Category: Statistics

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

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 (HR_adj ) 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 (HR_adj [95% CI] = 4.11 [2.26-7.48]), genotype C (HR_adj [95% CI] = 4.39 [1.96-9.81]) and the non-stationary group (HR_adj [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 (HR_adj [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

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

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

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

Phytother Res. 2024 Feb 27. doi: 10.1002/ptr.8170. Online ahead of print.

ABSTRACT

Considering the main component of cardiovascular disease and due to the high prevalence of hypertension, controlling blood pressure is required in individuals with various health conditions. Randomized clinical trials (RCTs) which studied the effects of pomegranate consumption on blood pressure have shown inconsistent findings. As a result, we intended to assess the effects of pomegranate consumption on systolic (SBP) and diastolic (DBP) blood pressure in adults. Systematic literature searches up to January 2024 were carried out using electronic databases, including PubMed, Web of Science, and Scopus, to identify eligible RCTs assessing the effects of pomegranate on blood pressure as an outcome. All the individuals who took part in our research were adults who consumed pomegranate in different forms as part of the study intervention. Heterogeneity tests of the selected trials were performed using the I² statistic. Random effects models were assessed based on the heterogeneity tests, and pooled data were determined as the weighted mean difference (WMD) with a 95% confidence interval (CI). Of 2315 records, 22 eligible RCTs were included in the current study. Our meta-analysis of the pooled findings showed that pomegranate consumption significantly reduced SBP (WMD: -7.87 mmHg; 95% CI: -10.34 to -5.39; p < 0.001) and DBP (WMD: -3.23 mmHg; 95% CI: -5.37 to -1.09; p = 0.003). Individuals with baseline SBP > 130 mmHg had a significantly greater reduction in SBP compared to individuals with baseline SBP < 130 mmHg. Also, there was a high level of heterogeneity among studies (SBP: I² = 90.0% and DBP: I² = 91.8%). Overall, the results demonstrated that pomegranate consumption lowered SBP and DBP in adults. Although our results suggest that pomegranate juice may be effective in reducing blood pressure in the pooled data, further high-quality studies are needed to demonstrate the clinical efficacy of pomegranate consumption.

PMID:38410857 | DOI:10.1002/ptr.8170

Cephalalgia. 2024 Feb;44(2):3331024241235156. doi: 10.1177/03331024241235156.

ABSTRACT

BACKGROUND: Comparative evaluations of preventive migraine treatments can help inform clinical decision making for managing migraine in clinical practice.

METHODS: An anchored matching-adjusted indirect comparison analysis was conducted using pooled participant-level data from two phase 3 atogepant trials (ADVANCE and PROGRESS) and one phase 2/3 rimegepant trial (BHV3000-305) to evaluate the relative efficacy and safety/tolerability of atogepant and rimegepant as preventive migraine treatments. Participants receiving atogepant 60 mg once daily, rimegepant orally disintegrating tablet 75 mg once every other day, and placebo were included. Only participants meeting the BHV3000-305 inclusion/exclusion criteria were analyzed: ≥6 monthly migraine days and ≤18 monthly headache days at baseline. The primary efficacy assessment of interest was change in monthly migraine days across weeks 1-12.

RESULTS: There were 252 participants in the atogepant group and 348 in the rimegepant group. Across weeks 1-12, atogepant 60 mg demonstrated a significantly greater reduction in mean monthly migraine days compared with rimegepant 75 mg (mean difference [95% CI]: -1.65 [-2.49, -0.81]; p < 0.001). Both atogepant and rimegepant demonstrated similar safety/tolerability profiles.

CONCLUSION: In this matching-adjusted indirect comparison analysis, oral atogepant 60 mg once daily demonstrated a significantly greater reduction in monthly migraine days compared with rimegepant 75 mg orally disintegrating tablet once every other day.

PMID:38410850 | DOI:10.1177/03331024241235156

Int J Adolesc Med Health. 2024 Feb 28. doi: 10.1515/ijamh-2023-0191. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aims to evaluate the effectiveness of a structured educational module on substance abuse prevention program among adolescents in enhancing their knowledge against substance abuse.

METHODS: A quasi-experimental design was employed involving 120 students (mean age: 14.3±1.03 years, 59.2% boys) from two English medium schools. Participants were exposed to a structured module on substance abuse over a month. The study assessed changes in knowledge through pretest and post-test evaluations. Statistical analyses examined improvements in scores and the relationship between class of study and post-test knowledge scores.

RESULTS: The intervention significantly improved students’ knowledge about substance abuse (p<0.001) across all measured domains, genders, and classes, with the exception of the 7th class. A positive correlation was found between the class of study and post-test scores (Rs=0.288, p<0.001), indicating that higher classes were associated with greater improvements in knowledge. These findings suggest that the training effectively increased awareness and understanding of substance abuse among participants.

CONCLUSIONS: The substance abuse prevention program successfully enhanced adolescents’ knowledge and equipped them with resilience and coping strategies, thus reducing their vulnerability to peer pressure and substance abuse. Despite the lack of significant improvement in the 7th class, the overall positive outcomes underscore the importance of implementing such educational interventions to foster healthy development and well-being among students. Further research is encouraged to explore the specific barriers to effectiveness in younger classes and to refine program content accordingly.

PMID:38410844 | DOI:10.1515/ijamh-2023-0191

Vox Sang. 2024 Feb 27. doi: 10.1111/vox.13609. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: The variability in the number of donations together with a growing demand for platelet concentrates and plasma-derived medicines make us seek solutions aimed at optimizing the processing of blood. Some mathematical models to improve efficiencies in blood banking have been published. The goal of this work is to validate and evaluate an algorithm’s impact in the production of blood components in the Blood and Tissues Bank of Aragon (BTBA).

MATERIALS AND METHODS: A mathematical algorithm was designed, implemented and validated through simulations with real data. It was incorporated into the fractionation area, which uses the Reveos® fractionation system (Terumo BCT) to split blood into its components. After 9 months of daily routine validation, retrospective activity data from the Blood Bank and Transfusion Services before and during the use of the algorithm were compared.

RESULTS: Using the algorithm, the outdating rate of platelet concentrates (PC) decreased by 87.8% in the blood bank. The average shelf life remaining of PC supplied to Transfusion Services increased by almost 1 day. As a consequence, the outdating rate in the Aragon Transfusion Network decreased by 33%. In addition, extra 100 litres of plasma were obtained in 9 months.

CONCLUSIONS: The algorithm improves the blood establishment’s workflow and facilitates the decision-making process in whole blood processing. It resulted in a decrease in PC outdating rate, increase in PC shelf life and finally an increase in the volume of recovered plasma, leading to significant cost savings.

PMID:38410835 | DOI:10.1111/vox.13609

Patient Relat Outcome Meas. 2024 Feb 22;15:61-70. doi: 10.2147/PROM.S450502. eCollection 2024.

ABSTRACT

BACKGROUND: The provision of intensive care services is advancing globally. However, in resource-limited settings, it is lagging far behind and intensive care unit mortality is still higher due to various reasons. This study aimed to assess determinants of mortality among medical patients admitted to the intensive care unit.

METHODS: A five-year facility-based retrospective Cohort Study was conducted. A total of 546 medical patients admitted to the intensive care unit from March 2017 to February 2022 were included. Document review using a structured questionnaire was implemented to collect data. Data entered into Epi Data were analyzed by STATA and summarized using frequency tables and graphs. Binary and multivariate logistic regression analyses were performed to identify determinants of mortality.

RESULTS: The overall mortality was 35.9%. Approximately half of the deaths were attributed to septic shock, congestive heart failure, severe community-acquired pneumonia, and stroke. The most common immediate cause of death was cardio-respiratory arrest. Source of admission, GCS level at admission, duration of ICU stay, treatment with inotropes, septic shock, and retroviral infection status were found to have a statistically significant association with ICU mortality.

CONCLUSION AND RECOMMENDATIONS: This study revealed a significantly higher mortality rate among patients admitted to the intensive care unit. Early identification and admission of patients to the intensive care unit are important factors that could decrease mortality. Patient selection is essential since some patients with a high likelihood of mortality might not benefit from intensive care unit admission in an area with high resource limitations.

PMID:38410832 | PMC:PMC10895994 | DOI:10.2147/PROM.S450502