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Nevin Manimala Statistics

Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial

Cerebrovasc Dis. 2021 Jul 28:1-7. doi: 10.1159/000517608. Online ahead of print.

ABSTRACT

BACKGROUND: The benefit of anticoagulation therapy in atrial fibrillation (AF) and chronic kidney disease (CKD) remains controversial. We aimed to evaluate the impact of renal function on the quality of anticoagulation control, and the effects of both these factors on outcomes in AF.

METHODS: Post hoc analysis of the AMADEUS trial. Trial-related outcomes were adjudicated and we studied the composite of first stroke/major bleeding/all-cause mortality, ischaemic stroke, major bleeding, all-cause mortality, and cardiovascular mortality.

RESULTS: We included 2,282 vitamin K antagonist (VKA)-treated patients {n = 787 (34.5%) females; median age 72 (interquartile ranges [IQR] 64-77) years}. Median follow-up was 365 (IQR 189-460) days. There were 1,922 (84.2%) non-CKD and 360 (15.8%) CKD patients. Renal function was inversely correlated with time-in-therapeutic range (r = -0.047, p = 0.025). There was no statistical difference in terms of crude study outcomes based on renal function. Multivariable regression analysis demonstrated that moderate renal failure with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 (p = 0.032) and percentage of time-in-therapeutic range (p = 0.011) were independent predictors for the composite outcome of stroke, major bleeding, and all-cause mortality.

CONCLUSION: Deteriorated renal function has a small negative impact on the quality of anticoagulation control with VKA which is linked to poor outcomes in AF. However, moderate renal failure itself was an independent risk factor for increased risk of stroke, major bleeding, and all-cause mortality amongst patients with AF.

PMID:34320504 | DOI:10.1159/000517608

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How Can eHealth Meet the Hearing and Communication Needs of Adults With Hearing Impairment and their Significant Others? A Group Concept Mapping Study

Ear Hear. 2021 Jul 27. doi: 10.1097/AUD.0000000000001097. Online ahead of print.

ABSTRACT

OBJECTIVES: To seek the perspectives of key stakeholders regarding: (1) how eHealth could help meet the hearing and communication needs of adults with hearing impairment and their significant others; and (2) how helpful each aspect of eHealth would be to key stakeholders personally.

DESIGN: Group concept mapping, a mixed-methods participatory research method, was used to seek the perspectives of key stakeholders: adults with hearing impairment (n = 39), significant others (n = 28), and hearing care professionals (n = 56). All participants completed a short online survey before completing one or more of the following activities: brainstorming, sorting, and rating. Brainstorming required participants to generate ideas in response to the focus prompt, “One way I would like to use information and communication technologies to address the hearing and communication needs of adults with hearing loss and their family and friends is to….” The sorting task required participants to sort all statements into groups that made sense to them. Finally, the rating task required participants to rate each of the statements according to “How helpful would this idea be to you?” using a 5-point Likert scale. Hierarchical cluster analysis was applied to the “sorting” data to develop a cluster map using the Concept Systems software. The “rating” data were subsequently analyzed at a cluster level and an individual-item level using descriptive statistics. Differences in cluster ratings between stakeholder groups were examined using Kruskal-Wallis tests.

RESULTS: Overall, 123 statements were generated by participants in response to the focus prompt and were included in subsequent analyses. Based on the “sorting” data and hierarchical cluster analysis, a seven-cluster map was deemed to be the best representation of the data. Three key themes emerged from the data, including using eHealth to (1) Educate and Involve Others; (2) Support Aural Rehabilitation; and (3) Educate About and Demonstrate the Impacts of Hearing Impairment and Benefits of Hearing Rehabilitation. Overall median rating scores for each cluster ranged from 3.97 (educate and involve significant others) to 3.44 (empower adults with hearing impairment to manage their hearing impairment from home).

CONCLUSIONS: These research findings demonstrate the broad range of clinical applications of eHealth that have the capacity to support the implementation of patient- and family-centered hearing care, with self-directed educational tools and resources typically being rated as most helpful. Therefore, eHealth appears to be a viable option for enabling a more biopsychosocial approach to hearing healthcare and educating and involving significant others in the hearing rehabilitation process without adding more pressure on clinical time. More research is needed to inform the subsequent development of eHealth interventions, and it is recommended that health behavior change theory be adhered to for such interventions.

PMID:34320524 | DOI:10.1097/AUD.0000000000001097

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Automated Adaptive Wideband Acoustic Reflex Threshold Estimation in Normal-hearing Adults

Ear Hear. 2021 Jul 26. doi: 10.1097/AUD.0000000000001102. Online ahead of print.

ABSTRACT

Acoustic stapedius reflex threshold (ART) tests are included in a standard clinical acoustic immittance test battery as an objective cross-check with behavioral results and to help identify site of lesion. In traditional clinical test batteries, middle-ear admittance of a 226 Hz probe is estimated using ear-canal measurements in the presence of a reflex-activating stimulus. In the wideband (WB) acoustic immittance ART test used in this study, the pure-tone probe is replaced by a WB probe stimulus and changes in absorbed power are estimated using ear-canal measurements in the presence of the activator. The ART is defined as the lowest level at which a criterion change in admittance (clinical) or absorbed power (WB) is observed in the presence of the activator. In the present study, ARTs were obtained in adults with normal hearing using the clinical, manual method and with a new WB automated adaptive threshold detection method. It was hypothesized that the WB test would result in lower ARTs than the clinical test because reflex-related changes in power absorbance could be observed across multiple frequency bands in the WB test compared with a single frequency in the traditional test.

DESIGN: Data were collected in a prospective research design. ARTs were obtained in ipsilateral and contralateral conditions using 500, 1000, 2000 Hz, and broadband noise (BBN) activators on a clinical system and on an experimental WB system. The bandwidth of the BBN activator was 125 to 4000 Hz on the clinical system and 200 to 8000 Hz on the wideband system. ARTs were estimated at both tympanometric peak pressure (TPP) and ambient pressure on the WB system. Data were collected in both ears of 39 adults (21 males) of mean age 47.7 years (range 23-72 years). Differences in ARTs among the three threshold estimation methods (clinical, WB at TPP, WB at ambient) were examined using the general linear model repeated measures test in SPSS. Post-hoc pairwise comparisons were completed with Bonferroni correction for multiple comparisons. Statistical significance was defined as p < 0.05 for all analyses.

RESULTS: ARTs obtained on the WB system at TPP and ambient pressure were significantly lower than obtained on the clinical system. ARTs obtained on the WB system at TPP were significantly higher than at ambient pressure in the 500 and 2000 Hz ipsilateral conditions.

CONCLUSIONS: WB automated adaptive ARTs in normal-hearing adults were lower than for clinical methods when measured at TPP and ambient pressure. Lower presentation levels required to estimate ART in the WB test may be more tolerable to patients. Patients with ARTs that are not present at the maximum level of a traditional reflex test may have present ARTs with a WB ART test, which may reduce the need to refer for additional testing for possible retrocochlear involvement. Automation of the test may allow clinicians more time to attend to the other requisite tasks of a hearing evaluation and make the system useful for telehealth applications.

PMID:34320528 | DOI:10.1097/AUD.0000000000001102

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Comparative Efficacy and Acceptability of 3 Repetitive Transcranial Magnetic Stimulation Devices for Depression: A Meta-Analysis of Randomized, Sham-Controlled Trials

Neuropsychobiology. 2021 Jul 28:1-9. doi: 10.1159/000517859. Online ahead of print.

ABSTRACT

INTRODUCTION: Repetitive transcranial magnetic stimulation (rTMS) has been employed worldwide for therapy-resistant depression. The Food and Drug Administration has approved a number of therapeutic devices for treating major depressive disorder; however, no studies have examined the differences in efficacy and acceptability among commercially available stimulation devices. The aim of our study was to compare the efficacy and acceptability of 3 stimulation devices (NeuroStar, MagPro, and Magstim) for depressive disorders.

METHODS: Our study included 31 randomized sham-controlled trials of high-frequency rTMS included in the network meta-analysis by Brunoni. We calculated the risk ratio and 95% confidence intervals, comparing each device with sham for the endpoints of response rate, remission rate, and all-cause discontinuation. We then analyzed the differences among the devices in effect size for those endpoints.

RESULTS: After determining the effect sizes for the endpoints, we found no statistically significant subgroup differences in the response rates, all-cause discontinuation, or remission rates among the devices (p = 0.12, p = 0.84, and p = 0.07, respectively).

CONCLUSION: Our results suggest similar efficacy and acceptability for the 3 stimulation devices. Future studies need to perform head-to-head comparisons of the efficacy and acceptability of the stimulation devices for treating depression using the same stimulation protocols.

PMID:34320488 | DOI:10.1159/000517859

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Morphological Lesion Types Are Associated with Primary and Secondary Patency Rates after High-Pressure Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas

Blood Purif. 2021 Jul 28:1-10. doi: 10.1159/000516883. Online ahead of print.

ABSTRACT

BACKGROUND: Neointimal hyperplasia (NIH) is believed to be the main reason for arteriovenous fistula (AVF) dysfunction, but other mechanisms are also recognized to be involved in the pathophysiological process. This study investigated whether different morphological types of AVF lesions are associated with the patency rate after percutaneous transluminal angioplasty (PTA).

METHODS: This retrospective study included 120 patients who underwent PTA for autogenous AVF dysfunction. All the cases were evaluated under Doppler ultrasound (DU) before intervention and divided into 3 types: Type I (NIH type), Type II (non-NIH type), and Type III (mixed type). Prognostic and clinical data were analyzed by Kaplan-Meier analysis and the Cox proportional hazards model.

RESULTS: There was no statistical difference in baseline variables among groups, except for lumen diameter. The primary patency rates in Type I, Type II, and Type III groups were 78.4, 93.2, and 83.2% at 6 months and 59.5, 84.7, and 75.5% at 1 year, respectively. The secondary patency rates in Type I, Type II, and Type III groups were 94.4, 97.1, and 100% at 6 months and 90.5, 97.1, and 94.7% at 1 year, respectively. The Kaplan-Meier curve showed that the primary and secondary patency rates of Type I group were lower than those of Type II group. Multivariable Cox regression analysis demonstrated that postoperative primary patency was correlated with end-to-end anastomosis (hazard ratio [HR] = 2.997, p = 0.008, 95% confidence interval [CI]: 1.328-6.764) and Type I lesion (HR = 5.395, p = 0.004, 95% CI: 1.730-16.824).

CONCLUSIONS: NIH-dominant lesions of AVF evaluated by DU preoperatively were a risk factor for poor primary and secondary patency rate after PTA in hemodialysis patients.

PMID:34320498 | DOI:10.1159/000516883

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Photodynamic Therapy of Vitiligo: A Pilot Study

Photodiagnosis Photodyn Ther. 2021 Jul 25:102439. doi: 10.1016/j.pdpdt.2021.102439. Online ahead of print.

ABSTRACT

BACK GROUND: Vitiligo is an acquired autoimmune skin disorder with depigmented macules and patches. There are several possible treatments for vitiligo, none of which could be considered as a definitive cure. Photodynamic therapy (PDT) is a novel treatment with controversial outcomes in vitiligo patients.

MATERIALS & METHODS: A total of 10 patches (5 patches on the trunk, 3 on the extremities, and 2 on the neck) were selected and received microderm abrasion. Then the lesion was covered with 5- aminolevulinic acid (ALA) for one hour. Afterwards, it received red light with a dose of 120 J/cm2.This cycle was repeated monthly for 5 sessions. Another vitiligo patch was considered as a control and received topical mometasone twice a day during the study. The therapeutic results were compared by a blind dermatologist.

RESULTS: The median of repigmentation score, which was determined by a blind dermatologist, was 0.5 in the PDT group and 1 in the steroid group, which did not show any statistically significant difference.

CONCLUSION: The results of this study demonstrated that PDT does not have any additional therapeutic effect in comparison with topical corticosteroids as the traditional treatment of vitiligo.

PMID:34320426 | DOI:10.1016/j.pdpdt.2021.102439

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Effects of curcumin-mediated antimicrobial photodynamic therapy associated to different chelators against Enterococcus faecalis biofilms

Photodiagnosis Photodyn Ther. 2021 Jul 25:102464. doi: 10.1016/j.pdpdt.2021.102464. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the curcumin-mediated antimicrobial photodynamic therapy (aPDT) action combined or not with ethylenediaminetetraacetic acid (EDTA) and hydroxyethylidene bisphosphonate (HEBP) on Enterococcus faecalis biofilms.

METHODS: Enterococcus faecalis biofilms were grown on dentin bovine discs in brain heart infusion (BHI) medium with 1% glucose, in aerobic conditions at 37°C for 7 days. Then, they were randomly distributed to one of experimental conditions, as follows: control, 75 J.cm-2 LED, 600 μmol.L-1 curcumin, 17% EDTA, 18% HEBP, 600 μmol.L-1 curcumin plus 75 J.cm-2 LED, 600 μmol.L-1 curcumin plus 17% EDTA, 600 μmol.L-1 curcumin plus 18% HEBP, 600 μmol.L-1 curcumin plus 17% EDTA and 75 J.cm-2 LED or 600 μmol.L-1 curcumin plus 18% HEBP and 75 J.cm-2 LED. The viability of microorganisms and the vitality of biofilms were determined by colony forming unit counts and confocal scanning laser microscopy (CSLM), respectively. Statistical analysis was conducted by Kruskal Wallis and Dunn’s post-hoc tests (α = 0.05).

RESULTS: The results showed that all combinations of aPDT with chelators significantly reduced the viability of microbial cells and the vitality of biofilms in comparison to control, even when considering deeper layers of biofilms.

CONCLUSION: The combination of curcumin with EDTA and HEBP similarly improved the effect of aPDT on E. faecalis biofilms.

PMID:34320428 | DOI:10.1016/j.pdpdt.2021.102464

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Revisiting FDA Approval of Aducanumab

N Engl J Med. 2021 Jul 28. doi: 10.1056/NEJMp2110468. Online ahead of print.

NO ABSTRACT

PMID:34320282 | DOI:10.1056/NEJMp2110468

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Discovering dynamic models of COVID-19 transmission

Transbound Emerg Dis. 2021 Jul 28. doi: 10.1111/tbed.14263. Online ahead of print.

ABSTRACT

Existing models about the dynamics of COVID-19 transmission often assume the mechanism of virus transmission and the form of the differential equations. These assumptions are hard to verify. Due to the biases of country-level data, it’s inaccurate to construct the global dynamic of COVID-19. This research aims to provide a robust data-driven global model of the transmission dynamics. We apply Sparse Identification of Nonlinear Dynamics (SINDy) to model the dynamics of COVID-19 global transmission. One advantage is that we can discover the nonlinear dynamics from data without assumptions in the form of the governing equations. To overcome the problem of biased country-level data on the number of reported cases, we propose a robust global model of the dynamics by using maximin aggregation. Real data analysis shows the efficiency of our model. This article is protected by copyright. All rights reserved.

PMID:34320273 | DOI:10.1111/tbed.14263

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Improvement in Hidradenitis Suppurativa and Quality of Life in Patients Treated With Adalimumab: Real-World Results From the HARMONY Study

J Eur Acad Dermatol Venereol. 2021 Jul 28. doi: 10.1111/jdv.17551. Online ahead of print.

ABSTRACT

BACKGROUND: Hidradenitis suppurativa (HS), a chronic, recurrent, debilitating skin disease, is characterized by painful, inflammatory, subcutaneous lesions of the axilla, inguinal, and anogenital regions. Overall prevalence of HS is ~1%, and impact of disease on patient quality of life (QoL) and healthcare resource utilization (HRU) is high.

OBJECTIVES: To estimate the real-world effectiveness of adalimumab (Humira® ) treatment in patients with moderate to severe HS on disease severity, pain, QoL, work productivity, and HRU.

METHODS: HARMONY (Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients – a Multi cOuNtry studY in Real Life Setting) is a multicenter, postmarketing observational study in adult patients with moderate to severe HS. Disease severity and QoL parameters were evaluated using validated measures at 12-week intervals over 52 weeks of treatment. The primary endpoint was the proportion of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR: ≥50% reduction in abscess and inflammatory nodule count, with no increase in abscess and draining fistula counts relative to baseline) at 12 weeks. Secondary endpoints were HiSCR at 24, 36, and 52 weeks and changes in QoL parameters and work productivity assessments. Analyses were conducted using as-observed data.

RESULTS: The proportion of patients reaching the primary HiSCR endpoint was 70.2% (n=132/188 enrolled) and remained ≥70% until study completion. There were statistically significant (P<0.0001) reductions in worst and average skin pain. All of the QoL measures evaluated improved significantly (P<0.0001) by 12 weeks of adalimumab treatment, as did work productivity assessments (P<0.05), and there was a ~50% decrease in HRU between baseline and week 52. Adalimumab was well tolerated.

CONCLUSIONS: In this real-world setting, adalimumab treatment of moderate to severe HS resulted in decreased disease severity and improvements in QoL and productivity. Response to adalimumab was rapid (within 12 weeks) and sustained (52 weeks). No unexpected safety signals were reported.

PMID:34320249 | DOI:10.1111/jdv.17551