Tag: pubmed

Interact J Med Res. 2022 May 25. doi: 10.2196/38542. Online ahead of print.

ABSTRACT

BACKGROUND: Bacopa monnieri, a herb used extensively, has shown neuroprotective effects in animal and invitro studies; human studies on patients with Alzheimer’s Disease (AD) have been inconclusive.

OBJECTIVE: The primary objective was to determine the clinical efficacy and safety of Bacopa monnieri (Brahmi) in persons with mild, moderate or severe dementia due to Alzheimer’s disease and Mild Cognitive Impairment-Alzheimer’s disease (MCI-AD).

METHODS: We searched PubMed, Excerpta Medica dataBASE (EMBASE), Cochrane library, clinical trial registries (WHO, Aus-New Zealand, US and SA clinical registry), metaRegister of Controlled Trials (mRCT) and Cumulative Index to Nursing and Allied Health Literature (CINAHL). We intended to include ll randomized and quasi-randomized controlled trials that compared Bacopa monnieri, its extract or active ingredients (at any dosage) with placebo or one of the Cholinesterase inhibitors among adults with dementia due to AD and MCI-AD.

RESULTS: Our comprehensive search yielded five eligible studies. Three studies used Bacopa in combination with herbal extracts while remaining two used Bacopa extracts only. Two studies compared Bacopa with Donepezil while others used placebo as control. There was considerable variation in dose of bacopa used (ranging between 125 mg to 500 mg twice daily) and heterogeneity in treatment durations, follow up and outcomes. The major outcomes were Mini-mental status examination reported in three trials, Alzheimer’s disease assessment scale – Cognitive (ADAS-Cog) in one and a battery of cognitive tests in two studies. Using Cochrane risk of bias tool, overall, we judged all five studies to be at high risk of bias. While all studies reported statistically significant difference between Bacopa and comparator in at least one outcome, we rated overall quality of evidence for ADAS-Cog, PGI memory scale, Mini-Mental State Examination (MMSE) and Weschler memory scale to be very low because of downgrading by two levels for high risk of bias and one more level for impreciseness consequent to small sample sizes and wide confidence intervals.

CONCLUSIONS: There is no difference between Bacopa and placebo or Donepezil in treatment of AD based on very low certainty evidence. No major safety issues were reported in the included trials. Future Randomized Controlled Trials (RCTs) must aim to recruit more participants and report clinically meaningful outcomes.

CLINICALTRIAL: Crd42020169421.

PMID:35612544 | DOI:10.2196/38542

Ann Plast Surg. 2022 Jun 1;88(6):606-611. doi: 10.1097/SAP.0000000000003111. Epub 2022 Feb 18.

ABSTRACT

BACKGROUND: Fifty percent of Asians are born without a supratarsal fold (also called single eyelid), and double eyelid blepharoplasty is one of the most commonly performed and most popular facial cosmetic surgeries in the Asian population. However, patients with single eyelid frequently present with concomitant mild blepharoptosis (degree of ptosis, ≤2 mm), which often fails to cause the attention of surgeons and misses correction.

METHODS: A retrospective study of all patients who underwent double eyelid blepharoplasty and blepharoptosis correction simultaneously with the modified levator aponeurosis plication technique was performed from June of 2017 to June of 2020.

RESULTS: A total of 108 patients (155 eyelids) underwent double eyelid blepharoplasty and blepharoptosis correction simultaneously with the modified levator aponeurosis plication technique and were enrolled in the study. The average follow-up period was 11.8 ± 4.5 months. There was a statistically significant difference between the preoperative margin reflex distance 1 (MRD1) and postoperative MRD1 (2.93 ± 0.37 vs 4.21 ± 0.39 mm, P = 0.000), and the mean MRD1 improvement was 1.28 ± 0.50 mm. Sufficient correction was obtained in 148 eyelids (95.5%), whereas undercorrection was observed in 5 eyelids (3.2%) and overcorrection was observed in 2 eyelids (1.3%). One hundred two patients (94.4%) were completely satisfied with the final result.All patients had smooth and elegant upper eyelid margin curve, and no patients complained of distortion of the eyelid margin contour and foreign body sensation.There were no cases of hematoma, infection, suture exposure, corneal abrasion, and keratitis in any patient.

CONCLUSIONS: This modified levator aponeurosis plication introduced in this study is a simple and effective method for creating double-eyelid crease and correcting mild blepharoptosis simultaneously, and provides a satisfactory outcome. As such, we recommend this method in treating patients with both single eyelid and mild blepharoptosis.

PMID:35612534 | DOI:10.1097/SAP.0000000000003111

J Biopharm Stat. 2022 May 25:1-7. doi: 10.1080/10543406.2022.2080691. Online ahead of print.

ABSTRACT

When applying group-sequential designs in clinical trials with normally distributed outcomes, approximate critical values are often applied. Here, normally distributed test statistics are assumed which, however, are in fact t-distributed. For small sample sizes, the approximation may lead to a serious inflation of the type I error rate. Recently, a method for computing the exact critical boundaries assuring type I error rate control was proposed and the critical boundaries for Pocock- and O’Brien-Fleming-like group-sequential designs were provided. For designs with one interim analysis, we present six alternative designs, which also control the type I error rate and in addition allow flexible design modifications. We compare the characteristics of these 6 two-stage designs. It is shown that considerable sample size savings can be achieved by including futility stopping and by optimizing the designs. Therefore, for clinical trials with small sample sizes as, for example, in the area of rare diseases, optimal two-stage designs with futility stopping may be a valuable alternative to classical group-sequential designs.

PMID:35612521 | DOI:10.1080/10543406.2022.2080691

Environ Sci Technol. 2022 May 25. doi: 10.1021/acs.est.2c01072. Online ahead of print.

ABSTRACT

Implementation of regulatory standards has reduced exhaust emissions of particulate matter from road traffic substantially in the developed world. However, nonexhaust particle emissions arising from the wear of brakes, tires, and the road surface, together with the resuspension of road dust, are unregulated and exceed exhaust emissions in many jurisdictions. While knowledge of the sources of nonexhaust particles is fairly good, source-specific measurements of airborne concentrations are few, and studies of the toxicology and epidemiology do not give a clear picture of the health risk posed. This paper reviews the current state of knowledge, with a strong focus on health-related research, highlighting areas where further research is an essential prerequisite for developing focused policy responses to nonexhaust particles.

PMID:35612468 | DOI:10.1021/acs.est.2c01072

Acta Otorhinolaryngol Ital. 2022 Apr;42(2):140-149. doi: 10.14639/0392-100X-N2055.

ABSTRACT

BACKGROUND: This study aimed to evaluate the performance of the 2017 8^th TNM edition and the latest update in 2020 compared to the 7^th in a large cohort of patients affected by oral tongue squamous cell carcinoma (OTSCC), considering all stages.

MATERIALS AND METHODS: The cohort involved 300 patients affected by OTSCC treated with surgery. All cases were classified according to the 7^th, 8^th (2017), and the latest updated TNM edition (October 2020),. Patients were grouped based on the shift in tumour (T) category, lymph nodal (N) category and final pathological stage. Overall survival (OS) and disease-free survival (DFS) were calculated with the Kaplan-Meier method. Univariate and multivariate analyses were carried out.

RESULTS: According to the 7^th edition, multivariate analysis OS revealed that stage IV patients had an almost 4-fold risk of death compared to stage I (HR = 3.81 95% CI: 2.32-6.25; p < 0.001). Regarding DFS, stage IV patients had a 2-fold greater risk of relapses, or second primary, than patients in stage I (HR = 2.51 95% CI: 1.68-3.74; p < 0.001). According to 2017 8^th edition for OS, stage IV patients presented a 5-fold higher risk of death compared to patients in stage I (HR = 5.18 95% CI: 2.96-9.08; p < 0.001) and almost 4-old greater risk of relapses or second primary compared to patients in stage I considering DFS (HR = 3.61 95% CI: 2.28-5.71; p < 0.001). Regarding the recent edition of 8^th TNM (2020), stage IV patients had an almost 5-fold greater risk of death compared to patients in stage I considering OS (HR = 4.84 95% CI: 2.74-8.55; p < 0.001), while for DFS they had 3-fold greater risk of relapse or second primary compared to patients in stage I (HR = 3.13 95% CI: 1.99-4.91; p < 0.001).

CONCLUSIONS: This study confirmed that the recent update of the 8th edition of the TNM (2020) improves stratification and identification of advanced tumours, reducing the number of T3 compared to the 2017 edition and increasing the number of patients with pT4. This improvement made by the updated edition may reduce the risk of skipping adjuvant therapy.

PMID:35612505 | DOI:10.14639/0392-100X-N2055

Int J Periodontics Restorative Dent. 2022 May 24. doi: 10.11607/prd.6002. Online ahead of print.

ABSTRACT

This study evaluated the efficacy of trapezoidal coronally advanced flap (tCAF), envelope coronally advanced flap (eCAF), and coronally advanced tunnel flap (TUN) in treating gingival recession (GR) through a network meta-analysis. Eligible articles from the PubMed, Embase, and Cochrane Library databases published up to September 2020 were selected to identify randomized controlled trials (RCTs) on tCAF, eCAF, and TUN treatments. Sample size, treatment time, and outcome measures including complete root coverage (CRC), root coverage esthetic score (RES), and other data were extracted from the article, and integrated analysis was conducted. In total, 10 RCTs met the inclusion criteria, involving 310 patients. Direct meta-analysis showed no significant differences in CRC among the three surgical methods; A significant difference was seen for RES, with TUN worse than tCAF (weighted mean difference: -0.73; 95% CI: -1.44, -0.02; P = .045). The network meta-analysis showed no statistical significance in the cross-comparison of tCAF, eCAF, and TUN. However, eCAF had the most significant effect on improving CRC (SUCRA = 69.2) and RES (SUCRA = 85.0). eCAF has the best prognosis in the treatment of GR, followed by tCAF and TUN. This may influence the surgeon’s treatment choice, as eCAF may be more effective in root coverage procedures.

PMID:35612437 | DOI:10.11607/prd.6002

Surg Infect (Larchmt). 2022 May 24. doi: 10.1089/sur.2022.072. Online ahead of print.

ABSTRACT

Background: Splenic abscess (SA) is a rare, life-threatening illness that is generally treated with splenectomy. However, this is associated with high mortality and morbidity. Recently, percutaneous drainage (PD) has emerged as an alternative therapy in select patients. In this study, we compare mortality and complications in patients with SA treated with splenectomy versus PD. Patients and Methods: A systematic literature search of 13 databases and online search engines was conducted from 2019 to 2020. A bivariate generalized linear mixed model (BGLMM) was used to conduct a separate meta-analysis for both mortality and complications. We used the risk of bias in non-randomized studies of interventions (ROBINS-I) tool to evaluate risk of bias in non-randomized studies, and the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach for assessing quality of evidence and strength of recommendations. Results were presented according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Results: The review included 46 retrospective studies from 21 countries. For mortality rate, 27 studies compared splenectomy and PD whereas 10 used PD only and nine used splenectomy only. Data for major complications were available in 18 two-arm studies, seven single-arm studies with PD, and seven single-arm studies with splenectomy. Of a total of 589 patients, 288 were treated with splenectomy and 301 underwent PD. Mortality rate was 12% (95% confidence interval [CI], 8%-17%) in patients undergoing splenectomy compared with 8% (95% CI, 4%-13%) with PD. Complication rates were 26% (95% CI, 16%-37%) in the splenectomy group compared with 10% (95% CI, 4%-17%) in the PD group. Conclusions: Percutaneous drainage s associated with a trend toward lower complications and mortality rates compared with splenectomy in the treatment of SA, however, these findings were not statistically significant. Because of the heterogeneity of the data, further prospective studies are needed to draw definitive conclusions.

PMID:35612434 | DOI:10.1089/sur.2022.072

Health Secur. 2022 May 24. doi: 10.1089/hs.2021.0214. Online ahead of print.

ABSTRACT

A disaster overwhelms the normal operating capacity of a health service. Minimal research exists regarding Australian hospitals’ capacity to respond to chemical, biological, radiological, or nuclear (CBRN) disasters. This article, and the research supporting it, begins to fill that research gap. We conducted a descriptive quantitative study with 5 tertiary hospitals and 1 rural hospital in Queensland, Australia. The study population was the hospitals’ clinical leaders for disaster preparedness. The 25-item survey consisted of questions relating to each hospital’s current response capacity, physical surge capacity, and human surge capacity in response to a CBRN disaster. Data were analyzed using descriptive statistics. The survey data indicated that over the previous 12 months, each site reached operational capacity on average 66 times and that capacity to respond and create additional emergency, intensive care, or surgical beds varied greatly across the sites. In the previous 12 months, only 2 sites reported undertaking specific hospital-wide training to manage a CBRN disaster, and 3 sites reported having suitable personal protective equipment required for hazardous materials. There was a noted shortfall in all the hospitals’ capacity to respond to a radiological disaster in particular. Queensland hospitals are crucial to CBRN disaster response, and they have areas for improvement in their response and capacity to surge when compared with international preparedness benchmarks. CBRN-focused education and training must be prioritized using evidence-based training approaches to better prepare hospitals to respond following a disaster event.

PMID:35612425 | DOI:10.1089/hs.2021.0214

Clin Ter. 2022 May 25;173(3):249-256. doi: 10.7417/CT.2022.2428.

ABSTRACT

CONTEXT: In Europe, during an era of globalization in which traveling and studying abroad is becoming easier and more affordable, an open question remains on whether different European medical schools educate students with a dissimilar level of preparedness and/or satisfaction.

OBJECTIVE: To develop and validate the EUropean Students’ Preparedness and Satisfaction Questionnaire (EUSPSQ), a standardized European tool to assess preparedness and satisfaction in medical education.

MATERIALS AND METHODS: 30 participants belonging to the 5th and 6th year of two different European medical schools (Sapienza University of Rome and Universidad Complutense de Madrid) participated in the validation of the study. A standard validation protocol that included item development, test-retesting, and a series of statistical validation analyses, was used. Feasibility, test-retest reliability, inter-item reliability were assessed quantitatively. Face validity was evaluated qualitatively by an expert professor in the field.

RESULTS: Test-retest and inter-item reliability were considered satisfactory for all the parts of the questionnaire. Part III and IV presented lower Cohen’s kappa values, probably as a consequence of their inherent subjectivity. When one item in Part III was removed, the Cronbach’s alpha values of both initial and 48h answers consider-ably increased (-0.355 to 0.713 and -0.202 to 0.808 respectively). We therefore decided to eliminate the question from the EUSPSQ. Internal and external validity were considered appropriate. The questionnaire was also feasible and viable to complete.

DISCUSSION: Preliminary findings indicate that the EUSPSQ can be a valid, viable and reliable questionnaire to measure preparedness and satisfaction of 5th and 6th year medical students across different European Universities.

PMID:35612340 | DOI:10.7417/CT.2022.2428

Clin Ter. 2022 May 25;173(3):274-279. doi: 10.7417/CT.2022.2431.

ABSTRACT

PURPOSE: To evaluate safety and efficacy of customized central corneal regularization (CCR), together with simultaneous accelerated corneal collagen cross-linking (A-CXL) – CCR-CXL protocol, to treat keratoconus-related corneal ectasia.

DESIGN: Retrospective, comparative observational case series.

METHODS: Patients that had undergone combined CCR-CXL protocol. Main inclusion criteria were keratoconus visual acuity deterioration and contact lens intolerance. All patients underwent complete ophthalmological evaluation, corrected distance visual acuity (CDVA) and Scheimpflug-corneal tomography. Central corneal regularization was performed by ablation using flying spot laser. Subsequently, the stroma was saturated with 0.17% riboflavin-5-phosphate added every 2 minutes, followed by A-CXL 9 mW/cm2 for 10 minutes. CDVA, medium keratometry value (Kmed), and total corneal morphological irregularity index (CMI) of patients were analyzed before surgery and after 1, 3 and 12 months. A P value of .05 or less was considered statistically significant.

RESULTS: 46 eyes of 39 keratoconus patients were treated. At 1 month, the mean CDVA (LogMar) increased from 0.19 ± 0.02 to 0.12 ± 0.02 (P < .05), and the difference remained stable at month 12. Kmax decrease was statistically significant from 57.02 ± 5.65 to 50.21 ± 4.48 (P < .05). CMI decreased significantly from 47.8 ± 2.84 to 30.1 ± 2.4 (P < .01).

CONCLUSIONS: CCR-CXL protocol is safe and effective in arresting keratectasia progression and increasing corneal optic regularity in keratoconus. These findings showed a significant improvement in CDVA, keratometry values and corneal optical aberrations after being treated with the CCR-CXL protocol.

PMID:35612343 | DOI:10.7417/CT.2022.2431