Tag: statistics

Headache. 2022 Jan 25. doi: 10.1111/head.14257. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study was to propose a definition of “wearing off” at the individual patient-level and determine the percentage of patients with migraine who experience “wearing off” of efficacy of galcanezumab at the end of a treatment cycle using this predefined threshold.

BACKGROUND: Anecdotal reports suggest that some patients may experience “wearing off” of efficacy during the last week of their calcitonin gene-related peptide monoclonal antibody treatment cycle. A previous post hoc analysis of galcanezumab demonstrated consistent efficacy at each week throughout all monthly dosing intervals at the population-level, but “wearing off” has not been assessed at the individual patient-level.

METHODS: Post hoc analyses of clinical trial data from four galcanezumab phase III, randomized, placebo-controlled studies in a total of 2680 patients with high-frequency episodic migraine (EVOLVE-1, EVOLVE-2, and CONQUER studies) or chronic migraine (CM; REGAIN and CONQUER studies) were conducted. “Wearing off” was defined as an increase of greater than or equal to 2 weekly migraine headache days in the last week of the treatment cycle compared to the second week for at least 2 months. The analyses were conducted (1) in all patients and (2) in patients with a clinically meaningful response to treatment.

RESULTS: The percentage of patients meeting the threshold of “wearing off” was not statistically significantly different among the placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups, both in the total population and in patients with a clinically meaningful response (all ≤9.0%). Although the frequency of “wearing off” in patients with CM and prior preventive failures was numerically greater in the galcanezumab groups (8/89 or 9.0%) compared to placebo (3/95 or 3.2%), these differences were not statistically significant.

CONCLUSIONS: Consistent with previous analyses at the population-level that showed no evidence of decreased efficacy at the end of a treatment cycle, rates of individual patients meeting the threshold of “wearing off” in this analysis were low and similar among placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups.

PMID:35076090 | DOI:10.1111/head.14257

J Public Health Dent. 2022 Jan 25. doi: 10.1111/jphd.12493. Online ahead of print.

ABSTRACT

INTRODUCTION: A multi-disciplinary, community-university-government collaboration resulted in the development of Oral Health for Community Workers, a brief, oral health online e-learning module. The e-learning module was designed to improve oral health literacy among frontline health workers who are members of underserved communities, and to address oral health disparities in safety net medical and behavioral health settings.

METHODS: Community-based participatory methods were used to design and evaluate the e-learning module. Participants took pre-, post-, and 3-month follow-up surveys.

RESULTS: Oral health literacy and confidence in incorporating oral health into practice improved. Satisfaction with the module was high.

DISCUSSION: Oral Health for Community Workers is now sustained as a standard module within Community Health Worker, Peer Support Specialist, and Peer Recovery Coach Certification and continuing education offerings in Michigan.

PMID:35076094 | DOI:10.1111/jphd.12493

Eur J Cardiothorac Surg. 2022 Jan 24:ezac017. doi: 10.1093/ejcts/ezac017. Online ahead of print.

ABSTRACT

OBJECTIVES: The benefit of rapid-deployment aortic valve replacement (RD-AVR) in patients with a bicuspid aortic valve (BAV) is controversial due to aortic root asymmetry and potential increased risk for valve dislocation and paravalvular leak. This study aimed to analyse the outcomes of surgical aortic valve replacement with a rapid-deployment bioprosthesis in patients with a BAV.

METHODS: Between May 2010 and December 2020, all consecutive patients who underwent RD-AVR at the Medical University of Vienna were included in our institutional database. Assessment of preoperative characteristics, operative outcomes, long-term survival and clinical events was performed. The outcomes of patients presenting with a native BAV were compared with a control group of patients with native tricuspid valve (TAV); reoperative aortic valve replacements were excluded.

RESULTS: Out of 816 patients, who underwent RD-AVR at our institution, 107 patients with a BAV, mean age 68 (standard deviation: 8) years, were compared with a control group of 690 patients with a TAV, mean age 74 (standard deviation: 7) years; patients presenting with a BAV were significantly younger than patients with a TAV (P < 0.001). Concomitant procedures were performed in 44 (41.1%) patients in the BAV group and in 339 (49.1%) patients in the TAV group (P = 0.123); surgery of the ascending aorta was necessary in 24 (22.4%) in the BAV group, compared with 29 (4.2%) in the control group (P < 0.001). The 5-year cumulative incidence of moderate-to-severe paravalvular regurgitation in the BAV group was 10.7% [95% confidence interval (CI): 4.2-20.7%] and 3.9% (95% CI: 2.4-6.1%) in the TAV group (P = 0.057). Reoperation with valve explantation due to non-structural valve dysfunction at 5 years was 2.8% (95% CI: 0.5-8.8%) in the BAV group, compared to 1.9% (95% CI: 1.0-3.2%) in the TAV cohort (P = 0.89). The overall long-term survival rate in the BAV group was 92% (95% CI: 81-97%) at 5 years and 88% (95% CI: 73-95%), at 10 years, significantly better compared to the TAV group (log-rank test P = 0.002).

CONCLUSIONS: RD-AVR can be performed in patients with a BAV with convincingly medical outcomes. However, a trend to increased frequency of moderate-severe paravalvular regurgitation was observed at long-term follow-up. Consequently, a different surgical approach, compared to tricuspid valves, with distinctly specific technical- and anatomical considerations and requirements, is recommended.

PMID:35076066 | DOI:10.1093/ejcts/ezac017

Elife. 2022 Jan 25;11:e71332. doi: 10.7554/eLife.71332.

ABSTRACT

Urinary metabolic profiling is a promising powerful tool to reflect dietary intake and can help understand metabolic alterations in response to diet quality. Here, we used ¹H NMR spectroscopy in a multicountry study in European children (1147 children from 6 different cohorts) and identified a common panel of 4 urinary metabolites (hippurate, N-methylnicotinic acid, urea, and sucrose) that was predictive of Mediterranean diet adherence (KIDMED) and ultra-processed food consumption and also had higher capacity in discriminating children’s diet quality than that of established sociodemographic determinants. Further, we showed that the identified metabolite panel also reflected the associations of these diet quality indicators with C-peptide, a stable and accurate marker of insulin resistance and future risk of metabolic disease. This methodology enables objective assessment of dietary patterns in European child populations, complementary to traditional questionary methods, and can be used in future studies to evaluate diet quality. Moreover, this knowledge can provide mechanistic evidence of common biological pathways that characterize healthy and unhealthy dietary patterns, and diet-related molecular alterations that could associate to metabolic disease.

PMID:35076016 | DOI:10.7554/eLife.71332

Eur J Cardiothorac Surg. 2022 Jan 24:ezac020. doi: 10.1093/ejcts/ezac020. Online ahead of print.

ABSTRACT

OBJECTIVES: Prior studies have reported a high mortality and incidence of post-repair pulmonary venous obstruction (PVO) in mixed total anomalous pulmonary venous connection (TAPVC). This study sought to review the surgical outcomes in this entity.

METHODS: A review of 61 patients undergoing surgical repair of mixed TAPVC was conducted. Patients with a single ventricle were excluded. Patients were subdivided into 3 groups according to Chowdhury’s classification. Predictors for death and postoperative PVO were explored by Cox regression model.

RESULTS: This study trended towards an older cohort with a median age of 88 days (interquartile range, 56.5-177). Twelve patients belonged to ‘2 + 2’ type, 40 belonged to ‘3 + 1’ type and the remaining 9 belonged to bizarre type. There were no early death and 7 late deaths. Follow-up was available in 96.7% of the patients after discharge with a median duration of 53 months (range, 1-177). Nineteen patients developed post-repair PVO among whom 2 required reintervention. Patients with preoperative PVO had a 4-fold higher risk (95% confidence interval, 1.36-12.38) of postoperative PVO than those without and were more likely to die (P = 0.009). No statistical difference was observed among the 3 subgroups in terms of mortality (P = 0.058) and postoperative PVO (P = 0.186).

CONCLUSIONS: Preoperative PVO was significantly associated with postoperative PVO. There was no statistical difference in terms of death and postoperative PVO among the 3 subtypes of mixed TAPVC. Mid-term results favoured a complete rechanneling of pulmonary veins in ‘3 + 1’ type.

PMID:35076062 | DOI:10.1093/ejcts/ezac020

J Biomol Struct Dyn. 2022 Jan 25:1-14. doi: 10.1080/07391102.2022.2029571. Online ahead of print.

ABSTRACT

An array of computational approaches DFT/QSAR/POM methods has been used for a better understanding of drug properties regarding 13 inhibitor derivatives containing either P2 cyclopentane P1 carboxylic acid moiety (1-9) or a P1 cyclopropyl acyl sulfonamide (10-13). To further recognize binding interactions and their activity trends, molecular docking studies were carried out with the use of HCV, which can be used to accurately predict the interactions of ligands with the receptor. The QSAR models are developed through the use of Multiple Linear Regression (MLR) together with Principal Component Analysis (PCA) methods. The statistical results indicate the multiple correlation coefficient R² = 0.840, which shows favorable estimation stability, as well as showing a significant correlation between the HCV NS3 protease of the studied compounds and their electron-accepting ability. The POM analysis of the Physico-chemical properties of compounds 1-13, shows that they are bearing (O1, O2) and/or (O1, O2, O3) antiviral pockets, whereby all oxygen atoms are Osp2 and bearing negative charges. Similar to the reference ligand (F9K), the most active compound 10 was bound deeply into the binding cavity of NS3 protease making interactions with the residues Gly137, His57, Ala157, and His528. The anti-hepatitis pharmacophore site is similar to the anti-HIV pharmacophore site.

PMID:35075979 | DOI:10.1080/07391102.2022.2029571

Int J Phytoremediation. 2022 Jan 25:1-12. doi: 10.1080/15226514.2022.2027865. Online ahead of print.

ABSTRACT

Direct discharge of raw domestic sewage enriched with nitrogenous and phosphorous compounds into the water bodies causes eutrophication and other environmental hazards with detrimental impacts on public and ecosystem health. The present study focuses on phycoremediation of gray water with Arthrospira sp. using an innovative hydrophobic ceramic membrane-based photobioreactor system integrated with CO₂ biofixation and biodiesel production, aiming for green technology development. Surfactant and oil-rich gray water collected from the domestic kitchen was used wherein, chloride, sulfate, and surfactant concentrations were statistically optimized using response surface methodology (RSM), considering maximum microalgal growth rate as a response for the design. Ideal concentrations (mg/L) of working parameters were found to be 7.91 (sulfate), 880.49 (chloride), and 144.02 (surfactant), respectively to achieve optimum growth rate of 0.43 g_dwt/L/day. Enhancement of growth rate of targeted microalgae by 150% with suitable CO₂ (19.5%) supply and illumination in the photobioreactor affirms its efficient operation. Additionally, harvested microalgal biomass obtained from the process showed a biodiesel content of around 5.33% (dry weight). The microalgal treatment enabled about 96.82, 87.5, and 99.8% reductions in BOD, COD, and TOC, respectively, indicating the potential of the process in pollutant assimilation and recycling of such wastewater along with value-added product generation.

PMID:35075966 | DOI:10.1080/15226514.2022.2027865

Waste Manag Res. 2022 Jan 25:734242X211073852. doi: 10.1177/0734242X211073852. Online ahead of print.

ABSTRACT

Optimising biogas yields from anaerobic digestion of organic wastes is significant to maximum energy recovery in the biodigestion process and has become an important topic of interest. Substrate particle size is an important process parameter in biogas production, and it precedes other pretreatments methods for the majority of the lignocellulose materials. Optimisation of biogas yield using Response Surface Methodology (RSM) was done, and temperature, hydraulic retention time and particle size were considered variables to develop the predictive models. Pretreatment of groundnut shells was investigated using particle size reduction of mechanical pretreatment methods. After pretreatment, 30 samples were digested in a batch digester at mesophilic temperature. The experimental results showed that the temperature, hydraulic retention time and particle size had significant effects of interaction (p < 0.05). The optimum experimental and predicted yields are: 44.70 and 42.92 (l_NkgoDM) organic dry matter biogas yield, 20.80 and 19.09 (l_N/kgFM) fresh mass biogas yield, 24.00 and 22.68 (l_NCH₄oDM) organic dry methane yield and 12.30 and 15.59 (l_NCH₄FM) fresh mass methane yield, respectively. The R² recorded for the four yield components were 0.6268, 0.5875, 0.6109 and 0.5547. These values seem to be lower and a sign of the average fit of the model. Biogas production from groundnut shells was significantly improved with statistical optimisation and the pretreatment method.

PMID:35075967 | DOI:10.1177/0734242X211073852

J Oncol Pharm Pract. 2022 Jan 25:10781552221074629. doi: 10.1177/10781552221074629. Online ahead of print.

ABSTRACT

BACKGROUND: Despite harboring a high burden of cancer patients who are at high risk of potential drug-drug interactions (pDDIs), there is scarcity of published information about pDDIs in cancer patients from Pakistan.

OBJECTIVE: To evaluate frequency, pattern, mechanism and factors associated with pDDIs in cancer patients treated at a tertiary care hospital in Pakistan.

METHODS: In this cross-sectional analytical study, a total of 253 eligible ambulatory cancer patients treated at Center for Nuclear Medicine and Radiotherapy Hospital Quetta were evaluated for pDDIs using IBM Micromedex® Drug Interactions. SPSS (version 26) was used for conducting multivariate analysis to find factors associated with the presence pDDIs. A p-value <0.05 was considered statistically significant.

RESULTS: A total of 141/253 (55.7%) patients were exposed to at-least one pDDI. A total of 251 pDDIs were noted with a median of one pDDI/per patient (interquartile range:1-2) Majority interactions were of major severity (72.9%), pharmacodynamic (49.8%) and had fair documentation level (64.1%). Anti-cancer drugs were involved in 73.0% pDDIs with doxorubicin as the most commonly involved (40.0%) anti-cancer followed by cyclophosphamide (27.6%) and cisplatin (13.5%). Potential cardiac adverse events made the bulk (33.8%) of predicted events. Receiving >2 anti-cancer (OR = 5.19, p-value = 0.001) and >6 ancillary drugs (OR = 4.16, p-value = 0.033) emerged as the risk factors of pDDIs.

CONCLUSIONS: The prevalence of pDDIs was within the range reported in published literature. Solid medication review, availability of DDI detecting tools and clinical pharmacist, and paying special attention to the high-risk patients may reduce the frequency of pDDIs at the study site.

PMID:35075930 | DOI:10.1177/10781552221074629

J Telemed Telecare. 2022 Jan 25:1357633X221074863. doi: 10.1177/1357633X221074863. Online ahead of print.

ABSTRACT

INTRODUCTION: To reduce COVID-19 exposure risk, virtual visits became widely adopted as a common form of healthcare delivery for the general population. It is unknown how this affected the deaf population, a sociolinguistic minority group that continues to face communication and healthcare barriers. The survey’s objective was to describe the deaf participants’ experiences with telehealth visits.

METHODS: A 28-item online survey, available in American Sign Language and English, was developed and disseminated between November 2020 and January 2021. Ninety-nine deaf participants responded. Descriptive statistics were performed to assess the participant’s virtual health care use, experiences, and communication approaches.

RESULTS: Seventy-five percent of respondents used telehealth at least once in the past 12 months (n = 74; age = 37.6 ± 14.5 years). Of those who used telehealth, nearly two-thirds experienced communication challenges (65.3%; n = 49). Half of the participants reported having to connect via a video relay service that employs interpreters who maintain general certification instead of a remote interpreter with specialized health care interpreting certifications for video visits with their health care providers (n = 37) and a third of participants reported needing to use their residual hearing to communicate with their providers (n = 25).

CONCLUSION: Standard protocols for health care systems and providers are needed to minimize the burden of access on deaf patients and ensure virtual visits are equitable. It is recommended these visits be offered on Health Insurance Portability and Accountability Act-compliant platforms and include multi-way video to allow for the inclusion of remote medical interpreters and/or real-time captionists to ensure effective communication between the provider and the deaf patient occurs.

PMID:35075938 | DOI:10.1177/1357633X221074863