[Determinants of observer variability in early diagnostic mammography--a ROC analysis]. / Determinanten der Beobachter-Variabilität bei der Früherkennungsmammographie--eine ROC-Analyse.

As part of the German mammographic study, the participating doctors were given test films of 30 histologically confirmed cases. Regarding the indications for biopsy there was good sensitivity (the median amongst 25 doctors was 0.87). Specificity (median 0.86) could be improved. Comparison of individual results with the majority showed considerable variability within the group of doctors performing mammography. ROC analysis indicated that there was considerable observer variability which was independent from the specialty or praxis characteristics of the participants. The inclusion of mammography in an early diagnostic programme requires continuing education of the participants in this technique. This should be supported by further methods of quality assurance.

Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries.

BACKGROUND: Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. OBJECTIVE: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: (1) Do existing procedures promote representation of women and gender expertise in the committee? (2) How are sex and gender issues dealt with in protocol evaluation? METHODS: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents (regulations, guidelines and review tools in use in 2003). RESULTS: All countries have rules (mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk-benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools. CONCLUSIONS: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs.