An Ethical Framework for Outcome Assessment in Psychiatric DBS

Abstract

Deep brain stimulation (DBS) is an up-and-coming therapeutic approach in psychiatry. Although recent studies have demonstrated that DBS is relatively safe, little is known about its impact on a patient's life. A comprehensive outcome assessment is required so as to ensure valid scientific findings for the proper counseling of future patients; a thorough benefit–harm assessment plays an important role in planning of the therapeutic process. Starting from a basic anthropological and ethical premise, disorder-specific and intervention-related parameters concerning a wide range of data relating to the individual person would need to be amassed. These data can be collected by means of a combination of quantitative tests and qualitative interviews, including the perspective of the patient and of a closely related person. They can be presented using codes from the WHO International Classification of Functioning, Disability and Health (ICF). An international consensus group on outcome assessment and coding according to the ICF could be established in psychiatric DBS.

Keywords:

• deep brain stimulation
• outcome assessment
• psychiatry
• research ethics
• risk–benefit assessment

Acknowledgments

We especially thank the German–Canadian ELSA-DBS study group for fruitful discussions and ongoing cooperation in ethical, legal, and social DBS research. The ELSA-DBS study is funded by the German Federal Ministry of Education and Research and by Health Canada. “ELSA-DBS” stands for “Ethical, Legal and Social Aspects of Deep Brain Stimulation—Health, Quality of Life and Personal Identity.” Christiane Woopen is also very grateful to the Expert Group funded by the Volkswagen Foundation for its recommendations regarding responsible research and DBS application, and the group's invitation to the expert workshop in Bonn in January 2011. Its productive discussion of Woopen's presentation provided the underlying basis for this article.