OBJECTIVE: Patients with congenital diaphragmatic hernia (CDH) can have up to 40 times more frequency of muskuloskeletal deformities and decreased perception of physical activity tan their pairs. The objective of this study is to evaluate the safety and efficacy of an individualized exercise program in late adolescents and young adults with repaired CDH, as well as a description of their basal status.
METHODS: Non randomized prospective trial of 13 patients with repaired CDH between 1997-2005. An initial physical exploration and a pre-post assessment of bioimpedance (BIA), dynamometry, maximal inspiratory and expiratory pressure (MIP/MEP), 6-minute walk test (6MWT), physical activity level (IPAQ) and quality of life (QoL) was made. The training program last for 4 weeks. For the statistical analysis, the Student\'s t test for paired samples and Wilcoxon test were used.
RESULTS: 77% (n=10) were male with a mean age of 19.23±2.13 years. In baseline BIA, 62% (n=8) had truncal sarcopenia that improved in -0.43±0.58, and P=.016. MIP, MEP, 6MWT and QoL tests increased by -7.27±8.26 cmH2O, P=.008; -11.91±10.20 cmH2O, P=.002; -70.63±17.88 m, P=.001; -42,19±26.79, P=.00 respectively. The IPAQ did not change significantly (P=0.86), however the time dedicated to muscle strengthening increased. No adverse effects were reported.
CONCLUSIONS: A personalized rehabilitation program is safe and could improve the respiratory muscle strength and truncal sarcopenia as well as the submaximal effort capacity in late adolescents and young adults with repaired CDH.

OBJECTIVE: The primary objective is to describe the real-life effectiveness and safety of nivolumab treatment in patients with relapsed or refractory classical Hodgkin\'s lymphoma. The secondary objective is to describe the therapeutic management after nivolumab monotherapy.
METHODS: Observational, retrospective, multidisciplinary study including all patients with relapsed or refractory classical Hodgkin\'s lymphoma treated with nivolumab monotherapy from November 2015 to March 2023. Patient and treatment-related variables were collected. Effectiveness was measured as overall response rate, progression-free survival and overall survival. Safety was measured as percentage of patients with adverse effects and severity.
RESULTS: Thirteen patients were included, median age 37.5 years (RIQ: 25.3-54.7), 84.6% male. The median number of previous lines of therapy was 3 (RIQ: 2.0-4.5), including autologous hematopoietic stem cell transplantation (84.6%) and brentuximab vedotin (100%). All received nivolumab 3 mg/kg/14 days, with a median of 11 cycles (RIQ: 6.5-20.5) per patient. Median time on treatment was 4.9 months (RIQ: 3.0-9.6) and median follow-up time was 9.2 months (RIQ: 5.6-32.3). Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%) and progression by 4 (30.8%). The objective response rate was 46.2%. Median progression-free survival was 23.9 months (95%CI: 0-49.1), median overall survival was not reached. At the study cutoff date, five patients had died (38.5%), four were in complete remission without active treatment (30.8%) and four were continuing treatment (30.8%). Adverse events occurred in 76.9% of patients, 44% of severity ≥3, the most frequent being hypothyroidism and hepatotoxicity. One patient discontinued treatment due to pneumonitis, two suffered treatment delays (thrombocytopenia and hypertransaminemia) and one changed the regimen to monthly (pulmonary toxicity).
CONCLUSIONS: Nivolumab in the treatment of relapsed or refractory classical Hodgkin\'s lymphoma has confirmed in the study sample favorable effectiveness data, expressed as objective response rate of 46.2% and clinical benefit of 69.2%. Safety was acceptable, manageable, and consistent with that described in the literature.

Incidents related to patient safety are a problem of great impact in Intensive Care Medicine (ICM). Multiple strategies have been developed to identify them, analyze, and develop policies aim at reducing their incidence and minimizing their effects and consequences. The development of a safety culture, an adequate organizational and structural design of the ICM, which contemplates the implementation of effective safe practices, with a provision of human resources adjusted to the care activity carried out and the periodic analysis of the different events and their factors, will allow us to bring the risk of critical patient care closer to zero, as would be desirable.

Clinical simulation in Intensive Care Medicine is a crucial tool to strengthen patient safety. It focuses on the complexity of the Intensive Care Unit, where challenging clinical situations require rapid decision making and the use of invasive techniques that can increase the risk of errors and compromise safety. Clinical simulation, by mimicking clinical contexts, is presented as essential for developing technical and non-technical skills and enhancing teamwork in a safe environment, without harm to the patient. in situ simulation is a valuable approach to practice in realistic environments and to address latent security threats. Other simulation methods as virtual reality and tele-simulation are gaining more and more acceptance. Herein, we provide current data on the clinical utility of clinical simulation related to improved safety in the practice of techniques and procedures, as well as improvements of teamwork performance and outcomes. Finally, we propose the needs for future research.

OBJECTIVE: To determine the importance of the supervision of the essential patient safety actions (AESP) in the different Medical Units of the different levels of care in Mexico City.
METHODS: The concern for quality in health care, understood as the safety of patients, is a fundamental aspect that involves the authorities and operational personnel. Supervisions were carried out in the different medical units of Mexico City.
RESULTS: Positive correlations were observed between the implementation of the AESP and the number of damages, incidents, events and errors existing in the medical units.
CONCLUSIONS: The supervision of the AESP program should be aimed at the prevention and management of risks in health care, recognizing the occurrence of adverse events as a reality resulting from a gradual work of a whole process of continuous improvement.
OBJECTIVE: Determinar la importancia de la supervisión de las acciones esenciales de seguridad del paciente (AESP) en las diferentes unidades médicas de los distintos niveles de atención en la Ciudad de México.
UNASSIGNED: La preocupación por la calidad en la atención de salud, entendida como la seguridad de los pacientes, es un aspecto fundamental que involucra a las autoridades y al personal operativo. Se realizaron supervisiones en las diferentes unidades médicas de la Ciudad de México.
RESULTS: Se observaron correlaciones positivas entre la supervisión de las AESP y el número de daños, incidentes, eventos y errores existentes en las unidades médicas.
CONCLUSIONS: La supervisión del programa de AESP debe estar destinado a la prevención y gestión de los riesgos en la atención de salud, reconociendo la ocurrencia de eventos adversos como una realidad producto de un trabajo paulatino de todo un proceso de mejora continua.

BACKGROUND: Pelvic organ prolapse is a condition with high prevalence in elderly women. With increasing life expectancy and a desire for improved quality of life, a rise in the frequency of surgical treatments for these women is anticipated. The aim is to compare complication, success, and satisfaction rates among elderly patients (aged >70 years) in comparison to younger women undergoing robotic sacrocolpopexy, thereby assessing the safety and efficacy of this surgery in this group of patients.
METHODS: A prospective observational comparative study of 123 robotic sacrocolpopexies conducted between December 2016 and June 2022. Patients were stratified by age (cutoff point: 70 years). Baseline characteristics, type, and grade of prolapse, intra and postoperative data, complications, functional and anatomical outcomes, and satisfaction levels were collected.
RESULTS: Among the 123 patients, 62.6% were under 70 years old, while 37.4% were 70 years or older, exhibiting similar baseline characteristics, prolapse grade, and type. The percentages of intraoperative (6.5%) and postoperative complications (4.4-9%) were comparable in both age groups. Furthermore, success and satisfaction rates exceeded 90%, with no significant differences between women under and over 70 years during a two-year follow-up.
CONCLUSIONS: Robotic sacrocolpopexy is at least as effective and safe in women aged 70 years or older as in younger individuals, with no higher rates of intra and postoperative complications and similar rates of anatomical and subjective success.

The continuous development of medicine in most fields requires physicians to apply the latest methods and technology to ensure patients\' safety. In the field of anesthesiology we are pioneers in the application of measures that guarantee the security of our patients, making possible the greatest reduction in mortality seen among all other specialties. This objective has been achieved thanks to the introduction of changes such as the one presented in this review article. The specific NRFit® connections for neuraxial and other regional anesthesia applications prevent wrong route medication errors to occur. These medication errors have been related to a high morbidity and mortality rate. This article reviews this new technology based in our own two-year experience at Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Madrid) as well as a literature review using PubMed, UpToDate and ClinicalKey.

OBJECTIVE: Evidence on the long-term use of tolvaptan in autosomal dominant polycystic kidney disease (ADPKD) is limited. The aim was to evaluate the tolvaptan effectiveness and safety in real clinical setting.
METHODS: A single-center observational study (2016-2022) involving ADPKD patients treated with tolvaptan was conducted. Annual change in serum creatinine (sCr) and estimated glomerular filtration rate (eGFR) before and after treatment initiation were evaluated. Change in total kidney volume (TKV), blood pressure (BP) and urinary albuminuria at 12, 24 and 36 months after initiation were also determined. Adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 were analyzed.
RESULTS: A total of 22 patients were included. No significant differences pre- vs post tolvaptan treatment in annual rate of change in eGFR (-3.52ml/min/1.73m2 [-4.98%] vs -3.98ml/min/1.73m2 [-8.48%], p=0.121) and sCr (+0.06mg/dL [4.22%] vs +0.15mg/dL [7.77%], p=0.429) were observed. Tolvaptan improved urinary osmolality at 12 (p=0.019) and 24 months (p=0.008), but not at 36 months (p=0.11). There were no changes in TKV, BP control and urinary albuminuria at 12, 24 or 36 months. A worse response was shown in patients with rapid kidney function decline (p=0.042). A 36.4% of the patients developed grade III/IV AEs. A 22.7% discontinued treatment due to unacceptable toxicity.
CONCLUSIONS: This study shows a modest benefit of tolvaptan in ADPKD patients, as well as safety concerns.

OBJECTIVE: Tislelizumab, a monoclonal antibody against programed death protein-1 (PD-1), has shown encouraging antitumor activity in urothelial cancer. This study was designed to assess the efficacy and safety of tislelizumab in urotelial cancer in a real-world setting.
METHODS: The study was a real-world retrospective study undertaken at Liaoning Cancer Hospital & Institute, China. Eligible patients were ≥18 years. Patients received 200-mg tislelizumab monotherapy intravenously every 3 weeks until the disease progressed to intolerable toxicity. Outcomes included an objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.
RESULTS: Between March 2020 and December 2022, 33 patients were enrolled. The median follow-up was 10.17 (IQR 5.73-12.47) months. Of all 33 patients, ORR and DCR were 30.30% (95% CI 15.6%-48.7%) and 42.42% (95% CI 25.48%-60.78%), respectively. The median PFS was 5.73 (95% CI 3.27-13.00) months, with a 12-month PFS rate of 31.90% (95% CI 19.20%-53.00%). The median OS was 17.7 (95% CI 12.80-not reach) months, with a 12-month OS rate of 67.50% (95% CI 52.70%-86.40%). Eleven (33.33%) and 8 (24.24%) experienced ≥grade 3 treatment-related adverse events (TRAEs) and immune-related Aes, respectively. No treatment-related deaths occurred.
CONCLUSIONS: The excellent efficacy and controllable safety of tislelizumab in locally advanced or metastatic urothelial cancer suggest that it may be a promising therapeutic option for this population.

BACKGROUND: Percutaneous ethanol injection (PEI) has been shown to be a valuable treatment for thyroid nodular pathology and metastatic cervical adenopathies.
OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies.
METHODS: A systematic review (SR) using meta-analysis was conducted on the effectiveness and safety of PEI. A SR on cost-effectiveness was also performed. The SRs were conducted according to the methodology developed by the Cochrane Collaboration with reporting in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation (RFA)), the model compared the costs of the alternatives with a horizon of six months and from the perspective of the Spanish National Health System.
RESULTS: The search identified three RCTs (n=157) that evaluated PEI versus RFA in patients diagnosed with benign thyroid nodules: ninety-six patients with predominantly cystic nodules and sixty-one patients with solid nodules. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in volume reduction (%), symptom score, cosmetic score, therapeutic success and major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure at €326 compared to €4781 for RFA, which means an incremental difference of -€4455.
CONCLUSIONS: There are no differences between PEI and RFA regarding their safety and effectiveness, but the economic evaluation determined that the former option is cheaper.