Bald mehr und sicherere Arzneimittel für Kinder? Die Revision des Heilmittelgesetzes bringt im Bereich der Kinderarzneimittel eine Anpassung an europäische Standards

Die Ende Oktober 2009 vom Bundesrat eröffnete ordentliche Revision des Heilmittelgesetzes sieht im Bereich der Kinderarzneimittel erhebliche Neuerungen vor. Zur Verbesserung der Versorgung mit sicheren Kinderarzneimitteln soll in der Schweiz ein in Europa und den USA bereits etabliertes Anreizsystem für die Pharmaindustrie eingeführt werden. Das Ziel der Neuerungen ist die Anpassung des schweizerischen Heilmittelrechts an europäische Standards, wodurch die Versorgung mit pädiatrischen Arzneimitteln verbessert und die Sicherheit der Medikation in der Pädiatrie erhöht werden soll.

International standards for programmes of training in intensive care medicine in Europe.

PURPOSE To develop internationally harmonised standards for programmes of training in intensive care medicine (ICM). METHODS Standards were developed by using consensus techniques. A nine-member nominal group of European intensive care experts developed a preliminary set of standards. These were revised and refined through a modified Delphi process involving 28 European national coordinators representing national training organisations using a combination of moderated discussion meetings, email, and a Web-based tool for determining the level of agreement with each proposed standard, and whether the standard could be achieved in the respondent's country. RESULTS The nominal group developed an initial set of 52 possible standards which underwent four iterations to achieve maximal consensus. All national coordinators approved a final set of 29 standards in four domains: training centres, training programmes, selection of trainees, and trainers' profiles. Only three standards were considered immediately achievable by all countries, demonstrating a willingness to aspire to quality rather than merely setting a minimum level. Nine proposed standards which did not achieve full consensus were identified as potential candidates for future review. CONCLUSIONS This preliminary set of clearly defined and agreed standards provides a transparent framework for assuring the quality of training programmes, and a foundation for international harmonisation and quality improvement of training in ICM.

Communion-over-Agency effects on advertising effectiveness

Gender-stereotypical portrayals of communal women and agentic men are highly common in advertising. But past research indicates that advertising effectiveness is higher when endorsers are portrayed as communal – irrespective of their gender. The aim of the current research is to explore this communion-over-agency effect on advertising effectiveness and its underlying mechanism. Two studies provide evidence for a communion-over-agency effect on advertising effectiveness (i.e., attitude toward the ad and brand). These studies show that the communion-over-agency effect on attitude toward the ad is mediated by endorser likeability (simple mediation). The effect on attitude toward the brand is mediated by endorser likeability and attitude toward the ad (serial multiple mediation). In concert, this research underscores the significance of communion (and agency) on endorser evaluation and advertising effectiveness.

Approaches to Ensure Quality Standards for Standardized/ Simulated Patient Performance in High Stakes Objective Structured Clinical Exams (OSCEs)

Introduction To meet the quality standards for high-stakes OSCEs, it is necessary to ensure high quality standardized performance of the SPs involved.[1] One of the ways this can be assured is through the assessment of the quality of SPs` performance in training and during the assessment. There is some literature concerning validated instruments that have been used to assess SP performance in formative contexts but very little related to high stakes contexts.[2], [3], [4]. Content and structure During this workshop different approaches to quality control for SPs` performance, developed in medicine, pharmacy and nursing OSCEs, will be introduced. Participants will have the opportunity to use these approaches in simulated interactions. Advantages and disadvantages of these approaches will be discussed. Anticipated outcomes By the end of this session, participants will be able to discuss the rationale for quality control of SPs` performance in high stakes OSCEs, outline key factors in creating strategies for quality control, identify various strategies for assuring quality control, and reflect on applications to their own practice. Who should attend The workshop is designed for those interested in quality assurance of SP performance in high stakes OSCEs. Level All levels are welcome. References Adamo G. 2003. Simulated and standardized patients in OSCEs: achievements and challenges:1992-2003. Med Teach. 25(3), 262- 270. Wind LA, Van Dalen J, Muijtjens AM, Rethans JJ. Assessing simulated patients in an educational setting: the MaSP (Maastricht Assessment of Simulated Patients). Med Educ 2004, 38(1):39-44. Bouter S, van Weel-Baumgarten E, Bolhuis S. Construction and validation of the Nijmegen Evaluation of the Simulated Patient (NESP): Assessing Simulated Patients' ability to role-play and provide feedback to students. Acad Med: Journal of the Association of American Medical Colleges 2012. May W, Fisher D, Souder D: Development of an instrument to measure the quality of standardized/simulated patient verbal feedback. Med Educ 2012, 2(1).

Reporting standards for studies of diagnostic test accuracy in dementia: The STARDdem Initiative.

OBJECTIVE To provide guidance on standards for reporting studies of diagnostic test accuracy for dementia disorders. METHODS An international consensus process on reporting standards in dementia and cognitive impairment (STARDdem) was established, focusing on studies presenting data from which sensitivity and specificity were reported or could be derived. A working group led the initiative through 4 rounds of consensus work, using a modified Delphi process and culminating in a face-to-face consensus meeting in October 2012. The aim of this process was to agree on how best to supplement the generic standards of the STARD statement to enhance their utility and encourage their use in dementia research. RESULTS More than 200 comments were received during the wider consultation rounds. The areas at most risk of inadequate reporting were identified and a set of dementia-specific recommendations to supplement the STARD guidance were developed, including better reporting of patient selection, the reference standard used, avoidance of circularity, and reporting of test-retest reliability. CONCLUSION STARDdem is an implementation of the STARD statement in which the original checklist is elaborated and supplemented with guidance pertinent to studies of cognitive disorders. Its adoption is expected to increase transparency, enable more effective evaluation of diagnostic tests in Alzheimer disease and dementia, contribute to greater adherence to methodologic standards, and advance the development of Alzheimer biomarkers.

“Therapeutic Advertising”: When Do Female Consumers Really Benefit?

This research examines whether female consumers benefit from brand strategies that attempt to decrease their self-discrepancies by setting more realistic ideals (i.e., therapeutic advertising, such as Body Shop, Aerie, and Always). The results of our preliminary study reveal that therapeutic advertising leads to stronger self-conscious emotions than idealistic advertising. More specifically, it leads to stronger emotions of both pride and shame. However, the latter only holds true for female consumers low in self-liking and high difficulties in abandoning unattainable goals. Female consumers who like themselves and are able to abandon unattainable goals do not feel more ashamed when being exposed to therapeutic advertising compared to idealized advertising. These findings have implications for marketing managers and policy makers.

Menschenrechtliche Standards der Haftbedingungen in der Untersuchungshaft und ihre Umsetzung in der Schweiz

Die Berechtigung der Untersuchungshaft liegt einzig in der Sicherstellung eines ordnungsgemäss verlaufenden Strafverfahrens, d.h. in der Verhinderung einer Flucht oder von Verdunkelungsaktivitäten. Umso bedeutsamer erscheint vor diesem Hintergrund das Verhältnismässigkeitsprinzip. Dieses verlangt, dass über den Freiheitsentzug an sich hinausgehende Restriktionen im Bereich der Haftmodalitäten nur rechtmässig sind, wenn sie sich im Einzelfall als notwendig erweisen, um den genannten öffentlichen Interessen Rechnung zu tragen. Basierend auf diesem Massstab prüft der Beitrag die Ausgestaltung der Untersuchungshaft in der Schweiz.