Predictability of Neutrophile to Lymphocyte Ratio and Platelet to Lymphocyte Ratio on the Effectiveness of Immune Checkpoint Inhibitors in Non-small Cell Lung Cancer patients: A Meta-Analysis.

OBJECTIVES: The associations between the neutrophil-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) with the responses of non-small cell lung cancer (NSCLC) patients receiving immune checkpoint inhibitors (ICI) and the NLR/PLR predictive potential were evaluated via meta-analysis. METHODS: A systematic review was conducted using the PubMed, Embase, and The Cochrane Library databases until October 2021. The relationship between NLR/PLR and overall survival (OS) and progression-free survival (PFS) was evaluated using pooled hazard ratios (HR). The relationship between NLR/PLR and overall response rate (ORR) and disease control rate (DCR) was assessed via pooled odds ratios (OR). Heterogeneity between studies, publication bias, subgroup and sensitivity analyses, trim and fill meta-analysis, and the contour-enhanced funnel plot were performed using the R software. RESULTS: A total of 44 (out of 875) studies met the eligibility criteria, providing a sample size of 4597 patients. Patients with a high NLR were statistically significantly associated with worse outcomes, including OS (pooled HR = 2.44; P < 0.001), PFS (pooled HR = 2.06; P < 0.001), DCR (pooled OR = 0.71; P < 0.001), and ORR (pooled OR = 0.33; P < 0.001). Similarly, a high PLR was associated with poorer outcomes in response to ICI drugs, including OS (pooled HR = 2.13; P < 0.001) and PFS (pooled HR = 1.61; P < 0.001). CONCLUSION: High NLR and PLR were associated with a statistically significant reduction in the efficacy of ICI drugs in NSCLC patients. Thereby, it is possible to use NLR and PLR as potential and available biomarkers in the clinical practice to predict the outcome of ICI treatment in NSCLC patients.

Yoga or Mindfulness on Diabetes: Scoping Review for Theoretical Experimental Framework.

Background: About one in 11 adults worldwide suffers from diabetic disease with constantly increasing prevalence; from the 529 million patients registered in 2021, the number of people with diabetes was predicted to rise to approximately 1.31 billion in 2050. In Italy, 5.9% of the population is diabetic, with a higher prevalence with increasing age and in the South of the country. Yoga and Mindfulness could represent a valid support for the care of diabetic subjects especially in a stressful caring context such as the Covid-19 pandemic. Study Design: A scoping review was conducted to achieve the goals of the study. Yoga or Mindfulness interventions on diabetic subjects were specifically analyzed and qualitative-quantitative data collected in the selected randomized controlled trials were extensive for possible meta-analysis. Methods: The review was conducted by two independent practitioners and a third one was consulted in case of conflict. The PRISMA method was used for both the selection and reporting of the studies to be included. Specific PICOS and search strategies have been developed on PubMed, Embase and PsycINFO databases. Included in the review were: randomised controlled trials, full dissertation articles and papers in English with a time limit on May 31, 2022. Results: The Review included 22 studies; 12 on Mindfulness, 9 on Yoga and one about both disciplines; among these, one studied patients with Type 1 Diabetes, 14 with Type 2 Diabetes, 6 with both and one with Gestational Diabetes. Only one paper studied adolescent subjects while the other 21 focused on a range of adult subjects. The studies showed that Yoga and Mindfulness have strong potential not only on stress management, but also on clinical-metabolic parameters. Conclusions: The recent Covid-19 pandemic has certainly redesigned a new way of treating and managing chronic diseases, such as diabetes. An increasingly fragile population, and with the growing need to reduce overall stress levels, could find alternative practices in Yoga and Mindfulness to support conventional therapies.

Associations between four polymorphisms of the SLCO1B1 and effectiveness of the statins: a meta-analysis.

OBJECTIVE: Statins are the first-choice therapy for dyslipidemia, but their effectiveness can be influenced by genetic polymorphisms. This study was conducted to assess the association of variants of the solute carrier anion transporter family 1B1 (SLCO1B1) gene, which encodes a transporter involving the hepatic clearance of the statins and their therapeutic efficacy. METHOD: A systematic review was performed on four electronic databases to identify relevant studies. The pooled mean difference with 95% confidence interval (CI) in percentage change of concentration of LDL-C, total cholesterol (TC), HDL-C, and triglycerides was calculated. Heterogeneity between studies and publication bias, subgroup analyses, and sensitivity analyses were also carried out using R software. RESULTS: Twenty-one studies on 24 365 participants and four variants [rs4149056 (c.521T>C), rs2306283 (c.388A>G), rs11045819 (c.463C>A), rs4363657 (g.89595T>C)] were analyzed. A statistically significant association was found between the LDL-C-lowering effectiveness and the rs4149056 and rs11045819 in the heterozygote model; and the rs4149056, rs2306283, and rs11045819 in the homozygote model. In the subgroup analyses, non-Asian populations, simvastatin, and pravastatin showed significant associations between LDL-C-lowering efficacy and the rs4149056 or rs2306283. Significant associations between the rs2306283 and HDL-C-increasing effectiveness were found in the homozygote model. Regarding TC-reducing, significant associations were observed in the heterozygote and homozygote models of the rs11045819. There was no heterogeneity and publication bias among most studies. CONCLUSION: SLCO1B1 variants can be used as signals to predict the statins' effectiveness.

Quality of life among chronic myeloid leukemia patients in the second-line treatment with nilotinib and influential factors.

PURPOSE: This study aims to evaluate the quality of life (QoL) of chronic myeloid leukemia (CML) patients prescribed with nilotinib as a second-line therapy and explores the influential factors. METHODS: A multicenter retrospective survey was conducted via face-to-face interviews based on the EORTC QLQ-C30 questionnaire. A total of 121 adult CML patients resistant to imatinib and used nilotinib for at least 3 months were enrolled. The influential features were assessed by multiple linear regression models. RESULTS: Patients had the mean age of 47.49 (SD = 13.67) years, dominated by middle-aged and male groups. The mean scores of functions ranged from 75 to 83, and those of symptoms were from 5 to 28, with the highest of fatigue (28.28), insomnia (22.87), and pain (21.07). The mean global health status/QoL score was 67.70 (SD = 16.80) with considerable financial difficulties (52.34 (SD = 32.15)). Male patients reported higher functional scores and fewer symptoms compared with female patients. All aspects of QoL became worse with increasing age. Besides age and gender, level of education, duration of nilotinib usage, and comorbidities were also significantly influential factors in many QoL domains. A predicted model for expected mean scores of QoL domains was built based on these factors. CONCLUSIONS: The CML patients treated with nilotinib had the above-moderate QoL scores, a light decrease of functional scores, great financial difficulties, and still experienced symptoms. Strategies and more therapeutic considerations to enhance QoL for CML patients targeted toward women, the old, low educational level, and long duration of nilotinib usage, and many comorbidities are needed in the setting.

A systematic review on the direct approach to elicit the demand-side cost-effectiveness threshold: Implications for low- and middle-income countries.

Several literature review studies have been conducted on cost-effectiveness threshold values. However, only a few are systematic literature reviews, and most did not investigate the different methods, especially in-depth reviews of directly eliciting WTP per QALY. Our study aimed to 1) describe the different direct approach methods to elicit WTP/QALY; 2) investigate factors that contribute the most to the level of WTP/QALY value; and 3) investigate the relation between the value of WTP/QALY and GDP per capita and give some recommendations on feasible methods for eliciting WTP/QALY in low- and middle-income countries (LMICs). A systematic review concerning select studies estimating WTP/QALY from a direct approach was carried out in seven databases, with a cut off date of 03/2022. The conversion of monetary values into 2021 international dollars (i$) was performed via CPI and PPP indexes. The influential factors were evaluated with Bayesian model averaging. Criteria for recommendation for feasible methods in LMICs are made based on empirical evidence from the systematic review and given the resource limitation in LMICs. A total of 12,196 records were identified; 64 articles were included for full-text review. The WTP/QALY method and values varied widely across countries with a median WTP/QALY value of i$16,647.6 and WTP/QALY per GDP per capita of 0.53. A total of 11 factors were most influential, in which the discrete-choice experiment method had a posterior probability of 100%. Methods for deriving WTP/QALY vary largely across studies. Eleven influential factors contribute most to the level of values of WTP/QALY, in which the discrete-choice experiment method was the greatest affected. We also found that in most countries, values for WTP/QALY were below 1 x GDP per capita. Some important principles are addressed related to what LMICs may be concerned with when conducting studies to estimate WTP/QALY.

COVID-19, Nutrients and Lifestyle Eating Behaviors: A Narrative Review.

BACKGROUND: COVID-19 infection, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), quickly emerged as the most significant event of the new millennium. A balanced diet seems to ensure the proper functioning of the immune system and plays a fundamental role in the prevention of viral disease, inflammation, or thrombosis. The principal aim of this secondary study was to investigate the relationship between nutrients, lifestyle eating behaviors, and SARS-CoV-2 infection. METHODS: A narrative review was conducted in the PubMed-Medline database, analyzing primary studies. RESULTS: Our review identified 21 relevant studies: 13 focused on vitamins, 1 on omega-3 supplementation, 1 on probiotics, and 6 on lifestyle and dietary behaviors. Vitamin supplementation has shown promise in attenuating COVID-19 symptoms and reducing mortality risk. Specifically, vitamin D has demonstrated efficacy in enhancing immune responses among patients with the disease. While preliminary evidence suggests the potential benefits of omega-3 and probiotic supplementation in improving health outcomes for COVID-19 outpatients, further research is needed to solidify these findings. CONCLUSIONS: The lifestyle changes imposed by lockdown measures have adversely affected psychological well-being and exacerbated health issues associated with reduced physical activity and poor dietary habits.

Glycemic Control in Diabetic Patients Receiving a Diabetes-Specific Nutritional Enteral Formula: A Case Series in Home Care Settings.

BACKGROUND AND AIM: In patients with Diabetes Mellitus (DM), Enteral Nutrition (EN) is associated with less hyperglycemia and lower insulin requirements compared to Parenteral Nutrition (PN). The primary aim of this study was to assess changes in glycemic control (GC) in DM patients on EN therapy. The secondary objectives included evaluating the impact of the specialized formula on various clinical parameters and the tolerability of the nutritional formula by monitoring potential gastrointestinal side effects. METHODS: We report a case series on the effects of a Diabetes-Specific Formula (DSF) on GC, lipid profile (LP), and renal and hepatic function in a DM cohort receiving EN support. RESULTS: Twenty-two DM subjects with total dysphagia (thirteen men, nine women) on continuous EN were observed. The use of a DSF in EN was associated with an improvement in glycemic indices across all patients studied, leading to a reduction in average insulin demand. No hospitalizations were reported during the study period. CONCLUSION: The study demonstrated that the use of DSFs in a multi-dimensional home care management setting can improve glycemic control, reduce glycemic variability and insulin need, and positively impact the lipid profile of the DM cohort. The metabolic improvements were supported by the clinical outcomes observed.

Metformin and Covid-19: a systematic review of systematic reviews with meta-analysis.

INTRODUCTION: the COVID-19 infection, caused by severe Coronavirus 2 syndrome (Sars-Cov-2), immediately appeared to be the most tragic global pandemic event of the twentieth century. Right from the start of the pandemic, diabetic patients treated with metformin experienced a reduction in mortality and complications from COVID-19 compared to those with different treatments or no treatment. Objective The main objective of the study was to observe the effects of metformin in hospitalized subjects infected with COVID-19. Specifically, the outcomes of hospitalization in Intensive Care Units or death were examined. Materials and Methods A specific research PICOS was developed and the Pubmed, Embase and Scopus databases were consulted down to April 30, 2022. To estimate the extent of the metformin effect and risk of severity in SARS-CoV-2 infection, the Odd Ratio (OR) with 95% Confidence Interval (CI) published by the authors of the selected systematic reviews was used. Results from five systematic reviews 36 studies were selected. The final meta-analysis showed that thanks to treatment with metformin, DM2 patients affected by COVID-19 had protection against risk of disease severity, complications (ES 0.80; 95% CI) and mortality (ES 0.69; 95% CI). Conclusions More in-depth studies on the use of metformin, compared to other molecules, may be required to understand the real protective potential of the drug against negative outcomes caused by COVID-19 infection in DM2 patients.

Mediterranean Diet (MedDiet) and Lifestyle Medicine (LM) for support and care of patients with type II diabetes in the COVID-19 era: a cross-observational study.

INTRODUCTION: Diabetes affects 425 million people worldwide (range 20-79 years). Of these, between 87% and 91% are affected by type 2 diabetes mellitus (DM2), and 79% live in medium/low income countries. OBJECTIVES: the main objective of the study was to observe, through the administration of specific questionnaires, the relationship existing between metabolic clinical parameters, quality of life of patients with DM2 and adherence to the MedDiet at first access to Diabetes Center in the period after the COVID-19 pandemic. The secondary objective was to observe the results obtained both qualitatively and quantitatively. MATERIALS AND METHODS: the study was a cross-sectional study. Two types of questionnaires were administered; the first (Medi-Lite) that expresses with specific score the level of "Mediterraneanness" diet while the second concerns the assessment of the SF-36 quality of life. Quantitative data such as biochemical and anthropometric parameters were collected and, through multiple regression, based on the method of least squares (OLS Model) and through the Gretl open source software were analyzed. RESULTS: fifty-two of the 90 patients at first access to the recruiting center in the period considered, met the inclusion criteria and and written consent. None of the estimated coefficients was statistically significant except Diastolic Blood Pressure (DBP), with a p-value < 0.0466. With an improvement in the level of "Mediterraneanness" there is a favorable relationship regarding creatinine, High-Density Lipoprotein (HDL), DBP and glycemia. CONCLUSIONS: The necessary post-COVID-19 territorial management cannot fail to take into consideration this new method of care which puts the patient and the community to which they belong at the center of the complex process of assistance.

An Assessment of Outpatient Satisfaction with Hospital Pharmacy Quality and Influential Factors in the Context of the COVID-19 Pandemic.

The study aims to evaluate outpatient satisfaction (OS) with health insurance drug dispensing at the central hospital in Vietnam and to explore the influential factors. A cross-sectional survey was conducted on adult outpatients via an adjusted SERVQUAL questionnaire. The questionnaire's internal consistency (Cronbach alpha) and construct validity (exploratory factor analysis) were considered. The difference between groups was solved using a t-test or ANOVA-test. The multiple-regression analysis determined the influence levels of each factor. A p-value less than 0.05 was statistically significant. A total of 210 participants participated, with most being over 55 years old, female, with a high school education, and freelancers. The mean general satisfaction score was 3.42 (SD = 0.79). The reliability obtained the highest satisfaction score, and the guarantee was the lowest. The final questionnaire, including five factors (reliability, responsiveness, assurance, sympathy, and tangible) with 26 observational variables, had an internal consistency reliability and construct validity. These five factors had a statistically significant correlation and influence on the general satisfaction of the outpatients. The reliability factor had the strongest influence, and assurance had the weakest. Training staff about communication, counseling, and consolidating the facilities are the core solutions for increasing OS.

Use of an Online Platform to Evaluate the Impact of Social Distancing Measures on Psycho-Physical Well-Being in the COVID-19 Era.

Background: The SARS-CoV-2 pandemic (Severe Acute Respiratory Syndrome Coronavirus 2) and the worldwide health crisis have significantly changed both people's habits and lifestyles. Most of the studies found in the literature were carried out on specific professional categories in the socio-health sector, taking into consideration psychological disorders in relation to work. The purpose of this study was to analyze the psychological impact on a portion of the normal population subjected to lockdown. Methods: A questionnaire was distributed in the period between 23 March 2020 and 18 May 2020 (during Italian lockdown) using an online platform. The scales GAD-7, IES-r, PHQ-9 and MANSA were used to investigate the level of anxiety, the presence of post-traumatic stress disorder, the severity of depression and the perceived quality of life, respectively. Results: Four hundred and eight Italian subjects responded. Females and younger people were more affected by anxiety and depression. Post-traumatic stress disorder affected about 40% of the population sample, significantly young people and women, thus attesting to an important psychopathological response. About one-fifth of the sample population recorded an unsatisfactory quality of life. Conclusions: The results highlight the need to set up preventive interventions (primary and secondary), trying to focus on the most fragile group of subjects from a psychosocial point of view, in order to obtain a significant reduction in psychophysical damage in terms of relapses and outcomes.

An instrument for measuring job satisfaction (VIJS): A validation study for community pharmacists in the context of the COVID-19 pandemic in Vietnam.

BACKGROUND: Job satisfaction is one of the main factors creating and bringing about work motivation, productivity, and efficiency as well as decreasing job-hopping and job turnover. No previous studies have been conducted to assess job satisfaction for community pharmacists in Vietnam. OBJECTIVE: This research was conducted to develop and validate an instrument used to measure community pharmacists' job satisfaction in the context of the COVID-19 pandemic in Vietnam. METHODS AND RESULTS: A total of 351 pharmacists participated in this survey. Data were analyzed using R software version 4.2.0. The final instrument (VIJS) has 34 items divided into six factors which were determined via a parallel analysis (including physical working conditions, work nature, income and other benefits, management policies and managers, relationships with coworkers and customers, and learning and advancement opportunities). VIJS's internal consistency was excellent (Cronbach's alpha = 0.97, Omega total = 0.98, split-half reliability = 0.985, and composite reliability>0.8). Two-week test-retest reliability results (intraclass correlation coefficient for the overall instrument: 0.97, for six factors: 0.865-0.938) demonstrated the consistency of the VIJS when the same test was repeated on the same sample (62 pharmacists) at different points in time. The Confirmatory Factor Analysis was employed to assess the construct validity. The VIJS was a good fit to a six-factor model (Chisq/df = 2.352, Comparative Fit Index = 0.937, Tucker-Lewis Index = 0.929, Standardized Root Mean Square Residual = 0.042, and Root Mean Square Error of Approximation = 0.062). VIJS's good convergent and discriminant validity was demonstrated via Average Variance Extrated>0.5 and the Heterotrait-Monotrait ratio of correlations<0.85. CONCLUSIONS: The VIJS possesses good reliability and validity and can be used to measure community pharmacists' job satisfaction.

A National Survey of Dispensing Practice and Customer Knowledge on Antibiotic Use in Vietnam and the Implications.

Misconceptions and pressures have increased the sales of antibiotics without a prescription across countries. There are concerns with such practices in Vietnam given rising antimicrobial resistance rates. A national survey was conducted among 360 private drugstores located in nine provinces in Vietnam. Anonymous interviews were conducted with participants selected by convenience sampling. Subsequently, multivariable logistic regression analyses were undertaken evaluating the relationship between customer characteristics and antibiotic purchases. A total of 480 out of 1626 surveyed participants purchased antibiotics, 81.7% of which did not have a prescription, involving 29 different antibiotics. In 86.4% of these, participants were prescribed antibiotics by drug sellers. Most antibiotics were sold to treat respiratory tract infections (61.4%), with the 'Access' antibiotics (amoxicillin and cephalexin) being the most frequently sold. Only one-fifth of participants understood that they were breaking the law by purchasing antibiotics without a prescription. Participants purchasing antibiotics without a prescription had lower awareness concerning antibiotic laws and treatment duration (p < 0.05). Under 50% agreed to having a doctors' prescription in the future when purchasing antibiotics. Freelancer occupation (OR = 0.52, 95% CI = 0.83−0.96) and a lower educational level (OR = 0.49, 95% CI = 0.25−0.96) were factors related to purchasing antibiotics without a prescription. Overall, we recommend increasing fines and monitoring of drugs stores, greater promotion of the family doctor system as well as increasing media and educational campaigns to limit self-purchasing of antibiotics in Vietnam and reduce resistance.

Diabetes and technology: A pilot study on the management of patients with insulin pumps during the COVID-19 pandemic.

BACKGROUND: The recent COVID-19 pandemic has accelerated the treatment process through IT/technological supports, useful in the management of chronic patients such as those affected by type 1 Diabetes Mellitus (T1DM). Specific routes for fragile patients such as those with micro-infusers have been created thanks to the application of "Diabetes Technology," which allows patients to monitor blood glucose quickly and easily. The present pilot study aimed to assess the quality of care provided to patients with micro-infusers in a delicate phase such as a pandemic lockdown. MATERIALS AND METHODS: A mixed-methods approach was used. In the first part, with prior written consent, patients with insulin pumps enrolled voluntarily. In the second part, the focus group discussion (FGD) was carried out with the voluntarily enrolled participants. The FGD data were organized and analyzed by the thematic areas. RESULTS: The number of patients with afferent insulin pumps at the center was 50 individuals. Among them, 20 patients voluntarily joined the first part of the study by completing the PACIC questionnaire, which gave an average result of 3.34 (min. 2.2 and max. 4.2). In the second part, the application of the focus group technique demonstrated that technology is decisive in the management of diabetic pathology, not only in the emergency phase. CONCLUSIONS: At the time of public health crises, alternative strategies such as Tele-Nursing or Telemedicine could be crucial for the management of patients with micro-infuser not only in critical moments, such as lockdown, but also in ordinary health management.

A systematic review of pharmacoeconomic evaluations of erlotinib in the first-line treatment of advanced non-small cell lung cancer.

OBJECTIVE: To review and assess the quality of the available evidence on the cost-effectiveness of erlotinib in the first-line treatment of advanced non-small cell lung cancer (NSCLC). METHODS: A systematic review was conducted to identify full-text original economic evaluations of erlotinib in the first-line treatment of advanced NSCLC written in English and published from the year 2000 onwards. Study characteristics and results were recorded and compared. The quality of the studies was assessed by the Quality of Health Economic Studies (QHES) questionnaire. RESULTS: Eleven out of 130 papers were chosen for this review. Comparative regimens consisted of a best supportive care, reverse strategy, bevacizumab, cisplatin plus pemetrexed, carboplatin plus gemcitabine or gefitinib. The methods most used in these studies were modeling and sensitivity analysis and cost-effectiveness analysis. All of the studies evaluated direct costs and used quality-adjusted life-year (QALY) and life-years gained (LYG) as outcome, with 3% and 3.5% discount rate. The studies assigned ICER that ranged from dominant to I$305,510.31/QALY and from I$31,209.55/LYG to I$66,540.20/LYG. Based on the willingness to pay threshold, seven studies concluded that erlotinib was cost-effective, two studies showed that erlotinib was cost-effective on specific patients with certain conditions, and two studies comparing erlotinib with reverse strategy did not find a difference in cost-effectiveness. The high quality of these studies was confirmed using the QHES tool: the mean score was 75.77 out of 100 (SD 9.38). CONCLUSION: Most of these high-quality studies suggested that erlotinib was cost-effective in the first-line treatment of advanced NSCLC.

Survey on smoking habits among seafarers.

BACKGROUND: Populations living in stressful environments experience higher mortality from lung cancer and chronic diseases. Work-related stress was identified as important determinant of smoking together to health problems caused by a incorrect lifestyles. Aim of the work was to analyze tobacco smoking addiction in seafarers working on merchant ships. Only a few studies are available on this topic. METHODS: The survey was conducted using an anonymous questionnaire. The total number of questionnaires filled-in was 1478, out of 2000 distributed (response rate 73.9 %). RESULTS: About half of the sample (55.07%) has never smoked, the 28.96% is currently a smoker, while 15.97% of responders belong to the category of ex-smokers. Analysis of the number of cigarettes smoked every day based on the rank shows that captains and officers smoke more cigarettes than the crew members who smoke 10 cigarettes maximum per day. Analysis of the level of dependence among the smokers group by the Fagerström Test for Nicotine Dependence (FTND) revealed that a 89.0% of sample has a low/very low dependence level, and only the 10.98% of the sample show a high/very high dependence. A further analysis of the results of FTND in the different age groups has shown that the 41-50 and 51-60 age groups have high dependence levels. CONCLUSIONS: Working on board is associated to a high risk for chronic, lifestyle-related diseases, due also to lifestyle behaviours. This study suggests to further investigate the presence of other risk factors such as diet, physical exercise, combined with tobacco smoking, obesity. (www.actabiomedica.it).