Treatment as usual (TAU) control practices in the PROSPECT Study: managing the interaction and tension between research design and ethics.

Abstract

The use of treatment as usual (TAU) as a control condition may pose the considerable challenge of maintaining both scientific rigor and meeting high ethical standards in experiments on human subjects. The authors illustrate the tension and explore the relationship between research design and ethics, especially the interaction between the two, in the NIMH-funded PROSPECT study (Prevention of Suicide in Primary Care Elderly - Collaborative Trial). The goal of PROSPECT is to determine whether placement of a depression health specialist in primary care practices will have a favorable impact on rates of depression, hopelessness and suicidal ideation in elderly primary care patients with major or persistent minor depression. PROSPECT randomly assigns practices either to an intervention arm (which includes the provision of depression health specialists) or to an enhanced care arm (TAU, with the addition of screening and assessment services). TAU, enhanced by the provision of screening and assessment services, is to be used as a benchmark for measuring the effectiveness of PROSPECT's intervention. However, TAU in the epidemiological and clinical literature has also been linked to high rates of suicide in the elderly related to unrecognized and untreated or under-treated depression. The authors present their approach to managing the tension, or interaction, between the use of TAU for scientific and public health purposes and the requirement for beneficence, that is, the duty to assure the safety of human subjects in research and to do no harm. Through enhancements of TAU, by the provision of information to primary care physicians concerning the psychiatric status of their patients, the investigators attempt to meet the challenge of maintaining rigor and meeting high ethical standards.