Personal genome testing: Test characteristics to clarify the discourse on ethical, legal and societal issues

Background: As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion: This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.' Summary: Consideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility

Nurse practitioners and physician assistants in Dutch hospitals: their role, extent of substitution and facilitators and barriers experienced in the reallocation of tasks

Aims:This paper is a report of a study exploring the role of nurse practitioners and physician assistants, the extent of substitution and the barriers and facilitators experienced by them as a consequence of substitution in public hospitals. Background: Nurse practitioners and physician assistants are emerging worldwide. However, despite the large amount of evidence showing the added value of these professionals, little evidence is available concerning the role, extent of substitution and facilitators and barriers experienced by them as a consequence of substitution. Methods: Interviews were conducted and a questionnaire was completed by 43 nurse practitioners and 13 physician assistants employed in public hospitals in the south of the Netherlands in 2007. Results: Nurse practitioners and physician assistants performed a broad spectrum of tasks, but differed significantly in the time spent and the kind of tasks performed. Nurse practitioners spent 25% (10·4 hours; sd = 5·5) and physician assistants 40% (18·7 hours; sd = 7·6) of their time on medical procedures. They both also performed new tasks or tasks for which there previously was insufficient capacity. Many of them experienced policy/organizational, legal, financial or facility problems in the reallocation of tasks. Conclusion: Nurse practitioners and physician assistants have wide ranging but different responsibilities in public hospitals. By performing medical procedures and new tasks or tasks for which there was not enough capacity, they function as substitutes and supplements for doctors. However, barriers are affecting the extent of substitution. The challenge ahead is to remove the barriers experienced by nurse practitioners and physician assistants. (aut.ref.