A public health approach to clinical therapeutics in psychiatry: directions for new research

The mental health field is transforming the culture of treatment research by moving from a narrow regulatory model geared to drug approval and registration to a more inclusive public health model. Thus, whereas regulatory antidementia trials will exclude patients with psychiatric or neurologic symptoms or substance abuse and require them to be physically healthy and living with a caregiver, ie, 90% of the presenting Alzheimer population, the public health model promises to improve patient care by addressing the types of practical questions and functional outcomes typically the concern of clinicians: Does treatment enhance function? How can we keep people well once they have been made well? Why do treatments not work as well in practice as in clinical trials? Public health studies are conducted in the world of actual practice with time-pressured clinicians taking care of large numbers of patients with uncertain clinical presentations, complex comorbidities, and varying degrees of interference with ideal levels of compliance. The exclusive focus on symptoms is expanded to include outcomes related to issues of function, disability, morbidity, mortality, resource use, and quality of life. Highly controlled efficacy research is still needed to establish treatment merit, but efficacy now marks only the beginning of the process of inquiry.