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PROBLEM Family medicine faculty and residents have observed that continuity clinic is often unsatisfying, attributed to a lack of patient and team continuity and erratic clinic schedules pieced together after the prioritization of hospital service and rotation schedules. APPROACH In 2019, a 3-year Clinic First project, called Clinic as Curriculum (CaC), was launched across the 4 family medicine residencies of the Department of Family Medicine and Community Health, University of Minnesota Medical School. The department began publishing quarterly CaC dashboard data. Each clinic completed a baseline assessment of their performance on the 13 Building Blocks of High-Functioning Primary Care Residency Clinics. Using their baseline data, each clinic identified which block or blocks, in addition to the blocks on continuity of care and resident scheduling, to focus on. The plan is to collaboratively implement the overall and local goals using dashboard data and iterative process improvement over 3 years. OUTCOMES At baseline, clinics functioned quite well with respect to the 13 building blocks, but CaC dashboard data varied across the 4 clinics, with large variation between clinics on how frequently faculty were scheduled in the clinic and the proportion of total clinic visits seen by faculty. Resident continuity rates were low (range: 38%-47%). Level loading (consistent physician availability to meet patient demand) rates ranged from 1 to 11 days a month. Regarding resident schedules, 2 programs are moving from 4-week to 2-week inpatient blocks, and 2 programs are exploring longitudinal scheduling. One clinic will assign faculty and residents to specific clinic days. Two clinics are implementing microteams of 1 faculty and 3-4 residents. NEXT STEPS The authors plan to analyze the dashboard data longitudinally; explore microteams, team continuity, and team scheduling adherence; and develop and implement resident scheduling changes over the next 3 years.

Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest types of cancer, and the increasing incidence of PDAC may be related to the prevalence of obesity. Physical activity (PA), a method known to mitigate obesity by increasing total energy expenditure, also modifies multiple cellular pathways associated with cancer hallmarks. Epidemiologic evidence has shown that PA can lower the risk of developing a variety of cancers, reduce some of the detrimental side effects of treatments, and improve patient's quality of life during cancer treatment. However, little is known about the pathways underlying the correlations observed between PA interventions and PDAC. Moreover, there is no standard dose of PA intervention that is ideal for PDAC prevention or as an adjuvant of cancer treatments. In this review, we summarize relevant literature showing how PDAC patients can benefit from PA, the potential of PA as an adjuvant treatment for PDAC, the studies using preclinical models of PDAC to study PA, and the clinical trials to date assessing the effects of PA in PDAC.

Background: The Department of Family Medicine and Community Health at the University of Minnesota engaged in a 5-year transformation to expand research and scholarship opportunities to all faculty. A harmonization framework was used to integrate the 3 missions of clinical care, education, and research to ensure that research and scholarship were an ongoing focus of the department. Methods: The key elements of our transformation included as follows: (1) a general culture of inquiry, (2) harmonized leadership, (3) training and mentoring, and (4) infrastructure and resources. Components of each of these elements were intentionally instituted simultaneously and iteratively across the 5 years to provide robust and sustainable research and scholarship opportunities for all faculty. Results: Outputs and outcomes of the harmonized transformation indicated that clinical and research faculty publications increased, and the percentage of clinical faculty trained in research and scholarship skills increased across the 5 years. Conclusions: Important lessons learned during the harmonized transformation included the following: (1) key elements of the transformation need to be balanced as an ensemble, (2) cultural and organizational shifts take concerted effort and time, (3) embrace iteration: allow “bumps in the road” to propel the work forward, (4) transformation is financially feasible, (5) career research faculty can mutually benefit from clinical faculty engaging in scholarship, and (6) honor skepticism or disinterest and let people cultivate enthusiasm for research and scholarship rather than being forced.

The objectives of the present study were to describe the frequency of aggressive multiple sclerosis (aMS) as well as to compare clinical and radiological characteristics in aMS and non-aMS patients included in RelevarEM (NCT03375177).The eligible study population and cohort selection included adult-onset patients (≥18 years) with definite MS. AMS were defined as those reaching confirmed EDSS ≥ 6 within 5 years from symptom onset. Confirmation was achieved when a subsequent EDSS ≥ 6 was recorded at least six months later but within 5 years of the first clinical presentation. AMS and non-aMS were compared using the χ2 test for categorical and the Mann-Whitney for continuous variables at MS onset and multivariable analysis was performed using forward stepwise logistic regression with baseline characteristics at disease onset.A total of 2158 patients with MS were included: 74 aMS and 2084 non-aMS. The prevalence of aMS in our cohort was 3.4% (95%CI 2.7-4.2). AMS were more likely to be male (p = 0.003), older at MS onset (p 0.001), have primary progressive MS (PPMS) phenotype (p = 0.03), multifocal presentation (p 0.001), and spinal cord as well as infratentorial lesions at MRI during disease onset (p = 0.004 and p = 0.002, respectively).3.4% of our patient population could be considered aMS. Men, patients older at symptom onset, multifocal presentation, PPMS phenotype, and spinal cord as well as brainstem lesions on MRI at clinical presentation all had higher odds of having aMS.

Angioleiomyomas are benign neoplasms, which usually present as solitary, slow-growing nodules on the skin of lower extremities, but acral location on the hands or feet is unusual. Yet, microscopically, they may show many histopathological variants, focal calcification is uncommon. Extensive calcification masquerading the real nature of the tumor has been rarely reported, the term acral calcified leiomyoma having been proposed for this entity. This change is more often in distal locations and has been interpreted as degenerative in nature, probably related to repetitive minor trauma. We report 3 examples of this unusual condition on the feet of 2 male and one female subjects (aged, 68, 69, and 80 years) and make a review of the 31 cases available in the literature. Two of our cases are associated with highly uncommon features, such as transepidermal calcium elimination and concomitant calcaneal spur.

A series is presented of sixteen cases of retinal capillary haemangioma (RCH) from consecutive patients at an ophthalmology teaching hospital in Mexico City. There were seven primary haemangioblastomas, and nine due to von Hippel-Lindau disease (VHL). All cases associated with VHL already had systemic manifestations, such as, cerebellar, medullary and renal tumours. Treatment of capillary haemangiomas must be individualised, based on several factors, including the number of lesions, exudation, or presence of retinal detachment. A multidisciplinary approach is essential.

Aim: To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years. Materials & methods: Postauthorization, observational, multicenter study, in which atrial fibrillation patients, treated with rivaroxaban ≥6 months were included. Results: A total of 1421 patients (74.2 ± 9.7 years, CHA 2 DS 2 -VASc 3.5 ± 1.6) were included. Overall, 22.9% received rivaroxaban 15 mg. The proper dose of rivaroxaban was taken by 83.3% (9.7% underdosed, 7.0% overdosed). Older age and renal insufficiency were associated with inadequate rivaroxaban dosage. There was a trend toward higher all-cause mortality among underdosed patients (adjusted hazard ratio 1.39; 95% CI 0.75–2.58), and more bleedings in overdosed patients (2.29 vs 0.80 events/100 patient-years; p = 0.14). Conclusion: In clinical practice, rivaroxaban is properly dosed in most patients.

BACKGROUND: Ankylosis of the temporomandibular joint (TMJ) is a debilitating condition and disabling as a result of craniomandibular fusion, which can result in trismus, pain and a poor quality of life. Current management includes interposition arthroplasty, gap arthroplasty, and reconstruction. Traditionally, the joints are reconstructed with pre-made prostheses (in stock), or the procedure is performed in two steps; with a computerized tomography scan, its design is observed between the respective and reconstructive procedures. STUDY DESIGN: A technical note about the customization management of ankylosis of the temporomandibular joint. OBJECTIVE AND METHODS: Describe a modification of technique using 3D surgical cutting and positioning guides digitally created to help determine the position and dimensions of the osteotomies as an auxiliary tool in the management of TMJ ankylosis, enabling the installation of personalized prostheses in a single stage. CONCLUSION: This technique has the advantage of allowing the installation of customized TMJ prostheses in a single stage, allowing greater predictability, less surgical time and less morbidity, in addition to being relatively simple and can be easily picked up by young surgeons.

Chronic atrophic gastritis and intestinal metaplasia are associated with higher gastric cancer risk and guidelines recommend endoscopic surveillance, as diagnosis of early gastric neoplasia allows endoscopic resection. This review summarizes the current approach to the diagnosis and surveillance of pre-malignant gastric conditions and endoscopic treatment of early gastric cancer. Virtual chromoendoscopy can diagnose extensive gastric metaplasia with great accuracy compared with histopathology and higher endoscopic staging is a risk factor for gastric cancer. Poorly differentiated and superficially invasive cancers have higher (up to 3%) lymph node metastasis risk even after curative resection, which should influence post-resection management. After non-curative resection, a histopathological score (eCura system) can predict LNM and survival without gastrectomy. Extensive pre-malignant gastric conditions should be surveilled with high-definition chromoendoscopy, which allows intestinal metaplasia staging and improves dysplasia diagnosis. Endoscopic submucosal dissection is well-established as the first-line treatment of early gastric cancer.

Introduction: Ejaculatory dysfunction is a common complication of surgeries for benign prostatic obstruction. It causes a clear deterioration in quality of life. Techniques have been developed to a...

espanolLa anemia es una condicion prevalente en pacientes con cancer y puede conducir a una disminucion de la capacidad funcional y de la calidad de vida en ellos. Las transfusiones de sangre siguen siendo eficaces cuando es necesario un aumento inmediato de los niveles de hemoglobina. Los agentes estimulantes de la eritropoyesis (AEE) elevan la hemoglobina y reducen los requerimientos de transfusion. Si los AEE se utilizan adecuadamente son agentes utiles y bien tolerados para el tratamiento de la anemia en pacientes que reciben radioterapia y/o quimioterapia. Sin embargo, los estudios han mostrado un mayor riesgo de eventos tromboembolicos, un tiempo mas corto para la progresion del cancer y un posible aumento del riesgo de mortalidad asociado al uso de los AEE, por lo que en los pacientes oncologicos que reciben tratamiento con intencion curativa debe evitarse su utilizacion. En el ambito paliativo, los AEE deben recetarse con precaucion y segun las directrices actuales. EnglishAnemia is a prevalent condition in cancer patients and can lead to a decrease in their functional capacity and quality of life. Blood transfusions continue to be effective when an immediate increase in hemoglobin levels is necessary. Erythropoiesis-stimulating agents (ESA) elevate hemoglobin and reduce transfusion requirements. If ESAs are used appropriately, they are useful, well-tolerated agents for the treatment of anemia in patients receiving radiotherapy and/or chemotherapy treatment. However, studies have shown a greater risk of thromboembolic events, a shorter cancer progression time, and a possible increase in mortality risk associated with ESA use. Therefore, oncological patients who receive curative care must avoid their use. In the scope of palliative care, ESAs must be prescribed with precaution and according to current guidelines.

espanolEl cancer de vejiga es la novena neoplasia mas frecuente en el mundo y la mas frecuente del tracto urinario. El factor de riesgo mas importante es el tabaquismo, ademas de la exposicion ambiental a carcinogenos. El sintoma habitual es la hematuria. El carcinoma de vejiga no musculoinvasivo incluye a los estadios pTa y pT1, aunque representan 2 entidades con curso clinico diferente; su tratamiento es la reseccion transuretral (RTU) de vejiga y, dependiendo de la estratificacion del riesgo, tambien la instilacion intravesical adyuvante de quimioterapia o inmunoterapia. El carcinoma de vejiga musculoinvasivo no metastasico se trata mediante la cistectomia radical y la administracion de quimioterapia perioperatoria basada en cisplatino. En casos seleccionados, existe como alternativa un tratamiento multimodal de preservacion vesical. En la enfermedad metastasica, el tratamiento se basa en la quimioterapia basada en cisplatino, en la inmunoterapia y en otros nuevos agentes inhibidores de tirosinquinasa (TKI) y anticuerpos conjugados. EnglishBladder cancer is the ninth most frequent neoplasm in the world and the most frequent urinary tract cancer. The most important risk factor is tobacco use in addition to environmental exposure to carcinogens. The most habitual symptom is hematuria. Nonmuscle-invasive bladder cancer includes stages pTa and pT1, although they are two entities with different clinical courses. Their treatment involves transurethral resection (TUR) of the bladder and, depending on the risk stratification, adjuvant intravesical instillation of chemotherapy or immunotherapy as well. Nonmetastatic muscle-invasive bladder cancer is treated with a radical cystectomy and administration of perioperative cisplatin-based chemotherapy. In select cases, multimodal treatment for bladder preservation is an alternative. In metastatic disease, treatment is based on cisplatin-based chemotherapy, immunotherapy, and other new tyrosine kinase inhibitor (TKI) agents and conjugated antibodies.

espanolEl cancer de prostata es el primer cancer en numero de casos en varones y el segundo mas mortal. La edad supone el principal factor de riesgo para su desarrollo, siendo al diagnostico en torno a 66 anos. El pronostico del cancer de prostata depende del estadio en el momento del diagnostico, presentando enfermedad localizada hasta en un 80% de los casos. Sin embargo, hasta un 20%-30% de los pacientes presentaran una recidiva de la enfermedad. Los factores determinantes para la estadificacion y la estratificacion del riesgo son la extension de la enfermedad, la gradacion de Gleason y los niveles de PSA. Los tumores confinados a la glandula se tratan con tecnicas radicales, tanto quirurgicas como radioterapicas, y requieren un abordaje multidisciplinar. El tratamiento en estadios avanzados se basa en la castracion androgenica acompanada de inhibidores de la senalizacion del receptor androgenico como abiraterona y enzalutamida, del uso de quimioterapia basada en docetaxel y cabazitaxel y del empleo de radium-223. EnglishProstate cancer is the leading malignancy in men and the second most deadly. Age is the main risk factor for the development of the disease, with an average age at diagnosis of 66 years and an increase in incidence from the age of 55. The prognosis of prostate cancer depends on the stage at diagnosis, with localised disease occurring in up to 80% of cases. However, up to 20%-30% of patients will have recurrent disease. The determining factors for staging and risk stratification in prostate cancer are the extent of disease, Gleason grade and PSA levels. PSA level is also the main screening tool. Tumours confined to the prostate gland are usually treated by radical surgical and radiotherapy-based techniques, always requiring a multidisciplinary approach. Treatment in advanced stages is based in androgen deprivation therapies with androgen-receptor signalling inhibitors abiraterone and enzalutamide, as well as treatment with docetaxel, cabazitaxel and radium-223.

espanolEl dolor se define como una experiencia sensorial y emocional desagradable. La percepcion del dolor es muy variable, pero se estima que hasta el 80% de los pacientes con cancer avanzado van a presentar dolor. Al menos un 30% de estos pacientes no tienen el dolor controlado, por lo que resulta imprescindible aprender a manejarlo. Las causas del dolor oncologico son diversas, siendo el dolor asociado a la enfermedad oncologica de base el mas frecuente. En el paciente oncologico podemos encontrar cuatro tipos distintos de dolor y es importante saber identificarlos para un correcto abordaje terapeutico. La escalera analgesica de la OMS fue disenada como un esquema de tratamiento progresivo del dolor y es nuestra base terapeutica. Aunque los opioides son los agentes mas utilizados, es habitual que se combinen con otros farmacos de la escalera, siendo necesario, en ocasiones, realizar una rotacion de opioides por falta de una actividad analgesica adecuada. EnglishPain is defined as an unpleasant sensory and emotional experience. Perception of pain varies widely, but it is estimated that 80% of patients with advanced cancer will present with pain. At least 30% of these patients have uncontrolled pain. Therefore, it is essential to learn to manage it. The causes of cancer pain are varied; pain associated with the underlying oncological disease is the most frequent. Among cancer patients, there are four different types of pain. It is important to know how to identify them for a proper therapeutic approach. The WHO pain scale was designed as a progressive treatment schedule for pain and is the foundation for our therapy. Although opioids are the most used agents, it is common to combine them with other drugs on the analgesic ladder. On occasion, it is necessary to rotate opioids due to lack of appropriate analgesic activity.

Laine de Carvalho Guerra Pessoa Mamede,1 Rafaela Lira Formiga Cavalcanti de Lima,2 Alexandre Sérgio Silva,1 João Carlos Lima Rodrigues Pita,3 Nadjeanny Ingrid Galdino Gomes,1 Elisama Araújo de Sena,1 Rhayra Priscila Moraes Nobrega,2 João Otávio Scarano Alcântara,2 Julie Hanna Fontes de Souza,2 Glêbia Alexa Cardoso,3 José Luiz de Brito Alves,1 Maria da Conceição Rodrigues Gonçalves1 1Post-Graduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa, Brazil; 2Department of Nutrition, Health Sciences Center, Federal University of Paraíba, João Pessoa, Brazil; 3Health Sciences Center, Federal University of Paraíba, João Pessoa, BrazilCorrespondence: Laine de Carvalho Guerra Pessoa MamedeDepartment of Nutrition, Health Sciences Center, Universidade Federal da Paraíba, Campus I – Jd, Cidade Universitária, João Pessoa, PB, CEP: 58051-900, BrazilTel/Fax +55 83 9 91089818Email laineguerramamede@gmail.comAim: The study aimed to evaluate the effects of vitamin D3 (VD3) supplementation on inflammation and oxidative stress markers in overweight and obese women with deficiency or insufficiency of vitamin D.Methods: Twenty-nine overweight or obese women who had a deficiency or insufficiency of vitamin D were placed into two groups according to VD3 intervention. Patients in the supplemented group received a single oral megadose of VD3 (VD3, n=14). Patients in placebo group received a single oral identical capsule without vitamin D (placebo, n = 15). Anthropometric and biochemical variables were assessed at baseline and after 4-weeks intervention.Results: Anthropometric variables (waist circumference, waist–hip ratio, waist–height ratio and body mass index) were similar between groups (p > 0.05). VD3 supplementation increased the serum levels of 25-hydroxyvitamin D (p=0.000), malondialdehyde (p=0.021) and C-reactive protein (p=0.043) in overweight and obese women. Additionally, VD3 supplementation reduced the serum levels of aspartate aminotransferase (AST, p=0.035), alanine aminotransferase (ALT, p< 0.0001) in overweight and obese women. Despite this, the serum levels of parathyroid hormone (PTH), fasting glucose (FG), and alpha-1- acid glycoprotein (A1GPA), total antioxidant capacity (TAC) were similar between groups.Conclusion: In summary, a single oral megadose of VD3 increased 25-hydroxyvitamin D serum levels but did not improve oxidative stress and inflammation markers.Keywords: vitamin D, obesity, inflammation, lipid peroxidation

Resumen El hueso es la localizacion mas frecuente de metastasis de los tumores solidos que se desarrollan en un 65%-75% de los pacientes con cancer avanzado. Suponen una de las principales amenazas potenciales del paciente por la comorbilidad y el deterioro en la calidad de vida que producen. Los eventos oseos relacionados con el cancer (skeletal related events —SRE—) son complicaciones derivadas de esta afectacion osea y son las fracturas patologicas, la necesidad de cirugia o radioterapia y la compresion medular. Estas lesiones pueden tener caracter osteoblastico u osteolitico y su diagnostico ha de estar basado tanto en la sospecha clinica como en las pruebas de imagen como la gammagrafia osea, la tomografia por emision de positrones combinada con tomografia computarizada o la resonancia magnetica. El tratamiento de las metastasis oseas debe ser multidisciplinar, tanto sistemico con bifosfonatos o denosumab, como local con radioterapia o cirugia, sin olvidar la importancia de un adecuado tratamiento de la enfermedad tumoral subyacente y del posible dolor asociado.

BACKGROUND: Approval of hypomethylating agents in patients with chronic myelomonocytic leukaemia is based on trials done in patients with myelodysplastic syndromes. We aimed to investigate whether hypomethylating agents provide a benefit in subgroups of patients with chronic myelomonocytic leukaemia compared with other treatments. METHODS: For this retrospective cohort study, data were retrieved between Nov 30, 2017, and Jan 5, 2019, from 38 centres in the USA and Europe. We included non-selected, consecutive patients diagnosed with chronic myelomonocytic leukaemia, who received chronic myelomonocytic leukaemia-directed therapy. Patients with acute myeloid leukaemia according to 2016 WHO criteria at initial diagnosis (ie, =20% blasts in the bone marrow or peripheral blood) or with unavailability of treatment data were excluded. Outcomes assessed included overall survival, time to next treatment, and time to transformation to acute myeloid leukaemia. Analyses were adjusted by age, sex, platelet count, and Chronic myelomonocytic leukaemia-Specific Prognostic Scoring System (CPSS). Patients were grouped by first received treatment with either hydroxyurea, hypomethylating agents, or intensive chemotherapy, and stratified by risk according to blast count, French-American-British subtype, CPSS, WHO 2016 subtype, and the eligibility criteria of the DACOTA trial (NCT02214407). FINDINGS: 949 patients diagnosed with chronic myelomonocytic leukaemia between April 13, 1981, and Oct 26, 2018, were included. Median follow-up was 23·4 months (IQR 11·5-42·3) from diagnosis and 16·2 months (6·6-31·6) from start of first-line treatment. 412 (43%) of 949 patients received hypomethylating agents as first treatment, 391 (41%) hydroxyurea, and 83 (9%) intensive chemotherapy. Adjusted median overall survival for patients treated with hydroxyurea versus hypomethylating agents was 15·6 months (95% CI 13·1-17·3) versus 20·7 months (17·9-23·4); hazard ratio (HR) 1·39 (1·17-1·65; p=0·0002) and 14·0 months (9·8-17·2) versus 20·7 months (17·9-23·4; HR 1·55 [1·16-2·05]; p=0·0027) for those treated with intensive chemotherapy versus hypomethylating agents. In patients with myeloproliferative chronic myelomonocytic leukaemia (myeloproliferative CMML), median overall survival was 12·6 months (10·7-15·0) versus 17·6 months (14·8-21·5; HR 1·38 [1·12-1·70]; p=0·0027) for patients treated with hydroxyurea versus hypomethylating agents, and 12·3 months (8·4-16·6) versus 17·6 months (14·8-21·5; HR 1·44 [1·02-2·03]; p=0·040) for intensive chemotherapy versus hypomethylating agents. Hypomethylating agents did not confer an overall survival advantage for patients classified as having lower-risk disease (ie, myelodysplastic chronic myelomonocytic leukaemia with

[EN] Trial Design: An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. Inclusion Criteria: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)- classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. Results: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix , administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first dose of Fendrix. 57.14% (12 out 21) had a positive response to second dose of Fendrix . 22.22% (2 out 9) had a positive response to third dose of Fendrix and 42.96% (3 out 7) had a positive response to last dose of Fendrix. Overall, 94.02% (64 out 67) of participants had a positive response to Fendrix . No serious adverse event occurred. Conclusions: The use of Fendrix , is a viable vaccine alternative for NHS workers classified as ‘‘nonresponders”. Revaccination of healthy non-responders with Fendrix, resulted in very high proportions of responders without adverse events. Trial registration: The trial was registered in the Spanish National Trial Register (REEC), ClinicalTrials.gov and inclusion has been stopped (identifier NCT03410953; EudraCT-number 2016-004991-23). Funding: GRS 1360/A/16: Call for aid for the financing of research projects in biomedicine, health management and socio-health care to be developed in the centres of the Regional Health Management of Autonomous Community of Castile-Leon. In addition, this work has been supported by the Spanish Platform for Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), funded by the Subdirectorate General for Research Evaluation and Promotion of the Carlos III Health Institute (ISCIII), through the project PT13/0002/0039 and project PT17/0017/0023 integrated in the State Plan for R&D&I 2013–2016 and co-financed by and the European Regional Development Fund (ERDF).

Resumen: Introducción: La cirugía del arco aórtico en neonatos ha pasado de la hipotermia profunda con paro circulatorio a la perfusión cerebral en 25 °C. Un paso más supone la perfusión cerebral y miocárdica simultánea, facilitando la cirugía a corazón latiendo. Métodos: Una cánula en «Y» desde la línea arterial proporciona sangre oxigenada al cerebro y al corazón. El arco es reparado latiendo. A continuación se administra cardioplejía por raíz para la corrección intracardíaca. Sesenta y ocho pacientes son distribuidos en 3 grupos: a) Norwood (9 neonatos); b) arco aórtico (20 niños); y c) arco más afectación intracardíaca (39 pacientes). Cardiopatía asociada en el grupo c): comunicación interventricular (15), switch arterial (9), comunicación interauricular (6), cor triatriatum (3), comisurotomía aórtica (2), comprehensive repair (2), ostium primum (1) y Yasui (1). Catorce de los últimos pacientes recibieron una canulación adicional en la aorta descendente, alcanzando una perfusión corporal total. Resultados: El tiempo medio de circulación extracorpórea fue de 155 minutos (63-353). La perfusión cerebral-miocárdica duró 36 minutos (18-60) y la isquemia miocárdica alcanzó 34 minutos (0-160), siendo de cero en el grupo «b». El seguimiento fue completo con una media de 52 meses (2-78). Cinco pacientes fallecieron y 3 precisaron angioplastia por recoartación. Conclusiones: La perfusión cerebral-miocárdica selectiva es factible y fácil de reconvertir a protección cardiopléjica convencional. Notablemente se reduce la isquemia miocárdica, siendo nula en casos de cirugía aislada del arco. Mediante la perfusión corporal total puede reducirse la morbilidad en cirugía neonatal del arco. Abstract: Introduction: Aortic arch repair has shifted from deep hypothermia plus circulatory arrest to cerebral perfusion at tepid temperatures. A step forward is simultaneous brain-coronary perfusion, allowing beating-heart arch surgery. Methods: A “Y” cannula from the arterial line delivers oxigenated blood to brain and heart. The arch is repaired on a beating heart at 25 °C. Intracardiac repair is performed after running cardioplegia through the root line. 68 patients are classified into three groups. A: Norwood (9 neonates); B: aortic arch (20 children); C: aortic arch plus intracardiac repair (39 patients). Associated anomalies in group C: ventricular septal defect (15), arterial switch (9), atrial septal defect (6), cor triatriatum (3), aortic commissurotomy (2), comprehensive repair (2), ostium primum (1), Yasui (1). Fourteen lately patients had their descending aorta additionally cannulated to achieve a total body perfusion strategy. Results: Mean by-pass time was 155 minutes (range 63-353). Mean brain-coronary perfusion was 36 minutes (18-60). Mean coronary ischemia was 34 minutes (0-160). The heart was not arrested in group B patients. Follow-up was complete for a mean of 52 months (2-78). Five patients died in the postop. Three requiered angioplasty for recoarctation. Conclusions: Selective brain-coronary perfusion is feasible and easy to switch to conventional cardioplegia delivery. Coronary ischemia can be notably reduced, being even zero minutes in isolated arch surgery. Total body perfusion may reduce morbidity in neonatal arch surgery.

Introduction:Heart transplant after Fontan completion poses a unique surgical challenge. Twenty patients are presented, stressing the technical hints performed in the five anastomoses to match the graft in the recipient.Methods:Data are collected from 20 Fontan patients between 2013 and 2019. Age (13 years), weight (37 kg.), and time interval between Fontan and transplant (7 years) are presented as median. Extracardiac conduit (size 18/20) was implanted in 15 patients, whereas atrio-pulmonary connection was performed in 4 and lateral tunnel in 1. Six patients developed protein-losing enteropathy. Seventeen stents had been previously deployed.Results:The five anastomoses underwent some changes. Left atrium once, aorta 9 times, superior vena cava 7 times, pulmonary branches 15 times, and inferior vena cava 12 times. Follow-up was complete for a median of 42 months (range 6–84). Two patients died. ECMO was needed in six cases for pulmonary hypertension. Four patients had collateral vessels occluded in the cath lab, and stents were placed in superior vena cava (1) and aorta (1) post-transplant. Protein-losing enteropathy was resolved in five patients. Interestingly, one patient was on a systemic assist device before transplant (Levitronix) and right assistance (ECMO) afterwards.Conclusions:Transplant in Fontan patients is actually challenging. Hints in every of the five proposed anastomoses must be anticipated, including stents removal. Extra tissue from the donor (innominate vein, aortic arch, and pericardium) is strongly advisable. ECMO for right ventricular dysfunction was needed in nearly one-third of the cases. Overall results can match other transplant cohorts.

Nutriscore is a malnutrition screening tool designed specifically for cancer patients. Our objective was to assess its performance in hospitalized cancer patients.Adult patients diagnosed with any solid neoplasm hospitalized in Medical Oncology were included. In the first 24-48 h, of admission they were screened with Nutriscore and Malnutrition universal screening tool (MUST). Both tests were compared using chi-square, kappa index and ROC curve. Nutriscore sensitivity (S), specificity (Sp) and predictive values (PV) were calculated using MUST as a reference.A total of 93 patients were included. The most frequent tumors were lung (36.6%), colorectal (24.8%) and breast (8.6%). MUST identified 69.9% of the patients at nutritional risk, and Nutriscore 44.1% (Nutriscore did not provided better screening results in hospitalized cancer patients than a validated tool such as MUST.

Objective The prostate-specific antigen density (PSAD) is an accessory tool when suspecting prostate cancer. Multiparametric magnetic resonance imaging (mpMRI) of the prostate has a high rate of false negatives. The aim of this study is to evaluate the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) when adding the PSAD and negative or equivocal mpMRI. Material and methods A retrospective study that included prostate biopsies performed using a transperineal approach and guided by ultrasound between 2015 and 2019 was conducted. Clinically significant prostate cancer (csPCa) was defined as Gleason score ≥3+4. The population was divided into groups according to the PSAD level-≤0.15 and >0.15. Sensitivity, specificity, NPV, and PPV of mpMRI were calculated. Results A total of 292 patients were included; 12.1% (4/33 patients) of the negative mpMRI group presented csPCa, and only 7 in the equivocal mpMRI group presented csPCa. NPV and sensitivity were 91.15% and 90.5%, respectively. In the positive mpMRI group, 53.7% (96/179) had csPCa, with a PPV of 53.6% and specificity of 55.3%. Of the patients with PSAD ≤0.15, 23 (16.54%) presented csPCa. All of them presented a positive mpMRI. All patients with a negative or equivocal mpMRI and a PSAD ≤0.15 presented a clinically non-significant tumor or benign result. The addition of this tool to mpMRI resulted in 100% sensitivity, 69% specificity, and 34.8% PPV. Conclusion In our series, PSAD ≤0.15 increased the NPV in negative or equivocal mpMRI, and through this unnecessary prostate biopsies could be avoided.

The Tepary bean (Phaseolus acutifolius) lectin fraction (TBLF) exhibits differential cytotoxicity on colon cancer cells and inhibition of early tumorigenesis in the colon (50 mg/kg, three times per week, for 6 weeks). TBLF showed low toxicity with the ability to activate the immune system; however, some adverse effects are the loss in body weight gain, intestinal atrophy, and pancreatic hyperplasia. After a recovery period of 2 weeks after treatment, reversion of pancreatic hyperplasia but no recovery of intestinal atrophy was observed. As TBLF has shown anticancer effects on the colon, it is important to characterize the adverse effects and how they can be reversed. Sprague Dawley rats were administered with TBLF (50 mg/kg) for 6 weeks, three times per week, and then allowed to recover for 6 weeks post-treatment. After TBLF administration, small intestine atrophy, villus atrophy, and cryptic hyperplasia were confirmed, as well as increased intestinal mucus production, increased permeability and a decrease in the apparent ileal digestibility of crude proteins. The colon showed damage in the simple prismatic tissue and decreased crypt depth, and changes in microbiota and a decrease in the apparent fecal digestibility of crude protein were determined. Our results show that the adverse effects provoked by TBLF were partially reversed after 6 weeks of recovery post-treatment, suggesting that increasing the recovery period it could be possible to reverse all adverse effects observed.

Differential diagnosis between a melanoma and a pseudomelanoma requires many years of experience and ocular studies, and requires paying attention to the smallest details. The case is presented of a 57 year-old male with an adenoma of the ciliary body pigment epithelium that was treated with an enucleation of the eye due to a suspicion of a choroidal melanoma.

Primary progressive multiple sclerosis (PPMS) is an infrequent clinical form of multiple sclerosis (MS). Scarce information is available about PPMS in Latin America. The aim of this work is to describe the clinical and demographic characteristics of PPMS patients in Argentina. RelevarEM is a longitudinal, strictly observational registry in Argentina. Clinical and epidemiological data from PPMS patients were described. There were 144 cases of PPMS. They represented 7% of MS patients. The mean age was 44.1 years. The female:male ratio was 1.08. The mean Expanded Disability Status Scale (EDSS) score was 5.5 and the mean disease evolution time was 10.6 years. Oligoclonal bands were found in 72.9%. At the time of diagnosis, magnetic resonance imaging showed spinal cord lesions in 82.6% and contrast-enhancing brain lesions in 18.1% of patients. Almost one third of patients were treated with a disease-modifying drug, and ocrelizumab was the most frequently used (55.8%). PPMS is an infrequent subtype of MS and its recognition is of the highest importance as it has its own evolution, treatment, and prognosis. The importance of our research resides in providing local data and contributing to a better understanding of PPMS and its treatment in Latin America.

Introduction This study radiographically analyzed the prevalence of root canal treatment (RCT) and apical periodontitis (AP) in type 1 diabetes mellitus (T1DM) and nondiabetic individuals and its association with the history/current status of T1DM. Methods In a cross-sectional paired study, the radiographic records of 50 individuals with T1DM and 100 age- and sex-matched nondiabetic subjects were examined. The presence of RCT and AP was evaluated. Information regarding the history and current status of T1DM was collected from the medical records of each patient. Results One or more RCTs were found in 76% and 44% of diabetic and nondiabetic subjects, respectively (P = .000). AP in 1 or more teeth was found in most T1DM patients (58%) and in 15% of the control subjects (P = .000). One or more RCTs associated with AP were found in 52% and 8% of T1DM and nondiabetic subjects, respectively (P = .000). Bivariate logistic regression analyses suggested that RCT (odds ratio [OR] = 10.435, P = .000), AP (OR = 3.508, P = .011), and RCT + AP (OR = 7.220, P = .000) were significantly associated with the presence of T1DM. Multivariate logistic regression showed that among T1DM individuals, there is an association between 11–15 years of diagnosis time and at least 1 RCT (OR = 46.316, P = .038) and an association between T1DM control and at least 1 tooth with AP (OR = 15.611, P = .016). Conclusions RCT, AP, and RCT with AP were more prevalent in individuals with T1DM than in nondiabetic individuals. RCT and AP were associated with the presence of T1DM, specifically RCT with diagnostic time and AP with glycemic control.

Introduction: Surveillance of Lynch syndrome (LS) is recommended to reduce cancer-risk. There is an increased awareness that cancer-risk may vary with mismatch-repair mutation and family history. H...

Background: Scales to assess disability in multiple sclerosis (MS) rarely provide reliable data on actual global impairment. Upper limb dysfunction is usually overlooked, which has a negative effect on patient well-being. We sought to analyze associations among upper limb dexterity, lower limb speed, and Expanded Disability Status Scale (EDSS) score; the difference in upper limb dexterity between patients with EDSS scores less than 5 and 5 or greater; and the associations that upper limb dexterity, lower limb speed, and EDSS score have with health-related quality of life measurements and depression. Methods: A total of 140 adults with MS were evaluated using the Nine-Hole Peg Test, Timed 25-Foot Walk test, EDSS, Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire, and Beck Depression Inventory. Thorough descriptive-analytical research was conducted using the Spearman correlation, multiple linear regression, and structural equation modeling. Results: Upper limb dexterity was more closely related to EDSS score than lower limb speed (r = 0.43 vs 0.29, R2 = 0.38) and was greatest in patients with EDSS scores less than 5 (P < .01). Moreover, upper limb dexterity was negatively associated with EDSS score and the MusiQoL questionnaire (rS = −0.557 to −0.321, P < .05). The correlation that depression has with upper limb dexterity loss was higher than the one it has with lower limb speed (0.098 vs 0.066, t > 1.96). Conclusions: Upper limb dexterity is associated with global disability, depression, and health-related quality of life. We advocate for the assessment of upper limb dexterity in patients with MS to adopt a better approach to their functional impairment.

The objective of this study was to describe and compare the baseline epidemiological data of multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) patients included in RelevarEM (Clinical Trials registry number NCT03375177). RelevarEM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. Epidemiological and comorbidity data from MS and NMOSD patients were described and compared. For comorbidities, the Charlson comorbidity index (CCI) was used to calculate the burden at entry. CCI was stratified in 0 and ≥ 1 and described for the entire cohort. A total of 1588 and 75 MS and NMOSD patients (respectively) were included. For MS patients, the mean age was 42 ± 7 years, female sex 65.3%, mean EDSS 2, and mean disease duration 8 ± 6 years. In NMOSD, the mean age was 40 ± 7 years, female sex 78.7%, mean disease duration 5 ± 3.5 years, and mean EDSS 2.5. The most frequent MS phenotype was RRMS in 82.4%. In MS, the CCI was 0 in 85.8.2% while ≥ 1 was in 14.2% of patients. Regarding phenotype stratification, CCI ≥ 1 was 3.9% in CIS, 13.5% in RRMS, 28.7% in SPMS, and 17.4% in PPMS (p

Background: There is no consensus regarding assessment of the brain function functional system (FS) of the Expanded Disability Status Scale (EDSS) in patients with multiple sclerosis (MS). We sought to describe brain function FS assessment criteria used by Argentinian neurologists and, based on the results, propose redefined brain function FS criteria. Methods: A structured survey was conducted of 113 Argentinian neurologists. Considering the survey results, we decided to redefine the brain function FS scoring using the Brief International Cognitive Assessment for MS (BICAMS) battery. For 120 adult patients with MS we calculated the EDSS score without brain function FS (basal EDSS) and compared it with the EDSS score after adding the modified brain function FS (modified EDSS). Results: Of the 93 neurologists analyzed, 14% reported that they did not assess brain function FS, 35% reported that they assessed it through a nonstructured interview, and the remainder used other tools. Significant differences were found in EDSS scores before and after the inclusion of BICAMS (P < .001). Redefining the brain function FS, 15% of patients modified their basal EDSS score, as did 20% of those with a score of 4.0 or less. Conclusions: The survey results show the importance of unifying the brain function FS scoring criteria in calculating the EDSS score. While allowing more consistent brain function FS scoring, including the modified brain function FS led to a change in EDSS score in many patients, particularly in the lower range of EDSS scores. Considering the relevance of the EDSS for monitoring patients with MS and for decision making, it is imperative to further validate the modified brain function FS scoring.

Acta médica portuguesa 35(2), 127-134 (2022). doi:10.20344/amp.15031, Published by Ordem dos Médicos, Lisboa

Introduction Temporal arteritis is an uncommon disorder in young people. A 39-year-old woman with juvenile temporal arteritis is described and we performed a literature review of all cases of juvenile temporal arteritis described to date. Case presentation A 39-year-old woman presented with a subcutaneous temporal nodule in the right temple with no other associated symptoms or background and unremarkable physical examination. Ultrasonography of the nodule revealed an anechoic perivascular halo surrounding the temporal artery. The nodule was excised resulting in the patient’s recovery. The results of the histopathological study showed features of juvenile temporal arteritis. Conclusions Juvenile temporal arteritis is a very uncommon disorder. Systemic manifestations should be ruled out by physical examination and complementary tests. Histopathology establishes the definitive diagnosis. Treatment is surgical excision and a follow-up should be conducted to rule out complications.

Topical treatment is the mainstay for mild or moderate psoriasis, but patients are generally little satisfied. Calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam has shown to improve signs and symptoms in plaque psoriasis patients. This study assessed patient's satisfaction with Cal/BD foam in a real-life Italian dermatological clinical practice. A multicenter, 4-week observational prospective cohort study enrolled, in 17 Italian dermatology clinics, adult patients with plaque psoriasis on the body and/or scalp. Treatment satisfaction was assessed by 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9), preference over previous treatments by Patient Preference Questionnaire (PPQ), and change in disease state by Psoriasis Area Severity Index (PASI). Overall 256 patients were eligible, with a mean (SD) age of 55.6 (15.4) years, 59.4% were males. Psoriasis severity was mild in 52.0% of patients, moderate in 43.3%, and severe in 4.7%. Scalp involvement was present in 36.7% of patients. Previous antipsoriatic treatments had been received by 80.5% of patients. TSQM-9 median (25th-75th percentile) scores were 83.3 (66.7-88.9) for effectiveness, 77.8 (66.7-88.9) for convenience, and 78.6 (64.3-92.9) for global satisfaction. Mean (SD) PASI value decreased from 7.3 (4.8) to 2.1 (2.7) after 4 weeks. More than 90% of patients previously treated for psoriasis evaluated the Cal/BD foam more effective, easier to use and better tolerated compared to previous topical treatments at PPQ. This observational study provides real-life evidence of a high level of satisfaction with effectiveness and convenience of the Cal/BD foam in a cohort of plaque psoriasis patients, with an objective improvement in PASI.

OBJECTIVE: The aims of the present study were to identify independent risk factors for conduit occlusion, compare outcomes of different AC placement sites, and investigate whether postoperative platelet antiaggregation is protective. BACKGROUND: Arterial conduits (AC) in liver transplantation (LT) offer an effective rescue option when regular arterial graft revascularization is not feasible. However, the role of the conduit placement site and postoperative antiaggregation is insufficiently answered in the literature. STUDY DESIGN: This is an international, multicenter cohort study of adult deceased donor LT requiring AC. The study included 14 LT centers and covered the period from January 2007 to December 2016. Primary endpoint was arterial occlusion/patency. Secondary endpoints included intra- and perioperative outcomes and graft and patient survival. RESULTS: The cohort was composed of 565 LT. Infrarenal aortic placement was performed in 77% of ACs whereas supraceliac placement in 20%. Early occlusion (≤30 days) occurred in 8% of cases. Primary patency was equivalent for supraceliac, infrarenal, and iliac conduits. Multivariate analysis identified donor age >40 years, coronary artery bypass, and no aspirin after LT as independent risk factors for early occlusion. Postoperative antiaggregation regimen differed among centers and was given in 49% of cases. Graft survival was significantly superior for patients receiving aggregation inhibitors after LT. CONCLUSION: When AC is required for rescue graft revascularization, the conduit placement site seems to be negligible and should follow the surgeon's preference. In this high-risk group, the study supports the concept of postoperative antiaggregation in LT requiring AC.

Anthracyclines are among the most used chemotherapeutic agents in breast cancer (BC). However their use is hampered by anthracycline-induced cardiotoxicity (AIC). The currently known clinical and genetic risk factors do not fully explain the observed inter-individual variability and only have a limited ability to predict which patients are more likely to develop this severe toxicity. To identify novel predictive genes, we conducted a two-stage genome-wide association study in epirubicin-treated BC patients. In the discovery phase, we genotyped over 700,000 single nucleotide variants in a cohort of 227 patients. The most interesting finding was rs62134260, located 4kb upstream of POLRMT (OR = 5.76, P = 2.23 × 10-5). We replicated this association in a validation cohort of 123 patients (P = 0.021). This variant regulates the expression of POLRMT, a gene that encodes a mitochondrial DNA-directed RNA polymerase, responsible for mitochondrial gene expression. Individuals harbouring the risk allele had a decreased expression of POLRMT in heart tissue that may cause an impaired capacity to maintain a healthy mitochondrial population in cardiomyocytes under stressful conditions, as is treatment with epirubicin. This finding suggests a novel molecular mechanism involved in the development of AIC and may improve our ability to predict patients who are at risk. ispartof: PHARMACEUTICS vol:13 issue:11 ispartof: location:Switzerland status: published

Introduction : peripheral inflammation can exacerbate pre-existing lesions in the Central Nervous System (CNS) in the context of neurodegenerative diseases, including Multiple Sclerosis (MS). Objective : To analyze the clinical effect of COVID-19 infection, as a generator of peripheral inflammation, in a MS patients group. Methods : A retrospective analysis of 400 medical records of MS patients from a referral center was carried out. MS patients who presented COVID-19 were surveyed about symptoms exacerbation: type, duration and onset of exacerbation, previous vaccination against COVID-19 and MS severity. Clinical and demographic information from the medical records were included. Descriptive and inferential analysis were performed using the GraphPad Prism V6. Results : 41 patients were included, 61% (n = 25) reported neurological worsening, 9.7% (n = 4) as relapses, and 7.3% (n = 3) required corticosteroids. We found significant differences in the EDSS between patients who exacerbated their MS symptoms and those who did not (p = 0.03). When performing a multivariate regression analysis, we found that EDSS was independently associated with the presence of exacerbations of MS in the context of SARS-CoV2 infection (OR = 2.44, p = 0.022). Conclusions : This preliminary study suggests that COVID-19 infection could trigger exacerbations of MS symptoms. New studies are needed to elucidate the relationship between COVID-19 and MS.

INTRODUCTION AND OBJECTIVE:Laparoscopic partial nephrectomy (LPN) is a very demanding procedure and a large proportion of complications occur during the surgeon's initial learning curve. There is a...

INTRODUCTION AND OBJECTIVE:Small renal masses (SRM) represent a diagnostic challenge despite advances in imaging and renal biopsy. Approximately 20% of SRM removed at surgery are found to be benign...

Background Rheumatoid arthritis (RA) and periodontitis (P) are chronic inflammatory diseases characterized by joint and radiographic bone loss, respectively. IL‐23 and IL‐17 have an essential role in the immunopathogenesis of RA, and P. IL‐23 stimulates Th17 cells through which produces IL‐17, IL‐21, and RANKL. IL‐17 stimulates fibroblasts to produce RANKL, which initiates bone loss in the joints in RA and the periodontal tissue in periodontitis. The aim of this study was to determine the expression pattern of IL‐23/IL‐17 axis and soluble receptors isoforms sIL‐23R and sIL‐17RA of patients with RA presenting P (RAP). Material and methods Healthy subjects (HS) (n = 42), patients with P (n = 40), RA (n = 20), and patients with RAP (n = 40) were included. Plasma samples were obtained to evaluate the IL‐23, IL‐17A, sIL‐23R, and sIL‐17RA by ELISA technique. A nonparametric Mann‐Whitney U test was used to compare the differences between groups. A Chi‐square was used to compare gender, grade and stage of periodontitis, and DAS28‐ESR between the groups. Spearman's rank correlation coefficient was used to study the association between the molecules and clinical parameters. Results IL‐23 levels were increased in the RAP group, and lower sIL‐23R levels were found in the RAP groups. However, IL‐17A was lower in the P and RAP group but not in RA patients. RAP group showed a decrease IL‐17A levels in advanced stages of the periodontal disease. Conclusion These results suggest that IL‐23 and IL‐17A tend to downregulate their expression patterns when patients present both rheumatoid arthritis and periodontitis., Blood sample was taken to obtain plasma from all study participants. IL‐23, IL‐23R, IL‐17A, and IL‐17RA were detected with ELISA technique. Results: (a) The sIL‐23R levels were found lower in the RAP group and IL‐23 levels were increased. (b) IL‐17A was lower in the P and RAP group but not in RA patients. According to the chronicity of periodontitis, RAP group showed a decreased IL‐17A levels in advanced stages of the periodontal disease.

OBJECTIVES: To develop a scoring model for stratifying patients with acute respiratory distress syndrome into risk categories (Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score) for early prediction of death in the ICU, independent of the underlying disease and cause of death. DESIGN: A development and validation study using clinical data from four prospective, multicenter, observational cohorts. SETTING: A network of multidisciplinary ICUs. PATIENTS: One-thousand three-hundred one patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The study followed Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis guidelines for prediction models. We performed logistic regression analysis, bootstrapping, and internal-external validation of prediction models with variables collected within 24 hours of acute respiratory distress syndrome diagnosis in 1,000 patients for model development. Primary outcome was ICU death. The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score was based on patient's age, number of extrapulmonary organ failures, values of end-inspiratory plateau pressure, and ratio of Pao2to Fio2assessed at 24 hours of acute respiratory distress syndrome diagnosis. The pooled area under the receiver operating characteristic curve across internal-external validations was 0.860 (95% CI, 0.831-0.890). External validation in a new cohort of 301 acute respiratory distress syndrome patients confirmed the accuracy and robustness of the scoring model (area under the receiver operating characteristic curve = 0.870; 95% CI, 0.829-0.911). The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score stratified patients in three distinct prognostic classes and achieved better prediction of ICU death than ratio of Pao2to Fio2at acute respiratory distress syndrome onset or at 24 hours, Acute Physiology and Chronic Health Evaluation II score, or Sequential Organ Failure Assessment scale. CONCLUSIONS: The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score represents a novel strategy for early stratification of acute respiratory distress syndrome patients into prognostic categories and for selecting patients for therapeutic trials.

Aim The delivery room intubation rate for babies born less than 32 weeks postmenstrual age (PMA) at the Mater Mothers' Hospital in 2017 was 51%. Delivery room intubation of preterm infants may be associated with an increased risk of developing bronchopulmonary dysplasia. This quality improvement project aimed to decrease the rate of delivery room intubation for infants born less than 32 weeks PMA. Methods A quality improvement process using the evidence-based practice for improving quality framework and Plan-Do-Study-Act cycles was undertaken from October 2018 to December 2019. Commencing bubble continuous positive airway pressure for initial resuscitation in the delivery room was the principal change idea. Results The delivery room intubation rate for infants born less than 32 weeks PMA before the commencement of this project was 48% (cohort 1, n = 221). There was a significant decrease in the rate to 37.2% while the project was being conducted (cohort 2, n = 277) and a further significant reduction to 28.2% after introducing bubble continuous positive airway pressure in the delivery room (cohort 3, n = 202). There was a significant improvement in admission temperatures and a significant decrease in mortality rate between cohort 1 and cohort 2 but not between cohort 2 and cohort 3. There was no change in the rate of discharge home on oxygen between cohorts. Conclusions This quality improvement project led to a significantly decreased delivery room intubation rate in infants born less than 32 weeks PMA. There was no evidence of any adverse outcomes with this approach.

Background: Collaboration between cardiac surgeons and cardiologists can offer interventions that each specialist may not be able to offer on their own. This type of collaboration has been demonstrated with the hybrid Stage I in patients with hypoplastic heart syndrome. Since that time, a hybrid approach to cardiac interventions has been expanded to an incredible variety of potential indications.Methods: Seventy-one patients were scheduled for a hybrid procedure along 8 years. This was defined as close collaboration between surgeon and cardiologist working together in the same room, either cath-lab (27 patients) or theater (44 patients).Results: Six groups were arbitrarily defined. A: vascular cut-down in the cath-lab (27 neonates); B: bilateral banding (plus ductal stent) in hypoplastic left heart syndrome or alike (15 children); C: perventricular closure of muscular ventricular septal defect (10 cases); D: balloon/stenting of pulmonary branches along with major surgical procedure (12 kids); E: surgical implantation of Melody valve (six patients) and others (F, one case). Two complications were recorded: left ventricular free wall puncture and previous conduit tearing. Both drawbacks were successfully sort out under cardiopulmonary by-pass.Conclusion: Surgeon and cardiologist partnership can succeed where their isolated endeavors are not enough. Hybrid procedures keep on spreading, overcoming initial expectations. As a bridge to biventricular repair or transplant, bilateral banding plus ductal stent sounds interesting. Novel indications can be classified into different groups. Hybrid procedures are not complication-free.

Background: SWAY was a cross-sectional survey that assessed the global impact and treatment of sickle cell disease (SCD) (James et al. ASH 2019). SCD puts patients at risk of multiple complications driven by vaso-occlusion and hemolytic anemia. Vaso-occlusive crises (VOCs) are the hallmark of SCD and can require healthcare attention. VOC frequency may be reduced by HU (Charache et al. N Engl J Med 1995). Aims: We assessed self-reported symptoms and quality of life (QoL) indicators for patients who reported using HU at the time of SWAY versus patients who did not, and we collected data on all treatments reported by SCD patients, by geographical region. Data were also collected regarding historical patient-reported use of HU prior to SWAY but these are not included here. Methods: SWAY was completed between April and October 2019 by SCD patients from 16 countries across 6 regions. A limitation is that Asia and South America were represented by single countries (India and Brazil, respectively). SWAY was completed by proxy (parent/guardian/caregiver) for patients aged 6-11 years and could be optionally self-completed by patients aged ≥12 years. Opinions were captured using a 1-7 Likert scale for some questions (5-7 indicated high satisfaction/impact/agreement). SWAY did not assess treatment outcomes. Results: Of 2145 patients, 652 (30%) reported receiving HU at the time of SWAY (56% female; 50% aged 6-25 years); 1493 patients reported not receiving HU at the time of SWAY (51% female; 59% aged 6-25 years). The number of patients reporting HU use varied regionally (Table). Patients who reported using HU also reported a lower VOC burden than patients who did not report using HU at the time of SWAY (median: 3 vs 4 VOCs in the 12 months before SWAY, respectively). However, considering other symptoms commonly experienced in the month prior to SWAY, a greater proportion of patients who reported using HU experienced these symptoms than patients who did not report using HU, except for headache and poor appetite, which were experienced by a lower proportion of patients who reported HU use (Figure). Similar proportions of patients reported that SCD had a high impact (Likert scale 5-7) on emotional wellbeing (61% [reported HU use at time of SWAY] vs 59% [did not report HU use at time of SWAY]) and daily activities (39% vs 40%, respectively). Overall, when including dietary supplements, the most common treatment reported at the time of SWAY in all regions except the Middle East was folic acid. Common treatments varied regionally when excluding supplements (Table). Top treatment goals for patients in all regions were to improve QoL and prevent SCD worsening. Treatment satisfaction (range: 57-92%) was highest in Asia (Table). Over 70% of patients wanted alternatives to their ongoing pain medications in all regions, except Asia (44%). Discussion: The proportion of patients reporting HU use at the time of SWAY was variable, but relatively low; HU was not in the top 3 treatments for Africa, Europe or North America. HU use was lowest in Africa, where no patients reported receiving HU at the time of the survey, which probably reflects high relative cost and poor access. Our regional analysis showed that many patients take supplements, such as folic acid, rather than HU. This may be indicative of limited alternatives to HU and reflects the differing global costs and availability of both medication and monitoring blood tests. Low reported use of HU may also reflect patients' concerns about side effects or reluctance to take daily medication. It should be noted that some patients may be familiar with 'hydroxycarbamide' as a name for HU and might not have recognized the term 'hydroxyurea' on the survey. Data from SWAY were not validated by medical records and depended on patients' recall. Patients reporting HU use at the time of SWAY had a lower VOC burden than patients not reporting HU use. QoL indicators were similar for the 2 groups, but the overall symptom burden was higher for patients who reported HU use compared with those who did not. However, the 2 groups were not matched for pre-treatment disease burden and no information was collected regarding adherence or duration of previous HU use. Overall, although many patients reported treatment satisfaction, many wanted alternative pain management therapies. A wider range of treatment options are needed to reduce SCD symptoms and improve QoL, ultimately helping patients achieve their treatment goals. Disclosures El Rassi: Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Cyclerion: Research Funding; Pfizer: Research Funding; Global Blood Therapeutics: Membership on an entity's Board of Directors or advisory committees; Bluebird bio: Membership on an entity's Board of Directors or advisory committees. James:Sickle Cell Society: Current Employment; Novartis: Honoraria. Andemariam:Terumo BCT: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi Genzyme: Consultancy, Membership on an entity's Board of Directors or advisory committees; Guidepoint: Honoraria; Accordant: Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; NovoNordisk: Consultancy, Membership on an entity's Board of Directors or advisory committees; Imara: Research Funding; Hemanext: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; CHNCT: Consultancy; Global Blood Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Vertex: Honoraria; bluebird bio: Consultancy, Membership on an entity's Board of Directors or advisory committees; Emmaus: Membership on an entity's Board of Directors or advisory committees; CRISPR/Vertex: Consultancy, Membership on an entity's Board of Directors or advisory committees; Cyclerion: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees. Inusa:Bluebird bio: Research Funding; AstraZeneca: Honoraria, Other: Steering committee participation, Research Funding, Speakers Bureau; Global Blood Therapeutics: Honoraria, Other: Steering committee participation, Research Funding, Speakers Bureau; Vertex: Research Funding; Novartis: Honoraria, Other: Steering committee participation, Research Funding, Speakers Bureau. Francis-Gibson:Sickle Cell Disease Association of America: Current Employment. Nero:Novartis: Consultancy; Bluebird bio: Consultancy. Minniti:Global Blood Therapeutics: Consultancy, Research Funding; Emmaus: Consultancy, Research Funding; Roche: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; TauTona: Consultancy, Research Funding; Bluebird bio: Consultancy, Research Funding; CLS Bering: Consultancy. Trimnell:Novartis: Consultancy; Cyclerion: Consultancy; Global Blood Therapeutics: Consultancy. Abboud:Eli Lilly: Research Funding; Modus Pharmaceuticals: Research Funding; Crispr Therapeutics: Membership on an entity's Board of Directors or advisory committees; Amgen: Other: Travel support; Novartis: Consultancy, Honoraria, Research Funding; Novo Nordisk: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Global Blood Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees, Research Funding. Arlet:Novartis: Consultancy, Honoraria. Colombatti:Global Blood Therapeutics: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Addmedica: Membership on an entity's Board of Directors or advisory committees. de Montalembert:Addmedica: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bluebird bio: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Vertex: Honoraria, Membership on an entity's Board of Directors or advisory committees. Jain:Thalassemia and Sickle Cell Society: Other: Chief Medical Research Officer and Secretary. Jastaniah:Novartis: Consultancy, Honoraria. Nur:Novartis: Consultancy. Ramscar:Novartis Pharma AG: Current Employment. Bailey:Novartis: Other: Employee of Adelphi Real World, which has received consultancy fees from Novartis; Adelphi Real World: Current Employment. Rajkovic-Hooley:Adelphi Real World: Current Employment; Novartis: Other: Employee of Adelphi Real World, which has received consultancy fees from Novartis. Osunkwo:Global Blood Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Acceleron: Membership on an entity's Board of Directors or advisory committees; Data and Safety Monitoring Board (DSMB) membership for Micella Biopharma: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; FORMA Therapeutics: Membership on an entity's Board of Directors or advisory committees; Health Resources and Services Administration (HRSA): Research Funding; Patient Centered Outcomes Research Institute (PCORI): Research Funding; Terumo: Consultancy; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees.