Cross-cultural adaptation of the CALCULATE instrument into Brazilian Portuguese: pressure injury in intensive care.

OBJECTIVE: To perform the cross-cultural adaptation of CALCULATE for Brazilian Portuguese. METHOD: A methodological study conducted from January to December 2021, divided into six stages: translation, synthesis, back-translation, expert committee with the application of the content validity index, pre-testing in 40 adult patients, and submission to the authors. The study took place in the intensive care units of a public tertiary teaching hospital in the interior of the state of São Paulo, Brazil. The original CALCULATE has eight risk assessment items and is stratified with a score of 0-3 (high risk) and 4-8 (very high risk). RESULTS: After expert evaluation, the final content validity was 0.9. They suggested words and phrases that should undergo changes regarding textual equivalences, as well as definitions of acronyms and terminologies. In the pre-test, the items were assessed as suitable for understanding; only one item required additional explanation for adequacy. CONCLUSION: The cross-cultural adaptation of CALCULATE for Brazilian Portuguese was successfully performed, revealing a good content validity index, confirming the relevance and appropriateness of its items. CALCULATE is suitable for use in intensive care units and research and teaching centers.

Incidence of radiodermatitis and factors associated with its severity in women with breast cancer: a cohort study

Abstract Background: One of the main adverse reactions of adjuvant radiotherapy for breast cancer is radiodermatitis. Objective: To assess the incidence of radiodermatitis in women with breast cancer, identify factors associated with its severity and determine the time at which this event occurs. Methods: Prospective cohort study in 113 women with breast cancer who were evaluated before radiotherapy and at every fifth session until the end of treatment. Logistic regression and Cox proportional regression model were used for the assessment of risk factors; P values < 0.05 were considered significant. Results: The incidence rate of radiodermatitis was 98.2% and it was demonstrated that for each additional point of the Body Mass Index (BMI), the chance of occurrence of grades II to IV radiodermatitis increases by 14% (OR = 1.14 [95% CI 1.04-1.26]; p = 0.004) and statin use increases the risk of more severe skin lesions by four-fold (OR = 4.27 [95% CI 1.11-16.42]; p = 0.035). The exclusive use of hydrogel for skin hydration was an independent factor in delaying the onset of radiodermatitis (HR = 0.55 [95% CI 0.36-0.82]; p = 0.004). Study limitations: The main limitation of this study was its external validity. The identified factors should be considered for services and populations similar to those in this study. Conclusions: There was a high incidence of radiodermatitis and its severity was related to higher BMI, statin use; there was a protective effect of hydrogel use.

Incidence of radiodermatitis and factors associated with its severity in women with breast cancer: a cohort study.

BACKGROUND: One of the main adverse reactions of adjuvant radiotherapy for breast cancer is radiodermatitis. OBJECTIVE: To assess the incidence of radiodermatitis in women with breast cancer, identify factors associated with its severity and determine the time at which this event occurs. METHODS: Prospective cohort study in 113 women with breast cancer who were evaluated before radiotherapy and at every fifth session until the end of treatment. Logistic regression and Cox proportional regression model were used for the assessment of risk factors; P values < 0.05 were considered significant. RESULTS: The incidence rate of radiodermatitis was 98.2% and it was demonstrated that for each additional point of the Body Mass Index (BMI), the chance of occurrence of grades II to IV radiodermatitis increases by 14% (OR=1.14 [95% CI 1.04-1.26]; p=0.004) and statin use increases the risk of more severe skin lesions by four-fold (OR=4.27 [95% CI 1.11-16.42]; p=0.035). The exclusive use of hydrogel for skin hydration was an independent factor in delaying the onset of radiodermatitis (HR=0.55 [95% CI 0.36-0.82]; p=0.004). STUDY LIMITATIONS: The main limitation of this study was its external validity. The identified factors should be considered for services and populations similar to those in this study. CONCLUSIONS: There was a high incidence of radiodermatitis and its severity was related to higher BMI, statin use; there was a protective effect of hydrogel use.

Efficacy of micrographic surgery versus conventional excision in reducing recurrence for basal cell carcinoma and squamous cell carcinoma: A systematic review and meta-analysis.

The standard of care for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) involves excision by conventional surgery (CS) with a predefined safety margin of resection or micrographic surgery (MS) with microscopic margin control. Previous studies have reported the superiority of MS in reducing recurrences for high-risk BCC and SCC. This systematic review aimed to assess MS and CS recurrence rates by including randomized clinical trials (RCTs) and cohort studies. A systematic review and meta-analysis were conducted for related studies in PubMed, LILACS, Embase, Scopus, Web of Science, CINHAL and Cochrane until May 2023. RCTs and cohorts involving patients with BCC or SCC submitted to MS and CS were included. Risk of bias assessment followed Cochrane-recommended tools for RCTs and cohorts, and certainty of evidence followed the GRADE approach. Pooled estimates were used to determine the relative risk (RR) and absolute risk difference (RD) using a random-effects model. Seventeen studies were included, two RCTs and fifteen cohorts. There were 82 recurrences in 3050 tumours submitted to MS, with an overall recurrence rate of 3.1% (95% CI 2.0%-4.7%). For CS, there were 209 recurrences in 3453 tumours, with a recurrence rate of 5.3% (95% CI 2.9%-9.3%). The combined estimate of RR was 0.48 (95% CI 0.36-0.63), without heterogeneity nor evidence of publication bias (p > 0.3). The RD resulted in 2.9% (95% CI 1.0%-4.9%; NNT = 35). Regarding subgroup analysis, the RR for BBC was 0.37 (95% CI 0.25-0.54), and RD was 3.7% (95% CI 0.8%-6.5%; NNT = 28). For SCC, RR was 0.57 (95% CI 0.29-1.13), and RD was 1.9% (95% CI 0.8%-4.7%; NNT = 53). Among primary tumours, RR was 0.39 (95% CI 0.28-0.54), and for recurrent tumours was 0.67 (95% CI 0.30-1.50). There is moderate evidence based on two RCTs, and low evidence based on 15 cohort studies that MS is superior to CS in reducing recurrences of BCCs and primary tumours. The development of protocols that maximize the cost-effectiveness of each method in different clinical scenarios is paramount.

Efficacy of sunscreen with photolyase or regular sunscreen associated with topical antioxidants in treating advanced photodamage and cutaneous field cancerization: a randomized clinical trial

Abstract Background Several treatments are available for skin with advanced photodamage, which is characterized by the presence of actinic keratoses (AK). Objectives Evaluate the efficacy of using sunscreen with photolyase compared to regular sunscreen, as well as to compare the combination of a topical formulation of antioxidants versus placebo in the treatment of advanced photodamage. Methods This was a randomized, double-blind, factorial clinical trial. Participants with AKs on their forearms were randomized to apply regular sunscreen (SC) or sunscreen with photolyase (SC+P) on both forearms during the day. One of the forearms in each group was randomized again to receive topical antioxidants (AOx), and the other forearm received a placebo cream (both for night application). The four groups were SC/AOx, SC/placebo, SC+P/AOx, and SC+P/placebo. The duration of treatment was 8 weeks. Primary outcomes were total AK clearance, decrease in Forearm Photoaging Scale (FPS), and AK severity scores. Secondary outcomes were reduction in AK count, partial clearance rate, and safety. Results Forty participants (80 forearms) were included. All groups showed significant improvement in outcomes at week eight. There were no significant differences between SC and SC+P for either outcome. AOx led to a significant reduction in AK count (22%; p < 0.05). Partial clearance was obtained in 18 (47.4%) forearms treated with AOx and in 9 (23.7%) treated with placebo (p < 0.05). All groups reduced the FPS score, without significant differences among them. Conclusions There is no difference in the treatment of advanced photodamage skin when comparing the use of sunscreen with photolyase and regular sunscreen, and topical antioxidants were more efficient in reducing AK count than placebo. Study limitations Short interval of follow-up and absence of re-evaluation in the absence of treatment were limitations of the present study.

Lesões por pressão relacionadas ao uso de máscaras N95 na pandemia por COVID-19 / Lesiones por presión relacionadas con el uso de mascarillas N95 en la pandemia de COVID-19 / Pressure injury related to the use of N95 mask in COVID-19 pandemic

Objetivo: avaliar o desenvolvimento de lesão por pressão em profissionais de saúde desencadeadas pelas máscaras de proteção individual N95, assim como avaliar o uso de barreiras de proteção usadas como interface para prevenção desse tipo de lesão. Método: Trata-se de um estudo transversal desenvolvido de julho de 2020 a julho de 2021. Para a coleta de dados, foi aplicado questionário para avaliar as particularidades da pele, desenvolvimento de lesão, classificação e os fatores de risco para seu desenvolvimento. Para análise estatística foi considerada a significância de p <0,1 e regressão logística múltipla. Resultados: Foram avaliados 85 profissionais, sendo que 91,8% destes apresentaram algum tipo de lesão. Conclusão: Conclui-se que a lesão por pressão relacionada ao uso de máscaras de proteção individual N95 apresentou alta ocorrência nessa população. E embora importantes, barreiras protetoras foram pouco utilizadas devido a questões financeiras da instituição(AU)

Objective: to evaluate the development of pressure injuries triggered by N95 personal protective masks in health professionals, as well as to evaluate the use of protective barriers used as an interface to prevent this type of injury. Method: This is a cross-sectional study developed from July 2020 to July 2021. For data collection, a questionnaire was applied to assess the particularities of the skin, lesion development, classification and risk factors for its development. For statistical analysis, significance of p <0.1 and multiple logistic regression were considered. Results: Eighty-five professionals were evaluated, and 91.8% of them developed some type of injury. Conclusion: Pressure injuries related to the use of N95 personal protective masks were highly prevalent in this population. And although important, protective barriers were under-used due to financial issues in the institution(AU)

Objetivo: evaluar el desarrollo de lesiones por presión en profesionales de la salud provocadas por máscaras de protección personal N95, así como evaluar el uso de barreras protectoras utilizadas como interfaz para prevenir este tipo de lesión. Método: Se trata de un estudio transversal desarrollado de julio de 2020 a julio de 2021. Para la recolección de datos se aplicó un cuestionario para evaluar las particularidades de la piel, desarrollo de la lesión, clasificación y factores de riesgo para su desarrollo. Para el análisis estadístico se consideró la significación de p < 0,1 y la regresión logística múltiple. Resultados: Se evaluaron 85 profesionales, de los cuales el 91,8% presentaba algún tipo de lesión. Conclusión: Se concluye que las lesiones por presión relacionadas con el uso de máscaras de protección personal N95 fueron altamente prevalentes en esta población. Y aunque importantes, las barreras de protección fueron poco utilizadas por cuestiones financieras de la institución.

Efficacy of sunscreen with photolyase or regular sunscreen associated with topical antioxidants in treating advanced photodamage and cutaneous field cancerization: a randomized clinical trial.

BACKGROUND: Several treatments are available for skin with advanced photodamage, which is characterized by the presence of actinic keratoses (AK). OBJECTIVES: Evaluate the efficacy of using sunscreen with photolyase compared to regular sunscreen, as well as to compare the combination of a topical formulation of antioxidants versus placebo in the treatment of advanced photodamage. METHODS: This was a randomized, double-blind, factorial clinical trial. Participants with AKs on their forearms were randomized to apply regular sunscreen (SC) or sunscreen with photolyase (SC+P) on both forearms during the day. One of the forearms in each group was randomized again to receive topical antioxidants (AOx), and the other forearm received a placebo cream (both for night application). The four groups were SC/AOx, SC/placebo, SC+P/AOx, and SC+P/placebo. The duration of treatment was 8 weeks. Primary outcomes were total AK clearance, decrease in Forearm Photoaging Scale (FPS), and AK severity scores. Secondary outcomes were reduction in AK count, partial clearance rate, and safety. RESULTS: Forty participants (80 forearms) were included. All groups showed significant improvement in outcomes at week eight. There were no significant differences between SC and SC+P for either outcome. AOx led to a significant reduction in AK count (22%; p < 0.05). Partial clearance was obtained in 18 (47.4%) forearms treated with AOx and in 9 (23.7%) treated with placebo (p < 0.05). All groups reduced the FPS score, without significant differences among them. CONCLUSIONS: There is no difference in the treatment of advanced photodamage skin when comparing the use of sunscreen with photolyase and regular sunscreen, and topical antioxidants were more efficient in reducing AK count than placebo. STUDY LIMITATIONS: Short interval of follow-up and absence of re-evaluation in the absence of treatment were limitations of the present study.

Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions.

BACKGROUND: Despite the expectations regarding the effectiveness of chloroquine (CQ) and hydroxychloroquine (HCQ) for coronavirus disease (COVID-19) management, concerns about their adverse events have remained. OBJECTIVES: The objective of this systematic review was to evaluate the safety of CQ and HCQ from malarial and non-malarial randomized clinical trials (RCTs). METHODS: The primary outcomes were the frequencies of serious adverse events (SAEs), retinopathy, and cardiac complications. Search strategies were applied to MEDLINE, EMBASE, LILACS, CENTRAL, Scopus, and Trip databases. We used a random-effects model to pool results across studies and Peto's one-step odds ratio (OR) for event rates below 1%. Both-armed zero-event studies were excluded from the meta-analyses. We used the Grading of Recommendations Assessment, Development, and Evaluation system to evaluate the certainty of evidence. RESULTS: One hundred and six RCTs were included. We found no significant difference between CQ/HCQ and control (placebo or non-CQ/HCQ) in the frequency of SAEs (OR: 0.98, 95% confidence interval [CI]: 0.76-1.26, 33 trials, 15,942 participants, moderate certainty of evidence). However, there was a moderate certainty of evidence that CQ/HCQ increases the incidence of cardiac complications (RR: 1.62, 95% CI: 1.10-2.38, 16 trials, 9908 participants). No clear relationship was observed between CQ/HCQ and retinopathy (OR: 1.63, 95% CI: - 0.4-6.57, 5 trials, 344 participants, very low certainty of evidence). CONCLUSIONS: CQ and HCQ probably do not increase SAEs, with low frequency of these adverse events on malarial and non-malarial conditions. However, they may increase cardiac complications especially in patients with COVID-19. No clear effect of their use on the incidence of retinopathy was observed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020177818.