Reference intervals for common carotid intima-media thickness measured with echotracking: relation with risk factors

AIMS Common carotid artery intima-media thickness (CCIMT) is widely used as a surrogate marker of atherosclerosis, given its predictive association with cardiovascular disease (CVD). The interpretation of CCIMT values has been hampered by the absence of reference values, however. We therefore aimed to establish reference intervals of CCIMT, obtained using the probably most accurate method at present (i.e. echotracking), to help interpretation of these measures. METHODS AND RESULTS We combined CCIMT data obtained by echotracking on 24 871 individuals (53% men; age range 15-101 years) from 24 research centres worldwide. Individuals without CVD, cardiovascular risk factors (CV-RFs), and BP-, lipid-, and/or glucose-lowering medication constituted a healthy sub-population (n = 4234) used to establish sex-specific equations for percentiles of CCIMT across age. With these equations, we generated CCIMT Z-scores in different reference sub-populations, thereby allowing for a standardized comparison between observed and predicted ('normal') values from individuals of the same age and sex. In the sub-population without CVD and treatment (n = 14 609), and in men and women, respectively, CCIMT Z-scores were independently associated with systolic blood pressure [standardized βs 0.19 (95% CI: 0.16-0.22) and 0.18 (0.15-0.21)], smoking [0.25 (0.19-0.31) and 0.11 (0.04-0.18)], diabetes [0.19 (0.05-0.33) and 0.19 (0.02-0.36)], total-to-HDL cholesterol ratio [0.07 (0.04-0.10) and 0.05 (0.02-0.09)], and body mass index [0.14 (0.12-0.17) and 0.07 (0.04-0.10)]. CONCLUSION We estimated age- and sex-specific percentiles of CCIMT in a healthy population and assessed the association of CV-RFs with CCIMT Z-scores, which enables comparison of IMT values for (patient) groups with different cardiovascular risk profiles, helping interpretation of such measures obtained both in research and clinical settings.

Addition of bevacizumab to chemotherapy in acute myeloid leukemia at older age: a randomized phase 2 trial of the Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and the Swiss Group for Clinical Cancer Research (SAKK)

An urgent need for new treatment modalities is emerging in elderly patients with acute myeloid leukemia (AML). We hypothesized that targeting VEGF might furnish an effective treatment modality in this population. Elderly patients with AML were randomly assigned in this phase 2 study (n = 171) to receive standard chemotherapy (3 + 7) with or without bevacizumab at a dose of 10 mg/kg intravenously at days 1 and 15. In the second cycle, patients received cytarabine 1000 mg/m(2) twice daily on days 1-6 with or without bevacizumab. The complete remission rates in the 2 arms were not different (65%). Event-free survival at 12 months was 33% for the standard arm versus 30% for the bevacizumab arm; at 24 months, it was 22% and 16%, respectively (P = .42). The frequencies of severe adverse events (SAEs) were higher in the bevacizumab arm (n = 63) compared with the control arm (n = 28; P = .043), but the percentages of death or life-threatening SAEs were lower in the bevacizumab arm (60% vs 75% of SAEs). The results of the present study show that the addition of bevacizumab to standard chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR904 in The Nederlands Trial Register (www.trialregister.nl).

Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group

This phase III trial compared the efficacy and safety of gemcitabine (Gem) plus capecitabine (GemCap) versus single-agent Gem in advanced/metastatic pancreatic cancer.

Standard procedures for adults in accredited sleep medicine centres in Europe

The present paper describes standardized procedures within clinical sleep medicine. As such, it is a continuation of the previously published European guidelines for the accreditation of sleep medicine centres and European guidelines for the certification of professionals in sleep medicine, aimed at creating standards of practice in European sleep medicine. It is also part of a broader action plan of the European Sleep Research Society, including the process of accreditation of sleep medicine centres and certification of sleep medicine experts, as well as publishing the Catalogue of Knowledge and Skills for sleep medicine experts (physicians, non-medical health care providers, nurses and technologists), which will be a basis for the development of relevant educational curricula. In the current paper, the standard operational procedures sleep medicine centres regarding the diagnostic and therapeutic management of patients evaluated at sleep medicine centres, accredited according to the European Guidelines, are based primarily on prevailing evidence-based medicine principles. In addition, parts of the standard operational procedures are based on a formalized consensus procedure applied by a group of Sleep Medicine Experts from the European National Sleep Societies. The final recommendations for standard operational procedures are categorized either as 'standard practice', 'procedure that could be useful', 'procedure that is not useful' or 'procedure with insufficient information available'. Standard operational procedures described here include both subjective and objective testing, as well as recommendations for follow-up visits and for ensuring patients' safety in sleep medicine. The overall goal of the actual standard operational procedures is to further develop excellence in the practice and quality assurance of sleep medicine in Europe.

Cooperative VET in Training Networks: Analysing the Free-Rider Problem in a Sociology-of-Conventions Perspective

In training networks, particularly small and medium-sized enterprises pool their resources to train apprentices within the framework of the dual VET system, while an intermediary organisation is tasked with managing operations. Over the course of their apprenticeship, the apprentices switch from one training company to another on a (half-) yearly basis. Drawing on a case study of four training networks in Switzerland and the theoretical framework of the sociology of conventions, this paper aims to understand the reasons for the slow dissemination and reluctant adoption of this promising form of organising VET in Switzerland. The results of the study show that the system of moving from one company to another creates a variety of free-rider constellations in the distribution of the collectively generated corporative benefits. This explains why companies are reluctant to participate in this model. For the network to be sustainable, the intermediary organisation has to address discontent arising from free-rider problems while taking into account that the solutions found are always tentative and will often result in new free-rider problems.

Collaborative Research in Childhood Cancer Survivorship: The Current Landscape.

Survivors of childhood cancer carry a substantial burden of morbidity and are at increased risk for premature death. Furthermore, clear associations exist between specific therapeutic exposures and the risk for a variety of long-term complications. The entire landscape of health issues encountered for decades after successful completion of treatment is currently being explored in various collaborative research settings. These settings include large population-based or multi-institutional cohorts and single-institution studies. The ascertainment of outcomes has depended on self-reporting, linkage to registries, or clinical assessments. Survivorship research in the cooperative group setting, such as the Children's Oncology Group, has leveraged the clinical trials infrastructure to explore the molecular underpinnings of treatment-related adverse events, and to understand specific complications in the setting of randomized risk-reduction strategies. This review highlights the salient findings from these large collaborative initiatives, emphasizing the need for life-long follow-up of survivors of childhood cancer, and describing the development of several guidelines and efforts toward harmonization. Finally, the review reinforces the need to identify populations at highest risk, facilitating the development of risk prediction models that would allow for targeted interventions across the entire trajectory of survivorship.

New Sites, New Challenges? Ethical and Methodological Questions in the Context of Research on Migration Exclusion

The challenges of research ethics and methodologies have been reflected on extensively, but – aside from the context of feminist methodologies – less so in relation to research on particular migration sites such as in transit, detention centres, at the borders or within migration administration. First attempts in this direction have been made (Düvell et al. 2010, Fresia et al. 2005, Riedner 2014, van Liempt/Bilger2009), however, more reflection and theorization is needed, considering the contested nature of these temporal and volatile sites. In this workshop, we thus aim at examining methodological as well as ethical questions that arise during field work: We attempt to reflect the power relations involved in the research process, the ethics of research design, the dissemination of research results, the question of gaining access to and – whenever necessary – staying in contact with our research subjects. How can we negotiate informed consent with subjects whose life is currently marked by transit and insecurity concerning their own future, and who are in an uncertain situation in which substantial information (legal, social, cultural etc.) is likely to be missing? How do we deal with the dilemma of possibly contributing to knowledge production that might facilitate removals and deportations in the future, considering that the reception of the results is not in the hands of the researchers? How do we deal with the anticipated as well as unexpected impacts of our research on social and political practice? Regarding fieldwork in state institutions, how do we negotiate the multiple loyalties we often find ourselves faced with as social researchers, both with the excluded migrants and with the authorities implementing the exclusions – two groupings considered to be opposite to each other (Lavanchy 2013)? Which different roles do researchers need to take on? The aim of our workshop is first and foremost to exchange experiences on fieldwork with others doing qualitative research on related topics and to consider its possible implications – including affective dimensions – for all participants involved in the research process: the migrants, the security staff of detention centres, its social workers, border police and bureaucrats and, last but not least, the researchers themselves. Furthermore, we generally wish to reflect upon the question of how best to conduct research in this contested field, applying an interdisciplinary perspective.