Study protocol for the development and validation of a questionnaire evaluating predisposition to immunosuppressant medication non-adherence of kidney pre-transplant patients. The KATITA project.

Non-adherence to immunosuppressive medication after kidney transplant is an important cause of graft rejection and loss. Approaches to minimization of non-adherence have focused on the identification of episodes of medication non-adherence, but by then irreparable harm to the graft may already have occurred, and a more effective approach would be to adopt preventive measures in patients who may have difficulty in adhering to medication. The aim of this study protocol is to develop and validate a clinical questionnaire for assessing, in kidney transplant candidate patients in the pre-transplant setting, the predisposition to non-adherence to immunosuppressive medication. In this multicenter, prospective study, a pilot questionnaire in Brazilian Portuguese language, composed of Likert-scaled statements expressing patients' beliefs, behaviors and barriers regarding medication taking will be assembled from a literature review, from focus groups, and an expert panel. The pilot questionnaire will be administered to a minimum of 300 patients in kidney transplant waiting lists and exploratory factor analysis will be used for development of the definitive questionnaire. A random subsample of a minimum of 60 patients will have the scale re-administered after one month for evaluation of test-retest reliability. A multicenter, external validation study will include 364 kidney transplant candidates who will be evaluated immediately before surgery and at months 3, 6 and 12 post-transplant for assessment of concurrent validity, by comparison with two scales that assess medication non-adherence, and for determination of predictive validity using a triangulation method for assessment of medication non-adherence. Structural validity will be assessed with confirmatory factor analysis using structural equation modeling. Cross-cultural generalizability and validity will be assessed by a multicenter study, in which a translation of the scale to another language will be administered to kidney transplant candidate patients from a different culture, with a subsample being selected for test-retest. This study will be conducted in Spain with a Spanish translation of the scale.

Prevalence of consumption of mechanically separated meat, consumer profile, nutrient intake and food choices among manufacturing workers in Northeastern Brazil.

Mechanically separated meat (MSM) is widely used in the food industry, however, there is a lack of studies on its consumption in populations. The objective of this study was to identify the frequency and amount of MSM consumption, factors associated with MSM consumption, nutrient intake and preferential choice of food groups among MSM consumers. This was an observational, cross-sectional prospective study based on a probability sample of manufacturing workers, conducted in Brazil. Logistic and linear multiple regression with robust standard errors were used. 921 workers from 33 manufacturing companies were studied, with an average age of 38.2 ± 10.7 years, 55.9% males. MSM products are consumed by 28.8% and represent in average 10% of total daily caloric intake, and 47.3% of the daily kcal from ultra-processed products. Younger age and greater waist circumference are associated with MSM consumption. Younger age and lesser educational level are associated with increased contribution of MSM to total daily kcal intake. MSM consumers have greater consumption of energy, fats, carbohydrates and sodium. Their dietary patterns are characterized by lower consumption of in natura and minimally processed foods, such as tubers and roots, fruits, white and red meat, and eggs and greater consumption of ultra-processed foods and beverages.

Correction: Risk factors for drug-related problems in a general hospital: A large prospective cohort.

[This corrects the article DOI: 10.1371/journal.pone.0230215.].

Assessing the impact of arsenic, lead, mercury, and cadmium exposure on glycemic and lipid profile markers: A systematic review and meta-analysis protocol.

The toxicity of metals presents a significant threat to human health due to the metabolic changes they induce. Thus, it is crucial to understand the impact of exposure to toxic elements on glycemic and lipid profiles. To this end, we developed a systematic review protocol registered in PROSPERO (CRD42023393681), following PRISMA-P guidelines. This review aims to assess environmental exposure to arsenic, cadmium, mercury, and lead in individuals aged over ten years and elucidate their association with glycemic markers such as fasting plasma glucose, glycated hemoglobin, as well as lipid parameters including total cholesterol, triglycerides, high-density lipoprotein, and low-density lipoprotein cholesterol. Articles published in the MEDLINE (PubMed), EMBASE, Web of Science, LILACS, and Google Scholar databases until March 2024 will be included without language restrictions. The modified Newcastle-Ottawa scale will be employed to assess the quality of the included studies, and the results will be presented through narrative synthesis. If adequate data are available, a meta-analysis will be conducted. This review can help understand the metabolic responses to exposure to toxic elements and the associated health risks.

Nonadherence to Immunosuppressant Therapy of Kidney Transplant Candidate Patients: External Validation of the KATITA-25 Scale.

BACKGROUND: The self-administered Kidney AlloTransplant Immunosuppressive Therapy Adherence (KATITA-25) questionnaire is a multidimensional scale for use in the pretransplant setting that evaluates the predisposition to nonadherence of patients who are candidates to kidney transplant. The scale has shown adequate internal consistency and test-retest reliability. This study presents the results of an external validation study of the KATITA-25 scale. METHODS: Patients >18 y old scheduled for kidney transplant were included in this multicenter study. The KATITA-25 scale was administered before surgery and then at 3-mo posttransplantation for evaluation of scale sensitivity to change. At this time, 2 validated medication adherence scales were applied for assessment of concurrent validity. For evaluation of predictive validity, nonadherence to immunosuppressive medication was assessed at 6 and 12 mo after transplantation by 3 independent methods: patient self-report of nonadherence using the Morisky-Green-Levine Medication Assessment Questionnaire scale, serum trough levels of immunosuppressants, and pharmacy refills. RESULTS: Three twenty-two patients were available for evaluation of concurrent validity and 311 patients of predictive validity. After kidney transplant, the median KATITA-25 score decreased from 20 to 8 ( P  < 0.001), demonstrating scale sensitivity to change, and the KATITA-25 score showed correlation with the Basel Assessment of Adherence to Immunosuppressive Medication Scale score (Spearman's ρ 0.18, P  = 0.002) and the Cuestionario para la Evaluación de la Adhesión al Tratamiento Antiretroviral scores (ρ -0.17, P  = 0.002), confirming concurrent validity. The nonadherence rate was 57.6%. The scale predictive validity was demonstrated by the area under the receiver operating characteristics curve (0.68), sensitivity (59.8%), specificity (68.2%), and positive predictive value (71.8%). CONCLUSIONS: This external validation study of KATITA-25 scale provided evidence of sensitivity to change, and structural, criterion, and predictive validity.

Development and Internal Validation of a Questionnaire Assessing Predisposition to Nonadherence to Immunosuppressive Medication in Kidney Pretransplant Patients.

BACKGROUND: After kidney transplant, nonadherence to immunosuppressive therapy is the main cause of impaired kidney function and graft loss. The objective of this study was the development and internal validation of a clinical questionnaire for assessing the predisposition to adherence to immunosuppressive therapy in kidney pretransplant patients. METHODS: Multicenter prospective study conducted in 7 kidney hemodialysis and 6 kidney transplant centers of 3 Brazilian state capitals. Kidney transplant candidate patients of both sexes and >18-y-old were included. Retransplanted patients were excluded. A 72-item pilot version of the questionnaire, created through literature review complemented with a focus group of 8 kidney pretransplant patients, was administered to 541 kidney transplant candidate patients. Factor analysis with varimax rotation was used for questionnaire development. Internal validity evaluation used Cronbach's alpha and test-retest reliability. Construct validity was assessed by differentiation by known groups. RESULTS: The final questionnaire, named Kidney AlloTransplant Immunosuppressive Therapy Adherence (KATITA) Questionnaire, consisting of 25 items in 3 dimensions, presented good internal consistency reliability (Cronbach's alpha 0.81). The 3 dimensions and respective Cronbach's alpha were "Carelessness" (14 items, 0.81), "Skepticism" (6 items, 0.57), and "Concern" (5 items, 0.62). The interdimension correlation matrix showed low correlation coefficients (<0.35). Test-retest reliability, evaluated with 154 patients, showed an intraclass correlation coefficient of 0.62 (moderate agreement). The scale showed construct validity. CONCLUSIONS: The KATITA-25 questionnaire is the first psychometric instrument for evaluation of predisposition to nonadherence to immunosuppressive medication in candidate patients for kidney transplant in the pretransplant setting.

Development and validation of a predictive tool for adverse drug reactions in neonates under intensive care.

AIMS: Neonates hospitalized in neonatal intensive care units (NICUs) commonly experience adverse drug reactions (ADRs). Thus, we aimed to develop and validate a tool for predicting ADRs in neonates hospitalized in NICUs. METHODS: A nested case-control study in an open cohort with neonates admitted to the NICU of a maternity hospital in Natal, Brazil was conducted from January 2019 to January 2022 [Correction added on 4 December 2023, after first online publication: 2023 has been changed to 2019 in the preceding sentence.]. Neonates with ADR were randomly paired with 2 controls. For the development of the tool, a multivariate logistic regression was applied on 2/3 of the sample (cases with respective controls). The model's fit was evaluated using the Hosmer-Lemeshow test for calibration and the Brier score for performance assessment. Validation of the tool was performed by determining the area under the receiver operating characteristic curve with bootstrap adjusted c-statistics. RESULTS: In all, 450 neonates (150 cases and 300 controls) were included in the study. We identified 5 independent risk factors for ADR, 4 related to the neonate (current mechanical ventilation, heart rate ≥178 beats/min, intravenous medications, ≥5 prescription medications) and 1 to the mother (gestational hypertension). The tool had a classification cut-off point of ≥15, and its total score ranged from 0 to 34. In validation, the tool had an area under the receiver operating characteristic curve of 0.74 (95% confidence interval [CI] 0.66-0.81) with sensitivity of 52.02% (95% CI 47.40-56.64) and specificity of 81.35% (95% CI 77.75-84.95). CONCLUSION: The tool demonstrated adequate discriminative ability and utilized 5 commonly monitored variables in the NICU.

Temporal profile of adverse drug reactions and associated clinical factors: a prospective observational study in a neonatal intensive care unit.

OBJECTIVE: Although adverse drug reactions (ADRs) are quite common in hospitalised neonates, pharmacovigilance activities in this public are still incipient. This study aims to characterise ADRs in neonates in a neonatal intensive care unit (NICU), identifying causative drugs, temporal profile and associated factors. DESIGN: Prospective observational study. SETTING: NICU of a public maternity hospital in Natal/Brazil. PARTICIPANTS: All neonates admitted to the NICU for more than 24 hours and using at least one medication were followed up during the time of hospitalisation. PRIMARY OUTCOME MEASURES: Incidence rate and risk factors for ADRs. The ADRs were detected by an active search in electronic medical records and analysis of spontaneous reports in the hospital pharmacovigilance system. RESULTS: Six hundred neonates were included in the study, where 118 neonates had a total of 186 ADRs. The prevalence of ADRs at the NICU was 19.7% (95% CI 16.7% to 23.0%). The most common ADRs were tachycardia (30.6%), polyuria (9.1%) and hypokalaemia (8.6%). Tachycardia (peak incidence rate: 57.1 ADR/1000 neonates) and hyperthermia (19.1 ADR/1000 neonates) predominated during the first 5 days of hospitalisation. The incidence rate of polyuria and hypokalaemia increased markedly after the 20th day, with both reaching a peak of 120.0 ADR/1000 neonates. Longer hospitalisation time (OR 0.018, 95% CI 0.007 to 0.029; p<0.01) and number of prescribed drugs (OR 0.127, 95% CI 0.075 to 0.178; p<0.01) were factors associated with ADRs. CONCLUSION: ADRs are very common in NICU, with tachycardia and hyperthermia predominant in the first week of hospitalisation and polyuria and hypokalaemia from the third week onwards.

Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool.

BACKGROUND: Algorithms for causality assessment of adverse drug reactions (ADRs) in a neonatal intensive care unit (NICU) are important in the management of adverse events, however, it is inconclusive which tool best suits pharmacovigilance in neonates. AIM: To compare the performance of the algorithms of Du and Naranjo in determining causality in cases of ADRs in neonates in a NICU. METHOD: This observational and prospective study was conducted in a NICU of a Brazilian maternity school between January 2019 and December 2020. Independently, three clinical pharmacists used the algorithms of Naranjo and Du in 79 cases of ADRs in 57 neonates. The algorithms were evaluated for inter-rater and inter-tool agreement using Cohen's kappa coefficient (k). RESULTS: The Du algorithm showed greater ability to identify definite ADRs (≈ 60%), but had low reproducibility (overall k = 0.108; 95% CI 0.064-0.149). In contrast, the Naranjo algorithm showed a lower proportion of definite ADRs (< 4%), but had good reproducibility (overall k = 0.402; 95% CI 0.379-0.429). The tools showed no significant correlation regarding ADR causality classification (overall k = - 0.031; 95% CI - 0.049 to 0.065). CONCLUSION: Although the Du algorithm has a lower reproducibility compared to the Naranjo, this tool showed good sensitivity for classifying ADRs as definite, proving to be a more suitable tool for neonatal clinical routine.

Drug-related problems in hypertension and gestational diabetes mellitus: A hospital cohort.

OBJECTIVE: To characterize the drug-related problems (DRPs) in high-risk pregnant women with hypertension and gestational diabetes mellitus according to frequency, type, cause, and factors associated with their occurrence in the hospital setting. METHODOLOGY: This is an observational, longitudinal, prospective study that included 571 hospitalized pregnant women with hypertension and gestational diabetes mellitus using at least one medication. DRPs were classified according to the Classification for Drug-Related Problems (PCNE V9.00). In addition to descriptive statistics, a univariate and multivariate logistic regression model was employed to determine the factors associated with the DRPs. RESULTS: A total of 873 DRPs were identified. The most frequent DRPs were related to therapeutic ineffectiveness (72.2%) and occurrence of adverse events (27.0%) and the main drugs involved were insulins and methyldopa. These were followed in the first five days of treatment by: the ineffectiveness of insulin (24.6%), associated with underdosage (12.9%) or insufficient frequency of administration (9.5%) and methyldopa associated with the occurrence of adverse reactions (40.2%) in the first 48h. Lower maternal age (OR 0.966, 95% CI 0.938-0.995, p = 0.022), lower gestational age (OR 0.966, 95% CI 0.938-0.996, p = 0.026), report of drug hypersensitivity (OR 2.295, 95% CI 1.220-4.317, p = 0.010), longer treatment time (OR 1.237, 95% CI: 1.147-1.333, p = 0.001) and number of prescribed medications (OR 1.211, 95% CI: 0.240-5.476, p = 0.001) were risk factors for occurrence of DRPs. CONCLUSION: DRPs are frequent in pregnant women with hypertension and gestational diabetes mellitus, and they are mainly related to therapeutic ineffectiveness and the occurrence of adverse events.

Effects of selenium supplementation on glycaemic control markers in healthy rodents: a systematic review and meta-analysis.

Overexposure to Se is detrimental to glucose metabolism, mainly because of its pro-oxidant effects and the overexpression of selenoproteins. This systematic review evaluated the effects of Se supplementation on glycaemic control in healthy rodents. The methodology followed the PRISMA. We searched the databases for articles published up to May 2022. The risk of bias and the methodological quality were assessed using the SYRCLE and CAMARADES. The results are presented as meta-analytic estimates of the overall standardised mean difference (SMD) and 95 % CI. Of the 2359 records retrieved, thirteen studies were included, of which eleven used sodium selenite and two used zero-valent Se nanoparticles as supplement. Nine studies were included in the meta-analysis. Generally, the risk of bias was high, and 23·1 % of the studies were of high quality. Supplementation with sodium selenite significantly increased fasting blood glucose (SMD = 2·57 (95 % CI (1·07, 4·07)), I2 = 93·5 % (P = 0·001). Subgroup analyses showed effect size was larger for interventions lasting between 21 and 28 d (SMD = 25·74 (95 % CI (2·29, 9·18)), I2 = 96·1 % (P = 0·001)) and for a dose of 864·7 µg/kg/d of sodium selenite (SMD = 10·26 (95 % CI (2·42, 18·11), I2 = 97·1 % (P = 0·010)). However, it did not affect glutathione peroxidase activity (SMD = 0·60 (95 % CI (-0·71, 1·91)), I2 = 83·2 % (P = 0·37)). The current analysis demonstrated the adverse effects of sodium selenite supplementation on glycaemic control in healthy rodents.

Participation in a food assistance program and excessive weight gain: an evaluation of the Brazilian Worker's Food Program in male and female manufacturing workers.

BACKGROUND: Several published studies have reported an association between participation in a food assistance program and greater prevalence of overweight/obesity. Our aim was to compare nutritional status and nutrient consumption between workers from manufacturing companies participant and non-participant in the Brazilian Workers' Food Program (WFP). DESIGN: Cross-sectional survey, based on a probability sample of manufacturing workers in Brazil obtained by stratified two-stage sampling, comparative between WFP and non-WFP participating companies. Body mass index (BMI), waist circumference (WC), and nutrient consumption (24-hour recall) were collected by trained nutritionists. Statistical analysis was done separately in each sex with mixed effects multilevel linear regression model including sampling weights and covariate adjustment. RESULTS: Thirty-three companies were randomly selected from all companies in three different economic activity sectors (food and beverages, non-metallic minerals, and textiles) in North-eastern Brazil, with stratification by company size, and a random sample of 929 workers (484 from non-WFP and 445 from WFP companies) was obtained from those companies. In males, the WFP group had higher BMI (+ 1.08 kg/m2, p < 0.001), greater WC (+ 3.27 cm, p < 0.001) and greater prevalence of obesity (OR 1.67, p < 0.001). In females, no statistical significant differences were observed in anthropometric parameters, but the WFP group had lower prevalence of obesity (OR 0.49, p = 0.05). Among workers in companies that provide lunch, males from WFP companies have greater consumption of carbohydrates (+ 39.5 kcal, p = 0.02) and protein (+ 11.1 kcal, p = 0.08), while females have lower protein consumption (- 14.2 kcal, p = 0.04) and also lower total daily consumption of carbohydrates (- 59.3 Kcal, p = 0.05) and total lipids (- 14.2 Kcal, p = 0.04). CONCLUSIONS: Participation in the WFP is associated with increased BMI and WC among male workers; however, this association was not found in females. Compared to the non-WFP group, in the WFP group, males have greater consumption of carbohydrates and protein at lunch, while women have lower protein intake. These results indicate the need that proposals for public policies aimed to the improvement of the nutritional status of populations take into consideration the different effects of food assistance programs in males and females.

Effects of selenium supplementation on glycemic control markers in healthy rodents: A systematic review protocol.

BACKGROUND: In vivo and in vitro studies have shown that Se has an insulin-mimetic action associated with its antioxidant activity. Other studies, in turn, suggest that high Se doses and high selenoprotein expression interfere with insulin signaling. This study aims to evaluate the effects of Se supplementation on glycemic control markers in healthy rodents. METHODS: The protocol was developed according to the Preferred Reporting Items for Systematic Review and Metaanalysis Protocol (PRISMA-P) and was published in the International Prospective Register of Systematic Reviews database (PROSPERO; CRD4202121201142019119181). Experimental, randomized, or non-randomized studies of healthy rodents models will be included. All forms of supplemented Se will be considered, including organic, inorganic, and synthetic compounds, selenium-enriched yeasts, zerovalent Se nanoparticles, and selenized polysaccharides. Fasting blood glucose will be considered the primary outcome. Homeostatic model assessment, plasma and erythrocyte Se concentration, GPX activity, SELENOP concentration, and other Se biomarkers will be considered secondary outcomes. EMBASE, Scopus, Pubmed/Medline, Web of Science, and CINAHL will be searched for articles published with no language restrictions. Two reviewers will independently conduct the search and selection of articles, data extraction, and quality analysis. The risk of bias and methodological quality analyses of the included studies will be performed using the Systematic Review Center for Laboratory Animal Experimentation (SYRCLE) and Collaborative Approach to Meta-Analysis and Review (CAMARADES) tools, respectively. The results will be presented as a narrative synthesis according to the Synthesis Without Meta-analysis (SWiM) Reporting Guideline. Meta-analyses will be conducted where appropriate using random-effects models. DISCUSSION: The review may clarify the interaction between different forms of supplemented Se and glycemic control in rodents models. The results will provide evidence that will help select doses and forms of Se to administer in clinical trials while according to impact on the glycemic control while elucidating mechanisms of Se metabolism.

Are PROMs passing the message? A reflection with real-life migraine patients.

BACKGROUND: Several patient-reported outcome measures are available to monitor headache impact, but are those reliable in real-life clinical practice? METHODS: Two identical patient-reported outcome measures (HALT-90 and MIDAS) were applied simultaneously in each clinical visit to a series of patients treated with monoclonal antibodies for migraine and intra-individual agreement was evaluated using the intraclass correlation coefficients. RESULTS: Our sample included 92 patients, 92.4% females, 45 years old on average. Moderate (0.50 to 0.75) and even poor (<0.50) ICC were observed in all but the first item of these patient-reported outcome measures in at least one evaluation. Over time, missing data were more frequent and no learning effect was detected. DISCUSSION: We observed intra-personal variation in reliability when answering patient-reported outcome measures, persisting in repeated applications, and a decrease in the motivation to respond, which should alert clinicians for these additional challenges in real-life clinical practice.

Proton pump inhibitor and community pharmacies: Usage profile and factors associated with long-term use.

AIM: To characterize the usage profile and the factors associated with the prolonged use of proton pump inhibitor drugs in a community pharmacy. METHODOLOGY: This is a cross-sectional, prospective and observational study involving interviews with 410 patients who acquired PPI for their own use from community pharmacies. To characterize the factors associated with the prolonged use of PPI, a multivariate logistic regression model was used. RESULTS: Pantoprazole (42.7%) and omeprazole (31%) were the most acquired PPIs, prescribed mainly by gastroenterologists (49.5%). They are used in the morning, especially for gastrointestinal symptoms, however, they had been consumed for more than 5 years in 30% of cases. The factors associated with prolonged use are old age (OR 1.03 CI95% 1.01-1.05), body mass index (OR 1.07 CI95% 1.01-1.12), use of non-steroidal anti-inflammatories (OR 3.18 CI95% 1.20-8.43) and selective serotonin reuptake inhibitors (OR 3.5 95% CI 1.39-8.88). CONCLUSION: PPIs are adequate in terms of indication and form of use, however, prolonged use associated with old age, being overweight and use of anti-inflammatories and antidepressants is frequent.

Headache Gauge: a real-life calendar-based tool for headache monitoring.

BACKGROUND: This study aimed to validate a semi-quantitative composite score tool, "Headache Gauge" (HG), to monitor the treatment effect in primary headaches in everyday clinic practice, adjustable to any chosen timeframe. METHOD: A cohort validation study of HG was performed in primary headache patients, recovering their clinical data and patient-related outcome measures (PROMs) for headache (HIT-6, MIDAS, HURT), work impact (WPAIQ), quality-of-life (SF-12), and mood (STAI, ZUNG). HG score distribution, its relation to clinical variables, its internal consistency, and its convergent validity were determined. RESULTS: HG was plotted in 233 patients: 90.1% females, age average 37 years, 86% with migraine, 27% with chronic headaches, and 28% with medication overuse. HG ranged from 0.21 to 58.3 in this sample, higher in chronic headaches (HG 16) and medication overuse (HG 15). HG presented good concurrent validity, significantly correlating with HIT-6 (p < 0.0001), SF-12 (p = 0.001), WPAIQ (p < 0.0001), MIDAS (p < 0.0001), and HURT (p < 0.0001). Good sensitivity to change (p < 0.001) and moderate test-retest reliability (p = 0.001) were calculated after reassessment of 147 patients (63.1% of the initial sample). CONCLUSIONS: Headache Gauge is a clinical data-based outcome measure that conceptually translates the percentage of lost time to headache in any given timeframe. It relates to headache impact, therefore bearing the potential to be relevant in real-life clinical monitoring.

Drug-drug interactions in neonatal intensive care: A prospective cohort study.

BACKGROUND: To characterize the prevalence and profile of drug-drug interactions (DDIs), the drugs most related to major DDIs and risk factors of their prescription in a neonatal intensive care unit (NICU). METHODS: Neonates admitted to a NICU who had at least one medication prescribed and a hospital stay >24 h were included in a prospective cohort study (August 2017 to July 2018). All medications prescribed during the hospitalization were collected from all neonates (n = 220), with the screening for DDIs. Prevalence and type of DDIs was identified. Network analysis was used to identify the drugs more implicated with DDIs. Logistic regression was used for the analysis of risk factors (p < 0.05). RESULTS: Over 70% of neonates were exposed to DDIs and 29% were exposed to major DDIs. The network analysis identified furosemide, fentanyl, aminophylline and fluconazole as most implicated with DDI, fentanyl was especially associated with major DDIs. The number of drugs (OR 1.60, p < 0.01), caesarean delivery (OR 2.68, p < 0.05), gestational age (OR 1.03, p < 0.01) and APGAR score (OR 0.78, p < 0.01) were identified as risk factors for exposure to DDI. CONCLUSION: Neonates in intensive care have a high exposure to DDIs and the occurrence of major DDIs is related specifically to the prescription of fentanyl. The number of prescribed drugs, gestational age, cesarean delivery and low APGAR score in the first minute were identified as risk factors for DDIs in NICU.

Development and validation of a clinical instrument to predict risk of an adverse drug reactions in hospitalized patients.

OBJECTIVE: Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. METHODOLOGY: Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient variables collected at the time of the ADR were analyzed by conditional logistic regression. Multivariate logistic regression with clustering of cases in a random sample of 2/3 of the cases and respective controls, with baseline odds-ratio corrected with an estimate of ADR incidence, was used to obtain regression coefficients for each risk factor and to develop a risk score. The clinical tool was validated in the remaining 1/3 observations. The study was approved by the institution's research ethics committee. RESULTS: In the 8060 hospitalized patients, ADR occurred in 343 (5.31%), who were matched to 686 controls. Fourteen variables were identified as independent risk factors of ADR: female, past history of ADR, heart rate ≥72 bpm, systolic blood pressure≥148 mmHg, diastolic blood pressure <79 mmHg, diabetes mellitus, serum urea ≥ 67 mg/dL, serum sodium ≥141 mmol/L, serum potassium ≥4.9 mmol/L, main diagnosis of neoplasia, prescription of ≥3 ATC class B drugs, prescription of ATC class R drugs, prescription of intravenous drugs and ≥ 6 oral drugs. In the validation sample, the ADR risk tool based on those variables showed sensitivity 61%, specificity 73% and area under the ROC curve 0.73. CONCLUSION: We report a clinical tool for ADR risk stratification in patients hospitalized in general wards based on 14 variables.

Relationship Between Metabolic Syndrome and the Brazilian Workers' Food Program in Male and Female Manufacturing Workers.

INTRODUCTION: Several studies have reported increased cardiometabolic risk among workers assisted by food assistance public policies. The aim of this study was to estimate the prevalence of metabolic syndrome (MetS) and its individual components among manufacturing workers and their relationship to the Brazilian Workers' Food Program (WFP). METHODS: It was a prospective, cross-sectional, two-stage survey comparative of manufacturing workers from companies adherent and non-adherent to the WFP stratified by sector of activity and company size. The workers were interviewed in the workplace, and data on waist circumference (WC), blood pressure, and 12-hours fasting blood glucose (FBG), serum triglycerides (TG), and total and HDL-cholesterol were obtained. Mixed effects multilevel regression was used to compare WFP and non-WFP groups separately in each sex. All subjects gave written informed consent. RESULTS: The survey included 332 workers from 16 WFP companies and 344 workers from 17 non-WFP companies. The general prevalence of MetS, according to IDF/AHA/NHLBI criteria, was high but not statistically different between sexes (39.8% in females versus 28.5% for males, p=0.16). Statistically significant differences were found between sexes in the prevalence of individual components: WC (77.8% in females versus 38.3% in males, p=0.002), TG (27.3% in females versus 40.8% in males, p=0.07), and HDL-C (52.2% in females versus 43.1% in males, p=0.05). Among males, MetS prevalence was significantly higher in the WFP group (33.0% versus 23.9%, p=0.008), and, in the individual components, the WFP group had higher prevalence of increased WC (47.0% versus 29.4%, p<0.001) and elevated FBG (8.9% versus 6.3%, p<0.001), as well as greater average levels of TG, HDL-C and FBG. Among female workers, no statistically significant differences between groups were observed in MetS prevalence and its individual components, but WFP female worker presented lower systolic and diastolic blood pressure. CONCLUSION: In a low-income population, male manufacturing workers participating in a food assistance program are at increased risk of MetS, an effect that was not identified among female workers.

Effects of vitamin D supplementation on fasting glucose, dyslipidemia, blood pressure, and abdominal obesity among patients with metabolic syndrome: a protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Vitamin D deficiency can play a role in extraskeletal functions that are involved with a set of risk factors associated with metabolic syndrome (MetS). The purpose of this review is to investigate the impact of vitamin D supplementation on fasting glucose, dyslipidemia, blood pressure, and abdominal obesity among patients with MetS. METHODS: EMBASE, Medline, Web of Science, Lilacs, the Cochrane Central Register of Controlled Trials, clinicaltrials.gov databases, and grey literature will be systematically searched for randomized controlled trials (RCTs) of vitamin D supplementation compared with placebo, through December 2020. We will include in the study patients with MetS diagnosed by the criteria set forth by the National Cholesterol Education Program Adult Treatment Panel III or the International Diabetes Federation. The effect of oral vitamin D supplementation on lipid profile improvement (triglycerides, high-density lipoprotein cholesterol-HDL-C) is this review's primary outcome. The systematic review will be performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The study screening, data extraction, and quality assessment will be fulfilled by two independent reviewers according to the Cochrane Risk of Bias tool (RoB 2.0). The results of the systematic review will be provided according to the type of intervention, characteristics of the target population, the methods of measurement of vitamin D, the calculated vitamin D concentrations, types of biological samples, and types of outcomes. Meta-analyses will be conducted where appropriate. The Cochran's Q test and the I2-heterogeneity test will be used to assess the presence of heterogeneity and whether the fixed or the random-effects model would be appropriate for combining study results using the inverse variance method or the DerSimonian-Lair method, respectively. Publication bias will be evaluated using funnel plots and Egger's and Begg's tests. The strength of the evidence will be assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). DISCUSSION: This systematic review will assess the effects of vitamin D supplementation on fasting glucose and triglyceride levels, waist circumference and mean blood pressure, and HDL-C among individuals with MetS. These findings may assist with decision-making within a clinical setting. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42019123212.