Nevin Manimala

Curr Med Res Opin. 2022 May 27:1-32. doi: 10.1080/03007995.2022.2083324. Online ahead of print.

ABSTRACT

OBJECTIVE: Analysis and comparison of country-level data from the VISIONARY study, examining treatment outcomes with the topical fixed-dose combination of preservative-free tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) who were insufficiently treated with or unable to tolerate either beta-blocker or prostaglandin analogue (PGA) topical monotherapy.

METHODS: A European, prospective, observational study was conducted in 11 countries. Adults with OAG/OHT were switched to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Statistical analysis examined changes in mean standard deviation (SD) intraocular pressure (IOP) from baseline at Week 4, Week 12 and Month 6. Data were documented for each eye separately at baseline and during follow up visits, with the eye reported to have the higher IOP (mmHg), as measured using Goldmann applanation tonometry, being selected for analysis (study eye). Country-level subanalysis examined outcomes by prior monotherapy, diagnosis and timing of dosing for those countries recruiting ≥20 patients (Country-level Subanalysis Population). Two-sided paired t-test was used to assess significance regarding mean IOP reduction from baseline and a compound symmetry covariance model was used in cross-country comparisons regarding variation in IOP change from baseline. Treatment-related adverse events (AEs) were evaluated.

RESULTS: Mean (SD) age among patients recruited to the VISIONARY study ranged between 63.9 (11.8) to 72.4 (10.6) years across all countries. The majority of participants (>50%) were female in each country. The Country-level Subanalysis Population included 551 eyes. Mean (SD) IOP was significantly reduced from baseline in each country at Week 4, Week 12 and Month 6 (p < 0.0001). Mean IOP reduction at Month 6 ranged from 5.0 mmHg (22.6%, Hungary) to 7.8 mmHg (31.8%, Latvia) and varied significantly between countries (p < 0.001). The greatest reductions were in Latvia and Russia, where baseline IOP was highest. Country-level IOP reductions were significant irrespective of prior monotherapy, diagnosis or dosing time (p < 0.0001). Most treatment-related AEs occurred in the UK (26 events, 73% mild). One serious AE was reported (Russia, status asthmaticus). Tolerability with PF tafluprost/timolol FC therapy was rated as good/very good by most patients (85.7-100%) in all countries.

CONCLUSION: Subanalysis of VISIONARY study data revealed significant IOP reductions following a switch to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Cross-country variation was likely due to baseline IOP differences. Within country, outcomes were consistent regardless of diagnosis, dosing or prior monotherapy. Treatment was generally well tolerated.

PMID:35621005 | DOI:10.1080/03007995.2022.2083324

Minerva Pediatr (Torino). 2022 May 27. doi: 10.23736/S2724-5276.22.06766-0. Online ahead of print.

ABSTRACT

BACKGROUD: The deprivation of components that exercise the body and mind by children and adolescents can lead to numerous long-term consequences in terms of physical health (cardiovascular diseases, bone problems, high cholesterol, obesity) and mental health (depression, low self-esteem and social isolation).

METHODS: This investigation intended to identify a profile of self-concept and self-esteem, on the academic performance of middle-school children between practitioners of curricular physical education and extracurricular sport activities. The participants consisted of a total of 107 students, 55 (51.4%) were males and 52 (48.6%) were female, aged between 10 and 12 years. A total of 41 children (38.3%) attending the fifth grade and 66 children (61.7%) the sixth grade were randomly selected. The data collection instrument, Self-concept of Susan Harter validated for the Portuguese population was used and it was proceeded to a descriptive and inferential statistics data analysis to confront the mean levels of self-concept, global self-esteem and academic performance.

RESULTS: As an influence of hours of weekly practice, we found statistically significant differences in terms of academic performance, that is, as the student practices more hours of physical exercise, there is a tendency for the student to obtain better academic results.

CONCLUSIONS: Apparently, the practice of extracurricular sport activities by students promotes a significant evolution in the formation of self-concept and academic performance, as well as suggesting a positive evolutionary trend in the formation of self-esteem of students who practice the several extracurricular sports.

PMID:35620993 | DOI:10.23736/S2724-5276.22.06766-0

Laryngoscope. 2022 May 27. doi: 10.1002/lary.30231. Online ahead of print.

ABSTRACT

OBJECTIVE: Evaluate the effects of α-difluoromethylornithine (DFMO) on hearing thresholds as part of a randomized, double-blind, placebo-controlled trial.

METHODS: Subjects were randomized and assigned to the control (placebo) or experimental (DFMO) group. DFMO or placebo were administered orally (500 mg/m² /day) for up to 5 years.

RESULTS: Subjects taking DFMO had, on average, increased hearing thresholds from baseline across the frequency range compared to subjects in the control group. Statistical analysis revealed this was significant in the lower frequency range.

CONCLUSIONS: This randomized controlled trial revealed the presence of increased hearing thresholds associated with long-term DFMO use. As a whole, DFMO may help prevent and treat certain types of cancers; however, it can result in some degree of hearing loss even when administered at low doses. This study further highlights the importance of closely monitoring hearing thresholds in subjects taking DFMO. Laryngoscope, 2022.

PMID:35620919 | DOI:10.1002/lary.30231

Int J Nurs Pract. 2022 May 27:e13067. doi: 10.1111/ijn.13067. Online ahead of print.

ABSTRACT

AIM: This study aimed to compare the effects of breastfeeding, breast milk odour and mother’s heartbeat sounds on perceived pain during heel lance procedures in term newborns.

DESIGN: This was a randomized three-group experimental study.

METHODS: The sample of the study consisted of 90 newborns. The data were collected using pulse oximeter, fetal hand doppler, voice recorder, loudspeaker, a data collection form and the ALPS-Neo Pain and Stress Assessment Scale for Newborn Infants.

RESULTS: During the procedure, newborns in the breast milk odour group had high levels of pain and stress, those in the mother’s heartbeat sounds group had mild pain and stress, and those in the breastfeeding group had no pain and stress. Additionally, a statistically significant difference was found between their crying times. This difference was the highest for newborns in the breast milk odour group, followed by the mother’s heartbeat sounds and breastfeeding groups, respectively.

CONCLUSION: Breastfeeding and mother’s heartbeat sounds, which are non-pharmacological pain relief methods, are effective in neonatal pain management. However, breast milk odour is not effective for pain control in newborns. Further studies should examine the efficacy combinations of these methods.

PMID:35620884 | DOI:10.1111/ijn.13067

BJOG. 2022 May 27. doi: 10.1111/1471-0528.17240. Online ahead of print.

ABSTRACT

OBJECTIVES: To examine the association between race and preeclampsia(PE) and gestational hypertension(GH) after adjustment for factors in maternal characteristics and medical history in screening study from the Fetal Medicine Foundation (FMF) in England, and to perform a systematic review and meta-analysis of studies on PE.

METHODS: In the FMF data regression analysis was performed to examine the association between race and PE or GH. Literature search to December 2021 was carried out to identify peer-reviewed publications on race and PE.

MAIN OUTCOME MEASURE: Relative risk of PE and GH in women of black, South Asian and East Asian race by comparison to white women.

RESULTS: In the FMF study there were 168,966 singleton pregnancies without major abnormalities delivering at ≥24 weeks’ gestation. In black women the respective risk of total-PE and preterm-PE was 2-fold and 2.5-fold higher and risk of GH was 25% higher, in South Asian women there was a 1.5-fold higher risk of preterm-PE but not total-PE, and in East Asian women there was no statistically significant difference in risk of hypertensive disorders. The literature search identified 19 studies that provided data on several million of pregnancies, but 17 were at moderate or high-risk of bias and only three provided risks adjusted for some maternal characteristics; consequently, these studies did not provide accurate contribution of different racial groups to the prediction of PE.

CONCLUSION: In women of black and South Asian origin the risk of PE, after adjustment for confounders, is higher than in white women.

PMID:35620879 | DOI:10.1111/1471-0528.17240

J Biomed Mater Res B Appl Biomater. 2022 May 27. doi: 10.1002/jbm.b.35104. Online ahead of print.

ABSTRACT

Infection associated with tissue-contacting biomedical devices is a compelling clinical problem initiated by the microbial colonization of the device surface. Among the possible sources of contaminating bacteria is the operating room (OR) itself, where viable bacteria in the atmosphere can sediment onto a device surface intraoperatively. We have developed an aerosolizing system that can reproducibly spray small quantities of aerosolized bacteria onto a surface to mimic OR contamination. This paper describes the design of the system and characterizes key aspects associated with its operation. The area density of sprayed bacteria is on the order of 10² /cm² . Using titanium (Ti) alloy coupons as test substrates contaminated by staphylococci, we quantify the fraction of bacteria that are well adhered to the substrate, those that can be removed by sonication, and those that are not recovered after spraying. Despite the relatively low levels of surface contamination, we furthermore show that such a model is able to demonstrate a statistically significant reduction in colonization of Ti coupons modified by antimicrobial quaternary ammonium compounds relative to unmodified controls.

PMID:35620867 | DOI:10.1002/jbm.b.35104

BJOG. 2022 May 27. doi: 10.1111/1471-0528.17241. Online ahead of print.

ABSTRACT

OBJECTIVE: Idiopathic intracranial hypertension (IIH) predominantly affects women of reproductive age with obesity and women have a distinct profile of hyperandrogenism and insulin resistance. Polycystic ovary syndrome (PCOS) has an established adverse fertility phenotype that typically affects obese women. As IIH may impact reproductive health, we sought to evaluate fertility, gestational complications, and pregnancy outcome in IIH.

DESIGN: Prospective cohort study from English Hospital Episode Statistic dataset SETTING: English hospitals, United Kingdom POPULATION: Women aged 18-45 years seen in English hospitals between 1^st April 2002 and 31^st March 2019. Patients were required to have an IIH diagnosis and were compared to those with PCOS and general population female controls.

MAIN OUTCOME MEASURES: Pregnancies resulting in live births, complications of gestational diabetes and pre-eclampsia, and method of delivery.

RESULTS: Data was collected from 17587 IIH, 199633 PCOS, and 10947012 general population women. The live birth rate, adjusted for age, was significantly lower amongst women with IIH (54.1%) compared to PCOS (67.9%), p<0.0001 and general population (57.7%), p<0.0001. Pre-eclampsia and gestational diabetes risks were higher following a diagnosis of IIH (5.3-fold and 2.7-fold respectively, p<0.0001) compared to the general population controls. Following a diagnosis of IIH, elective caesarean section rates were more than twice that of general population (OR 2.4) and prior to a diagnosis of IIH (OR 2.2).

CONCLUSIONS: This data indicates there are lower age-adjusted total pregnancy rates, increased risk of pre-eclampsia and gestational diabetes and a doubling of elective caesarean section rates in those with a diagnosis of IIH.

PMID:35620863 | DOI:10.1111/1471-0528.17241

Brain Behav. 2022 May 27:e2635. doi: 10.1002/brb3.2635. Online ahead of print.

ABSTRACT

OBJECTIVE: Deep brain stimulation (DBS) has been used on drug-resistant Gilles de la Tourette syndrome (GTS) for more than two decades until now, but the stimulating targets are still under exploration until now. In this study, the authors reported the efficacy of the bilateral posteroventral globus pallidus interna (GPi) DBS on tic severity and neuropsychiatry symptoms of seven individuals with GTS.

METHOD: Seven patients with drug-resistant GTS were enrolled in this study. The severity of these patients was evaluated with Yale Global Tics Severity Scale (YGTSS), Yale Brown Obsessive Compulsive Scale (YBOCS), Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), and Global Assessment of Functioning Scale (GAF). Bilateral posteroventral GPi were selected as the permanent stimulating targets. Follow-up period was at least 5 years after surgery in the enrolled patients.

RESULTS: After surgery, one patient reported no improvement during the follow-up period, and a device removal surgery was performed. The other six patients reported minor to significant improvement. The overall YGTSS, YBOCS, HAMA HAMD, and GAF scores of these patients were changed positively after surgery, but only the improvement of the motor tic and HAMD scores had a statistical difference. No surgical complication was reported.

CONCLUSIONS: Bilateral posteroventral GPi DBS could relieve the motor tics and depressive symptoms of the enrolled patients significantly, but the vocal tics and other psychiatric symptoms presented a progression without statistical difference during the follow-up period. The results of this study suggested that bilateral posteroventral GPi are effective targets for the motor tics in GTS patients, especially with prominent depressive symptoms.

PMID:35620847 | DOI:10.1002/brb3.2635

J Asthma. 2022 May 27:1-9. doi: 10.1080/02770903.2022.2082308. Online ahead of print.

ABSTRACT

Objective: To identify features related to management of patients prior to referral from primary care physicians (PCPs) to pulmonologists and allergists.Methods: This is an analysis of patient claims data from Symphony Health (2013-2018). To characterize referrals, a longitudinal cohort included 12 months with no asthma claims prior to the index date, followed by 36 months of observation. We also assessed a cross-sectional cohort for 12 months at the end of the observational period to characterize disease control and treatment patterns. Referral was defined as the first appearance of a claim from an allergist or pulmonologist for a patient’s initial visit for asthma. Descriptive statistics were used to analyze the data.Results: The majority of patients with asthma were managed by PCPs (60%), followed by pulmonologists (16%) and allergists (8%). Forty-three percent had uncontrolled asthma. Only 8% of were referred to specialists within the first 24 months after initial diagnosis, of which 76% were seen by pulmonologists and 24% by allergists. Referrals resulted in treatment change in 55%-68% of the cases. Patients who received a referral were more likely to be on oral corticosteroids (OCS) and/or have more hospitalizations/ED visits.Conclusions: About one third of the patients managed by PCPs received intermittent and/or chronic OCS prior to referral which may be an indication of uncontrolled disease. The referral patterns in this analysis illustrate underutilization of specialists in the consultation and management of patients with uncontrolled asthma.

PMID:35620831 | DOI:10.1080/02770903.2022.2082308

Psychiatry Investig. 2022 May;19(5):394-400. doi: 10.30773/pi.2022.0014. Epub 2022 May 23.

ABSTRACT

OBJECTIVE: Baseline amyloid burden in mild cognitive impairment (MCI) has been linked to conversion to Alzheimer’s disease (AD), but the comparison of baseline and longitudinal changes in amyloid burden for predicting AD remains unresolved. The objectives of this study aimed to compare the prognostic ability of baseline and longitudinal changes in amyloid burden in MCI patients.

METHODS: Seventy-five individuals with MCI were recruited and examined annually by clinical interviews for a mean follow-up of 24 months (range, 11.6-42.0). [18F]Florbetaben positron emission tomography (PET) scans were performed. T1-weighted 3D volumes were acquired for co-registration, and to define regions of interest. We examined whether baseline and longitudinal amyloid burden changes can improve AD conversion by Cox proportional hazard model analysis and receiver operating characteristic (ROC) curve analysis.

RESULTS: Cox proportional hazards model analysis showed that baseline amyloid burden was significantly associated with increased risk of conversion to AD (hazard ratio [HR]=10.0; 95% confidence interval [CI], 1.15-85.39; p=0.04), but longitudinal amyloid burden changes was not (HR=0.2; 95% CI, 0.02-1.18; p=0.07). When predicting AD, longitudinal amyloid burden changes had better ROC accuracy of 65.2% (95% CI, 48.4-82.0) than baseline amyloid burden of 59.6% (95% CI, 40.3-79.0), without statistical significance in pairwise comparison.

CONCLUSION: A single baseline amyloid PET could be sufficient in the prediction of AD conversion in MCI.

PMID:35620825 | DOI:10.30773/pi.2022.0014