Clinical Equivalence: A Step, a Misstep, or Just a Misnomer?

Most current approaches to assess clinical significance and clinical equivalence rely principally on concepts and methods drawn from population statistics, yet these strategies fall far short of the qualitative nature of the judgments rendered by clinicians. Just as the construct of clinical diagnosis in research settings benefitted by drawing upon the so-called LEAD standard (longitudinal, expert, all data) to achieve research diagnoses with the greatest clinical credibility, the concepts of "clinically significant change" or "clinically equivalent to normal" need similar standards. As an alternative, for future purposes of assessing clinical significance, I recommend the application of a "SMARTER" standard, as follows: (a) whenever possible, the method should use standardized measures, (b) it should address all relevant outcomes across settings, raters, and domains; and (c) it should make use of trained expert clinicians, trained to achieve reliability.