Clinical Trials and Effectiveness Research

To the Editor: Kenneth B. Wells, M.D., M.P.H, has made an important contribution with his article (1). It may be helpful to keep the following considerations in mind in interpreting both efficacy and effectiveness studies for both clinical and policy decision making.

Outcomes are most often defined in terms of easy-to-measure markers. Features such as autonomy or authenticity are rarely considered and are also never measured in either type of study. Yet they are most relevant in terms of the utility of given outcomes to individuals, as well as our culture and our society (2–4). More easily measurable outcomes continue to dominate the studies reported even in this Journal. Should all outcome studies carry at least an explanation of why the particular outcomes were chosen and why meaningful outcomes were not considered?