Clinical effectiveness, construct and assessment.

BACKGROUND

In an era of contention about the efficacy of antidepressants, the concept of clinical effectiveness has surfaced as a basic tenet of real-world practice. The concept of clinical effectiveness can lead to important insights into the treatment of depression and, by acting as an organizing concept for research, can help studies better focus on obtaining information necessary to improve clinical practice.

METHODS

The limitations and strengths of efficacy and effectiveness studies in psychiatry are explored, and recent effectiveness studies in psychiatry are discussed, and their implications for re-examining treatment goals and remission.

RESULTS

Efficacy studies are invaluable for the development of new drugs, but often lack generalizability. In contrast, effectiveness studies are broader in scope and offer the potential to assess quality of life and functional change. Studies that explore the clinical effectiveness of treatments for depression can identify important treatment gaps and suggest ways to address them. Although the efficacy of an antidepressant is important, other factors such as patient adherence, safety and tolerability, and the alignment of treatment outcomes with dimensions likely to be critical to patients (quality of life and functioning) also need to be examined.

CONCLUSIONS

Antidepressant treatment, both in clinical practice and in research, should involve clinical considerations that go beyond efficacy data. Broader issues of tolerability, safety, residual symptoms, functioning, and quality of life must also be addressed. Accomplishing this objective may involve the development of new global effectiveness measures; better outcome measures; and a broader, more patient-centered orientation towards clinical care.