Comparison between the spanish and catalan versions of the Supports Intensity Scale for Children (SIS-C)

The new socio-ecological model of disability directs attention to the importance of the environment in understanding individual functioning and promotes the provision of support from an early age. Following on from that thinking, the SIS-C (Supports Intensity Scale for Children) has been developed as an innovative assessment tool focused on designing individualized support plans. The aim of this study was to establish a comparison between the psychometric properties of the Spanish and Catalan versions of this scale. Method: The SIS-C allows us to assess the support needs of children (5-16 years old) with intellectual disabilities to fully participate in 61 daily activities within seven different contexts. The Spanish version was administered to 814 participants and the Catalan version to 949. Results: Findings show that both versions have adequate psychometric properties, such as high levels of internal consistency and criterion validity. In terms of scale structure, adjustment indices derived from factor analysis showed that both versions reproduced a correlational model composed of seven factors better than unidimensional or hierarchical models. Conclusions: Although the Spanish version of the scale showed better statistical indices, both versions are similarly suitable for accurately assessing the support needs of this population.Antecedentes: la nueva concepción socioecológica de la discapacidad centra su mirada en la importancia del entorno para comprender el funcionamiento individual y promueve la provisión de apoyos desde edades tempranas. Surge así la SIS-C (Supports Intensity Scale for Children) como herramienta de evaluación innovadora para diseñar planes de apoyo personalizados. El objetivo del presente estudio consistió en establecer una comparación entre las propiedades psicométricas de las versiones castellana y catalana de esta escala. Método: la SIS-C permite evaluar las necesidades de apoyo de niños y adolescentes (5-16 años) con discapacidad intelectual para participar satisfactoriamente en 61 actividades diarias desarrolladas en siete contextos diferentes. La versión castellana fue administrada a 814 participantes y la catalana a 949. Resultados: los datos refl ejan que ambas versiones poseen adecuadas propiedades psicométricas, obteniéndose elevados índices de consistencia interna y validez. En relación a su estructura, los índices de ajuste derivados de los análisis factoriales realizados mostraron que las dos versiones reproducen mejor un modelo correlacional de siete factores que un modelo unidimensional o de segundo orden. Conclusiones: aunque estadísticamente la versión castellana de la escala presentó mejores datos, ambas versiones lingüísticas obtuvieron resultados similares para evaluar adecuadamente las necesidades de apoyo de esta población

Maintenance therapy with vinflunine plus best supportive care versus best supportive care alone in patients with advanced urothelial carcinoma with a response after first-line chemotherapy (MAJA; SOGUG 2011/02): a multicentre, randomised, controlled, open-label, phase 2 trial.

Maintenance therapy improves outcomes in various tumour types, but cumulative toxic effects limit the choice of drugs. We investigated whether maintenance therapy with vinflunine would delay disease progression in patients with advanced urothelial carcinoma who had achieved disease control with first-line chemotherapy. We did a randomised, controlled, open-label, phase 2 trial in 21 Spanish hospitals. Eligible patients had locally advanced, surgically unresectable, or metastatic transitional-cell carcinoma of the urothelial tract, adequate organ function, and disease control after four to six cycles of cisplatin and gemcitabine (carboplatin allowed after cycle four). Patients were randomly assigned (1:1) to receive vinflunine or best supportive care until disease progression. We initially used block randomisation with a block size of six. Four lists were created for the two stratification factors of starting dose of vinflunine and presence of liver metastases. After a protocol amendment, number of cisplatin and gemcitabine cycles was added as a stratification factor, and eight lists were created, still with a block size of six. Finally, we changed to a minimisation procedure to reduce the risk of imbalance between groups. Vinflunine was given every 21 days as a 20 min intravenous infusion at 320 mg/m2 or at 280 mg/m2 in patients with an Eastern Cooperative Oncology Group performance status score of 1, age 75 years or older, previous pelvic radiotherapy, or creatinine clearance lower than 60 mL/min. The primary endpoint was median progression-free survival longer than 5·3 months in the vinflunine group, assessed by modified intention to treat. Comparison of progression-free survival between treatment groups was a secondary endpoint. This trial is registered with ClinicalTrials.gov, number NCT01529411. Between April 12, 2012, and Jan 29, 2015, we enrolled 88 patients, of whom 45 were assigned to receive vinflunine and 43 to receive best supportive care. One patient from the vinflunine group was lost to follow-up immediately after randomisation and was excluded from the analyses. One patient in the best supportive care group became ineligible for the study and did not receive treatment due to a delay in enrolment, but was included in the intention-to-treat efficacy analysis. After a median follow-up of 15·6 months (IQR 8·5-26·0), 29 (66%) of 44 patients in the vinflunine group had disease progression and 24 (55%) had died, compared with 36 (84%) of 43 patients with disease progression and 32 (74%) deaths in the best supportive care group. Median progression-free survival was 6·5 months (95% CI 2·0-11·1) in the vinflunine group and 4·2 months (2·1-6·3) in the best supportive care group (hazard ratio 0·59, 95% CI 0·37-0·96, p=0·031). The most common grade 3 or 4 adverse events were neutropenia (eight [18%] of 44 in the vinflunine group vs none of 42 in the best supportive care group), asthenia or fatigue (seven [16%] vs one [2%]), and constipation (six [14%] vs none). 18 serious adverse events were reported in the vinflunine group and 14 in the best supportive care group. One patient in the vinflunine group died from pneumonia that was deemed to be treatment related. In patients with disease control after first-line chemotherapy, progression-free survival exceeded the acceptable threshold with vinflunine maintenance therapy. Moreover, progression-free survival was longer with vinflunine maintenance therapy than with best supportive care. Vinflunine maintenance had an acceptable safety profile. Further studies of the role of vinflunine are warranted. Pierre-Fabre Médicament

Contemporary use of cefazolin for MSSA infective endocarditis: analysis of a national prospective cohort

Objectives: This study aimed to assess the real use of cefazolin for methicillin-susceptible Staphylococcus aureus (MSSA) infective endocarditis (IE) in the Spanish National Endocarditis Database (GAMES) and to compare it with antistaphylococcal penicillin (ASP). Methods: Prospective cohort study with retrospective analysis of a cohort of MSSA IE treated with cloxacillin and/or cefazolin. Outcomes assessed were relapse; intra-hospital, overall, and endocarditis-related mortality; and adverse events. Risk of renal toxicity with each treatment was evaluated separately. Results: We included 631 IE episodes caused by MSSA treated with cloxacillin and/or cefazolin. Antibiotic treatment was cloxacillin, cefazolin, or both in 537 (85%), 57 (9%), and 37 (6%) episodes, respectively. Patients treated with cefazolin had significantly higher rates of comorbidities (median Charlson Index 7, P <0.01) and previous renal failure (57.9%, P <0.01). Patients treated with cloxacillin presented higher rates of septic shock (25%, P = 0.033) and new-onset or worsening renal failure (47.3%, P = 0.024) with significantly higher rates of in-hospital mortality (38.5%, P = 0.017). One-year IE-related mortality and rate of relapses were similar between treatment groups. None of the treatments were identified as risk or protective factors. Conclusion: Our results suggest that cefazolin is a valuable option for the treatment of MSSA IE, without differences in 1-year mortality or relapses compared with cloxacillin, and might be considered equally effective