Clinical Journaling with TAG: Evaluating Outcomes and Maximizing the Patient Experience: Top Journal Articles from 2024Clinical Journaling with TAG: Evaluating Outcomes and Maximizing the Patient Experience: Top Journal Articles from 2024

Continued development and innovation are not limited to the novel device or treatment. While patients reportedly clamor for the latest advancement or hottest trend in aesthetic medicine, millions of dollars are spent daily across the globe on the established mainstays of facial therapy, including injectables such as botulinum toxin and other minimally invasive skin treatments. Effectively evaluating these outcomes and maximizing both the patient experience and results helps to boost confidence in developing longstanding patient relationships. The following review of three journal articles examines research results designed to better understand and improve key aspects of these kinds of cosmetic treatments.

ASSESSING TIME SAVINGS WITH RTU NEUROTOXIN

The safety, efficacy and popularity of injectable botulinum neurotoxin type A (BoNT-A) needs no elaboration. Typically, the product is purchased and stored as a powder, requiring reconstitution before injection, but a novel and innovative ready-to-use (RTU) formulation of abobotulinumtoxinA is now available. This product was developed to facilitate injection procedures and prevent reconstitution errors. A recent article in the Journal of Cosmetic Dermatology¹ details the results of an openlabel, randomized, multicenter Phase IV study whose primary endpoint was time to prepare for injection. Efficacy, safety and patient satisfaction were among the secondary endpoints.

Was the product easier to use? Did it take significantly less time to prepare? Did it retain both the safety and efficacy patients and clinicians have come to expect? In short: yes, according to plastic surgeon and lead author Priyanka Chadha, MBBS, owner of Amer Clinic and co-director of Acquisition Aesthetics (both in London, U.K.), an award-winning, globally recognized aesthetic training academy. “We engaged multiple centers across Germany and the U.K. in order to make it as clinically relevant to as many readers as possible,” Dr. Chadha stated. “The main focus of treatment was glabellar lines, as that is the approved use of this product.”

Patients (all women) with previous BoNT-A treatment experience were randomized approximately 2:1 into two groups. The RTU group (n=99) was treated for glabellar lines (GL) using 50U of the RTU abobotulinumtoxinA product; the powder (n=51) group was treated with reconstituted, powdered BoNT-A. Follow up was at various time points as well as up to six months for the RTU group, and up to one month for the powder group. Assessments included time to prepare product for injection (primary endpoint), investigator experience with product preparation/reconstitution, investigator and subject treatment experience and safety; and for the RTU product, aesthetic improvement of GLs as well as subject satisfaction. The followup for each treatment group was notably different for a reason, according to Dr. Chadha. “With the primary endpoint being time for preparation for injection, the focus was on that comparison,” she explained. “As for safety and efficacy, it is already proven for the powder products requiring reconstitution as well as the RTU product, but we wanted adequate follow-up to further establish credibility for the RTU product’s safety and efficacy, if applicable.”

There were no serious adverse events reported. Preparation time was significantly less for the RTU group versus the powder group (mean preparation time 0:33 versus 1:34 minutes, respectively, p < 0.0001). All investigators (100%) agreed that the RTU product was easy to use and learn and fulfilled their expectations. Investigators overwhelmingly (in 81% of treatment sessions) preferred to use the RTU abobotulinumtoxinA product over the powdered BoNT-A, and 97% reported that it allowed more time to focus on patients. For patients, 91% described their treatment as comfortable. The majority of patients reported satisfaction with appearance (approximately 88%), looking natural (approximately 95%) and looking refreshed (approximately 80%). Investigators reported aesthetic improvement in 99% of patients at one month for the RTU group and in 76% at six months.

Dr. Chadha noted that one key area for further study would be RTU abobotulinumtoxinA in male patients. More importantly, she added, what does the time savings mean to practitioners? “There are probably many ways in which one might see this benefit manifest. For me and many others, the distraction of reconstitution puts a pause on the attention that clinical staff can give the patient because you need to pay strict attention to the accuracy of your reconstitution, and it generates a lot of clinical waste – primarily consumables. The easier, quicker preparation allows us to maintain that rapport with the patient during the entire process without any uncomfortable silence or distraction. In addition to this, the RTU gives reproducible results regarding product concentration (as no reconstitution is required) and thus injection dosing can be predictably tailored. That is very important to me, but many may analyze cost per minute saved or reduction in wasted product. Regardless, the one thing we are sure of is that the time savings is positive.”

Reference:

1. Chadha P, Gerber PA, Hilton S, et al. Ready-to-use abobotulinumtoxinA solution versus powder botulinumtoxinA for treatment of glabellar lines: investigators’ and subjects’ experience in a phase IV study. J Cosmet Dermatol. 2024 Sep;23(9):2857-2866.

Editor’s Note: The original article Ready-to-use abobotulinumtoxinA solution versus powder botulinumtoxinA for treatment of glabellar lines: investigators’ and subjects’ experience in a phase IV study, is open access and available online at: https:// pubmed.ncbi.nlm.nih.gov/38807515/

SKIN Q: EVALUATING MINIMALLY INVASIVE SKIN TREATMENTS

Patient satisfaction is the ultimate measure of success in aesthetic medicine. The availability of valid scales for measuring patient satisfaction provides clinical tools for advancing the field in a variety of ways. Collectively these are known as patient reported outcome measures, or PROMs, according to Anne Klassen, DPhil, professor in the Department of Pediatrics and associate member of the Departments of Surgery and Health Research Methods, Evidence and Impact at McMaster University (Hamilton, Ontario, Canada).

Dr. Klassen is lead author of an article¹ featured in Facial Plastic Surgery and Aesthetic Medicine that unveils an innovative new PROM known as SKIN-Q for evaluating minimally invasive skin treatments for the face or body. If the name seems familiar, it may be calling to mind the FACE-Q, BODY-Q and BREAST-Q PROMs that have been developed by the same group, which have been scientifically validated as tools for research. The article details the creation of the PROM as well as the rationale behind its inception.

“We were looking for what is known as content validity,” according to Dr. Klassen. “Do the questions effectively elicit information about things that really matter to patients? Much of the work was done along those lines, leading to the elimination or modification of questions as we went farther down the road.”

While still following internationally established guidelines for the development and validation of PROMs, the approach with SKIN-Q is a little different. “Instead of a straightforward short form questionnaire, as with FACE-Q,” which has some overlap with SKIN-Q, she explained, “we developed SKIN-Q as a comprehensive library of questions carefully designed and tested for their applicability, based largely on what matters to patients. Providers choose from among the questions based on what would fit their needs. Although skin is skin, there are differences depending on the indication or treatment, location, etc., which would influence which questions or groups of questions might be most appropriate for a specific application.”

Researchers conducted qualitative interviews with 26 patients (88% women, 65%  40 years of age) to help form the original body of questions. This was refined with input from 12 experts, 11 patients and 174 online participants. An online crowd-working platform was employed to further test content validity. “We were not just looking for clinically relevant questions, we were looking at how patients felt these applied to them, and how easy they were for prospective patients to understand,” noted Dr. Klassen. A body of aesthetic experts also received questions for feedback on which items may or may not be relevant in addition to soliciting suggestions to see what might have been missed. A psychometric sample of 657 participants (82% women; 36% aged  40 years) elicited 713 completed surveys (facial, n=595; body, n=118). Further psychometric testing was then performed to establish reliability and validity. “What we ended up with is a 20-item question set that measures how skin feels, and a 46-item set measuring how skin looks. Short-form scales were tested to provide examples for how to utilize the item sets,” mentioned Dr. Klassen.

The hope is that SKIN-Q will attract attention similar to that seen with the FACE-Q, BODY-Q and BREAST-Q PROMs. “When people understand a PROM and see its practical value, they will apply it to their research,” Dr. Klassen asserted. “With enough use this may lead to the qualification of SKIN-Q, as with the FACE-Q and BREAST-Q, as a medical device development tool (MDDT) by the FDA. It does not happen overnight.” Access to licensing and guides for usage, as well as translations, are available at https://qportfolio.org/skin-q/, where those interested can also learn more about the new PROM and its design.

Reference:

1 Klassen AF, Pusic AL, Kaur M, et al. The SKIN-Q: an innovative patient-reported outcome measure for evaluating minimally invasive skin treatments for the face and body. Facial Plast Surg Aesthet Med. 2024 May-Jun;26(3):247-255.

Editor’s Note: The original article The SKIN-Q: An Innovative Patient-Reported Outcome Measure for Evaluating Minimally Invasive Skin Treatments for the Face and Body, is open access and available online at: https://pubmed.ncbi.nlm.nih.gov/38466952/

EXAMINING THE NEUROTOXIN TREATMENT EXPERIENCE

In recognition of the importance of patient satisfaction, a multidisciplinary team of nine experts in facial aesthetics collaborated on a report¹ published in Clinical, Cosmetic and Investigational Dermatology detailing a multifactorial approach to best practices. The goal was to maximize results with injectable BoNT-A as well as patient quality of life. Instead of collecting injection tips or similar pearls of wisdom, however, the advisory board looked at office protocols and procedures regarding evaluation and measurement (before, after and throughout), consultation and addressing patient concerns, the role of photography, patient comfort, and more – all aspects of the total positive patient experience, which contributes greatly to overall patient satisfaction and may impact patient perspective on their own results as well.

The main focus was on patient reported outcomes (PROs) before and after treatment, according to co-author Nick Lowe, MD. “The group felt it important to discuss and recommend the different patient satisfaction score methods to optimize future patient experiences with this treatment,” he commented. “It is thought that many patients are not evaluated by any particular method after treatment, and therefore the practitioner is unaware of the actual patient satisfaction response to their treatment with neurotoxin, and thus may not be aware of perceived poor outcomes.” In addition to private practice, Dr. Lowe is honorary senior lecturer on dermatology at the University of Manchester (Manchester, U.K.) and clinical professor of dermatology at UCLA School of Medicine (Los Angeles, Calif.).

According to the study, the advisory board convened a multistep consensus discussion based on current literature, structured questions, group discussion and panel expertise.

The consensus was to focus on patient goals during initial assessment, with use of PROs to provide baseline information. PROs may have to be tailored to properly address individual patient needs because of differences in age, gender identity, ethnicity or other common factors. “PROs such as the FACE-Q, Facial Line Satisfaction Questionnaire (FLSQ) and the Facial Line Outcomes (FLO-11) assessments also look at the psychological impact and satisfaction with their patient’s facial appearance,” Dr. Lowe explained. “The group felt this was important for optimizing patient outcome and success of treatment because many practitioners do not evaluate their patients using these kinds of tools.” If a follow-up questionnaire suggests less-than-optimal patient satisfaction, the practitioner has a golden opportunity to pursue the reasons and address them, if possible.

Among the other recommendations:

• Standardized patient photography before and after is essential.

• Discussion of benefits during consultation should be balanced with questioning to determine patient needs and concerns about discomfort, adverse events, etc.

• Touch-ups should be limited based on patient need and not made a regular habit.

• Patient self-assessment videos of facial muscle movements are valuable and particularly popular with patients.

A case study was also presented, highlighting how an optimal decades-long patient journey might look, with the goal of building lifelong practitioner-patient relationships being idealized. “Patient needs and preferences change over time, but careful, regular assessment of outcomes and patient satisfaction are always essential,” Dr. Lowe added. “We hope to see greater use of PROs to assess satisfaction with treatment, which will in turn lead to improved post-treatment assessment helping practitioners evaluate the safety and optimum benefits of their neurotoxin treatment,” Dr. Lowe stated. “This would lead to further improvement in individual practice results over time.”

Reference:

1. Philipp-Dormston WG, De Boulle K, Gronovich Y, et al. The patient journey in facial aesthetics: findings from a European consensus meeting on improving the quality of life for patients receiving botulinum toxin injections. Clin Cosmet Investig Dermatol. 2024 Feb 2;17:329-337.

Editor’s Note: The original article The Patient Journey in Facial Aesthetics: Findings from a European Consensus Meeting on Improving the Quality of Life for Patients Receiving Botulinum Toxin Injections, is open access and available online at: https:// pubmed.ncbi.nlm.nih.gov/38327550/