Suchergebnisse

Altres ajuts: This study has been funded by [.] and the Basque Government Health Department (2012111045). ; Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data collection: Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Statistical analysis: Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications. Date of registration: May 8, 2015 (retrospectively registered).

BACKGROUND: Tools to aid in the prognosis assessment of colon cancer patients in terms of risk of mortality are needed. Goals of this study are to develop and validate clinical prediction rules for 1- and 2-year mortality in these patients. METHODS: This is a prospective cohort study of patients diagnosed with colon cancer who underwent surgery at 22 hospitals. The main outcomes were mortality at 1 and 2 years after surgery. Background, clinical parameters, and diagnostic tests findings were evaluated as possible predictors. Multivariable multilevel logistic regression and survival models were used in the analyses to create the clinical prediction rules. Models developed in the derivation sample were validated in another sample of the study. RESULTS: American Society of Anesthesiologists Physical Status Classification System (ASA), Charlson comorbidity index (> = 4), age (>75 years), residual tumor (R2), TNM stage IV and log of lymph nodes ratio (> = -0.53) were predictors of 1-year mortality (C-index (95% CI): 0.865 (0.792-0.938)). Adjuvant chemotherapy was an additional predictor. Again ASA, Charlson Index (> = 4), age (>75 years), log of lymph nodes ratio (> = -0.53), TNM, and residual tumor were predictors of 2-year mortality (C-index:0.821 (0.766-0.876). Chemotherapy was also an additional predictor. CONCLUSIONS: These clinical prediction rules show very good predictive abilities of one and two years survival and provide clinicians and patients with an easy and quick-to-use decision tool for use in the clinical decision process while the patient is still in the index admission. ; This work was supported in part by grants from the Instituto de Salud Carlos III and by the European Regional Development Funds-ERDF (PS09/00314, PS09/00910, PS09/00746, PS09/00805, PI09/90460, PI09/90490, PI09/90453, PI09/90441, PI09/90397); Department of Health of the Basque Country (2010111098); the Research Committee of the Hospital Galdakao; and the thematic networks REDISSEC (Red de Investigación en Servicios de Salud en Enfermedades Crónicas)-of the Instituto de Salud Carlos III RD12/0001/0001 and Education, Politic Linguistic and Culture of the Basque Government IT620-13. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ; Sí