Categories
Nevin Manimala Statistics

Sense2Stop: A micro-randomized trial using wearable sensors to optimize a just-in-time-adaptive stress management intervention for smoking relapse prevention

Contemp Clin Trials. 2021 Aug 7:106534. doi: 10.1016/j.cct.2021.106534. Online ahead of print.

ABSTRACT

BACKGROUND: Relapse to smoking is commonly triggered by stress, but behavioral interventions have shown only modest efficacy in preventing stress-related relapse. Continuous digital sensing to detect states of smoking risk and intervention receptivity may make it feasible to increase treatment efficacy by adapting intervention timing.

OBJECTIVE: Aims are to investigate whether the delivery of a prompt to perform stress management behavior, as compared to no prompt, reduces the likelihood of (a) being stressed and (b) smoking in the subsequent two hours, and (c) whether current stress moderates these effects.

STUDY DESIGN: A micro-randomized trial will be implemented with 75 adult smokers who wear Autosense chest and wrist sensors and use the mCerebrum suite of smartphone apps to report and respond to ecological momentary assessment (EMA) questions about smoking and mood for 4 days before and 10 days after a quit attempt and to access a set of stress-management apps. Sensor data will be processed on the smartphone in real time using the cStress algorithm to classify minutes as probably stressed or probably not stressed. Stressed and non-stressed minutes will be micro-randomized to deliver either a prompt to perform a stress management exercise via one of the apps or no prompt (2.5-3 stress management prompts will be delivered daily). Sensor and self-report assessments of stress and smoking will be analyzed to optimize decision rules for a just-in-time adaptive intervention (JITAI) to prevent smoking relapse.

SIGNIFICANCE: Sense2Stop will be the first digital trial using wearable sensors and micro-randomization to optimize a just-in-time adaptive stress management intervention for smoking relapse prevention.

PMID:34375749 | DOI:10.1016/j.cct.2021.106534

Categories
Nevin Manimala Statistics

Distribution of Hypomelanotic Macules in Tuberous Sclerosis Complex: a Retrospective Cohort Study

J Am Acad Dermatol. 2021 Aug 7:S0190-9622(21)02282-9. doi: 10.1016/j.jaad.2021.07.071. Online ahead of print.

NO ABSTRACT

PMID:34375666 | DOI:10.1016/j.jaad.2021.07.071

Categories
Nevin Manimala Statistics

Efficacy evaluation of PCSK9 monoclonal antibody (Evolocumab) in combination with Rosuvastatin and Ezetimibe on cholesterol levels in patients with coronary heart disease (CHD): A retrospective analysis from a single center in China

Transpl Immunol. 2021 Aug 7:101444. doi: 10.1016/j.trim.2021.101444. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Proprotein convertase subtilisin-kexin type 9(PCSK9) monoclonal antibody (Mab; Evolocumab) has been reported to inhibit low-density lipoprotein cholesterol (LDL-C) and Lipoprotein(a) [LP(a)] in coronary heart diseases (CHD) patients in America, Europe and Japan. However, little is known about the effect of Evolocumab in Chinese population. This retrospective study in Chinese CHD patients compared the efficacy without or with Evolocumab therapy added to the conventional treatment with a statin (Rosuvastatin) and a gut cholesterol absorption inhibitor (Ezetimibe).

METHODS: CHD patients from our hospital were divided into three therapeutic groups, A) the statin monotherapy group (10 mg Rosuvastatin every night); B) the statin/cholesterol absorption inhibitor group (10 mg Rosuvastatin and 10 mg Ezetimibe daily); and C) the triple therapy with PCSK9 Mab group (10 mg Rosuvastatin daily, 10 mg Ezetimibe daily, and 140 mg Evolocumab once 2 weeks). The plasma lipid data were collected at 0, 4, 12, and 24 Week(s). The Graphpad Prism 7 program was used to perform all the statistical analysis.

RESULTS: Out of 103 patients 91 were eligible for further evaluation with 31 in group A, 31 in group B, and 29 in group C. The plasma LDL-C levels were reduced only by 33.82% in the Rosuvastatin monotherapy group, 52.13% in the Rosuvastatin/Ezetimibe group, and 73.59% in the Evolocumab/Rosuvastatin/Ezetimibe group (P < 0.0001) at 24 weeks compared to the prior therapy levels. Neither the statin therapy alone (5.95%; P = 0.6), nor the double therapy (5.27%; P = 0.7) affected LP(a) levels. In contrast, addition of Evolocumab to the double therapy significantly decreased LP(a) level by 37.2% (P < 0.0001).

CONCLUSION: Addition of Evolocumab to the standard double therapy in Chinese CHD patients improved the efficacy in LDL-C reduction when compared to Rosuvastatin alone or in Rosuvastatin/Ezetimibe double therapy. Furthermore, the addition of Evolocumab lowered LP(a) level in Chinese CHD patients.

PMID:34375677 | DOI:10.1016/j.trim.2021.101444

Categories
Nevin Manimala Statistics

Racial Disparities in COVID-19 Vaccine Acceptance: Building Trust to Protect Nursing Home Staff and Residents

J Am Med Dir Assoc. 2021 Jul 21:S1525-8610(21)00644-7. doi: 10.1016/j.jamda.2021.07.006. Online ahead of print.

ABSTRACT

Vaccines are critical to protect both nursing home residents and staff from COVID-19, but some staff have expressed reservations about being vaccinated. In this brief report, we describe interventions that Genesis HealthCare-one of the largest US long-term care providers-implemented after recognizing midway through vaccinations that racial and ethnic disparities existed in vaccine uptake among employees, with black and Hispanic employees having significantly lower rates of vaccination than their peers. Specifically, Genesis engaged its Diversity, Equity, and Inclusion (DEI) Committee to identify ways to augment its already comprehensive vaccine education campaign in order to build confidence among employees from minority communities. Interventions implemented beginning in late January 2021 included adding DEI representatives to information sessions to facilitate culturally sensitive discussions; holding information sessions at all times of day and night, and inviting employees’ family members to join; increasing availability of multilingual educational materials; and featuring DEI representatives in social media campaigns. Between the end of January and beginning of March 2021, we observed statistically significant improvements in the likelihood of black and Hispanic employees being vaccinated relative to white employees, calculated as the relative risk of vaccination, suggesting a reduction in vaccination disparity. Whether these trends are directly related to the organization’s efforts, or rather reflect individuals needing longer to become comfortable with the vaccines, is difficult to discern in the absence of a formal pragmatic trial. Still, these findings support the continuation of targeted educational and engagement efforts to improve vaccine uptake among staff, and the critical need to ensure that nursing homes have ongoing access to vaccine supply to continue their vaccination programs.

PMID:34375655 | DOI:10.1016/j.jamda.2021.07.006

Categories
Nevin Manimala Statistics

Ochratoxin A levels in serum of Polish dialysis patients with chronic renal failure

Toxicon. 2021 Aug 7:S0041-0101(21)00213-0. doi: 10.1016/j.toxicon.2021.08.002. Online ahead of print.

ABSTRACT

Ochratoxin A (OTA) is a mycotoxin produced by the fungi Aspergillus and Penicillium. It occurs naturally in many products of plant origin and in animals because of the carry-over from feed to meat or milk. Ochratoxin A has nephrotoxic, carcinogenic, hepatotoxic, neurotoxic, and genotoxic properties. Data on ochratoxin concentrations in blood or serum from patients with different kidney disorders are available for several European countries, as well as for Africa and Asia. In this study, we determined OTA concentrations in serum samples from chronic renal failure patients receiving dialysis and from healthy controls, collected in central Poland. Ochratoxin A was analyzed after extraction and purification using immunoaffinity columns by liquid chromatography with fluorescence detection (limit of quantification: 0.1 ng/mL) in 88 patients and 16 healthy volunteers. The dialysis group consisted of 40 women and 48 men aged between 23 and 85 years. The mean OTA concentrations were 0.75 ng/mL (maximum 2.78 ng/mL) in dialysis patients and 0.70 ng/mL (maximum 1.44 ng/mL) in healthy controls. The mean concentrations in patients treated by dialysis were 0.76 and 0.74 ng/ml for women and men, respectively (maximum 2.53 ng/ml for women and 2.78 ng/ml for men). Statistical analysis using Student’s t-test showed no statistically significant differences between the control group (non-dialysis patients) and all dialysis patients.

PMID:34375657 | DOI:10.1016/j.toxicon.2021.08.002

Categories
Nevin Manimala Statistics

Associations between Chronic Cigarette Smoking and Taste Function: Results from the 2013-2014 National Health and Nutrition Examination Survey

Physiol Behav. 2021 Aug 7:113554. doi: 10.1016/j.physbeh.2021.113554. Online ahead of print.

ABSTRACT

We identified associations between cigarette-smoking and taste function in the U.S. NHANES 2013-2014. Adults ≥40 years (n=2849, nearly half former or current smokers) rated whole-mouth and tongue-tip bitter (1mM quinine) and salt (1M NaCl, 0.32 M NaCl) intensities and reported smoking history (pack years, PY), dependence (time to first cigarette, TTFC) and menthol/non-menthol use. Perceived intensity on the tongue-tip averaged just below moderate for quinine and moderate to strong for 1M NaCl. Current chronic smokers (≥20 PY) reported lower bitter and salty intensities on the tongue-tip (β: -2.0, 95% CI: -3.7 to -0.4 and β: -3.6, 95% CI: -6.9 to -0.3, respectively) than never smokers. Similarly, compared to never smokers, dependent current smokers (TTFC≤30 minutes) and dependent chronic smokers (≥20 PY, TTFC≤30 minutes) rated less bitter (β: -2.0, 95% CI: -4.0 to 0.1 and β: -2.9, 95% CI: -4.5 to -1.3, respectively) and salty (β: -5.3, 95% CI: -9.3 to -1.4 and β: -4.7, 95% CI: -8.6 to -0.7, respectively) intensities on the tongue-tip. Depressed tongue-tip intensity in dependent smokers (with/without chronicity) versus never smokers was significant in younger (40-65 years), but not older (>65 years) adults. Former smokers, non-chronic/less dependent smokers, and menthol smokers were more likely to report elevated whole-mouth quinine and 1 M NaCl intensities. Tongue-tip and whole-mouth taste intensity concordance varied between smokers and never smokers-current dependent smokers were more likely to rate tongue-tip quinine and NaCl lower than their respective whole-mouth tastants (OR: 1.8, 95% CI: 1.0 to 3.1 and OR: 1.8, 95% CI: 1.1 to 2.8, respectively). In summary, these U.S. nationally-representative data show that current smoking with chronicity and/or dependence associates with lower tongue-tip intensity for bitter and salty stimuli. Smokers with greater exposure to nicotine and/or dependence showed greater risk of taste alterations, with implications for diet- and smoking-related health outcomes.

PMID:34375623 | DOI:10.1016/j.physbeh.2021.113554

Categories
Nevin Manimala Statistics

Vitamin D levels in children with COVID-19: a report from Turkey

Epidemiol Infect. 2021 Aug 10;149:e180. doi: 10.1017/S0950268821001825.

ABSTRACT

Several studies have demonstrated that higher levels of vitamin D are associated with better prognosis and outcomes in infectious diseases. We aimed to compare the vitamin D levels of paediatric patients with mild/moderate coronavirus disease 2019 (COVID-19) disease and a healthy control group. We retrospectively reviewed the medical records of patients who were hospitalised at our university hospital with the diagnosis of COVID-19 during the period between 25 May 2020 and 24 December 2020. The mean age of the COVID-19 patients was 10.7 ± 5.5 years (range 1-18 years); 43 (57.3%) COVID-19 patients were male. The mean serum vitamin D level was significantly lower in the COVID-19 group than the control group (21.5 ± 10.0 vs. 28.0 ± 11.0 IU, P < 0.001). The proportion of patients with vitamin D deficiency was significantly higher in the COVID-19 group than the control group (44% vs. 17.5%, P < 0.001). Patients with low vitamin D levels were older than the patients with normal vitamin D levels (11.6 ± 4.9 vs. 6.2 ± 1.8 years, P = 0.016). There was a significant male preponderance in the normal vitamin D group compared with the low vitamin D group (91.7% vs. 50.8%, P = 0.03). C-reactive protein level was higher in the low vitamin D group, although the difference did not reach statistical significance (9.6 ± 2.2 vs. 4.5 ± 1.6 mg/l, P = 0.074). Our study provides an insight into the relationship between vitamin D deficiency and COVID-19 for future studies. Empiric intervention with vitamin D can be justified by low serum vitamin D levels.

PMID:34375576 | DOI:10.1017/S0950268821001825

Categories
Nevin Manimala Statistics

Genomic Profile – a possible Diagnostic and Prognostic Marker in Upper Tract Urothelial Carcinoma

BJU Int. 2021 Aug 10. doi: 10.1111/bju.15566. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate gene alterations as diagnostic and prognostic markers in upper tract urothelial carcinoma (UTUC).

PATIENTS AND METHODS: Patients with UTUC who underwent nephroureterectomy in 2005-2012 were followed until November 2020. DNA was extracted from paraffin-embedded tumour tissue. Next-generation sequencing using a 388-gene panel was performed. First a blinded analysis using principal component analysis and hierarchical clustering was used to search for patterns of mutations. Then a comparative analysis using ANOVA was used to search for mutations enriched in groups of various grade, stage and survival. In addition, careful manual annotation was used to identify pathogenic mutations overrepresented in tumours of high grade/stage and/or poor survival.

RESULTS: 39 patients were included. All tumour stages and grades were represented in the cohort. The median follow-up was 10.6 years. Eleven patients died from UTUC during the follow-up time. Tumour mutational burden showed a statistically significant correlation with stage, grade and stage + grade. G1, G2 and G3 tumours had different mutational patterns. Patients who died from UTUC had pathogenic mutations in specific genes e.g. TP53 and HRAS. Patients with TaG1 tumours with a known pathogenic FGFR3 mutation did not die of UTUC.

CONCLUSION: The genetic analysis was highly concordant with histopathological features and added prognostic information in some cases. Thus, results from genomic profiling may contribute to the choice of treatment and follow-up regimens in the future.

PMID:34375486 | DOI:10.1111/bju.15566

Categories
Nevin Manimala Statistics

Contemporary outcomes of bladder carcinoma in situ treated with an adequate BCG immunotherapy

BJU Int. 2021 Aug 10. doi: 10.1111/bju.15567. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess whether bacillus Calmette-Guérin (BCG) responsiveness after initiation of an adequate BCG treatment (at least five of six instillations of induction and at least two of three instillations of maintenance) impacts oncological outcomes in patients with CIS of the bladder treated with BCG immunotherapy.

PATIENTS AND METHODS: Data were available for 193 patients with bladder CIS with or without associated cTa/cT1 disease who received an adequate BCG treatment between 2008 and 2015. Bladder biopsies were performed at 6 months and patients were then stratified as either BCG responsive (negative biopsies) or BCG unresponsive (positive biopsies). Inverse probability weighting (IPW)-adjusted Kaplan-Meier and IPW-adjusted Cox regression were performed to compare progression-free survival (PFS), radical cystectomy-free survival (RCFS), overall survival OS, and cancer-specific survival (CSS) in the two groups.

RESULTS AND LIMITATIONS: Comparing the BCG-responsive and BCG-unresponsive groups, IPW-adjusted Kaplan-Meier analysis revealed, respectively, a PFS of 9 months (IQR 5-15) vs 48.5 months (IQR 28-77) (p=0.001), an RCFS of 11 months (IQR 9-15) vs 49 months (IQR 24-76) (p<0.001), and a CSS of 25 months (IQR 13-60) vs 109 months (IQR 78-307) (p=0.004). On IPW-adjusted Cox regression analysis, BCG-unresponsive patients had a worse PFS (HR 3.40, 95% CI 1.59-7.27), RCFS (HR 3.52, 95% CI 1.77-7), and CSS (HR 4.42, 95% CI 1.95-10.01). We found no significant differences for OS.

CONCLUSION: Using an IPW method we found that lack of response after initiation of an adequate BCG treatment has prognostic implications beyond identification of complete response in patients with CIS. BCG-unresponsive patients, satisfying the novel definition of BCG unresponsive, showed a poor PFS, RCFS, and CSS. In this setting, the patients should be counseled regarding radical cystectomy as a first option or enrolled in a clinical trial if they refuse radical cystectomy or are unfit for surgery.

PMID:34375494 | DOI:10.1111/bju.15567

Categories
Nevin Manimala Statistics

The renal excretory responses to acute renal interstitial angiotensin (1-7) infusion in anaesthetized spontaneously hypertensive rats

Clin Exp Pharmacol Physiol. 2021 Aug 10. doi: 10.1111/1440-1681.13570. Online ahead of print.

ABSTRACT

This study investigated the impact of intra-renal angiotensin 1-7 (Ang (1-7)) infusion on renal excretory function in a rat model of hypertension. Eleven-week-old spontaneously hypertensive rats (SHRs, n=7) and Han Wistar controls (NCR, n=7) were anaesthetised with sodium pentobarbital (60mg/kg i.p.) and prepared for the measurement of mean arterial pressure (MAP) and left renal function during renal interstitial infusion of Ang (1-7) (50ng/min). The kidneys were harvested, the renal cortex and medulla separated, prepared for measurement of Ang II and Ang (1-7) and Western blot determination of AT1 and Mas receptor protein expression. MAP, glomerular filtration rate (GFR), urine flow (UF) and absolute sodium excretion (UNaV) were 109±16mmHg, 4.4±1.0ml/min/kg, 102±16µl/min/kg and 16±3µmol/min/kg, respectively in the NCR and 172±24mmHg, 3.4±0.7ml/min/kg, 58±30μl/min/kg and 8.6±4.8μmol/min/kg respectively in the SHR. Ang (1-7) increased UF (31%), UNa V (50%) and FENa+ (22%) in the NCR group (all P<0.05) but had no effect on GFR in either group. The magnitudes of the Ang (1-7)-induced increases in UF and UNa V were significantly blunted in the SHR group (model×drug P<0.05). Renal cortical AT1:Mas receptor expression ratio was significantly higher in the SHR group (P<0.05) but renal Ang II and Ang (1-7) levels were not statistically different between groups. The Ang (1-7) induced increases in sodium and water excretion were impaired in the SHR group in the context of an unstimulated RAS. The decrease in responsiveness of the SHR kidney to Ang (1-7) appears to be associated with higher levels of AT1 receptor expression in the renal cortex.

PMID:34375480 | DOI:10.1111/1440-1681.13570