Patient-reported outcomes with botulinum neurotoxin type A.

Clinical trials establishing the efficacy of botulinum neurotoxin type A historically have included as outcomes investigator assessments and general patient global assessments of treatment. However, these outcomes are of limited value in determining the specific benefits desired by patients who seek facial rejuvenation. To address this issue, several patient-reported outcomes measures have been developed and utilized in clinical trials of botulinum neurotoxin type A (specifically, the BOTOX Cosmetic brand). The outcomes include the Self-Perception of Age (SPA) measure and the Facial Line Outcomes (FLO) questionnaire. On the FLO questionnaire, patients rate the degree to which their facial lines bother them; make them look older than they would like; prevent them from having a smooth facial appearance; and make them look tired, stressed, or angry when that is not how they feel. Several clinical trials have demonstrated significant improvements in these outcomes from baseline and versus placebo for the treatment of multiple upper facial lines as well as for treating the glabella as a single region. These outcomes data help in understanding patient objectives and motivations, establishing a treatment plan, and ensuring patient satisfaction. Clinicians can use the SPA measure for all patients to help show the value of treatment.