Inequities in occupational diseases recognition in France.

BACKGROUND: In France, complex cases of occupational disease (OD) are submitted to regional committees who are in charge of accepting, or rejecting, the claim. Their mean annual acceptance rate varies from one region to another, which may reflect differences in the cases, or discrepancies between committees. The objective of this study was to assess the comparability of the decisions of the committees on the basis of standardized cases. METHODS: Three experienced occupational physicians specialized in OD were asked to develop 28 clinical cases representative of claims for compensation usually seen in these committees. The cases, in the form of short vignettes, were submitted to the 18 French regional committees, asking if they would recognise each case as an OD. RESULTS: All committees participated. The acceptance rate (recognition of the case as an OD) varied, ranging from 18% to 70%. All the committees took the same decision for only 7 out of the 28 cases, but half accepted and half refused for 3 cases. For 10 cases, one quarter of the committees gave a decision different than the other 75%. The highest discordance rates were observed for the cases concerning musculoskeletal disorders and asbestos related diseases. CONCLUSION: The committees take very different decisions in terms of recognition of OD, especially for the most frequently compensated OD in France, i.e. musculoskeletal disorders and asbestos related diseases. This is a major source of injustice for the employees who seek compensation and there is a need to develop methods to harmonize decisions between committees.

Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer.

Background: A nivolumab monotherapy flat-dosing regimen of 480 mg every 4 weeks (Q4W) has been approved in several markets, including the United States, Canada, and European Union, as an alternative dosing regimen for several indications. Approvals of this Q4W regimen were based on population pharmacokinetic (PK) analyses, established flat exposure-response relationships, and clinical safety. The objective of this study was to compare the PK exposure of 480 mg Q4W with 3 mg/kg every 2 weeks (Q2W) and 240 mg Q2W using modeling and simulation, and to evaluate clinical safety of the Q4W regimen. Patients and methods: Nivolumab PK exposure for the 480 mg Q4W schedule was simulated for 3817 patients across multiple tumor types and compared with those for the 3 mg/kg Q2W and 240 mg Q2W schedules. The safety profile of the Q4W schedule was assessed by analysis of clinical data from 61 patients who transitioned to nivolumab 480 mg Q4W from 3 mg/kg Q2W during four phase III clinical trials. Results: Compared with 3 mg/kg Q2W, nivolumab 480 mg Q4W produced similar time-averaged concentration, approximately 16% lower trough concentration, and 45% higher peak concentration at steady state. The peak concentration for 480 mg Q4W was significantly lower than that of 10 mg/kg Q2W, a dose previously shown to have an acceptable tolerability and safety profile. Treatment-related adverse events (TRAEs) that started after transitioning from 3 mg/kg Q2W to 480 mg Q4W were reported in 14.8% of patients, with 1.6% of patients reporting grades 3-4 TRAEs. Pooled safety data for these patients are consistent with those for the 3 mg/kg Q2W schedules, and no new safety signals were identified. Conclusions: The time-averaged steady-state exposure and safety profile of nivolumab 480 mg Q4W are consistent with that of 3 mg/kg Q2W across multiple tumor types. Nivolumab 480 mg Q4W represents a new dosing schedule option, and in addition to 240 mg Q2W, provides convenience and flexibility for patient care. Clinical trial numbers: NCT01721772, NCT01668784, NCT01673867, NCT01642004.

Multidisciplinary department of "Return to Work After a Cancer": a French experience of support groups for vocational rehabilitation.

This qualitative pilot exploratory study focuses on support groups for vocational rehabilitation after cancer implemented in a French and innovative multidisciplinary department of "Return to Work after a Cancer." Sixty-three patients were invited to participate to constitute two support groups of 20 participants. Questionnaires are sent to assess their benefit according to the participants' point of view. For 58% of participants, support groups helped the return to work, and for 70% it provided personal, family, and relational support. Support groups are a relevant response to expectations and specific issues of patients experiencing return to work after cancer.

Follow-up of children suffering from lead poisoning or at risk of lead poisoning in Greater Paris, 1992--2002.

BACKGROUND: It is essential for children suffering from or at risk of lead poisoning to have regular follow-up, and specifically for their blood lead (Pb) levels to be monitored. The present study assessed the occurrence of late follow-up testing of blood lead levels in children in Greater Paris, and factors related to such delays. METHODS: Since 1992, the SSSIILF has been systematically recording data on lead levels in blood tests conducted for screening and follow-up in Greater Paris. For Pb greater or equal to 45 microg/dL (Group 4), a further blood lead test has to be done within three weeks. For levels of 25 microg/dL < or = Pb < 45 microg/dL (Group 3) and 10 microg/dL < or = Pb < 25 microg/dL (Group 2), a second test must be done within 6 months. For Pb less than 10 microg/dL combined with one or more risk factors (Group 1: children at risk of poisoning), a second test is required within 6 to 12 months. Children aged 1 to 6 years who were screened between 1992 and 2002 were selected. The occurrence of late follow-up testing was estimated, and the independent effect of each variable associated with a delay was measured using a logistic regression model. RESULTS: Delays in re-testing were reported for 66.9% of Group 4 children (n=356), 45.3% of Group 3 children (n=921), 74.1% of Group 2 children (n=5,466), and 88.7% of Group 1 children (n=15,612). In the three groups with Pb greater or equal to 10 microg/dL, there was better follow-up (i.e. less delay to re-testing) for children screened most recently, those whose initial blood lead test results were elevated, those who lived in sub-standard housing built before 1949, and those who lived in suburban districts of Paris. The delay was longer for children aged 4 to 6 compared to younger children. When the size of the group was large enough, these differences were significant. In Group 1, similar results were observed except for a home address in a suburban district. Furthermore, follow-up was better for children of Sub-Saharan African parents, children whose initial prescription had been issued by a "PMI" mother/child healthcare centre and children from large families. CONCLUSION: Despite substantial delays in carrying out follow-up blood lead level testing, these delays were shorter for the populations with the greatest exposure.