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Experimental cadaveric study assesing protection and osteotomy guide system (BARU) in hallux valgus surgery using Reverdin-Isham technic

Acta Ortop Mex. 2021 Mar-Apr;35(2):132-136.

ABSTRACT

INTRODUCTION: Hallux valgus is a high frequency disorder, affecting the first ray. Operative correction techniques have grown popularity lately. One of them is the Reverdin-Isham technique (first metatarsal medial incomplete osteotomy). Recently, a protection and osteotomy cutting guide has been developed: the BARU system.

OBJECTIVE: To test the usefulness of the BARU system as a protective factor for soft structures adjacent to the surgical site and guidance for osteotomy.

MATERIAL AND METHODS: Experimental cadaveric study. Six cadaveric feet (two fresh-frozen and four in formaldehyde solution), unapproached. Feet were numbered and intervened with RI technique, three of them with BARU system and three without it. Afterwards, dissection by two dissectors who did not know whether the BARU system had been used or not, establishing a single-blinded model. 13 structures were evaluated in each foot. Data was recovered into Microsoft Office Excel and processed with SPSS. 2 test (significative if p value < 0.05) and relative risk were calculated.

RESULTS: Approach using BARU system was satisfactory, with usual-size operation-ports. BARU system colocation was simple and radiological control showed adequate spatial location. The device contributed as reference for cutting direction and depth. 65 out of the 78 searched structures were found (83.3%). Six injuries were found among the assessed structures: plantar medial nerve (one injury), plantar medial artery (one injury), flexor brevis muscle (three injuries), abductor muscle (one injury). Five of these injuries occurred in non-utilizing BARU system feet.

CONCLUSION: Promising results in terms of protection of nearby structures, cutting guide, and ease of intervention. Avoids X-rays exposure. Not significant statistical calculations, the sample should be enlarged.

PMID:34731912

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Medial Olivocochlear Reflex Effect on Cochlear Response in Humans: Elicitor Side and Level

J Am Acad Audiol. 2021 Jun;32(6):366-373. doi: 10.1055/s-0041-1728649. Epub 2021 Nov 3.

ABSTRACT

BACKGROUND: Understanding the functional differences between crossed and uncrossed medial olivocochlear (MOC) neurons has been of interest to researchers for decades. Previous reports revealed conflicting results about which MOC pathway, crossed or uncrossed, is stronger in humans. Both crossed and uncrossed MOC neurons synapse at the base of the outer hair cells (OHCs) in each ear. OHCs generate the cochlear microphonic, which is a major contributor to the cochlear response (CR) PURPOSE: The current study investigated the effects of eliciting the crossed and uncrossed MOC reflex (MOCR) on CR in humans with three levels of noise.

RESEARCH DESIGN: Normal-hearing, young adults (n = 16) participated in this study. The CR was recorded using 500 Hz tone-burst stimuli presented at 80 dB nHL. To examine the crossed and uncrossed MOCR, CR was recorded without and with continuous ipsilateral or contralateral broadband noise (BBN) at three levels (40, 50, and 60 dB SPL).

DATA ANALYSIS: Analysis of the CR was completed using the amplitude of the response extracted using fast Fourier transform. Statistical analysis was completed using repeated measures analysis of variance and post-hoc analysis.

RESULTS: Compared with baseline, the presentation of BBN, specifically contralaterally, resulted in CR enhancement with no significant difference as a function of the three BBN levels. Greater enhancement of the CR amplitude was observed with contralateral than ipsilateral BBN elicitor.

CONCLUSIONS: The current findings suggest that a contralateral elicitor of the uncrossed MOC pathway results in a larger CR amplitude enhancement compared with an ipsilateral elicitor of the crossed MOC pathway, regardless of the elicitor level. Eliciting the MOCR appears to modulate the OHCs function. Furthermore, assessing the MOCR with the 500 Hz CR with BBN elicitors at moderate levels should separate its effects (i.e., increase response amplitude) from those associated with the middle ear muscle reflex (i.e., reduce response amplitude).

PMID:34731904 | DOI:10.1055/s-0041-1728649

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The Eye Van – An Evaluation of the Quality of Care of Visually Impaired People in the Rural Areas of South Baden

Klin Monbl Augenheilkd. 2021 Nov 3. doi: 10.1055/a-1553-4256. Online ahead of print.

ABSTRACT

BACKGROUND: Especially in rural areas, access of visually impaired people to ophthalmic care and counselling can be limited. The Eye Van is a project supported by the Ministry for Rural Affairs and Consumer Protection Baden-Württemberg which offers visually impaired people an on-the-spot ophthalmological examination and counselling on low-vision aids and social support services. The aim of this project was to evaluate the quality of care provided to visually impaired people in the rural areas of South Baden.

MATERIALS AND METHODS: Between 2016 and 2019, 45 villages in South Baden participated in this project. The visits were advertised in the local press. Appointments were assigned and participant eligibility was assessed over the telephone by the local Federation of the Blind and Partially Sighted in South Baden. During the on-site visits, a medical history was obtained from participants, who then received a comprehensive ophthalmological examination and counselling on low-vision aids and social support services. Interviews were conducted in order to determine the expectations of the participants and to assess their quality of life. A second interview, focused on the measures that had been implemented and changes in the participants’ quality of life, was carried out three months later.

RESULTS: In total, 264 participants were examined. Of these, 101 participants fulfilled the criteria of moderate/severe visual impairment or blindness defined by the WHO (World Health Organization). The mean age of the visually impaired participants was 85 years. The median decimal visual acuity was 0.08. The median length of time since the participants’ last ophthalmological examination was one year. Among the visually impaired participants, 13% did not have any low-vision aids. Their use was recommended to 62% of the visually impaired participants. The main expectation of participants was counselling on low-vision aids and support services. Among all the participants, 42 did one interview and 28 did two interviews. In the second interview, 72% of the participants claimed to have implemented the recommendations. There was no statistically significant change in their quality of life.

CONCLUSION: The access of visually impaired people to ophthalmic care does not seem to be limited in the rural areas of South Baden. Nevertheless, there was a high demand for counselling on low-vision aids and social support services.

PMID:34731897 | DOI:10.1055/a-1553-4256

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Outcomes of Resident Performed Hydrus, iStent, and Kahook Glaucoma Procedures in a Predominantly African-American Population

J Glaucoma. 2021 Nov 3. doi: 10.1097/IJG.0000000000001958. Online ahead of print.

ABSTRACT

PRECIS: This retrospective study characterized the efficacy and safety of three different microinvasive glaucoma surgery (MIGS) procedures in a predominantly African-American population at the Philadelphia Veterans Affairs Hospital (Hydrus, Kahook, iStent), demonstrating no significant difference in IOP and medication reduction between the three at long term follow up.

PURPOSE: To compare the efficacy and safety of three different microinvasive glaucoma surgery (MIGS) procedures in a predominantly African-American population.

METHODS: Retrospective cohort study of patients undergoing cataract extraction combined with one of three MIGS procedures (Hydrus, iStent, Kahook) at the Philadelphia Veterans Affairs Medical Center between 1/1/2015 and 11/1/2020. Analysis of variance and regression models were used to compare reduction in intraocular pressure (IOP) and medication use among three MIGS types.

RESULTS: 123 eyes of 112 patients were included, including 56 (45.5%) eyes for Hydrus, 40 (32.5%) eyes for iStent , and 27 (22.0%) eyes for Kahook. Adjusted mean IOP reduction was greater for Hydrus at postoperative day 1 (-4.49 vs. -1.76 for iStent and -1.69 for Kahook, P=0.05 and greater for Kahook at postoperative week 1 (-2.53 vs. +0.70 for iStent vs. -1.41 for Hydrus, P=0.02), but did not differ significantly between MIGS types at subsequent postoperative visits (all P>0.05). In multivariable analysis, MIGS type was not significantly associated with reduction in IOP or medication use at 9-12 months postoperatively. There were no significant differences in complication rates across MIGS types.

CONCLUSION: In this study, the difference in IOP lowering and medication reduction postoperatively between the Hydrus, iStent, and Kahook was not statistically significant after postoperative day 1. More studies are needed to evaluate outcomes of MIGS surgeries in glaucoma populations of different disease severity.

PMID:34731870 | DOI:10.1097/IJG.0000000000001958

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Minimally Invasive Micro Sclerostomy (MIMS) Procedure – A Novel Glaucoma Filtration Procedure

J Glaucoma. 2021 Nov 3. doi: 10.1097/IJG.0000000000001955. Online ahead of print.

ABSTRACT

PRECIS: Intermediate term results suggest that ab-interno Minimally Invasive Micro Sclerostomy (MIMS) stent less subconjunctival filtration procedure is a promising treatment option for patients with open angle glaucoma.

PURPOSE: Minimally Invasive Micro Sclerostomy (MIMS) is a novel ab-interno, stent-less, subconjunctival filtration procedure. This study set to investigate the safety, performance and efficacy of MIMS in open angle glaucoma patients.

METHODS: Prospective, open-label, single arm clinical trial with intra-subject comparisons. Study participants were adults with open angle glaucoma who were candidates for a filtration procedure. Patients were operated by a single surgeon (A.A) in Chennai, India. Following mitomycin C pretreatment, Ab-interno MIMS procedure was performed alone or combined with Phacoemulsification surgery. Procedure-related complications and adverse events were assessed. Primary outcomes: patients (%) achieving an IOP≥5▒mmHg and ≤18▒mmHg, and an IOP reduction of >20% as compared to baseline, with or without hypotensive medications, with no need for recurrent surgery.

RESULTS: 21 Phacoemulsification-MIMS and 10 standalone MIMS procedures were performed. Mean age was 63.94±6.33 years. Mean duration of MIMS was 1:58±0:25 (min:sec). Scleral tunnels were achieved in all cases. No device malfunctions, intra-operative complications, or serious adverse events were reported. Five (16.12%) patients presented with iris clogging 1-24 weeks following procedure. Two were treated with laser and 3 required trabeculectomy. Mean IOP change from baseline at 24 weeks was 47.4% (31.2 to 16.4▒mmHg, P<0.0001, n=23). The mean difference was -14.8▒mmHg (95% CI: -17.6, -11.9) with no statistically significant differences between groups. Qualified success was achieved in 21 (84%), 17 (74%) and 13 (93%) after 12, 24, and 52 weeks, respectively. Complete success was achieved in 17 (68%), 13 (57%) and 8 (57%) after 12, 24, and 52 weeks, respectively.

CONCLUSIONS: The interim results suggest that MIMS procedure may be a simple and effective surgical option for early open angle glaucoma patients requiring target IOP in high teens although iris clogging of incision site is the major concern with this procedure.

PMID:34731867 | DOI:10.1097/IJG.0000000000001955

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Comparison of Efficacy and Safety of XEN45 Implant Versus Trabeculectomy in Asian Eyes

J Glaucoma. 2021 Nov 3. doi: 10.1097/IJG.0000000000001954. Online ahead of print.

ABSTRACT

PRECIS: Combined phacoemulsification and trabeculectomy is able to achieve greater reduction in intraocular pressure (IOP), higher rates of complete surgical success and fewer postoperative manipulations and visits compared with combined phacoemulsification and Xen implantation in glaucomatous eyes.

PURPOSE: Our study aims to compare and understand the differences between the efficacy and safety of XEN45 implantation and trabeculectomy in Asian eyes with glaucoma.

MATERIALS AND METHODS: This was a retrospective, single-center, comparative study of consecutive patients who underwent combined phacoemulsification and trabeculectomy (Phaco-Trab) from January 2013 to June 2014 and combined phacoemulsification and XEN45 implantation (Phaco-Xen) from May 2017 to September 2018 in a tertiary Ophthalmology center in Singapore. Outcome measures included IOP, number of anti-glaucoma eyedrops, success rate, factors leading to success/failure, number of postoperative interventions and visits required, and surgical complications.

RESULTS: A total of 137 eyes (91 Phaco-Trab, 46 Phaco-Xen) were included. Phaco-Trab group had greater mean IOP reduction at all time points beyond postoperative month (POM) 1 (mean difference 2.9 to 3.8 mm Hg; P<0.05), and greater reduction in mean number of antiglaucoma eyedrops beyond POM3, thought this was not statistically significant. At POM12, complete success was achieved in 83.5% in Phaco-Trab and 52.2% of Phaco-Xen group, respectively (P<0.001). There was no significant factor associated with surgical failure, other than the difference in surgical procedure. Phaco-Trab group required fewer number of postoperative interventions (P=0.009), with only a mean of 0.1 bleb interventions required per patient, versus 1.5 in Phaco-Xen group (P<0.001). Safety profiles in both groups were comparable, with no statistically significant difference in intraoperative/postoperative complications.

CONCLUSION: Phaco-Trab has significantly higher reduction in both IOP and number of antiglaucoma medications compared with Phaco-Xen group, with greater surgical success and fewer postoperative manipulations and visits. Safety profiles were comparable.

PMID:34731866 | DOI:10.1097/IJG.0000000000001954

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Review of available data for the efficacy and effectiveness of nabiximols oromucosal spray (Sativex) in multiple sclerosis patients with moderate to severe spasticity

Neurodegener Dis. 2021 Nov 3. doi: 10.1159/000520560. Online ahead of print.

ABSTRACT

BACKGROUND: Sativex (USAN: nabiximols) oromucosal spray is indicated for treatment of multiple sclerosis (MS) patients with moderate to severe spasticity and inadequate response to other antispasticity medications who demonstrate clinically significant improvement during an initial trial of therapy. This narrative review investigated the efficacy and effectiveness of nabiximols oromucosal spray for moderate to severe MS spasticity by examining spasticity 010 Numerical Rating Scale (NRS) data from interventional and observational studies which featured a 4-week trial period as per the European Union approved label.

SUMMARY: Across both study types, clinically relevant and statistically significant reductions in mean MS spasticity 0-10 NRS scores were measured soon after treatment start and were maintained in the mid to long term in treatment responders. Initial responder rates (≥ 20% NRS improvement from baseline at week 4) ranged from 47.6% to 81.4%, tending lower in the randomized clinical trials setting. Clinically relevant responder rates (≥ 30% NRS improvement from baseline at week 12) were similar between study types (range 3041%) except for one outlier (74% in an observational study). Two open studies reported treatment continuation for ≥ 18 months in approximately half of patients who initiated treatment. In most longer-term studies, symptomatic improvement in MS spasticity was maintained at mean daily dosages of about 67 sprays/day. Safety was consistent with the known profile of nabiximols. Key messages: Experimental and observational studies of nabiximols oromucosal spray recorded similar findings. About half to two-thirds of MS patients who begin treatment will perceive initial symptomatic relief of spasticity within the 4-week trial period. About 40% of patients who initiate treatment will reach the ≥ 30% NRS improvement threshold at 3 months, comprising the majority of patients who continue long-term treatment. A trial of therapy with nabiximols is useful to identify patients most likely to gain longer-term improvement in spasticity symptoms and discontinue those with insufficient benefit.

PMID:34731865 | DOI:10.1159/000520560

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The Association between Serum Bilirubin and Kernicterus Spectrum Disorder: A Systematic Review and Meta-Analysis

Neonatology. 2021 Nov 3:1-11. doi: 10.1159/000519497. Online ahead of print.

ABSTRACT

BACKGROUND: Total serum bilirubin (TSB) is used in managing neonates with jaundice, but clear evidence on its association with major outcomes is lacking.

OBJECTIVES: We evaluated the association between TSB and kernicterus spectrum disorder (KSD).

METHODS: We searched PubMed, EMBASE, and CENTRAL till July 2021. Two authors independently selected relevant cohort studies, extracted data (CHARMS checklist), assessed risk of bias (RoB) (QUIPS tool), and rated certainty-of-evidence (Grades of Recommendation, Assessment, Development, and Evaluation). We pooled adjusted odds ratio (aOR) (random-effect) via generic inverse variance methods.

RESULTS: From 2,826 records retrieved, we included 37 studies (n = 648,979). Fifteen studies had low, 16 moderate, and 6 high RoB, with majority having concerns on confounder adjustment and statistical analysis. Twenty-two studies contributed meta-analysis data, and 15 were summarized narratively. TSB appears associated with KSD in infants with certain risk factors (aOR 1.10, 95% CI: 1.07-1.13; 5 studies [n = 4,484]). However, TSB (aOR 1.10, 95% CI: 0.98-1.23; 1 study [n = 34,533]) or hyperbilirubinemia (aOR 1.00, 95% CI: 0.51-1.95; 2 studies [n = 56,578]) have no clear association with kernicterus or neurological diagnosis in overall neonatal population (moderate-certainty-evidence). One study shows that infants with hyperbilirubinemia appear likelier to develop attention-deficit disorder (aOR 1.90, 95% CI: 1.10-3.28) and autistic spectrum disorder (aOR 1.60, 95% CI: 1.03-2.49, n = 56,019) (low-certainty-evidence). Certain clinical factors appear associated with KSD, although very few studies contributed to the analyses.

CONCLUSIONS: Despite the importance of this question, there is insufficient high-quality evidence on the independent prognostic value of TSB for adverse neurodevelopmental outcomes in most neonatal populations. Future studies should incorporate all known risk factors alongside TSB in a multivariable analysis to improve certainty-of-evidence.

PMID:34731859 | DOI:10.1159/000519497

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Impact of work routines on parents’ and children’s sleep during the COVID-19 pandemic lockdown

Sleep Med. 2021 Oct 15;88:61-67. doi: 10.1016/j.sleep.2021.10.005. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effects of parental sleep and work arrangements on children’s sleep duration during the national lockdown period, referred to as ‘Circuit Breaker’ (CB), due to COVID-19.

METHODS: Cross-sectional, anonymous, online questionnaire to parents with school-going children aged between 3 and 16 years. Child and parental sleep duration in relation to change in parental work arrangements, housing type and number of individuals in the household as reported by parents were evaluated. Descriptive statistics and tests of comparison were used to evaluate data.

RESULTS: School-going children (n = 593) had a mean age of 8.68 (SD = 3.65; median 7) years. Both, fathers and mothers had gains in sleep during CB (based on self-reported sleep data), compared to pre-CB. Change in both maternal and paternal sleep duration positively correlated with change in child sleep duration (based on parent-reported sleep data) among all children (r2 = 0.27, p < 0.001 and r2 = 0.17, p < 0.001 respectively); pre-schoolers mirrored their mothers’ sleep more closely. Parents who changed to working from home during the CB (compared to working from outside home previously) had the greatest gains in sleep during this period. Housing type was not significantly associated with change in child sleep duration from pre-CB to CB.

CONCLUSIONS: Greater gains in sleep in parents was associated with working from home during CB. Child sleep duration mirrored gains in parental sleep, especially in pre-school and primary-school-going children. Optimising parental sleep may therefore be one of the means to improve child sleep.

PMID:34731830 | DOI:10.1016/j.sleep.2021.10.005

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Effect of resveratrol supplementation on biomarkers associated with atherosclerosis in humans

Complement Ther Clin Pract. 2021 Oct 6;46:101491. doi: 10.1016/j.ctcp.2021.101491. Online ahead of print.

ABSTRACT

Previous studies have suggested the beneficial effects of resveratrol against cardiovascular disease (CVD). However, there are inconsistent results on cardiovascular-related biomarkers mainly because of variable dosage, intervention time and baseline characteristics of the population. Thus, the exact effect of resveratrol remains unclear. We conducted a review to classify the studies that applied resveratrol to supplement humans according to the major biomarkers and identify which protocol characteristics would be associated with each result profile. Randomized clinical trials that assessed resveratrol effect on biomarkers related to atherosclerosis were searched in databases. Biochemical data were collected from 27 studies on the baseline and post-intervention time. We selected 12 biomarkers to compose the matrix, based on their clinical relevance and higher variation level. A total of 32 assays were obtained from these 27 studies. The net change (%) was calculated for each biomarker. Applying multivariate analysis, the assays were grouped into 3 clusters. Studies that composed Cluster II were characterized by a mean dose of 454.14 mg/day for 74.21 days and showed higher reduction of triglyceride concentration and blood pressure, while those composing Cluster III applied doses around 273.75 mg/day for about 175.33 days and showed the highest HDL increase. Thus, interventions with resveratrol could be customized according to the patient condition, in terms of “dose/time of intervention”. This information can be applied to combine resveratrol with drugs to reduce blood pressure or improve lipid profile in further clinical studies.

PMID:34731768 | DOI:10.1016/j.ctcp.2021.101491