Reliability and validity of the Spanish version of the IDEAL Schedule for assessing care needs in dementia: Cross-sectional, multicenter study.

OBJECTIVE: The IDEAL Schedule was developed for staging "care needs" in patients with dementia. We here aim to validate the Spanish version, further test its psychometric properties and explore a latent construct for "care needs". METHODS: A multicenter study was done in 8 dementia care facilities across Spain. Patients referred with a reliable ICD-10 diagnosis of dementia (n = 151) were assessed with the IDEAL Schedule by pairs of raters. Inter-rater reliability (intra-class correlation [ICC] coefficients), internal consistency (Cronbach's alpha), and factor analysis were calculated. Convergent validity for individual items was tested against validated Spanish versions of international instruments. RESULTS: Pilot testing with numerical scales supported the feasibility, face, and content validity of the schedule. The psychometric coefficients were good/clinically acceptable: inter-rater reliability (mean ICC = 0.861; 85% of the ICCs > 0.8), internal consistency (global alpha coefficient = 0.74 in 5 nuclear items), and concurrent validity (global score against the Clinical Dementia Rating schedule, r = 0.63; coefficients for individual items ranging from 0.40 to 0.84, all statistically significant, p < 0.05). Internal consistency was low for the "nonprofessional care" and "social support" dimensions. Factor analysis supported a unidimensional solution, suggesting a latent "care needs" construct. CONCLUSION: The Spanish version of the IDEAL Schedule confirms the main psychometric properties of the original version and documents for the first time the convergent validity of individual items. Factor analysis identified a latent construct consistent with the concept "care needs" although 2 dimensions need further psychometric research.

The Role of Ki-67 and Pre-cytoreduction Parameters in Selecting Diffuse Malignant Peritoneal Mesothelioma (DMPM) Patients for Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).

BACKGROUND: We conducted a prognostic analysis of preoperative parameters and Ki-67 determination to develop selection criteria for cytoreductive surgery (CRS) and HIPEC in patients with diffuse malignant peritoneal mesothelioma (DMPM). METHODS: DMPM patients treated with CRS and HIPEC at NCI of Milan participated in this study. Multivariate analysis was conducted using Cox proportional hazard model and conditional inference tree method to select independent predictors of overall survival (OS) from the followings pre-cytoreduction parameters: age, sex, ECOG performance status, Charlson comorbidity index, previous systemic chemotherapy, CA-125, histological subtype (epithelioid vs. biphasic/sarcomatoid), Ki-67 (determined with immunohistochemistry), and peritoneal cancer index (PCI). RESULTS: A total of 117 patients (male/female: 67/50) with median age of 60.5 (range 22-75) years were included. Eighty-three patients had ECOG performance status = 0, median Charlson comorbidity index was 4 (range 2-9), and 102 cases had epithelioid subtype. Median Ki-67 was 5 % (range 1-60). Ninety-four (80.3 %) cases were optimally cytoreduced. The Cox analysis identified Ki-67, PCI, and histological subtype as independent prognosticators of OS. Conditional inference tree method identified three prognostic subsets: (I) Ki-67 ≤ 9 %; (II) Ki-67 > 9 % and PCI ≤ 17; and (III) Ki-67 > 9 % and PCI > 17. The median OS for subsets I, II, and III were, 86.6, 63.2, and 10.3 months, respectively. CONCLUSIONS: Ki-67 is a powerful prognosticator that allows, along with PCI, and histological subtype, a good prediction of OS in patients with DMPM. Patients with Ki-67 > 9 % and PCI > 17 are unlikely to benefit from the procedure and should be considered for other treatment protocols.

Association between the IL28B genotype and hepatitis C viral kinetics in the early days of treatment with pegylated interferon plus ribavirin in HIV/HCV co-infected patients with genotype 1 or 4.

OBJECTIVES: To evaluate the effect of the interleukin 28B (IL-28B) genotype on hepatitis C virus (HCV) viral kinetics in the first 4 weeks from start of treatment with pegylated interferon plus ribavirin (PEG-IFN/RBV) in HIV/HCV co-infected patients. METHODS: HIV/HCV co-infected patients naive to PEG-IFN/RBV treatment were enrolled in a prospective study. HCV RNA plasma viral loads were measured at baseline and at weeks 1, 2 and 4 after commencement of treatment. Patients were grouped by HCV genotype (genotype 1/4 versus 3) and by IL-28B genotype (CC versus non-CC). Differences in viral load reduction were evaluated by IL-28B genotype between baseline, week 1, week 2 and week 4. RESULTS: One hundred and nineteen HIV/HCV patients were included in the study. HCV patients with genotype 1/4 and bearing the IL-28 CC genotype showed the greatest reductions in HCV RNA plasma levels between baseline and weeks 1 (B-1), 2 (B-2) and 4 (B-4) than did those with non-CC genotypes (B-1: 1.06 ± 0.89 versus 0.48 ± 0.48 log IU/mL, P = 0.009; B-2: 1.36 ± 0.72 versus 0.77 ± 0.66 log IU/mL, P = 0.01; and B-4: 1.91 ± 0.64 versus 1.38 ± 0.96 log IU/mL, P = 0.03). However, differences between weeks 1 and 2 (W1-2) and between weeks 2 and 4 (W2-4) were not associated with the IL-28B genotype (W1-2: CC 0.48 ± 0.42 versus non-CC 0.38 ± 0.38 log IU/mL, P = 0.62; W2-4: CC 0.32 ± 0.23 versus non-CC 0.39 ± 0.31 log IU/mL, P = 0.67). No differences in decline of HCV RNA viral load were found in HCV genotype 3 patients. CONCLUSIONS: The IL-28B genotype impacts on viral kinetics during the first week of treatment with PEG-IFN/RBV in patients with HCV genotype 1/4.

LDLr genotype modifies the impact of IL28B on HCV viral kinetics after the first weeks of treatment with PEG-IFN/RBV in HIV/HCV patients.

OBJECTIVE: To evaluate the effect of low-density lipoprotein receptor (LDLr) and IL28B genotypes on hepatitis C virus (HCV) viral kinetics in the first 4 weeks of treatment with pegylated-interferon (PEG-IFN)/ribavirin (RBV) in HIV patients co-infected with HCV genotype 1. METHODS: HIV patients co-infected with HCV genotype 1 and naïve to PEG-IFN/RBV treatment were enrolled in a prospective study. HCV RNA viral loads were measured at baseline and at weeks 1, 2 and 4 after start of therapy. Differences in viral load decline were evaluated for IL28B (CC versus non-CC) and LDLr (CC versus non-CC) genotypes between baseline and weeks 1, 2 and 4. Additionally, the effect of LDLr genotype on HCV viral decline in IL28B CC genotype patients (CC/CC versus CC/non-CC) was analyzed. RESULTS: Eighty-seven HIV/HCV genotype 1 co-infected patients were included in the study. Patients carrying the LDLr-CC or IL28B-CC genotypes showed greater HCV viral decline than those with IL28B non-CC or LDLr non-CC genotypes at every time-point analyzed. CC/CC patients had higher rapid virological response (RVR) rates than CC/non-CC patients (41.2 versus 13.3%; P < 0.001). Moreover, at all time points, the CC/CC pattern was associated with greater HCV viral decline than the CC/non-CC genotype (week 1: 1.18 ± 0.51 versus 0.31 ± 0.29, P = 0.041; week 2: 1.55 ± 0.81 versus 0.93 ± 0.73, P = 0.032; week 4: 2.23 ± 1.1 versus 1.5 ± 0.94, P = 0.039). CONCLUSION: The LDLr genotype impacts on viral kinetics during the first days of starting treatment with PEG-IFN/RBV in HIV/HCV genotype 1 co-infected patients, and modifies the impact of IL28B on HCV viral decay.

Low-density lipoprotein receptor genotyping enhances the predictive value of IL28B genotype in HIV/hepatitis C virus-coinfected patients.

OBJECTIVE: The aims of this study were to appraise the predictive value of variations in a single-nucleotide polymorphism (SNP) in the low-density lipoprotein receptor (LDLR) gene for sustained virological response (SVR) to pegylated interferon (Peg-IFN) and ribavirin (RBV), as well as to analyze the relationship between LDLR genotype and other predictors of SVR, particularly IL28B genotype, in patients coinfected with HIV and hepatitis C virus (HCV). METHODS: One hundred and eighty-four HIV/HCV-coinfected, treatment-naive patients with chronic HCV infection, who received Peg-IFN and RBV, were included. Variations in the SNP rs14158 and rs12979860 were tested by Taqman PCR assay. RESULTS: Twenty-eight (38%) patients with rs14158 TT/TC and 61 (55%) with CC (P = 0.028) achieved SVR. The rates of SVR in patients with rs14158 TT/TC and with CC harboring HCV 1-4 were 20 and 41% (P = 0.020), respectively, and, in those with HCV genotype 2-3, 75 and 84% (P = 0.513), respectively. Patients with rs14158 CC showed less commonly plasma HCV-RNA load at least 600000 IU/ml (57 vs. 71%, P = 0.047) and lower likelihood of relapse (13 vs. 30%, P = 0.023). In patients with HCV genotype 1-4, the rates of SVR according to the combination of IL28B/LDLR genotypes were: CC/CC = 69%; CC/non-CC: 30%; non-CC/CC: 25%; non-CC/non-CC: 14% (P < 0.001). CONCLUSION: Variations in rs14158 are associated with SVR to Peg-IFN and RBV in HIV/HCV-coinfected patients harboring HCV genotype 1-4. LDLR and IL28B genotypes seem to have a synergistic effect on SVR. The combined use of LDLR and IL28B genotypes in routine clinical practice could enhance the predictive value of IL28B genotype alone.

Respuesta clínica completa postneoadyuvancia en cáncer de recto estadio III: observación o cirugía / Complete Clinical Response following Neoadjuvant Treatment of Stage II Rectal Cancer: Observation of Surgery

La respuesta clínica completa posterior a la terapia neoadyuvante del cáncer localmente avanzado de recto, se ha considerado suficiente para la implementación de una estrategia no quirúrgica, de observación y seguimiento por algunos autores. El manejo estándar de esta patología es la realización de manejo quirúrgico oncológico radical del tumor primario, 6 a 10 semanas posterior a la finalización de la neoadyuvancia. En esta revisión se exponen los pros y contras de cada propuesta y se describen las implicaciones y recomendaciones de cada alternativa de manejo.

Complete clinical response after neoadjuvant therapy for locally advanced rectal cancer has been considered sufficient for implementation of a non-surgical approach of observation and monitoring by some authors. Standard management of this condition is radical resection of the primary tumor six to ten weeks after completion of neoadjuvant therapy. In this review the pros and cons of each proposal are presented, and implications and recommendations for each alternative are described.

Desenlaces del manejo no quirúrgico posterior a neoadyuvancia del cáncer localmente avanzado de recto / Outcomes of the nonsurgical management of locally advanced rectal cancer after neoadjuvant treatment / Outcomesofthenon-surgicalmanagementoflocallyadvancedrectalcancerafterneoadjuvanttreatment

Objetivos: Describir características clínicas, histopatológicas y desenlaces de pacientes con cáncer localmente avanzado de recto y respuesta clínica completa posterior a la neoadyuvancia, sin manejo quirúrgico. Métodos: Estudio de cohorte retrospectiva de pacientes con cáncer de recto estadios II y III, llevados a quimiorradiación, en seguimiento clínico. Se evaluó supervivencia libre de enfermedad, global y tasa de recaída. Se describen características biológicas (Kras, Ki67, p53) y morfológicas del tumor (grado, invasión linfovascular y perineural). Resultados: Entre enero de 2003 y junio de 2013, 19 pacientes con cáncer localmente avanzado de recto y respuesta clínica completa postneoadyuvancia, no aceptaron el tratamiento quirúrgico radical. Con mediana de seguimiento de 21 meses (4-92 meses), se presentaron recaídas del: 21% en el primer año, 36% a los 3 años y 42% a los 5 años (total: 8 pacientes). Se presentó recaída local en 50% de casos, regional en 50% y no hubo recaída sistémica. La tasa estimada de recaída local fue 2,3 recaídas por 100 pacientes/mes (IC 95%:1,21-4,5) y de recaída regional 1,3 recaídas por 100 pacientes/mes (IC 95%:0,5-3,1). No se estableció relación, entre la expresión de factores biológicos del tumor primario y los desenlaces. Conclusiones: Se ratifica la indicación del tratamiento quirúrgico radical, posterior a la neoadyuvancia, en todos los pacientes con cáncer localmente avanzado de recto. Las bajas tasas de recaída local y regional de nuestra serie, sugieren la posibilidad de resección local u observación, en casos seleccionados. La individualización y deseo del paciente, debe orientar la toma de decisiones.

Objectives: To describe the clinical and histopathological characteristics and outcomes of patient with non-surgically managed locally advanced rectal cancer and a complete clinical response to neoadjuvant treatment. Methods: A retrospective study was conducted on a cohort of patients with stages II and III rectal cancer, on clinical follow up after subjected to chemoradiotherapy. The overall disease free survival and recurrence rates were evaluated. The biological (Kras, Ki67, p53) and morphological (grade, lymphovascular and perineural invasion) characteristics of the tumor were recorded. Results: Between January 2003 and June 2013, a total of 19 patients with locally advanced rectal cancer and a complete clinical response after neoadjuvant treatment, did not accept radical surgical treatment. With a median follow-up of 21 months (range 4-92 months), the recurrences were: 21% in the first year, 36% at 3 years, and 42% at 5 years (total: 8 patients). There was local recurrence in 50% of the cases, regional in 50%, and there were no systemic recurrences. The estimated local recurrence rate was 2.3 recurrences per 100 patients/month (95% CI; 1.21 - 4.5), and a regional recurrence of 1.3 recurrences per 100 patients/month (95% CI: 0.5 - 3.1). No relationship was found between the expression of biological factors of the primary tumor and the outcomes. Conclusions: The indication for radical surgical treatment after neoadjuvant treatment is demonstrated in all patients with locally advanced rectal cancer. The low local and regional recurrence rates of this series suggest the possibility of local resection or observation in selected cases. Individualization and the wishes of the patient must be taken into account when making decisions.

Asistencia ventricular mecanica un nuevo reto para el profesional de enfermeria / Mechanical ventricular assistance and Nursing

La investigación clínica en dispositivos de asistencia ventricular mecánica, data de finales de los años 50. En 1966 Michael DeBakey obtiene resultados positivos asistiendo a un paciente durante 10 días. En la última década la tecnología ha evolucionado rápidamente pasando del balón de contrapulsación a los sistemas neumáticos. Para enfermería esta revolución tecnológica representa un gran reto, ya que el cuidado de los pacientes sometidos a asistencia ventricular significa además de una gran responsabilidad, el acceso a nuevas tecnologías, conocimientos y habilidades para el crecimiento profesional. Enfermería necesita trabajar mancomunadamente con otros profesionales para lograr su objetivo, como es el de mantener y/o mejorar la calidad de vida de los pacientes. La experiencia en asistencia ventricular mecánica en niños, es poca. La sobrevida de un paciente de 10 años sometido a asistencia ventricular derecha durante 48 horas, motiva este reporte de caso y pretende dar a conocer los aspectos más importantes tanto técnicos (manejo de consola, técnicas de canulación) como prácticos (indicaciones, técnicas de asistencia, contraindicaciones, complicaciones, principios fisiológicos y registro) necesarios para entender el funcionamiento de éstos dispositivos, finalmente plantear intervenciones de enfermería en términos de diagnósticos de enfermería...