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Nevin Manimala Statistics

Study protocol for a randomized controlled trial comparing the effectiveness of physical exercise and melatonin supplement on treating sleep disturbance in children with autism spectrum disorders

PLoS One. 2022 Jul 6;17(7):e0270428. doi: 10.1371/journal.pone.0270428. eCollection 2022.

ABSTRACT

BACKGROUND: Previous study showed that both melatonin supplement and physical exercise intervention could improve sleep quality in children with autism spectrum disorders (ASD) with the increase in endogenous melatonin level. However, none of the studies have directly compared the effectiveness between the two interventions on treating sleep disturbance in children with ASD. Without direct comparison, we do not know which intervention is better. Thus, we designed a study to compare which intervention is more effective to treat sleep disturbance in children with ASD and to examine whether the combination of the two could be the most efficacious. We present a protocol for conducting a randomized controlled trial to compare the effectiveness of physical exercise and melatonin supplement on treating sleep disturbance in children with ASD.

STUDY DESIGN: The proposed study will be a four-group randomised control trial (RCT) design, with equal allocation of participants to the three intervention groups and one control group.

METHODS: All eligible participants will be randomly allocated to a morning jogging group, a melatonin supplement group, a combination group and a control group. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. Melatonin levels represented by 6-sulfoxymelatonin will be measured from the participants’ 24-h and the first morning void urinary samples. All the assessments will be carried out before the intervention (T1), in the mid of the study (5 weeks after the commencement of the study) (T2) and after the 10-week intervention (T3). Level of statistical significance will be set at 5% (i.e. p < .05). The results of this trial will be submitted for publication in peer-reviewed journal.

FINDINGS: The findings will provide evidence to determine whether physical exercise or melatonin supplement or the combination of interventions is the most effective to treat sleep disturbance in children with ASD.

PMID:35793342 | DOI:10.1371/journal.pone.0270428

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Nevin Manimala Statistics

Small sight-Big might: Economic impact of bird tourism shows opportunities for rural communities and biodiversity conservation

PLoS One. 2022 Jul 6;17(7):e0268594. doi: 10.1371/journal.pone.0268594. eCollection 2022.

ABSTRACT

Birdwatching is considered one of the fastest growing nature-based tourism sectors in the world. Tourists who identify as birdwatchers tend to be well-educated and wealthy travellers with a specific interest in the places they visit. Birdwatchers can bring economic resources to remote communities diversifying their economies and contribute to biodiversity conservation in areas of bird habitat with global significance. Alaska plays a critical role in understanding the link between bird conservation and bird tourism as it supports the world’s largest concentration of shorebirds and is a global breeding hotspot for hundreds of migratory species, including many species of conservation concern for their decline across their ranges. Alaska is also a global destination for birders due to the large congregations of birds that occur during the spring, summer and fall seasons. Despite its global importance, relatively little information exists on the significance of bird tourism in Alaska or on opportunities for community development that align with conservation. This study used ebird data to look at trends in Alaska birdwatching and applied existing information from the Alaska Visitor Statistics Program to estimate visitor expenditures and the impact of that spending on Alaska’s regional economies. In 2016, nearly 300,000 birdwatchers visited Alaska and spent $378 million, supporting approximately 4,000 jobs. The study describes bird tourism’s contributions to local jobs and income in remote rural and urban economies and discusses opportunities for developing and expanding the nature-based tourism sector. The study points toward the importance of partnering with rural communities and landowners to advance both economic opportunities and biodiversity conservation actions. The need for new data collection addressing niche market development and economic diversification is also discussed.

PMID:35793337 | DOI:10.1371/journal.pone.0268594

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Nevin Manimala Statistics

Spatiotemporal mapping of major trauma in Victoria, Australia

PLoS One. 2022 Jul 6;17(7):e0266521. doi: 10.1371/journal.pone.0266521. eCollection 2022.

ABSTRACT

BACKGROUND: Spatiotemporal modelling techniques allow one to predict injury across time and space. However, such methods have been underutilised in injury studies. This study demonstrates the use of statistical spatiotemporal modelling in identifying areas of significantly high injury risk, and areas witnessing significantly increasing risk over time.

METHODS: We performed a retrospective review of hospitalised major trauma patients from the Victorian State Trauma Registry, Australia, between 2007 and 2019. Geographical locations of injury events were mapped to the 79 local government areas (LGAs) in the state. We employed Bayesian spatiotemporal models to quantify spatial and temporal patterns, and analysed the results across a range of geographical remoteness and socioeconomic levels.

RESULTS: There were 31,317 major trauma patients included. For major trauma overall, we observed substantial spatial variation in injury incidence and a significant 2.1% increase in injury incidence per year. Area-specific risk of injury by motor vehicle collision was higher in regional areas relative to metropolitan areas, while risk of injury by low fall was higher in metropolitan areas. Significant temporal increases were observed in injury by low fall, and the greatest increases were observed in the most disadvantaged LGAs.

CONCLUSIONS: These findings can be used to inform injury prevention initiatives, which could be designed to target areas with relatively high injury risk and with significantly increasing injury risk over time. Our finding that the greatest year-on-year increases in injury incidence were observed in the most disadvantaged areas highlights the need for a greater emphasis on reducing inequities in injury.

PMID:35793336 | DOI:10.1371/journal.pone.0266521

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Nevin Manimala Statistics

Early Neurocognitive Function With Propofol or Desflurane Anesthesia After Laser Laryngeal Surgery With Low Inspired Oxygen

Laryngoscope. 2022 Jul 6. doi: 10.1002/lary.30273. Online ahead of print.

ABSTRACT

PURPOSE: The effects of general anesthetics on cognitive impairment are unclear and complicated. Laser laryngeal surgery (LLS) requires the administration of low levels of oxygen, which may increase the risk of desaturation and brain function impairment. This prospective randomized trial aimed to compare the effects of desflurane and propofol-based general anesthesia on the occurrence of early postoperative cognitive decline in elderly patients undergoing LLS.

METHODS: Seventy-three patients classified as American Society of Anesthesiologists grade I or II and at least 65 years of age were randomly allocated to receive either desflurane-based (Group D) or propofol-based (Group P) anesthesia during LLS. The standard anesthesia protocol was performed, with a bispectral index between 40 and 60 and a mean arterial pressure within 20% of baseline values. Intraoperative regional oxygen saturation values were recorded. Each patient was assessed using the mini-mental state examination (MMSE) test during the preoperative period (baseline), 30 min after extubation in the postanesthesia care unit, and 1, 3, and 24 h after surgery.

RESULTS: MMSE scores improved slightly in both groups compared to baseline during the early postoperative period, but these increases were not statistically significant. No significant differences were identified in MMSE scores between groups. Only three patients (9.6%) in group D and one patient (3.1%) in group P developed cognitive impairment (p = 0.583).

CONCLUSION: Low intraoperative inspired oxygen concentration during short-duration LLS did not reduce early postoperative cognitive function in elderly patients. Desflurane or propofol-based anesthesia had similar effects on early neurocognition after LLS.

LEVEL OF EVIDENCE: 2 Laryngoscope, 2022.

PMID:35791905 | DOI:10.1002/lary.30273

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Nevin Manimala Statistics

Risk difference, relative risk, and odds ratio for non-inferiority clinical trials with risk rate endpoint

J Biopharm Stat. 2022 Jul 6:1-16. doi: 10.1080/10543406.2022.2065502. Online ahead of print.

ABSTRACT

Non-inferiority (NI) clinical trials are widely used to evaluate whether the new experimental treatment is not unacceptably worse than the current active-control treatment by more than a pre-specified non-inferiority margin (NI margin). However, choosing either an absolute difference [risk difference (RD)] or a relative difference [relative risk (RR) and odds ratio (OR)] to evaluate efficacy in NI clinical trials is still controversial. In this study, we aim to evaluate the performance of abovementioned three metrics for testing NI clinical trials with risk rate endpoint. Herein, extensive Monte Carlo simulations based on various parameter settings (NI margin as well as risk rates in the experimental group and active-control group) are conducted to compare the Type I error rate, statistical power, and the necessary sample size to achieve a desired power for testing NI using RD, RR, and OR. We show that testing NI using RD not only controls well the Type I error and achieves the highest statistical power but also requires the smallest sample size compared to RR and OR. In practice, however, the choice among three metrics still needs to be based upon clinical interpretations and regulatory perspectives.

PMID:35791856 | DOI:10.1080/10543406.2022.2065502

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Nevin Manimala Statistics

The Impact of Psychological Capital and Workplace Social Support on Pediatric Oncology Nurses’ Post Traumatic Stress Disorder (PTSD) Symptomology

J Pediatr Hematol Oncol Nurs. 2022 Jul-Aug;39(4):231-242. doi: 10.1177/27527530211073737. Epub 2022 Apr 13.

ABSTRACT

Introduction: Work-related post traumatic stress disorder (PTSD) can develop in nurses. Pediatric oncology nursing is a potentially high-risk subspecialty for PTSD secondary to the nature of the work. This study aimed to describe the prevalence of PTSD symptomology and explore relationships between nurse psychological capital, workplace social supports, and PTSD symptomology in pediatric oncology nurses. Methods: The study utilized a cross-sectional correlational survey design. Pediatric oncology nurses working in direct patient care in the United States completed a demographics questionnaire, Psychological Capital Questionnaire (PCQ), Coworker Support Scale, Supervisor Support Scale, and the Post traumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Descriptive and inferential statistics, including logistic regression models, were used to analyze data. A cutoff score of ≥31 on the PCL-5 was used to determine the prevalence of PTSD symptomology. Results: The sample included 424 nurses. The prevalence of PTSD symptomology was 13.4%. Work setting (inpatient), decreased coworker and leadership social support, and psychological capital were independently associated with PTSD symptomology. After controlling for covariates, only psychological capital was associated with PTSD symptomology. For a 1 unit decrease in PCQ score, pediatric oncology nurses were 4.25 times more likely to have PTSD symptomology. Discussion: PTSD prevalence rates in pediatric oncology nurses are aligned with rates found in other nursing specialties. Nurse psychological capital may play a protective role against PTSD symptomology. Implications for Future Research: Findings support PTSD as a serious workplace concern for nurses. Workplace programs that foster nurses’ psychological capabilities should be considered to protect against the development of PTSD symptomology.

PMID:35791851 | DOI:10.1177/27527530211073737

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Nevin Manimala Statistics

Combination treatment with 30% salicylic acid and fractional CO2 laser for acne scars: A 20-week prospective, randomized, split-face study

Dermatol Ther. 2022 Jul 6:e15693. doi: 10.1111/dth.15693. Online ahead of print.

ABSTRACT

BACKGROUND: Multiple approaches are used to treat acne scars, but some are expensive, ineffective, and cause complications. We aimed to evaluate the efficacy and safety of ultra-pulsed CO2 fractional laser combined with 30% supramolecular salicylic acid in the treatment of acne scars in a prospective split-face control study.

METHODS: Twenty patients with facial symmetrical acne scars were enrolled. One side of face was randomly treated with 30% supramolecular salicylic acid, and two sides were treated with ultra-pulsed CO2 fractional laser. The Echelle d’evaluation clinique des cicatrices d’acne (ECCA) scale was used to evaluate the clinical efficacy before and three months after treatment, and a quartile scale was used to self-evaluate the improvement of patients. A visual analog scale was used to record pain scores after each treatment, and side effects and other adverse reactions on the face were recorded.

RESULTS: All the patients completed treatment and follow-up. There was statistical difference in ECCA scores of bilateral facial acne scars after three treatments (P<0.001). ECCA scores on the combined side were lower after three treatments than those on the laser side (P=0.003). The patient satisfaction quartile scale on the combined side was higher than that on the laser side alone (P=0.015).

CONCLUSION: Ultra-pulsed CO2 fractional laser combined with 30% supramolecular salicylic acid has better efficacy in the treatment of acne scars than laser alone, and patient self-assessment of combined treatment has a greater degree of improvement in acne scars, and does not increase patient pain scores and related adverse reactions. This article is protected by copyright. All rights reserved.

PMID:35791845 | DOI:10.1111/dth.15693

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Nevin Manimala Statistics

Abutment mechanical complications of a Morse taper connection implant system: A 1- to 9-year retrospective study

Clin Implant Dent Relat Res. 2022 Jul 6. doi: 10.1111/cid.13115. Online ahead of print.

ABSTRACT

BACKGROUND: The fracture of a Morse tapered abutment connection in an osseointegrated implant is one of the most serious mechanical complications, and it is extremely hard to deal with this complication in clinical practice.

PURPOSE: The aim of this study was to explore the cumulative mechanical complications focus on abutment of a platform switching Morse taper connection implant system after loading, and to perform a retrospective, approximately 1- to 9-year follow-up study to identify the predisposing factors.

MATERIALS AND METHODS: A total of 495 patients with 945 fitted implants were enrolled in this study with a follow-up from January 2012 to January 2020. The data of mechanical complications of the abutment, including abutment fracture (AF) and abutment screw loosening (ASL), and possible causative factors were extracted and evaluated statistically.

RESULTS: A total of 25 out of 945 (2.65%) cumulative abutment mechanical complications occurred. AF was the most common complication (n = 13, 1.38%), followed by ASL (n = 12, 1.27%). For AF, gender, type of prosthesis, abutment design, and implant diameter were identified as the causative factors. AF was mostly observed in the single crown of males in molar areas, while ASL was more likely to occur on an angled abutment than on a non-angled abutment. Moreover, the abutment with the positioning index (/X) had a higher incidence of fracture than the abutment without the positioning index (C/).

CONCLUSIONS: This study shows that the Morse taper connection is a safe abutment connection. AF occurs more frequently within single crowns in molar area of males, especially with the positioning index (/X), while ASL is more likely to occur in an angled abutment.

PMID:35791805 | DOI:10.1111/cid.13115

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Nevin Manimala Statistics

Evaluation of the efferent auditory system in COVID-19 adult patients

Acta Otolaryngol. 2022 Jul 6:1-6. doi: 10.1080/00016489.2022.2093967. Online ahead of print.

ABSTRACT

BACKGROUND: The short- and long-term effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on the medial olivocochlear reflex and outer hair cells in the cochlea remain largely unclear.

AIMS: The aim of this study was to investigate the efferent auditory system effects in adult patients with COVID-19.

MATERIALS AND METHODS: The study included 18-50 years old 44 volunteers: 26 individuals (52 ears) with COVID-19 in the study group and 18 healthy individuals (36 ears) in the control group. Otolaryngological examination, immitancemetric evaluation, distortion product otoacoustic emission (DPOAE), contralateral acoustic stimulation with DPOAE, audiometric evaluation, and high frequency audiometric evaluation were performed in all individuals participating in the study.

RESULTS: In our study, patients with COVID-19 had significantly lower DPOAE results with or without broadband noise at only 6 kHz frequency and contralateral suppression results at all frequencies compared to healthy individuals. A statistically significant difference was found between the study and control groups according to whether the participants had a response in the high frequency audiometry at 12 and 16 kHz frequencies.

CONCLUSIONS: COVID-19 affects many systems in the body. As a result of the findings obtained in the present study, it is shown that the auditory efferent system may also be affected.

PMID:35791801 | DOI:10.1080/00016489.2022.2093967

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Nevin Manimala Statistics

Influence of supplement administration of omega-3 on the subcutaneous tissue response of endodontic sealers in Wistar Rats

Int Endod J. 2022 Jul 6. doi: 10.1111/iej.13795. Online ahead of print.

ABSTRACT

AIM: Natural substances such as omega-3 have been used in the medical field due to their numerous properties and, in particular, modulating effect on the systemic and local inflammatory processes. Thus, this study evaluated the influence of omega-3 supplementation on the subcutaneous tissue response of endodontic sealers in Wistar Rats.

METHODOLOGY: Polyethylene tubes were implanted in the subcutaneous tissue of 48 animals (one empty for control and three filled with Sealapex, AH Plus or Endofill). The animals were treated with omega-3 (TO) or water (TW). Treatments started 15 days before implantation until euthanasia. After 5, 15 and 30 days (n=8), animals were euthanized and polyethylene tubes and surrounding tissue were removed and processed for histological analysis. The inflammatory reaction was analysed by Haematoxylin and Eosin stain and immunolabeling for IL-6 and TNF-α. The collagen maturity was analysed by picrosirius red stain and calcium deposition by von Kossa stain and polarized light. Results were statistically analysed (p<0.05).

RESULTS: Among TW sealers groups, Endofill evoked a more intense inflammatory infiltrate compared with AH Plus and control in the 30-day period (p=0.009). However, in TO sealers groups, there was no difference among the sealers and control in all periods (p>0.05). Comparing each sealer as a function of the supplementation with water or omega-3, there are differences for Endofill (p=0.001) and Sealapex (p=0.005) in the 30-day period, presenting lower inflammatory infiltrate in the animals treated with omega 3. A higher percentage of immature fibres was observed at 15 and 30 days in the TO group, compared with TW group (p<0.05). The deposition of calcium particles was observed only by Sealapex in all periods, despite the supplementation procedure.

CONCLUSIONS: Omega-3 supplementation influence the tissue reactions of endodontic sealers, modulating inflammation, the immunolabeling of IL-6 and TNF-α, the repair process and it does not interfere with calcium deposition.

PMID:35791796 | DOI:10.1111/iej.13795