Towards a European Clinical Research Infrastructures Network: the ECRIN programme

On the basis of the interconnection of national networks of clinical research centres (CRCs) and clinical trials units (CTUs), the European Clinical Research Infrastructures Network (ECRIN) programme aims to develop an infrastructure allowing for bottom-up harmonisation of the support and training for, and practice of, clinical research, and to provide public sponsors for biotechnology small and medium-sized companies (SMEs) with support for translational research and multicentre clinical studies in Europe. This will be achieved through an application to the next FP6 'Integrated Infrastructure Initiatives' call. However, prior work is required to improve the reciprocal knowledge of partners in the ECRIN consortium and, as a first step, country-specific workshops will be organised by national networks in order to address the organisation of CRC/CTUs and national networks, and their interaction with the national environment of clinical research; this will enable in-depth discussion addressing the bottlenecks hampering transnational studies.     

Building complementary and alternative health care research capacity: workshop report

Lack of research into the safety and efficacy of CAM has been identified as a barrier to collaboration between conventional and CAM practitioners. As an initial step to address this issue, Health Canada held an invitational roundtable discussion with researchers, practitioners and policy makers to explore specific issues related to CAM research capacity and literacy. The objectives of this workshop were to identify and prioritize CAM research infrastructure and training needs; and to identify strategies for meeting high priority needs. Eleven individuals representing three CAM groups, university-based researchers with experience in CAM research, and policy makers attended. Discussion focussed around research literacy, capacity, funding and leadership. Several recommendations were made including an advisory group, a needs assessment, support for research networks, development of learning modules, a review of existing research programmes, support for centres of excellence in CAM research, and funding for research meetings.     

Medical record keeping in France: the French PMSI system and anaesthesiology

Conclusion For the physician, an understanding of cost-management is indispensable to preserving his independence. The PMSI system, based on medical data, as implemented by physicians, and recognized by the management staff, has demonstrated itself as a useful tool in the discussion between medical and management staffs, and the Health Authority. For anaesthesiology, its use is not only interesting, but an absolute necessity for departmental management. And, all of this is made possible with the help of computers and a medical information department for processing the data.Information systems are important for achieving a balance between cost and quality of care.     

Conference report: interdisciplinary workshop in the philosophy of medicine: parentalism and trust

On 13 June 2014, the Centre for the Humanities and Health at King's College London hosted a 1‐day workshop on ‘parentalism and trust’. This workshop was the sixth in a series of workshops whose aim is to provide a new model for high‐quality open interdisciplinary engagement between medical professionals and philosophers. This report briefly describes the workshop methodology and the discussions on the day.     

The attractive position of France in international clinical research: 2006 survey assessed by Leem (French pharmaceutical companies)

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Initiated in 2006, the current survey was much more representative than the previous ones with 20 companies accounting for 61% of the French market. This survey included 352 international phase II and III clinical studies carried out in 2004 and 2005, 74 countries, 17 345 centres and 137 989 patients. France has participated to half of the overall number of international clinical trials. France ranked among the best European recruiters (0,19 patient/1000 inhabitants) at the second position behind Scandinavian countries, taking in account numbers of inhabitants. Protocols are now to be given the go-ahead by Ethics Committee (CCPPRB) within 60 days. With a high productivity in phase IIb and in oncology, France is still an attractive place to locate clinical research.     

Non-mediastinal grey zone lymphomas and report from the workshop

Grey zone lymphomas represent borderline lesions between classical Hodgkin lymphoma (cHL) and other morphologically and immunophenotypically related diseases and entities like nodular lymphocyte predominant HL, T-cell rich B-cell lymphoma, ALK-negative anaplastic large cell lymphoma (ALCL), diffuse large B cell lymphoma (DLBCL) anaplastic variant and primary mediastinal LBCL. The sharp definition of morphological, immunophenotypical and molecular features of the "text-book cases" of each disease and the comparison with grey zone cases has reduced most of the latter cases. Two reports in this workshop dealt with the problematic non-mediastinal grey zone lymphomas, one with a cHL of T cell-type presenting in the skin as a ALK-negative ALCL and the other with the grey zone between cHL of B-cell type and ALK-negative ALCL.     

Innovating across disciplines: report on a national workshop of stakeholders in Australia

The most effective innovations in healthcare require the input of multidisciplinary teams working from white board to bedside. Innovations must ultimately deliver tangible results in the real world. The skills required at each stage of the development from drawing board to bench top and from the lab to the clinic may be entirely unrelated. The key results at each stage also vary depending on perspective; they may be acclaim and awards, sales and profits or improved clinical parameters. As teams are enlisted on a specific challenge they each focus primarily on their own key performance indicators. In this paper we report the deliberations at a workshop involving a variety of disciplines working in healthcare. The participants emphasised the need for clear agreement on three aspects: the outputs of the project including the financial and intellectual property rights; the risks, costs and benefits; and the timelines for completion. A lead organisation must broker and maintain relationships ideally facilitated by an experienced project manager. The greatest challenges were highlighted as: the return on investment for commercial partners; the timelines for academic outputs; and the potential for disruption of clinical practice routines.     

Clinical research 6: writing and research

This six-part research series is aimed at clinicians who wish to develop research skills, or who have a particular clinical problem that they think could be addressed through research. The series aims to provide insight into the decisions that researchers make in the course of their work, and to also provide a foundation for decisions that nurses may make in applying the findings of a study to practice in their own Unit or Department. The series emphasises the practical issues encountered when undertaking research in critical care settings; readers are encouraged to source research methodology textbooks for more detailed guidance on specific aspects of the research practice.     

Cancer-Related Symptom Assessment in France: Validation of the French M. D. Anderson Symptom Inventory

This multicenter study was intended to validate the French version of the M. D. Anderson Symptom Inventory (MDASI-Fr) in French cancer patients (n = 162) with solid tumors or hematological malignancies. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used as a part of the validation. Factor analysis showed three underlying constructs for symptom items: general symptoms (pain, fatigue, disturbed sleep, shortness of breath, drowsiness, dry mouth, and numbness or tingling items); emotional and cognitive components (distress, sadness, and remembering items); and a gastrointestinal component (nausea, vomiting, and lack of appetite items), with Cronbach's alphas of 0.79, 0.73, and 0.71, respectively. Convergent validity was established by comparing MDASI-Fr items with the EORTC QLQ-C30 scale and the Brief Pain Inventory (BPI). Overall, the 19-item MDASI-Fr score correlated well with the QLQ-C30 global health status, and the pain item of the MDASI-Fr was highly correlated with the short form of the BPI. The most prevalent symptoms were fatigue, distress, dry mouth, and pain. Twenty-five percent of patients reported moderate or severe pain (numeric rating scale >4 on 0–10 severity ratings). Physician ratings of global change on a second visit were significantly associated with changes in patient ratings on the MDASI-Fr, supporting the sensitivity of the measure. Symptoms interfered most with work and general activity. The MDASI-Fr is a valid and reliable tool for measuring symptom severity and interference in French cancer patients.     

France, an attractive country for international clinical research: 2010 survey assessed by Leem (French association of pharmaceutical companies)

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Twenty-nine companies (72% of the French market) including 10 newly participants, have participated in the current survey which included 328 international phase II and III clinical studies, 79 countries, 24,337 centres and 249,704 patients (included in 2008/2009). France (291 patients/million inhabitants) ranked among the best European recruiters in second position behind Scandinavia. Since 2008, protocols are still to be given the go-ahead by French Authorities (Afssaps and CPP) within 60 days, in accordance with European directive. The continuation of reduction in deadlines for hospital contracts is encouraging and highlights the positive effect of CeNGEPS. French state-of-art is well recognized in Oncology/Hematology and Orphan disease which could be an example to improve the competitiveness of France in other key therapeutic areas such as Alzheimer's disease and Immuno-Inflammation.     

Promoting critical appraisal of the research literature: a workshop for school nurses

To promote healthy lifestyles and prevent youth obesity, school nurses collaborate with teachers and other professionals to implement effective health promotion activities (e.g., physical fitness initiatives and nutrition education). Critical appraisal of relevant, published literature is an essential competency for school nurses engaged in health promotion within their schools. A 1-day continuing education workshop was conducted to enhance literature appraisal skills needed for evidence-based practice among school nurses employed within one urban school district. Forty-six school nurses, students, and other professionals attended this workshop and participated in appraisals of selected research articles. Although the attendees rated the faculty and content highly, their intent to apply the findings to practice was limited. Applying a critical appraisal approach to the literature focused on youth obesity prevention and health promotion was innovative for educating school nurses in this process while helping them choose whether and how existing literature may be applied to their practice. Nurse educators and faculty may replicate this process with school nurses or other nursing specialties.     

Apheresis registry in France: indications, techniques, and complications. French Registry Study Group.

The French Registry for Plasma Exchange (PE) was set up in 1985. For 13 years it has allowed for the analysis of the techniques used, along with the indications and complications. After a decrease in the number of participating centers due to the heaviness of the data collection mode, the telematic network created in 1991 led to a new increase in participants from 26 in 1990 to 69 in 1998. Follow-up shows a slight fall in activity since some protocols ended, while the neurological pathologies remain the most frequent indicators. The important modifications observed over the years are the increase of the centrifugation technique, the development of plasma treatment, and the plasma substitution by an association of albumin-pentastarch. The French Registry for plasma exchange is the largest data base dealing with therapeutic hemapheresis. The registry set-up through the internet is the first step toward an international data base.     

Clinical research 2: Legal and ethical issues in research

This research series is aimed at clinicians who wish to develop research skills, or who have a particular clinical problem that they think could be addressed through research. The series aims to provide insight into the decisions that researchers make in the course of their work, and to also provide a foundation for decisions that nurses may make in applying the findings of a study to practice in their own Unit or Department. The series emphasises the practical issues encountered when undertaking research in critical care settings; readers are encouraged to source research methodology textbooks for more detailed guidance on specific aspects of the research process.