The Rise of Patients Declining Rectal Cancer Surgery in the Era of Total Neoadjuvant Therapy.

BACKGROUND: The treatment landscape for rectal cancer is rapidly evolving, particularly with the increasing use of neoadjuvant therapies. Still, up to 50% of patients with stage II-III disease require surgical resection post-neoadjuvant therapy to achieve the best oncologic outcomes. Many patients, however, hope to avoid surgery. This study aimed to assess trends and factors associated with declining recommended oncologic resection after systemic therapy nationally and in our institution. PATIENTS AND METHODS: This is a retrospective analysis using the National Cancer Database from 2009 to 2021 and an institutional cohort at an academic center between 2009 and 2022 including adults with stage I-III rectal adenocarcinoma who underwent neoadjuvant therapy and were suitable for surgery. RESULTS: Of 96,997 patients nationally, the rate of declining surgery increased from 2.3% in 2009 to 6.3% in 2021, a trend mirrored in our institutional cohort of 365 patients (0% in 2009/2010 to approximately 6-12% in 2021/2022). Locally, patients who declined surgery had higher rates of tobacco use, temporary loss to follow-up during therapy, and a more robust, albeit incomplete, tumor response to neoadjuvant therapy compared with controls who underwent surgery. Despite a stoma being the most cited reason for declining surgery, 30.4% of patients who declined oncologic resection died with a stoma. CONCLUSIONS: Our findings underscore a notable trend of patients declining oncologic resections following neoadjuvant therapy for rectal cancer. By shedding light on the outcomes of patients who opt against surgery, we address a critical gap in the literature essential for informing patients about potential risks.

Contemporary Axillary Surgical Management in Patients with Pathologically Node Positive Disease After Neoadjuvant Chemotherapy: A Survey of Members of the American Society of Breast Surgeons.

BACKGROUND: Axillary lymph node dissection (ALND) is increasingly omitted for breast cancer patients with pathologic nodal disease after neoadjuvant chemotherapy (NAC). This study aimed to understand when and why surgeons consider omitting ALND after NAC. METHODS: The American Society of Breast Surgeons membership was surveyed, and responses were tabulated. To identify patterns, multiple correspondence analyses followed by cluster analysis on coordinates provided by the former were performed. Chi-squared analyses determined whether cluster characteristics were significantly (P < 0.05) associated with omission of ALND. RESULTS: Of members, 328/2172 (15.1%) completed the survey. Most (60.7%) always offer sentinel lymph node surgery to cN1 patients who respond to NAC, and many (43.9%) sometimes omit ALND in the setting of residual nodal disease. Respondents less often consider omitting ALND with increasing volume of pathologic nodal disease after NAC and are less likely to omit ALND among patients with cN1 disease at presentation than cN0 (P < 0.05 across all volumes). Respondents cited radiation administration (74.1%) and belief that ALND would not improve locoregional (48.2%), distant recurrence or survival (47.6%) outcomes when axillary radiation is administered as reasons to omit ALND. The respondent group comprising male private practice surgeons, practicing ≥ 21 years, consider omitting ALND significantly more frequently. CONCLUSIONS: Surgeons sometimes consider ALND omission for patients with pathologic nodal disease after NAC but are more likely to do so in cN0 patients and patients with smaller volumes of nodal disease. These decisions are largely based on perceived lack of oncologic benefit despite absence of prospective data supporting this deescalation.

Quality of life of patients after kidney transplant: ADHERE Brazil multicenter cross-sectional study.

BACKGROUND: Quality of life (QoL) is a measure to evaluate kidney transplant (KT) results. AIM: To describe the QoL profile in a larger sample of Brazilian patients who underwent KT according to age, sex, and access to KT. METHODS: We conducted a secondary data analysis of the ADHERE BRAZIL multicenter cross-sectional study including 1105 patients from 20 centers, considering KT access region and transplant activity. QoL was assessed by the WHOQOL-BREF. Data was compared using Generalized Estimating Equations. RESULTS: Overall, 58.5 % of the patients were men, mean age of 47.6 ± 12.6 years. The general QoL score was 81 ± 15.1, 58.6 ± 11.6 for physical, 65.5 ± 11.4 for psychological, 68.3 ± 17.1 for social relationships, and 64.2 ± 13.3 for environmental domain. Higher QoL scores were observed in men compared to women in three WHOQOL-BREF domains: psychological (OR:2.62; CI, 1.29 ̶ 3.95, p < 0.0001), social relationships (OR:3.21; CI, 1.2 ̶ 5.23, p = 0.002) and environmental (OR:3.79; CI:2.23 ̶ 5.35, p < 0.0001). Younger patients (18-44 years) had higher scores in the psychological (OR:-2.69; CI, -4.13 ̶ -1.25; p < 0.001; OR:-3.52; CI, -5.39 ̶ -1.66; p < 0.001) and social (OR:-3.46; CI, -5.64 ̶ -1.27; p = 0.002; OR:-7.17; CI, -10 ̶ -4.35; p < 0.0001) domains than older ones (45-59 and > 60 years, respectively). Patients from higher KT access region had higher scores in environmental domain (OR:3.53; CI, 0.28 ̶ 6.78; p = 0.033). CONCLUSIONS: Featuring the results of KT under patient view, the physical and social relationships domains were the most and least affected, respectively. Lower QoL subgroups (females and age > 45 years) should be targeted in future multi-professional interventions.

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.

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.

Electronic Decision-Making Tool for Smoking Cessation (Pare de Fumar Conosco) Versus Standard of Care: A Cost-Effectiveness Analysis.

OBJECTIVES: The study aimed to evaluate the cost-effectiveness of the Pare de Fumar Conosco software compared with the standard of care adopted in Brazil for the treatment of smoking cessation. METHODS: In the cohort of smokers with multiple chronic conditions, we developed an decision tree model for the benefit measures of smoking cessation. We adopted the perspectives of the Brazilian Unified Health System and the service provider. Resources and costs were measured by primary and secondary sources and effectiveness by a randomized clinical trial. The incremental cost-effectiveness ratio (ICER) was calculated, followed by deterministic and probabilistic sensitivity analyses and deterministic and probabilistic sensitivity analyses. No willingness to pay threshold was adopted. RESULTS: The software had a lower cost and greater effectiveness than its comparator. The ICER was dominant in all of the benefits examined (-R$2 585 178.29 to -R$325 001.20). The cost of the standard of care followed by that of the electronic tool affected the ICER of the benefit measures. In all probabilistic analyses, the software was superior to the standard of care (53.6%-82.5%). CONCLUSION: The Pare de Fumar Conosco software is a technology that results in cost savings in treating smoking cessation.

Factors Associated With Physical Inactivity of Recipients of a Kidney Transplant: Results From the ADHERE BRAZIL Multicenter Study.

OBJECTIVE: Physical activity is recommended for recipients of a kidney transplant. However, ADHERE BRAZIL study found a high prevalence (69%) of physical inactivity in Brazilian recipients of a kidney transplant. To tackle this behavior, a broad analysis of barriers is needed. This study aimed to identify factors (patient and transplant center levels) associated with physical inactivity among recipients of a kidney transplant. METHODS: This was a subproject of the ADHERE BRAZIL study, a cross-sectional, multicenter study of 1105 recipients of a kidney transplant from 20 kidney transplant centers. Using a multistage sampling method, patients were proportionally and randomly selected. Applying the Brief Physical Activity Assessment questionnaire, patients were classified as physically active (≥150 min/wk) or physically inactive (<150 min/wk). On the basis of an ecological model, 34 factors associated with physical inactivity were analyzed by sequential logistic regression. RESULTS: At the patient level, physical inactivity was associated with smoking (odds ratio = 2.43; 95% CI = 0.97-6.06), obesity (odds ratio = 1.79; 95% CI = 1.26-2.55), peripheral vascular disease (odds ratio = 3.18; 95% CI = 1.20-8.42), >3 posttransplant hospitalizations (odds ratio = 1.58; 95% CI = 1.17-2.13), family income of >1 reference salary ($248.28 per month; odds ratio = 0.66; 95% CI = 0.48-0.90), and student status (odds ratio = 0.58; 95% CI = 0.37-0.92). At the center level, the correlates were having exercise physiologists in the clinical team (odds ratio = 0.54; 95% CI = 0.46-0.64) and being monitored in a teaching hospital (undergraduate students) (odds ratio = 1.47; 95% CI = 1.01-2.13). CONCLUSIONS: This study identified factors associated with physical inactivity after kidney transplantation that may guide future multilevel behavioral change interventions for physical activity. IMPACT: In a multicenter sample of recipients of a kidney transplant with a prevalence of physical inactivity of 69%, we found associations between this behavior and patient- and center-level factors. At the patient level, the chance of physical inactivity was positively associated with smoking, obesity, and patient morbidity (peripheral vascular disease and hospitalization events after kidney transplantation). Conversely, a high family income and a student status negatively correlated with physical inactivity. At the center level, the presence of a dedicated professional to motivate physical activity resulted in a reduced chance of physical inactivity. A broad knowledge of barriers associated with physical inactivity can allow us to identify patients at a high risk of not adhering to the recommended levels of physical activity.

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

Resumo 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.

Abstract 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.

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 / Driving pressure, em oposição ao volume corrente ajustado para o peso corporal predito, associa-se com a mortalidade: resultados de uma coorte prospectiva de pacientes com síndrome do desconforto respiratório agudo por COVID-19

ABSTRACT 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.

RESUMO Objetivo: Avaliar a associação entre driving pressure e volume corrente ajustado pelo peso predito com a mortalidade em uma coorte de pacientes com síndrome do desconforto respiratório agudo por COVID-19. Métodos: Estudo prospectivo e observacional que incluiu pacientes com síndrome do desconforto respiratório agudo por COVID-19 admitidos em duas unidades de terapia intensiva. Foi realizada análise multivariada para determinar se a driving pressure e o volume corrente/kg de peso predito, aferidos no primeiro dia de ventilação mecânica, associavam-se de forma independente com a mortalidade hospitalar. Resultados: Foram incluídos 231 pacientes. A mediana de idade foi de 64 (53 - 74) anos, e a mediana do Simplified Acute and Physiology Score 3 foi de 45 (39 - 54). A mortalidade hospitalar foi de 51,9%. A driving pressure se associou de forma independente com a mortalidade hospitalar (razão de chance de 1,21; IC95% de 1,04 - 1,41 para cada cm H2O de aumento da driving pressure, p = 0,01). Com base na análise de dupla estratificação, encontrou-se que, para o mesmo nível de volume corrente/kg de peso predito, o risco de mortalidade hospitalar aumentava com o incremento da driving pressure. No entanto, mudanças no volume corrente/kg de peso predito não se associaram com a mortalidade quando não resultavam em aumento da driving pressure. Conclusão: Em pacientes com síndrome do desconforto respiratório agudo por COVID-19, exposição a maior driving pressure, ao contrário da exposição a maior volume corrente/kg de peso predito, associou-se com maior mortalidade hospitalar. Os resultados sugerem que a driving pressure poderia ser o alvo primário para a condução da ventilação mecânica protetora nesses pacientes.

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.

A proposal to analyze the progression of non-dialytic chronic kidney disease by surrogate endpoints: introducing parametric survival models.

Introduction: Chronic kidney disease (CDK) progression studies increasingly use surrogate endpoints based on the estimated glomerular filtration rate. The clinical characteristics of these endpoints bring new challenges in comparing groups of patients, as traditional Cox models may lead to biased estimates mainly because they do not assume a hazard function. Objective: This study proposes the use of parametric survival analysis models with the three most commonly used endpoints in nephrology based on a case study. Estimated glomerular filtration rate (eGFR) decay > 5 mL/year, eGFR decline > 30%, and change in CKD stage were evaluated. Method: The case study is a 5-year retrospective cohort study that enrolled 778 patients in the predialysis stage. Exponential, Weibull, Gompertz, lognormal, and logistic models were compared, and proportional hazard and accelerated failure time (AFT) models were evaluated. Results: The endpoints had quite different hazard functions, demonstrating the importance of choosing appropriate models for each. AFT models were more suitable for the clinical interpretation of the effects of covariates on these endpoints. Conclusion: Surrogate endpoints have different hazard distributions over time, which is already recognized by nephrologists. More flexible analysis techniques that capture these relevant clinical characteristics in decision-making should be encouraged and disseminated in nephrology research.

Effectiveness of a smoking cessation decision-making electronic tool (Pare de Fumar Conosco): A randomized clinical trial.

There is an underutilization of smoking cessation treatment among patients with chronic conditions, which indicates a need for new strategies to engage them. Web-based smoking cessation decision-making tools can be beneficial. This study assessed the effectiveness of the Pare de Fumar Conosco software at increasing engagement to smoking cessation counseling groups among Brazilian smokers with chronic conditions. Clinical trial participants were randomized to Pare de Fumar Conosco or standard of care. Engagement in the smoking cessation counseling group was the primary outcome. Secondary outcomes included motivation level, cessation rate, completion, and treatment adherence. The t-tests and Chi-square analyzed baseline differences between groups and the Poisson models, the effects of the intervention. Engagement rates were higher in the Pare de Fumar Conosco (IR=2.22; 95% CI: 1.06 - 4.63) concerning the standard of care. Pare de Fumar Conosco group was more adherent to treatment over time (6.4% versus 4.2% in the final week). Cessation rate was 26.3% in standard care and 23.1% in Pare de Fumar Conosco. Both interventions maintained significant motivation levels to quit smoking. The Pare de Fumar Conosco intervention effectively increases the engagement in the smoking cessation counseling groups. There is a need to improve the smoking cessation rate.

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

ABSTRACT 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.

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.

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.

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.

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.

Association between tobacco and alcohol use among hospital inpatients / Associação do uso de álcool e tabaco entre pacientes hospitalizados

We aimed to evaluate concurrent use of alcohol and tobacco among hospitalized patients as well as to compare the use of both substances among people living with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome and those with other diagnoses. A cross-sectional study took place in a hospital in Minas Gerais (Brazil). Structured surveys were used to evaluate tobacco and alcohol use. Data analysis was conducted using descriptive statistics and chi-square test. We interviewed 972 patients, in which 20.3% were hazardous drinkers and 14.9% tobacco users. Almost half of the smokers (47.6%) were hazardous drinkers, while 15.5% of nonsmokers engaged in harmful consumption of alcohol (p < 0.001). Tobacco use was higher among people living with Human Immunodeficiency Virus when compared with patients that did not have an Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome diagnosis (32.1% vs 14.4%, p = 0.009). Our findings showed the association of tobacco use and hazardous drinking among hospitalized patients in Brazil and a higher prevalence of tobacco use among patients living with Human Immunodeficiency Virus. These findings can be used to develop smoking cessation interventions that address the comorbidities associated with substance use.

O presente estudo teve como objetivo avaliar a associação do uso de álcool e tabaco entre pacientes internados em um hospital geral e comparar o uso das duas substâncias entre pacientes que vivem com o Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida e outros diagnósticos. Realizou-se um estudo observacional em um hospital público para avaliação do uso de tais substâncias. Entre 972 pacientes, 20,3% fizeram uso prejudicial de álcool e 14,9% de tabaco. Quase metade dos tabagistas (47,6%) fizeram uso prejudicial do álcool, enquanto 15,5% dos não tabagistas relataram uso excessivo da substância (p < 0,001). A porcentagem de fumantes foi significativamente mais alta no grupo de pacientes que vivem com o Virus da Imunodeficiência Humana do que nos demais diagnósticos (32,1% vs 14,4%, p = 0,009). Percebe-se a associação do uso de tabaco e uso prejudicial de álcool entre pacientes hospitalizados e alta prevalência do uso de tabaco entre pacientes que vivem com o Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida. Esses dados podem direcionar o planejamento de intervenções para cessação do consumo de tabaco que consigam direcionar as comorbidades relacionadas ao uso da substância

Educational Differences in Diabetes Mortality among Hispanics in the United States: An Epidemiological Analysis of Vital Statistics Data (1989-2018).

BACKGROUND: Diabetes accounted for approximately 10% of all-cause mortality among those 20-79 years of age worldwide in 2019. In 1986-1989, Hispanics in the United States of America (USA) represented 6.9% of the national population with diabetes, and this proportion increased to 15.1% in 2010-2014. Recently published findings demonstrated the impact of attained education on amenable mortality attributable to diabetes among Non-Hispanic Whites (NHWs) and Non-Hispanic Blacks (HNBs). Previous cohort studies have shown that low education is also a detrimental factor for diabetes mortality among the Hispanic population in the USA. However, the long-term impact of low education on diabetes mortality among Hispanics in the USA is yet to be determined. AIMS AND METHODS: The aim of this study was to measure the impact of achieving a 12th-grade education on amenable mortality due to diabetes among Hispanics in the USA from 1989 to 2018. We used a time-series designed to analyze death certificate data of Hispanic-classified men and women, aged 25 to 74 years, whose underlying cause of death was diabetes, between 1989 and 2018. Death certificate data from the USA National Center for Health Statistics was downloaded, as well as USA population estimates by age, sex, and ethnicity from the USA Census Bureau. The analyses were undertaken using JointPoint software and the Age-Period-Cohort Web Tool, both developed by the USA National Cancer Institute. RESULTS: The analyses showed that between 1989 to 2018, age- and sex-standardized diabetes mortality rates among the least educated individuals were higher than those among the most educated individuals (both sexes together, p = 0.036; males, p = 0.053; females, p = 0.036). The difference between the least and most educated individuals became more pronounced in recent years, as shown by independent confidence intervals across the study period. Sex-based analyses revealed that the age-adjUSAted diabetes mortality rate had increased to a greater extent among the least educated males and females, respectively, than among the most educated. CONCLUSIONS: The results of the analyses demonstrated a powerful effect of low education on amenable mortality attributable to diabetes among the Hispanic population in the USA. As an increasing prevalence of diabetes among the least educated Hispanics has been reported, there is a great need to identify and implement effective preventive services, self-management, and quality care practices, that may assist in reducing the growing disparity among those most vulnerable, such as minority populations.