Peripherally Inserted Central Catheter Versus Centrally Inserted Central Catheter for In-Hospital Infusion Therapy: A Cost-Effectiveness Analysis.

OBJECTIVES: To evaluate the comparative effectiveness and cost-effectiveness of peripherally inserted central catheters (PICCs) compared with centrally inserted central catheters (CICCs). METHODS: Prospective cohort study was followed by an economic analysis over a 30-day time horizon. Propensity score matching was used to select hospitalized adults with similar indications for PICC or CICC. The composite outcome was device removal or replacement because of complications before the end of treatment. The economic evaluation was based on a decision tree model for cost-effectiveness analysis, with calculation of the incremental cost-effectiveness ratio (ICER) per catheter removal avoided. All costs are presented in Brazilian reais (BRL) (1 BRL = 0.1870 US dollar). RESULTS: A total of 217 patients were followed in each group; 172 (79.3%) of those receiving a PICC and 135 (62.2%) of those receiving a CICC had no device-related complication, respectively. When comparing the events leading to device removal, the risk of composite endpoint was significantly higher in the CICC group (hazard ratio 0.20; 95% CI 0.11-0.35). The cost of PICC placement was BRL 1290.98 versus BRL 467.16 for a CICC. In the base case, the ICER for placing a PICC instead of a CICC was BRL 3349.91 per removal or replacement avoided. On univariate sensitivity analyses, the model proved to be robust within an ICER range of 2500.00 to 4800.00 BRL. CONCLUSIONS: PICC placement was associated with a lower risk of complications than CICC placement. Although the cost of a PICC is higher, its use avoided complications and need for catheter replacement before the end of treatment.

Comparison of Incidence and Prognosis of Myocardial Injury in Patients with COVID-19-Related Respiratory Failure and Other Pulmonary Infections: A Contemporary Cohort Study.

Myocardial injury (MI) is frequent in critically ill patients with COVID-19, but its pathogenesis remains unclear. We hypothesized that MI is not solely due to viral infection by SARS-CoV-2 but rather due to the common pathophysiological mechanisms associated with severe pulmonary infections and respiratory failure. This contemporary cohort study was designed to compare the incidence of MI in patients with acute respiratory failure caused by COVID-19 to patients with other pulmonary infections. In addition, we aimed to investigate whether MI was a distinct risk factor for in-hospital mortality in patients with COVID-19 compared to those with non-COVID-19 infections. This study included 1444 patients with COVID-19 (55.5% men; age 58 (46;68) years) and 182 patients with other pulmonary infections (46.9% men; age 62 (44;73) years). The incidence of MI at ICU admission was lower in COVID-19 patients (36.4%) compared to non-COVID-19 patients (56%), and this difference persisted after adjusting for age, sex, coronary artery disease, heart failure, SOFA score, lactate, and C-reactive protein (RR 0.84 (95% CI, 0.71-0.99)). MI at ICU admission was associated with a 59% increase in mortality (RR 1.59 (1.36-1.86); p < 0.001), and there was no significant difference in the mortality between patients with COVID-19 and those with other pulmonary infections (p = 0.271). We concluded that MI is less frequent in patients with critical COVID-19 pneumonia and respiratory failure compared to those with other types of pneumonia. The occurrence of MI is a significant risk factor for in-hospital mortality, regardless of the etiology of the pulmonary infection.

Ketoconazole as second-line treatment for Cushing's disease after transsphenoidal surgery: systematic review and meta-analysis.

Introduction: The first-line treatment for Cushing's disease is transsphenoidal surgery for pituitary tumor resection. Ketoconazole has been used as a second-line drug despite limited data on its safety and efficacy for this purpose. The objective of this meta-analysis was to analyze hypercortisolism control in patients who used ketoconazole as a second-line treatment after transsphenoidal surgery, in addition to other clinical and laboratory criteria that could be related to therapeutic response. Methods: We searched for articles that evaluated ketoconazole use in Cushing's disease after transsphenoidal surgery. The search strategies were applied to MEDLINE, EMBASE, and SciELO. Independent reviewers assessed study eligibility and quality and extracted data on hypercortisolism control and related variables such as therapeutic dose, time, and urinary cortisol levels. Results: After applying the exclusion criteria, 10 articles (one prospective and nine retrospective studies, totaling 270 patients) were included for complete data analysis. We found no publication bias regarding reported biochemical control or no biochemical control (p = 0.06 and p = 0.42 respectively). Of 270 patients, biochemical control of hypercortisolism occurred in 151 (63%, 95% CI 50-74%) and no biochemical control occurred in 61 (20%, 95% CI 10-35%). According to the meta-regression, neither the final dose, treatment duration, nor initial serum cortisol levels were associated with biochemical control of hypercortisolism. Conclusion: Ketoconazole can be considered a safe and efficacious option for Cushing's disease treatment after pituitary surgery. Systematic review registration: https://www.crd.york.ac.uk/prospero/#searchadvanced, (CRD42022308041).

UltraSound guided PEripheral Catheterization increases first-atTempt success RAte in hospitalized patients when compared with conventional technique: SPECTRA - Randomized Clinical Trial.

BACKGROUND: Peripheral intravenous catheter (PIVC) insertion is the most common invasive procedure in the hospital setting. Ultrasound guided PIVC insertion in specific populations and settings has shown patient care benefits. OBJECTIVE: To compare the success rate of first attempts of ultrasound guided PIVC insertion performed by nurse specialists with conventional PIVC insertion performed by nurse assistants. METHOD: Randomized, controlled, single-center clinical trial registered on the ClinicalTrials.gov platform under registration NTC04853264, conducted at a public university hospital from June to September 2021. Adult patients hospitalized in clinical inpatient units with an indication for intravenous therapy compatible with a peripheral venous network were included. Participants in the intervention group (IG) received ultrasound guided PIVC performed by nurse specialists from the vascular access team, while those in the control group (CG) received conventional PIVC by nurse assistants. RESULTS: The study included a total of 166 patients: IG (n = 82) and CG (n = 84), mean age 59.5 ± 16.5 years, mostly women (n = 104, 62.7%) and white (n = 136, 81.9%). Success rate on the first attempt of PIVC insertion in IG was 90.2% and in CG was 35.7% (p < 0.001), with a relative risk of 2.5 (95% CI 1.88-3.40) for success in IG versus CG. Overall assertiveness rate was 100% in IG and 71.4% in CG. Regarding procedure performance time, the medians in IG and CG were 5 (4-7) and 10 (6-27.5) min respectively (p < 0.001). As for the incidence of negative composite outcomes, IG had lower rates compared to CG, 39% versus 66.7% (p < 0.001), generating a 42% lower probability of negative outcomes in IG, 0.58 (95% CI: 0.43-0.80). CONCLUSION(S): Successful first-try insertion was higher in the group receiving ultrasound-guided PIVC. Moreover, there were no insertion failures and IG presented lower insertion time rates and incidence of unfavorable outcomes.

Systemic lupus erythematosus: a systematic review with meta-analysis on muscle strength, muscle mass, and physical function.

To perform a systematic review with meta-analysis to verify muscle strength, muscle mass, and physical function of patients with systemic lupus erythematosus (SLE) and compare then with healthy individuals and patients with rheumatoid arthritis (RA). A systematic review with meta-analysis of observational studies published in English up to 2022 was performed using MEDLINE (via PubMed) and other relevant sources. Search strategies were based on pre-defined keywords and medical subject headings. The methodological quality of the studies was assessed using the Newcastle-Ottawa Scale. Mean difference (MD) or standardized mean difference (SMD) and 95% confidence intervals (CI) were combined using a random-effects model. Sensitivity analyses were performed when necessary. The significance level was set at p < 0.05. The systematic review included 19 studies and the meta-analysis included 11 studies. SLE patients appear to have less muscle strength assessed by handgrip than healthy controls (SLE = 21.74 kg; healthy controls = 29.34 kg; p < 0.05). SLE patients seem to have greater strength than patients with RA, but this difference was not statistically significant (RA = 17.24 kg; p = 0.210). However, in the sensitivity analysis, SLE group without deforming arthropathy showed higher muscle strength than the RA (p = 0.0001). SLE patients with deforming arthropathy have lower muscle strength compared to SLE patients without deforming arthropathy (p < 0.01). Muscle mass was similar in SLE patients compared to the RA group and healthy controls (p > 0.05). However, RA patients have a higher BMI than the two groups (p < 0.05). Patients with SLE have regular physical function. Muscle strength is affected in SLE patients. SLE patients with deforming arthropathy have less muscle strength than patients without deforming arthropathies.

Overt diabetes imposes a comparable burden on outcomes as pregestational diabetes: a cohort study.

BACKGROUND: Women with diabetes first diagnosed during pregnancy (overt diabetes) may be at the same risk level of adverse outcomes as those with known pregestational diabetes. We compared pregnancy outcomes between these groups. METHODS: We evaluated pregnant women with type 2 diabetes, pregestational or overt diabetes, attending high risk antenatal care in two public hospitals in Southern Brazil, from May 20, 2005 to June 30, 2021. Outcomes were retrieved from electronic medical records. Risk of adverse outcomes, expressed as relative risk (RR) and 95% confidence interval (CI), were calculated using Poisson regression with robust estimates. RESULTS: Of 618 women, 33% were labelled as having overt diabetes and 67%, pregestational diabetes. Baseline maternal characteristics were similar: there was a slight, non-clinically relevant, difference in maternal age (33 ± 5.7 years in women with pregestational diabetes vs. 32 ± 6.0 years in women with overt diabetes, p = 0.004); and women with overt diabetes reported smoking almost twice compared to those with pregestational diabetes (12.3% vs. 6.5%, p = 0.024). There were no relevant differences between the groups regarding pregnancy outcomes, although there was a trend of higher neonatal intensive care admission in the group of women with pregestational diabetes (45.2% vs. 36.1%, p = 0.051). CONCLUSIONS: Overt diabetes was diagnosed in one third of this cohort of pregnant women with hyperglycemia. Their pregnancy outcomes were similar to those of women with pregestational diabetes and were mostly related to maternal demographic characteristics and metabolic control. A call to action should be made to identify women of childbearing age at risk for pre-pregnancy diabetes; to detect hyperglycemia before conception; and to implement timely preconception care to all women with diabetes.

Cross-cultural and clinical validation of the MDHAQ/RAPID3 questionnaire in electronic format for a Brazilian population of patients with rheumatoid arthritis.

BACKGROUND: Patients with rheumatologic diseases are monitored fundamentally through metric tools or index calculated from clinical data and patient exams, which allow us to assess the severity of the disease and guide the therapeutic decision. In rheumatoid arthritis (RA), for treatment to be optimized and considered effective, periodic assessment with composite disease activity index and a 'treat-to-target' approach is required. The Routine Assessment of Patient Index Data 3 (RAPID3) in the Multidimensional Health Assessment Questionnaire (MDHAQ) includes only three measures based on the central patient self-reported dataset and can be used in a 'treat-to-target' approach analogous to the Clinical Disease Activity Index (CDAI) and the Disease Activity Score 28-joints (DAS28). This tool, however, has not undergone cross-cultural or clinical validation in Brazil. In this research, we performed the MDHAQ cross-cultural and clinical validation for the Brazilian population of RA patients. METHODS: The Portuguese version of the MDHAQ was created identically in an electronic questionnaire and underwent a cross-cultural validation process with 38 participants. Test-retest was performed in 29 patients. Further, a clinical validation with 129 Rheumatoid Arthritis patients was performed. Electronic MDHAQ was answered through an online platform. We also collected socioeconomic data as well as other clinical (CDAI, SDAI, DAS28) and functional (HAQ) scores during the face-to-face assessment of patients. RESULTS: MDHAQ/RAPID3 maintained semantic, idiomatic, as well as conceptual and experience equivalence for the Brazilian population, with 92% acceptance of participants. It showed test-retest reliability, adequate internal consistency (Cronbach's α 0.85) and correlation of the scores obtained with adequate association with the DAS28 gold standard. RAPID3 also had high sensitivity (98%), adequate specificity (48%), high negative predictive value (92%) and negative post-test probability of 8%, attributes expected for a test tool for population screening. CONCLUSION: The use of MDHAQ/RAPID3 associated with traditional clinical measures can adequately allow for remote follow-up based on the 'treat-to-target' approach with performance comparable to the gold standard DAS28, being a viable tool in the sample of Brazilian patients with RA in the current context of telehealth.

Quality management of the periodic medical examination at a university hospital, from the workers' perspective.

Introduction: Implementation of quality assessment methodologies at healthcare services enables the results achieved to be monitored in terms of established objectives and standards of care delivery. Objectives: To assess the quality of the processes involved in provision of periodic medical examinations at a University Hospital, from the workers' perspective. Methods: This is a cross-sectional study using questionnaires to conduct quality assessment of the periodic medical examination processes, including Net Promoter Score satisfaction questions. Statistical analysis of the results was performed using SPSS version 18. Data on categorical variables are expressed as absolute frequencies and data on continuous variables as means and standard deviations. Chi-square tests and analysis of variance were used to identify associations. A significance level of 0.05 was adopted to determine the statistical relevance of findings. Results: A total of 381 respondents with a mean age of 45.25 years were included, 66% of whom were female. There was a statistically significant (p < 0.001) association between duration of consultations and the number of items assessed in the periodic medical examination. In general, the findings from application of the Net Promoter Score for self-scheduling (45%) and service at reception (42%) indicate a need for process improvement, whereas clinical care (50%) rated as a quality process. Conclusions: This study identified a set of information that can be used to describe, analyze, and improve the care delivered by the institution's occupational health service and to identify opportunities for improvement of periodic medical examination processes.

Effectiveness and Efficacy of Therapeutic Interventions Performed by Nurses for Anxiety Disorders: A Systematic Review.

BACKGROUND: Anxiety disorders are characterized by excessive anxiety, fear, and behavioral disorders that can lead the individual to have losses in daily, social, and work activities, generating a negative impact on their quality of life. AIM: To evaluate the quality of evidence of the therapeutic interventions performed by nurses for anxiety disorders. METHOD: An analysis of the quality of evidence was performed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. The systematic review protocol was registered in the Prospective Register of Systematic Reviews (Prospero), CRD420202939. RESULTS: The interventions performed by nurses were effective (d = 0.44), with significant improvement in reducing anxiety levels, reducing drug use, and improving self-control. CONCLUSIONS: The study indicates that therapeutic interventions performed by nurses are beneficial for individuals who suffer from anxiety disorders, with significant improvement in reducing anxiety levels, reducing medication use, improving self-control, and remission of anxiety symptoms.

Patterns, appropriateness and outcomes of peripherally inserted central catheter use in Brazil: a multicentre study of 12 725 catheters.

BACKGROUND: Little is known about peripherally inserted central catheter (PICC) use, appropriateness and device outcomes in Brazil. METHODS: We conducted an observational, prospective, cohort study spanning 16 Brazilian hospitals from October 2018 to August 2020. Patients ≥18 years receiving a PICC were included. PICC placement variables were abstracted from medical records. PICC-related major (deep vein thrombosis (DVT), central line-associated bloodstream infection (CLABSI) and catheter occlusion) and minor complications were collected. Appropriateness was evaluated using the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC). Devices were considered inappropriate if they were in place for <5 days, were multi-lumen, and/or were placed in patients with a creatinine >2.0 mg/dL. PICCs considered appropriate met none of these criteria. Mixed-effects logistic regression models adjusting for patient-level and hospital-level characteristics assessed the association between appropriateness and major complications. RESULTS: Data from 12 725 PICCs were included. Mean patient age was 66.4±19 years and 51.0% were female. The most common indications for PICCs were intravenous antibiotics (81.1%) and difficult access (62.7%). Most PICCs (72.2%) were placed under ultrasound guidance. The prevalence of complications was low: CLABSI (0.9%); catheter-related DVT (1.0%) and reversible occlusion (2.5%). Of the 12 725 devices included, a total of 7935 (62.3%) PICCs were inappropriate according to MAGIC. With respect to individual metrics for appropriateness, 17.0% were placed for <5 days, 60.8% were multi-lumen and 11.3% were in patients with creatinine >2.0 mg/dL. After adjusting for patient and hospital-level characteristics, multi-lumen PICCs considered inappropriate were associated with greater odds of major complications (OR 2.54, 95% CI 1.61 to 4.02). CONCLUSIONS: Use of PICCs in Brazilian hospitals appears to be safe and comparable with North America. However, opportunities to improve appropriateness remain. Future studies examining barriers and facilitators to improving device use in Brazil would be welcomed.

High plasma IL-6 levels following haploidentical allogeneic hematopoietic stem cell transplantation post-transplant cyclophosphamide as predictor of early death and worse outcome.

INTRODUCTION: Haploidentical hematopoietic stem cell transplantation (haplo-HSCT) can be used as an alternative procedure in the absence of HLA-compatible donors. The use of high doses of cyclophosphamide after infusion improves the prognosis and eliminates the need for T cell depletion in vivo. Among the main complications of haplo-HSCT are acute graft-versus-host disease (a-GVHD) and cytokine release syndrome (CRS). This is a systemic inflammatory response that leads to the release of inflammatory proteins, including IL-6. This syndrome has several clinical features, with mild to severe symptoms. This study aimed to compare plasma IL-6 levels in patients submitted to different HSCT types and to associate them with the presence of acute graft versus host disease (a-GVHD), CRS and survival. METHODS: A total of 84 patients (22 haploidentical and 62 non-haploidentical) were evaluated at different times. The IL-6 levels in haplo and non-haplo-HSCT recipients were measured before transplantation and on days D7, D14, D28, D60, and D100. RESULTS: IL-6 levels were higher in haplo-HSCT recipients than in non-haplo-HSCT recipients, remaining elevated from D14 until D100 (P = 0.006) and a cut-off ≥11 pg/mL on D7, which is related to worse overall survival. In our study, we found no association with a-GVHD (P = 0.239), a common complication of this type of transplant, but we found a relationship between the increase in IL-6 and CRS (P = 0.021). CONCLUSION: IL6 can be used as a biomarker for patients submitted to haplo-HSCT, allowing clinical interference in patients having levels of IL-6 times larger than normality values, avoiding early death in this group of patients.

PSS Health: como calcular tamanho de amostra para testes de comparação de médias de dois grupos / PSS Health: how to calculate sample sizes for mean comparison tests between two groups

Dando continuidade à série de artigos que pretendem orientar o usuário na utilização da ferramenta PSS Health para o planejamento de uma pesquisa, esta edição apresenta um passo a passo de como realizar o cálculo e de quais informações são necessárias para comparar médias: de dois grupos dependentes ou independentes, de dois grupos independentes com duas medidas repetidas (deltas), e com duas ou mais medidas repetidas. Todos os exemplos também são ilustrados e disponibilizados em vídeos no canal da Unidade de Bioestatística.

Following the series of articles aiming to guide users in using the PSS Health tool for research planning, this issue presents a step-by-step guide on how to calculate and what information is needed to compare means between 2 dependent or independent groups, 2 independent groups with 2 repeated measures (deltas), and 2 independent groups with 2 or more repeated measures. All examples are accompanied by figures and available in video on the Biostatistics Unit's channel.

PSS Health: como calcular tamanho de amostra para testar relações de variáveis com um desfecho binário / PSS Health: how to calculate the sample size to test variables relationships with a binary outcome

Dando continuidade à série de artigos que pretendem orientar o usuário na utilização da ferramenta PSS Health para o planejamento de uma pesquisa, esta edição apresenta um passo a passo de como realizar o cálculo para tamanho de amostra e de quais informações são necessárias para testar relações estatísticas entre variáveis e um desfecho binário: comparação de proporções entre grupos independentes (dois ou mais), comparação de duas proporções dependentes e regressão logística. Todos os exemplos também são ilustrados e disponibilizados em vídeos no canal da Unidade de Bioestatística.

Following the series of articles that aim to guide the user in using the PSS Health tool for planning research, this issue presents a step-by-step guide on how to perform the sample size calculation and what information is needed to test statistical relationships between variables and a binary outcome: comparison of proportions between independent groups (two or more), comparison of two dependent proportions, and logistic regression. All examples are also illustrated and available in videos on the Biostatistics Unit's channel.

Prevalence of Gender Dysphoria in Southern Brazil: A Retrospective Study.

To ensure that public health services provide comprehensive and inclusive health care to the general population, it is important for countries to estimate how many of their citizens experience gender dysphoria and wish to receive specialized hormone treatment or gender-affirming surgery. The aim of this study was to estimate the prevalence of individuals with gender dysphoria seeking transgender health care in a public teaching hospital in southern Brazil. In this retrospective follow-up study, we analyzed the medical records and sociodemographic data of individuals aged > 15 years living in Rio Grande do Sul, Brazil, that enrolled in a specialized program to receive hormone therapy and gender-affirming surgery between 2000 and 2018. This study is the first to attempt estimating the prevalence of gender dysphoria in Rio Grande do Sul; it describes novel data on the clinical profile of individuals with gender dysphoria treated in a public hospital specialized in providing transgender health care. Prevalence estimates were calculated based on statewide annual population data in the study period. Of 934 identified individuals, 776 (601 trans women and 175 trans men) were included in this study. The overall prevalence of individuals with gender dysphoria was 9.3 per 100,000 individuals (95% CI: 8.6 to 9.8). Meanwhile, there were 15 trans women per 100,000 people (95% CI: 14 to 16) and 4.1 trans men per 100,000 people (95% CI: 3.5 to 4.8). There was a progressive increase in the number of people seeking hormone therapy and gender-affirming surgery during the study period. Future research is needed to determine the size of the trans population in other regions of Brazil and to expand the knowledge regarding gender dysphoria to allow for the development of effective public policies for people with gender dysphoria.

Venous ulcer healing treated with conventional therapy and adjuvant laser: is there a difference?

OBJECTIVES: to evaluate the effects of venous ulcer healing in patients after six months of conventional treatment and adjuvant low-power laser therapy. METHODS: prospective cohort study nested in a randomized clinical trial with 38 patients, allocated into an intervention group (conventional treatment and adjuvant laser therapy) and a control group (conventional treatment). Patients were followed up as outpatients, sociodemographic and clinical variables were collected, and indicators of the outcomes Wound healing: secondary intention (1103) and Tissue integrity: skin and mucous membranes(1101) of the Nursing Outcomes Classification. Generalized estimating equations, Kaplan-Meier tests, and robust Poisson regression were used in the analysis. RESULTS: the clinical indicators Decreased wound size and Scar formation showed a statistically significant difference in the intervention group, higher number of healed wounds, lower rate, longer time to relapse. CONCLUSIONS: laser therapy adjuvant to conventional treatment returned better results in healing and lower recurrence rates after six months of intervention.

The influence of the municipal human development index and maternal education on infant mortality: an investigation in a retrospective cohort study in the extreme south of Brazil.

BACKGROUND: Infant mortality is considered an important and sensitive health indicator in several countries, especially in underdeveloped and developing countries. Most of the factors influencing infant mortality are interrelated and are the result of social issues. Therefore, this study performed an investigation of the influence of the MHDI and maternal education on infant mortality in a capital in the extreme south of Brazil. METHODS: It is a retrospective cohort study with data on births and deaths in the first year of life for the period of 2000-2017. The association between the independent variables and the outcome was done by bivariate analysis through simple Poisson regression. The variables that can potentially be considered confounding factors were used in a multiple Poisson regression for robust variances - adjusted model. RESULTS: The study included 317,545 children, of whom 3107 died. The medium MHDI showed associated with infant death in the first year of life. Maternal education, individually and jointly analyzed with the MHDI, showed association with the outcome of infant death in the first year of life, particularly for children of mothers with lower maternal education (p < 0.001). In relation to other related factors, maternal age; number of Prenatal Care Consultations; gestational age, weight, gender and Apgar Index (5th minute) of the newborn showed association with IM (p < 0.001). CONCLUSIONS: The HDI is considered a good predictor of infant mortality by some authors and the analyzes of the present study also confirm an association of the medium MHDI and its low MHDIE component with infant mortality. In addition, it was maternal education with less than 8 years of study that that demonstrated a higher risk of death, revealing itself to be a social determinant with a relevant impact on infant mortality. Thus, it is possible to conclude that maternal education is available information, and it is superior to the MHDI to assess the infant mortality outcome.

Venous ulcer healing treated with conventional therapy and adjuvant laser: is there a difference? / Cicatrización de úlceras venosas tratadas con terapia convencional y láser adyuvante: ¿Hay alguna diferencia? / Cicatrização de úlceras venosas tratadas com terapia convencional e laser adjuvante: existe diferença?

ABSTRACT Objectives: to evaluate the effects of venous ulcer healing in patients after six months of conventional treatment and adjuvant low-power laser therapy. Methods: prospective cohort study nested in a randomized clinical trial with 38 patients, allocated into an intervention group (conventional treatment and adjuvant laser therapy) and a control group (conventional treatment). Patients were followed up as outpatients, sociodemographic and clinical variables were collected, and indicators of the outcomes Wound healing: secondary intention (1103) and Tissue integrity: skin and mucous membranes(1101) of the Nursing Outcomes Classification. Generalized estimating equations, Kaplan-Meier tests, and robust Poisson regression were used in the analysis. Results: the clinical indicators Decreased wound size and Scar formation showed a statistically significant difference in the intervention group, higher number of healed wounds, lower rate, longer time to relapse. Conclusions: laser therapy adjuvant to conventional treatment returned better results in healing and lower recurrence rates after six months of intervention.

RESUMEN Objetivos: evaluar efectos de cicatrización de úlceras venosas en pacientes tras seis meses de tratamiento convencional y laserterapia de baja potencia adyuvante. Métodos: estudio de cohorte prospectiva anidada a un ensayo clínico randomizado con 38 pacientes, alocados en equipo de intervención (tratamiento convencional y laserterapia adyuvante) y equipo de control (tratamiento convencional). Pacientes acompañados en consulta ambulatoria; y recogidas variables sociodemográficas, clínicas, indicadores de resultados Cicatrización de heridas: segunda intención (1103) e Integridad tisular: piel y mucosas (1101) de Nursing Outcomes Classification. En análisis, utilizaron ecuaciones de estimativas generalizadas, testes de Kaplan-Meier y regresión de Poisson robusta. Resultados: indicadores clínicos Tamaño de herida disminuido y Formación de cicatriz presentaron diferencia estadísticamente significante en equipo de intervención, mayor número de heridas cicatrizadas, menor tasa, mayor tiempo para recidivas. Conclusiones: laserterapia adyuvante al tratamiento convencional volvió mejores resultados en la cicatrización y menores índices de recidiva tras seis meses de la intervención.

RESUMO Objetivos: avaliar os efeitos da cicatrização de úlceras venosas em pacientes após seis meses de tratamento convencional e laserterapia de baixa potência adjuvante. Métodos: estudo de coorte prospectivo aninhado a um ensaio clínico randomizado com 38 pacientes, alocados em grupointervenção (tratamento convencional e laserterapia adjuvante) e grupo-controle (tratamento convencional). Os pacientes foram acompanhados em consulta ambulatorial; e foram coletadas variáveis sociodemográficas, clínicas, indicadores dos resultados Cicatrização de feridas: segunda intenção (1103) e Integridade tissular: pele e mucosas (1101) da Nursing Outcomes Classification. Na análise, utilizaram-se equações de estimativas generalizadas, testes de Kaplan-Meier e regressão de Poisson robusta. Resultados: os indicadores clínicos Tamanho da ferida diminuído e Formação de cicatriz apresentaram diferença estatisticamente significante no grupo-intervenção, maior número de feridas cicatrizadas, menor taxa, maior tempo para recidivas. Conclusões: a laserterapia adjuvante ao tratamento convencional retornou melhores resultados na cicatrização e menores índices de recidiva após seis meses da intervenção.

PSS Health: como calcular tamanho de amostra para estimar média, proporção e correlação / PSS Health: how to calculate a sample size to estimate means, proportions, and correlations

A ferramenta PSS Health (Power and Sample Size for Health Researchers) foi desenvolvida com o propósito de facilitar o cálculo do tamanho amostral e do poder de testes de hipóteses para diferentes objetivos de estudo, usando interface amigável e terminologia comum à área da saúde. Este é o primeiro de uma série de artigos que pretendem orientar o usuário na utilização da ferramenta PSS Health para o planejamento de uma pesquisa. Neste artigo, se ensina como utilizar o PSS Health quando o objetivo principal do estudo é estimar uma média, estimar uma proporção (prevalência ou incidência) ou estimar uma correlação. São disponibilizados vídeos demonstrando o uso da ferramenta em cada um dos contextos citados. (AU)

The PSS Health (Power and Sample Size for Health Researchers) tool was developed with the purpose of facilitating the calculation of sample size and power of hypothesis tests for different study objectives, based on a user-friendly interface and common health care terminology. This is the first in a series of articles intending to guide the user in how to use the PSS Health tool for planning a research project. This article teaches how to use PSS Health when the main objective of the study is to estimate means, proportions (prevalence or incidence), or correlations. Videos showing how to use the tool in each of the mentioned contexts are available. (AU)

Nursing Guidelines on Cardiac Surgery and Parents' Anxiety: Randomized Clinical Trial.

OBJECTIVE: The preparation of parents of children who should undergo cardiac surgery requires special treatment such as the explanations about the event. This study aims to compare the effects of standardized nursing guidelines with routine institutional orientation on the anxiety of parents of children undergoing cardiac surgery. METHODS: Randomized clinical trial. The sample consisted of parents of children who underwent cardiac surgery from December 2010 to April 2011. Twenty-two parents were randomized to the intervention group (IG) and received the standard nursing guidelines and 22 participated in the control group (CG) and received the routine guidelines from the institution. Anxiety was assessed by the State-Trait Anxiety Inventory (STAI) applied in the preoperative period, between 12 and 20 hours before surgery and before receiving standard or institutional guidelines and 48 hours after surgery. The analysis of variance (ANOVA) for repeated measures was performed to evaluate the differences between the variations in STAI scores between the groups during the studied period. The level of significance was 0.05. RESULTS: There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18). Likewise, the variation in score after 48 hours was similar between groups (STAI-trait P=0.77; STAI-state P=0.61). CONCLUSION: There were no significant differences in the parents' anxiety levels when comparing the two types of guidelines: the standard nursing and the institutional orientation.

Nursing guidelines on cardiac surgery and parents anxiety: randomized clinical trial

Abstract Objective: The preparation of parents of children who should undergo cardiac surgery requires special treatment such as the explanations about the event. This study aims to compare the effects of standardized nursing guidelines with routine institutional orientation on the anxiety of parents of children undergoing cardiac surgery. Methods: Randomized clinical trial. The sample consisted of parents of children who underwent cardiac surgery from December 2010 to April 2011. Twenty-two parents were randomized to the intervention group (IG) and received the standard nursing guidelines and 22 participated in the control group (CG) and received the routine guidelines from the institution. Anxiety was assessed by the State-Trait Anxiety Inventory (STAI) applied in the preoperative period, between 12 and 20 hours before surgery and before receiving standard or institutional guidelines and 48 hours after surgery. The analysis of variance (ANOVA) for repeated measures was performed to evaluate the differences between the variations in STAI scores between the groups during the studied period. The level of significance was 0.05. Results: There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18). Likewise, the variation in score after 48 hours was similar between groups (STAI-trait P=0.77; STAI-state P=0.61). Conclusion: There were no significant differences in the parents' anxiety levels when comparing the two types of guidelines: the standard nursing and the institutional orientation.