The purpose of this study was to describe the characteristics of patients with bronchiolitis admitted to a paediatric intensive care unit (PICU), and to evaluate a national registry of hospitalizations (Programme de Médicalisation des Systèmes d'Information; PMSI) as a potential source of epidemiological data. Of the 49 French PICUs invited to take part in a retrospective survey of children aged <2 years who were hospitalized during the 2005-2006 epidemic season, 24 agreed to participate. Overall, 467 children were enrolled: 75% were aged <2 months, 76% had positive respiratory syncytial virus (RSV) tests, 34·9% required non-invasive ventilation, 36·6% were mechanically ventilated, and six infants died. The main neonatal characteristics were: prematurity (31·9%), respiratory disease (16·5%), congenital heart disease (6·4%), receiving mechanical ventilation (11·6%), and bronchopulmonary dysplasia at day 28 (3·8%). For bronchiolitis episode, the kappa coefficient between the survey and PMSI data was good only for mechanical ventilation (0·63) and the death rate (0·86).
Objective: This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and costeutility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). Design: 120 patients with medial knee OA (VAS pain at rest >40/100), classified as KellgreneLawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and costeutility over 1 year were also assessed. Results: The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of À11.8; 95% CI: À21.1 to À2.5); all KOOS subscales (pain: þ8.8; 95% CI: 1.4e16.2); other symptoms (þ10.4; 95% CI: 2.7e18); function in activities of daily living (þ9.2; 95% CI: 1.1e17.2); function in sports and leisure (þ12.3; 95% CI: 4.3e20.3); quality of life (þ9.9; 95% CI: 0.9e15.9), OAKHQOL subscales (pain: þ14.8; 95% CI: 5.0e24.6); and physical activities (þ8.2; 95% CI: 0.6e15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of V45 000 per QALY.
Introduction
The organization of health care for breast cancer (BC) constitutes a public health challenge to ensure quality of care, while also controlling expenditure. Few studies have assessed the global care pathway of early BC patients, including a description of direct medical costs and their determinants. The aims of this multicenter prospective study were to describe care pathways of BC patients in a geographic territory and to calculate the global direct costs of early stage BC during the first year following diagnosis.
Methods
OPTISOINS01 was a multicenter, prospective, observational study including early BC patients from diagnosis to one-year follow-up. Direct medical costs (in-hospital and out-of-hospital costs, supportive care costs) and direct non-medical costs (transportation and sick leave costs) were calculated by using a cost-of-illness analysis based on a bottom-up approach. Resources consumed were recorded
in situ
for each patient, using a prospective direct observation method.
Results
Data from 604 patients were analyzed. Median direct medical costs of 1 year of management after diagnosis in operable BC patients were €12,250. Factors independently associated with higher direct medical costs were: diagnosis on the basis of clinical signs, invasive cancer, lymph node involvement and conventional hospitalization for surgery. Median sick leave costs were €8,841 per patient and per year. Chemotherapy was an independent determinant of sick leave costs (€3,687/patient/year without chemotherapy versus €10,706 with chemotherapy). Forty percent (n = 242) of patients declared additional personal expenditure of €614/patient/year. No drivers of these costs were identified.
Conclusion
Initial stage of disease and the treatments administered were the main drivers of direct medical costs. Direct non-medical costs essentially consisted of sick leave costs, accounting for one-half of direct medical costs for working patients. Out-of-pocket expenditure had a limited impact on the household.
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