Objective: The aim of this study is to prove the effectiveness of a low cost, artificial model for training of a taparoscopic urethrovesicat anastomosis. Materials and methods: This study included urologists who attended specialised courses on taparoscopic radical prostatectomy (LRP) held during the period 2015 to 2017. They were divided into 2 groups according to their previous experience in taparoscopic surgery. The tasks performed on the artificial simulator were prostate resection, "task 1", and urethrovesical anastomosis, "task 2". Once these exercises were completed, the study participants filled in an anonymous questionnaire regarding their demographic data and experience level in laparoscopic surgery (LS). In addition, they gave their opinions about the didactic capacity of the artificial organ and evaluated its usefulness as a tool for LRP training. To demonstrate face and content validity, the participants judged the texture, consistency, morphology and evaluated its similarity to the real organ. The assessment was made with a five-point Likert scale. Results: The students were divided into 2 groups: 10 experts (Group E) and 12 novices (Group N). The only significant difference between the scores of novices and experts was regarding the inclusion of this tool in the training programs (Group E = 5 points versus group N = 4.4 +/- 0.59, P=.024). The experts' group rated all the items with higher scores than the novices' one. Regarding the general assessment of the simulation model, the novice participants gave an average score of 8.00 +/- 0.91 points out of 10, while the experts' group granted higher scores of 9.4 +/- 0.51. Conclusion: This artificial model has shown to have an elevated face, content and construct validity, as well being an optimal didactic tool for training in the techniques of prostate resection and laparoscopic urethrovesical anastomosis. (C) 2019 AEU. Published by Elsevier Espana, S.L.U. All rights reserved.
ObjetivoEl objetivo de este estudio es demostrar la validez de un modelo inorgánico de bajo coste para el aprendizaje y entrenamiento de la anastomosis uretrovesical laparoscópica.Materiales y métodosEn este estudio participaron alumnos que asistieron a alguna de las ediciones de los cursos monográficos sobre prostatectomía radical laparoscópica (PRL) celebrados durante el periodo de 2015 a 2017. Estos participantes se dividieron en 2 grupos de acuerdo con su experiencia previa en cirugía laparoscópica (CL).Las tareas que realizaron sobre el simulador inorgánico fueron la resección de la próstata, «tarea 1» y la anastomosis uretrovesical, «tarea 2». Una vez realizados estos ejercicios, los participantes del estudio completaron un cuestionario anónimo donde se recogieron sus datos demográficos y su nivel de experiencia en CL. Además, los asistentes realizaron una valoración de la capacidad didáctica del órgano sintético empleado, evaluando su utilidad como herramienta para la formación específica de PRL.Para demostrar la validación aparente y de contenidos los participantes mostraron su opinión acerca de la textura, la consistencia, la morfología y la similitud del órgano con el paciente real. La valoración se realizó según una escala de Likert de 5 puntos.ResultadosLos alumnos se distribuyeron en 2grupos: 10 expertos (grupo E) y 12 noveles (grupo N). La única diferencia significativa entre las puntuación de noveles y de expertos fue respecto a la inclusión de esta herramienta en los programas de formación (grupo E=5 puntos frente al grupo N=4,4 ±0,59, p=0,024). Los expertos calificaron todas las cuestiones con mayores puntaciones que los noveles. En cuanto a la valoración general del modelo inorgánico, los participantes noveles dieron una calificación media de 8,00±0,91 puntos sobre 10, siendo superada por la valoración de los participantes del grupo de expertos, que dieron una puntuación media de 9,4±0,51.ConclusiónEste modelo inorgánico ha demostrado poseer validez aparente, de contenidos y constructiva, además de ser una herramienta didáctica ideal para el aprendizaje y el entrenamiento de la resección prostática y de la anastomosis uretrovesical laparoscópica.
Background Regardless of disease activity, functional status gets worse in patients with rheumatoid arthritis (RA) with comorbidities. However, the impact of comorbidities on physical function in ankylosing spondylitis (AS) and psoriatic arthritis (PsA) is less known. Objectives To assess the impact of comorbidities on physical function (PF) in patients with AS and PsA. Methods Analysis of the baseline visit from the ongoing multicentric, observational, prospective, CARMA study. Data from patients with AS and PsA were analysed. Two different adjusted multivariate models were performed, where PF was the dependent variable (BASFI in AS and HAQ in PsA) and the following independent variables: comorbidities, a proxy for the Charlson index (ChI) (minimum 0; maximum 11), sociodemographic, disease activity (ESR, CRP and BASDAI in AS; while SJC, TJC, CRP, ESR, DAS, dactylitis count and PASI in PsA) and duration, radiographic damage and treatments. Results are presented as β coefficients and p-values. Results 738 patients with AS and 721 with PsA included (mean age at inclusion 48.1±11.7 and 51.8±12 years, respectively). AS patients: median BASFI 3.1 [interquartile range (IQR): 1.3–5.2], BASDAI 3.5 [IQR: 1.7–5.3], mean ChI 1.32±0.73. PsA patients: HAQ 0.4 [IQR: 0.0–0.9], DAS28 2.9 [IQR: 2.0–3.8], mean ChI 1.30±0.66. A ChI >1 found in 21% of the patients. Hypertension in 25.7% and 29.5%; hypercholesterolemia in 27% and 35.6% and diabetes in 7.6% and 9.2% of the patients with AS and PsA, respectively. Cardiovascular events occurred in 7.6% AS and 7.2% PsA, in most cases after the rheumatic disease diagnosis. Only patients with PsA with higher ChI showed worse adjusted physical function (β: 0.09; p=0.03). Also female sex (β: 0.03; p=0.001), obesity (β: 0.09; p=0.04), disease duration (β: 0.01; p=0.009), NSAIDs (β: 0.1; p=0.02), corticosteroids (β: 0.12; p=0.02) and biologics (β: 0.15; p=0.07) were associated with worse function in patients with PsA. In contrast, a higher educational level was associated with less disability. In patients with AS, thyroid disease (β: 1.19, p=0.002) and raised ESR (β: 0.01, p=0.010) were independently associated with function. Conclusions The presence of comorbidities in patients with PsA is independently associated with worse physical function, similar to what happens in RA. Early detection and control may yield an integral management of the disease and better final outcomes. Disclosure of Interest None declared
Background Dose tapering of biological therapies (BT) in patients with rheumatoid arthritis (RA) or spondyloarthritis (SpA) is frequent in Spain. However, there is variability in BT optimization (BTO). So, Spanish Society of Rheumatology published in 2015 recommendations on how to optimize BT (1). Nevertheless, there is no solid evidence on which patient profiles BTO is appropriated. Objectives To develop appropriateness criteria for BTO in patients with RA, axial SpA (axSpA) or peripheral SpA (pSpA) Methods The RAND/UCLA appropriateness method was used. Five rheumatologists experienced in RA and/or SpA clinical research selected and defined the variables considered relevant when deciding reduction of BT in order to define patient profiles. Ten BT experienced rheumatologists anonymously rated 1 (completely inappropriate) to 9 (completely appropriate) each profile after reading evidence synthesis. Then, in a meeting, classification variables and profiles with disagreement were revised and all profiles were scored again. Profiles with a median score >6 were considered appropriate, those with a median score <3.5 were considered inappropriate and the remaining uncertain. In addition, a study of the prevalence of these profiles was performed in 9 Spanish hospitals. Results Combining the options of variables 2,304 different profiles were obtained for RA, 768 for axSpA, and 3,072 for pSpA. 327 (14.2%) profiles in RA, 80 (10.4%) in axSpA, and 154 (5%) in pSpA were considered appropriate for BT dose reduction. By contrast, 749 (53.3%) profiles in RA, 270 (54.4%) in axSpA, and 1243 (54.5%) in pSpA were considered inappropriate. The remaining profiles were considered uncertain. In the preliminary study to determine profiles prevalence, we collected information from 242 RA, 171 axSpA and 172 pSpA patients that underwent BTO. We found that BTO was performed appropriately in 23% RA, 67% axSpA and 61% pSpA patients. BTO was indicated in uncertain profiles in 67% RA, 23% axSpA and 37% pSpA patients. Only in RA we detected BT dose reduction in patient profiles considered inappropriate (2%). Conclusions Appropriateness criteria for BT dose reduction in three inflammatory conditions were developed and the preliminary prevalence study suggests that BTO was wiselly applied. However, further research in this field is needed to determine the real prevalence of clinical profiles of patients undergoing BTO in daily clinical practice and validate these criteria in real life. References Gonzalez-Alvaro I et al. Rheumatology 2015; 54: 1200–1209. Disclosure of Interest I. Gonzalez-Alvaro: None declared, C. Sánchez-Piedra Grant/research support from: Unrestricted grant from Abbvie, R. Almodovar: None declared, J. Bachiller: None declared, A. Balsa: None declared, A. Blasco Grant/research support from: Unrestricted grant from Abbvie, R. Caliz: None declared, G. Candelas: None declared, C. Fernández-Carballido: None declared, A. García-Aparicio: None declared, B. García-Magallόn: None declared, R. García-Vicuña: None declared, A. Gomez-Centeno: None declared, A. Ortiz: None declared, R. Sanmartí: None declared, J. Sanz: None declared, B. Tejera: None declared, I. Notario: None declared, M. Soto: None declared, C. Plasencia: None declared, V. Hernández: None declared, M. Espinosa: None declared, C. Ramos: None declared, P. Lazaro Grant/research support from: Unrestricted grant from Abbvie
Background Lupus nephritis (LN) is one of the most common and serious complications of Systemic Lupus Erythematosus (SLE). There are several factors that are considered related to the development of LN like malar erythema, anti-dsDNA and low serum complement. However not all patients with high level of anti-dsDNA or low level of serum complement present LN. Objectives To determine if patients with low serum complement, high level of anti-dsDNA and malar erythema are more likely to have NL and analyze other clinical and immunological characteristics associated with NL. Methods This is an observational, retrospective study in which 30 patients with LN, diagnosed with renal biopsy are compared with 61 SLE patients without LN, followed in the Rheumatology Unit of the University Hospital Ramόn y Cajal in the last 15 years. We excluded the patients diagnosed with other non lupus nephropathy or other associated autoimmune disease. The triad we9ve studied was the simultaneous presence of malar erythema, low level of serum complement (C3 and/or C4, <90 mg/dl and <10 mg/dl respectively) and high level of anti-dsDNA title (more than 3 times the normal limit as the standard technique >45 IU/ml by EliAUniCAP). Clinical and immunological data were collected following a review of medical records and analyzed using bivariate and multivariate methods in SPSS version 20. Results Patients with NL were significantly younger at diagnosis of SLE than the control group (26.4±10.7 years vs 32.7±12.5 years), p=0.022. There were no differences between gender, ethnicity and time of evolution of SLE. In bivariate analysis, significant associations between NL and malar erythema (OR 6.25, p=0.0001), oral ulcers (OR 2.68, p=0.029), leukopenia (OR 2.97, p=0.034), lymphopenia (OR 5.5, p=0.001), serositis (OR 3.4, p=0.013) and fever (OR 2.56, p=0.045) were observed. Among the immunological parameters that are associated with NL were anti-dsDNA>45 U/ml antibody (Cramer9s V =0.360, p=0.001), anti-U1RNP (OR 3.2, p=0.013), and low level of complement (OR 10.3, p=0.008). Chronic cutaneous lupus erythematosus and rheumatoid factor had a negative association with LN (p=0.02; p=0.049 respectively). The LN type IV was significantly associated with the studied triad (p=0.013). In the multivariate analysis the patients who had the triad were more likely to have LN (OR 42.5, 95% CI 7.7 to 233, p=0.0001); in 75% of these patients the time from the onset of the triad to the onset of LN was equal to or less than 10.2 months. The triad has higher specificity than anti-dsDNA alone (93.4% vs 55%), but lower sensitivity (76.6% vs 96%), the positive predictive value of the triad was 85% and the negative predictive value was 89%. Conclusions The presence of the triad (malar erythema, low level serum complement and anti-DNAds) is an important predictive factor for the development of lupus nephritis and more specific than the presence of each of these alterations separately. Given these results, although larger studies are needed to confirm this profile, special care must be taken to the patients with this clinical and analytically features. References Ravirajan CT, et al. An analysis of clinical disease activity and nephritis-associated serum autoantibody profiles in patients with systemic lupus erythematosus: a cross-sectional study. Rheumatology (Oxford) 2001;40:1405–12. Disclosure of Interest None declared
Objective: To assess a training model focused on laparoscopic nephrectomy.Material and methods: 16 residents participated in the study, who attended a training program with a theoretical session (1 hour) and a dry (7 hours) and a wet tab (13 hours). During animal training, the first and last nephrectomies were assessed through the completion time and the global rating scale "Objective and Structured Assessment of Technical Skills" (OSATS). Before and after the course, they performed 3 tasks on the virtual reality simulator LAPMentor (1) eye-hand coordination; 2) hand-hand coordination; and 3) transference of objects), registering time and movement metrics. All participants completed a questionnaire related to the training components on a 5-point rating scale.Results: The participants performed the last nephrectomy faster (P<.001) and with higher OSATS scores (P<.001). After the course, they completed the LAPMentor tasks faster (P<.05). The number of movements decreased in all tasks (1) P<.001, 2) P<.05, and 3) P<.05), and the path length in tasks 1 (P<.05) and 2 (P<.05). The movement speeds increased in tasks 2 (P<.001) and 3 (P<.001). With regards to the questionnaire, the usefulness of the animal training and the necessity of training on them prior to their laparoscopic clinical practice were the questions with the highest score (4.92 +/-.28).Conclusions: The combination of physical simulation and animal training constitute an effective training model for improving basic and advanced skills for laparoscopic nephrectomy. The component preferred by the urology residents was the animal training. (C) 2015 AEU. Published by Elsevier Espana, S.L.U. All rights reserved.
ObjetivoEvaluar un modelo de formación enfocado a la nefrectomía laparoscópica.Material y métodosParticiparon en el estudio 16 residentes, quienes realizaron un programa formativo con una sesión teórica (1h) y práctica en simulador (7h) y modelo animal (13h). La primera y última nefrectomía experimental fue evaluada mediante el tiempo y la escala global Objective and Structured Assessment of Technical Skills (OSATS). Antes y después del curso realizaron 3 ejercicios en el simulador de realidad virtual LAPMentor: 1) coordinación ojo-mano; 2) coordinación mano-mano; y 3) transferencia de objetos, registrando las métricas de tiempo y movimiento. Todos los participantes rellenaron un cuestionario sobre los componentes formativos en una escala del 1 al 5.ResultadosLos participantes realizaron la última nefrectomía más rápido (p<0,001) y con mayor puntuación OSATS (p<0,001). Después del curso realizaron los ejercicios en LAPMentor más rápido (p<0,05). El número de movimientos disminuyó en todos los ejercicios: 1) p<0,001; 2) p<0,05; y 3) p<0,05, y la distancia recorrida en los ejercicios 1 (p<0,05) y 2 (p<0,05). La velocidad de movimientos aumentó en los ejercicios 2 (p<0,001) y 3 (p<0,001). En el cuestionario las preguntas con la mayor puntuación fueron la utilidad del entrenamiento en animal y la necesidad del mismo antes de la práctica de laparoscopia clínica (4,92±0,28).ConclusionesLa combinación de simulación física y entrenamiento en animal constituye un modelo de formación efectivo para la mejora de habilidades básicas y avanzadas para la nefrectomía laparoscópica. El componente preferido por los residentes fue el modelo animal.
Background: Musculoskeletal disorders (MSDs) are a frequent cause of work disability, accounting for productivity losses in industrialized societies equivalent to 1.3% of the U.S. gross national product.Objective: To evaluate whether a population-based clinical program offered to patients with recent-inset work disability caused by MSDs is cost-effective.Design: Randomized controlled intervention study. The inclusion and follow-up periods each lasted 12 months.Setting: Three health districts in Madrid, Spain.Patients: All patients with MSD-related temporary work disability in 1998 and 1999.Intervention: The control group received standard primary care management, wit referral to specialized care if needed. The intervention group received a specific program, administered by rheumatologists, in which care was delivered during regular visits and included 3 main elements: education, protocol-based clinical management, and administrative duties.Measurements: Efficacy variables were 1) days of temporary work disability and 2) number of patients with permanent work disability. All analyses were done on an intention-to-treat basis.Results: 13 077 patients were included in the study, 7805 in the control group and 5272 in the intervention group, generating 16 297 episodes of MSD-related temporary work disability. These episodes were shorter in the intervention group than in the control group (man, 26 days compared with 41 days; P < 0.001), and the groups had similar numbers of episodes per patient. Fewer patients received long-term disability compensation in the intervention group (n = 38 [0.7%]) than in the control group (n = 99 [1.3%]) (P < 0.005). Direct and indirect costs were lower in the intervention group than in the control group. To save 1 day of temporary work disability, $6.00 had to be invested in the program. Each dollar invested generated a benefit of $11.00. The program's net benefit was in excess of $5 million.Limitations: The study was unblinded.Conclusions: Implementation of the program, offered to the general population, improves short- and long-term work disability outcomes and is cost-effective.