Safety and pharmacokinetics of Roscovitine (Seliciclib) in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa, a randomized, placebo-controlled study.

BACKGROUND: The orally available kinase inhibitor R-roscovitine has undergone clinical trials against various cancers and is currently under clinical evaluation against Cushing disease and rheumatoid arthritis. Roscovitine displays biological properties suggesting potential benefits in CF: it partially corrects F508del-CFTR trafficking, stimulates the bactericidal properties of CF alveolar macrophages, and displays anti-inflammatory properties and analgesic effects. METHODS: A phase 2 trial study (ROSCO-CF) was launched to evaluate the safety and effects of roscovitine in Pseudomonas aeruginosa infected adult CF patients carrying two CF causing mutations (at least one F508del-CFTR mutation) and harboring a FEV1 ≥40%. ROSCO-CF was a multicenter, double-blind, placebo-controlled, dose-ranging study (200, 400, 800 mg roscovitine, orally administered daily for 4 days/week/4 weeks). RESULTS: Among the 34 volunteers enrolled, randomization assigned 11/8/8/7 to receive the 0 (placebo)/ 200/400/800 mg roscovitine doses, respectively. In these subjects with polypharmacy, roscovitine was relatively safe and well-tolerated, with no significant adverse effects (AEs) other than five serious AEs (SAEs) possibly related to roscovitine. Pharmacokinetics of roscovitine were rather variable among subjects. No significant efficacy, at the levels of inflammation, infection, spirometry, sweat chloride, pain and quality of life, was detected in roscovitine-treated groups compared to the placebo-treated group. CONCLUSION: Roscovitine was relatively safe and well-tolerated in CF patients especially at the 200 and 400 mg doses. However, there were 5 subject withdrawals due to SAEs in the roscovitine group and none in the placebo group. The lack of evidence for efficacy of roscovitine (despite encouraging cellular and animal results) may be due to high pharmacokinetics variability, short duration of treatment, and/or inappropriate dosing protocol.

Interprofessional Communication Concerning Work-Related Musculoskeletal Disorders: A Qualitative Study.

Purpose Understanding and treating musculoskeletal disorders (MSDs) requires coordination between the numerous healthcare professionals involved, including occupational physicians (OPs), general practitioners (GPs) and social insurance physicians (SIPs). The main objective of this study was to assess communication between OPs, GPs and SIPs in the management of MSDs. Methods This is a qualitative study in the form of semi-structured interviews with OPs in the French region of Brittany. The interviews were conducted until data saturation was achieved. The interviews were fully coded and analysed thematically using NVivo® software. Results The interviews were carried out among 17 OPs from companies and external occupational healthcare services who treated employees from various activity sectors. Different communication channels were used depending on the interlocutor, though they were mainly contacted by mail or phone. Most of the communication passed through the patient, either verbally or in writing. No major failure was detected in communication between the various types of practitioners, but instances of communication were influenced by various factors such as differences in perception, representation and objectives, as well as by how well the physicians knew each other. A number of instances of non-communication were found. Conclusion This study showed that patients play a key role in the interactions between different practitioners. It also revealed that different types of professional relationships depend on the objectives of the various interlocutors, which in turn vary according to their roles and competences.

[What are the main factors assisting general practitioners in the development of educational strategies?] / Quels sont les facteurs prioritaires à mettre en œuvre pour développer une démarche éducative en médecine générale ?

General practitioners (GP) are in a special position to conduct educational strategies for their patients with chronic disease. Despite the GP's desire to be involved in patient education, this approach remains underdeveloped.Objective: To determine the factors required support the development of educational strategies in general practice from the GPs' perspective.Methods: Qualitative study based on a "modified nominal group technique" carried out among 21 GPs (not specifically trained in patient education) participating as investigators in an interventional study testing a structured educational strategy. The interventional study based on processes and tools specifically developed to suit general practice was held during their usual consultations. Thirty one patients with COPD were followed for 9 months.Results: GPs identified 23 specific factors restructured after the clarification-reformulation step in 6 main factors required for the development of educational strategies in general practice. The consensus revealed that reinforcement of initial and continuing medical training was the most frequently cited factor and was considered to be a priority. The development of inter- and intra-professional cooperation was the second leading factor to be taken into account.Conclusion: The improvement of GP training and the promotion of areas of cooperation could help GPs to develop educational strategies during their consultations. These results may provide insight to regional health agencies concerning the deployment of patient education in primary care.

[What Are the Main Factors Assisting General Practitioners in the Development of Educational Strategies?]

General practitioners (GP) are in a special position to conduct educational strategies for their patients with chronic disease. Despite the GP's desire to be involved in patient education, this approach remains underdeveloped.Objective: To determine the factors required support the development of educational strategies in general practice from the GPs' perspective.Methods: Qualitative study based on a "modified nominal group technique" carried out among 21 GPs (not specifically trained in patient education) participating as investigators in an interventional study testing a structured educational strategy. The interventional study based on processes and tools specifically developed to suit general practice was held during their usual consultations. Thirty one patients with COPD were followed for 9 months.Results: GPs identified 23 specific factors restructured after the clarification-reformulation step in 6 main factors required for the development of educational strategies in general practice. The consensus revealed that reinforcement of initial and continuing medical training was the most frequently cited factor and was considered to be a priority. The development of inter- and intra-professional cooperation was the second leading factor to be taken into account.Conclusion: The improvement of GP training and the promotion of areas of cooperation could help GPs to develop educational strategies during their consultations. These results may provide insight to regional health agencies concerning the deployment of patient education in primary care.

[Musculoskeletal disorders: Role of medical advisers and inter-professional relations]. / Troubles musculo-squelettiques?: rôles des médecins-conseils et relations interprofessionnelles.

INTRODUCTION: Musculoskeletal disorders (MSD) were responsible for 9.7 million days of sick leave in 2010 in France. They are also a leading cause of occupational exclusion. The objective was to study the role of medical advisers (Mas) in the care of patients with MSD and their interactions with general practitioners (GPs) and occupational health physicians (OPs). METHODS: We performed a qualitative study with semi-structured interviews with medical advisers from the Brittany region. Semistructured interviews were double-coded and were submitted to thematic analysis. RESULTS: Nine interviews were conducted with MAs from the general regime, agricultural regime, and independent workers regime. MAs described an increase in MSD, especially with complex forms. They explained that their activity was not limited to control, but that they also had an important role in limiting occupational exclusion. It is important to anticipate difficulties related to return to work in this setting. They reported contrasted but necessary relations with GPs who are at the centre of care. Return to work may require negotiation with OPs. CONCLUSION: Relations between MAs and GPs are partly based on control of prescriptions, which can create a climate of suspicion. Emphasizing the fight against occupational exclusion can provide new light on the role of MAs. Improving relations between MAs and GPs can be achieved by a better understanding of their respective roles.

The influence of academic discourses on medical students' identification with the discipline of family medicine.

PURPOSE: To understand the influence of academic discourses about family medicine on medical students' professional identity construction during undergraduate training. METHOD: The authors used a multiple case study research design involving international medical schools, one each from Canada, France, Spain, and the United Kingdom (UK). The authors completed the fieldwork between 2007 and 2009 by conducting 18 focus groups (with 132 students) and 67 semistructured interviews with educators and by gathering pertinent institutional documents. They carried out discursive thematic analyses of the verbatim transcripts and then performed within- and cross-case analyses. RESULTS: The most striking finding was the diverging responses between those at the UK school and those at the other schools. In the UK case, family medicine was recognized as a prestigious academic discipline; students and faculty praised the knowledge and skills of family physicians, and students more often indicated their intent to pursue family medicine. In the other cases, family medicine was not well regarded by students or faculty. This was expressed overtly or through a paradoxical academic discourse that stressed the importance of family medicine to the health care system while decrying its lack of innovative technology and the large workload-to-income ratio. Students at these schools were less likely to consider family medicine. CONCLUSIONS: These results stress the influence of academic discourses on medical students' ability to identify with the practice of family medicine. Educators must consider processes of professional identity formation during undergraduate medical training as they develop and reform medical education.

Family physicians' professional identity formation: a study protocol to explore impression management processes in institutional academic contexts.

BACKGROUND: Despite significant differences in terms of medical training and health care context, the phenomenon of medical students' declining interest in family medicine has been well documented in North America and in many other developed countries as well. As part of a research program on family physicians' professional identity formation initiated in 2007, the purpose of the present investigation is to examine in-depth how family physicians construct their professional image in academic contexts; in other words, this study will allow us to identify and understand the processes whereby family physicians with an academic appointment seek to control the ideas others form about them as a professional group, i.e. impression management. METHODS/DESIGN: The methodology consists of a multiple case study embedded in the perspective of institutional theory. Four international cases from Canada, France, Ireland and Spain will be conducted; the "case" is the medical school. Four levels of analysis will be considered: individual family physicians, interpersonal relationships, family physician professional group, and organization (medical school). Individual interviews and focus groups with academic family physicians will constitute the main technique for data generation, which will be complemented with a variety of documentary sources. Discourse techniques, more particularly rhetorical analysis, will be used to analyze the data gathered. Within- and cross-case analysis will then be performed. DISCUSSION: This empirical study is strongly grounded in theory and will contribute to the scant body of literature on family physicians' professional identity formation processes in medical schools. Findings will potentially have important implications for the practice of family medicine, medical education and health and educational policies.