Category: Nevin Manimala

J Clin Epidemiol. 2021 Mar 7:S0895-4356(21)00077-9. doi: 10.1016/j.jclinepi.2021.03.005. Online ahead of print.

ABSTRACT

KEY FINDINGS: Despite clear scope, most guidelines for SARS CoV-2 infections and for other care in the context of COVID-19 fell short of basic methodological standards. Only 4% were based on a systematic literature search and a structured consensus process by representative experts (classified as the highest methodological quality). Patients were included in the development of one guideline. A process for regular updates was described in 14%. What this adds to what is known: Our study explored if basic methodological standards of guideline development have been met in the published clinical practice guidelines related to COVID-19. What is the implication/what should change now: An insufficient consideration of appropriate methodologies in the guideline development process could lead to misleading information, uncertainty among the professionals, and potentially harmful actions for patients. This paper provides an important benchmark for the future assessment of the quality of COVID-19 guidelines. Abstract Objective: The number of published clinical practice guidelines related to COVID-19 has rapidly increased. This study explored if basic methodological standards of guideline development have been met in the published clinical practice guidelines related to COVID-19.

STUDY DESIGN AND SETTING: Rapid systematic review from February 1^st until April 27^th, 2020 using MEDLINE [PubMed], CINAHL [Ebsco], Trip and manual search, including all types of healthcare workers providing any kind of healthcare to any patient population in any setting.

RESULTS: There were 1342 titles screened and 188 guidelines included. The highest average AGREE II domain score was 89% for scope and purpose, the lowest for rigor of development (25%). Only eight guidelines (4%) were based on a systematic literature search and a structured consensus process by representative experts (classified as the highest methodological quality). The majority (156; 83%) was solely built on an informal expert consensus. A process for regular updates was described in 27 guidelines (14%). Patients were included in the development of only one guideline.

CONCLUSION: Despite clear scope, most publications fell short of basic methodological standards of guideline development. Clinicians should use guidelines that include up-to-date information, were informed by stakeholder involvement, and employed rigorous methodologies.

PMID:33691153 | DOI:10.1016/j.jclinepi.2021.03.005

Eur J Pharm Sci. 2021 Mar 7:105791. doi: 10.1016/j.ejps.2021.105791. Online ahead of print.

ABSTRACT

Panama, like most Latin American countries, has insufficient regulatory safeguards to ensure the safety and efficacy of all pharmaceutical products in the market, a situation that results in a two-tier system, where affluent citizens can afford innovator products while poor citizens must consume ‘generics’ of uncertain quality. Given that one lot of each drug product is analyzed every five years during registration while commercial lots are not, and since most products are not bioequivalent but simply copies or similars, there is a concern that commercial and registration lots of these ‘generics’ may not be of the same quality. The objective of this study was to assess the ability of various in vitro quality control tests to detect difference among five amlodipine products available in the Panamanian market: four ‘generics’, made in various countries, and the innovator, made in Germany and used as reference listed drug in Panama (Pan-RLD). The innovator manufactured in the United States (US-RLD) was used to compare the two RLDs. The Content Uniformity test, 30-min Dissolution test and multiple-pH Dissolution Profiles did not show any difference among the products. However, the in vitro dissolution absorption system 1 (IDAS1) showed a statistically significant difference in the amount dissolved between Pan-RLD and three out of the four ‘generics’, and significantly lower permeated amount for all the ‘generics’ compared with Pan-RLD; only US-RLD was similar to Pan-RLD. Thus, IDAS1 showed promise as a potential tool that authorities in weakly regulated markets can use to monitor for possible lot-to-lot product changes, which can help improve the quality of pharmaceutical products available to their entire populations. The significance of the similarity between the innovators made in Germany and the United States and their difference from the ‘generics’ (manufactured in other countries) is not known but deserves investigation.

PMID:33691154 | DOI:10.1016/j.ejps.2021.105791

J Wound Ostomy Continence Nurs. 2021 Mar-Apr 01;48(2):163-168. doi: 10.1097/WON.0000000000000735.

ABSTRACT

PURPOSE: The purpose of this study was to investigate the risk factors for major amputation in persons hospitalized with diabetic foot ulcers involving the midfoot.

DESIGN: Retrospective study.

SUBJECTS AND SETTING: Between January 2003 and May 2019, a total of 1931 patients with diabetes were admitted to the diabetic wound center for the management of foot ulcers. Among the admitted patients, 169 patients with midfoot ulcers were included in this study. One hundred fifty-four patients (91%) healed without major amputation, while 15 patients (9%) healed post-major amputation.

METHODS: Data related to 88 potential risk factors including demographics, ulcer condition, vascularity, bioburden, neurology, and serology were collected from patients in these 2 groups for comparison. Univariate and multivariate logistic regression analyses were performed to analyze risk factors for major amputation.

RESULTS: Among the 88 potential risk factors, 15 showed statistically significant differences between the 2 groups. Using univariate analysis of 88 potential risk factors, 8 showed statistically significant differences. Using stepwise multiple logistic regression analysis, 3 of the 8 risk factors remained statistically significant. Multivariate-adjusted odds ratios for deep ulcers invading bone, cardiac disorders, and Charcot foot were 26.718, 18.739, and 16.997, respectively.

CONCLUSION: The risk factors for major amputation in patients hospitalized with diabetic midfoot ulcers included deep ulcers invading the bone, cardiac disorders, and Charcot foot.

PMID:33690250 | DOI:10.1097/WON.0000000000000735

J Infect Dev Ctries. 2021 Mar 7;15(2):280-288. doi: 10.3855/jidc.12141.

ABSTRACT

INTRODUCTION: Salivirus (SalV) represents an emerging problem in public health especially during the recent years. In this study, the Bayesian evolutionary history and the spread of the virus through the different countries have been reported.

METHODOLOGY: a database of 81 sequences of SalV structural VP1 fragment were downloaded from GenBank, aligned and manually edited by Bioedit Software. ModelTest v. 3.7 software was used to estimate the simplest evolutionary model fitting the sequence dataset. A Maximum-Likelihood tree has been generated using MEGA-X to test the “clockliness” signal using TempEst 1.5.1. The Bayesian phylogenetic tree was built by BEAST. Homology modelling was performed by SWISS-Model and protein variability evaluated by ConSurf server.

RESULTS: the phylogenetic tree showed a clade of SalV A2 and three main clades of SalV A1, revealing several infections in humans in South Korea, India, Tunisia, China, Nigeria, Ethiopia and USA. The Bayesian maximum clade credibility tree and the time of the most common recent ancestor dated back the root of the tree to the year 1788 with the probable origin in USA. Selective pressure analysis revealed two positive selection sites, His at 100th and Leu at 116th positions that at the homology modelling resulted important to guarantee protein stability and variability. This could contribute to the development of new mutations modifying the clinical features of this evolving virus.

CONCLUSIONS: Bayesian phylogenetic and phylodynamic represented a useful tool to follow the transmission dynamic of SalV and to prevent new epidemics worldwide.

PMID:33690212 | DOI:10.3855/jidc.12141

J Infect Dev Ctries. 2021 Mar 7;15(2):289-296. doi: 10.3855/jidc.12864.

ABSTRACT

INTRODUCTION: Increased risk of cardiovascular disease in HIV-infected patients was tought to be the cause of multiple mechanistic factors, which changing the HIV care landscape. Antiretroviral therapy (ART), especially protease inhibitors (PI), is one of common HIV treatments that may have some association with this. The mechanism of PI in comparison to other regimens, however, are not clearly understood.

METHODOLOGY: Age-and gender-match HIV-infected patients treated with either boosted-PI-based regimen (boosted-PI group, N=30) or NNRTI-based ART (non-PI group, N = 30) were recruited for this cross-sectional study. Parameters determined cardiovascular risks, inflammation, endothelial function, and bone metabolic function were evaluated.

RESULTS: Compared with non-PI, patients in the boosted-PI group had more evidence of dyslipidemia. No statistical difference in the prevalence of subclinical atherosclerosis was found between the two groups. Circulating levels of inflammatory markers, C-reactive protein (CRP) (5.4±9.1 vs. 14.9 ± 19.4 mg/L, p = 0.019) and lectin-liked oxidized lipoprotein receptor-1 (LOX-1) (387 ± 299 vs. 554 ± 324 pg/mL, p = 0.042) were lower in boosted-PI group. Contrastingly, Vascular adhesion molecules-1 (VCAM-1) (160.2 ± 80.0 vs. 147.8 ± 66.3 ng/mL, p = 0.010), and osteoprotegerin (OPG) (153.7 ± 57.1 vs. 126.4 ± 35.8, p = 0.031) were higher. After adjustment in the multivariate analysis, PI treatment is the only independent parameter associated with the changes of CRP, LOX-1, VCAM-1, and OPG. Subgroup analysis showed that ARV treatment effects differed among participant having dyslipidemia.

CONCLUSIONS: The major mechanism in which PI-mediated was triggering atherogenesis could be through alteration of lipid metabolism and endothelial function, but no evidence of accelerated pro-inflammatory response was attested.

PMID:33690213 | DOI:10.3855/jidc.12864

J Wound Ostomy Continence Nurs. 2021 Mar-Apr 01;48(2):153-161. doi: 10.1097/WON.0000000000000740.

ABSTRACT

PURPOSE: We evaluated the effects of biofeedback-guided pelvic floor muscle training (EMG-BF), with and without extracorporeal magnetic innervation (EMG-BF+ExMI) therapy on lower urinary tract symptoms based on frequency of stress urinary incontinence (SUI) and grams of urine loss, health-related quality of life, and sexual function in women with SUI.

DESIGN: This was a randomized controlled trial.

SUBJECTS AND SETTING: The sample comprised 51 adult women with SUI. Their mean age was 50.92 years (SD 8.88). Twenty-six were randomly allocated to EMG-BF alone and 25 were allocated to undergo EMG-BF+ExMI.

METHODS: This study’s main outcome was lower urinary tract symptoms measured via the 1-hour pad test (grams of urine loss) and a 3-day bladder diary (frequency of stress incontinence episodes). Additional outcome measures were health-related quality of life measured with the Incontinence Quality of Life (I-QOL) questionnaire, sexual function evaluated via the Female Sexual Function Index (FSFI), and pelvic floor muscle contraction force measured via a perineometer and Modified Oxford Scale (MOS). All participants underwent biofeedback-enhanced pelvic floor muscle training using EMG during 20-minute sessions twice weekly for a period of 8 weeks. In addition to the EMG-BF+ExMI group, ExMI was applied during 20-minute sessions twice weekly for a period of 8 weeks. Participants from both groups were asked to perform pelvic floor muscle exercises at home (60 pelvic floor muscle contractions daily, divided into 3 sessions of 20 contractions each). Outcome measures were made at baseline and repeated at the end of treatment.

RESULTS: Fifteen (57.7%) in the EMG-BF group and 13 (52.0%) in the EMG-BF+ExMI group achieved dryness. Four participants (15.4%) in the EMG-BF group and 5 (20%) in the EMG-BF+ExMI group experienced improvement. Seven patients (26.9%) in the EMG-BF group and 7 (28%) in the EMG-BF+ExMI group did not benefit from the treatments. There was no statistically significant difference between the groups in terms of cure and improvement (P = .895).

CONCLUSIONS: Findings indicate that use of magnetic innervation does not improve lower urinary tract symptoms, health-related quality of life, sexual function, and pelvic floor muscle strength when compared to pelvic floor muscle training alone.

PMID:33690249 | DOI:10.1097/WON.0000000000000740

J Infect Dev Ctries. 2021 Mar 7;15(2):230-236. doi: 10.3855/jidc.13926.

ABSTRACT

INTRODUCTION: The spatiotemporal patterns of Corona Virus Disease 2019 (COVID-19) is detected in the United States, which shows temperature difference (TD) with cumulative hysteresis effect significantly changes the daily new confirmed cases after eliminating the interference of population density.

METHODOLOGY: The nonlinear feature of updated cases is captured through Generalized Additive Mixed Model (GAMM) with threshold points; Exposure-response curve suggests that daily confirmed cases is changed at the different stages of TD according to the threshold points of piecewise function, which traces out the rule of updated cases under different meteorological condition.

RESULTS: Our results show that the confirmed cases decreased by 0.390% (95% CI: -0.478 ~ -0.302) for increasing each one degree of TD if TD is less than 11.5°C; It will increase by 0.302% (95% CI: 0.215 ~ 0.388) for every 1°C increase in the TD (lag0-4) at the interval [11.5, 16]; Meanwhile the number of newly confirmed COVID-19 cases will increase by 0.321% (95% CI: 0.142 ~ 0.499) for every 1°C increase in the TD (lag0-4) when the TD (lag0-4) is over 16°C, and the most fluctuation occurred on Sunday. The results of the sensitivity analysis confirmed our model robust.

CONCLUSIONS: In US, this interval effect of TD reminds us that it is urgent to control the spread and infection of COVID-19 when TD becomes greater in autumn and the ongoing winter.

PMID:33690205 | DOI:10.3855/jidc.13926

J Appl Biomech. 2021 Mar 8:1-7. doi: 10.1123/jab.2020-0206. Online ahead of print.

ABSTRACT

Knee osteoarthritis is thought to result, in part, from excessive and unbalanced joint loading. Toe-in and toe-out gait modifications produce alterations in external knee joint moments, and some improvements in pain over the short- and long-term. The aim of this study was to probe mechanisms of altered joint loading through the assessment of tibiofemoral contact in standing with toe-in and toe-out positions using an open magnetic resonance scanner. In this study, 15 young, healthy participants underwent standing magnetic resonance imaging of one of their knees in 3 foot positions. Images were analyzed to determine contact in the tibiofemoral joint, with primary outcomes including centroid of contact and contact area for each compartment and overall. The centroid of contact shifted laterally in the lateral compartment with both toe-in and toe-out postures, compared with the neutral position (P < .01), while contact area in the medial and lateral compartments showed no statistical differences. Findings from this study indicate that changes in the loading anatomy are present in the tibiofemoral joint with toe-in and toe-out and that a small amount of lateralization of contact, especially in the lateral compartment, does occur with these altered lower limb orientations.

PMID:33690165 | DOI:10.1123/jab.2020-0206

J Phys Condens Matter. 2021 Mar 9. doi: 10.1088/1361-648X/abed1d. Online ahead of print.

ABSTRACT

In the Hamiltonian adaptive resolution simulation method (H-AdResS) it is possible to simulate coexisting atomistic and ideal gas representations of a physical system that belong to different subdomains within the simulation box. The Hamiltonian includes a field that bridges both models by smoothly switching on (off) the intermolecular potential as particles enter (leave) the atomistic region. In practice, external one-body forces are calculated and applied to enforce a reference density throughout the simulation box, and the resulting external potential adds up to the Hamiltonian. This procedure suggests an apparent dependence of the final Hamiltonian on the system’s thermodynamic state that challenges the method’s statistical mechanics consistency. In this paper, we explicitly include an external potential that depends on the switching function. Hence, we build a grand canonical potential for this inhomogeneous system to find the equivalence between H-AdResS and density functional theory (DFT). We thus verify that the external potential inducing a constant density profile is equal to the system’s excess chemical potential. Given DFT’s one-to-one correspondence between external potential and equilibrium density, we find that a Hamiltonian description of the system is compatible with the numerical implementation based on enforcing the reference density across the simulation box. In the second part of the manuscript, we focus on assessing our approach’s convergence and computing efficiency concerning various model parameters, including sample size and solute concentrations. To this aim, we compute the excess chemical potential of water, aqueous urea solutions and Lennard-Jones mixtures. The results’ convergence and accuracy are convincing in all cases, thus emphasising the method’s robustness and capabilities.

PMID:33690194 | DOI:10.1088/1361-648X/abed1d

IEEE Trans Vis Comput Graph. 2021 Mar 10;PP. doi: 10.1109/TVCG.2021.3065124. Online ahead of print.

ABSTRACT

This paper contributes a novel visualization method, Missingness Glyph, for analysis and exploration of missing values in data. Missing values are a common challenge in most data generating domains and may cause a range of analysis issues. Missingness in data may indicate potential problems in data collection and pre-processing, or highlight important data characteristics. While the development and improvement of statistical methods for dealing with missing data is a research area in its own right, mainly focussing on replacing missing values with estimated values, considerably less focus has been put on visualization of missing values. Nonetheless, visualization and explorative analysis has great potential to support understanding of missingness in data, and to enable gaining of novel insights into patterns of missingness in a way that statistical methods are unable to. The Missingness Glyph supports identification of relevant missingness patterns in data, and is evaluated and compared to two other visualization methods in context of the missingness patterns. The results are promising and confirms that the Missingness Glyph in several cases perform better than the alternative visualization methods.

PMID:33690119 | DOI:10.1109/TVCG.2021.3065124