The impact of upper facial lines and psychological impact of crow's feet lines: content validation of the Facial Line Outcomes (FLO-11) Questionnaire.
BACKGROUND
Treatments for upper facial lines (UFL), the most visible sign of aging, are of interest to patients and clinicians alike. Patient-reported outcomes (PROs) are valuable in evaluating the impact of such treatments; however, regulatory recommendations have stipulated that the patient perspective be central in developing these assessments.


OBJECTIVE
(1) To evaluate the content validity of the Facial Lines Outcomes Questionnaire, a PRO instrument developed to assess upper facial line impacts, according to the regulatory guidance of the United States Food and Drug Administration and (2) assess whether it adequately measures the psychological impacts associated with crow's feet lines (CFL) (lateral canthal lines) from the patient perspective.


METHODS
Two patient groups participated in face-to-face qualitative interviews. One group included patients with UFL (Group 1, n = 25 interviews), and the other included patients specifically with CFL (Group 2, n = 41 interviews). Each interview consisted of a concept elicitation and cognitive debriefing phase.


RESULTS
Interviews with both groups elicited all key concepts of the instrument, including "bothered by facial lines"; "looking older"; "looking less attractive"; and looking "tired," "stressed," or "angry." Most Group 2 patients (n = 35, 85%) agreed that the instrument adequately assessed the psychological impacts associated with CFL. During cognitive debriefing, the majority of patients in both groups agreed the instrument was understandable, comprehensive, and easy to complete.


CONCLUSIONS
The Facial Line Outcomes Questionnaire is an appropriate and valid tool to assess the impact of UFL and the psychological impacts associated with CFL.
Adelphi Values, Boston, MA, USA.
Andrew
A
Yaworsky
Selena
S
Daniels
Shannon
S
Tully
Frederick
F
Beddingfield
Jonathan
J
Kowalski
Kristina
K
Fitzgerald
Christine
C
Somogyi
Somali M
SM
Burgess
D000328:Adult; D000368:Aged; D001828:Body Image / Q000523:psychology*; D005145:Face; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012649:Self Concept; D015595:Skin Aging; D011795:Surveys and Questionnaires
Facial Line Outcomes questionnaire; content validity; facial esthetics; facial lines; impacts; patient reported outcomes