Categories
Nevin Manimala Statistics

Comparative statistical analysis of the release kinetics models for nanoprecipitated drug delivery systems based on poly(lactic-co-glycolic acid)

PLoS One. 2022 Mar 10;17(3):e0264825. doi: 10.1371/journal.pone.0264825. eCollection 2022.

ABSTRACT

Poly(lactic-co-glycolic acid) is one of the most used polymers for drug delivery systems (DDSs). It shows excellent biocompatibility, biodegradability, and allows spatio-temporal control of the release of a drug by altering its chemistry. In spite of this, few formulations have reached the market. To characterize and optimize the drug release process, mathematical models offer a good alternative as they allow interpreting and predicting experimental findings, saving time and money. However, there is no general model that describes all types of drug release of polymeric DDSs. This study aims to perform a statistical comparison of several mathematical models commonly used in order to find which of them best describes the drug release profile from PLGA particles synthesized by nanoprecipitation method. For this purpose, 40 datasets extracted from scientific articles published since 2016 were collected. Each set was fitted by the models: order zero to fifth order polynomials, Korsmeyer-Peppas, Weibull and Hyperbolic Tangent Function. Some data sets had few observations that do not allow to apply statistic test, thus bootstrap resampling technique was performed. Statistic evidence showed that Hyperbolic Tangent Function model is the one that best fit most of the data.

PMID:35271644 | DOI:10.1371/journal.pone.0264825

Categories
Nevin Manimala Statistics

Introduction to the PLOS ONE collection on ‘Understanding and preventing suicide: Towards novel and inclusive approaches’

PLoS One. 2022 Mar 10;17(3):e0264984. doi: 10.1371/journal.pone.0264984. eCollection 2022.

ABSTRACT

More than 700,000 people lose their lives to suicide each year and evidence suggests that the current COVID-19 pandemic is leading to increases in risk factors for suicide and suicide-related behaviour, in particular among young people. It is widely documented that some sectors of the population are over-represented in the suicide statistics. It is also well established that the pathways that lead someone to a suicidal crisis are complex and differ across regions and sectors of the population; as such a multi-faceted approach to prevention is required. Many of us would also argue that novel approaches, that combine broad population-based strategies with individual interventions, and approaches that capitalise on new technologies and methodologies are also required. For these reasons, when bringing together this collection, we deliberately sought studies that focused upon those groups who are over-represented in the suicide statistics yet under-represented in research. We also called for studies that reported on novel approaches to suicide prevention and for studies that reflected the voices of people with lived experience of suicide, also often unheard in research efforts.

PMID:35271638 | DOI:10.1371/journal.pone.0264984

Categories
Nevin Manimala Statistics

The impact of COVID-19 induced emergency remote instruction on students’ academic performance at an HBCU

PLoS One. 2022 Mar 10;17(3):e0264947. doi: 10.1371/journal.pone.0264947. eCollection 2022.

ABSTRACT

The outbreak of the COVID-19 pandemic early in 2020 forced universities to shut down their campuses and transition to emergency remote instruction (ERI). Students had to quickly adapt to this new mode of instruction while dealing with all other distractions caused by the pandemic. This study integrates extensive data from students’ institutional records at a large Historically Black College and University (HBCU) institution with data from a students’ survey about the impact of COVID-19 on learning during the Spring 2020 semester to examine the impact of the transition to ERI on students’ performance and identify the main factors explaining variations in students’ performance. The main findings of our analysis are: (a) students’ university experience was positively correlated with performance (continuing students who spent at least one academic year at the university prior to the outbreak had better performance than freshman and new transfer students), (b) students’ perceived change in performance after the transition was positively associated with actual performance (students who perceived a decline in their performance after transition to ERI had significantly worse performance than other students), and (c) students’ prior online learning experiences and students’ emotional experiences with the COVID-19 disease were not significantly associated with performance. These results suggest that the approaches adopted by higher education institutions to support students during times of crisis should pay special attention to certain groups of students.

PMID:35271626 | DOI:10.1371/journal.pone.0264947

Categories
Nevin Manimala Statistics

Development of a predictive model for vitamin D deficiency based on the vitamin D status in young Japanese women: A study protocol

PLoS One. 2022 Mar 10;17(3):e0264943. doi: 10.1371/journal.pone.0264943. eCollection 2022.

ABSTRACT

BACKGROUND: Vitamin D deficiency (VDD) is associated with an increased risk for lifestyle-related diseases. In Japan, VDD is quite prevalent in all age groups, with its high risk in young women. Furthermore, its association during pregnancy with gestational hypertension and low birth weight has also been reported. VDD can be diagnosed by serum 25-hydroxyvitamin D [25(OH)D] levels, which, however, is not suited for screening. Therefore, we will create a predictive model for serum 25(OH)D concentration and prevalence of VDD based on such data as region, sun exposure habit, and vitamin D intake in young women.

METHODS: From 2020 to 2022, we conduct a cross-sectional study of 600 young women in four regions of Japan, identify the indices associated with serum 25(OH)D concentrations such as sun exposure habits, habitual vitamin D intake, ultraviolet-B irradiation, seasons (summer and winter) and latitude, and construct prediction models for serum 25(OH)D concentrations and VDD risk. This study has been registered with UMIN-CTR (ID: UMIN000041527).

RESULTS: One hundred and fifteen subjects have been collected from 6 institutions in winter as of May 2021. When data from more than 200 subjects have become available, we will conduct the interim analysis, summarize the data by region and facility, review the inclusion criteria for analysis, and check for missing values and outliers. Prediction models for serum 25(OH)D concentration and VDD will be determined in the final analysis when all cases have been collected.

CONCLUSIONS: A screening tool for VDD risk to be developed in our study based on the predictive model would help the public and medical professionals prevent lifestyle-related diseases through improving VDD. Additionally, the results may serve as the scientific basis for determining the appropriate vitamin D intake and sun exposure standards.

PMID:35271624 | DOI:10.1371/journal.pone.0264943

Categories
Nevin Manimala Statistics

Clinical efficacy of the socket shield technique used in the aesthetic zone: A systematic review and meta-analysis

Int J Oral Implantol (Berl). 2022 Mar 10;15(1):45-55.

ABSTRACT

PURPOSE: To systematically review and analyse the efficacy of the socket shield technique in conjunction with immediate implant placement in the aesthetic zone in randomised controlled trials.

MATERIALS AND METHODS: The PubMed, Web of Science, Embase and Cochrane databases were searched from 1 January 2010 to 31 December 2020. All randomised controlled trials reporting on immediate implantation with the socket shield technique in the aesthetic zone, with at least 15 patients and a 6-month follow-up, were included and analysed. A meta-analysis was then performed using both fixed and random effects models to evaluate the differences in buccal plate height, buccal plate width and pink aesthetic score between immediate implant placement with the socket shield technique and the conventional immediate implant placement technique.

RESULTS: Four randomised controlled trials were included and underwent quantitative analysis in the present systematic review and meta-analysis. When compared with the conventional immediate implantation group, the buccal plate height and buccal plate width for the socket shield technique group were statistically significant, with an overall increase of 0.57 mm (95% confidence interval -0.73 to -0.40) and 0.21 mm (95% confidence interval -0.26 to -0.16), respectively, at 6 months. Moreover, the pink aesthetic score for the socket shield technique group improved significantly by 1.59 points (95% confidence interval 0.05 to 3.15) at 6 months, and also demonstrated a statistically significant increase of 1.39 points (95% confidence interval 0.32 to 2.46) compared to the control group at the medium-term follow-up (12 to 36 months).

CONCLUSIONS: The present findings suggest that the socket shield technique has the potential to maintain buccal tissue contours and peri-implant tissue stability, improving functional and aesthetic outcomes in the aesthetic zone compared with the conventional immediate implant placement technique.

PMID:35266668

Categories
Nevin Manimala Statistics

Post-traumatic stress disorder, depression and anxiety symptoms in COVID-19 outpatients with different levels of respiratory and ventilatory support in the acute phase undergoing three months follow up

Minerva Med. 2022 Mar 10. doi: 10.23736/S0026-4806.22.07847-8. Online ahead of print.

ABSTRACT

BACKGROUND: The well-known COVID-19 pandemic totally transformed people’s lives, paving the way to various psychopathological symptoms. In particular, patients may experience a short- and long-term decreasing in their wellbeing. In this vein, the aim of this paper is to assess the COVID-19 patients’ psychopathological profile (Post Traumatic Stress Disorder, distress, anxiety and depression symptoms), detecting possible differences linked to the ventilatory treatments.

METHODS: Outpatients who recovered from COVID-19 were asked to provide socio-demographic and clinical information, and to complete a brief psychological screening evaluation (Impact of Event Scale-Revised – IES-R, Depression Anxiety Stress Scale – DASS-21).

RESULTS: Overall, after informed consent, 163 Italian patients took part in this research. Of them, 31,9% did not undergo any ventilatory therapy, 27,6% undertook oxygen therapy; 28,2% underwent noninvasive mechanical ventilation and 12.3% received invasive mechanical ventilation. Although no statistically significant differences were revealed among patients stratified by spontaneous breathing or ventilatory therapies, they reported statistically significant more depression (4.5+5.2 vs 3.5+3.2; p=.017) and anxiety (4.3+4.5 vs 2.4+2.6; p<.00001) symptoms than normative groups. Moreover, patients experiencing COVID-19 disease as a trauma, complained statistically significant higher levels of depression, anxiety and stress symptoms than who did not describe a clinically relevant traumatic experience (p<0.001).

CONCLUSIONS: Thus, this study suggests to healthcare professionals to consider COVID-19 experience as a potential real trauma for patients and underlines the necessity to define patients’ psychopathological profile in order to propose tailored and effective preventive and supportive psychological interventions.

PMID:35266658 | DOI:10.23736/S0026-4806.22.07847-8

Categories
Nevin Manimala Statistics

Nurses’ authentic leadership and their perceptions of safety climate: differences across areas of work and hospitals

Leadersh Health Serv (Bradf Engl). 2022 Mar 14;ahead-of-print(ahead-of-print). doi: 10.1108/LHS-05-2021-0040.

ABSTRACT

PURPOSE: This study aims to compare nurses’ authentic leadership and perceptions of the safety climate and concepts association according to different areas of work and types of hospitals.

DESIGN/METHODOLOGY/APPROACH: A cross-sectional design was used to conduct this comparative study on 314 Jordanian nurses. The Authentic Leadership Questionnaire (ALQ) and the Safety Climate Survey (SCS) were used.

FINDINGS: Nurses in private hospitals were more educated. True leadership was mild. Unit nurses had higher ALQ and subscale mean scores. Armed forces hospitals had the highest ALQ subscales, while governmental hospitals had the lowest. The ALQ mean scores favored military hospitals. Governmental hospitals have a negative safety climate. Unit nurses had a higher SCS mean than ward nurses. Military, governmental and private hospitals are rated the safest. Nurses benefited from higher SCS scores in military hospitals. Nurses’ ALQ and safety climate perceptions were moderately positive.

RESEARCH LIMITATIONS/IMPLICATIONS: A larger, randomized and equal-sized sample is recommended in future studies to conclude different areas of work and hospitals. It is also recommended to report the confidence interval in further studies using different statistical methods, increasing confidence when interpreting statistical significance variables. Other mediating, moderating and predicting variables could be studied and compared across different areas of work and types of hospitals. Sample characteristics should be handled as confounding variables in the next planned study using various ways to control confounding variables such as randomization, restriction, matching, regression and statistical control. The authors plan to statistically control for the confounding variables by entering them into the regression model. Future studies could investigate safety culture; both safety culture and safety climate are formative and inclusive terms (Experts Insight, 2017).

PRACTICAL IMPLICATIONS: This paper fills in the gap in the literature and practice. Authentic leadership is associated with safety climate perceptions and varies across different areas of work and hospitals. Interventions are required to improve safety climate perceptions and promote authentic leadership in all settings and hospitals. Military hospitals ranked the highest in nurses’ perceptions of authentic leadership and safety climate.

SOCIAL IMPLICATIONS: The current study’s favorable association between authentic leadership and safety climate measurement would apply to many high-risk institutions, including public and private hospitals. It becomes necessary to include the impacts of authentic leadership on the safe climate within the nursing curriculum and continuing education courses. This may be put into action by executing a hands-on activity, followed by information and reflection conversations that highlight the link between authentic leadership and safety climate measurement. According to the findings of this study, authentic leadership appears to be a basic block in making a difference in nurses’ views of safety climate.

ORIGINALITY/VALUE: Authentic leadership style is a relatively new concept in the health-care sector, and its link to safety climate security still needs empirical evidence. It is still unclear how leadership resulted in more effective outcomes (Maziero et al., 2020). Few studies investigated both the concepts of authentic leadership and the nursing safety climate (Dirik and Intepeler, 2017; Lee et al., 2019a; Woo and Han, 2018). Aside from the scarcity of studies, no study has compared “working area,” “department” or “hospital type” concepts. Few comparative studies have been conducted using concepts of interest. For example, authentic leadership was linked to empowerment and burnout (Laschinger et al., 2013) and nurses’ satisfaction with safety climates (Vatani et al., 2021). No research has examined authentic leadership in Jordan’s nursing and health-care context. Few studies focused on the safety climate other than authentic leadership (Abualrub et al., 2012) or the safety culture in Jordan rather than the safety climate (Khater et al., 2015).

PMID:35266654 | DOI:10.1108/LHS-05-2021-0040

Categories
Nevin Manimala Statistics

A fast, fully validated GC-MS method using a simplified pretreatment for the quantification of short and branched chain fatty acids in human stool

J Mass Spectrom. 2022 Apr;57(4):e4817. doi: 10.1002/jms.4817.

ABSTRACT

The study of short (SCFAs) and branched chain fatty acids (BCFAs) in human stool related to gastrointestinal diseases, gut microbiota, metabolism, and diet has dramatically increased. As a result, a fast, reliable method with minimal pretreatment is needed for quantification of these metabolites (acetic, propionic, isobutyric, butyric, isovaleric, valeric, and caproic acid) in stool. Therefore, a GC-MS method meeting this criterion was developed. A bias sampling study showed no statistical difference (p > 0.05) in analyte means when comparing 100 mg subsamples of homogenized to non-homogenized samples (n = 6, p values 0.153-0.910). Stool samples were homogenized, diluted with 80:20 water:methanol (v/v), and adjusted to a pH of 1.5-2.5. Samples were vortexed, centrifuged, and directly injected into the GC-MS using pulsed splitless injection offering twofold-to-threefold signal enhancement over a 10:1 split injection. DB-FATWAX Ultra Inert Polyethylene Glycol (PEG) Column showed no peak tailing, reduced responses, or retention time shifts after 1,476 stool injections, while other columns failed before 361 injections. Intra- and inter-day accuracy for stool supernatant samples ranged from -10.21% to 8.88% and -13.25% to 9.91%, while intra- and inter-day precision ranged from 0.21% to 1.21% and 0.89% to 2.84% coefficient of variation (CV), respectively. This method demonstrates excellent linearity (0.9999-1.0000) and low limits of quantification (1.50-8.01 μM). Stool samples proved stable stored at -20°C up to 28 days, and recoveries ranged from 85.04% to 106.59%. Matrix effects in stool are non-significant determined by comparing standard and stool supernatant calibration curve slopes (p > 0.05).

PMID:35266592 | DOI:10.1002/jms.4817

Categories
Nevin Manimala Statistics

Concurrent large spontaneous portosystemic shunt embolization for the prevention of overt hepatic encephalopathy after transjugular intrahepatic portosystemic shunt: A randomized controlled trial

Hepatology. 2022 Mar 10. doi: 10.1002/hep.32453. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Large spontaneous portosystemic shunt (SPSS) is associated with increased risk of hepatic encephalopathy (HE) in patients undergoing transjugular intrahepatic portosystemic shunt (TIPS). This study aimed to evaluate whether prophylactic embolization of large SPSS at the time TIPS creation could reduce the incidence of post-TIPS HE in patients with cirrhosis and variceal bleeding.

METHOD: From June 2014 to August 2017, 56 patients with cirrhosis and large SPSS planning to undergo TIPS for the prevention of variceal bleeding were randomly assigned (1:1) to receive TIPS alone (TIPS group, n=29) or TIPS plus simultaneous SPSS embolization (TIPS+E group, n=27). The primary endpoint was overt HE.

RESULTS: TIPS placement and SPSS embolization was successful in all patients. During a median follow-up of 24 months, the primary endpoint was met in 15 patients (51.7%) in the TIPS group and 6 patients (22.2%) in the TIPS+E group (p=0.045). The 2-year cumulative incidence of overt HE was significantly lower in the TIPS+E group compared with TIPS group (21.2% vs 48.3%; HR: 0.38, 95%CI, 0.15-0.97; p=0.043). The 2-year incidence of recurrent bleeding (TIPS+E vs TIPS: 15.4% vs 25.1%, p=0.522), shunt dysfunction (12.3% vs 18.6%, p=0.593), death (15.0% vs 6.9%, p=0.352) and other adverse events was not significantly different between the two groups.

CONCLUSION: In patients with cirrhosis treated with TIPS for variceal bleeding, concurrent large SPSS embolization reduced the risk for overt HE without increasing other complications. Concurrent large SPSS embolization should therefore be considered for prophylaxis of post-TIPS HE.

PMID:35266571 | DOI:10.1002/hep.32453

Categories
Nevin Manimala Statistics

Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): a pilot randomized trial

Acad Emerg Med. 2022 Mar 10. doi: 10.1111/acem.14481. Online ahead of print.

ABSTRACT

BACKGROUND: The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.

METHODS: Severely injured children (0 up to 18th birthday) were randomized into a double-blind randomized trial of 1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/hr infusion over 8 hours, 2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/hr infusion over 8 hours, or 3) normal saline placebo bolus and infusion. The trial was conducted at 4 pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month.

RESULTS: A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified.

CONCLUSION: Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.

PMID:35266589 | DOI:10.1111/acem.14481