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Nevin Manimala Statistics

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: A randomized, double-blind, placebo-controlled study

PLoS One. 2023 Jan 18;18(1):e0279204. doi: 10.1371/journal.pone.0279204. eCollection 2023.

ABSTRACT

BACKGROUND: Previous clinical and in vitro investigations have supported the efficacy of a glycerol throat spray containing cold-adapted cod trypsin (ColdZyme) against respiratory viruses causing the common cold bycreating a protective mucosal barrier shown to deactivate common cold virus in vitro and decrease pharyngeal rhinovirus load.

METHODS AND FINDINGS: This was a double-blind, randomized, parallel-group, placebo-controlled study conducted at 10 German sites to evaluate the efficacy of the medical device ColdZyme, a glycerol mouth spray containing cold-adapted cod trypsin for a naturally occurring common cold versus placebo spray. Adults experiencing a minimum of three common colds during the previous year, but otherwise healthy, were enrolled to begin treatment with the mouth spray or placebo six times daily at first sign of a common cold. Jackson’s symptom scale and the 9-item Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) quality of life (QoL) domain and a sore throat scale were recorded daily by subjects, as well as any use of allowed rescue treatment. Between January and April 2019, 701 subjects were enrolled and randomly assigned to the ColdZyme group (n = 351) or the placebo group (n = 350). Of the 701 subjects, 438 (62.5%) subjects developed symptoms typical of common cold, and all 438 started study treatment (n = 220 in the ColdZyme group and n = 218 in the placebo group). The demographic profile of the treatment groups were comparable with 68.1% female and almost all subjects being Caucasian (98.4%). The age ranged between 18 and 70 years with a mean age of 41.3 (±14.4) years. There were no differences between the groups in primary and major secondary endpoints, however, the assessment using the WURSS-21 QoL domain and Jackson score suggests a slightly faster recovery with ColdZyme as symptoms and complaints affecting the quality of life were shortened by about 1 day. The beneficial effect of ColdZyme was particularly noticeable on the fifth day of the common cold. A positive difference between treatment groups was also seen for the subjects’ assessments of global efficacy of the investigational product A robust safety profile for ColdZyme was demonstrated throughout the study.

CONCLUSION: The safety and tolerability of ColdZyme have been confirmed in a large study population and further establishes evidence of a faster recovery from common cold symptoms. Early self-diagnosis and early use of ColdZyme mouth spray is a safe alternative for treatment of naturally occurring colds.

PMID:36652464 | DOI:10.1371/journal.pone.0279204

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Nevin Manimala Statistics

Generalized Marshall-Olkin exponentiated exponential distribution: Properties and applications

PLoS One. 2023 Jan 18;18(1):e0280349. doi: 10.1371/journal.pone.0280349. eCollection 2023.

ABSTRACT

In this study, we propose a generalized Marshall-Olkin exponentiated exponential distribution as a submodel of the family of generalized Marshall-Olkin distribution. Some statistical properties of the proposed distribution are examined such as moments, the moment-generating function, incomplete moment, and Lorenz and Bonferroni curves. We give five estimators for the unknown parameters of the proposed distribution based on maximum likelihood, least squares, weighted least squares, and the Anderson-Darling and Cramer-von Mises methods of estimation. To investigate the finite sample properties of the estimators, a comprehensive Monte Carlo simulation study is conducted for the models with three sets of randomly selected parameter values. Finally, four different real data applications are presented to demonstrate the usefulness of the proposed distribution in real life.

PMID:36652462 | DOI:10.1371/journal.pone.0280349

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Nevin Manimala Statistics

SMARTer Goalsetting: A Pilot Innovation for Coaches During the Transition to Residency?

Acad Med. 2023 Jan 16. doi: 10.1097/ACM.0000000000005153. Online ahead of print.

ABSTRACT

PROBLEM: Ability to set goals and work with coaches can support individualized, self-directed learning. Understanding the focus and quality of graduating medical student and first-year resident goals and the influence of coaching on goal-setting can inform efforts to support learners through the transition from medical school to residency.

APPROACH: This observational study examined goal-setting among graduating medical students and first-year residents from April 2021-March 2022. The medical students set goals while participating in a Transition to Residency elective. The residents in internal medicine, obstetrics and gynecology, emergency medicine, orthopedics, and pathology set goals through meeting 1:1 with coaches. Raters assessed goals using a 3-point rubric on domains of specific, measurable, attainable, relevant, and timely (i.e., the SMART goal framework) and analyzed descriptive statistics, Mann-Whitney-U tests, and linear regressions.

OUTCOMES: Among 48 medical students, 30 (62.5%) set 108 goals for early residency. Among 134 residents, 62 (46.3%) entered goals. The residents met with coaches 2.8 times on average (range 0-8 meetings, median = 3). Goal quality was higher in residents than medical students (average score for S: 2.71 vs 2.06, P < .001; M: 2.38 vs 1.66, P < .001; A: 2.92 vs 2.64, P < .001; R: 2.94 vs 2.86, P = .002; T: 1.71 vs 1.31, P < .001). Linear regression showed the number of coaching meetings was associated with more specific and measurable goals (specific: F [1, 1.02] = 6.56, P = .01, R2 =.10; measurable: F [1, 1.49] = 4.74, P = .03, R2 =.07).

NEXT STEPS: Learners set realistic and attainable goals through the transition to residency, but the goals could be more specific, measurable, and timely. The residents set SMARTer goals, with coaching improving goal quality. Understanding how best to scaffold coaching and support goal-setting through this transition may improve trainees’ self-directed learning and well-being.

PMID:36652456 | DOI:10.1097/ACM.0000000000005153

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Nevin Manimala Statistics

An analysis of prehospital pediatric medication dosing errors after implementation of a state-wide EMS pediatric drug dosing reference

Prehosp Emerg Care. 2023 Jan 18:1-13. doi: 10.1080/10903127.2022.2162648. Online ahead of print.

ABSTRACT

BACKGROUND: Medication dosing errors are common in prehospital pediatric patients. Prior work has shown the overall medication error rate by emergency medical services (EMS) in Michigan was 34.7%. To reduce these errors, the state of Michigan implemented a pediatric dosing reference in 2014 listing medication doses and volume to be administered.

OBJECTIVE: To examine changes in pediatric dosing errors by EMS in Michigan after implementation of the pediatric dosing reference.

METHODS: We conducted a retrospective review of the Michigan Emergency Medical Services Information System (MIEMSIS) of children ≤ 12 years of age from June 2016-May 2017 treated by 16 EMS agencies. Agencies were a mix of public, private, third-service, and fire-based. A dosing error was defined as >20% deviation from the weight-appropriate dose listed on the pediatric dosing reference. Descriptive statistics with confidence intervals and standard deviations are reported.

RESULTS: During the study period, there were 9,247 pediatric encounters, of whom 727 (7.9%) received medications and are included in the study. There were 1078 medication administrations, with 380 dosing errors (35.2% [95% CI 25.3-48.4]). The highest error rates were for dextrose 50% (3/4 or 75% [95% CI 32.57-100.0]) and glucagon (3/4 or 75% [95% CI 32.57-100.0]). The next highest proportions of incorrect doses were opioids: intranasal fentanyl (11/16 or 68.8% [95% CI 46.04-91.46]) and intravenous fentanyl (89/130 or 68.5% [95% CI 60.47-76.45]). Morphine had a much lower error rate (24/51 or 47.1% [95% CI 33.36-60.76]). Midazolam had the third highest error rate, for intravenous (27/50 or 54.0% [95% CI (40.19-67.81]) and intramuscular (25/68 or 36.8% [95% CI 40.19-67.81]) routes. Epinephrine 1 mg/10 ml had an incorrect dosage rate of 35/119 (29.4% [95% CI 20.64-36.99]). Asthma medications had the lowest rate of incorrect dosing (albuterol sulfate 9/247 or 3.6% [95% CI 1.31-5.98]).

CONCLUSIONS: Medications administered to prehospital pediatric patients continue to demonstrate dosing errors despite pediatric dosing reference implementation. Although there have been improvements in error rates in asthma medications, the overall error rate has increased. Continued work to build patient safety strategies to reduce pediatric medication dosing errors by EMS is needed.

PMID:36652452 | DOI:10.1080/10903127.2022.2162648

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Nevin Manimala Statistics

Combination prevention package of interventions for reducing vulnerability to HIV among adolescent girls and young women in Nigeria: An action research

PLoS One. 2023 Jan 18;18(1):e0279077. doi: 10.1371/journal.pone.0279077. eCollection 2023.

ABSTRACT

BACKGROUND: Adolescent girls and young women (AGYW) in Nigeria are especially at risk of HIV in Nigeria. Their vulnerability to HIV is linked to multiple concurrent sexual relationships, transgenerational sex, and transactional sex, amongst other factors. These factors have sociocultural contexts that vary across a multi-cultural country like Nigeria. The aim of this study was to use an innovative collaborative approach to develop a minimum HIV prevention package for AGYW which is responsive to sociocultural settings and based on combination HIV prevention.

METHODS: We conducted action research to develop and implement actionable HIV prevention intervention models that address AGYW’s vulnerabilities to HIV in three Nigerian States and the Federal Capital Territory (FCT) Abuja. The action research adopted the breakthrough series (BTS) collaborative, which accelerates improvement through mutual learning. The BTS implementation involved rapid Plan-Do-Study-Act (PDSA) cycles: an iterative process to plan and implement a basket of interventions. Problems or problematic situations, termed change topics, for which interventions could be carried out were identified in each study location. Using participatory approaches during a series of meetings called learning sessions, specific and innovative interventions, termed change ideas, were developed. These learning sessions were conducted with young women groups and other stakeholders. The change ideas were tested, studied, adapted, adopted, or discarded at each participating site. Exposure to and uptake of the implemented interventions was assessed in the study areas using a household survey with 4308 respondents, 53 focus group discussions, and 40 one-on-one interviews in intervention and control study sites.

RESULTS: Five categories of interventions were collaboratively developed, namely: Parental communication; Peer to peer interventions; Facilitator-led interventions; Non-traditional outlets for condoms, and Social media-based interventions. A good reach of the interventions was demonstrated as 77.5% of respondents reported exposure to at least one type of intervention. Nearly half of the respondents reported being exposed to the parental communication interventions, while 45.1% reported being exposed to the youth facilitator-driven interventions. Social media interventions had the lowest penetration. Also, there was between 15 to 20 positive percentage point difference between intervention and control for the uptake of HIV testing, and between 5 to 9 positive percentage point difference for uptake of male condoms. These differences were statistically significant at p<0.001.

CONCLUSIONS: Interventions developed through participatory approaches with young people and well-tailored to local realities can improve the acceptability and accessibility of programs that are able to reduce the risk of HIV infection among AGYW.

PMID:36652442 | DOI:10.1371/journal.pone.0279077

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Nevin Manimala Statistics

Effects of aromatherapy with Rosa damascene and lavender on pain and anxiety of burn patients: A systematic review and meta-analysis

Int Wound J. 2023 Jan 18. doi: 10.1111/iwj.14093. Online ahead of print.

ABSTRACT

Pain and anxiety were considered the most common complications of treatment procedures in burn patients. Non-pharmacological drugs, including aromatherapy, can decrease these issues. This systematic review and meta-analysis aim to summarise the effects of aromatherapy with Rosa damascene (RD) and lavender on the pain and anxiety of burn patients. A systematic search was performed on international electronic databases such as Scopus, PubMed, and Web of Science, as well as on Iranian electronic databases such as Iranmedex and Scientific Information Database (SID) with keywords extracted from Medical Subject Headings such as “Burns”, “Pain”, “Pain management”, “Anxiety”, and “Aromatherapy” were performed from the earliest to November 1, 2022. The Joanna Briggs Institute (JBI) critical appraisal checklist assessed the quality of randomised control trials (RCTs) and quasi-experimental studies. STATA v.14 software was used to estimate pooled effect size. Heterogeneity was assessed with I2 value. Random effect model and inverse-variance method using sample size, mean, and standard deviation changes were applied to determine standard mean differences (SMD). The confidence interval of 95% was considered to determine the confidence level. A total of 586 burn patients participated in six studies, including three RCT studies and three quasi-experimental studies. The results based on RCT studies showed RD significantly decreased the dressing pain average when compared to the control group (SMD: -1.61, 95%CI: -2.32 to -0.99, Z = 5.09, I2 : 66.2%, P < 0.001). Aromatherapy with lavender decreased the average pain in the interventional group more than in the control group (SMD: -1.78, 95%CI: -3.62 to 0.07, Z = 1.89, I2 : 97.2%, P = 0.06). Using aromatherapy with RD and lavender significantly decreased pain average in the interventional group than the control group (SMD: -1.68, 95%CI: -2.64 to -0.72, Z = 3.42, I2 : 94.2%, P = 0.001). The results showed RD significantly decreased the anxiety average in the interventional group than the control group (SMD: -2.49, 95%CI: -2.98 to -2.0, Z = 9.94, I2 : 51.6%, P < 0.001). Overall, this study showed that aromatherapy with RD decreased pain and anxiety of dressing procedures in burn patients. Although aromatherapy with lavender decreased pain in the patients, it was not statistically significant. More RCTs studies are required to be able to better judge the effects of aromatherapy with RD and lavender on the pain and anxiety of burn patients.

PMID:36651329 | DOI:10.1111/iwj.14093

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Nevin Manimala Statistics

Efficacy of Er:YAG Laser as a Debridement Method in Surgical Treatment for Peri-Implantitis: A Systematic Review

Oral Health Prev Dent. 2023 Jan 18;21(1):17-24. doi: 10.3290/j.ohpd.b3818041.

ABSTRACT

PURPOSE: The present study systematically reviewed randomised controlled trials (RCT) to investigate the efficacy of Er:YAG laser (ERL) as a debridement method in surgical treatment of advanced peri-implantitis.

MATERIALS AND METHODS: An electronic database search and a manual search were performed until March 2022. Outcome measures were clinical attachment level (CAL) gain, probing depth (PD) reduction, plaque index (PI) and bleeding on probing (BOP). The addressed PICO question was: Is ERL an effective debridement tool in the surgical treatment of advanced peri-implantitis?

RESULTS: Five eligible randomised clinical trials (RCTs) were included in the qualitative analysis, one of which had unclear risk of bias. One study reported a statistically significant difference in terms of implant CAL gain and PD reduction in favour of the experimental group vs the control group, while four studies did not report any difference between the two groups.

CONCLUSION: Due to methodological heterogeneity, such as non-standard control groups and laser parameters, this systematic review demonstrated inconclusive findings in terms of the efficacy of Er:YAG laser as a debridement method in surgical treatment of advanced peri-implantitis. The results of this review should be considered preliminary and further, well-designed studies with standardised comparators with laser parameters are warranted.

PMID:36651312 | DOI:10.3290/j.ohpd.b3818041

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Nevin Manimala Statistics

Glycemic and Insulin Status in Periodontitis Patients using the Homeostasis Model Assessment (HOMA): A Pilot Study

Oral Health Prev Dent. 2023 Jan 18;21(1):1-6. doi: 10.3290/j.ohpd.b3818027.

ABSTRACT

PURPOSE: This study aimed to compare insulin status and dysglycemia (prediabetes/diabetes) of patients with chronic (stage III, grade B) or aggressive periodontitis (stage III, grade C) to that of a healthy population.

MATERIALS AND METHODS: Patients with chronic (CP, n = 16) or aggressive periodontitis (AP, n = 15) and periodontally healthy controls (n = 32) were recruited. Body mass index was calculated. Glycemia, plasma insulin, glycated hemoglobin, C-reactive protein, and lipid levels were measured in fasting. The Homeostasis Model Assessment was used to calculate the insulin sensitivity (HOMA-%S), the beta-cell function (HOMA-%B), and their hyperbolic product (HOMA-%BxS).

RESULTS: The CP group showed statistically significantly insulin resistance with a lower HOMA-%S (p = 0.0003) and a reduced HOMA-%BxS (p = 0.049) despite a higher insulin level (p = 0.01) vs the control group, even after BMI adjustment. There was also a trend to dysglycemia (prediabetes/diabetes) in the chronic group. In patients with AP, no abnormalities in insulin status were observed and glycemic levels were comparable with controls. Additionally, patients in both AP and CP groups presented significantly higher CRP levels compared to those of the control group (p = 0.02).

CONCLUSION: Patients with CP showed reduced insulin sensitivity, increased insulin levels but a reduced %BxS product and a trend to dysglycemia. These abnormalities were not observed in AP.

PMID:36651310 | DOI:10.3290/j.ohpd.b3818027

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Nevin Manimala Statistics

ALDH2 attenuates LPS-induced increase of brain microvascular endothelial cell permeability by promoting fusion and inhibiting fission of the mitochondria

Nan Fang Yi Ke Da Xue Xue Bao. 2022 Dec 20;42(12):1882-1888. doi: 10.12122/j.issn.1673-4254.2022.12.18.

ABSTRACT

OBJECTIVE: To investigate the effect of aldehyde dehydrogenase 2 (ALDH2) on lipopolysaccharide (LPS)- induced damage of mouse brain microvascular endothelial barrier and explore the role of mitochondrial fusion and fission in maintaining the integrity of endothelial barrier.

METHODS: Mouse brain microvascular endothelial cells were treated with 1 μg/ mL LPS for 24 h with or without pretreatment with 20 μmol/mL Alda-1 (a ALDH2 agonist) for 1 h. The changes in cell viability were assessed using cell counting Kit-8 (CCK8) assay, and the cell permeability was evaluated using transendothelial cell resistance (TEER) and FITC-Dextran assay. The level of oxidative stress in the cells was assessed by detecting the levels of malondialdehyde (MDA) and superoxide dismutase (SOD), and the content of reactive oxygen species (ROS) was detected using a superoxide anion fluorescent probe (DHE). Western blotting was performed to detect the expressions of ALDH2, tight junction proteins ZO-1 and occludin, and mitochondrial fusion- and division-related proteins Mfn2, OPA1, Drp1 and Fis1.

RESULTS: Compared with the untreated cells, the cells treated with LPS showed significantly decreased TEER, increased FITC-dextran leakage, MDA content and ROS production, decreased SOD activity expressions of ALDH2, ZO-1, occludin, Mfn2 and OPA1, and increased expressions of Drp1 and Fis1 (P < 0.05). Pretreatment with Alda-1 prior to LPS exposure strongly suppressed the increase of endothelial cell membrane permeability, reduced ROS production, increased the expressions of ALDH2, ZO-1, occludin, OPA1 and Mfn2, and lowered the expressions of Drp1 and Fis1 (P < 0.05).

CONCLUSION: ALDH2 can alleviate LPS-induced damage of brain microvascular endothelial cell barrier by inhibiting the mitochondrial ROS production and promoting mitochondrial fusion and inhibiting mitochondrial fission.

PMID:36651258 | DOI:10.12122/j.issn.1673-4254.2022.12.18

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Nevin Manimala Statistics

The effect of interviewer-respondent age difference on the reporting of sexual activity in the Demographic and Health Surveys: Analysis of data from 21 countries

J Glob Health. 2023 Jan 30;13:04002. doi: 10.7189/jogh.13.04002.

ABSTRACT

BACKGROUND: Interviewer effects can have consequential impacts on survey data, particularly for reporting sensitive attitudes and behaviours such as sexual activity and drug use, yet these effects remain understudied in low- and middle-income countries. The Demographic and Health Surveys (DHS) present a unique opportunity to study interviewer effects on the self-report of sensitive topics in low- and middle-income countries by including interviewer characteristics data. This paper aims to narrow the gap in research on interviewer effects by studying the effects that age difference between interviewer and respondent and interviewer survey experience have on the reporting of ever having sexual intercourse.

METHODS: We used DHS data from 91 066 women and 56 336 men in 21 countries where the standard DHS was implemented among all women of reproductive age, and interviewer characteristics were included in the data set. Using a Bayesian cross-classified model with random intercepts for interviewer and cluster, we assessed whether the effect of an age difference of 10 years or greater was associated with a difference in self-report of ever having sexual intercourse, adjusting for respondent demographics.

RESULTS: There was a meaningful association between an age difference of greater than ten years and reporting of ever having had sexual intercourse in most countries for both genders after adjusting for interviewer age and experience, rural or urban cluster, and individual-level characteristics. Among women, the marginal posterior probability of reporting ever having sexual intercourse if the interviewer was ten years or more years older was lower for 17 of 19 countries (countries ranged from -12.50 to 3.90 percentage points). Among men, the marginal posterior probability was lower for 16 of 20 countries, ranging from -18.30 to 17.10 percentage points.

CONCLUSIONS: In most countries, women and men were less likely to report ever having sexual activity if the interviewer was ten or more years older than them, adjusting for potential confounders. These findings have important implications for interpreting numerous sexual health indicators, such as unmet family planning needs and human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) risk. Survey administrators may consider more careful interviewer-respondent characteristic matching or novel approaches like Audio Computer Assisted Self Interview to minimize interviewer-induced variance.

PMID:36651233 | DOI:10.7189/jogh.13.04002