Nevin Manimala

Contemp Clin Trials. 2024 Jun 7:107603. doi: 10.1016/j.cct.2024.107603. Online ahead of print.

ABSTRACT

BACKGROUND: As part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial.

METHODS: In the updated statistical analysis plan for NU IMPACT, the primary implementation outcome patient adoption, as measured by clinic-level monthly proportions of patient engagement with the EHR-based cancer symptom monitoring system, will be analyzed using generalized least squares linear regression with auto-regressive errors and adjustment for cluster and time effects (underlying secular trends). A similar strategy will be used for secondary patient and provider implementation outcomes.

DISCUSSION: The analytic updates described here resulted from highly iterative, collaborative efforts among statisticians, implementation scientists, and trial leads in the IMPACT Consortium. This updated statistical analysis plan will serve as the a priori specified approach for analyzing implementation outcomes for the NU IMPACT trial.

PMID:38852769 | DOI:10.1016/j.cct.2024.107603

Food Chem Toxicol. 2024 Jun 7:114808. doi: 10.1016/j.fct.2024.114808. Online ahead of print.

ABSTRACT

The chemical safety of poly(butylene adipate-co-terephthalate) (PBAT) based food contact articles (FCAs) has aroused increasing toxicological concerns in recent years, but the chemical characterization and associated risk assessment still remain inadequate as it failed to elucidate the distribution pattern and discern the potential genotoxic and carcinogenic hazards of the identified substances. Herein, the volatile organic compounds (VOCs) in 50 batches of PBAT-based FCAs of representative categories and 10 batches of PLA and PBAT pellets were characterized, by which 237 VOCs of 10 chemical categories were identified and exhibited characteristic distribution patterns in the chemical spaces derived from their molecular descriptors. Chemical hazards associated with the identified VOCs were discerned by a hazard-driven classification scheme integrating hazard-related knowledge from multiple publicly available sources, and 34 VOCs were found to bear genotoxic or carcinogenic hazards and to feature higher average molecular weight than the other VOCs. Finally, the Risk and hazard quotient (HQ) calculated as the metrics of risk suggested that all identified VOCs posed acceptable risks (Risk<10-4 or HQ<1), whereas oxolane, butyrolactone, N,N-dimethylacetamide, 2-butoxyethanol, benzyl alcohol, and 1,2,3-trichloropropane posed non-negligible (Risk>10-6) genotoxic or carcinogenic risk and thus should be of prioritized concern to promote the chemical safety of PBAT-based FCAs.

PMID:38852758 | DOI:10.1016/j.fct.2024.114808

Rev Clin Esp (Barc). 2024 Jun 7:S2254-8874(24)00084-5. doi: 10.1016/j.rceng.2024.06.005. Online ahead of print.

ABSTRACT

OBJECTIVE: Systematic review of current evidence to analyze the prevalence of extracranial large vessel vasculitis (LVV) using ¹⁸F-FDG PET/CT in patients with polymyalgia rheumatica (PMR) or giant cell arteritis (GCA).

MATERIALS AND METHODS: PubMed and EMBASE were searched and the results were screened by two reviewers. Study quality was assessed using a modified version of the Newcastle-Ottawa scale. Heterogeneity between studies was assessed using the I² statistic and the Q test. Further subgroup analyses were performed by disease type, study quality, and ¹⁸F-FDG PET/CT uptake criteria. Publication bias was assessed by funnel plot and Egger’s test.

RESULTS: 268 publications were identified, of which 17 met the selection criteria and were included in the meta-analysis. The overall pooled prevalence of extracranial LVV by ¹⁸F-FDG PET/CT was 54.5% [95% CI: 42.6% to 66.1%]. In patients with GCA the prevalence was significantly higher than in patients with PMR (60.1% vs. 41.8%, p = 0.006). Likewise, studies with a lower risk of bias reported a higher prevalence of extracranial LVV (61.1% vs. 46.9%; p = 0.010). No publication bias was observed.

CONCLUSIONS: The ¹⁸F-FDG PET/CT test may be useful in the detection of extracranial LVV, both in patients with PMR or GCA. Such involvement is more frequent in patients with GCA, and may vary depending on the quality of the studies.

PMID:38852739 | DOI:10.1016/j.rceng.2024.06.005

Transfus Clin Biol. 2024 Jun 7:S1246-7820(24)00062-4. doi: 10.1016/j.tracli.2024.05.003. Online ahead of print.

ABSTRACT

BACKGROUND: The World Health Organization advocates for the achievement of 100% voluntary non-remunerated blood donation (VNRD) globally by the year 2020. However, until today, little was known in Lebanon regarding its actual rate or influencing factors, particularly donor motivations and behaviors. Therefore, the aim of this study was to assess the knowledge, attitudes, and practices of blood donors in Lebanon. The ultimate goals were to retain first-time donors, encourage them to become regular ones, and facilitate the transition from replacement donation to VNRD.

MATERIALS AND METHODS: A multi-centric cross-sectional study was carried across the five governorates in Lebanon. A self-administered and structured questionnaire was used in this survey. Results were presented in terms of odds ratios, with statistical significance defined at a P value of 0.05 and a 95% confidence interval. Additionally, a benchmarking analysis of the situation of blood donation in Lebanon was also conducted, identifying several areas for improvement.

RESULTS: A total of 620 blood donors participated in this study, with 21.3% being first-time donors and 78.7% repeat donors. While the latter were primarily motivated by self-esteem, solidarity or returning a favor (89%, 77.9% and 78.1%), the main obstacle for becoming regular donors was a lack of initiative (34.6%). Female donors (9.9% of the total) exhibited better knowledge (OR= 2.20, p=0.011) and were more inclined to donate voluntarily (OR= 1.52, p=0.048). Conversely, male donors were more likely to be repeat donors, often through replacement donation (OR= 2.95, p=0.001).

CONCLUSION: There is a significant disparity between the low rate of voluntary donation in Lebanon (22.2%) and the relatively high proportion of donors with adequate knowledge of the donation process (60.5%). Therefore, urgent action by public authorities, based on the evidence based strategies outlined in this article, is crucial to enhancing the voluntary donation rate in Lebanon.

PMID:38852712 | DOI:10.1016/j.tracli.2024.05.003

J Shoulder Elbow Surg. 2024 Jun 7:S1058-2746(24)00410-5. doi: 10.1016/j.jse.2024.04.020. Online ahead of print.

ABSTRACT

BACKGROUND: Utilization in outpatient total shoulder arthroplasties (TSAs) has increased significantly in recent years. It remains largely unknown whether utilization of outpatient TSA differs across gender and racial groups. This study aimed to quantify racial and gender disparities both nationally and by geographic regions.

METHODS: 168,504 TSAs were identified using Medicare fee-for-service (FFS) inpatient and outpatient claims data and beneficiary enrollment data from 2020 to 2022Q4. The percentage of outpatient cases, defined as cases discharged on the same day of surgery, was evaluated by racial and gender groups and by different census divisions. A multivariate logistics regression model controlling for patient socio-demographic information (white vs. non-white race, age, gender, and dual eligibility for both Medicare and Medicaid), hierarchical condition category (HCC) score, hospital characteristics, year fixed effects, and patient residency state fixed effects was performed.

RESULTS: The TSA volume per 1000 beneficiaries was 2.3 for the White population compared to 0.8, 0.6 and 0.3 for the Black, Hispanic, and Asian population, respectively. A higher percentage of outpatient TSAs were in White patients (25.6%) compared to Black patients (20.4%) (p < 0.001). The Black TSA patients were also younger, more likely to be female, more likely to be dually eligible for Medicaid, and had higher HCC risk scores. After controlling for patient socio-demographic characteristics and hospital characteristics, the odds of receiving outpatient TSAs were 30% less for Black than the White group (OR 0.70). Variations were observed across different census divisions with South Atlantic (0.67, p < 0.01), East North Central (0.56, p < 0.001), and Middle Atlantic (0.36, p < 0.01) being the four regions observed with significant racial disparities. Statistically significant gender disparities were also found nationally and across regions, with an overall odds ratio of 0.75 (p < 0.001).

DISCUSSION: Statistically significant racial and gender disparities were found nationally in outpatient TSAs, with Black patients having 30% (p < 0.001) fewer odds of receiving outpatient TSAs than white patients, and female patients with 25% (p < 0.001) fewer odds than male patients. Racial and gender disparities continue to be an issue for shoulder arthroplasties after the adoption of outpatient TSAs.

PMID:38852710 | DOI:10.1016/j.jse.2024.04.020

Psychiatr Pol. 2024 Feb 28;58(1):183-199. doi: 10.12740/PP/OnlineFirst/151068. Epub 2024 Feb 28.

ABSTRACT

OBJECTIVES: Some studies suggest that homosexual identity, compared to heterosexual, may be associated with a reduced risk of premature ejaculation (PE). The aim of this study was to test this relationship and to investigate possible underlaying mechanisms.

METHODS: The present study drew on a database obtained from a cross-sectional online study of the sexuality of Polish heterosexual (HM; N = 1,121), gay (GM; N = 1,789) and bisexual (BM; N = 743) men. The dependent variable was the PE diagnosis based on the PEDT questionnaire. The explanatory variables were characteristics of sexual and partnership patterns, health and minority stress among GM and BM. Statistical one- and multifactor analyses were performed.

RESULTS: Homosexual identity proved to be an independent negative predictor of PE diagnosis. The preference for insertive penetration activity (including vaginal), performance anxiety and financial difficulties increased the risk of PE, while the experience of insertive and receptive forms of oral and anal sex but not vaginal sex, a higher level of education, better general sexual functioning and regular physical activity reduced such risk. The predictive meaning of homosexual identity has not been present in multifactor models for group of men in relationships.

CONCLUSIONS: Homosexual identity is associated with a lower risk of PE diagnosis. This may be due to the differences in sexualities of GM and HM, as well as other psychosocial factors.

PMID:38852188 | DOI:10.12740/PP/OnlineFirst/151068

Psychiatr Pol. 2024 Feb 28;58(1):121-151. doi: 10.12740/PP/177073. Epub 2024 Feb 28.

ABSTRACT

OBJECTIVES: To depict overall psychological well-being of a large group of students of different universities in Ukraine three months after the emerge of the full-scale war.

METHODS: A total of 1,142 participants were asked to measure their psychological well-being on a 0-10 scale before and after the onset of full-scale war. Mental health symptoms were measured with questionnaires targeting depression (PHQ-9), anxiety (GAD-7), sleep problems (ISI), eating disorders (SCOFF), alcohol abuse (CAGE), and PTSD symptoms (PC-PTSD-5). To evaluate the connection between variables a χ2 was conducted. Phi and Cramer’s V coefficient were stated to demonstrate the power of the relationships. Additionally, machine learning (the XGBoost regression model) was used to build a predictive model for depressive symptoms.

RESULTS: Of all respondents, 66% screened positive for PTSD symptoms, 45% – moderate and severe anxiety symptoms, 47% – moderate and severe depressive symptoms. Regarding sleep, alcohol use and eating behavior, 19% of surveyed students had signs of moderate and severe insomnia, 15% reported alcohol abuse and 31% disordered eating. The severity of the aforementioned disorders varied depending on gender, year of study, social status, etc. According to the predictive model, lower initial psychological well-being, female gender, younger age, first years of study and any traumatic experience, including multiple trauma, predicted increases in depression score. Return to home after relocation was a protective factor.

CONCLUSIONS: The study demonstrated the high prevalence of mental health symptoms among university students in Ukraine during the first months of the full-scale war. The psychological well-being pre-war was the strongest predictor of depressive symptoms in the model.

PMID:38852187 | DOI:10.12740/PP/177073

Psychiatr Pol. 2024 Feb 28;58(1):7-24. doi: 10.12740/PP/161864. Epub 2024 Feb 28.

ABSTRACT

OBJECTIVES: Anxiety disorders are significant predictors of suicidality and are proposed to be independent risk factors for suicide attempts. They are common in people with type 2 diabetes (T2DM) and are associated with longer duration of diabetes and poorer treatment outcomes. The aim was to examine associations between anxiety disorders and suicidal thoughts and behaviour in people with T2DM, to establish the prevalence of suicidality among people with T2DM in the selected European countries and to examine whether anxiety disorders were predictive of current outcomes of suicidality in this population using data from the International Prevalence and Treatment of Diabetes and Depression study.

METHODS: The study sample comprised 1063 adults with T2DM from 6 European countries. The presence of anxiety disorders and suicidality was assessed with the MINI International Neuropsychiatric Interview. The group of participants with current suicidal risk was compared with the group of participants with no suicidal risk.

RESULTS: The participants from Germany were more likely to report suicidality than those from other countries, whereas people from Serbia and Ukraine were less likely to report it. Depression and anxiety disorders significantly contributed to the increased presence of suicidality among people with T2DM. Agoraphobia was a significant predictor of suicidality when controlling for depression. The participants with T2DM and comorbid agoraphobia had 4.86 times higher odds to report suicidality than those without agoraphobia.

CONCLUSIONS: Agoraphobia was a significant predictor of suicidality in people with T2DM.

PMID:38852182 | DOI:10.12740/PP/161864

Oral Dis. 2024 Jun 9. doi: 10.1111/odi.15014. Online ahead of print.

ABSTRACT

OBJECTIVE: This study investigated the effect of metabolic syndrome (MetS) on periodontal clinical parameters and salivary biomarkers’ matrix metalloproteinase-8 (MMP-8) and myeloperoxidase (MPO) in patients with periodontitis.

METHODS: A total of 120 participants aged 25-55 were categorized into three groups: MetS with periodontitis (n = 40); systemically healthy with periodontitis (n = 40); and systemically and periodontally healthy controls (n = 40). Data collected included systemic parameters like waist circumference (WC), blood pressure (BP), high- and low-density lipoproteins, triglycerides (TG), fasting blood sugar (FBS), and glycated hemoglobin (HbA1c). Periodontal parameters estimated included bleeding on probing score (BoP), full-mouth plaque score (FMPS), periodontal probing depth (PPD), clinical attachment loss (CAL), and the number of missing teeth. Unstimulated whole saliva was analyzed via ELISA for active MMP-8 (aMMP-8), total MMP-8 (tMMP-8), and MPO.

RESULTS: Participants with MetS and periodontitis exhibited significantly higher periodontal parameters, salivary aMMP-8, and MPO (26.26 vs. 24.1 ng/mL and 13.53 vs. 11.55 ng/mL compared to systemically healthy periodontitis patients) (all p < 0.01). Positive correlations occurred between aMMP-8 and WC, TG, and FBS (p < 0.01), and between MPO and WC, BP, and TG (p < 0.01).

CONCLUSIONS: The positive associations between these biomarkers and metabolic parameters indicate their potential utility for monitoring cardiovascular and glycemic risk in patients with periodontal disease.

PMID:38852177 | DOI:10.1111/odi.15014

Magn Reson Med. 2024 Jun 9. doi: 10.1002/mrm.30184. Online ahead of print.

ABSTRACT

PURPOSE: Multiparametric arterial spin labeling (MP-ASL) can quantify cerebral blood flow (CBF) and arterial cerebral blood volume (CBV_a). However, its accuracy is compromised owing to its intrinsically low SNR, necessitating complex and time-consuming parameter estimation. Deep neural networks (DNNs) offer a solution to these limitations. Therefore, we aimed to develop simulation-based DNNs for MP-ASL and compared the performance of a supervised DNN (DNN_Sup), physics-informed unsupervised DNN (DNN_Uns), and the conventional lookup table method (LUT) using simulation and in vivo data.

METHODS: MP-ASL was performed twice during resting state and once during the breath-holding task. First, the accuracy and noise immunity were evaluated in the first resting state. Second, CBF and CBV_a values were statistically compared between the first resting state and the breath-holding task using the Wilcoxon signed-rank test and Cliff’s delta. Finally, reproducibility of the two resting states was assessed.

RESULTS: Simulation and first resting-state analyses demonstrated that DNN_Sup had higher accuracy, noise immunity, and a six-fold faster computation time than LUT. Furthermore, all methods detected task-induced CBF and CBV_a elevations, with the effect size being larger with the DNN_Sup (CBF, p = 0.055, Δ = 0.286; CBV_a, p = 0.008, Δ = 0.964) and DNN_Uns (CBF, p = 0.039, Δ = 0.286; CBV_a, p = 0.008, Δ = 1.000) than that with LUT (CBF, p = 0.109, Δ = 0.214; CBV_a, p = 0.008, Δ = 0.929). Moreover, all the methods exhibited comparable and satisfactory reproducibility.

CONCLUSION: DNN_Sup outperforms DNN_Uns and LUT with respect to estimation performance and computation time.

PMID:38852172 | DOI:10.1002/mrm.30184