Effect of Mobile Health Interventions on Lifestyle and Anthropometric Characteristics of Uncontrolled Hypertensive Participants: Secondary Analyses of a Randomized Controlled Trial.

Our objective was to evaluate the effect of a mobile health (mHealth) intervention on lifestyle adherence and anthropometric characteristics among individuals with uncontrolled hypertension. We performed a randomized controlled trial (ClinicalTrials.gov NCT03005470) where all participants received lifestyle counseling at baseline and were randomly allocated to receive (1) an automatic oscillometric device to measure and register blood pressure (BP) via a mobile application, (2) personalized text messages to stimulate lifestyle changes, (3) both mHealth interventions, or (4) usual clinical treatment (UCT) without technology (control). The outcomes were achieved for at least four of five lifestyle goals (weight loss, not smoking, physical activity, moderate or stopping alcohol consumption, and improving diet quality) and improved anthropometric characteristics at six months. mHealth groups were pooled for the analysis. Among 231 randomized participants (187 in the mHealth group and 45 in the control group), the mean age was 55.4 ± 9.5 years, and 51.9% were men. At six months, achieving at least four of five lifestyle goals was 2.51 times more likely (95% CI: 1.26; 5.00, p = 0.009) to be achieved among participants receiving mHealth interventions. The between-group difference reached clinically relevant, but marginally significant, reduction in body fat (-4.05 kg 95% CI: -8.14; 0.03, p = 0.052), segmental trunk fat (-1.69 kg 95% CI: -3.50; 0.12, p = 0.067), and WC (-4.36 cm 95% CI: -8.81; 0.082, p = 0.054), favoring the intervention group. In conclusion, a six-month lifestyle intervention supported by application-based BP monitoring and text messages significantly improves adherence to lifestyle goals and is likely to reduce some anthropometric characteristics in comparison with the control without technology support.

Systematic review and meta-analysis of anti-thymocyte globulin dosage as a component of graft-versus-host disease prophylaxis.

Rabbit anti-thymocyte globulin (ATG) has been used in allogeneic hematopoietic stem cell transplantation (Allo-HSCT) for graft-versus-host disease (GvHD) prophylaxis. Since the best dose has not been defined yet, this study aimed to determine the efficacy and safety of different doses of ATG in Allo-HSCT. Data sources were MEDLINE/PUBMED, EMBASE, Cochrane Library, Web of Science, LILACS, and SciELO. Studies were eligible when comparing doses of ATG. The higher dose was in the intervention group. A total of 22 articles (2002-2022) were included. Higher doses (4-12 mg/kg) of ATG-T reduced the incidence of grade III-IV acute GvHD (RR 0.60; 95%CI 0.42-0.84) and limited chronic GvHD (RR 0.64 95%CI 0.45-0.92) compared with lower doses (2-7.5 mg/kg). Higher doses increased the Epstein-Barr virus (RR 1.90 95% CI 1.49-2.42) and Cytomegalovirus reactivation (RR, 1.30; 95% CI 1.03-1.64). Relapse rates were higher in the higher dose group (RR 1.34, 95% CI 1.07-167). The ATG-T dose ≥7mg/kg versus the lower dose showed a number needed to treat 7.4 for acute GvHD III-IV, with a number to harm of 7.7 for relapse at one year in the higher dose group. A dose lower than 7 mg/kg suggests a better risk-benefit ratio than a higher one. Well-designed RCT is needed to define the best risk-benefit doses. Trial registration: Trial registration number: PROSPERO: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173449.

Comparison of COVID-19 hospitalization costs across care pathways: a patient-level time-driven activity-based costing analysis in a Brazilian hospital.

BACKGROUND: The COVID-19 pandemic raised awareness of the need to better understand where and how patient-level costs are incurred in health care organizations, as health managers and other decision-makers need to plan and quickly adapt to the increasing demand for health care services to meet patients' care needs. Time-driven activity-based costing offers a better understanding of the drivers of cost throughout the care pathway, providing information that can guide decisions on process improvement and resource optimization. This study aims to estimate COVID-19 patient-level hospital costs and to evaluate cost variability considering the in-hospital care pathways of COVID-19 management and the patient clinical classification. METHODS: This is a prospective cohort study that applied time-driven activity-based costing (TDABC) in a Brazilian reference center for COVID-19. Patients hospitalized during the first wave of the disease were selected for their data to be analyzed to estimate in-hospital costs. The cost information was calculated at the patient level and stratified by hospital care pathway and Ordinal Scale for Clinical Improvement (OSCI) category. Multivariable analyses were applied to identify predictors of cost variability in the care pathways that were evaluated. RESULTS: A total of 208 patients were included in the study. Patients followed five different care pathways, of which Emergency + Ward was the most followed (n = 118, 57%). Pathways which included the intensive care unit presented a statistically significant influence on costs per patient (p <  0.001) when compared to Emergency + Ward. The median cost per patient was I$2879 (IQR 1215; 8140) and mean cost per patient was I$6818 (SD 9043). The most expensive care pathway was the ICU only, registering a median cost per patient of I$13,519 (IQR 5637; 23,373) and mean cost per patient of I$17,709 (SD 16,020). All care pathways that included the ICU unit registered a higher cost per patient. CONCLUSIONS: This is one of the first microcosting study for COVID-19 that applied the TDABC methodology and demonstrated how patient-level costs vary as a function of the care pathways followed by patients. These findings can be used to develop value reimbursement strategies that will inform sustainable health policies in middle-income countries such as Brazil.

Frequency and burden of neurological manifestations upon hospital presentation in COVID-19 patients: Findings from a large Brazilian cohort.

BACKGROUND: Scientific data regarding the prevalence of COVID-19 neurological manifestations and prognosis in Latin America countries is still lacking. Therefore, the study aims to understand neurological manifestations of SARS-CoV 2 infection and outcomes in the Brazilian population. METHODS: This study is part of the Brazilian COVID-19 Registry, a multicentric cohort, including data from 37 hospitals. For the present analysis, patients were grouped according to the presence of reported symptoms (i.e., headache; anosmia and ageusia; syncope and dizziness) vs. clinically-diagnosed neurological manifestations (clinically-defined neurological syndrome: neurological signs or diagnoses captured by clinical evaluation) and matched with patients without neurological manifestations by age, sex, number of comorbidities, hospital of admission, and whether or not patients had underlying neurological disease. RESULTS: From 6,635 hospitalized patients with COVID-19, 30.8% presented reported neurological manifestations, 10.3% were diagnosed with a neurological syndrome and 60.1% did not show any neurological manifestations. In patients with reported symptoms, the most common ones were headache (20.7%), ageusia (11.1%) and anosmia (8.0%). In patients with neurological syndromes, acute encephalopathy was the most common diagnosis (9.7%). In the matched analysis, patients with neurological syndromes presented more cases of septic shock (17.0 vs. 13.0%, p = 0.045), intensive care unit admission (45.3 vs. 38.9%, p = 0.023), and mortality (38.7 vs. 32.6%, p = 0.026; and 39.2 vs. 30.3%, p < 0.001) when compared to controls. CONCLUSION: COVID-19 in-hospital patients with clinically defined neurological syndromes presented a higher incidence of septic shock, ICU admission and death when compared to controls.

Time-driven activity-based costing as a strategy to increase efficiency: An analyses of interventional coronary procedures.

Monitoring the costs is one of the key components underlying value-based health care. This study aimed to evaluate the cost-saving opportunities of interventional coronary procedures (ICPs). Data from 90 patients submitted to elective ICP were evaluated in five Brazilian hospitals. Time-driven activity-based costing, that guides the cost estimates using the time consumed and the capacity cost rates per resource as the data input, was used to assess costs and the time spent over the care pathway. Descriptive cost analyses were followed by a labour cost-saving estimate potentially achieved by the redesign of the ICP pathway. The mean cost per patient varied from $807 to $2639. The length of the procedure phase per patient was similar among the hospitals, while the post-procedure phase presented the highest variation in length. The highest direct cost saving opportunities are concentrated in the procedure phase. By comparing the benchmark service with the most expensive one, it was estimated that redesigning physician practices could decrease 51% of the procedure cost. This application is pioneered in Brazil and demonstrates how detailed cost information can contribute to driving health care management to value by identifying cost-saving opportunities.

Chagas disease and SARS-CoV-2 coinfection does not lead to worse in-hospital outcomes.

Chagas disease (CD) continues to be a major public health burden in Latina America. Information on the interplay between COVID-19 and CD is lacking. Our aim was to assess clinical characteristics and in-hospital outcomes of patients with CD and COVID-19, and to compare it to non-CD patients. Consecutive patients with confirmed COVID-19 were included from March to September 2020. Genetic matching for sex, age, hypertension, diabetes mellitus and hospital was performed in a 4:1 ratio. Of the 7018 patients who had confirmed COVID-19, 31 patients with CD and 124 matched controls were included (median age 72 (64-80) years-old, 44.5% were male). At baseline, heart failure (25.8% vs. 9.7%) and atrial fibrillation (29.0% vs. 5.6%) were more frequent in CD patients than in the controls (p < 0.05). C-reactive protein levels were lower in CD patients compared with the controls (55.5 [35.7, 85.0] vs. 94.3 [50.7, 167.5] mg/dL). In-hospital management, outcomes and complications were similar between the groups. In this large Brazilian COVID-19 Registry, CD patients had a higher prevalence of atrial fibrillation and chronic heart failure compared with non-CD controls, with no differences in-hospital outcomes. The lower C-reactive protein levels in CD patients require further investigation.

The Economic Impact of COVID-19 Treatment at a Hospital-level: Investment and Financial Registers of Brazilian Hospitals.

Background: The economic impact associated with the treatment strategies of coronavirus disease-2019 (COVID-19) patients by hospitals and health-care systems in Brazil is unknown and difficult to estimate. This research describes the investments made to absorb the demand for treatment and the changes in occupation rates and billing in Brazilian hospitals. Methods: This research covers the initial findings of "COVID-19 hospital costs and the proposition of a bundled reimbursement strategy for the health-care system," which includes 10 hospitals. The chief financial officer, the chief medical officer, and hospital executives of each participating hospital provided information regarding investments attributed to COVID-19 patient treatment. The analysis included variations in occupation rates and billing from 2019 to 2020 observed in each institution, and the investments for medical equipment, individual protection materials and building construction per patient treated. Results: The majority of hospitals registered a decrease in hospitalization rates and revenue from 2019 to 2020. For intensive care units (ICUs), the mean occupancy rate ranged from 88% to 83%, and for wards, it ranged from 85% to 73%. Monthly average revenue decreased by 10%. The mean hospital investment per COVID-19 inpatient was I$6800 (standard deviation 7664), with the purchase of ventilators as the most common investment. For this item, the mean, highest and lowest acquisition cost per ventilator were, respectively, I$31 468, I$48 881 and I$17 777. Conclusion: There was significant variability in acquisition costs and investments by institution for responding to the COVID-19 pandemic. These findings highlight the importance of continuing microeconomic studies for a comprehensive assessment of hospital costs. Only with more detailed analyses, will it be possible to define and drive sustainable strategies to manage and reimburse COVID-19 treatment in health-care systems.

Effect of metformin on blood pressure in patients with hypertension: a randomized clinical trial.

OBJECTIVE: Part of the beneficial effects of metformin on the prevention of cardiovascular events in diabetes can be attributed to pleiotropic effects, including a blood pressure (BP)-lowering effect. In a double-blind parallel clinical trial (NCT02072382), the effect of metformin on BP evaluated by ambulatory blood pressure monitoring (ABPM) was measured. METHODS: Ninety-seven patients with hypertension, but without diabetes mellitus, were randomized to receive 850-1700 mg of metformin (n = 48) or placebo (n = 49). Clinical, laboratory, and ABPM data were collected at the baseline and after 8 weeks of follow-up. RESULTS: The sample consisted mainly of White overweight women. There was no difference in BP reduction measured by ABPM between both groups. There was no effect in BP measured in the different periods of ABP monitoring and office BP. Additionally, fasting plasma glucose, lipids, and C-reactive protein remained unchanged during the trial. There was a significant reduction in waist circumference with metformin (95.1 ± 10.4 to 89.3 ± 27.4 cm; p = 0.02). CONCLUSION: In the present trial, metformin did not reduce BP, measured by ABP monitoring, in hypertensive patients without diabetes.

Brazilian Analytical Decision Model for Cardiovascular Disease: An Adaptation of the Scottish Cardiovascular Disease Policy Model.

INTRODUCTION: Despite the significant impact of cardiovascular disease (CVD), there is not yet an analytical decision tool for assessing efficiency of interventions to prevent primary CVD events in Brazil. Therefore, we sought to adapt a Scottish CVD Policy Model to be used in the proposed population. METHODS: Calibration consisted of identifying multiplicative factors for linear predictors of existing survival analysis models to produce predictions that closely match observed data (Life-table and Brazilian cohort study). Target data were life expectancy (LE) and cumulative incidence of coronary heart disease (CHD), cerebrovascular disease (CBVD), fatal CVD and fatal non-CVD. Root-Mean-Square-Error (RMSE) was used to estimate differences between predictions and observations. Acceptance criteria were defined as a fit of less than one year for LE and 1% for cumulative incidence. Male and female models were built separately. RESULTS: The original model underestimated LE (RMSE=2.85 for men and 1.91 for women), CHD and CBVD for women (RMSE=0.044 and 0.041, respectively). The calibration process identified multiplicative factors to reach acceptance criteria for the four target data mentioned above (RMSE=0.61, 0.21, 0.016 and 0.017, respectively). Over prediction was identified only for CHD events in men (RMSE=0.031) being further calibrated (RMSE=0.008). All other target data met the acceptance criteria. Overall, the calibrated model predicts properly to individuals aging 35-80 years old, diabetics or not, smokers or not, with or without family history of CVD, and presenting at least one of the risk factors uncontrolled: Systolic Blood Pressure, Total Cholesterol or HDL-Cholesterol. DISCUSSION: This is the first decision analytic model capable of assessing efficiency of interventions that prevent primary CVD events in Brazil. In future research, independent external validation should be carried out to corroborate the reliability of the model outputs.

COMPARATIVE EFFECTIVENESS AND SAFETY BETWEEN AMPHOTERICIN B LIPID-FORMULATIONS: A SYSTEMATIC REVIEW.

OBJECTIVES: It is not yet established the advantages between amphotericin B lipid complex (ABLC) and liposomal (L-AmB) in patients with invasive fungal infections refractory to usual doses of conventional AmB (d-AmB), previous renal impairment, or unacceptable d-AmB renal toxicity. This systematic review aims to compare ABLC and L-AmB effectiveness and safety outcomes in these subgroups of patients. METHODS: The search was performed on Medline, Cochrane Library, EMBASE, and LILACS databases. INCLUSION CRITERIA: treatment comparing L-AmB with ABLC; patients who had (i) refractory infection after being treated with d-AmB, (ii) previous renal impairment, or (iii) unacceptable d-AmB toxicity. Two investigators independently screened the search results, assessed trial quality, and extracted data. A total of 1,054 articles were identified in the literature. Among those, eleven were selected for full-text reading and five met the inclusion criteria. RESULTS: The five articles included reported on four separate observational studies. Overall, no significant difference was found in clinical relevant outcomes as new-onset dialysis, length of hospital stay, or mortality when comparing both lipid formulations. The studies reported a trend toward lower nephrotoxicity in patients treated with L-AmB. However, the results were imprecise and heterogeneous and the studies presented important methodological biases. CONCLUSIONS: The studies included in this systematic review pointed toward less nephrotoxicity events in the L-AmB group. However, due to low quality of evidence and no statistically significant differences in other clinical relevant outcomes, there is no definitive evidence of overall superiority in effectiveness or safety outcomes regarding one lipid formulation or another in this population subgroup.

Efficacy of nutritional recommendations given by registered dietitians compared to other healthcare providers in reducing arterial blood pressure: Systematic review and meta-analysis.

INTRODUCTION: The multidisciplinary health practitioners can facilitate adherence to treatment of hypertension. Nutritional recommendations delivered by an expert in nutrition might increase the blood pressure control through a better comprehension about how nutrition plays a role on hypertension. OBJECTIVE: To evaluate the effect of nutritional intervention performed by a multidisciplinary team with and without registered dietitians compared to usual care in blood pressure control of hypertensive patients. METHODOLOGY: Systematic review including randomized clinical trials that assessed participants >18 years, both sexes, with blood pressure ≥140/90 mmHg or use of antihypertensive, ≥8 weeks duration and at least one nutritional planned intervention versus usual care. The search was conducted in July 2015 in MEDLINE, EMBASE, BIREME, Web of Science and LILACS without limitation to language. Outcome was defined as deltas of systolic (SBP) and diastolic blood pressure (DBP). Sub-group analysis was conducted according to the presence or not of the registered dietitians in the staff. The analyses were performed in RevMan 5.3 software, using random effects model with heterogeneity assessed by statistical I2. RESULTS: From 7280 identified titles, 62 studies were selected for data extraction, and 13 were included in the meta-analysis, with a total of 2050 participants. There was a greater reduction in ΔSBP -2.82 mmHg (95% CI: 4.03 to -1.62) and ΔDBP -1.37 mmHg (95% CI: -2.11 to -0.62) when diet recommendations have been delivered by multi-professional team versus usual care. In stratified analyses only the subgroup of studies with registered dietitians showed statistical significant reduction in blood pressure ΔSBP -3.21 mmHg (95% CI: -4.14 to -2.27); ΔDBP -1.46 mmHg (95% CI: -2.06 to -0.86). There were significant differences between the deltas of blood pressure according to sodium restriction (ΔSBP -3.5 mmHg (95% CI: -4.52 to -2.48), ΔDBP -1.69 mmHg (95% CI: -2.36 to -1, 02)) and caloric restriction (ΔSBP -2.83 mmHg (95% CI: -5.11 to -0.54); ΔDBP -0.92 mmHg (95% CI: -2.21 to 0.37)) only when there was a registered dietitians in the multidisciplinary team. CONCLUSION: Nutritional recommendation made by multidisciplinary team has a statistical significant effect on blood pressure control in hypertensive patients, mainly when a registered dietitian is present in the team.

The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial.

BACKGROUND: The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months. METHODS/DESIGN: This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection - estimating sodium intake - and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up. DISCUSSION: The study "The effectiveness of an educational intervention to sodium restriction in patients with hypertension" is based on the results of the DSRQ application, whose objective is to evaluate aspects related to nonadherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, hypertension control. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, Identifier: NCT02848690 . Registered retrospectively on 27 July 2016.

Diabetes and cardiovascular events in high-risk patients: Insights from a multicenter registry in a middle-income country.

AIMS: The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country. METHODS: REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke). RESULTS: A total of 5006 subjects was included and analyzed in four groups: No diabetes and no previous cardiovascular event, n=430; diabetes and no previous cardiovascular event, n=1138; no diabetes and previous cardiovascular event, n=1747; and diabetes and previous cardiovascular event, n=1691. Major clinical events in one-year follow-up occurred in 332 patients. A previous cardiovascular event was associated with a higher risk of having another event in the follow-up (HR 2.31 95% CI 1.74-3.05, p<0.001), as did the presence of diabetes (HR 1.28 95% CI 1.10-1.73, p=0.005). In patients with diabetes,failure to reach HbA1c targetswas related topoorer event-free survival compared to patients with good metabolic control (HR 1.70 95% CI 1.01-2.84, p=0.044). CONCLUSIONS: In Brazil, diabetes confers high risk for major clinical events, but this condition is not equivalent to having a previous cardiovascular event. Moreover, not so strict targets for HbA1c in patients with diabetes and previous cardiovascular events might be considered.

Aprepitant in pediatric patients using moderate and highly emetogenic protocols: a systematic review and meta-analyses of randomized controlled trials.

AIMS: To review the efficacy and safety of aprepitant in combination with ondansetron and dexamethasone (triple therapy) in children and adolescents on moderate to highly emetogenic chemotherapy. METHODS: Medline, Embase, Scielo, Lilacs, Cochrane and congress abstracts published until September 2016 were used as data sources. Two reviewers independently selected manuscripts and extracted data. A third reviewer solved discrepancies in study selection and data extraction. The primary outcome was overall complete response (no vomiting from 0 to 120 h). Secondary outcomes were: response in acute phase, delayed phase and reported toxicities. Each study was considered a unit of analysis. Summarized relative risks were recalculated based on reported data. All meta-analyses used a random-effects model and heterogeneity was reported using the I2 method. RESULTS: From 1004 studies, we screened 288 titles and abstracts and included three trials for data extraction. The population comprised 451 patients. Most patients were males, ranging from 6 months to 19 years of age, and weighing from 6 to 134 kg. Bone cancer was the most incident (≥50%) neoplasm, followed by rhabdomyosarcoma and Hodgkin's lymphoma. Triple therapy was associated with a reduced risk of developing chemotherapy-induced vomiting (CIV) (RR = 0.48; 95% CI 0.34-0.67). There were no differences in incidence of febrile neutropenia between groups (RR = 1.02; 95% CI 0.66-1.58). CONCLUSIONS: Triple therapy decreased CIV risk, without increasing the occurrence of febrile neutropenia. However, this review could not address which subpopulations would most benefit from using this strategy. Future studies should focus on assessing risk factors for nausea and vomiting, as many patients did not achieve a complete antiemetic response.

Diabetes and cardiovascular events in high-risk patients: Insights from a multicenter registry in a middle-income country

AIMS:The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country.METHODS:REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke).

Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

BACKGROUND: Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. METHODS/DESIGN: This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. DISCUSSION: Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. TRIAL REGISTRATION: ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial.

BACKGROUND: Obstructive sleep apnea (OSA) and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. Several drugs are used to control hypertension, but the only consistently effective treatment of OSA is continuous positive airway pressure. The identification of a drug capable of improving OSA and hypertension simultaneously would provide a novel approach in the treatment of both diseases. METHODS/DESIGN: This is a randomized double-blind clinical trial, comparing the use of chlorthalidone with amiloride versus amlodipine as a first drug option in patients older than 40 years of age with stage I hypertension (140 to 159/90 to 99 mmHg) and moderate OSA (15 to 30 apneas/hour of sleep). The primary outcomes are the variation of the number of apneas per hour and blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes are adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein levels. The follow-up will last 8 weeks. There will be 29 participants per group. The project has been approved by the ethics committee of our institution. DISCUSSION: The role of fluid retention in OSA has been known for several decades. The use of diuretics are well established in treating hypertension but have never been appropriately tested for sleep apnea. As well as testing the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and their treatment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01896661.

Randomized controlled trial to evaluate the impact of pharmaceutical care on therapeutic success in HIV-infected patients in Southern Brazil.

A non-blinded randomized controlled trial evaluated efficacy of pharmaceutical care (PC) (Dáder method) on self-reported antiretroviral adherence and undetectable plasma viral load (UPVL), compared with usual care (UC) in HIV-positive patients in Brazil. Most were male (63 %), mean age 40.3 years (SD = 10). After 12 months, 79.8 % of those receiving PC versus 73.8 % in UC were adherent (RR 1.05, 95 % CI 0.95-1.15, P = 0.35), and 50.3 versus 49.8 % (PC vs. UC, respectively) had UPVL (RR 1.08, 95 % CI 0.97-1.20, P = 0.15). Factors associated with self-reported adherence were regular employment, UPVL, no depressive symptoms, and lower pill load in the treatment regimen. Older age, education, CD4 count <200 cells/mm(3), and shorter treatment duration were associated with UPVL. Of 94 reported drug-related problems, 43 % resolved. In subgroup analyses of patients who experienced therapeutic failure and who were non-adherent at the beginning of the trial (N = 50), no differences were found in UPVL (HR 1.35, 95 % CI 0.57-3.19). Only education level (>12 years) was independently predictive of viral suppression (HR 7.47, 95 % CI 1.69-32.91). In conclusion, PC was not associated with increased self-reported adherence to ART or UPVL in patients treated at a health care facility in southern Brazil. The study suggests, however, that PC could be effective for the subgroup of patients with poor adherence.