First patient-reported outcome tools to assess acne scarring

The Global Alliance to Improve Outcomes in Acne have developed two patient-reported outcome measures to assess the severity and impact of facial atrophic acne scarring (Dermatol Ther (Heidelb) June 2016; 6(2):219-233).

The authors note that most patients with acne have some degree of scarring and approximately 40% have clinically relevant scars (Clin Exp Dermatol 1994;19:303–308). They also note that while there is a link between acne severity and scarring, acne scarring can occur with acne of any severity.

“Acne scarring is a significant burden for patients with active acne. They are concerned about scars, they are concerned about whether the scars will improve or not, and whether they are developing more scars over time,” said Dr. Jerry Tan of Windsor, Ont., adjunct professor in the Department of Dermatology at Western University, London, Ont.,and a co-developer of the assessment tools.“In the past, we have not really had a good way to evaluate whether patients feel that they have more scars developing or whether [they are] changing over time, or whether it bothers them in a comprehensive way.”

Following the U.S. Food and Drug Administration guidance methodology, the investigators

developed the self-assessment of clinical acne-related scars (SCARS) and the facial acne scar quality of life (FASQoL) tools.

The researchers conducted 30 concept elicitation interviews to determine concepts of interest

regarding appearance, symptoms, impacts, and bothersomeness, as well as to understand the language patients use to describe what they believe to be the symptoms and impacts of their acne scarring.

Next, the investigators generated the most relevant items and the tools were tested with 20 cognitive interviews. These participants were asked to think aloud about the process they used to arrive at each answer in the tools. They were also asked to suggest any changes they would make to improve the tools. A second phase of cognitive interviews was conducted once the feedback was incorporated into the tools.

Defining acne scarring

The most critical part in the tool development, according to Dr. Tan, was creating a definition of

acne scarring that patients could easily understand. The statements in the tools are “active acne includes zits, breakouts, pimples, whiteheads, and blackheads” and “atrophic acne scars are indents or holes in the skin from previous active acne (not from injury, scratching or picking).”

“The reason that type of contextual set of statements was provided was to ensure that they understood the questions were about the indents and holes, and not referring to the breakouts, zits, pimples, blackheads, and whiteheads," said Dr. Tan.

SCARS starts with two visual analog scales that measure from zero to 10 the severity of the

patients’ active acne and indents or holes. The second part consists of five questions—each with a five category scale—to understand the patient self assessment of severity in terms of how much of their face is covered with indents or holes (ranging from almost none of my face to almost all of my face); how small or large are the indents or holes (very small to very large); the amount of holes and indents (very few to many); the depth of the indents or holes (not at all deep to extremely deep); and the visibility of the indents or holes (not at all visible to extremely visible).

The FASQoL is a set of 10 questions that reflects the emotional response of patients over the past seven days to their indents or holes. Each question has a five categorical scale and the vernacular changes depending on the question. For example “Over the past seven days, have you felt self-conscious when you were with people because of the indents or holes on your face?” (with answers ranging from not at all self-conscious to extremely selfconscious) and “over the past seven days, have you felt annoyed because of the indents or holes on your face?” (with answers ranging from not at all annoyed to extremely annoyed).

Bothered by impact on appearance

During the interviews the investigators found that patients identified being bothered by acne scarring because it impacted their appearance/attractiveness (16.6%), confidence (13.3%), social activities (13.3%), and that it inconveniently requires them to use make-up (13.3%).

“[The impact of acne scarring] would be quite variable between patients and it will depend on

many factors including how many, how widespread, and how large their scars are,” said Dr. Tan. “Plus, it will also depend quite a bit on the way people view their whole sociological milieu. Some people are totally disinterested in that—it is not an issue for them. Others will be quite bothered by even a few scars because it impacts their sense of attractiveness, and maybe their sense of employability if they are in the public eye. So all of those things can make a difference to people, but it does so differentially and on a very individual basis.”

Dr. Tan said that the tools were primarily developed to help with acne scar research. However, he

noted that they would be useful in clinical practice as well because the tools are short and straightforward. He said they are useful tools to initiate a conversation about acne scarring and to gain a better understanding if it is something that bothers the patient or not. “If they are not [bothered] then that is fine, you just leave [the scars] alone. But if they are [bothered], then as clinicians we need to try to help them address how to improve [the scars] or how to minimize further [scars] in the future.”

Once treatment has been started it can be useful to determine if the therapy is effectively managing the scars to the patients’ satisfaction or if a different course of treatment is warranted, he said.

“If the patient is increasingly noticing more and more scars then you may wish to consider monitoring their therapy, because perhaps therapy is not as effective based on the patient reporting more scars. So that would be very helpful,” said Dr. Tan. “The FASQoL scale is one where if you are seeing more and more impact on QoL then that also gives you a clear indicator

that the treatment needs to be intensified.”

The authors noted that a limitation of the study was that the interviews were only conducted in the

U.S. and that it should be tested in other populations. As well, Dr. Tan noted that it has not yet been tested for responsivity through therapeutic interventions.

#Acne #Dermatology #Dermcity #TheChronicleofSkinAllergy #Scars #Patientreported #AcneScarring #OutcomeTools #DrJerryTan


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