [GI] sealants resulting in an inability to detect sealant fragments that still provide preventive benefits or increased use of composite restorations leading to misclassifying sealants as restorations), and 3) examination sensitivity and specificity. We used NHANES data to estimate the prevalences of sealants, untreated caries, and restorations in ≥1 first permanent molar among children aged 7 to 10 y and used Medical Expenditure Panel Survey data to estimate the annual clinical delivery of sealants and fluoride treatments. We examined changes in outcomes between 2 periods (P < 0.05) controlling for selected sociodemographic characteristics. NHANES sealant examination quality was based on the reference examiner’s replicate examinations. The adjusted prevalence of sealants decreased relatively by 27.5% (46.6% vs. 33.8%). Overall, untreated caries decreased. Untreated caries and restoration decreased among children without sealants. Annual clinical sealant delivery did not change, whereas fluoride treatment delivery increased. The decrease in sealant prevalence held when assessed for various age ranges and NHANES cycle combinations. While sealant examination specificity remained similar between the periods, sensitivity (weighted by the proportion of exams by each examiner) decreased relatively by 17.4% (0.92 vs. 0.76). These findings suggest that decreased sealant prevalence was not supported by decreased clinical sealant delivery nor increased use of composite restorations. Decreased examination sensitivity, which could be due to an increased use of GI sealants, could contribute to the decrease in sealant prevalence. The decrease in caries among children without sealants could suggest the increased use of GI sealants. However, we could not rule out that the decrease in caries could be attributable to increased fluoride treatment delivery.

PMID:38410889 | DOI:10.1177/00220345241231774

Categories
Nevin Manimala Statistics

Postoperative complications in rheumatic disease patients undergoing arthroscopy on immunosuppression

Phys Sportsmed. 2024 Feb 27. doi: 10.1080/00913847.2024.2324363. Online ahead of print.

ABSTRACT

BACKGROUND: There are currently no guidelines on peri-arthroscopic management of immunosuppressive (IS) treatment in rheumatic disease patients.

PURPOSE: The purpose of this study is to characterize the rheumatic disease patient population undergoing arthroscopy, compare the incidence of postoperative complications among patients who either remained on IS perioperatively, held IS perioperatively or were not on IS at baseline, and compare the incidence of postoperative complication by rheumatic disease type, medication type, and procedure.

METHODS: We conducted a retrospective review of all arthroscopic sports medicine surgeries in patients with a rheumatic disease diagnosis at our institution over an 11-year period. Patients on IS at baseline were grouped into those who remained on IS perioperatively or held all IS before the date of their surgery. These two groups were compared to patients who were not on IS at baseline. Incidence of postoperative complications was calculated for the three cohorts and by medication class, rheumatic disease type, and procedure risk. Analysis of variance (ANOVA), Chi-squared, and Fisher’s exact tests were used to determine the statistical significance of between-group differences in postoperative complication incidence.

RESULTS: We identified 1,316 rheumatic disease patients undergoing arthroscopy, with 214 of them taking IS medications at baseline. Overall, 8.4% (n = 110) remained on IS perioperatively, 7.9% (n = 104) held IS perioperatively, and 83.7% (n = 1102) were not on IS at baseline. In all cohorts, seven patients experienced postoperative complications; six of whom experienced infections. Two (1.82%) occurred in patients remaining on IS perioperatively, zero infections occured in patients who held all IS, and four (0.36%) occured in patients who were not on any IS at baseline. There was no statistically significant difference in postoperative infections or complication rates among the three cohorts or further subgroups.

CONCLUSION: The risk of postoperative complications including infectious, major, and minor complications in patients on IS at the time of arthroscopy is low and acceptable.

PMID:38410886 | DOI:10.1080/00913847.2024.2324363

Categories
Nevin Manimala Statistics

Status of abortion curriculum in genetic counseling: Survey of graduate programs and recent graduates in the United States

J Genet Couns. 2024 Feb 27. doi: 10.1002/jgc4.1875. Online ahead of print.

ABSTRACT

Genetic counselors (GCs) are trained to help individuals navigate the medical and psychological implications of genetic test results, familial conditions, and ultrasound anomalies. Therefore, familiarity with reproductive options, including abortion, is vital. However, previous studies have found gaps in GCs’ knowledge regarding abortion care and there are currently no recommendations regarding abortion curriculum. This study aimed to assess the state of abortion curriculum in genetic counseling graduate programs in the United States and to examine and compare the satisfaction levels of program representatives and recent graduates. Program representatives and recent graduates were invited to complete an anonymous survey evaluating the abortion curriculum, satisfaction with said curriculum, and perceived preparedness to counsel on abortion. Quantitative data from 46 program representatives and 123 recent graduates were analyzed using descriptive statistics and appropriate statistical analyses, including the Mann-Whitney U-test and the Kruskal-Wallis test. Large variability existed in the amount and types of abortion training. Results showed greater satisfaction and feelings of preparation to counsel on abortion in graduates whose program provided a dedicated abortion curriculum (p < 0.001, p = 0.005). In addition, graduates with abortion counseling experience felt less prepared to counsel on abortion than their programs believed them to be (p = 0.04). Graduates perceived procedural timing, facilitation of genetic testing, and resources/support desired by patients before, during, or after an abortion, to be the most important topics, although these were not included in all programs’ curriculum. Program representatives and recent graduates alike noted that variability in clinical training is a barrier to abortion education. Our results demonstrate a need for curricular reform to reduce variability in training and ensure that all graduates receive the same foundational abortion education. Further research is needed to determine the scope of GCs in abortion care, as well as which topics and education formats are most helpful in graduate education.

PMID:38410885 | DOI:10.1002/jgc4.1875

Categories
Nevin Manimala Statistics

Persistently high HBsAg levels during HBeAg-seropositive stage predict lower risk of hepatocellular carcinoma in chronic hepatitis B patients

Aliment Pharmacol Ther. 2024 Feb 27. doi: 10.1111/apt.17915. Online ahead of print.

ABSTRACT

BACKGROUND: High hepatitis B surface antigen (HBsAg) level predicts hepatocellular carcinoma (HCC) in chronic hepatitis B (CHB) patients with low viral load. The role of longitudinal HBsAg levels in predicting HCC in HBeAg-positive CHB patients remains unknown.

METHOD: HBeAg-positive CHB participants from the REVEAL-HBV cohort with ≥2 HBsAg measurements before HBeAg seroclearance were enrolled. Group-based trajectory modelling identified distinct HBsAg trajectory groups during a median of 11 years of HBeAg-positive status. Cox regression models were applied for investigating independent predictors of HCC and estimating adjusted hazard ratio (HRadj ) with a 95% confidence interval (CI). A p-value less than 0.05 was considered statistically significant.

RESULTS: A total of 319 patients were enrolled and classified by HBsAg trajectory patterns as (A) persistently high group (n = 72): HBsAg persistently ≥104 IU/mL, and (B) non-stationary group (n = 233): low HBsAg at baseline or declining to <104 IU/mL during the follow-up. Group B had higher proportions of abnormal ALT levels, HBV genotype C and basal core mutation than group A (p < 0.05); age at entry and gender were comparable. The annual incidence of HCC in group A and group B were 0.37% and 1.16%, respectively (p = 0.03). In multivariate analysis, age >40 years (HRadj [95% CI] = 4.11 [2.26-7.48]), genotype C (HRadj [95% CI] = 4.39 [1.96-9.81]) and the non-stationary group (HRadj [95% CI] = 3.50 [1.49-8.21]) were independent predictors of HCC. Basal core promoter mutation was the only risk factor of HCC in the persistently high HBsAg group (HRadj [95% CI] = 32.75 [5.41-198.42]).

CONCLUSION: Patients with persistently high HBsAg levels during HBeAg-seropositive stage represent a unique population with low risk of HCC development.

PMID:38410882 | DOI:10.1111/apt.17915

Categories
Nevin Manimala Statistics

Pharmacokinetics, Safety, and Tolerability of Cedirogant in Healthy Japanese and Chinese Adults

Clin Pharmacol Drug Dev. 2024 Feb 27. doi: 10.1002/cpdd.1386. Online ahead of print.

ABSTRACT

Cedirogant is an inverse agonist of retinoic acid-related orphan receptor gamma, thymus (RORγt) developed for treatment of psoriasis. This study aimed to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of cedirogant following a single oral dose in Japanese participants and multiple oral doses in Japanese and Chinese participants. The single doses evaluated in healthy Japanese participants were 75, 225, and 395 mg. The multiple doses evaluated in both healthy Japanese and Chinese participants was 375 mg once daily for 14 days. Cedirogant plasma exposure increased dose proportionally with administration of single doses. Maximum cedirogant plasma concentration was reached within a median time of 4-5 hours after dosing. The harmonic mean elimination half-life ranged from 19 to 25 hours. Cedirogant pharmacokinetics were similar between Japanese and Chinese participants. Compared with healthy Western participants in a cross-study analysis, steady-state cedirogant plasma exposure was 38%-73% higher in Japanese or Chinese participants. Ex vivo interleukin-17 inhibition increased in a dose-dependent manner and was maximized by 375 mg once-daily doses. The cedirogant regimens tested were generally well tolerated, and no new safety issues were identified. The results supported enrollment of Japanese and Chinese subjects in subsequent clinical trials for cedirogant.

PMID:38410874 | DOI:10.1002/cpdd.1386

Categories
Nevin Manimala Statistics

Being in a meaningful context. Nature and animal-assisted activities as perceived by adults with autism

Aust Occup Ther J. 2024 Feb 27. doi: 10.1111/1440-1630.12940. Online ahead of print.

ABSTRACT

INTRODUCTION: Animal-assisted and nature-based interventions in psychosocial treatment for various groups of clients have been studied internationally. However, there is little knowledge about how young adults with autism experience participation in such types of interventions. This clinical study aimed to describe the feasibility of animal-assisted and nature-based activities on a farm as a complementary intervention for young adults with autism and social withdrawal.

METHODS: The participants were aged 18-30 years, diagnosed with autism and social withdrawal, with no organised occupation during the previous year. Eleven of 13 participants completed a 12-week intervention in small groups. They took part in interviews before and after, which focused on their current life situation and expectations about, and experiences of the intervention. The feasibility was described in terms of participants’ characteristics, attendance, and their experiences of participating in the activity. Data were analysed with descriptive statistics and qualitative content analysis.

CONSUMER AND COMMUNITY INVOLVEMENT: The intervention was formed in collaboration with participating supervisors, ordinary clinical staff, and a young woman with a user perspective.

FINDINGS: The level of feasibility was found to be high. The mean participation rate during the activity days was 75% and varied from 50 to 100%. The analysis of the participants’ experiences from the activity generated three categories, “Being in a meaningful context”, “Creating a comfort zone” and “Developing structure in everyday life”, and each of these included sub-categories.

CONCLUSION: The main categories revealed a dynamic process based in meaningfulness, comfort and structure in everyday life. The positive experiences of undemanding activities, emotional relationships and non-verbal communication with the horses were prominent and might facilitate the development of social interaction. However, the intervention’s timeframe of 12 weeks was experienced as too short for long-lasting change.

PMID:38410868 | DOI:10.1111/1440-1630.12940

Categories
Nevin Manimala Statistics

Comparison of bias adjustment in meta-analysis using data-based and opinion-based methods

JBI Evid Synth. 2024 Feb 27. doi: 10.11124/JBIES-23-00462. Online ahead of print.

ABSTRACT

INTRODUCTION: Several methods exist for bias adjustment of meta-analysis results, but there has been no comprehensive comparison with non-adjusted methods. We compare 6 bias-adjustment methods with 2 non-adjusted methods to examine how these different methods perform.

METHODS: We re-analyzed a meta-analysis that included 10 randomized controlled trials. Two data-based methods: i) Welton’s data-based approach (DB) and ii) Doi’s quality effects model (QE) and 4 opinion-informed methods: i) opinion-based approach (OB), ii) opinion-based distributions combined statistically with data-based distributions (O+DB), iii) numerical opinions informed by data-based distributions (OID [num]), and iv) opinions obtained by selecting areas from data-based distributions (OID [select]) were used to incorporate methodological quality information into the meta-analytical estimates. The results of these 6 methods were compared with 2 unadjusted models: i) the DerSimonian-Laird random effects model and ii) Doi’s inverse variance heterogeneity (IVhet) model.

RESULTS: The 4 opinion-based methods returned the random effects model estimates with wider uncertainty. The DB and QE methods returned different results and aligned with the IVhet method with some minor downward bias adjustment.

CONCLUSION: Opinion-based methods seem to just add uncertainty rather than bias adjust.

PMID:38410861 | DOI:10.11124/JBIES-23-00462