Improving Consent Procedures and Evaluation of Treatment Success in Cosmetic Use of IncobotulinumtoxinA: An Assessment of the Treat-to-Goal Approach

January 2013 | Volume 12 | Issue 1 | Original Article | 72 | Copyright © 2013

Ravi Jandhyala MSc(Lond) MBBS(Lond) MRCS(Glasg) MFPM

The Jandhyala Institute, Banbury, UK

Abstract

Background: Despite the escalating number of patients undergoing aesthetic BoNT-A procedures, a standardized, objective means of setting treatment goals and measuring the success of treatment is lacking. Treat-To-Goal (TTG) is a new approach to consent that utilizes the Merz Aesthetics Scale to set objectively defined start points and treatment goals to better inform the consent process and provide a means of measuring the success of treatment.
Objective: To evaluate the TTG approach vs standard consent procedures in terms of patient understanding of the risks and benefits of treatment.
Methods: This study was undertaken in 2 phases among consecutive patients presenting for BoNT-A treatment. Phase 1 consisted of a crossover comparison of patient satisfaction with standard consent vs the TTG approach (n=20). Patient understanding of the likely outcomes and risks associated with treatment following consent and their overall preference were assessed using 10-point visual analog scales (VAS). Phase 2 assigned patients to receive no treatment (n=10) or treatment with BoNT-A (n=54) following consent with the TTG approach. Patients were followed up with 28 days later to assess whether the goals defined during consent had been met.
Results: The TTG approach significantly improved patient understanding of likely outcomes of BoNT-A treatment compared with standard consent (P=.004 when standard consent assessed first, and P=.002 when TTG assessed first). All patients assessed preferred the TTG approach (median VAS score in favor of TTG: 7.0, P<.0001). Target improvements were successfully met or exceeded in at least one treatment area (forehead, glabellar lines, crow's feet) in all patients treated with BoNT-A. In contrast, none of the untreated patients met their target improvements unless the target was defined as no change.
Conclusion: The TTG approach represents a significant improvement over standard consent in terms of the information it provides to patients. Further investigation of this concept is warranted.

J Drugs Dermatol. 2013;12(1):72-78.

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INTRODUCTION

Requests for cosmetic treatment of facial lines have become common in developed countries,1 including the use of minimally invasive therapies such as botulinum toxin A (BoNT-A). Indeed, BoNT-A treatment has become a mainstay of the modern treatment approach, with applications extending from the smoothing of glabellar lines to a wide range of aesthetic facial treatments.2 However, despite the increasing numbers of patient undergoing BoNT-A treatment, there is currently no standardized, objective measure available to assess whether treatment is successful and meets with patient expectations; outcomes are typically measured using subjective patient satisfaction scores. This has implications for the consent process. For any consent to be valid, a key requirement is that the patient is sufficiently informed as to the potential risks and benefits of treatment.3 Under the current system, patients are not provided with an objective assessment of the likely cosmetic effects of their treatment, which precludes this criterion being met.

To overcome this shortfall, it could be reasoned that a treatment goal should be set and agreed to by every patient before treatment, and treatment success should be measured and assessed against this target. This will not only allow patients to better assess whether they wish to continue with treatment, but also has the potential to provide practitioners with valuable information on how effectively the treatment is working in individual patients. It may also provide information to allow doses to be tailored accordingly in successive treatments.

The Treat-to-Goal (TTG) approach described in this paper sets objectively defined start points and treatment goals for BoNT-A treatment, utilizing the Merz Aesthetics Scale,4-11 in an attempt to provide a standardized means of establishing patient expectations and measuring treatment success as an integral part of the consent process. The aim of this study is to evaluate the TTG approach against standard consent procedures to compare their utility in providing patients with information on the risks and benefits of treatment, the likely outcome of treatment, and overall satisfaction with the consent process.

METHODS

Standard consent and the TTG approach were defined as shown in Table 1. The only difference in the 2 approaches is the incorporation in the TTG approach of a wrinkle severity score before treatment and the definition of the target severity score


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