A study of the impact of an interprofessional education module in Vietnam on students' readiness and competencies.

INTRODUCTION: The literature puts forward a range of challenges of interprofessional education (IPE) related to its planning, initiation, implementation, and especially to IPE assessment. The present study aims to map changes in students' readiness and interprofessional collaboration competence (IPCC) in implementing an innovative IPE module. Potential differences in impact related to the health education programs and IPCC scores resulting from self-, peer-, and tutor assessments will also be analysed. METHODS: A pre-post design was adopted. The student's readiness for interprofessional learning was assessed using the Readiness for Interprofessional Learning Scale, and the student's IPCC score was calculated based on self-, peer-, and tutor assessments with the interprofessional collaborator assessment rubric. RESULTS: Students' mean post-test readiness scores and mean post-test IPCC scores were significantly higher than the total and subscales/domain pre-test scores (p<0.01). No significant within-subject differences were observed in students' readiness total or subscale scores when comparing health educational programs. However, significant differences were observed in students' mean total IPCC scores between programs (p<0.01). Significant differences in students' average IPCC scores were found when comparing self-, peer- and tutor assessment scores in six domains (p<0.01). Also, significant correlations between peer and tutor assessment scores were observed (p<0.01). CONCLUSION: The IPE module, designed and implemented to focus on patient-centred practice within a primary care context, positively impacted students' readiness and IPCC development. These results offer insights to expand the implementation of the IPE module to all health educational programs.

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.

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.

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.

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.

Implementation outcomes and strategies for delivering evidence-based hypertension interventions in lower-middle-income countries: Evidence from a multi-country consortium for hypertension control.

Guidance on contextually tailored implementation strategies for the prevention, treatment, and control of hypertension is limited in lower-middle income countries (Lower-MIC). To address this limitation, we compiled implementation strategies and accompanying outcomes of evidence-based hypertension interventions currently being implemented in five Lower-MIC. The Global Research on Implementation and Translation Science (GRIT) Coordinating Center (CC) (GRIT-CC) engaged its global network sites at Ghana, Guatemala, India, Kenya, and Vietnam. Purposively sampled implementation science experts completed an electronic survey assessing implementation outcomes, in addition to implementation strategies used in their ongoing hypertension interventions from among 73 strategies within the Expert Recommendations for Implementing Change (ERIC). Experts rated the strategies based on highest priority to their interventions. We analyzed the data by sorting implementation strategies utilized by sites into one of the nine domains in ERIC and summarized the data using frequencies, proportions, and means. Seventeen implementation experts (52.9% men) participated in the exercise. Of Proctor's implementation outcomes identified across sites, all outcomes except for appropriateness were broadly assessed by three or more countries. Overall, 59 out of 73 (81%) strategies were being utilized in the five countries. The highest priority implementation strategies utilized across all five countries focused on evaluative and iterative strategies (e.g., identification of context specific barriers and facilitators) to delivery of patient- and community-level interventions, while the lowest priority was use of financial and infrastructure change strategies. More capacity building strategies (developing stakeholder interrelationships, training and educating stakeholders, and supporting clinicians) were incorporated into interventions implemented in India and Vietnam than Ghana, Kenya, and Guatemala. Although robust implementation strategies are being used in Lower -MICs, there is minimum use of financial and infrastructure change strategies. Our study contributes to the growing literature that demonstrates the use of Expert Recommendations for Implementing Change (ERIC) implementation strategies to deliver evidence-based hypertension interventions in Lower-MICs and will inform future cross-country data harmonization activities in resource-constrained settings.

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.

Association between FLT3-ITD and additional chromosomal abnormalities in the prognosis of acute promyelocytic leukemia.

OBJECTIVES: Internal tandem duplications of the Fms-like tyrosine kinase 3 gene (FLT3-ITD) and additional chromosomal abnormalities (ACA) are prognostic factors in patients with acute promyelocytic leukemia (APL). This study aimed to determine the effect of the association between FLT3-ITD and ACA in the prognosis of APL. METHODS: This was a retrospective cohort study including 60 patients with APL treated with all-trans retinoic acid (ATRA) and chemotherapy. Five-year overall survival (OS) and progression-free survival (PFS) were analyzed in patient groups according to the presence of FLT3-ITD and ACA. RESULTS: FLT3-ITD was an independent adverse factor for 5-year PFS, and ACA was an independent adverse factor for 5-year OS. There were significant differences in OS and PFS among the groups: FLT3-ITD-negative without ACA, FLT3-ITD-positive without ACA, FLT3-ITD-negative with ACA, and FLT3-ITD-positive with ACA. The OS times were 52.917, 45.813, 25.375, and 23.417 months, and the PFS times were 48.833, 38.563, 23.250, and 17.333 months, respectively. CONCLUSION: FLT3-ITD and ACA are associated with the poorest OS and PFS outcomes in patients with APL treated with chemotherapy plus ATRA.

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.

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.

Cytogenetic characteristics in Vietnamese patients diagnosed with primary myelodysplastic syndromes.

Background: The karyotype is the important factor for the diagnosis and prognosis of primary myelodysplastic syndromes (MDS). Some previous studies have suggested that the incidence of chromosomal variations in MDS was related to race. We analyze the chromosomal characteristics in Vietnamese patients with MDS to find differences compared to other races and the association with subtypes by WHO classification. Methods: Sixty patients with new primary MDS diagnoses underwent cytogenetic analysis and FISH for del(5q). Results: Twenty-five patients (41.67%) had an abnormal karyotype at the time of diagnosis, in which 18 patients with a complex karyotype (≥3 chromosomal abnormality) represented the highest percentage (30%). The most frequent chromosomal abnormalities were +8 found in 10/60 patients (16.7%), del (5q) in 9/60 patients (15%), -18 in 5/60 patients (8.3%), only one patient had isolated del(5q) with 1.67%. Patients with abnormal karyotype had higher odds of being MDS-EB (MDS with excess blast) compared to those with normal karyotype (OR = 3.407, 95% CI = 1.164 - 9.976). Patients with complex karyotypes had a higher probability of having MDS-EB compared to those without complex karyotype (OR = 3.25, 95% CI = 1.018 - 10.379). Conclusions: The complex karyotype was the most frequent chromosomal abnormality. Patients with an abnormal or complex karyotype had a higher probability of having MDS with excess blast. The isolated del (5q) ratio is very low compared to Europe and North Africa, but similar to China and Japan as they are the same countries in East Asia.

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.

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.

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.

Cytogenetic Influence on Prognosis in Acute Promyelocytic Leukaemia: A Cohort Study in Vietnam.

OBJECTIVE/BACKGROUND: To analyse the influence of chromosomal aberrations in addition to t(15;17)(q22;q21) in acute promyelocytic leukaemia (APL) on clinical characteristics and treatment outcomes. METHODS: Fifty-seven patients with new APL diagnoses underwent conventional cytogenetic analysis; fluorescence in situ hybridization for t(15;17)(q22;q21) and reverse transcriptase-polymerase chain reaction detected PML/RARα in two forms: L (length) and S (short) and accepted treatment with all-trans retinoic acid and chemotherapy. Patients with additional chromosome aberrations were designated as the complex karyotype group and were compared with patients with only t(15;17), who were designated as the simple karyotype group. RESULTS: Additional chromosome aberrations was observed in 18/57 patients (31.6%) at initial diagnosis. Outcome was significantly different between the simple karyotype group and the complex karyotype group for complete remission (92.3% vs. 66.7% respectively, p = .025), overall survival at 3 years (92.3% vs. 65.0%, respectively, p = .017), and progression-free survival at 3 years (81.4% vs. 44.4%, respectively, p = .024). CONCLUSIONS: Additional chromosome aberrations had adverse effects on the prognosis in APL.

Role of Cell Wall Polyphosphates in Phosphorus Transfer at the Arbuscular Interface in Mycorrhizas.

Arbuscular mycorrhizal fungi provide plants with soil mineral nutrients, particularly phosphorus. In this symbiotic association, the arbuscular interface is the main site for nutrient exchange. To understand phosphorus transfer at the interface, we analyzed the subcellular localization of polyphosphate (polyP) in mature arbuscules of Rhizophagus irregularis colonizing roots of Lotus japonicus wild-type (WT) and H+-ATPase ha1-1 mutant, which is defective in phosphorus acquisition through the mycorrhizal pathway. In both, the WT and the ha1-1 mutant, polyP accumulated in the cell walls of trunk hyphae and inside fine branch modules close to the trunk hyphae. However, many fine branches lacked polyP. In the mutant, most fine branch modules showed polyP signals compared to the WT. Notably, polyP was also observed in the cell walls of some fine branches formed in the ha1-1 mutant, indicating phosphorus release from fungal cells to the apoplastic regions. Intense acid phosphatase (ACP) activity was detected in the periarbuscular spaces around the fine branches. Furthermore, double staining of ACP activity and polyP revealed that these had contrasting distribution patterns in arbuscules. These observations suggest that polyP in fungal cell walls and apoplastic phosphatases may play an important role in phosphorus transfer at the symbiotic interface in arbuscules.

Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam.

BACKGROUND: The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. METHODS: Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient's daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. RESULTS: Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient's homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. CONCLUSIONS: Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. TRIAL REGISTRATION: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).

Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial.

BACKGROUND: Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster randomized trial design. METHODS: Sixteen communities will be randomized to either an intervention (8 communities) or a comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a "storytelling intervention," which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well. DISCUSSION: Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam. TRIAL REGISTRATION: ClinicalTrials.gov NCT03590691 . Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019.

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.

Evaluation of urinary L-FABP as an early marker for diabetic nephropathy in type 2 diabetic patients.

BACKGROUND: Albuminuria is the standard biomarker for the diagnosis of diabetic nephropathy (DN). However, some patients with persistent microalbuminuria still progress to chronic kidney disease, raising the question of finding a better biomarker. This study aimed to evaluate the correlation of urinary liver-type fatty acid-binding protein (L-FABP) levels with renal function and to compare the role of urinary albumin-to-creatinine ratio (ACR) with urinary L-FABP in early detection of DN in type 2 diabetic patients. METHODS: The cross-sectional study was done on 106 type 2 diabetic patients and 30 non-diabetic people. L-FABP was measured with the Latex enhanced immunoturbidimetric technique. RESULTS: There was a strong and negative correlation between the urine L-FABP levels and eGFR (r = -0.606, p<0.001). The urinary L-FABP levels were significantly higher (p<0.001) in the normoalbuminuria diabetic group than the non-diabetic control group. The ROC-curve analyses in the diabetic patients and the normoalbuminuria diabetic patients showed that the AUCL-FABP was remarkably higher (p<0.001) than the AUCACR. An optimal cutoff value of 5 mg L-FABP/g Cr (with the sensitivity of 98.1% and specificity of 90%) and of 4.3 mg L-FABP/g Cr (with the sensitivity of 100% and specificity of 86.67%) was set to detect DN in the diabetic patients and the normoalbuminuria diabetic patients, respectively. CONCLUSIONS: The change in urinary L-FABP levels happened earlier than in urinary albumin during renal function impairment. Urinary L-FABP can be used as a better indicator than ACR for early detection of DN in type 2 diabetes.