Robot-assisted radical nephroureterectomy using the KangDuo Surgical Robot-01 System versus the da Vinci System: a multicenter prospective randomized controlled trial

ABSTRACT Introduction: We aim to compare the safety and effectiveness of the KangDuo (KD)-Surgical Robot-01 (KD-SR-01) system and the da Vinci (DV) system for robot-assisted radical nephroureterectomy (RARNU). Materials and Methods: This multicenter prospective randomized controlled trial was conducted between March 2022 and September 2023. Group 1 included 29 patients undergoing KD-RARNU. Group 2 included 29 patients undergoing DV-RARNU. Patient demographic and clinical characteristics, perioperative data, and follow-up outcomes were collected prospectively and compared between the two groups. Results: There were no significant differences in patient baseline demographic and preoperative characteristics between the two groups. The success rates in both groups were 100% without conversion to open or laparoscopic surgery or positive surgical margins. No significant difference was observed in docking time [242 (120-951) s vs 253 (62-498) s, P = 0.780], console time [137 (55-290) min vs 105 (62-220) min, P = 0.114], operative time [207 (121-460) min vs 185 (96-305) min, P = 0.091], EBL [50 (10-600) mL vs 50 (10-700) mL, P = 0.507], National Aeronautics and Space Administration Task Load Index scores, and postoperative serum creatinine levels between the two groups. None of the patients showed evidence of distant metastasis, local recurrence, or equipment-related adverse events during the four-week follow-up. One (3.4%) patient in Group 2 experienced postoperative enterovaginal and enterovesical fistulas (Clavien-Dindo grade III). Conclusions: The KD-SR-01 system is safe and effective for RARNU compared to the DV Si or Xi system. Further randomized controlled studies with larger sample sizes and longer durations are required.

Healthy Change Intervention: A Cluster RCT in Preschooler Mothers in Mexico and the United States.

OBJECTIVE: To assess effects of Healthy Change intervention on maternal perception of her child's body weight (MPCW), maternal feeding style, and obesogenic home environment. METHODS: A randomized control trial was conducted, consisting of two arms: the intervention group received the Healthy Change program, and the control group received the Hygiene and Accident Prevention program. A total of 356 mother-preschool child dyads participated, 182 in the intervention group and 174 in the control group, residing in Mexico and the United States. Data were collected at baseline and after the program through self-administered questionnaires completed by mothers and child anthropometric measurements. RESULTS: Although no significant between-group difference in pre- and post-intervention change of MPCW was found, sub-analyses revealed that a higher proportion of mothers in the intervention group accurately perceived their child's body weight at the study endpoint using categorical (67% vs. 57.1%, p < 0.005) and visual scales (48.9% vs. 41.8%, p < 0.015). Additionally, more mothers of overweight children in the intervention group accurately perceived their children's overweight and obese status compared to those in the control group (29.8% vs. 10.3%, X2 = 4.26, df = 1, p < 0.039). The intervention group also displayed a higher proportion of mothers with authoritative feeding style (26.4% vs. 16.5%, p < 0.036) and significantly higher family nutrition and physical activity scores (29.1 vs. 28.0, p < 0.000) at the study endpoint. CONCLUSIONS FOR PRACTICE: Healthy Change Intervention led to improved accuracy of MPCW, a shift toward maternal authoritative feeding styles, and positive changes in obesogenic home environments.

Interlaboratory Study Toward Combining Gait Kinematics Data Sets of Long-Distance Runners.

The limited sample size in gait studies has hampered progress in the field. This challenge could be addressed through multicenter studies, thereby leveraging data sets from different laboratories. This study compared 3-dimensional lower-extremity running kinematics between the Biomechanics and Motor Control Laboratory, Federal University of ABC (Brazil), and the Running Injury Clinic, University of Calgary (Canada). Three-dimensional lower-extremity kinematics from 23 male runners were collected from each laboratory using comparable instrumentation and experimental procedures. The 3-dimensional hip, knee, and ankle angles were compared within and between centers using root-mean-square deviation. Two-sample t tests Statistical Parametric Mapping tested the hypothesis that the data from both laboratories were not different. The sagittal plane hip, knee, and ankle angles were similar between laboratories, while notable differences were observed for frontal (hip and ankle) and transverse (hip and knee) plane angles. The average interlaboratory root-mean-square deviation (2.6°) was lower than the intralaboratory root-mean-square deviation (Biomechanics and Motor Control = 4.8°, Running Injury Clinic = 5.6°), with the ankle transverse angle displaying the smallest, and the knee transverse angle displaying the largest variability. This study demonstrates the potential of combining gait kinematics data from different laboratories to increase sample size, but frontal and transverse plane data should be considered with caution.

Robot-assisted radical nephroureterectomy using the KangDuo Surgical Robot-01 System versus the da Vinci System: a multicenter prospective randomized controlled trial.

INTRODUCTION: We aim to compare the safety and effectiveness of the KangDuo (KD)-Surgical Robot-01 (KD-SR-01) system and the da Vinci (DV) system for robot-assisted radical nephroureterectomy (RARNU). MATERIALS AND METHODS: This multicenter prospective randomized controlled trial was conducted between March 2022 and September 2023. Group 1 included 29 patients undergoing KD-RARNU. Group 2 included 29 patients undergoing DV-RARNU. Patient demographic and clinical characteristics, perioperative data, and follow-up outcomes were collected prospectively and compared between the two groups. RESULTS: There were no significant differences in patient baseline demographic and preoperative characteristics between the two groups. The success rates in both groups were 100% without conversion to open or laparoscopic surgery or positive surgical margins. No significant difference was observed in docking time [242 (120-951) s vs 253 (62-498) s, P = 0.780], console time [137 (55-290) min vs 105 (62-220) min, P = 0.114], operative time [207 (121-460) min vs 185 (96-305) min, P = 0.091], EBL [50 (10-600) mL vs 50 (10-700) mL, P = 0.507], National Aeronautics and Space Administration Task Load Index scores, and postoperative serum creatinine levels between the two groups. None of the patients showed evidence of distant metastasis, local recurrence, or equipment-related adverse events during the four-week follow-up. One (3.4%) patient in Group 2 experienced postoperative enterovaginal and enterovesical fistulas (Clavien-Dindo grade III). CONCLUSIONS: The KD-SR-01 system is safe and effective for RARNU compared to the DV Si or Xi system. Further randomized controlled studies with larger sample sizes and longer durations are required.

Mexican Multicenter Experience of Metastatic Spinal Disease.

Background Spinal metastatic disease is a silent progressive cancer complication with an increasing prevalence worldwide. The spine is the third most common site where solid tumors metastasize. Complications involved in spinal metastasis include root or spinal cord compression, progressing to a declining quality of life as patient autonomy reduces and pain increases. The main objective of this study is to report the incidence of patients and typology of spinal metastases in three reference centers in Mexico. Methodology Retrospective cohorts of patients diagnosed with spinal metastases from January 2010 to February 2017 at the National Cancer Institute, National Rehabilitation Institute, and the Traumatology and Orthopedics Hospital "Lomas Verdes" in Mexico City were analyzed. Results A total of 326 patients (56% males) with spinal metastases were reported. The mean age was 58.06 ± 14.05 years. The main sources of spinal metastases were tumors of unknown origin in 53 (16.25%) cases, breast cancer in 67 (20.5%) cases, prostate cancer in 59 (18%) cases, myeloma in 24 (7.4%) cases, and lung cancer in 23 (7.1%) cases. Conclusions The data obtained in this analysis delivers an updated standpoint on Mexico, providing the opportunity to distinguish the current data from global references. Collecting more epidemiological information for better recording of cancer and its associated complications, as well as further studies on them, is necessary.

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

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

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.

Transition between peritoneal dialysis modalities: Impact on blood pressure levels and drug prescription in a national multicentric cohort.

BACKGROUND: Hypertension is a leading cause of kidney failure, affects most dialysis patients and associates with adverse outcomes. Hypertension can be difficult to control with dialysis modalities having differential effects on sodium and water removal. There are two main types of peritoneal dialysis (PD), automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD). It is unknown whether one is superior to the other in controlling blood pressure (BP). Therefore, the aim of our study was to analyse the impact of switching between these two PD modalities on BP levels in a nationally representative cohort. METHODS: This was a cohort study of patients on PD from 122 dialysis centres in Brazil (BRAZPD II study). Clinical and laboratory data were collected monthly throughout the study duration. We selected all patients who remained on PD at least 6 months and 3 months on each modality at minimum. We compared the changes in mean systolic/diastolic blood pressures (SBP/DBP) before and after modality transition using a multilevel mixed-model where patients were at first level and their clinics at the second level. RESULTS: We analysed data of 848 patients (814 starting on CAPD and 34 starting on APD). The SBP decreased by 4 (SD 22) mmHg when transitioning from CAPD to APD (p < 0.001) and increased by 4 (SD 21) mmHg when transitioning from APD to CAPD (p = 0.38); consistent findings were seen for DBP. There was no significant change in the number of antihypertensive drugs prescribed before and after transition. CONCLUSIONS: Transition between PD modalities seems to directly impact on BP levels. Further studies are needed to confirm if switching to APD could be an effective treatment for uncontrolled hypertension among CAPD patients.

Association of mandibular canine impaction and anatomical factors: A multicentre retrospective panoramic study in Latin America.

INTRODUCTION: Mandibular canine impaction is infrequent in dental eruption anomalies and treatment is very challenging. The aim of this multicenter retrospective panoramic study in Latin America was to evaluate panoramic radiographic imaging characteristics of mandibular canine impaction (impaction area, mandibular base contact, transmigration, impaction height and sex) and their associations. MATERIAL AND METHODS: This cross-sectional study evaluated 212 digital panoramic radiographs from three radiological centres in Tingo Maria (Peru), Bogota and Tunja (Colombia). The study included children of both sexes with impacted mandibular canines. Mandibular alpha angle, contact with mandibular basal bone (MBB), impacted sector according to 10 sectors with an adaptation of the Ericson and Kurol method, presence of transmigration and the impacted height were measured and the relationship among these measures was analyzed. Fisher's exact test, Chi-square and binary logistic regression were used. (P<0.05). RESULTS: The mandibular canine impaction showed contact with the MBB (32.08%), dental transmigration (36.79%), mainly located at an apical (40.09%) and sub-apical (36.79%) level. Transmigration mainly occurred in sectors 6 (33.30%) and 10 (25.60%) (P<0.001). It was found that for each year of increase in age, the possibility of contact with the MBB decreased (ß=0.89, P=0.010), and as the alpha angle increased by one degree the probability of contact with the MBB decreased (ß=0.97, P=0.001) and the probability of transmigration increased (ß=1.05, P<0.001). CONCLUSIONS: One third of the impacted canines were in contact with the MBB, while another third presented dental transmigration and were mainly located apically and subapically of the incisor roots. These imaging features should be taken into account when planning orthodontic treatment.

Does the intensity of pain and disability affect health-related quality of life of older adults with back pain? Multilevel analysis between Brazil and Netherlands: a cross-sectional study of the BACE consortium.

BACKGROUND: The prognosis of back pain (BP) in the older adults is less favorable than in younger adults and progress to adverse outcomes and consequent worsening of health-related quality of life (HRQoL). The present study aimed to verify the association between BP intensity, disability and HRQoL in older adults residents in Brazil and Netherlands, and to evaluate whether the country of residence influences the associations. METHODS: Data were collected from 602 Brazilian and 675 Dutch participants with a new episode of BP from the Back Complaints in Elders (BACE) consortium. For the present study, a cross section was used. Pain intensity and disability were assessed using the Numerical Rating Scale (NRS) and the Roland-Morris Disability Questionnaire (RMDQ), respectively. HRQoL was assessed using the Short Form Health Survey (SF-36) quality of life questionnaire. Age, sex, and education were descriptive variables. Pain intensity (NPS score) and country were the independent variables and quality of life assessed by each SF domain - 36 was the dependent variable. Analysis of models at the individual level was performed to verify the association between pain and disability, also HRQoL in Netherlands and Brazil in the total sample. The multilevel model was used to verify whether the older adults person's country of residence influenced this relationship. RESULTS: The average age of the participants was 67.00 (7.33) years. In the total sample, linear regression analysis adjusted for sex and age showed a significant association between BP intensity scores and HRQoL, for all domains. There was no association between disability and HRQoL. In the multilevel analysis, there was an association between BP intensity and HRQoL in all domains and an association between the country of residence and HRQoL, influencing the effect of pain, in all domains, except for the physical functioning. CONCLUSION: Socioeconomic and cultural aspects of different countries can affect the perception of the elderly about their HRQoL in the presence of BP. Pain and disability in Brazilian and Dutch older adults ones are experienced differently in relation to their HRQoL.

Seguimiento Funcional hasta Seis Meses después de Sobrevivir a Cuidados Intensivos: Lecciones aprendidas de un Estudio Chileno Multicéntrico / Functional follow-up six months after surviving intensive care: lessons learned from a Chilean multicenter study

Introducción. Las tasas de retención en los estudios de seguimiento oscilan entre el 32 y 100%, demostrando el desafío que implica realizar estudios longitudinales de sobrevivientes de la unidad de cuidados intensivos (UCI). Objetivo. Identificar las estrategias implementadas y lecciones aprendidas en un estudio prospectivo multicéntrico de seguimiento de sobrevivientes de la UCI durante la pandemia. Métodos. Estudio post-hoc de las lecciones aprendidas mediante encuestas y entrevistas dirigidas a explorar la experiencia de los investigadores y coordinadores del estudio IMPACCT COVID-19, realizado en siete centros chilenos entre octubre 2020 y abril 2021 evaluando el síndrome post-cuidados intensivos de sobrevivientes hasta seis meses después. Resultados. Identificamos ocho lecciones: 1) selección de instrumentos de medición, 2) identificación de centros participantes, 3) aprobación del estudio, 4) financiamiento, 5) capacitación de evaluadores, 6) coordinación/aseguramiento de calidad, 7) reclutamiento y 8) seguimiento de pacientes. Incluso durante el primer año de pandemia, reclutamos 252 pacientes a una tasa de 1,4 pacientes/día con una retención del 48% a los 6 meses de seguimiento. El uso de redes académicas existentes y las estrategias de comunicación entre investigadores, coordinadores y evaluadores fueron aspectos positivos; mientras que la fidelización con evaluadores al egreso de la UCI y con pacientes durante el seguimiento son aspectos que deberían considerarse en futuros estudios. Conclusiones. Se evaluaron más de 250 pacientes en seis meses durante la pandemia, con tasas de retención post UCI acorde a la literatura. Futuros estudios debiesen optimizar los procesos de medición y de seguimiento para minimizar la pérdida de pacientes.

Background. Retention rates of follow-up studies range from 32 to 100%, demonstrating the challenge to conduct longitudinal studies of intensive care unit (ICU) survivors. Objective. To identify the strategies implemented and lessons learned in a multicenter prospective follow-up study of ICU survivors during pandemic times. Methods. Post-hoc study of lessons learned through surveys and interviews aimed at exploring the experience of the researchers and coordinators of the IMPACCT COVID-19 study. The original study was performed in seven Chilean sites between October 2020 and April 2021 evaluating the post-intensive care syndrome of survivors up to six-month follow-up. Results. We identified eight lessons: 1) selection of measurement instruments, 2) identification of participating sites, 3) Study approval, 4) funding, 5) evaluators training, 6) coordination/quality assurance, 7) recruitment, and 8) patient follow-up. Even during the first year of the pandemic, we recruited 252 patients at a rate of 1.4 patients/day with a retention rate of 48% at 6 months of follow-up. The use of existing academic networks and communication strategies between researchers, coordinators and evaluators were positive aspects; while evaluators fidelity at ICU discharge and patient engagement during follow-up are aspects should be considered. Conclusions. More than 250 patients were evaluated in six months during the pandemic, with post-ICU retention rates consistent with the literature. Future studies should optimize measurement and monitoring processes to minimize patient atrition.

Maternal vaccination against COVID-19 and neonatal outcomes during Omicron: INTERCOVID-2022 study.

BACKGROUND: In early 2023, when Omicron was the variant of concern, we showed that vaccinating pregnant women decreased the risk for severe COVID-19-related complications and maternal morbidity and mortality. OBJECTIVE: This study aimed to analyze the impact of COVID-19 during pregnancy on newborns and the effects of maternal COVID-19 vaccination on neonatal outcomes when Omicron was the variant of concern. STUDY DESIGN: INTERCOVID-2022 was a large, prospective, observational study, conducted in 40 hospitals across 18 countries, from November 27, 2021 (the day after the World Health Organization declared Omicron the variant of concern) to June 30, 2022, to assess the effect of COVID-19 in pregnancy on maternal and neonatal outcomes and to assess vaccine effectiveness. Women diagnosed with laboratory-confirmed COVID-19 during pregnancy were compared with 2 nondiagnosed, unmatched women recruited concomitantly and consecutively during pregnancy or at delivery. Mother-newborn dyads were followed until hospital discharge. The primary outcomes were a neonatal positive test for COVID-19, severe neonatal morbidity index, severe perinatal morbidity and mortality index, preterm birth, neonatal death, referral to neonatal intensive care unit, and diseases during the neonatal period. Vaccine effectiveness was estimated with adjustment for maternal risk profile. RESULTS: We enrolled 4707 neonates born to 1577 (33.5%) mothers diagnosed with COVID-19 and 3130 (66.5%) nondiagnosed mothers. Among the diagnosed mothers, 642 (40.7%) were not vaccinated, 147 (9.3%) were partially vaccinated, 551 (34.9%) were completely vaccinated, and 237 (15.0%) also had a booster vaccine. Neonates of booster-vaccinated mothers had less than half (relative risk, 0.46; 95% confidence interval, 0.23-0.91) the risk of being diagnosed with COVID-19 when compared with those of unvaccinated mothers; they also had the lowest rates of preterm birth, medically indicated preterm birth, respiratory distress syndrome, and number of days in the neonatal intensive care unit. Newborns of unvaccinated mothers had double the risk for neonatal death (relative risk, 2.06; 95% confidence interval, 1.06-4.00) when compared with those of nondiagnosed mothers. Vaccination was not associated with any congenital malformations. Although all vaccines provided protection against neonatal test positivity, newborns of booster-vaccinated mothers had the highest vaccine effectiveness (64%; 95% confidence interval, 10%-86%). Vaccine effectiveness was not as high for messenger RNA vaccines only. Vaccine effectiveness against moderate or severe neonatal outcomes was much lower, namely 13% in the booster-vaccinated group (all vaccines) and 25% and 28% in the completely and booster-vaccinated groups, respectively (messenger RNA vaccines only). Vaccines were fairly effective in protecting neonates when given to pregnant women ≤100 days (14 weeks) before birth; thereafter, the risk increased and was much higher after 200 days (29 weeks). Finally, none of the neonatal practices studied, including skin-to-skin contact and direct breastfeeding, increased the risk for infecting newborns. CONCLUSION: When Omicron was the variant of concern, newborns of unvaccinated mothers had an increased risk for neonatal death. Neonates of vaccinated mothers had a decreased risk for preterm birth and adverse neonatal outcomes. Because the protective effect of COVID-19 vaccination decreases with time, to ensure that newborns are maximally protected against COVID-19, mothers should receive a vaccine or booster dose no more than 14 weeks before the expected date of delivery.

Pain symptoms and physical performance in older adults: cross-sectional findings from the International Mobility in Aging Study (IMIAS).

PURPOSE: To analyze the associations between pain and physical performance in different aging contexts. METHODS: Data from 1725 older adults from Canada, Brazil, Colombia, and Albania from the 2014 wave of the IMIAS were used to assess the associations between Back Pain (BP) or Lower Limb Pain (LLP) and physical performance by the Short Physical Performance Battery (SPPB). Three binary logistic regression models adjusted for sex, age, study site, education, income sufficiency, BMI, depressive symptoms, and chronic conditions were used to estimate the associations between LLP or BP and SPPB. The SPPB was classified into good performance (8 points or more) and poor physical performance (< 8 points). RESULTS: The mean age of the older men was 71.2 (± 3.0) and the mean age of the women was 71.2 (± 2.8) years. Older men (72.8%, p < 0.05) and women (86.1%, p-value < 0.05) from Albania had the highest frequencies of self-reported general pain. Older women in Colombia had the highest frequencies of LLP or BP (33.5%, p-value < 0.05). In the fully adjusted logistic regression model, LLP or BP was significantly associated with poor SPPB (OR = 0.48, 0.35 to 0.66 95% CI, p < 0.01). CONCLUSIONS: Pain symptoms are associated with reduced physical performance in older people, even when adjusted for other clinical and sociodemographic factors. Protocols for aiming to increase the level of physical activity to manage pain should be incorporated into health care strategies.

Bodies of desire: use of nonprescribed hormones among transgender women and travestis in five brazilian capitals (2019–2021) / Corpos do desejo: uso de hormônios sem prescrição médica entre mulheres trans e travestis em cinco capitais brasileiras (2019–2021)

Objective: To analyze the experiences of transgender women and travestis regarding the use of hormones for body changes without a medical prescription. Methods: This is a cross-sectional, quantitative and qualitative study, using data from “TransOdara”, which estimated the prevalence of Sexually Transmitted Infections in transgender women and travestis recruited through Respondent-Driven Sampling, between December 2019 and July 2021, in São Paulo, Campo Grande, Manaus, Porto Alegre, and Salvador, Brazil. The main outcome was: use of hormones without medical prescription and associated risk factors. Descriptive analysis, mixed univariate logistic regression models, and semi-structured interviews were carried out. Results: Of the 1,317 recruited participants, 85.9% had already used hormones. The current use of hormones was reported by 40.7% (536) of them. Of those who were able to inform the place where they obtained them, 72.6% (381/525) used them without a medical prescription. The variables associated with the outcome were: current full-time sex work (OR 4.59; 95%CI 1.90–11.06) or in the past (OR 1.92; 95%CI 1.10–3.34), not having changed their name (OR 3.59; 95%CI 2.23–5.76), not currently studying (OR 1.83; 95%CI 1.07–3.13), being younger (OR 2.16; 95%CI 1.31–3.56), and having suffered discrimination at some point in life for being a transgender women and travestis (OR 0.40; 95%CI 0.20–0.81). Conclusion: The use of nonprescribed hormones is high among transgender women and travestis, especially among those who are younger, did not study, have not changed their name, and with a history of sex work. This use is related to the urgency for gender transition, with excessive use and damage to health.

Objetivo: Analisar experiências de mulheres trans e travestis com o uso de hormônios para mudança corporal sem prescrição médica. Métodos: Estudo de corte transversal, quantitativo e qualitativo, utilizando um recorte do TransOdara, que estimou prevalência de Infecções Sexualmente Transmissíveis em mulheres trans e travestis, recrutadas por meio de Respondent-Driven Sampling, entre dezembro de 2019 e julho de 2021, em São Paulo, Campo Grande, Manaus, Porto Alegre e Salvador. Principal desfecho: uso de hormônios sem prescrição médica e fatores associados. Foram realizados análise descritiva e modelos de regressão logísticos univariados mistos e entrevistas semiestruturadas. Resultados: Das 1.317 participantes recrutadas, 85,9% já haviam usado hormônios. O uso atual de hormônios foi referido por 40,7% (536) delas. Das que souberam informar o local onde os conseguiram, 72,6% (381/525) faziam uso sem prescrição médica. As variáveis associadas ao uso sem prescrição foram: exercer trabalho sexual em tempo integral (OR 4,59; IC95% 1,90–11,06) ou no passado (OR 1,92; IC95% 1,10–3,34); não ter retificado o nome (OR 3,59; IC95% 2,23–5,76); não estar estudando (OR 1,83; IC95% 1,07–3,13); ser mais jovem (OR 2,16; IC95% 1,31–3,56); ter sofrido discriminação em algum momento na vida por ser mulheres trans e travestis (OR 0,40 – IC95% 0,20–0,81). Conclusão: O uso de hormônios não prescritos é alto entre mulheres trans e travestis, principalmente entre as mais jovens, as que não estudavam, as que não retificaram o nome e as com histórico de trabalho sexual. Está relacionado à urgência para a transição de gênero, com uso exagerado e danos à saúde.

Fatty acid intake and prevalence of depression among Brazilian graduates and postgraduates (CUME Study).

BACKGROUND: Dietary fatty acids are related to the development of several inflammatory-related diseases, which may include depression. So, the association between fatty acids, culinary oils and fat intake and depression in highly educated Brazilians was evaluated. METHODS: Multicenter cross-sectional study using baseline data from the Cohort of Universities of Minas Gerais. The diagnosis of depression was self-reported, and the daily intake of fatty acids was assessed using a 144-item food frequency questionnaire (FFQ). RESULTS: A total of 7157 participants (68.83 % women) with a median age of 33 years were included. The prevalence of depression was 12.60 % (N = 902). In the adjusted analyses, it was observed that individuals with the highest intake of omega-6 fatty acids (n-6) (OR: 1.36, 95 % CI 1.11-1.67) had a higher prevalence of depression. This increased n-6 intake was identified as a risk factor for depression only among male participants, while among overweight participants, higher n-6 intake was also positively associated with depression. Conversely, a higher ratio of polyunsaturated to monounsaturated and saturated fatty acids (PM/S) was also found to be positively associated with depression, but this association was observed only among non-overweight participants. No associations were found between the consumption of culinary oils or fats and depression. LIMITATIONS: Cross-sectional design limits the assessment of causality. The use of the FFQ can make estimates more difficult. CONCLUSION: Higher consumption of n-6, and higher PM/S ratios were associated with depression, and individual factors can interfere. The mental health care policies should include specific nutritional strategies.

Data collection via phone in multicentric research on nursing care in the face of covid-19 / Recolección de datos vía telefónica en investigación multicéntrica sobre cuidados de enfermería frente al covid-19 / Coleta de dados via telefone em pesquisa multicêntrica sobre cuidado de enfermagem frente à covid-19

ABSTRACT Objective: to report data collection via telephone carried out in multicenter research on nursing care assessment during the COVID-19 pandemic. Method: this is an experience report on using the telephone to collect quantitative and qualitative data with participants from ten Brazilian university hospitals from October 2020 to December 2021. The experience was presented in stages: 1) Operationalization of data collection via telephone; 2) Interviewing team training; 3) Monitoring and adjustments to data collection; and 4) Results of telephone contact with patients. Results: data collection planning and organization involved creating guidance manuals to guide the collectors, which were validated for clarity and agreement. For monitoring and adjustments, a weekly meeting was held with the interviewers in charge and researchers. Data from 539 respondents from the Patient Measure of Safety instrument, 643 from the Care Transitions Measure instrument and 56 from open interviews were included. Conclusion: using guidance manuals for data collection via telephone, training and follow-up meetings are strategies that can enhance this strategy in multicenter research when in-person data collection is impossible.

RESUMEN Objetivo: informar la recolección de datos vía telefónica realizada en una investigación multicéntrica sobre la evaluación de los cuidados de enfermería durante la pandemia de COVID-19. Método: informe de experiencia sobre el uso del teléfono para la recolección de datos cuantitativos y cualitativos con participantes de diez hospitales universitarios brasileños, de octubre de 2020 a diciembre de 2021. La experiencia fue presentada en etapas: 1) Operacionalización de la recolección de datos por teléfono; 2) Capacitación del equipo entrevistador; 3) Monitoreo y ajustes a la recolección de datos; y 4) Resultados del contacto telefónico con el paciente. Resultados: la planificación y organización de la recolección de datos implicó la creación de manuales de orientación para guiar a los recolectores, los cuales fueron validados por su claridad y acuerdo. Para el seguimiento y ajustes se realizó una reunión semanal con los entrevistadores e investigadores responsables. Se incluyeron datos de 539 encuestados del instrumento Patient Measure of Safety, 643 del instrumento Care Transitions Measure y 56 entrevistas abiertas. Conclusión: el uso de manuales de orientación para la recolección de datos vía telefónica, capacitación y reuniones de seguimiento son estrategias que pueden potenciar esta estrategia en investigaciones multicéntricas cuando la recolección de datos presencial es imposible.

RESUMO Objetivo: Relatar a coleta de dados via telefone realizada em pesquisa multicêntrica sobre avaliação do cuidado de enfermagem durante a pandemia da COVID-19. Método: Relato de experiência sobre o uso do telefone para coleta de dados quantitativos e qualitativos com participantes de dez Hospitais Universitários Brasileiros, de outubro de 2020 a dezembro de 2021. A experiência foi apresentada segundo etapas: 1) Operacionalização da coleta de dados via telefone; 2) Capacitação da equipe de entrevistadores; 3) Acompanhamento e ajustes da coleta de dados; e 4) Resultados do contato telefônico com o paciente. Resultados: O planejamento e a organização da coleta de dados envolveram a construção de manuais de orientação para guiar os coletadores, os quais passaram por validação quanto à clareza e concordância. Para acompanhamento e ajustes, realizou-se reunião semanal com os entrevistadores e pesquisadores responsáveis. Foram incluídos dados de 539 respondentes do instrumento Patient Measure of Safety, de 643 do instrumento Care Transitions Measure e de 56 entrevistas abertas. Conclusão: A utilização de manuais de orientação para coleta de dados via telefone, realização de treinamentos e reuniões de acompanhamento são estratégias que podem potencializar essa estratégia em pesquisas multicêntricas, quando da impossibilidade de coleta face-a-face.

Bodies of desire: use of nonprescribed hormones among transgender women and travestis in five Brazilian capitals (2019-2021) / Corpos do desejo: uso de hormônios sem prescrição médica entre mulheres trans e travestis em cinco capitais brasileiras (2019-2021)

ABSTRACT Objective: To analyze the experiences of transgender women and travestis regarding the use of hormones for body changes without a medical prescription. Methods: This is a cross-sectional, quantitative and qualitative study, using data from "TransOdara", which estimated the prevalence of Sexually Transmitted Infections in transgender women and travestis recruited through Respondent-Driven Sampling, between December 2019 and July 2021, in São Paulo, Campo Grande, Manaus, Porto Alegre, and Salvador, Brazil. The main outcome was: use of hormones without medical prescription and associated risk factors. Descriptive analysis, mixed univariate logistic regression models, and semi-structured interviews were carried out. Results: Of the 1,317 recruited participants, 85.9% had already used hormones. The current use of hormones was reported by 40.7% (536) of them. Of those who were able to inform the place where they obtained them, 72.6% (381/525) used them without a medical prescription. The variables associated with the outcome were: current full-time sex work (OR 4.59; 95%CI 1.90-11.06) or in the past (OR 1.92; 95%CI 1.10-3.34), not having changed their name (OR 3.59; 95%CI 2.23-5.76), not currently studying (OR 1.83; 95%CI 1.07-3.13), being younger (OR 2.16; 95%CI 1.31-3.56), and having suffered discrimination at some point in life for being a transgender women and travestis (OR 0.40; 95%CI 0.20-0.81). Conclusion: The use of nonprescribed hormones is high among transgender women and travestis, especially among those who are younger, did not study, have not changed their name, and with a history of sex work. This use is related to the urgency for gender transition, with excessive use and damage to health.

RESUMO Objective Analisar experiências de mulheres trans e travestis com o uso de hormônios para mudança corporal sem prescrição médica. Métodos: Estudo de corte transversal, quantitativo e qualitativo, utilizando um recorte do TransOdara, que estimou prevalência de Infecções Sexualmente Transmissíveis em mulheres trans e travestis, recrutadas por meio de Respondent-Driven Sampling, entre dezembro de 2019 e julho de 2021, em São Paulo, Campo Grande, Manaus, Porto Alegre e Salvador. Principal desfecho: uso de hormônios sem prescrição médica e fatores associados. Foram realizados análise descritiva e modelos de regressão logísticos univariados mistos e entrevistas semiestruturadas. Resultados: Das 1.317 participantes recrutadas, 85,9% já haviam usado hormônios. O uso atual de hormônios foi referido por 40,7% (536) delas. Das que souberam informar o local onde os conseguiram, 72,6% (381/525) faziam uso sem prescrição médica. As variáveis associadas ao uso sem prescrição foram: exercer trabalho sexual em tempo integral (OR 4,59; IC95% 1,90-11,06) ou no passado (OR 1,92; IC95% 1,10-3,34); não ter retificado o nome (OR 3,59; IC95% 2,23-5,76); não estar estudando (OR 1,83; IC95% 1,07-3,13); ser mais jovem (OR 2,16; IC95% 1,31-3,56); ter sofrido discriminação em algum momento na vida por ser mulheres trans e travestis (OR 0,40 - IC95% 0,20-0,81). Conclusão: O uso de hormônios não prescritos é alto entre mulheres trans e travestis, principalmente entre as mais jovens, as que não estudavam, as que não retificaram o nome e as com histórico de trabalho sexual. Está relacionado à urgência para a transição de gênero, com uso exagerado e danos à saúde.

Violência contra pessoas idosas dependentes no Brasil: um estudo multicêntrico / Violence against dependent older people in Brazil: a multi-center study / Violencia contra ancianos dependientes en Brasil: un estudio multicéntrico

Este estudo analisa narrativas sobre violência no âmbito do cuidado contra pessoas idosas dependentes no Brasil. A pesquisa possui abordagem qualitativa e caráter multicêntrico, realizada no ano de 2019 em oito municípios brasileiros: Porto Alegre, Rio de Janeiro, Brasília, Fortaleza, Recife, Teresina, Manaus e Araranguá. Foram entrevistas semiestruturadas com 193 pessoas: 64 pessoas idosas com dependência física e/ou cognitiva, 72 cuidadores familiares, 27 cuidadores formais, vinte profissionais de saúde e dez gestores. As informações foram analisadas por meio da "Análise de narrativa". Abandono, negligência e maus-tratos foram evidenciados. As violências foram cometidas pelos familiares e no ambiente domiciliar. As consequências para as pessoas idosas incluem sofrimento psicológico, adoecimento físico e redução da qualidade de vida. Constatou-se a importância dos profissionais de saúde na identificação da violência, a negligência estatal na atenção e a implementação de políticas públicas específicas.(AU)

This study analyzes narratives on violence against dependent older people in Brazil. We conducted a qualitative multi-center study in 2019 in eight municipalities: Porto Alegre, Rio de Janeiro, Brasília, Fortaleza, Recife, Teresina, Manaus and Araranguá. Semi-structured interviews were conducted with 193 people: 64 physically and/or cognitively dependent older people, 72 family caregivers, 27 formal caregivers, 20 health professionals and 10 managers. The data were analyzed using "narrative analysis". The findings revealed abandonment, neglect and maltreatment. Violence was committed by family members and in the home environment. Consequences for the older persons included psychological suffering, physical illness and a decline in quality of life. Our results also highlight the importance of health professionals in the identification of violence, state negligence when it comes to care, and the implementation of specific public policies.(AU)

Este estudio analiza narrativas sobre violencia en el ámbito del cuidado contra ancianos dependientes en Brasil. La investigación tiene un abordaje cualitativo y carácter multicéntrico, realizado en el año 2019 en ocho municipios brasileños: Porto Alegre, Río de Janeiro, Brasilia, Fortaleza, Recife, Teresina, Manaus y Araranguá. Se realizaron entrevistas semiestructuradas con 193 personas: 64 ancianos con dependencia física y/o cognitiva, 72 cuidadores familiares, 27 cuidadores profesionales, veinte profesionales de salud y diez gestores. Las informaciones se analizaron por medio del "Análisis de Narrativa". Quedaron en evidencia abandono, negligencia y malos tratos. Los actos de violencia fueron cometidos por familiares y en el ambiente del hogar. Las consecuencias para los ancianos incluyen sufrimiento psicológico, enfermedad física y reducción de la calidad de vida. Se constató la importancia de los profesionales de la salud en la identificación de la violencia, la negligencia estatal en la atención y la implementación de políticas públicas específicas.(AU)

Historia de la hipertensión arterial: revisión narrativa / History of high blood pressure: narrative review

Introducción: La medición de la presión arterial es uno de los procedimientos más realizados en la práctica clínica. La presente revisión narrativa pretende sintetizar los aspectos relevantes que rodearon la definición de la hipertensión arterial, el recorrido histórico del tratamiento de esta y el aporte de los estudios a la disminución de la mortalidad por enfermedad cardiovascular en el tiempo. Metodología: Revisión narrativa de la historia de la hipertensión arterial, desde el reconocimiento de la presión arterial alta como un factor asociado al riesgo cardiovascular y la evolución histórica del tratamiento hasta los hallazgos significativos del estudio SPRINT, publicado en 2015. Resultados: Hasta hace aproximadamente 50 años la hipertensión arterial era conocida como una patología esencial, es decir, esta condición no siempre fue considerada como una enfermedad. El descubrimiento de la presión sanguínea ha sido atribuido a Stephen Hales, poeta, orador y sacerdote nacido en Inglaterra. La primera medición de la presión sanguínea e incidentalmente de la presión del pulso la realizó en 1733 en animales. Se describe el origen de la presión arterial, la hipertensión arterial, el camino recorrido para el reconocimiento de esta condición como enfermedad y posteriormente su tratamiento, hasta llegar al estudio SPRINT en 2015, el cual fue contundente en demostrar el beneficio de reducir la cifra de presión arterial sistólica objetivo en una población no diabética. Conclusión: Los resultados de esta revisión narrativa exponen cómo el reconocimiento de la presión arterial alta como un factor de riesgo cardiovascular permitió el avance en la investigación científica para determinar el tratamiento y las cifras de presión arterial que favorecen la reducción de la mortalidad y morbilidad por esta causa.

Background: Blood pressure measurement is one of the most performed procedures in clinical practice. This narrative review aims to expose the relevant aspects surrounding the definition of arterial hypertension, the historical path of its treatment, and the contribution of studies to the decrease in mortality due to cardiovascular disease over time. Methodology: Narrative review of the history of arterial hypertension from recognizing high blood pressure as a factor associated with cardiovascular risk to the historical evolution of treatment up to the SPRINT study published in 2015. Results: Until about 50 years ago, arterial hypertension was known as an essential pathology; this condition was not always considered a disease. The discovery of blood pressure has been attributed to Stephen Hales, a poet, orator and priest born in England. The first measurement of blood pressure and incidentally pulse pressure was made in 1733 in animals. The origin of blood pressure, arterial hypertension, and the path travelled for recognizing this condition as a disease and later its treatment until reaching the SPRINT study in 2015, which demonstrated the benefit of reducing the target systolic blood pressure figure in a non-diabetic population. Conclusion: This narrative review demonstrates that the recognition of high blood pressure as a cardiovascular risk factor allowed progress in scientific research to determine the treatment and blood pressure figures that favor the reduction of mortality and morbidity from this cause.

The impact of data quality monitoring of a multicenter prospective registry of cardiac implantable electronic devices.

Data quality monitoring plays a crucial role in multicenter prospective registries. By maintaining high data accuracy, completeness, and consistency, researchers can improve the overall quality and reliability of the registry data, enabling meaningful conclusions and supporting evidence-based decisions. The purpose of the present study was to evaluate data quality metrics (completeness, accuracy, and temporal plausibility) of a Multicenter Registry of Cardiac Implantable Electronic Devices (CIEDs) and to perform a direct data audit of a random sample of records to assess the agreement levels with the source documents. The CIED Registry was a prospective, multicenter, real-world observational study carried out from January 2020 to December 2022 in five designated centers across Sao Paulo, Brazil. We assessed the data quality of the CIED Registry by using two distinct approaches:•Dynamic data monitoring using features of the REDCap (Research Electronic Data Capture) software, including data reports and data quality rules•Direct data audit in which information from a random sample of 10 % of cases from the coordinating center was compared with original source documents Our findings suggest that the methodological approach applied to the CIED Registry resulted in high data completeness, accuracy, temporal plausibility, and excellent agreement levels with the source documents.