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Objectives and Methods:Many authors have argued that ethical, legal, and social issues (?ELSIs?) should be explicitly integrated into health technology assessment (HTA), yet doing so poses challenges. This discussion may be particularly salient for technologies viewed as ethically complex, such as genetic screening. Here we provide a brief overview of contemporary discussions of the issues from the HTA literature. We then describe key existing policy evaluation frameworks in the fields of disease screening and public health genomics. Finally, we map the insights from the HTA literature to the policy evaluation frameworks, with discussion of the implications for HTA in genetic screening.Results and Conclusions:A critical discussion in the HTA literature considers the definition of ELSIs in HTA, highlighting the importance of thinking beyond ELSIs as impacts of technology. Existing HTA guidance on integrating ELSIs relates to three broad approaches: literature synthesis, involvement of experts, and consideration of stakeholder values. The thirteen key policy evaluation frameworks relating to disease screening and public health genomics identified a range of ELSIs relevant to genetic screening. Beyond straightforward impacts of screening, these ELSIs require consideration of factors such as the social and political context surrounding policy decisions. The three broad approaches to addressing ELSIs described above are apparent in the screening/genomics literatures. In integrating these findings we suggest that the method chosen for addressing ELSIs in HTA for genetic screening may determine which ELSIs are prioritized; and that an important challenge is the lack of guidance for evaluating such methods. [ABSTRACT FROM AUTHOR]

Background. GPs are increasingly expected to meet the needs of patients concerned about their risk of inherited breast cancer, but may lack skills or confidence to use complex management guidelines. We developed an evidence-based, multifaceted intervention intended to promote confidence and skills in this area.Objective. To evaluate the effectiveness of the intervention in improving GP confidence in managing patients concerned about genetic risk of breast cancer.Methods.Design. Cluster randomized controlled trial.Setting. General practices in the Grampian region of Scotland.Subjects. GPs and the patients they referred for genetic counselling for risk of breast cancer.Main outcome measures. GPs’ self-reported confidence in four activities related to genetics; rates of referral of patients at elevated genetic risk; and referred patients’ understanding of cancer risk factors.Results. No statistically significant differences were observed between intervention and control arms in the primary or secondary outcomes. A possible effect of the intervention on the proportion of referred patients who were at elevated risk could not be discounted. Only a small proportion of intervention GPs attended the educational session, were aware or the software, or made use of it in practice.Conclusions. No convincing evidence of the effectiveness of the intervention was found, probably reflecting barriers to its use in routine practice. [ABSTRACT FROM AUTHOR]