Tag: nevin manimala

BMC Palliat Care. 2023 Apr 21;22(1):47. doi: 10.1186/s12904-023-01169-6.

ABSTRACT

BACKGROUND: The need to spread the culture of palliative care and to train health care professionals from undergraduate courses is recognised internationally. The article presents the outcomes of a project devoted to palliative care training in university courses in four countries.

AIMS: This article considered the outcomes of a course designed for university students who had the potential to work in a palliative care team. The main aim was to check the efficacy of the course and the motivation to work in palliative care settings, considering the impact of fear and representations of death.

METHODS: The project presented the essential contents related to palliative care, using psychodramatic and photo-voice techniques. Longitudinal measurements were taken using a quantitative method design to detect changes among the students involved. The project involved 341 students at the first administration of the survey consisted of a protocol composed of standardized questionnaires in five countries (Austria, Israel, Italy, Poland and Romania), of whom 276 completed the pre- and post-surveys-165 of them in the experimental group and 111, in the control group.

RESULTS: The experience showed that it is possible to address death-related issues seriously and competently without necessarily causing discomfort and despondency in students. The results of the changes over time in the experimental and control groups highlight how the view of death as annihilation is correlated with the fear of death and the need for avoidance of thoughts concerning dying. The main result is that competence in palliative care facilitates familiarisation with issues of death and dying, as well as the ability to work in this area, thereby enhancing interpersonal skills.

CONCLUSION: The project showed that it is possible to implement death education on palliative care topics in undergraduate courses to increase motivation to work in this field.

PMID:37085886 | DOI:10.1186/s12904-023-01169-6

Trials. 2023 Apr 21;24(1):289. doi: 10.1186/s13063-023-07290-4.

ABSTRACT

Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we suggest improved solutions. Starting from a principled approach and building upon previous proposals, we offer concrete and easily understood displays, including related computer code. While leveraging modern tools, the most important is that these displays support the DMC’s workflow in answering the relevant questions of interest. We hope that the adoption of these proposals can ease the task of DMCs, and importantly, lead to better decision-making for the benefit of patients.

PMID:37085883 | DOI:10.1186/s13063-023-07290-4

Arch Public Health. 2023 Apr 21;81(1):63. doi: 10.1186/s13690-023-01092-5.

ABSTRACT

BACKGROUND: Under-five mortality remains a global public health concern, particularly in East African countries. Short birth interval is highly associated with under-five mortality, and birth spacing has a significant effect on a child’s likelihood of survival. The association between short birth intervals and under-five mortality was demonstrated by numerous observational studies. However, the effect of short birth intervals on under-five mortality has not been investigated yet. Therefore, this study aimed to investigate the impact of short birth intervals on under-five mortality in East Africa using Propensity Matched Analysis.

METHODS: A secondary data analysis was conducted based on the most recent Demographic and Health Survey (DHS) data of 12 East African countries. A total weighted sample of 105,662 live births was considered for this study. A PSM analysis was carried out to evaluate the effect of short birth intervals on under-five mortality. Under-five mortality was the outcome variable, while the short birth interval was considered a treatment variable. To determine the Average Treatment Effect on the population (ATE), Average Treatment Effect on the treated (ATT), and Average Treatment Effect on the untreated (ATU), we performed PSM analysis with a logit-based model using the psmatch2 ate STATA function. The quality of matching was assessed statistically and graphically. The common support assumption was checked and fulfilled. We have employed Mantel-Haenszel bounds to examine whether the result would be free from hidden bias or not.

RESULTS: The prevalence of short birth intervals in East Africa was 44%. The under-five mortality rate among mothers who had optimal birth intervals was 39.9 (95% CI: 38.3, 41.5) per 1000 live births while it was 60.6 (95% CI: 58.5, 62.8) per 1000 live births among mothers who had a short birth intervals. Propensity score matching split births from mothers into treatment and control groups based on the preceding birth interval. In the PSM analysis, the ATT values in the treated and control groups were 6.09% and 3.97%, respectively, showed under-five mortality among births to mothers with short birth intervals was 2.17% higher than births to mothers who had an optimal birth interval. The ATU values in the intervention and control groups were 3.90% and 6.06%, respectively, indicating that for births from women who had an optimal birth interval, the chance of dying within five years would increase by 2.17% if they were born to mother with short birth interval. The final ATE estimate was 2.14% among the population. After matching, there was no significant difference in baseline characteristics between the treated and control groups (p-value > 0.05), which indicates the quality of matching was good.

CONCLUSIONS: We conclude that enhancing mothers to have optimal birth spacing is likely to be an effective approach to reducing the incidence of under-five mortality. Our findings suggest that births to mothers with short birth intervals have an increased risk of death in the first five years of life than births to mothers who had an optimal birth interval. Therefore, public health programs should enhance interventions targeting improving birth spacing to reduce the incidence of under-five mortality in low-and middle-income countries like East African countries. Moreover, to achieve a significant reduction in the under-five mortality rate, interventions that encourage birth spacing should be considered. This will improve child survival and help in attaining Sustainable Development Goal targets in East African countries.

PMID:37085879 | DOI:10.1186/s13690-023-01092-5

Biomed Eng Online. 2023 Apr 21;22(1):37. doi: 10.1186/s12938-023-01098-8.

ABSTRACT

BACKGROUND: Although titanium plates/screws are effective fixation methods (FM) after L-shaped osteotomy reduction malarplasty (LORM), the ideal FM remains controversial. This first finite element analysis (FEA) aimed to study the effect of various zygomatic body/zygomatic arch FM combinations and their placement vectors on the zygoma complex stability after virtual LORM under the effect of both average (150 N/mm²) and maximum (750 N/mm²) forces and three-dimensional (3D) mapping of stress and strain parameters distribution over the zygomatic bone, fixation methods, and total model.

RESULTS: The fixation methods about the short-arm of the L-shaped osteotomy showed lower stress, strain, and displacement values than those across the long-arm osteotomy site. Combined with any zygomatic arch fixation methods (ZAFm), the two bicortical screws group (2LS) on the zygomatic body osteotomy site resulted in smaller displacements and the lowest zygoma bone stress and displacement when combined with Mortice-Tenon structure (MT) as zygomatic arch fixation method. Applied forces caused statistically significant differences in zygomatic bone stress (P < 0.001 and P = 0.001) and displacement (P = 0.001 and P = 0.002).

CONCLUSION: All FMs both on the zygomatic body and zygomatic arch provide adequate zygomatic complex stability after LORM. The 2LS group showed better resistance than rectangular plate (RP) and square plate (SP) with lower stress concentrations. The L-shaped plate with short-wing on the maxilla (LPwM) is more stable than having the short-wing on the zygoma bone (LPwZ). Future prospective clinical studies are required to validate the current findings.

PMID:37085878 | DOI:10.1186/s12938-023-01098-8

Trials. 2023 Apr 21;24(1):288. doi: 10.1186/s13063-023-07313-0.

ABSTRACT

BACKGROUND: Over the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and implementation studies have natural areas of overlap, particularly relating to the goal of using clinical trial data to leverage health care system policy changes. Few investigations have addressed pragmatic and implementation science randomized trial methods development while also considering policy impact.

METHODS: The investigation used the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) and PRECIS-2-Provider Strategies (PRECIS-2-PS) tools to evaluate the design of two multisite randomized clinical trials that targeted patient-level effectiveness outcomes, provider-level practice changes and health care system policy. Seven raters received PRECIS-2 training and applied the tools in the coding of the two trials. Descriptive statistics were produced for both trials, and PRECIS-2 wheel diagrams were constructed. Interrater agreement was assessed with the Intraclass Correlation (ICC) and Kappa statistics. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach was applied to understanding integrative themes derived from the PRECIS-2 ratings and an end-of-study policy summit.

RESULTS: The ICCs for the composite ratings across the patient and provider-focused PRECIS-2 domains ranged from 0.77 to 0.87, and the Kappa values ranged from 0.25 to 0.37, reflecting overall fair-to-good interrater agreement for both trials. All four PRECIS-2 wheels were rated more pragmatic than explanatory, with composite mean and median scores ≥ 4. Across trials, the primary intent-to-treat analysis domain was consistently rated most pragmatic (mean = 5.0, SD = 0), while the follow-up/data collection domain was rated most explanatory (mean range = 3.14-3.43, SD range = 0.49-0.69). RAPICE field notes identified themes related to potential PRECIS-2 training improvements, as well as policy themes related to using trial data to inform US trauma care system practice change; the policy themes were not captured by the PRECIS-2 ratings.

CONCLUSIONS: The investigation documents that the PRECIS-2 and PRECIS-2-PS can be simultaneously used to feasibly and reliably characterize clinical trials with patient and provider-level targets. The integration of pragmatic and implementation science clinical trial research methods can be furthered by using common metrics such as the PRECIS-2 and PRECIS-2-PS. Future study could focus on clinical trial policy research methods development.

TRIAL REGISTRATION: DO-SBIS ClinicalTrials.gov NCT00607620. registered on January 29, 2008. TSOS ClinicalTrials.gov NCT02655354, registered on July 27, 2015.

PMID:37085877 | DOI:10.1186/s13063-023-07313-0

Int J Biostat. 2023 Apr 24. doi: 10.1515/ijb-2022-0106. Online ahead of print.

ABSTRACT

Mediation analysis studies situations where an exposure may affect an outcome both directly and indirectly through intervening variables called mediators. It is frequently of interest to test for the effect of the exposure on the outcome, and the standard approach is simply to regress the latter on the former. However, it seems plausible that a more powerful test statistic could be achieved by also incorporating the mediators. This would be useful in cases where the exposure effect size might be small, which for example is common in genomics applications. Previous work has shown that this is indeed possible under complete mediation, where there is no direct effect. In most applications, however, the direct effect is likely nonzero. In this paper we study linear mediation models and find that under certain conditions, power gain is still possible under this incomplete mediation setting for testing the null hypothesis that there is neither a direct nor an indirect effect. We study a class of procedures that can achieve this performance and develop their application to both low- and high-dimensional mediators. We then illustrate their performances in simulations as well as in an analysis using DNA methylation mediators to study the effect of cigarette smoking on gene expression.

PMID:37084462 | DOI:10.1515/ijb-2022-0106

Pediatr Emerg Care. 2023 Apr 24. doi: 10.1097/PEC.0000000000002948. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the trend in incidence of pediatric magnet ingestions at 2 large Canadian tertiary pediatric hospitals after reintroduction of magnets to the US marketplace and to evaluate morbidity and mortality related to these ingestions.

METHODS: This was a retrospective study performed in 2 tertiary care pediatric hospitals between 2004 and 2019. We reviewed the charts of all children who presented with a foreign body ingestion and included those with reported magnet ingestion. We characterized all events and compared the incidence rate before and after the US ban was overturned in 2016. Descriptive statistics were used to summarize our results. Incidence rate ratio was calculated using the total number of magnet ingestion cases and total emergency department visits normalized to 100,000 emergency department visits/year.

RESULTS: We screened a total of 6586 ingestions and identified 192 patients with magnet ingestions. The period after the mandatory recall was compared with the period after the US ban revocation yielding an incidence rate ratio of 0.76 for all magnet ingestions (P = 0.15) and 0.73 (P = 0.34) for multiple magnet ingestions. There was, however, a graphical upward trend that immediately followed the US ban revocation. Sixty-nine patients (36%) were admitted to the hospital and 45 (23%) required a procedure to remove the magnet ingested. No deaths occurred.

CONCLUSIONS: Our findings suggest that the overturning of the US ban did not lead to a significant increase in the incidence of rare earth magnet ingestion in 2 large tertiary pediatric hospitals in Canada despite noting a trend upwards.

PMID:37083691 | DOI:10.1097/PEC.0000000000002948

J Clin Psychopharmacol. 2023 Apr 22. doi: 10.1097/JCP.0000000000001679. Online ahead of print.

ABSTRACT

BACKGROUND: Depressive symptoms are frequent in schizophrenia and associated with a poorer outcome. Currently, the optimal treatment for depressive symptoms in schizophrenia remains undetermined. Amisulpride, aripiprazole, and olanzapine all have antidepressive pharmacodynamic properties, ranging from serotonergic affinities to limbic dopaminergic selectivity. Consequently, in a 12-month pragmatic, randomized clinical trial, we aimed to investigate differences in antidepressive effectiveness among amisulpride, aripiprazole, and olanzapine as a secondary outcome, measured by change in the Calgary Depression Scale for Schizophrenia sum score in patients within the schizophrenia spectrum.

METHODS: Psychotic patients within the schizophrenia spectrum were included, and effectiveness was analyzed with latent growth curve modeling.

RESULTS: Of the 144 patients, 51 (35%) were women, the mean age was 31.7 (SD 12.7), and 39% were antipsychotic naive. At inclusion, 68 (47%) participants had a Calgary Depression Scale for Schizophrenia sum score >6, indicating severe depressive symptoms. Across the 12-month follow-up, there was a depressive symptom reduction in all medication groups, but no statistically significant differences between the study drugs. Separate analyses of the subcohort with elevated depressive symptoms at inclusion also failed to find differences in depressive symptom reduction between study drugs. The reduction in depressive symptoms mainly occurred within 6 weeks after randomization.

CONCLUSIONS: There was a reduction in depressive symptoms under treatment with amisulpride, aripiprazole, and olanzapine in acutely psychotic patients with schizophrenia spectrum disorder, but no differences between the drugs.

PMID:37083542 | DOI:10.1097/JCP.0000000000001679

J Pediatr Gastroenterol Nutr. 2023 Apr 21. doi: 10.1097/MPG.0000000000003796. Online ahead of print.

ABSTRACT

OBJECTIVES: Nonalcoholic fatty liver disease is the most common chronic liver disease in children. Elafibranor, a dual peroxisome proliferator-activated receptor α/δ agonist, has been proposed as a treatment for NASH. The aims were to: 1. describe pharmacokinetics, safety, and tolerability of oral elafibranor at 2 doses (80 and 120mg) in children 8-17 years and 2. assess changes in aminotransferases.

METHODS: Children with NASH were randomized to open-label elafibranor 80mg or 120mg daily for 12 weeks. The intent-to-treat analysis included all participants who received at least one dose. Standard descriptive statistics and PK analyses were performed.

RESULTS: Ten males (mean 15.1yrs, SD 2.2) with NASH were randomized to 80mg (n=5) or 120mg (n=5). Baseline mean ALT was 82 U/L (SD 13) and 87 U/L (SD 20) for 80mg and 120mg groups, respectively. Elafibranor was rapidly absorbed and well tolerated. Elafibranor plasma exposure increased between the 80mg and 120mg dose with a 1.9- and 1.3-fold increase in median Cmax and AUC0-24, respectively. End of treatment mean ALT was 52 U/L (SD 20) for the 120mg group, with a relative mean ALT change from baseline of -37.4% (SD 23.8%) at 12 weeks.

CONCLUSIONS: Once daily dosing of elafibranor was well tolerated in children with NASH. There was a 37.4% relative reduction from mean baseline ALT in the 120mg group. Decreasing ALT may be associated with improvement in liver histology, thus could be considered a surrogate for histology in early phase trials. These results may support further exploration of elafibranor in children with NASH.

PMID:37084342 | DOI:10.1097/MPG.0000000000003796

JCO Oncol Pract. 2023 Apr 21:OP2200761. doi: 10.1200/OP.22.00761. Online ahead of print.

ABSTRACT

PURPOSE: Patients with cancer are often hospitalized with complications from cancer and cancer treatment. Many experience a decline in physical functioning, including loss of mobility, which likely contributes to increased length of stay (LOS) and increased readmissions. We aimed to determine whether a mobility program would improve quality of care and decrease health care utilization.

METHODS: We implemented a mobility aide program on an oncology unit in a large academic medical center for all patients without bedrest orders between October 1, 2018, and February 28, 2021. The program consisted of nursing evaluation using the Activity Measure for Post-Acute Care (AMPAC), an ordinal scale ranging from bed rest to ambulating ≥ 250 feet, to quantify mobility. Plan of care was determined in a multidisciplinary manner with physical therapy (PT), nursing, and a mobility aide, who is a medical assistant with enhanced rehabilitation training. Patients were then mobilized two times per day 7 days a week. Using descriptive statistics and mixed effects logistic regression, we evaluated the programs impact on LOS, readmissions, and changes in mobility during this time period compared with the 6-month interval before implementation.

RESULTS: A total of 1,496 hospitalized patients were identified. The odds of hospital readmission within 30 days of discharge was significantly less for those who received the intervention (OR, 0.53; 95% CI, 0.37 to 0.78; P = .001). The odds ratio (OR) of having a final AMPAC score at or above the median was significantly higher for those who received the intervention (OR, 1.60; 95% CI, 1.04 to 2.45; P < .05). There was no significant difference in LOS.

CONCLUSION: Use of this mobility program resulted in a significant decrease in readmissions and maintained or improved patients’ mobility. This demonstrates that non-PT professionals can effectively mobilize hospitalized patients with cancer, thereby decreasing the burden on PT and nursing resources. Future work will evaluate the sustainability of the program and evaluate association with health care costs.

PMID:37084332 | DOI:10.1200/OP.22.00761