Seeing eye to eye

"Over the years, we've evaluated our own work personally and made assumptions and assessments based on how we view the outcome. I've always believed that it is equally, if not more, important to evaluate how patients perceive their results," says Steven Fagien, M.D., an aesthetic oculoplastic surgeon based in Boca Raton, Fla.

This double-blinded, placebo-controlled study isn't the first to look at patient assessments of cosmetic results, he says.

The eyes of the beholder

Just as patients might be disappointed with the results of any procedure, he notes that in some instances, "Either the doctor disagrees with the patient's perspective, or even in some cases, the patient is thrilled, but the doctor knows he or she could have done better.

"Ultimately, what brings patients back to one's office and makes them (refer) more patients is that they're satisfied."

To get a better handle on this issue, Dr. Fagien says he and his colleagues (including Jonathan W. Kowalski, Pharm.D.) have looked at numerous ways of gauging patient satisfaction, including a parameter called Patient-Reported Outcomes (PRO). Likewise, he says previous studies have, in fact, looked at global assessments of results by both physicians and patients.

However, Dr. Fagien tells Dermatology Times, global assessments proved too nonspecific and "didn't address what we thought were possibly more important questions: Did the treatment make the patient look younger or more attractive" or improve the patient's self-esteem?

He notes, "The answers to these questions have shed more light onto the many reasons why patients return for treatments."

Gauging appearance perceptions

To better gauge how patients feel about changes in their appearance achieved by botulinum toxin A injections, researchers in this study randomly assigned 70 patients to treatment with 20 units of this material for glabellar furrows - namely, a four-unit injection to the procerus muscle and two such injections in each corrugator muscle - or placebo.

At week four, researchers gave patients who still had moderate or severe glabellar lines the same dose under open-label conditions. Sixty-five patients completed the study.

Investigators then assessed glabellar line severity at rest and maximum attempted contraction using the four-point Facial Wrinkle Scale (none, mild, moderate, severe). They found that between baseline and week four, patients in the treated group fared better in both areas. In particular, these patients' glabellar line severity scores at maximum contraction declined from 2.8 to 0.7 and at rest from 1.7 to 0.5. However, as would be expected, glabellar line severity scores in both areas remained unchanged in the placebo group, Dr. Fagien says.

Perhaps more importantly, patients reported seeing similar improvements based on their answers to the Facial Line Outcomes (FLO) questionnaire, an 11-question tool developed by Dr. Fagien and his colleagues. Though patients answered all 11 questions, researchers subsequently found that focusing on seven key questions (FLO-7) yielded valuable insights in a more streamlined fashion.

For the study, he says, "We wanted a questionnaire that patients could complete very quickly and easily" without laboring over answers.