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Nevin Manimala Statistics

Evaluation of radiographic visibility of root pulp in mandibular second molars using cone beam computed tomography images for age estimation

Forensic Sci Med Pathol. 2023 Feb 28. doi: 10.1007/s12024-023-00594-6. Online ahead of print.

ABSTRACT

The purpose of this study is to estimate chronological age and determine whether individuals were aged under or over 18 years using root pulp visibility (RPV) in cone-beam computed tomography (CBCT) images. The study included CBCT images of 699 individuals aged between 15 and 75 years. One thousand twenty-three mandibular second molar (2M) teeth were evaluated using Olze’s RPV method in four stages. Descriptive statistics of the stages and the relationship between the stages and the chronological age were assessed. The distribution of the stages was analyzed according to the 18-year age threshold. There was a positive correlation between RPV stages and chronological ages in both sexes. For females and males, the mean ages of stage 0, stage 1, and stage 2, for females and males, were found as 27.21, 28.93, and 33.68 years, and 37.69, 40.9, and 44.88 years, respectively. Stage 0 and stage 1 were found both in individuals aged under and over 18 years, and stage 2 and stage 3 were not observed in individuals aged under 18 years. The presence of stage 2 and stage 3 may be an indication that an individual is aged over 18 years according to Olze’s RPV age estimation method. For more reliable results, 2M teeth should be examined bilaterally in forensic science.

PMID:36853501 | DOI:10.1007/s12024-023-00594-6

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Nevin Manimala Statistics

Benefits and Risks of Antidepressant Drugs During Pregnancy: A Systematic Review of Meta-analyses

Paediatr Drugs. 2023 Feb 28. doi: 10.1007/s40272-023-00561-2. Online ahead of print.

ABSTRACT

BACKGROUND: The prescription of antidepressant drugs during pregnancy has been steadily increasing for several decades. Meta-analyses (MAs), which increase the statistical power and precision of results, have gained interest for assessing the safety of antidepressant drugs during pregnancy.

OBJECTIVE: We aimed to provide a meta-review of MAs assessing the benefits and risks of antidepressant drug use during pregnancy.

METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a literature search on PubMed and Web of Science databases was conducted on 25 October, 2021, on MAs assessing the association between antidepressant drug use during pregnancy and health outcomes for the pregnant women, embryo, fetus, newborn, and developing child. Study selection and data extraction were carried out independently and in duplicate by two authors. The methodological quality of included studies was evaluated with the AMSTAR-2 tool. Overlap among MAs was assessed by calculating the corrected covered area. Data were presented in a narrative synthesis, using four levels of evidence.

RESULTS: Fifty-one MAs were included, all but one assessing risks. These provided evidence for a significant increase in the risks for major congenital malformations (selective serotonin reuptake inhibitors, paroxetine, fluoxetine, no evidence for sertraline; eight MAs), congenital heart defects (paroxetine, fluoxetine, sertraline; 11 MAs), preterm birth (eight MAs), neonatal adaptation symptoms (eight MAs), and persistent pulmonary hypertension of the newborn (three MAs). There was limited evidence (only one MA for each outcome) for a significant increase in the risks for postpartum hemorrhage, and with a high risk of bias, for stillbirth, impaired motor development, and intellectual disability. There was inconclusive evidence, i.e., discrepant results, for an increase in the risks for spontaneous abortion, small for gestational age and low birthweight, respiratory distress, convulsions, feeding problems, and for a subsequent risk for autism with an early antidepressant drug exposure. Finally, MAs provided no evidence for an increase in the risks for gestational hypertension, preeclampsia, and for a subsequent risk for attention-deficit/hyperactivity disorder. Only one MA assessed benefits, providing limited evidence for preventing relapse in severe or recurrent depression. Effect sizes were small, except for neonatal symptoms (small to large). Results were based on MAs in which overall methodological quality was low (AMSTAR-2 score = 54.8% ± 12.9%, [19-81%]), with a high risk of bias, notably indication bias. The corrected covered area was 3.27%, which corresponds to a slight overlap.

CONCLUSIONS: This meta-review has implications for clinical practice and future research. First, these results suggest that antidepressant drugs should be used as a second-line treatment during pregnancy (after first-line psychotherapy, according to the guidelines). The risk of major congenital malformations could be prevented by observing guidelines that discourage the use of paroxetine and fluoxetine. Second, to decrease heterogeneity and bias, future MAs should adjust for maternal psychiatric disorders and antidepressant drug dosage, and perform analyses by timing of exposure.

PMID:36853497 | DOI:10.1007/s40272-023-00561-2

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Sagittal correction after short percutaneous fixation for thoracolumbar compression fractures: comparison of the combination of SpineJack® kyphoplasty and fractured vertebra screw fixation

Int Orthop. 2023 Feb 28. doi: 10.1007/s00264-023-05734-9. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to compare two percutaneous pedicle fixations for the treatment of thoracolumbar fractures: one associating a jack kyphoplasty (SpineCut) and the other using intermediate screws (Trident).

METHODS: All adult patients treated for single-level Magerl/AO type A thoracolumbar traumatic fractures in four orthopaedic departments, with SpineCut or Trident, with a one year minimum follow-up, were retrospectively included. Neurological disorders and osteoporotic fractures were not included. The following data were collected: age, sex, Magerl/AO type, type of surgery, and complications. Radiological parameters were analyzed on pre-operative CT scan, and on standing X-rays before discharge, at three months and one year post-operative: vertebral wedge angle (VWA), regional kyphosis angle (RKA), and traumatic regional angulation (TRA: difference between RKA and physiological values for each vertebra).

RESULTS: Eighty patients were included, with 42 patients in SpineCut group and 38 in Trident group. Mean age was 41 ± 15.7 years. TRA correction did not differ between the groups: respectively 11.2 ± 8.1° in SpineCut versus 10.2 ± 9.1° in Trident group (p = 0.52). TRA loss of correction between early post-operative and three months was statistically higher in Trident group: -4 ± 5.1° versus -1.5 ± 3.8° (p = 0.03). After 3 months, TRA correction loss was comparable between the groups. Multivariate analysis demonstrated that pre-operative VWA was the only factor significantly associated with early TRA correction loss (p = 0.01). VWA correction and loss of correction did not differ significantly between the groups. No complications were observed.

CONCLUSION: Percutaneous pedicle fixations of traumatic thoracolumbar fractures associating jack kyphoplasty and intermediate screws are both safe and efficient techniques.

PMID:36853432 | DOI:10.1007/s00264-023-05734-9

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Vertical ridge augmentation of atrophic posterior mandible with corticocancellous onlay symphysis graft versus sandwich technique: clinical and radiographic analysis

Odontology. 2023 Feb 28. doi: 10.1007/s10266-023-00794-0. Online ahead of print.

ABSTRACT

Alveolar ridge augmentation of atrophic posterior mandibular ridge represents a challenge in oral and maxillofacial surgery to restore aesthetic and function. The aim of the study was to compare the clinical and radiographic outcomes of bone formation in atrophic posterior mandibles augmented using onlay symphysis cortico-cancellous bone block with that augmented using sandwich bone augmentation technique (Inlay). Twelve patients were selected with missing mandibular posterior teeth. CBCT were done for all patients preoperatively to assess the residual bone height, ranged between 5 and 7 mm from the inferior alveolar nerve with adequate sufficient alveolar ridge width more than 4 mm. Patients required bone augmentation procedure with autologous onlay chin graft (group I) versus those used as inlay sandwich technique (group II). Clinical and radiographic analysis were done to analyses the newly formed bone and bone height. Percent of change in bone height was also calculated and revealed that group I was higher than group II, however, statistically insignificant differences between the two groups were found regarding the percentage of newly formed bone. Vertical ridge augmentation procedures using onlay chin graft took lesser time than the interpositional grafting with fixation technique, however, both techniques are promising for vertical ridge augmentation.

PMID:36853425 | DOI:10.1007/s10266-023-00794-0

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Neuro-protective potentials of N-acetylcysteine and zinc against di(2-ethylhexyl)-phthalate-induced neuro-histopathology and dys-regulations of Dopamine and Glutamate in rat brain

J Environ Sci Health A Tox Hazard Subst Environ Eng. 2023 Feb 28:1-10. doi: 10.1080/10934529.2023.2177449. Online ahead of print.

ABSTRACT

This study examined neuro-protective potentials of N-acetyl-cysteine (NAC) and Zinc on expression levels of Dopamine and Glutamate in the Cerebrum, Hypothalami and Pituitary Glands in Di(2-ethylhexyl)-phthalate (DEHP)-induced neurotoxicity in rats. Thirty-six adult male Wistar rats were randomly divided into 6 groups (n = 6). Group 1 was control. Groups 2-6 received oral administrations of 100 mg/kg NAC, 0.5 mg/kg Zinc, 750 mg/kg DEHP, DEHP + NAC doses and DEHP + Zinc doses respectively for 21 days. Brain histology (Heamatoxyline and Eosine technique), histochemical and enzyme-linked-immunosorbent assays of Dopamine and Glutamate in homogenates of Cerebrum, Hypothalami and Pituitary Glands were evaluated. Data were statistically analyzed using One-way-ANOVA with Tukey-post-hoc test at p ≤ 0.05. Histo-pathological evaluations of Cerebrum, Hypothalami and Pituitary Glands showed gross histo-alterations and neurodegenerative changes (Group 4), mild histo- and neuro-degenerative changes (Groups 5 and 6) and normal histology (Group 1). Histochemical analyses showed higher Dopamine levels in Hypothalami (Group 5) and Pituitary Glands (Groups 5 and 6), compared with Group 4. Furthermore, results showed lower Glutamate levels in Cerebrum, Hypothalami and Pituitary Glands of Groups 5 and 6, compared with Group 4. Overall, NAC and Zinc conferred neuro-protection and histo-protection against DEHP-induced neuro-toxicity, neuro-histopathology, decreased Dopamine levels and increased Glutamate levels.

PMID:36852734 | DOI:10.1080/10934529.2023.2177449

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Effect of Dysphagia on the Older Adults’ Nutritional Status and Meal Pattern

J Prim Care Community Health. 2023 Jan-Dec;14:21501319231158280. doi: 10.1177/21501319231158280.

ABSTRACT

INTRODUCTION/OBJECTIVES: Dysphagia is a widespread clinical condition among older adults. Although known as a risk factor for nutritional status and dehydration, dysphagia also affects meal patterns. This study aimed to determine the relationship between dysphagia and undernutrition, as well as dietary consumption patterns in older adults.

METHODS: 268 older adults (144 women, 124 men) were included in the study. Mini Nutritional Assessment (MNA), dysphagia assessment (EAT-10), oral examination, and Semi-quantitative Food Frequency Questionnaire (SFFQ) were used for collecting data. Odds ratio and Chi square were used to compare independent variables in subjects with and without undernutrition as well as those who intake texture modified and non-texture modified diet.

RESULTS: Mean age of the undernutrition and normal nutrition groups was 68.9 ± 6.1 and 68.8 ± 6.0 years, respectively. The undernutrition group’s activities of daily living (ADL) were 19.7 ± 0.9, and the normal nutrition group was 19.8 ± 0.7. Older adults with dysphagia were 4.8 times more likely to experience undernutrition than older adults without dysphagia (95% CI = 1.75-13.13, P = .002). There was a statistically difference between the meal patterns among the dysphagic older adult group and the normal-swallowing older adults’ group at the .05 level.

CONCLUSIONS: According to this study, dysphagia was associated with the nutritional status of older adults and dietary patterns. The study results suggested some recommendations for dental health personnel on oral care related to dietary consumption and dietary patterns in older adults.

PMID:36852733 | DOI:10.1177/21501319231158280

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Health Literacy, Health Outcomes and Equity: A Trend Analysis Based on a Population Survey

J Prim Care Community Health. 2023 Jan-Dec;14:21501319231156132. doi: 10.1177/21501319231156132.

ABSTRACT

Health literacy continues to be an issue among minority groups. Population surveys are one strategy used to help better understand health disparities. The Behavioral Risk Factor Surveillance System (BRFSS) in Kansas added health literacy questions to the survey in 2012. This study examined population health literacy levels and health trends from 2012 to 2018. The health status variables included health care coverage status, general health rating, presence of chronic conditions, and length of time since the last check-up. The percentage of individuals reporting low health literacy decreased from 67% in 2012 to 51% in 2018. The percentage of participants with income levels less than $15 000 was 9% in 2012 and 7% in 2018. Health literacy was lowest among the age group 18 to 24-year-olds, those who identified as multiracial, separated, not graduated from high school, out of work for more than 1 year, income less than $10 000, with other living arrangements, and living in a suburban county of metropolitan statistical area. Additionally, many health conditions improved, and those reporting health insurance increased slightly. The study demonstrates how health literacy continues to be an issue, and how education and primary prevention are necessary to improve limited health literacy and health outcomes. Findings from both state-level and national BRFSS population surveys can help educate the public health and clinical health services workforce to provide better care and address health disparities for highrisk populations.

PMID:36852725 | DOI:10.1177/21501319231156132

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Population Pharmacokinetics of Monalizumab in Patients with Advanced Solid Tumors

J Clin Pharmacol. 2023 Feb 28. doi: 10.1002/jcph.2220. Online ahead of print.

ABSTRACT

Monalizumab is a novel, first-in-class humanized immunoglobulin G (IgG)-4 monoclonal antibody (mAb) immune checkpoint inhibitor that targets the inhibitory CD94/NKG2A receptors. The objectives of this analysis were to develop a population pharmacokinetic (PK) model of monalizumab, evaluate the impact of clinically relevant covariates on monalizumab PK, and provide dose justification for clinical trials. We developed a monalizumab population PK model to characterize the PK properties of monalizumab in patients with advanced solid tumors or head and neck squamous cell carcinoma. Data from clinical studies D419NC00001 (NCT02671435) and IPH2201-203 (NCT02643550) were pooled for the analysis, resulting in a dataset of 3066 PK samples derived from 507 subjects. The PK of monalizumab were reasonably described by a 2-compartment model with first-order elimination. Monalizumab generally exhibited linear PK over a dose range of 22.5-750 mg or 10 mg/kg every 2 weeks. The estimate of clearance was approximately 0.255 L/day and apparent volume of distribution was 6.36 L for a typical individual, consistent with previous findings for endogenous IgGs and other therapeutic mAbs. Baseline albumin and body weight were identified as significant covariates of clearance; body weight, sex, and smoking status had a significant impact on volume of distribution; and none of these covariates had impact on peripheral volume of distribution. Although these covariates were identified as statistically significant, they are considered to be not clinically meaningful, as changes in monalizumab exposure were less than 30%. Therefore, no dose adjustments of monalizumab based on patient or disease characteristics is recommended. This article is protected by copyright. All rights reserved.

PMID:36852723 | DOI:10.1002/jcph.2220

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A National Survey Assessing the Variability in the Management of Traumatic Cardiac Arrest

Am Surg. 2023 Feb 28:31348231161089. doi: 10.1177/00031348231161089. Online ahead of print.

ABSTRACT

BACKGROUND: Resuscitation of traumatic cardiac arrest (TCA) is variable, with approaches that overlap Advanced Trauma Life Support (ATLS) and Advanced Cardiac Life Support (ACLS) algorithms. There is no standard algorithm for TCA, with some withholding ACLS protocols given abysmal outcomes. This study aims to assess surgeon practices and attitudes toward resuscitation practices in TCA.

MATERIALS AND METHODS: A 16-question web-based survey was distributed to the membership of a national trauma association. Respondent demographics and management of TCA were analyzed. Chi-squared tests determined statistical significance. Open-ended responses were coded and analyzed inductively.

RESULTS: Two hundred and three surveys were completed. 73.4% of respondents reported utilizing ACLS, while 26.6% reported they never utilized ACLS. A statistically significant difference in the performance of ACLS was found based on number of years in practice (P = .025) and the state of practice (P = .006). There was no significant difference in self-reported survival rates or legal, ethical, or interpersonal conflicts. Qualitative data highlighted themes of interpersonal conflict and futility.

DISCUSSION: This study shows that one-quarter of respondents never utilize ACLS in TCA. Of those that utilize ACLS, there was variability in the technique, indication, and duration of resuscitation. Despite significant variability in technique, there appears to be similar survival rates and incidence of conflict. The association between years in practice and ACLS use suggests this may represent an emerging change in practice. The low response rate limits generalizability; however, there is significant variability in practice, highlighting a need for evidence-based guidelines.

PMID:36852712 | DOI:10.1177/00031348231161089

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Using Epidemiological Data to Inform Clinical Trial Feasibility Assessments: A Case Study

Stroke. 2023 Feb 28. doi: 10.1161/STROKEAHA.122.041650. Online ahead of print.

ABSTRACT

BACKGROUND: Clinical trial enrollment and completion is challenging, with nearly half of all trials not being completed or not completed on time. In 2014, the National Institutes of Health StrokeNet in collaboration with stroke epidemiologists from GCNKSS (Greater Cincinnati/Northern Kentucky Stroke Study) began providing proposed clinical trials with formal trial feasibility assessments. Herein, we describe the process of prospective feasibility analyses using epidemiological data that can be used to improve enrollment and increase the likelihood a trial is completed.

METHODS: In 2014, DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3) trialists, National Institutes of Health StrokeNet, and stroke epidemiologists from GCNKSS collaborated to evaluate the initial inclusion/exclusion criteria for the DEFUSE 3 study. Trial criteria were discussed and an assessment was completed to evaluate the percent of the stroke population that might be eligible for the study. The DEFUSE 3 trial was stopped early with the publication of DAWN (Thrombectomy 6 to 24 Hours After Stroke With a Mismatch Between Deficit and Infarct), and the Wilcoxon rank-sum statistic was used to analyze whether the trial would have been stopped had the proposed changes not been made, following the DEFUSE 3 statistical analysis plan.

RESULTS: After initial epidemiological analysis, 2.4% of patients with acute stroke in the GCNKSS population would have been predicted to be eligible for the study. After discussion with primary investigators and modifying 4 key exclusion criteria (upper limit of age increased to 90 years, baseline modified Rankin Scale broadened to 0-2, time since last well expanded to 16 hours, and decreased lower limit of National Institutes of Health Stroke Scale score to <6), the number predicted to be eligible for the trial increased to 4%. At the time of trial conclusion, 57% of the enrolled patients qualified only by the modified criteria, and the trial was stopped at an interim analysis that demonstrated efficacy. We estimated that the Wilcoxon rank-sum value for the unadjusted predicted enrollment would not have crossed the threshold for efficacy and the trial not stopped.

CONCLUSIONS: Objectively assessing trial inclusion/exclusion criteria using a population-based resource in a collaborative and iterative process including epidemiologists can lead to improved recruitment and can increase the likelihood of successful trial completion.

PMID:36852687 | DOI:10.1161/STROKEAHA.122.041650