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Nevin Manimala Statistics

Development and Validation of a Model for Postpancreatectomy Hemorrhage Risk

JAMA Netw Open. 2023 Dec 1;6(12):e2346113. doi: 10.1001/jamanetworkopen.2023.46113.

ABSTRACT

IMPORTANCE: Postpancreatectomy hemorrhage (PPH) due to postoperative pancreatic fistula (POPF) is a life-threatening complication after pancreatoduodenectomy. However, there is no prediction tool for early identification of patients at high risk of late PPH.

OBJECTIVE: To develop and validate a prediction model for PPH.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective prognostic study included consecutive patients with clinically relevant POPF who underwent pancreatoduodenectomy from January 1, 2009, to May 20, 2023, at the University Hospital Mannheim (derivation cohort), and from January 1, 2012, to May 31, 2022, at the University Hospital Dresden (validation cohort). Data analysis was performed from May 30 to July 29, 2023.

EXPOSURE: Clinical and radiologic features of PPH.

MAIN OUTCOMES AND MEASURES: Accuracy of a predictive risk score of PPH. A multivariate prediction model-the hemorrhage risk score (HRS)-was established in the derivation cohort (n = 139) and validated in the validation cohort (n = 154).

RESULTS: A total of 293 patients (187 [64%] men; median age, 69 [IQR, 60-76] years) were included. The HRS comprised 4 variables with associations: sentinel bleeding (odds ratio [OR], 35.10; 95% CI, 5.58-221.00; P < .001), drain fluid culture positive for Candida species (OR, 14.40; 95% CI, 2.24-92.20; P < .001), and radiologic proof of rim enhancement of (OR, 12.00; 95% CI, 2.08-69.50; P = .006) or gas within (OR, 12.10; 95% CI, 2.22-65.50; P = .004) a peripancreatic fluid collection. Two risk categories were identified with patients at low risk (0-1 points) and high risk (≥2 points) to develop PPH. Patients with PPH were predicted accurately in the derivation cohort (C index, 0.97) and validation cohort (C index 0.83). The need for more invasive PPH management (74% vs 34%; P < .001) and severe complications (49% vs 23%; P < .001) were more frequent in high-risk patients compared with low-risk patients.

CONCLUSIONS AND RELEVANCE: In this retrospective prognostic study, a robust prediction model for PPH was developed and validated. This tool may facilitate early identification of patients at high risk for PPH.

PMID:38055279 | DOI:10.1001/jamanetworkopen.2023.46113

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Nevin Manimala Statistics

Economic Burden of Health Conditions Associated With Adverse Childhood Experiences Among US Adults

JAMA Netw Open. 2023 Dec 1;6(12):e2346323. doi: 10.1001/jamanetworkopen.2023.46323.

ABSTRACT

IMPORTANCE: Adverse childhood experiences (ACEs) are preventable, potentially traumatic events in childhood, such as experiencing abuse or neglect, witnessing violence, or living in a household with substance use disorder, mental health problems, or instability from parental separation or incarceration. Adults who had ACEs have more harmful risk behaviors and worse health outcomes; the economic burden associated with these issues is uncertain.

OBJECTIVE: To estimate the economic burden of ACE-associated health conditions among US adults.

DESIGN, SETTING, AND PARTICIPANTS: In this economic evaluation, regression models of cross-sectional survey data from the 2019-2020 Behavioral Risk Factor Surveillance System (BRFSS) and previous studies were used to estimate ACE population-attributable fractions (PAFs) (ie, the fraction of total cases associated with a specific exposure) for selected health outcomes (anxiety, arthritis, asthma, cancer, chronic obstructive pulmonary disease, depression, diabetes, heart disease, kidney disease, stroke, and violence) and risk factors (heavy drinking, illicit drug use, overweight and obesity, and smoking) among the 2019 US adult population. Adverse childhood experience PAFs were used to calculate the proportion of total condition-specific medical spending and lost healthy life-years related to ACEs using Global Burden of Disease Study data. Data analysis was performed from September 10, 2021, to November 29, 2022.

EXPOSURE: Adverse childhood experiences (age <18 years).

MAIN OUTCOMES AND MEASURES: Monetary valuation of ACE-associated morbidity and mortality using standard US value of statistical life methods and presented in terms of annual and lifetime per affected person and total population estimates at the national and state levels.

RESULTS: A total of 820 673 adults, representing 255 million individuals, participated in the BRFSS in 2019 and 2020. An estimated 160 million of the total 255 million US adult population (63%) had 1 or more ACE, associated with an annual economic burden of $14.1 trillion ($183 billion in direct medical spending and $13.9 trillion in lost healthy life-years). This was $88 000 per affected adult annually and $2.4 million over their lifetimes. The lifetime economic burden per affected adult was lowest in North Dakota ($1.3 million) and highest in Arkansas ($4.3 million). Twenty-two percent of adults had 4 or more ACEs and comprised 58% of the total economic burden-the estimated per person lifetime economic burden for those adults was $4.0 million.

CONCLUSIONS AND RELEVANCE: In this cross-sectional analysis of the US adult population, the economic burden of ACE-related health conditions was substantial. The findings suggest that measuring the economic burden of ACEs can support decision-making about investing in strategies to improve population health.

PMID:38055277 | DOI:10.1001/jamanetworkopen.2023.46323

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Nevin Manimala Statistics

Addressing State-Based Differences in Suicide Fatalities Among Children and Adolescents-Finding Another Way

JAMA Psychiatry. 2023 Dec 6. doi: 10.1001/jamapsychiatry.2023.4313. Online ahead of print.

NO ABSTRACT

PMID:38055275 | DOI:10.1001/jamapsychiatry.2023.4313

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Nevin Manimala Statistics

Risk Prediction for Atherosclerotic Cardiovascular Disease With and Without Race Stratification

JAMA Cardiol. 2023 Dec 6. doi: 10.1001/jamacardio.2023.4520. Online ahead of print.

ABSTRACT

IMPORTANCE: Use of race-specific risk prediction in clinical medicine is being questioned. Yet, the most commonly used prediction tool for atherosclerotic cardiovascular disease (ASCVD)-pooled cohort risk equations (PCEs)-uses race stratification.

OBJECTIVE: To quantify the incremental value of race-specific PCEs and determine whether adding social determinants of health (SDOH) instead of race improves model performance.

DESIGN, SETTING, AND PARTICIPANTS: Included in this analysis were participants from the biracial Reasons for Geographic and Racial Differences in Stroke (REGARDS) prospective cohort study. Participants were aged 45 to 79 years, without ASCVD, and with low-density lipoprotein cholesterol level of 70 to 189 mg/dL or non-high-density lipoprotein cholesterol level of 100 to 219 mg/dL at baseline during the period of 2003 to 2007. Participants were followed up to 10 years for incident ASCVD, including myocardial infarction, coronary heart disease death, and fatal and nonfatal stroke. Study data were analyzed from July 2022 to February 2023.

MAIN OUTCOME/MEASURES: Discrimination (C statistic, Net Reclassification Index [NRI]), and calibration (plots, Nam D’Agostino test statistic comparing observed to predicted events) were assessed for the original PCE, then for a set of best-fit, race-stratified equations including the same variables as in the PCE (model C), best-fit equations without race stratification (model D), and best-fit equations without race stratification but including SDOH as covariates (model E).

RESULTS: This study included 11 638 participants (mean [SD] age, 61.8 [8.3] years; 6764 female [58.1%]) from the REGARDS cohort. Across all strata (Black female, Black male, White female, and White male participants), C statistics did not change substantively compared with model C (Black female, 0.71; 95% CI, 0.68-0.75; Black male, 0.68; 95% CI, 0.64-0.73; White female, 0.77; 95% CI, 0.74-0.81; White male, 0.68; 95% CI, 0.64-0.71), in model D (Black female, 0.71; 95% CI, 0.67-0.75; Black male, 0.68; 95% CI, 0.63-0.72; White female, 0.76; 95% CI, 0.73-0.80; White male, 0.68; 95% CI, 0.65-0.71), or in model E (Black female, 0.72; 95% CI, 0.68-0.76; Black male, 0.68; 95% CI, 0.64-0.72; White female, 0.77; 95% CI, 0.74-0.80; White male, 0.68; 95% CI, 0.65-0.71). Comparing model D with E using the NRI showed a net percentage decline in the correct assignment to higher risk for male but not female individuals. The Nam D’Agostino test was not significant for all race-sex strata in each model series, indicating good calibration in all groups.

CONCLUSIONS: Results of this cohort study suggest that PCE performed well overall but had poorer performance in both BM and WM participants compared with female participants regardless of race in the REGARDS cohort. Removal of race or the addition of SDOH did not improve model performance in any subgroup.

PMID:38055247 | DOI:10.1001/jamacardio.2023.4520

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Nevin Manimala Statistics

Oral Acitretin Plus Topical Triamcinolone vs Topical Triamcinolone Monotherapy in Patients With Symptomatic Oral Lichen Planus: A Randomized Clinical Trial

JAMA Dermatol. 2023 Dec 6. doi: 10.1001/jamadermatol.2023.4889. Online ahead of print.

ABSTRACT

IMPORTANCE: Symptomatic oral lichen planus (OLP) can be challenging to treat.

OBJECTIVE: To compare the efficacy of oral acitretin plus topical triamcinolone acetonide (TAC), 0.1%, with TAC monotherapy in patients with symptomatic OLP.

DESIGN, SETTING, AND PARTICIPANTS: This monocentric, investigator-initiated, placebo-controlled, investigator- and patient-blinded randomized clinical trial was conducted from December 2018 to June 2020 at the Postgraduate Institute of Medical Education and Research, a tertiary referral center in Chandigarh, India. Sixty-four patients 18 years or older with symptomatic OLP were recruited by consecutive sampling. Data were analyzed from July to December 2020.

INTERVENTION: The patients were randomized to receive either a combination of oral acitretin (25-35 mg/d) and TAC (treatment group) or TAC in combination with placebo (placebo group) for 28 weeks, with an additional 8 weeks of treatment-free follow-up after the end of treatment (36 weeks of total study duration).

MAIN OUTCOMES AND MEASURES: The disease severity and treatment response were assessed using Oral Disease Severity Score (ODSS), Oral Health Impact Profile 14 (OHIP-14), and visual analog scale (VAS). The primary aim was to assess the number of patients achieving ODSS-75 (75% reduction in ODSS compared with baseline) in both groups at 28 weeks and at the end of 36 weeks.

RESULTS: Among 64 patients, 31 in the treatment group and 30 in the placebo group completed the study (mean [SD] age, 50.6 [15.2] years vs 49.2 [14.4] years; male-female ratio, 13:19 vs 16:16). Baseline ODSS, visual analog scale, and Oral Health Impact Profile 14 scores were comparable in both groups. In the intention-to-treat analysis, there was a statistically significant higher number of patients achieving 75% or higher reduction in ODSS in the treatment group compared with the placebo group at the end of 28 weeks (28 [88%] vs 15 [47%], a 41 [95% CI, 20-61] percentage point difference between groups; P < .001; Cramér V = 0.47) and 36 weeks (27 [84%] vs 13 [41%], a 43 [95% CI, 23-67] percentage point difference between groups; P < .001; Cramér V = 0.47). Relapses during the posttreatment follow-up of 8 weeks were low among patients in both treatment and placebo groups (1 [3%] vs 2 [6%], a 3 [95% CI, -13 to 7] percentage point difference between groups; P > .99; Cramér V = 0.07).

CONCLUSION AND RELEVANCE: In this randomized clinical trial, the combination of oral acitretin and TAC was more effective than TAC monotherapy in patients with symptomatic OLP.

TRIAL REGISTRATION: Clinical Trial Registry of India Identifier: CTRI/2018/11/016448.

PMID:38055232 | DOI:10.1001/jamadermatol.2023.4889

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Nevin Manimala Statistics

Exploring National Trends and Organizational Predictors of Violence and Mistreatment From Patients and Visitors

J Healthc Manag. 2023 Dec 4. doi: 10.1097/JHM-D-23-00105. Online ahead of print.

ABSTRACT

GOAL: Rising incidents of violence and mistreatment of healthcare workers by patients and visitors have been reported. U.S. healthcare workers are five times more likely to experience nonfatal workplace violence (WPV) than workers in any other profession. However, less is known about the national trends in the incidence of violence and mistreatment in healthcare. The specific organizational and individual-level factors that relate to stress arising from these occurrences specifically by patients and family members are also not fully understood. The goals of this study were to examine national trends of violence toward healthcare workers, understand which populations are most vulnerable to stress from violence and mistreatment, and explore organizational factors that are related to these occurrences.

METHODS: Data were collected from three sources: (1) The Bureau of Labor Statistics Intentional Injury by Another Person data for the period 2011-2020, (2) data from a large national workers’ compensation claim services provider for the period 2018-2022, and (3) results from a survey distributed at a large medical center in June and July 2022. Data were represented graphically and analyzed using multivariate regression and dominance analysis to identify specific predictors of WPV and mistreatment among healthcare workers.

PRINCIPAL FINDINGS: Of the total surveyed sample, 23.7% of participants reported mistreatment from patients or visitors as a major stressor and 14.6% reported WPV from patients or visitors as a major stressor. Stress from mistreatment and WPV was most frequently reported by nurses, employees aged 18 to 24 years other than nurses, those who identified as White, and those who identified as female or a gender minority. The emergency room (ER) showed the highest percentages of stress from mistreatment (61.8%) and violence (55.9%) from patients or visitors. The top predictors of stress from WPV and mistreatment by patients or visitors among healthcare workers ranked high to low were working in the ER, working as a nurse, a lack of necessary supplies or equipment, patient or visitor attitudes or beliefs about COVID-19, and working in a hospital-based unit.

PRACTICAL APPLICATIONS: In addition to protecting employees as a moral imperative, preventing WPV is critical for organizational performance. Employee productivity is estimated to decrease up to 50% in the 6 to 18 weeks following an incident of violence, while turnover can increase 30% to 40%. An effective WPV prevention plan and a proactive approach to supporting the physical and mental health conditions that may result from WPV can mitigate the potential costs and exposures from these incidents. Organizations must also set clear expectations of behavior with patients and visitors by refusing to tolerate violence and mistreatment of caregivers. The impact of WPV can remain present and active for up to 8 years following an incident. Policy-level interventions are also needed. Currently, there are no federal protections for healthcare workers related to violence, though some states have made it a felony to abuse healthcare workers.

PMID:38055205 | DOI:10.1097/JHM-D-23-00105

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Nevin Manimala Statistics

Efficacy of Preventing Relapse Evaluated by a Multicenter Randomized Double-Blind Placebo-Controlled Withdrawal Study of Escitalopram in Japanese Adolescents with Major Depressive Disorder

J Child Adolesc Psychopharmacol. 2023 Dec 7. doi: 10.1089/cap.2023.0048. Online ahead of print.

ABSTRACT

Objective: To evaluate the efficacy and safety of escitalopram (ESC) in a 48-week relapse prevention study in Japanese adolescents with major depressive disorder (MDD). Methods: This was a 48-week multicenter randomized double-blind placebo-controlled parallel-group study of patients aged 12-17 years with MDD. Patients received ESC for 12 weeks as an open-label treatment period (open-label period). Patients who achieved criteria for remission or response in the open-label period received either ESC or placebo for 36 weeks as a double-blind treatment period (double-blind period). The primary endpoint was the time to relapse during the double-blind period. Safety was evaluated in terms of type, incidence, and severity of adverse events. Results: Of the 128 patients who entered the open-label period, 80 patients entered the double-blind period, all of whom were in the primary analysis population. The primary endpoint, time to relapse, was marginally less than statistically significant between the ESC and placebo groups (p = 0.051, log-rank test). In the Cox proportional hazards model, the estimated hazard ratio [two-sided 95% confidence interval] for relapse in the placebo group versus the ESC group was 2.96 [0.94, 9.30]. There were statistically significant differences between the ESC and placebo groups in several secondary endpoints (change in Children’s Depression Rating Scale-Revised, change in Clinical Global Impressions-Severity Scale, etc.). No notable safety/tolerability issues were observed in this study compared with the results of studies in Japanese adults with MDD. Conclusions: Superiority of ESC over placebo for relapse prevention in Japanese adolescents aged 12-17 years with MDD could not be verified with time to relapse evaluated by log-rank test. However, secondary endpoint results and a post hoc analysis of time to relapse suggest that ESC may be effective in preventing MDD relapse. No notable safety/tolerability issues were observed compared with the results of studies in Japanese adults with MDD. Study Registry Number: jRCT2080224520.

PMID:38055198 | DOI:10.1089/cap.2023.0048

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Nevin Manimala Statistics

Environmental effects from petroleum product transportation spillage in Nigeria: a critical review

Environ Sci Pollut Res Int. 2023 Dec 6. doi: 10.1007/s11356-023-31117-z. Online ahead of print.

ABSTRACT

Nigeria has struggled to meet sustainable development goals (SDGs) on environmental sustainability, transportation, and petroleum product distribution for decades, endangering human and ecological health. Petroleum product spills contaminate soil, water, and air, harming humans, aquatic life, and biodiversity. The oil and gas industry contributes to environmental sustainability and scientific and technological advancement through its supply chain activities in the transport and logistics sectors. This paper reviewed the effects of petroleum product transportation at three accident hotspots on Nigeria highway, where traffic and accident records are alarming due to the road axis connecting the southern and northern regions of the country. The preliminary data was statistically analysed to optimise the review process and reduce risk factors through ongoing data monitoring. Studies on Nigeria’s petroleum product transportation spills and environmental impacts between the years 2013 and 2023 were critically analysed to generate updated information. The searches include Scopus, PubMed, and Google Scholar. Five hundred and forty peer-reviewed studies were analysed, and recommendations were established through the conclusions. The findings show that petroleum product transport causes heavy metal deposition in the environment as heavy metals damage aquatic life and build up in the food chain, posing a health risk to humans. The study revealed that petroleum product spills have far-reaching environmental repercussions and, therefore, recommended that petroleum product spills must be mitigated immediately. Furthermore, the study revealed that better spill response and stricter legislation are needed to reduce spills, while remediation is necessary to lessen the effects of spills on environmental and human health.

PMID:38055166 | DOI:10.1007/s11356-023-31117-z

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Evaluation of liver and spleen stiffness measurement with shear wave elastography in brucellosis

Ir J Med Sci. 2023 Dec 6. doi: 10.1007/s11845-023-03577-2. Online ahead of print.

ABSTRACT

BACKGROUND: Human brucellosis, which is endemic in the eastern region of Turkey, infects the reticulo-endothelial system. Acute brucellosis may cause hepatomegaly or splenomegaly.

AIMS: The main purpose of this study was to investigate the effectiveness of the point shear wave elastography (pSWE) method in identifying and detecting liver and spleen stiffness in acute brucellosis.

METHODS: This case-control study included 40 patients with acute brusellosis and 60 healthy individuals as a control group. The demographic data, abdominal ultrasonography (USG) and pSWE results of the patient and control groups were evaluated. Statistical and ROC analyses were performed.

RESULTS: The liver pSWE value was 3.8395 ± 1.171 kPa in the patient group and 1.6619 ± 0.495 kPa in the control group. The spleen pSWE value was 3.2431 ± 1.803 kPa in the patient group and 1.3793 ± 0.622 kPa in the control group. The mean liver and spleen pSWE values were statistically significantly higher in the patient group than in the control group (p < 0.001). Cut-off values were determined as 2.524 for the liver pSWE and 1.62667 for the spleen pSWE. From the AUC values (0.959, 0.903), the diagnostic performance of liver and spleen pSWE values were seen to be excellent in distinguishing between patient and control groups.

CONCLUSIONS: The study results showed that liver and spleen stiffness were high in acute brucellosis patients and had predictive significance above certain cut-off values. It can be considered that pSWE, which evaluates liver and spleen stiffness in acute brucellosis, may provide diagnostic benefit as a reliable, non-invasive technique.

PMID:38055148 | DOI:10.1007/s11845-023-03577-2

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Nevin Manimala Statistics

Polymorphisms in the Runx2 and osteocalcin genes affect BMD in postmenopausal women: a systematic review and meta-analysis

Endocrine. 2023 Dec 6. doi: 10.1007/s12020-023-03621-2. Online ahead of print.

ABSTRACT

PURPOSE: Runx2 and osteocalcin have pivotal roles in bone homeostasis. Polymorphism of these two genes could alter the function of osteoblasts and consequently bone mineral density (BMD). Attempts to understand the relationship between these polymorphisms and BMD in postmenopausal women across a variety of populations have yielded inconsistent results. This meta-analysis seeks to define the relationship between these polymorphisms with BMD in postmenopausal women.

METHODS: Eligible studies were identified from three electronic databases. Data were extracted from the eligible studies (4 studies on Runx2 and 6 studies on osteocalcin), and associations of Runx2 T > C and osteocalcin HindIII polymorphisms with BMD in postmenopausal women were assessed using standard difference in means (SDM) and 95% confidence intervals (CI) as statistical measures.

RESULTS: A significant difference in the lumbar spine (LS) BMD in postmenopausal women was observed between the TT and CC homozygotes for the Runx2 T > C (SDM = -0.445, p-value = 0.034). The mutant genotypes (CC) showed significantly lower LS BMD in comparison to wild type genotypes under recessive model of genetic analysis (TC + TT vs. CC: SDM = -0.451, p-value = 0.032). For osteocalcin, HindIII polymorphism, the mutant genotypes (HH) was associated with significantly higher BMD for both LS and femoral neck (FN) than the wild type (hh) homozygotes (SDM = 0.152, p-value = 0.008 and SDM = 0.139, p-value = 0.016 for LS and FN, respectively). There was no association between total hip (TH) BMD and the osteocalcin HindIII polymorphism.

CONCLUSIONS: Runx2 T > C and osteocalcin HindIII polymorphisms influence the level of BMD in postmenopausal women and may be used as predictive markers of osteoporosis.

PMID:38055125 | DOI:10.1007/s12020-023-03621-2