Navigating challenges in anesthesia for robotic urological surgery: a comprehensive guide.

Robotic surgery has emerged as a cornerstone in urological interventions, offering effectiveness and safety for patients. For anesthesiologists, this technological advancement presents a myriad of new challenges, spanning from patient selection and assessment to intraoperative dynamics and post-surgical pain management. This article aims to elucidate these challenges and provide guidance for anesthesiologists in navigating the complexities of anesthesia administration in robotic urological procedures. Through a detailed exploration of patient optimization, team coordination, intraoperative adjustments, and post-surgical care, this article serves as a valuable resource for ensuring the success of such interventions.

Cardioneuroablation for the treatment of reflex syncope and functional bradyarrhythmias. a scientific statement of the european heart rhythm association (ehra) of the esc, the heart rhythm society (hrs), the asia pacific heart rhythm society (aphrs) and the latin american heart rhythm society (lahrs)

Cardioneuroablation has emerged as a potential alternative to cardiac pacing in selected cases with vasovagal reflex syncope, extrinsic vagally induced sinus bradycardia-arrest or atrioventricular block. The technique was first introduced decades ago, and its use has risen over the past decade. However, as with any intervention, proper patient selection and technique are a prerequisite for a safe and effective use of cardioneuroablation therapy. This document aims to review and interpret available scientific evidence and provide a summary position on the topic.

Endoscopic treatment of gastroesophageal reflux disease.

The endoscopic treatment of gastroesophageal reflux disease (GERD) has evolved significantly in the past 20 years. Current practices include devices specifically designed for GERD. Newer techniques aim to use less extra equipment, to be less costly, and to use accessories readily available in endoscopy units, as well as using standard endoscopes to apply such techniques. It is of utmost importance to properly select the patients for endoscopic therapy, and it should be done in a multidisciplinary approach.

El tratamiento endoscópico de la enfermedad por reflujo gastroesofágico (ERGE) ha evolucionado significativamente en los últimos 20 años. Las prácticas actuales incluyen dispositivos diseñados específicamente para la ERGE. Las técnicas más nuevas tienen como objetivo utilizar menos equipos adicionales, ser menos costosos y utilizar accesorios fácilmente disponibles en las unidades de endoscopia, así como utilizar endoscopios estándar para aplicar dichas técnicas. Es de suma importancia seleccionar adecuadamente a los pacientes para la terapia endoscópica, y debe hacerse en un enfoque multidisciplinario.

ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer.

INTRODUCTION: ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation. METHODS: The platform's database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted. RESULTS: ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months. DISCUSSION: ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.

Fundamentals of deep brain stimulation for Parkinson's disease in clinical practice: part 1.

Deep brain stimulation (DBS) is recognized as an established therapy for Parkinson's disease (PD) and other movement disorders in the light of the developments seen over the past three decades. Long-term efficacy is established for PD with documented improvement in the cardinal motor symptoms of PD and levodopa-induced complications, such as motor fluctuations and dyskinesias. Timing of patient selection is crucial to obtain optimal benefits from DBS therapy, before PD complications become irreversible. The objective of this first part review is to examine the fundamental concepts of DBS for PD in clinical practice, discussing the historical aspects, patient selection, potential effects of DBS on motor and non-motor symptoms, and the practical management of patients after surgery.

Nas últimas três décadas, a estimulação cerebral profunda (ECP) se tornou um tratamento bem estabelecido para doença de Parkinson (DP) e outros transtornos do movimento. A eficácia a longo prazo na DP foi bem documentada para a melhora dos sintomas motores cardinais da DP e das complicações induzidas pelo uso do levodopa, como as flutuações motoras e as discinesias. O momento da seleção do paciente é crucial para se obter os benefícios ideais da ECP, antes que as complicações da DP se tornem irreversíveis. O objetivo desta primeira parte da revisão é examinar os conceitos fundamentais da ECP na prática clínica, discutindo os aspectos históricos, a seleção de pacientes, os potenciais efeitos da ECP nos sintomas motores e não motores da doença e o manejo prático dos pacientes após a cirurgia.

Germline pathogenic variants associated with triple-negative breast cancer in US Hispanic and Guatemalan women using hospital and community-based recruitment strategies.

PURPOSE: Recruit and sequence breast cancer subjects in Guatemalan and US Hispanic populations. Identify optimum strategies to recruit Latin American and Hispanic women into genetic studies of breast cancer. METHODS: We used targeted gene sequencing to identify pathogenic variants in 19 familial breast cancer susceptibility genes in DNA from unselected Hispanic breast cancer cases in the US and Guatemala. Recruitment across the US was achieved through community-based strategies. In addition, we obtained patients receiving cancer treatment at major hospitals in Texas and Guatemala. RESULTS: We recruited 287 Hispanic US women, 38 (13%) from community-based and 249 (87%) from hospital-based strategies. In addition, we ascertained 801 Guatemalan women using hospital-based recruitment. In our experience, a hospital-based approach was more efficient than community-based recruitment. In this study, we sequenced 103 US and 137 Guatemalan women and found 11 and 10 pathogenic variants, respectively. The most frequently mutated genes were BRCA1, BRCA2, CHEK2, and ATM. In addition, an analysis of 287 US Hispanic patients with pathology reports showed a significantly higher percentage of triple-negative disease in patients with pathogenic variants (41% vs. 15%). Finally, an analysis of mammography usage in 801 Guatemalan patients found reduced screening in women with a lower socioeconomic status (p < 0.001). CONCLUSION: Guatemalan and US Hispanic women have rates of hereditary breast cancer pathogenic variants similar to other populations and are more likely to have early age at diagnosis, a family history, and a more aggressive disease. Patient recruitment was higher using hospital-based versus community enrollment. This data supports genetic testing in breast cancer patients to reduce breast cancer mortality in Hispanic women.

Is central venous catheter in haemodialysis still the main factor of mortality after hospitalization?

BACKGROUND: Haemodialysis is the most frequently prescribed Renal Replacement Therapy modality worldwide. However, patients undergoing this therapy have an unpredictable evolution related to vascular access. OBJECTIVE: To determine the factors associated with the mortality and hospitalization rate in haemodialysis patients at a third-level care Centre in the Dominican Republic. METHODS: This was an observational and prospective study involving a cohort of 192 haemodialysis patients. The patient selection was non-probabilistic for convenience, and a direct source questionnaire was applied. RESULTS: Of the 192 patients in the cohort, 103 (53.6%) were hospitalized and evaluated. The most frequent cause of hospitalization was catheter-related bloodstream infections (53.4%). Almost one-third (28.2%) of the hospitalized patients died, mostly due to infections (12.6%). Of those who died 29 patients (90%) had a Central venous catheter (CVC) with a non-tunnelled catheter (NTCVC) (65.5%); having an NTC CVC makes a patient 85.5 times more likely to be hospitalized than patients with arteriovenous fistulas. CONCLUSION: Vascular access plays a predominant role in the hospitalization and mortality rates in haemodialysis. Patients with an arteriovenous fistula obtained significantly better outcomes than those with central venous catheters.

Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry.

BACKGROUND: Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized. METHODS: Patients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up. RESULTS: A total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection. CONCLUSIONS: Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.

Utility of exome sequencing for the diagnosis of pediatric-onset neuromuscular diseases beyond diagnostic yield: a narrative review.

Diagnosis of neuromuscular diseases (NMD) can be challenging because of the heterogeneity of this group of diseases. This review aimed to describe the diagnostic yield of whole exome sequencing (WES) for pediatric-onset neuromuscular disease diagnosis, as well as other benefits of this approach in patient management since WES can contribute to appropriate treatment selection in NMD patients. WES increases the possibility of reaching a conclusive genetic diagnosis when other technologies have failed and even exploring new genes not previously associated with a specific NMD. Moreover, this strategy can be useful when a dual diagnosis is suspected in complex congenital anomalies and undiagnosed cases.

Vigilancia activa en cáncer de próstata en un grupo de pacientes asistidos en el Centro Docente Asociado de Oncología Médica Rivera: Cooperativa Médica de Rivera (COMERI) / Active surveillance in prostate cancer in a group of patients assisted at the Rivera Associated Teaching Center for Medical Oncology: Rivera Medical Cooperative (COMERI) / Vigilância ativa do câncer de próstata em um grupo de pacientes atendidos no Rivera Associated Teaching Center for Medical Oncology: Rivera Medical Cooperative (COMERI)

Introducción: En Uruguay el cáncer de próstata ocupa el primer lugar en incidencia y el tercer lugar en mortalidad en el hombre. La mayoría de estos cánceres se diagnostican en estadios precoces. Hoy en día, para pacientes con adenocarcinoma de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, la vigilancia activa es una opción adecuada. Objetivos: Describir una población de pacientes con cáncer de próstata de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, en vigilancia activa en COMERI. Material y métodos: Estudio descriptivo, observacional, retrospectivo. Se incluyeron pacientes con cáncer de próstata de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, tratados entre 2010 y 2018 en COMERI. Se recopilaron datos en el sistema de registro clínico electrónico. Resultados: Se incluyeron 33 pacientes, la mediana de edad al diagnóstico fue de 74 años. Todos los pacientes fueron sometidos a controles clínicos y determinación de PSA cada 3 meses. El tacto rectal se realizó en forma anual. El tiempo mediano de vigilancia activa fue de 33 meses. Durante el seguimiento, se observaron pocas variaciones en los valores de PSA. El 21% de los pacientes fue sometido a una nueva biopsia durante el seguimiento activo, y en todos los casos, el Gleason se mantuvo incambiado. Ningún paciente abandonó la modalidad de vigilancia activa. Conclusión: En nuestro entorno, la vigilancia activa se considera una opción terapéutica válida para pacientes altamente seleccionados con cáncer de próstata de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, y es bien aceptada por ellos.

Introduction: In Uruguay, prostate cancer ranks first in incidence and third in mortality among men. The majority of these cancers are diagnosed at early stages. Nowadays, active surveillance is an appropriate option for patients with adenocarcinoma of very low risk, low risk, or favorable intermediate risk. Objectives: To describe a population of patients with prostate cancer of very low risk, low risk, or favorable intermediate risk under active surveillance at COMERI. Materials and Methods: Descriptive, observational, retrospective study. Patients with prostate cancer of very low risk, low risk, or favorable intermediate risk treated between 2010 and 2018 at COMERI were included. Data were collected from the electronic clinical registry system. Results: Thirty-three patients were included, with a median age at diagnosis of 74 years. All patients underwent clinical monitoring and PSA determination every 3 months. Digital rectal examination was performed annually. The median time of active surveillance was 33 months. During follow-up, there were few variations in PSA values. 21% of patients underwent a repeat biopsy during active surveillance, and in all cases, the Gleason score remained unchanged. No patient discontinued active surveillance. Conclusion: In our setting, active surveillance is considered a valid therapeutic option for highly selected patients with prostate cancer of very low risk, low risk, or favorable intermediate risk, and it is well accepted by them.

Introdução: No Uruguai, o câncer de próstata ocupa o primeiro lugar em incidência e o terceiro lugar em mortalidade entre os homens. A maioria desses cânceres é diagnosticada em estágios precoces. Atualmente, para pacientes com adenocarcinoma de risco muito baixo, baixo risco ou risco intermediário favorável, a vigilância ativa é uma opção adequada. Objetivos: Descrever uma população de pacientes com câncer de próstata de risco muito baixo, baixo risco ou risco intermediário favorável sob vigilância ativa em COMERI. Material e métodos: Estudo descritivo, observacional, retrospectivo. Foram incluídos pacientes com câncer de próstata de risco muito baixo, baixo risco ou risco intermediário favorável, tratados entre 2010 e 2018 em COMERI. Os dados foram coletados no sistema de registro clínico eletrônico. Resultados: Foram incluídos 33 pacientes, com mediana de idade no diagnóstico de 74 anos. Todos os pacientes foram submetidos a controles clínicos e determinação de PSA a cada 3 meses. O toque retal foi realizado anualmente. O tempo médio de vigilância ativa foi de 33 meses. Durante o acompanhamento, houve poucas variações nos valores de PSA. 21% dos pacientes foram submetidos a uma nova biópsia durante a vigilância ativa, e em todos os casos, o Gleason permaneceu inalterado. Nenhum paciente abandonou a modalidade de vigilância ativa. Conclusão: Em nosso ambiente, a vigilância ativa é considerada uma opção terapêutica válida para pacientes altamente selecionados com câncer de próstata de risco muito baixo, baixo risco ou risco intermediário favorável, e é bem aceita por eles.

Mexican Americans agree to participate in longitudinal clinical research more than non-Hispanic whites.

BACKGROUND: The National Institutes of Health has advocated for improved minority participation in clinical research, including clinical trials and observational epidemiologic studies since 1993. An understanding of Mexican Americans (MAs) participation in clinical research is important for tailoring recruitment strategies and enrollment techniques for MAs. However, contemporary data on MA participation in observational clinical stroke studies are rare. We examined differences between Mexican Americans (MAs) and non-Hispanic whites (NHWs) participation in a population-based stroke study. METHODS: We included 3,594 first ever stroke patients (57.7% MAs, 48.7% women, median [IQR] age 68 [58-79]) from the Brain Attack Surveillance in Corpus Christi Project, 2009-2020 in Texas, USA, who were approached and invited to participate in a structured baseline interview. We defined participation as completing a baseline interview by patient or proxy. We used log-binomial models adjusting for prespecified potential confounders to estimate prevalence ratios (PR) of participation comparing MAs with NHWs. We tested interactions of ethnicity with age or sex to examine potential effect modification in the ethnic differences in participation. We also included an interaction between year and ethnicity to examine ethnic-specific temporal trends in participation. RESULTS: Baseline participation was 77.0% in MAs and 64.2% in NHWs (Prevalence Ratio [PR] 1.20; 95% CI, 1.14-1.25). The ethnic difference remained after multivariable adjustment (1.17; 1.12-1.23), with no evidence of significant effect modification by age or sex (Pinteraction by age = 0.68, Pinteraction by sex = 0.83). Participation increased over time for both ethnic groups (Ptrend < 0.0001), but the differences in participation between MAs and NHWs remained significantly different throughout the 11-year time period. CONCLUSION: MAs were persistently more likely to participate in a population-based stroke study in a predominantly MA community despite limited outreach efforts towards MAs during study enrollment. This finding holds hope for future research studies to be inclusive of the MA population.

OLIGOMETASTASIS IN GASTRIC CANCER TREATMENT: IS THERE A PLACE FOR THE SURGEON?

Metastatic gastric cancer traditionally hinders surgical treatment options, confining them to palliative procedures. The presence of metastases in these tumors is classified as M1, irrespective of their characteristics, quantity, or location. However, oligometastatic disease emerged as an intermediate state between localized and widely disseminated cancer. It exhibits diverse patterns based on metastatic disease extent, type, and location. Adequately addressing this distinctive metastatic state necessitates tailored strategies that surpass the realm of palliative care. Differentprimary tumor types present discernible scenarios of oligometastatic disease, including preferred sites of occurrence and chronological progression. Due to the novelty of this theme and the heterogeneity of the disease, uncertainties still exist, and the ability to provide confident guidelines is challenging. Currently, there are no effective predictors to determine the response and provide clear indications for surgical interventions and systemic treatments in oligometastatic disease. Treatment decisions are commonly based on apparent disease control by systemic therapies, with a short observation period and imaging assessments. Nonetheless, the inherent risk of misinterpretation remains a constant concern. The emergence of novel technologies and therapeutic modalities, such as immunotherapy, cellular therapy, and adoptive therapies, holds the potential to reshape the landscape of surgical treatment for the oligometastatic disease in gastric cancer, expanding the surgeon's role in this multidisciplinary approach. Prospective tools for patient selection in oligometastatic gastric cancer are being explored. Using non-invasive, cost-effective, widely available imaging techniques that provide real-time information may revolutionize medical practice, ensuring precision medicine accessibility, even in resource-constrained small healthcare facilities. Incorporating molecular classifications, liquid biopsies, and radiomic analysis in a complementary protocol will augment patient selection precision for surgical intervention in oligometastasis. Hopefully, these advancements will render surgeries unnecessary in many cases by providing highly effective alternative treatments.

Composição de grupo de diálogo sobre o tema gênero e sexualidade nas escolas / Composition of a dialogue group on the theme of gender and sexuality in schools / Composición de un grupo de diálogo sobre el tema de género y sexualidad en las escuelas

Considerando-se os desafios da composição de grupos de diálogos em temas socialmente polêmicos, este estudo teve como objetivo apresentar as estratégias utilizadas para compor um grupo de diálogo a partir da metodologia do Projeto de Conversações Públicas entre pessoas com distintas opiniões sobre a abordagem do tema da diversidade sexual e de gênero nas escolas brasileiras. As transcrições das audiogravações das conversas preparatórias e dos encontros grupais e as anotações de diário de campo compuseram o corpus de análise deste estudo. A análise temática de conteúdo serviu para o destaque das seguintes estratégias consideradas úteis para a composição grupal: 1) Reconhecendo as pessoas envolvidas no conflito; 2) Entrando em contato com pessoas-chave; 3) Recrutando participantes reservas; 4) Pensando formas alternativas de presença no grupo; 5) Reconhecendo quem precisaria estar na conversa; 6) Flexibilidade com relação a entrada de novas/os participantes; 7) Lidando com os estereótipos com relação as/aos facilitadoras/es; 8) Co-construindo estratégias para maior adesão grupal. Esses eixos analíticos foram discutidos a partir da literatura da área.

Considering the challenges of composing dialogue groups in polemic issues, this study aimed to present the strategies used to compose a dialogue group based on the methodology of the Public Conversations Project among people with different opinions on the approach to the topic of sexual and of gender in Brazilian schools. Transcripts of audio recordings of preparatory conversations and group meetings and field diary notes composed the corpus of analysis of this study. The thematic content analysis served to highlight the following strategies considered useful for group composition: 1) Recognizing the people involved in the conflict; 2) Contacting key people; 3) Recruiting reserve participants; 4) Thinking about alternative forms of presence in the group; 5) Recognizing who would need to be in the conversation; 6) Flexibility regarding the entry of new participants; 7) Dealing with stereotypes regarding facilitators; 8) Co-building strategies for greater group membership. The selected material was discussed based on the literature in the area.

Considerando los desafíos de la composición de grupos de diálogo, este estudio tuvo como objetivo presentar las estrategias utilizadas para la composición de un grupo de diálogo basado en la metodología del Proyecto Conversaciones Públicas entre personas con opiniones diferentes sobre el abordaje del tema sexual y de género en las escuelas brasileñas. Transcripciones de grabaciones de audio de conversaciones preparatorias y reuniones grupales y notas del diario de campo componen el corpus de análisis de este estudio. El análisis de contenido temático sirvió para resaltar las siguientes estrategias consideradas útiles para la composición del grupo: 1) Reconocimiento de las personas involucradas en el conflicto; 2) Ponerse en contacto con personas clave; 3) Reclutamiento de participantes de reserva; 4) Pensar en formas alternativas de presencia en el grupo; 5) Reconocer quién debería estar en la conversación; 6) Flexibilidad en la entrada de nuevos participantes; 7) Abordar los estereotipos sobre los facilitadores; 8) Estrategias de co-construcción para una mayor membresía del grupo. El material seleccionado se discutió con base en la literatura en el área.

Automated Matching of Patients to Clinical Trials: A Patient-Centric Natural Language Processing Approach for Pediatric Leukemia.

PURPOSE: Matching patients to clinical trials is cumbersome and costly. Attempts have been made to automate the matching process; however, most have used a trial-centric approach, which focuses on a single trial. In this study, we developed a patient-centric matching tool that matches patient-specific demographic and clinical information with free-text clinical trial inclusion and exclusion criteria extracted using natural language processing to return a list of relevant clinical trials ordered by the patient's likelihood of eligibility. MATERIALS AND METHODS: Records from pediatric leukemia clinical trials were downloaded from ClinicalTrials.gov. Regular expressions were used to discretize and extract individual trial criteria. A multilabel support vector machine (SVM) was trained to classify sentence embeddings of criteria into relevant clinical categories. Labeled criteria were parsed using regular expressions to extract numbers, comparators, and relationships. In the validation phase, a patient-trial match score was generated for each trial and returned in the form of a ranked list for each patient. RESULTS: In total, 5,251 discretized criteria were extracted from 216 protocols. The most frequent criterion was previous chemotherapy/biologics (17%). The multilabel SVM demonstrated a pooled accuracy of 75%. The text processing pipeline was able to automatically extract 68% of eligibility criteria rules, as compared with 80% in a manual version of the tool. Automated matching was accomplished in approximately 4 seconds, as compared with several hours using manual derivation. CONCLUSION: To our knowledge, this project represents the first open-source attempt to generate a patient-centric clinical trial matching tool. The tool demonstrated acceptable performance when compared with a manual version, and it has potential to save time and money when matching patients to trials.

Exclusion of Families Who Speak Languages Other than English from Federally Funded Pediatric Trials.

OBJECTIVE: To determine whether individuals in the United States who speak languages other than English (LOE) are excluded from federally funded pediatric clinical trials and whether such trials adhere to the National Institutes of Health policy regarding inclusion of members of minority groups. STUDY DESIGN: Using ClinicalTrials.gov, we identified all completed, federally funded, US-based trials inclusive of children ≤17 and focused on one of 4 common chronic childhood conditions (asthma, mental health, obesity, and dental caries) as of June 18, 2019. We reviewed ClinicalTrials.gov online content, as well as published manuscripts linked to ClinicalTrials.gov entries, to abstract information about language-related exclusion criteria. Trials were deemed to exclude LOE participants/caregivers if explicit statements regarding exclusion were identified in the study protocol or published manuscript. RESULTS: Of total, 189 trials met inclusion criteria. Two-thirds (67%) did not address multilingual enrollment. Of the 62 trials that did, 82% excluded LOE individuals. No trials addressed the enrollment of non-English, non-Spanish-speaking individuals. In 93 trials with nonmissing data on ethnicity, Latino individuals comprised 31% of participants in trials that included LOE individuals and 14% of participants in trials that excluded LOE individuals. CONCLUSIONS: Federally funded pediatric trials in the United States do not adequately address multilingual enrollment, a seeming violation of federal and contractual requirements for accommodation of language barriers by entities receiving federal funding.

Barriers to patient recruitment in a poststroke neurorehabilitation multicenter trial in Brazil.

There is a high demand for stroke rehabilitation in the Brazilian public health system, but most studies that have addressed rehabilitation for unilateral spatial neglect (USN) after stroke have been performed in high-income countries. Therefore, the aim of this study was to analyze USN patient recruitment in a multicenter noninvasive brain stimulation clinical trial performed in Brazil and to provide study design recommendations for future studies. We evaluated the reasons for exclusion of patients from a multicenter, randomized, double-blinded clinical trial of rehabilitation of USN patients after stroke. Clinical and demographic variables were compared between the included and excluded patients. A descriptive statistical analysis was performed. Only 173 of the 1953 potential neglect patients (8.8%) passed the initial screening. After screening evaluation, 87/173 patients (50.3%) were excluded for clinical reasons. Cognitive impairment led to the exclusion of 21/87 patients (24.1%). Low socioeconomic status led to the exclusion of 37/173 patients (21.4%). Difficulty obtaining transportation to access treatment was the most common reason for their exclusion (16/37 patients, 43.3%). The analyzed Brazilian institutions have potential for conducting studies of USN. The recruitment of stroke survivors with USN was restricted by the study design and limited financial support. A history of cognitive impairment, intracranial stenting or craniectomy, and lack of transportation were the most common barriers to participating in a multicenter noninvasive brain stimulation trial among patients with USN after stroke.

Impact of stereotactic body radiation therapy volume on surgical patient selection, short-term survival, and long-term survival in early-stage non-small cell lung cancer.

OBJECTIVES: Stereotactic body radiation therapy (SBRT) is increasingly used to treat non-small cell lung cancer. The purpose of this study is to analyze relationships between facility SBRT utilization and surgical patient selection and survival after surgery. METHODS: Data on patients with TI/T2N0M0 lesions and treatment facility characteristics were abstracted from the National Cancer Database, 2008 to 2017. Facilities were stratified using an SBRT/surgery ratio previously associated with short-term survival benefit for patients treated surgically, and by a previously identified surgical volume threshold. Multiple regression analyses, Cox proportional-hazard regressions, and Kaplan-Meier log rank test were employed. RESULTS: In total, 182,610 patients were included. Proportion of high SBRT:surgery ratio (≥17%) facilities increased from 118 (11.5%) to 558 (48.4%) over the study period. Patients undergoing surgery at high-SBRT facilities had comparable comorbidity scores and tumor sizes to those at low-SBRT facilities, and nonclinically significant differences in age, race, and insurance status. Among low-volume surgical facilities, treatment at a high SBRT-using facility was associated with decreased 30-day mortality (1.8% vs 1.4%, P < .001) and 90-day mortality (3.3% vs 2.6%, P < .001). At high-volume surgical facilities, no difference was observed. At 5 years, a survival advantage was identified for patients undergoing resection at facilities with high surgical volumes (hazard ratio, 0.91; confidence interval, 0.90-0.93 P < .001) but not at high SBRT-utilizing facilities. CONCLUSIONS: Differences in short-term survival following resection at facilities with high-SBRT utilization may be attributable to low surgical volume facilities. Patients treated at high volume surgical facilities do not demonstrate differences in short-term or long-term survival based on facility SBRT utilization.