Skin Deep - Clinical & Cosmetic Dermatology Blog

Skin Deep is a blog for dermatologists and skin care professionals with focus on theoretical, cosmetic and aesthetic dermatology. This blog is associated with ‘Dermatologists Sans Borders’ one of the largest curated groups of skin care professionals on facebook. If you are looking for non-technical information, please visit http://skinhelpdesk.com


Patient-reported outcome instruments for facial lines

The questionnaire we used to select patients.
The questionnaire we used to select patients. (Photo credit: Wikipedia)
It is often difficult to achieve an objective definition of beauty. It is even more difficult to assess the self-perception of beauty at a cognitive level. Though FDA often does not get involved much in the realm of cosmetic dermatology, Botox(R) is indeed a different matter as it is an injectable with real medical indications. Do upper facial lines (UFL) cause enough psychological morbidity to justify intervention? FDA might ask for real evidence and we better be ready.

To prove the impact of UFL treatment, first of all we need a validated tool. FDA recommends patient-reported outcome instruments or PRO as objective evidence. PRO as defined by FDA

is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.

One of the PRO instruments available for upper facial lines is the FLO-11 questionnaire. But unfortunately FLO-11 is not validated to the FDA standards. You don’t usually find many good qualitative studies in cosmetic dermatology. But this study (1) stands apart and has been quite methodical in validating the FLO-11 questionnaire.

Yet another study in the same journal (2) presents another questionnaire called Aesthetic Dermatology and Emotional Well-being (DEBIE), designed to know the general population motivations with regard to skin appearance. Though DEBIE is quite long, the authors have done a good job in validating the questionnaire using qualitative research principles. An abridged version may be more practical.

Both these questionnaires will be useful for those planning patient satisfaction studies in cosmetic dermatology. All we need now is proof. Botulinum Toxin for UFL is fortunately our best shot at objective proof.

Read More

1. Yaworsky A, Daniels S, Tully S, Beddingfield F 3rd, Kowalski J, Fitzgerald K, Somogyi C, Burgess SM. The impact of upper facial lines and psychological impact of crow’s feet lines: content validation of the Facial Line Outcomes (FLO-11)
Questionnaire. J Cosmet Dermatol. 2014 Dec;13(4):297-306. doi: 10.1111/jocd.12117. PubMed PMID: 25399622.  ↩

2. Martínez-González MC, Martínez-González RA, Guerra-Tapia A. Aesthetic dermatology and emotional well-being questionnaire. J Cosmet Dermatol. 2014
Dec;13(4):336-45. doi: 10.1111/jocd.12109. PubMed PMID: 25399627. ↩

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About Me

As a Dermatologist and Informatician my research mainly involves application of bioinformatics techniques and tools in dermatological conditions. However my research interests are varied and I have publications in areas ranging from artificial intelligence, sequence analysis, systems biology, ontology development, microarray analysis, immunology, computational biology and clinical dermatology. I am also interested in eHealth, Health Informatics and Health Policy.

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