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PURPOSE: Conventional osteosarcoma is an orphan disease. Current treatment approaches include combining a three drug chemotherapy schedule and surgery. The 3- and 5-year event-free survival (EFS) in localized disease is roughly 65 and 60%, respectively. The registration study of mifamurtide reported survival benefit, but some methodological controversies have been insufficient for FDA market authorization in contrast to EMA. METHODS: prospective single centre survival analysis of a mifamurtide addition to conventional therapy in 23 patients over a 5.5 year enrolment period is reported and compared to a historical control of 26 patient with localized disease. Bias arising from observational methodology was addressed using Landmark analysis and time-dependent Cox models. Blood count dynamics were analysed during the treatment. RESULTS: The adverse event profile was as expected with no dose limiting toxicities. There were no local relapses observed, one patient died in the first complete remission due to doxorubicin cardiotoxicity, one patient had pulmonary metastatic relapse. The observed 3- and 5-year EFS was 87.4% (CI 72.4-100%) and 87.4% (CI 72.4-100%), progression free survival (PFS) was 92.9% (CI 80.3-100%) and 92.9% (CI 80.3-100%), overall survival was 94.1% (CI 83.6-100) and 80.7% (CI 58.3-100), respectively. Comparison to the historical control showed statistically significant better PFS for mifamurtide patients (Landmark analysis; p = 0.044). Risk of progression was 5-times lower for the mifamurtide group (Cox model; HR 0.21, p = 0.136). Only subtle differences in lymphocyte counts were observed across treatment. CONCLUSION: the PFS benefit of mifamurtide is reported herein. The addition of mifamurtide could be considered as a best treatment option for localized osteosarcoma.
RESUMO
BACKGROUND: Exposure to patient or user suicide (PUS) is identified as a challenging occupational hazard for mental health and social work professionals. Professionals exposed to PUS may encounter several ranges of emotional, traumatic or professional impacts in the aftermath. A high proportion of exposed professionals reports a lack of support in the aftermath of PUS. SUPPORT is a postvention program designed to provide a comprehensive, adaptative and effective support to professionals impacted by PUS. The aims of the SUPPORT-S study are to (1) improve the design of the SUPPORT program, (2) evaluate the effectiveness of the program to buffer the emotional, traumatic and professional impacts and to improve the perceived social support for professionals exposed to PUS, and (3) provide more insights into the consequences of PUS on both professionals and organizations. METHOD: The SUPPORT-S study is a mixed method collaborative and participatory action research. The simultaneous and complementary collection and analysis of qualitative and quantitative data will offer an in-depth evaluation of the implementation and the effectiveness of the program. The qualitative evaluation includes: (a) an ethnographic observation; (b) 25 semi-directed interviews with randomized participants; (c) an activity analysis with providers of the program; and (d) collaborative sharing of the results with providers and participants. The quantitative evaluation includes pre- and post-measures in participants of: (a) emotional impact (Differential Emotions Scale IV); (b) traumatic impact (Impact of Event Scale-Revised); (c) professional impact (non-validated questionnaire); and (d) perceived social support (Perceived Social Support Scale for Professionals). The action research design will rely on: (a) the cycling process of implementation/evaluation/data sharing/adjustment and (b) the participatory approach through data sharing with providers and participants. Triangulation, saturation, randomization, and participatory design will also reduce the risk of biases and will improve the generalizability of conclusions. EXPECTED RESULTS: We expect the SUPPORT-S study to evaluate and improve the design of the SUPPORT program to effectively help professionals to cope with PUS. CONCLUSION: The results of the study will allow us to disseminate an effective and adaptive postvention program for professionals and institutions encountering PUS.
RESUMO
Based on summarizing the international experiences and reviewing the historical evolution and current situation of the physicians'compensation system of public hospitals in China,this paper clarified the existing problems of the current compensation system.Such problems namely included lack of security on the source of the physicians'compensation,low level of sunshine salary which caused thecompensatory mechanism,lack of scientific design of the salary structure and allocation,as well as other underlying causes.Drawing lessons from reform practices at home and abroad,the basic principles and reform directions were put forward,as well as 4 route selections,namely establishing an security investment system to guarantee a stable and higher level salary under the current compensation system, implementing a high level of flip-type annual compensation with locking the current salary into files, establishing an appropriate compensation system referring to an innovated evaluation system of physicians in public hospitals,and coordinating closely with public institution reforms to promote physicians' compensation system reform.