Effectiveness of Mindfulness-Based Relapse Prevention Program as an Adjunct to the Standard Treatment for Smoking: A Pragmatic Design Pilot Study.

INTRODUCTION: Posttreatment relapse is a major roadblock to stemming the global epidemic of tobacco-related illness. This article presents results from a pilot trial evaluating the feasibility and initial efficacy of Mindfulness-Based Relapse Prevention (MBRP) as an adjunct to standard relapse prevention treatment (ST) for smoking cessation. AIMS AND METHODS: Smokers (n = 86) in the maintenance phase of treatment were randomized to receive either ST plus MBRP (MBRP) (n = 44) or ST alone (ST) (n = 42). Data were collected at baseline and at 4-, 12-, and 24-week follow-up points. We evaluated the feasibility of the protocol with frequency analysis, and the efficacy with both intention to treat and complete case analyses of the effects of MBRP on abstinence. Secondary outcomes included mindfulness, craving, depression, anxiety, and positive/negative affect. RESULTS: High adherence suggested MBRP is acceptable and feasible. Participants in the MBRP group reported increases in mindfulness (M = -7.833, p = .016), and reductions in craving (M = 17.583, p = .01) compared with the ST group. Intention to treat analysis found that, compared with MBRP (36.4%), ST (57.1%) showed trend-level superiority in abstinence at Week 4 (Prevalence Ratio = 0.63, p = .06); however at Week 24, the ST group (14.3%) demonstrated a twofold greater decrease in abstinence, compared with the MBRP group (20.1%) (Prevalence Ratio = 2.25, p = .08). Therefore, the MBRP group maintained a higher abstinence rate for longer. Reported effects were greater in the complete case analysis. CONCLUSIONS: MBRP holds promise for preventing relapse after aided tobacco quit attempts. IMPLICATIONS: Findings suggest that MBRP is acceptable, feasible, and valued by participants. At 24-week follow-up, there was a large effect size and a statistical trend toward fewer MBRP patients relapsing compared with ST patients. MBRP conferred ancillary benefits including reductions in craving and increases in levels of mindfulness. MBRP for tobacco cessation is highly promising and merits further research. TRIAL REGISTRATION: clinicaltrials.gov. IDENTIFIER: NCT02327104.

A prospective evaluation of inter-rater agreement of routine medical records audits at a large general hospital in São Paulo, Brazil.

BACKGROUND: The quality of patient medical records is intrinsically related to patient safety, clinical decision-making, communication between health providers, and continuity of care. Additionally, its data are widely used in observational studies. However, the reliability of the information extracted from the records is a matter of concern in audit processes to ensure inter-rater agreement (IRA). Thus, the objective of this study is to evaluate the IRA among members of the Patient Health Record Review Board (PHRRB) in routine auditing of medical records, and the impact of periodic discussions of results with raters. METHODS: A prospective longitudinal study was conducted between July of 2015 and April of 2016 at Hospital Municipal Dr. Moysés Deutsch, a large public hospital in São Paulo. The PHRRB was composed of 12 physicians, 9 nurses, and 3 physiotherapists who audited medical records monthly, with the number of raters changing throughout the study. PHRRB meetings were held to reach a consensus on rating criteria that the members use in the auditing process. A review chart was created for raters to verify the registry of the patient's secondary diagnosis, chief complaint, history of presenting complaint, past medical history, medication history, physical exam, and diagnostic testing. The IRA was obtained every three months. The Gwet's AC1 coefficient and Proportion of Agreement (PA) were calculated to evaluate the IRA for each item over time. RESULTS: The study included 1884 items from 239 records with an overall full agreement among raters of 71.2%. A significant IRA increase of 16.5% (OR = 1.17; 95% CI = 1.03-1.32; p = 0.014) was found in the routine PHRRB auditing, with no significant differences between the PA and the Gwet's AC1, which showed a similar evolution over time. The PA decreased by 27.1% when at least one of the raters was absent from the review meeting (OR = 0.73; 95% CI = 0.53-1.00; p = 0.048). CONCLUSIONS: Medical record quality has been associated with the quality of care and could be optimized and improved by targeted interventions. The PA and the Gwet's AC1 are suitable agreement coefficients that are feasible to be incorporated in the routine PHRRB evaluation process.

Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

BACKGROUND: Non-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest public transplantation program in the world and with regional differences regarding access to health services and service implementation, is in a unique position to study this multilevel approach. Therefore, the Adhere Brazil Study (ADHERE BRAZIL) was designed to assess the prevalence and variability of non-adherence to immunosuppressants and to health behaviours among adult KT recipients in Brazil, and to assess the multilevel correlates of non-adherence to immunosuppressive medication. We describe the rationale, design, and methodology of the ADHERE BRAZIL study. METHODS/DESIGN: This is an observational, cross-sectional, multicentre study that includes 20 Brazilian KT centres. A stratified sampling approach is used, based on strata, with the following characteristics considered: geographical region and transplant activity (number of KTs per year). A random sample of patients (proportional to the size of the centre within each stratum) is selected from each centre. The prevalence of different health behaviours is assessed through self-report. The assessment of multilevel correlates of non-adherence is guided by the ecological model that considers factors at the level of the patient, health-care professional, and transplant centre, using established instruments or instruments developed for this study. Data will be collected over an 18-month period, with information obtained during the regular follow-up visits to the transplant outpatient clinic and directly entered into the Research Electronic Data Capture (RedCap) system. Data entry is performed by a trained professional who is part of the transplant team. The data collection began in December 2015. DISCUSSION: This multicentre study is the first to evaluate multilevel correlates of non-adherence in KT patients and will provide a reliable estimate of non-adherence in Brazilian KT patients. TRIAL REGISTRATION: ClinicalTrials.gov on 10/10/2013, NCT02066935 .

Screening for Fabry Disease in Kidney Disease: a Cross-Sectional Study in Males and Females.

BACKGROUND/AIMS: Evaluate the prevalence of Fabry disease in men and women with kidney disease; and observe the presence and importance of the main signs and symptoms in patients with kidney disease. METHODS: A cross-sectional analysis of secondary data from a multicenter project of Clinical and Epidemiological Analysis of Fabry Disease in 854 Dialysis Centers. A total of 36,442 patients underwent the questionnaire and algorithm; of them, 28,284 were discarded for not presenting signs and symptoms of Fabry disease, while the other 8,087 submitted to blood collection and analysis. All participants signed a Free and Informed Consent Form and a questionnaire was applied. The questionnaire data were analyzed using a computerized algorithm. This program/algorithm analyzes and separates patients into: discarded, patients unlikely to have Fabry disease; suspect, patients who submitted to blood collection. The blood of suspect patients was collected on filter paper for enzyme measurement and genetic testing. A descriptive data analysis was performed and the likelihood ratio was determined. RESULTS: The general prevalence was 0.19% and after use of algorithm was 0.87%. Although more men were screened (59.3%), the prevalence was higher in women (65.1%). The most prevalent signs and symptoms were: heart disease (60.6%), decreased or lack of sweating (42.3%), heat and cold intolerance (28.2%), and pain crises spreading throughout the body (26.8%). CONCLUSION: The prevalence was higher in women, and the most prevalent symptom was heart diseases.

Self-efficacy beliefs, locus of control, religiosity and non-adherence to immunosuppressive medications in kidney transplant patients.

AIM: Adherence to immunosuppressive medication is essential for favourable kidney transplant outcomes. The present study aims to investigate how self-efficacy beliefs, health locus of control and religiosity are associated with adherence to immunosuppressives in post kidney transplant recipients. METHODS: This is a cross-sectional study with 88 recipients with more than 1 year after transplantation. Three methods were used to classify patients as adherent or non-adherent: Basel Assessment of Adherence Scale for Immunosuppressives - BAASIS, the collateral report and blood levels of immunosuppressive medications. Self-efficacy, health locus of control, and religiosity were evaluated applying General Perceived Self-Efficacy Scale, Multidimensional Health Locus of Control Scale and Duke University Religion Index, respectively. Non-adherence was modelled by uni- and multivariated analysis. RESULTS: Sixty-three percent of the patients were male, age 47.2 ± 12.9 years, and median post-transplant time 108.71 (49.0-266.0) months. We found 70.5% of patients were non-adherent through at least one method. Adherent patients presented higher self-efficacy scores (45.1 ± 4.9 vs 38.3 ± 8.6; P < 0.001) and higher intrinsic religiosity (14.0 ± 1.6 vs. 12.8 ± 2.5; P = 0.016) compared to the non-adherents. Organizational and non-organizational religiosity did not differ between these groups. By logistic regression, non-adherence was associated with lower self-efficacy (OR 0.81, IC 0.70-0.92, P = 0.002), chance locus of control (OR 1.23, IC 1.04-1.45, P = 0.016) and lower intrinsic religiosity (OR 0.56, IC 0.38-0.84, P = 0.006). CONCLUSION: Our study showed that self-efficacy, chance locus of control, and intrinsic religiosity were associated with non-adherence to immunosuppressives. A broader perception of the kidney transplant patient´s integrality can help health professionals to design strategies to promote adherence in this population.

Implementation of integration strategies between primary care units and a regional general hospital in Brazil to update and connect health care professionals: a quasi-experimental study protocol.

BACKGROUND: Better communication among field health care teams and points of care, together with investments focused on improving teamwork, individual management, and clinical skills, are strategies for achieving better outcomes in patient-oriented care. This research aims to implement and evaluate interventions focused on improving communication and knowledge among health teams based on points of care in a regional public health outreach network, assessing the following hypotheses: 1) A better-working communication process between hospitals and primary health care providers can improve the sharing of information on patients as well as patients' outcomes. 2) A skill-upgrading education tool offered to health providers at their work sites can improve patients' care and outcomes. METHODS/DESIGN: A quasi-experimental study protocol with a mixed-methods approach (quantitative and qualitative) was developed to evaluate communication tools for health care professionals based in primary care units and in a general hospital in the southern region of São Paulo City, Brazil. The usefulness and implementation processes of the integration strategies will be evaluated, considering: 1) An Internet-based communication platform that facilitates continuity and integrality of care to patients, and 2) A tailored updating distance-learning course on ambulatory care sensitive conditions for clinical skills improvements. The observational study will evaluate a non-randomized cohort of adult patients, with historical controls. Hospitalized patients diagnosed with an ambulatory care sensitive condition will be selected and followed for 1 year after hospital discharge. Data will be collected using validated questionnaires and from patients' medical records. Health care professionals will be evaluated related to their use of education and communication tools and their demographic and psychological profiles. The primary outcome measured will be the patients' 30-day hospital readmission rates. A sample size of 560 patients was calculated to fit a valid logistic model. In addition, qualitative approaches will be used to identify subjective perceptions of providers about the implementation process and of patients about health system use. DISCUSSION: This research project will gather relevant information about implementation processes for education and communication tools and their impact on human resources training, rates of readmission, and patient-related outcomes.

Association of frailty with endothelial dysfunction and its possible impact on negative outcomes in Brazilian predialysis patients with chronic kidney disease.

BACKGROUND: Frailty is a state of physiological vulnerability common in the elderly. It is more predominant in patients with Chronic Kidney Disease in comparison to healthy subjects, which can also be diagnosed in non-elderly individuals and be associated with innumerous causes such as muscle strength, body composition and inflammation. The association between frailty and endothelial function, as well as the association between frailty and the combined outcome of mortality multiple cause and start of renal replace therapy were assessed. METHODS: In the initial analysis, sixty-one predialysis patients with Chronic Kidney Disease stages were evaluated and included in this study. Due to patient drop-out during follow-up, fifty-seven patients were subsequently re-evaluated 12 months later. The diagnosis of frailty was based on the Johansen et al. (J Am Soc Nephrol 18(11):2960-67, 2007) criteria. The groups were divided into Non-frail and Frail. Sociodemographic, inflammatory markers (IL-6, TNF-?, CRP-us), endothelial dysfunction (flow-mediated vasodilatation - FMD), body composition (DXA) and the 25-hidroxi-vitamin D parameters were analyzed. RESULTS: The average age of the patients used in the study was 64.9 ± 10.3 years old. The predominance of frailty was 42.6%, of which 46% were non-elderly. After some adjustments, frailty was associated with gender (OR = 11.32; IC 95% = 2.30 to 55.67), advanced age (OR = 4.07; IC 95% = 1.02 to 16.20), obesity (OR = 6.63; IC 95% = 0.82 to 11.44) and endothelial dysfunction (OR = 3.86; IC 95% = 1.00 to 14.88). The ratio of the incidence of frail subjects to the variable outcome was 2.5 (CI 95%, 1.04 to 6.50). CONCLUSIONS: Although an observational study does not allow one to determine the casual relation between frailty and endothelial dysfunction, we conclude that frailty was predominant in our sample of Brazilian patients with chronic kidney disease on predialysis, even in elderly individuals. This was linked to either worse endothelial function or mortality.

Factors Associated with the Treatment Costs within the First Year after Pacemaker Implantation or Pulse Generator Replacement. / Fatores Associados aos Custos do Tratamento no Primeiro Ano após Implantes Iniciais ou Trocas de Geradores de Pulsos de Marca-passos Cardíacos.

BACKGROUND: The use of artificial cardiac pacemakers has grown steadily in line with the aging population. OBJECTIVES: To determine the rates of hospital readmissions and complications after pacemaker implantation or pulse generator replacement and to assess the impact of these events on annual treatment costs from the perspective of the Unified Health System (SUS). METHODS: A prospective registry, with data derived from clinical practice, collected during index hospitalization and during the first 12 months after the surgical procedure. The cost of index hospitalization, the procedure, and clinical follow-up were estimated according to the values reimbursed by SUS and analyzed at the patient level. Generalized linear models were used to study factors associated with the total annual treatment cost, adopting a significance level of 5%. RESULTS: A total of 1,223 consecutive patients underwent initial implantation (n=634) or pulse generator replacement (n=589). Seventy episodes of complication were observed in 63 patients (5.1%). The incidence of hospital readmissions within one year was 16.4% (95% CI 13.7% - 19.6%) after initial implants and 10.6% (95% CI 8.3% - 13.4%) after generator replacements. Chronic kidney disease, history of stroke, length of hospital stays, need for postoperative intensive care, complications, and hospital readmissions showed a significant impact on the total annual treatment cost. CONCLUSIONS: The results confirm the influence of age, comorbidities, postoperative complications, and hospital readmissions as factors associated with increased total annual treatment cost for patients with pacemakers.

FUNDAMENTO: O uso de marca-passos cardíacos artificiais tem crescido constantemente, acompanhando o envelhecimento populacional. OBJETIVOS: Determinar as taxas de readmissões hospitalares e complicações após implante de marca-passo ou troca de gerador de pulsos e avaliar o impacto desses eventos nos custos anuais do tratamento sob a perspectiva do Sistema Único de Saúde (SUS). MÉTODOS: Registro prospectivo, com dados derivados da prática clínica assistencial, coletados na hospitalização índice e durante os primeiros 12 meses após o procedimento cirúrgico. O custo da hospitalização índice, do procedimento e do seguimento clínico foram estimados de acordo com os valores reembolsados pelo SUS e analisados ao nível do paciente. Modelos lineares generalizados foram utilizados para estudar fatores associados ao custo total anual do tratamento, adotando-se um nível de significância de 5%. RESULTADOS: No total, 1.223 pacientes consecutivos foram submetidos a implante inicial (n= 634) ou troca do gerador de pulsos (n= 589). Foram observados 70 episódios de complicação em 63 pacientes (5,1%). A incidência de readmissões hospitalares em um ano foi de 16,4% (IC 95% 13,7% - 19,6%) após implantes iniciais e 10,6% (IC 95% 8,3% - 13,4%) após trocas de geradores. Doença renal crônica, histórico de acidente vascular encefálico, tempo de permanência hospitalar, necessidade de cuidados intensivos pós-operatórios, complicações e readmissões hospitalares mostraram um impacto significativo sobre o custo anual total do tratamento. CONCLUSÕES: Os resultados confirmam a influência da idade, comorbidades, complicações pós-operatórias e readmissões hospitalares como fatores associados ao incremento do custo total anual do tratamento de pacientes com marca-passo.

Fenofibrate attenuates renal lipotoxicity in uninephrectomized mice with high-fat diet-induced obesity.

INTRODUCTION: The objective of this study was to investigate the role of fenofibrate, a peroxisome proliferator-activated receptor-α agonist, in obesity-induced kidney damage (lipotoxicity) in mice with uninephrectomy. METHODS: C57BL/6 mice underwent uninephrectomy and sham surgeries and were fed normocaloric or high-fat diets. After 10 weeks, obese mice were administered 0.02% fenofibrate for 10 weeks. Kidney function and morphology were evaluated, as well as levels of inflammatory and fibrotic mediators and lipid metabolism markers. RESULTS: High-fat diet-fed mice developed characteristic obesity and hyperlipidemia, with subsequent renal lipid accumulation and damage, including mesangial expansion, interstitial fibrosis, inflammation, and proteinuria. These changes were greater in obese uninephrectomy mice than in obese sham mice. Fenofibrate treatment prevented hyperlipidemia and glomerular lesions, lowered lipid accumulation, ameliorated renal dysfunction, and attenuated inflammation and renal fibrosis. Furthermore, fenofibrate treatment downregulated renal tissue expression of plasminogen activator inhibitor-1, monocyte chemoattractant protein-1, and local expression of fibroblast growth factor-21. CONCLUSION: Peroxisome proliferator-activated receptor-α activation by fenofibrate, with subsequent lipolysis, attenuated glomerular and tubulointerstitial lesions induced by renal lipotoxicity, thus protecting the kidneys of uninephrectomy mice from obesity-induced lesions. The study findings suggest a pathway in the pharmacological action of fenofibrate, providing insight into the mechanisms involved in kidney damage caused by obesity in kidney donors.

Driving pressure, as opposed to tidal volume based on predicted body weight, is associated with mortality: results from a prospective cohort of COVID-19 acute respiratory distress syndrome patients.

OBJECTIVE: To evaluate the association between driving pressure and tidal volume based on predicted body weight and mortality in a cohort of patients with acute respiratory distress syndrome caused by COVID-19. METHODS: This was a prospective, observational study that included patients with acute respiratory distress syndrome due to COVID-19 admitted to two intensive care units. We performed multivariable analyses to determine whether driving pressure and tidal volume/kg predicted body weight on the first day of mechanical ventilation, as independent variables, are associated with hospital mortality. RESULTS: We included 231 patients. The mean age was 64 (53 - 74) years, and the mean Simplified Acute and Physiology Score 3 score was 45 (39 - 54). The hospital mortality rate was 51.9%. Driving pressure was independently associated with hospital mortality (odds ratio 1.21, 95%CI 1.04 - 1.41 for each cm H2O increase in driving pressure, p = 0.01). Based on a double stratification analysis, we found that for the same level of tidal volume/kg predicted body weight, the risk of hospital death increased with increasing driving pressure. However, changes in tidal volume/kg predicted body weight were not associated with mortality when they did not lead to an increase in driving pressure. CONCLUSION: In patients with acute respiratory distress syndrome caused by COVID-19, exposure to higher driving pressure, as opposed to higher tidal volume/kg predicted body weight, is associated with greater mortality. These results suggest that driving pressure might be a primary target for lung-protective mechanical ventilation in these patients.

Effect of a structured early mobilization protocol on the level of mobilization and muscle strength in critical care patients: A randomized clinical trial.

BACKGROUND: Few studies have evaluated the effects of structured early mobilization (EM) protocols on the level of mobilization in critical care patients. OBJECTIVE: To evaluate the impact of a structured EM protocol on the level of mobilization, muscle strength, and the level of activities of daily living (LADL) after intensive care unit (ICU) and hospital discharge. METHODS: This randomized clinical trial (U1111-1245-4840) included adults patients who were randomized into two groups: intervention (n = 40) and control (n = 45). The intervention group underwent conventional physiotherapy and structured EM protocols, and the control group underwent conventional physiotherapy. The level of mobilization from 0 (no mobilization) to 5 (walking), muscle strength (Medical Research Council scale), LADL (Katz Index), and incidence of complications were evaluated. RESULTS: The level of mobilization from day 1 to day 7 increased in the intervention group compared with the control group (p < .05). Muscle strength did not change during the protocol in the intervention and control groups {day 1 [effect size (r) = 0.15, p = .161], at ICU discharge [r = 0.16, p = .145], and after ICU discharge [r = 0.16, p = .191]}. The LADL did not differ between the intervention and control groups after ICU discharge [4 (1-6) vs. 3 (1-5), p = .702] or 30 days after hospital discharge [6 (5-6) vs. 6 (5-6), p = .945]. The structured EM protocol was safe, and no severe complications were observed during the protocol. CONCLUSION: A structured EM protocol increased the level of mobilization without improving muscle strength and the LADL compared with conventional physiotherapy.

COVID-19's intra-urban inequalities and social vulnerability in a medium-sized city.

BACKGROUND: Social conditions are related to the impact of epidemics on human populations. This study aimed to investigate the spatial distribution of cases, hospitalizations, and deaths from COVID-19 and its association with social vulnerability. METHODS: An ecological study was conducted in 81 urban regions (UR) of Juiz de Fora from March to November 2020. Exposure was measured using the Health Vulnerability Index (HVI), a synthetic indicator that combines socioeconomic and environmental variables from the Demographic Census 2010. Regression models were estimated for counting data with overdispersion (negative binomial generalized linear model) using Bayesian methods, with observed frequencies as the outcome, expected frequencies as the offset variable, and HVI as the explanatory variable. Unstructured random-effects (to capture the effect of unmeasured factors) and spatially structured effects (to capture the spatial correlation between observations) were included in the models. The models were estimated for the entire period and quarter. RESULTS: There were 30,071 suspected cases, 8,063 confirmed cases, 1,186 hospitalizations, and 376 COVID-19 deaths. In the second quarter of the epidemic, compared to the low vulnerability URs, the high vulnerability URs had a lower risk of confirmed cases (RR=0.61; CI95% 0.49-0.76) and a higher risk of hospitalizations (RR=1.65; CI95% 1.23-2.22) and deaths (RR=1.73; CI95% 1.08-2.75). CONCLUSIONS: The lower risk of confirmed cases in the most vulnerable UR probably reflected lower access to confirmatory tests, while the higher risk of hospitalizations and deaths must have been related to the greater severity of the epidemic in the city's poorest regions.

Impact of an educational intervention in the management of individuals with uncontrolled type 2 diabetes mellitus using insulin therapy.

OBJECTIVE: To investigate the effects of problematizing intervention in the treatment of individuals with type 2 diabetes mellitus. METHODOLOGY: A randomized clinical trial was conducted in 41 patients ages 18 to 64 with type 2 diabetes who were treated with insulin and had glycosylated hemoglobin greater than 7.0%. The mean age of participants was 55.9 (SD = 5.49). A high percentage of patients had comorbidities such as hypertension (92.7%), dyslipidemia (68.3%), overweight (95%), retinopathy (41%), and neuropathy (39%). The patients in the intervention group participated in 6 educational groups using problematization methodology, whereas the patients in the control group attended only routine consultations. Sociodemographic, clinical, behavioral, and lifestyle variables were assessed. RESULTS: After 6 months of follow-up, no statistically significant difference in glycemic control and anthropometric parameters was observed between participants in either study group. The intervention group showed an increase in knowledge about the disease, and an improvement in total cholesterol and uric acid levels. CONCLUSION: The use of a problematizing intervention provided an improvement in behavioral as well as specific clinical parameters, compared to routine diabetes care. However, longer follow-up time for these patients could bring benefits regarding glycemic control.

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study.

BACKGROUND: Epidemiological studies involving large samples usually face financial and operational challenges. OBJECTIVES: To describe the planning and execution of ADHERE Brazil, an epidemiological study on 1,105 kidney transplant patients, and report on how the study was structured, difficulties faced and solutions found. DESIGN AND SETTING: Cross-sectional multicenter study in 20 Brazilian kidney transplantation centers. METHODS: Actions developed in each phase of implementation were described, with emphasis on innovations used within the logistics of this study, aimed at estimating the prevalence of nonadherence to treatment. RESULTS: Coordination of activities was divided into four areas: general, regulatory, data collection and statistics. Weekly meetings were held for action planning. The general coordination team was in charge of project elaboration, choice of participating centers, definition of publication policy and monitoring other coordination teams. The regulatory team provided support to centers for submitting the project to ethics committees. The data collection team prepared a manual on the electronic collection system, scheduled web meetings and was available to respond to queries. It also monitored the data quality and reported any inadequacies found. Communication with the centers was through monthly reports via e-mail and distribution of exclusive material. The statistical team acted in all phases of the study, especially in creating the data analysis plan and data bank, generation of randomization lists and data extraction. CONCLUSIONS: Through these logistics, we collected high-quality data and built a local research infrastructure for further studies. We present supporting alternatives for conducting similar studies. CLINICAL TRIAL ANNOTATION: http://clinicaltrials.gov/ on October 10, 2013; NCT02066935.

Smoking Cessation Mobile Interventions in Latin America: A Systematic Review.

OBJECTIVE: To systematically review published articles reporting the use of smoking cessation mobile health (mHealth) interventions in Latin America. METHODS: Five different databases were searched from database inception to 2020. Criteria: (1) the research was a smoking cessation randomized controlled trial (RCT), quasi-experimental research, or single-arm study; (2) the intervention used at least one type of mHealth intervention; (3) the research was conducted in Latin American; and (4) the research reported the cessation rate. RESULTS: Of the seven selected studies, four were conducted in Brazil, two in Mexico, and one in Peru. Only one study was an adequately powered RCT. Interventions relied on text messages (n = 3), web-based tools (n = 2), and telephone calls (n = 3). Some studies (n = 4) provided pharmacotherapy support. Smoking cessation outcomes included self-reported (n = 5) and biochemically verified (n = 2) abstinence. Follow-ups were conducted at Month 6 (n = 2), Week 12 (n = 4), and Day 30 (n = 1). Cessation rates varied from 9.4% at Week 12 to 55.5% at Day 30. CONCLUSION: Despite the promising cessation rates of mHealth interventions in Brazil, Mexico, and Peru, there is a need to rigorously evaluate these interventions in different Latin American countries with RCTs that are long-term, adequately powered, and use biochemical verification of cessation.

Multidisciplinary treatment for patients with chronic kidney disease in pre-dialysis minimizes costs: a four-year retrospective cohort analysis.

INTRODUCTION: Chronic kidney disease (CKD) can progress to end-stage renal disease (ESRD), and clinical studies show that this progression can be slowed. The objective of this study was to estimate the costs to Brazil's public health system (SUS) throughout the course of CKD in the pre-dialysis stage compared to the costs to the SUS of dialysis treatment (DT). METHODS: A retrospective cohort study was conducted to analyze clinical and laboratory variables; the outcome analyzed was need for DT. To assess cost, a microcosting survey was conducted according to the Methodological Guidelines for Economic Evaluations in Healthcare and the National Program for Cost Management, both recommended by the Brazilian Ministry of Health for economic studies. RESULTS: A total of 5,689 patients were followed between 2011 and 2014, and 537 met the inclusion criteria. Average costs increased substantially as the disease progressed. The average cost incurred in stage G1 in Brazilian reals was R$ 7,110.78, (US$1,832.06) and in stage G5, it was R$ 26,814.08 (US$6,908.53), accumulated over the four years. CONCLUSION: A pre-dialysis care program may reduce by R$ 33,023.12 ± 1,676.80 (US$ 8,508.26 ± 432.02) the average cost for each year of DT avoided, which is sufficient to cover the program's operation, minimizing cost. These results signal to public health policy makers the real possibility of achieving significant cost reduction in the medium term for CKD care (4 years), to a program that disbursed R$ 24 billion (US$ 6.8 billion) for DT in Brazil between 2009 and 2018.

Observing the Working Alliance in Videoconferencing Psychotherapy for Alcohol Addiction: Reliability and Validity of the Working Alliance Inventory Short Revised Observer.

The coronavirus disease-2019 (COVID-19) pandemic has affected the mental health and alcohol consumption of individuals. Videoconferencing psychotherapy has become a fundamental mode of treatment for people with alcohol use disorders. However, there are still doubts about its effectiveness and the therapeutic relationship. The working alliance is considered a foundation of effective practice in cognitive behavioral therapy (CBT). Observer measurements of the working alliance have demonstrated reliability and meaningful associations with the reduction of symptoms. However, translations of instruments to evaluate the working alliance and examine its construct have not previously been conducted for online psychotherapy for alcohol addiction. This study aimed for the cross-cultural adaptation of the Working Alliance Inventory-Short Form-Observer (WAI-SR-O) for Brazil and the evaluation of its reliability and evidence of its validity in videoconferencing psychotherapy for alcoholism. The WAI-SR-O was applied by pairs of observers for the evaluation of the working alliance in 19 recorded sessions of videoconferencing psychotherapy of 10 clients with a diagnosis of alcohol addiction. The sessions were also evaluated by the therapist (WAI-T) and client (WAI-C). The WAI-SR-O shows a moderate inter-rater intraclass correlation coefficient (ICC = 0.67) for the general scale, higher ICC for the goals and bond subscales, and a moderate value for the task subscale. The internal consistency was good (a = 0.86). The results show low but significant correlations among the goals and bond subscales of the WAI-SR-O and the general, goals, and bond scales of the WAI-T. No correlations were found with the WAI-C. As the literature points out, the client, therapist, and observer versions of the WAI evaluated the alliance differently, requiring further study. The WAI-SR-O proved to be a reliable and valid measurement for the evaluation of the working alliance in videoconferencing psychotherapy for alcohol addiction, becoming an important tool for the study of the working alliance in telepsychotherapy.

Similar quality in chronic kidney disease multidisciplinary follow-up between kidney.

INTRODUCTION: Multidisciplinary clinics are the best approach towards Chronic Kidney Disease (CKD) patients in pre-dialysis phases. The few studies regarding kidney transplant recipients (KTR) compare multidisciplinary and non-multidisciplinary clinics. METHODS: In this study, we compared the quality of multidisciplinary CKD care between 101 KTR and 101 propensity score-matched non-transplant pre-dialysis patients (PDP). Prevalence of patients without specific treatment at any time and percent time without specific treatment for CKD complications were the main outcomes and patient and kidney function survival, glomerular filtration rate (GFR) decline, prevalence of CKD-related complications, and percent time within therapeutic goals were the exploratory ones. RESULTS: Time within most goals was similar between the groups, except for diastolic blood pressure (83.4 vs. 77.3%, RR 0.92, CI 0.88-0.97, p = 0.002) and hypertriglyceridemia (67.7 vs. 58.2%, OR 0.85, CI 0.78-0.93, p < 0.001), better in non-transplant PDP, and for proteinuria (92.7 vs. 83.5%, RR 1.1, CI 1.05-1.16, p < 0.001), better in KTR. Patient survival and GFR decline were similar between the groups, although non-transplant PDP tended to progress earlier to dialysis (9.9% vs. 6.9%, HR 0.39, p = 0.07, CI 0.14-1.08). DISCUSSION: The similar findings between non-transplant PDP and KTR suggests that good and comparable quality of multidisciplinary is a valid strategy for promoting optimal clinical management of CKD-related complications in KTR.

The prevalence and associated factors of nonadherence to antihypertensive medication in secondary healthcare.

PURPOSE: Non-adherence (NA) to medication is a major contributor to treatment failure in hypertensive patients. Factors of the ecological model, at family/healthcare professional, service, and system levels, are rarely evaluated as correlates of NA in hypertensive patients. METHODS: This crossectional study assessed the prevalence of and associated factors of NA to antihypertensive medication among 485 hypertensive patients upon receiving secondary healthcare. The Morisky Green Levine Scale (MGLS) measured the implementation phase of adherence, and the Short Assessment of Health Literacy for Portuguese-speaking Adults (SAHLPA) instrument, health literacy. Multivariate analysis to NA included variables according to the levels of the ecological model. RESULTS: Most patients were female (56.3%), white (53.2%), mean age of 62.0 ± 12.6 years, illiterate (61.6%), with low health literacy (70.9%), and low income (65.4%). Uncontrolled BP was frequent (75.2%); 57.1% of patients were nonadherent. In multivariate analysis based on the ecological model, adjusted for micro, meso- and macro-level correlates, NA was associated only with variables of patient-level: low health literacy (OR 1.62, CI 1.07-2.44, p = 0.020), income ≥ two reference wages (OR 0.46, CI 0.22-0.93, p = 0.031), lack of homeownership (OR 1.99, CI 1.13-3.51, p = 0.017), sedentarism (OR 1.78, CI 1.12-2.83, p = 0.014), and complexity of treatment (number of medications taken ≥ two times/day) (OR 1.56, CI 1.01-2.41, p = 0.042). CONCLUSION: In this group of severely hypertensive patients with high cardiovascular risk, only patient-related characteristics were associated with NA. Our findings highlight the need for effective actions to optimize clinical outcomes in similar healthcare programs.

Factors Associated with Functional Capacity in CKD Patients.

To evaluate the factors associated with functional capacity in patients with chronic kidney disease (CKD). All patients were submitted to six-minute walk test (6MWT), 10-repetition sit-to-stand test (STS-10) and SF-36 health-related quality of life questionnaire (HRQoL). Patients with functional capacity ≥80% exhibited higher education level, family income, body mass index, estimated glomerular filtration rate, and lower age and STS-10 time. Multiple linear regression showed that gender, age, family income, chronic kidney disease stage, STS-10 time, and physical component summary of HRQoL were significantly associated with the 6MWT distance. Functional capacity was significantly associated with gender, age, family income, CKD stage, STS-10 time, and physical component of HRQoL. The progression of CKD has an impact on the decrease in functional capacity in these patients.