Author Affiliations: Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California (Dr Kraemer); and Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (Drs Kraemer and Frank).
The evaluation of the comparative effectiveness of treatments should not depend on the statistical effect of treatments on individual measures of outcome (benefits or harms), but rather on the clinical effects of treatments (both benefits and harms) on individual patients who experience both benefits and harms. Such evaluation requires both statistical assessment of the rates of co-occurrence of such benefits and harms and clinical assessment of their combined clinical effects on patients.
Kraemer HC, Frank E. Evaluation of Comparative Treatment TrialsAssessing Clinical Benefits and Risks for Patients, Rather Than Statistical Effects on Measures. JAMA. 2010;304(6):683–684. doi:10.1001/jama.2010.1133