¿Cómo diseñar, aplicar y evaluar un programa de Mentoring en enfermedad renal crónica? evaluación narrativa del impacto en 6 centros asistenciales

Antecedentes y objetivo La enfermedad renal crónica (ERC) requiere de un proceso de adaptación en el paciente, que se puede facilitar con el apoyo de los profesionales sanitarios, así como por iguales capacitados. El objetivo de este estudio es presentar la puesta en marcha de un programa piloto de paciente mentor para promover la adaptación de los pacientes con ERC. Materiales y método Diseño mixto (cuantitativo y cualitativo) pre-post. El estudio se llevó a cabo en 6 hospitales de España. Los instrumentos utilizados para medir el impacto fueron escalas elaboradas ad-hoc (formato de respuesta escala de Likert de 10 puntos) de satisfacción y adquisición de competencias, así como la creación de grupos focales con 8 pacientes mentores y 10 profesionales sanitarios. Se dividió el programa en 4 fases: 1) Diseño y validación de contenidos del programa manualizado y selección de pacientes mentores; 2) Formación a mentores, satisfacción con la formación y competencias adquiridas por los mentores; 3) Implementación de los grupos de apoyo mutuo y perfil de los asistentes a los grupos de apoyo mutuo, y 4) Evaluación y resultados del programa de Mentoring. Resultados Se han formado a un total de 39 mentores en habilidades para conducción de grupos, así como para facilitar apoyo emocional. Se han conducido 22 grupos de apoyo con 121 participantes (22% cuidadores). El 65% de los pacientes estaban en consulta de ERC. Un 65% de los pacientes participantes consideraron hacer algún cambio en su estilo de vida tras la asistencia al programa. Todos los ítems que evalúan satisfacción y utilidad han mostrado una puntuación muy elevada, por encima del valor 8, 5 sobre 10. Conclusiones Este es el primer programa manualizado de Mentoring en ERC llevado a cabo de manera simultánea en 6 hospitales españoles. La naturaleza del programa, manualizado y altamente estructurado, permite su replicabilidad minimizando el riesgo de error. Background and objective Chronic kidney disease (CKD) requires patients to participate in an adaptation process, which may be facilitated with the support of healthcare professionals and trained peers. The objective of this study is to present the implementation of a pilot patient mentoring programme to promote adaptation in patients with CKD. Materials and method Pre-test-post-test design (quantitative and qualitative). The study was carried out in six hospitals in Spain. The instruments used to measure impact were ad-hoc scales (10-point Likert scale response format) on satisfaction and skill acquisition, as well as the creation of focus groups with eight patient mentors and 10 healthcare professionals. The programme was split into four phases: 1. Design and validation of the manualised programme''s content, and selection of patient mentors; 2. Mentor training, satisfaction with training and skills acquired by the mentors; 3. Implementation of mutual support groups and profile of those attending these mutual support groups; 4. Assessment and results of the Mentoring programme. Results In total, 39 mentors were trained on group management skills, as well as how to provide emotional support. 22 support groups were held, with 121 participants (22% carers). The 65% of the patients were attending the CKD clinic. 65% of the participating patients considered making some form of lifestyle change after taking part in the programme. All the items assessing satisfaction and usefulness scored very highly, achieving 8.5 out of 10 or above. Conclusions This is the first manualised mentoring programme in CKD to be undertaken simultaneously in six Spanish hospitals. The manualised and highly structured nature of the programme make it easy to replicate, minimising the risk of error

Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.