Need of reduced and harmonized bureaucracy in multi-centre clinical research - a case-report from a Swiss trial

Introduction: We launched an investigator-initiated study (ISRCTN31181395) to evaluate the potential benefit of pharmacokinetic-guided dosage individualization of imatinib for leukaemiapatients followed in public and private sectors. Following approval by the research ethics committee (REC) of the coordinating centre, recruitment throughout Switzerland necessitatedto submit the protocol to 11 cantonal RECs.Materials and Methods: We analysed requirements and evaluation procedures of the 12 RECs with associated costs.Results: 1-18 copies of the dossier, in total 4300 printed pages, were required (printing/posting costs: ~300 CHF) to meet initial requirements. Meeting frequencies of RECs ranged between 2 weeks and 2 months, time from submission to fi rst feedback took 2-75 days. Study approval was obtained from a chairman, a subor the full committee, the evaluation work being invoiced by0-1000 CHF (median: 750 CHF, total: 9200 CHF). While 5 RECs gave immediate approval, the other 6 rose in total 38 queries before study release, mainly related to wording in the patient information, leading to 7 different fi nal versions approved. Submission tasks employed an investigator half-time over about 6 months.Conclusion: While the necessity of clinical research evaluation by independent RECs is undisputed, there is a need of further harmonization and cooperation in evaluation procedures. Current administrative burden is indeed complex, time-consuming and costly. A harmonized electronic application form, preferably compatible with other regulatory bodies and European countries, could increase transparency, improve communication, and encourage academic multi-centre clinical research in Switzerland.

Perception et communication du risque: du diabète à la maladie cardiovasculaire [Risk perception and communication: from diabetes to cardiovascular diseases].

Evidence-based medicine has enabled to approach disease in a more rational and scientific way. Clinical research has identified behaviours and risk factors that could cause disease often "silent" at the beginning, such as diabetes. Despite the clear impact of these evidences on public health, it seems that the individual risk perception level remains weak. To mention as well, the health professionals very often have a different views, which makes it difficult to communicate the risk with patients. In this article we describe the principles of risk perception, the diabetes related risk perception concerning cardiovascular complications, and suggest some practical strategies and tools which could improve risk communication in the everyday practice.

Editorial research and the publication process in biomedicine and health: Report from the Esteve Foundation Discussion Group, December 2012.

Despite the fact that there are more than twenty thousand biomedical journals in the world, research into the work of editors and publication process in biomedical and health care journals is rare. In December 2012, the Esteve Foundation, a non-profit scientific institution that fosters progress in pharmacotherapy by means of scientific communication and discussion organized a discussion group of 7 editors and/or experts in peer review biomedical publishing. They presented findings of past editorial research, discussed the lack of competitive funding schemes and specialized journals for dissemination of editorial research, and reported on the great diversity of misconduct and conflict of interest policies, as well as adherence to reporting guidelines. Furthermore, they reported on the reluctance of editors to investigate allegations of misconduct or increase the level of data sharing in health research. In the end, they concluded that if editors are to remain gatekeepers of scientific knowledge they should reaffirm their focus on the integrity of the scientific record and completeness of the data they publish. Additionally, more research should be undertaken to understand why many journals are not adhering to editorial standards, and what obstacles editors face when engaging in editorial research.

Underfunding of stroke research: a Europe-wide problem.

BACKGROUND AND PURPOSE: Previous studies in the United States and the United Kingdom have shown that stroke research is underfunded compared with coronary heart disease (CHD) and cancer research despite the high clinical and financial burden of stroke. We aimed to determine whether underfunding of stroke research is a Europe-wide problem. METHODS: Data for the financial year 2000 to 2001 were collected from 9 different European countries. Information on stroke, CHD, and cancer research funding awarded by disease-specific charities and nondisease-specific charity or government- funded organizations was obtained from annual reports, web sites, and by direct communication with organizations. RESULTS: There was marked and consistent underfunding of stroke research in all the countries studied. Stroke funding as a percentage of the total funding for stroke, CHD, and cancer was uniformly low, ranging from 2% to 11%. Funding for stroke was less than funding for cancer, usually by a factor of > or =10. In every country except Turkey, funding for stroke research was less than that for CHD. CONCLUSIONS: This study confirms that stroke research is grossly underfunded, compared with CHD and cancer, throughout Europe. Similar data have been obtained from the United States suggesting that relative underfunding of stroke research is likely to be a worldwide phenomenon.

Statistics in science and in society: From a state-of-the-art to a new research agenda

Statistics occupies a prominent role in science and citizens' daily life. This article provides a state-of-the-art of the problems associated with statistics in science and in society, structured along the three paradigms defined by Bauer, Allum and Miller (2007). It explores in more detail medicine and public understanding of science on the one hand, and risks and surveys on the other. Statistics has received a good deal of attention; however, very often handled in terms of deficit - either of scientists or of citizens. Many tools have been proposed to improve statistical literacy, the image of and trust in statistics, but with little understanding of their roots, with little coordination among stakeholders and with few assessments of impacts. These deficiencies represent as many new and promising directions in which the PUS research agenda could be expanded.

Speaking from the Inside: Challenges Faced by Communication Researchers Investigating Disease-Related Issues in a Hospital Setting.

This commentary came from within the framework of integrating the humanities in medicine and from accompanying research on disease-related issues by teams involving clinicians and researchers in medical humanities. The purpose is to reflect on the challenges faced by researchers when conducting emotionally laden research and on how they impact observations and subsequent research findings. This commentary is furthermore a call to action since it promotes the institutionalization of a supportive context for medical humanities researchers who have not been trained to cope with sensitive medical topics in research. To that end, concrete recommendations regarding training and supervision were formulated.

Communication skills training in oncology: it works!

While the previous chapter by L. Fallowfield and V. Jenkins focuses on different communication skills training (CST) concepts currently being utilized, this chapter reviews and comments the scientific evidence of the impact of CST on improving communication skills. The aim of this chapter is not to provide a complete review of the evidence-this has already been done in systematic reviews-but to discuss the scientific evidence and reflect on the available results and relevant topics for further investigations.

Attitudes and beliefs of palliative care physicians regarding communication with terminally ill cancer patients.

The subject of communication between palliative care physicians and their patients regarding their diagnosis and prognosis has not been extensively researched. The purpose of this survey was to compare the attitudes and beliefs of palliative care specialists regarding communication with the terminally ill in Europe, South America, and Canada. A sample of palliative care physicians from South America (Argentina and Brazil), French-speaking Europe, and Canada were identified, and posted a questionnaire. Physicians who stated that they practised palliative care at least 30% of their time were considered evaluable as palliative care specialists. Of a total of 272 questionnaires, 228 were returned (84%); and 182/228 (81%) respondents were considered to be palliative care specialists. Palliative care physicians in all three regions believed that cancer patients should be informed of their diagnosis and the terminal nature of their illness. Physicians reported that at least 60% of their patients knew their diagnosis and the terminal stage of their illness in 52% and 24% of cases in South America, and 69% and 38% of cases in Europe, respectively. All physicians agreed that 'do not resuscitate' orders should be present, and should be discussed with the patient in all cases. While 93% of Canadian physicians stated that at least 60% of their patients wanted to know about the terminal stage of their illness, only 18% of South American, and 26% of European physicians said this (P < 0.001). Similar results were found when the physicians were asked the percentage of families who want patients to know the terminal stage of their illness. However, almost all of the physicians agreed that if they had terminal cancer they would like to know. There was a significant association between patient based decision-making and female sex (P = 0.007), older age (P = 0.04), and physicians from Canada and South America (P < 0.001). Finally, in their daily decision making, South American physicians were significantly more likely to support beneficence and justice as compared with autonomy. Canadian physicians were more likely to support autonomy as compared with beneficence. In summary, our findings suggest that there are major regional differences in the attitudes and beliefs of physicians regarding communication at the end of life. More research is badly needed on the attitudes and beliefs of patients, families, and health care professionals in different regions of the world.

The Political Communication of Independent Regulatory Agencies

Since independent regulatory agencies (IRAs) became key actors in European regulatory governance in the 1990s, a significant share of policy-making has been carried out by organizations that are neither democratically elected nor directly accountable to elected politicians. In this context, public communication plays an important role. On the one hand, regulatory agencies might try to use communication to raise their accountability and thereby to mitigate their democratic deficit. On the other hand, communication may be used with the intent to steer the behavior of the regulated industry when more coercive regulatory means are unfeasible or undesirable. However, empirical research focusing directly on how regulators communicate is virtually non-existent. To fill this gap, this paper examines the public communication of IRAs in four countries (the United Kingdom, Germany, Ireland, and Switzerland) and three sectors (financial services, telecommunications, and broadcasting). The empirical analysis, based on qualitative interviews and a quantitative content analysis, indicates that the organization of the communication function follows a national pattern approach while a policy sector approach is helpful for understanding the use of communication as a soft tool of regulation.

The Political Communication of Independent Regulatory Agencies

Since independent regulatory agencies (IRAs) became key actors in European regulatory governance in the 1990s, a significant share of policy-making has been carried out by organizations that are neither democratically elected nor directly accountable to elected politicians. In this context, public communication plays an important role. On the one hand, regulatory agencies might try to use communication to raise their accountability and thereby to mitigate their democratic deficit. On the other hand, communication may be used with the intent to steer the behavior of the regulated industry when more coercive regulatory means are unfeasible or undesirable. However, empirical research focusing directly on how regulators communicate is virtually non-existent. To fill this gap, this paper examines the public communication of IRAs in four countries (the United Kingdom, Germany, Ireland, and Switzerland) and three sectors (financial services, telecommunications, and broadcasting). The empirical analysis, based on qualitative interviews and a quantitative content analysis, indicates that the organization of the communication function follows a national pattern approach while a policy sector approach is helpful for understanding the use of communication as a soft tool of regulation.

Cross-Cultural Communication in Oncology: Challenges and Training Interests.

PURPOSE/OBJECTIVES: To survey oncology nurses and oncologists about difficulties in taking care of culturally and linguistically diverse patients and about interests in cross-cultural training.
. DESIGN: Descriptive, cross-sectional.
. SETTING: Web-based survey.
. SAMPLE: 108 oncology nurses and 44 oncologists. 
. METHODS: 31-item questionnaire derived from preexisting surveys in the United States and Switzerland.
. MAIN RESEARCH VARIABLES: Self-rated difficulties in taking care of culturally and linguistically diverse patients and self-rated interests in cross-cultural training.
. FINDINGS: All respondents reported communication difficulties in encounters with culturally and linguistically diverse patients. Respondents considered the absence of written materials in other languages, absence of a shared common language with patients, and sensitive subjects (e.g., end of life, sexuality) to be particularly problematic. Respondents also expressed a high level of interest in all aspects of cross-cultural training (task-oriented skills, background knowledge, reflexivity, and attitudes). Nurses perceived several difficulties related to care of migrants as more problematic than physicians did and were more interested in all aspects of cross-cultural training. 
. CONCLUSIONS: The need for cross-cultural training is high among oncology clinicians, particularly among nurses.
. IMPLICATIONS FOR NURSING: The results reported in the current study may help nurses in decision-making positions and educators in introducing elements of cross-cultural education into oncology curricula for nurses. Cross-cultural training should be offered to oncology nurses.

Nouveautés dans l'ostéogenèse imparfaite: de la recherche à la prise en charge multidisciplinaire [News in osteogenesis imperfecta: from research to clinical management]

Osteogenesis imperfecta (OI) is a rare genetic disease. Today we are able to propose an adapted and efficient management to the patients with this rare disorder (and their families) thanks to a strong collaboration of clinicians and researchers. Recent knowledge regarding the genetics of OI permits an accurate diagnosis of the specific type of OI and its own molecular mechanism, a genetic counseling for family planning and prenatal diagnosis, and in addition more targeted therapeutic options. A specific support with re-education for patients with OI is necessary and efficient. To optimize patient care, a multidisciplinary consultation is proposed at the CHUV, moreover a web site is available for patients, families and therapists: www.infomaladiesrares.ch