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.

The role of education on Cancer amenable mortality among non-Hispanic blacks & non-Hispanic whites in the United States (1989-2018).

BACKGROUND: Cancer mortality in the U.S. has fallen in recent decades; however, individuals with lower levels of education experienced a smaller decline than more highly educated individuals. This analysis aimed to measure the influence of education lower than a high school diploma, on cancer amenable mortality among Non-Hispanic Whites (NHW) and Non-Hispanic Blacks (NHB) in the U.S. from 1989 to 2018. METHODS: We analyzed data from 8.2 million death certificates of men and women who died from cancer between 1989 and 2018. We examined 5-year and calendar period intervals, as well as annual percent changes (APC). APC was adjusted for each combination of sex, educational level, and race categories (8 models) to separate the general trend from the effects of age. RESULTS: Our study demonstrated an increasing mortality gap between the least and the most educated NHW and NHB males and females who died from all cancers combined and for most other cancer types included in this study. The gap between the least and the most educated was broader among NHW males and females than among NHB males and females, respectively, for most malignancies. CONCLUSIONS: In summary, we reported an increasing gap in the age-adjusted cancer mortality among the most and the least educated NHW and NHB between 25 and 74 years of age. We demonstrated that although NHB exhibited the greatest age-adjusted mortality rates for most cancer locations, the gap between the most and the least educated was shown for NHW.

Adherence to antihypertensive medication after referral to secondary healthcare: A prospective cohort study.

BACKGROUND: Nonadherence (NAd) to antihypertensive medication is associated with lack of blood pressure control and worsened long-term outcomes. Increased access to a programme for high-risk cardiovascular patients has the potential to reduce NAd and improve clinical outcomes. We evaluated implementation NAd prevalence and risk factors among severely hypertensive patients after 12-month-long access to secondary healthcare centres. METHODS: The Morisky Green Levine Scale (MGLS) was used to analyse antihypertensive medication NAd in a prospective cohort of 485 patients. Logistic regression models evaluated the influence of ecological model factors on NAd. RESULTS: The majority of patients were female, had low health literacy, a low family income and a mean age of 61.8 ± 12.5 years. Prevalence of NAd fell from 57.1% at programme entry to 28.3% (P < .001) at the end of the study. After access to a secondary healthcare centre, we observed better blood pressure control, an increase in the number of pills/day and a higher number of antihypertensive medications. Predictive variables of NAd were age (OR 1.027; CI 1.003-1.051; P = .023), low health literacy (OR 1.987; CI 1.009-3.913; P = .047), systolic blood pressure (OR 1.010; CI 1.003-1.021; P = .049), dosages ≥ 2 times/day (OR 1.941; CI 1.091-3.451; P = .024) and patient satisfaction with the healthcare team (OR 0.711; IC 0.516-0.980; P = .037). CONCLUSIONS: Greater access to health services is associated with a reduction in NAd to antihypertensive medication and better blood pressure control. NAd was correlated with modifiable variables such as treatment complexity and, for the first time, team satisfaction, suggesting that implementation of similar programmes may limit NAd in similar patient groups.

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.

An Experimental Feasibility Study of a Hybrid Telephone Counseling/Text Messaging Intervention for Post-Discharge Cessation Support Among Hospitalized Smokers in Brazil.

OBJECTIVE: Text messaging interventions are effective. Despite high utilization of smartphones, few studies evaluate text messaging for cessation in middle-/lower-income countries. Initiating tobacco treatment in hospitals is an effective but underutilized approach for reaching smokers. We evaluated a hybrid phone counseling/text messaging intervention for supporting cessation among hospitalized smokers in Brazil. METHODS: We used an experimental design to assess the feasibility and potential effect size of the intervention. Participants (N = 66) were recruited from a university hospital and randomized in a 2:1 ratio into TXT (one session of telephone counseling plus 2 weeks of text messaging; N = 44) or Standard Care control group (N = 22). Participants lost to follow-up were counted as smokers. RESULTS: Counselors sent 1186 texts, of which 924 (77.9%) were received by study participants. Participants rated the TXT content as "helpful" (80.4%) and the phone counseling length to be "just right" (95.1%). Although the study was not powered to evaluate abstinence rates, we did observe a higher prevalence of abstinence in the TXT compared to control group at both 1-month follow-up (25.0% vs. 9.1%) and 3-month follow-up (31.8% vs. 9.1%). Carbon monoxide-verified abstinence at month 3 was also higher in TXT (20.5% vs. 4.5%). CONCLUSIONS: This hybrid telephone/text intervention should progress to full-scale effectiveness testing as it achieved favorable outcomes, was acceptable to participants, and was readily implemented. This type of intervention has strong potential for expanding the reach of hospital-initiated tobacco treatment in middle-/lower-income countries. IMPLICATIONS: This study extends research on hospital-initiated smoking cessation by establishing the feasibility of a novel text-messaging approach for post-discharge follow-up. Text messaging is a low-cost alternative to proactive telephone counseling that could help overcome resource barriers in middle- and lower-income countries. This hybrid texting/counseling intervention identified smokers in hospitals, established rapport through a single telephone follow-up, and expanded acceptability and reach of later support by using text-messaging, which is free of charge in this and other low-income countries. The favorable cessation outcomes achieved by the hybrid intervention provide support for a fully powered effectiveness trial.

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.

Frailty and quality of life: a cross-sectional study of Brazilian patients with pre-dialysis chronic kidney disease.

PURPOSE: Chronic kidney disease (CKD) induces frailty and worsens quality of life (QOL), even in the early stages of the disease and in young patients. However, there is a lack of knowledge about the relationship between frailty and QOL in CKD patients. Thus, we investigated this relationship in a sample of CKD patients. METHODS: A cross-observational study was conducted, in which 61 CKD patients receiving pre-dialysis treatment were assessed. All participants completed the Short Form-36 Health Survey (SF-36). We used valid and reliable methods to classify subjects as frail or non-frail according to Johansen's et al. (2007) criteria. A one-way analysis of variance (ANOVA) and chi-square tests were used to compare the groups. In addition, Spearman's correlation analysis was conducted to measure associations between identified variables and frailty. We also performed simple linear regression using the SF-36 physical and mental composite scores. RESULTS: Almost half of the sample (42.6%) exhibited evidence of frailty. The groups differed significantly in terms of age, gender, and all SF-36 domains, excluding Social Functioning and Role Emotional. Frailty was significantly associated with all SF-36 domains, again excluding Social Functioning and Role Emotional. Regression analysis revealed no significant between-group differences in composite physical and mental health scores generated by the SF-36 (p > 0.05). CONCLUSION: Frail and non-frail CKD patients differed significantly in seven of the eight SF-36 domains. The frail group displayed diminished physical and mental functioning when their SF-36 scores were divided by their physical and mental composite scores. Frailty was correlated with QOL domains, with the exception of the social domain. There is a need for interventions targeting the characteristics of frailty, to provide better treatment and optimize overall QOL.

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.

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.

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.

Transcultural adaptation and initial validation of Brazilian-Portuguese version of the Basel assessment of adherence to immunosuppressive medications scale (BAASIS) in kidney transplants.

BACKGROUND: Transplant recipients are expected to adhere to a lifelong immunosuppressant therapeutic regimen. However, nonadherence to treatment is an underestimated problem for which no properly validated measurement tool is available for Portuguese-speaking patients. We aimed to initially validate the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS®) to accurately estimate immunosuppressant nonadherence in Brazilian transplant patients. METHODS: The BAASIS® (English version) was transculturally adapted and its psychometric properties were assessed. The transcultural adaptation was performed using the Guillemin protocol. Psychometric testing included reliability (intraobserver and interobserver reproducibility, agreement, Kappa coefficient, and the Cronbach's alpha) and validity (content, criterion, and construct validities). RESULTS: The final version of the transculturally adapted BAASIS® was pretested, and no difficulties in understanding its content were found. The intraobserver and interobserver reproducibility variances (0.007 and 0.003, respectively), the Cronbach's alpha (0.7), Kappa coefficient (0.88) and the agreement (95.2%) suggest accuracy, preciseness and reliability. For construct validity, exploratory factorial analysis demonstrated unidimensionality of the first three questions (r = 0.76, r = 0.80, and r = 0.68). For criterion validity, the adapted BAASIS® was correlated with another self-report instrument, the Measure of Adherence to Treatment, and showed good congruence (r = 0.65). CONCLUSIONS: The BAASIS® has adequate psychometric properties and may be employed in advance to measure adherence to posttransplant immunosuppressant treatments. This instrument will be the first one validated to use in this specific transplant population and in the Portuguese language.

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.

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.

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.