Elective aesthetic procedures include both surgical (e.g., breast augmentation) and non-surgical (e.g., cosmetic botulinum toxin injection) medical services that aim to restore or enhance physical form to meet the aesthetic goals of the individual patient. Informed consent in this clinical environment is unique in that patients often seek consultation with preconceived expectations of desired procedure(s) and outcome.23–26
In patients presenting for elective aesthetic procedures, miscommunication during informed consent leads to poor decisions made about treatments. These decisions are uninformed, discordant with patient goals and preferences, and are associated with decreased patient satisfaction and increased litigation.1,27
The purpose of this project is to improve the effectiveness of the informed consent process in elective aesthetic procedures. The global aim is to promote informed shared decision-making in which patients are meaningfully engaged, understand risks, benefits and alternatives of proposed treatment(s), and results in treatment decisions that align best practice with patient values.
Methods: An initial needs assessment was accomplished through review of relevant peer-reviewed publications and grey literature, informal interviews with plastic surgeons, plastic surgery residents, and patients. A critical review of the literature for best evidence for effective informed consent in the setting of elective aesthetic procedures was performed with the following search terms: informed consent, informed decision, informed decision making; procedure, surgery; shared decision making, decision quality; plastic, cosmetic, aesthetic, preference sensitive. Additional MESH terms were included as appropriate. Professional codes of ethics and legal doctrine were also reviewed. A gap analysis was conducted and included review of informed consent materials and informal interviews to assess local culture. A working casual and program theory was constructed to guide project development, implementation and future evaluation. Overarching theoretical, conceptual, and operational guidance drew from complexity science, quality improvement, and derivatives of knowledge translation theory.
Results: Deficits in the current practice of informed consent are a failure in preparation, conversation, presentation or documentation. Miscommunication occurs when there is a failure in one or more parts of the informed consent process. There is significant variability in the depth and breadth of content, presentation, and delivery of informed consent. The common practice of informed consent does not reflect ethical standards but regarded by both clinicians and patients as a legal formality of a signature on an informed consent document. Completion of some form of documentation to fulfill minimum legal requirements is universal. Malpractice concerns related to failures in informed consent are notable. Evidence and ethics support a process of shared decision-making as being the gold standard for informed consent. When each component of this process is individually examined problems become clear and leverage points for improvement can be identified. Use of certified patient decision aids may be an effective method to ensure process reliability of informed consent execution and documentation. No patient decision aids that meet certification standards were found for use in elective aesthetic procedures.
Discussion: Improvement efforts should focus on replacing current informed consent documents with patient decision aids that meet certification standards as published by the International Patient Decision Aids Standards (IPDAS). We present a multiphase development process model for the creation of patient decision aids for use in elective aesthetic procedures. Specific ethical, legal, contextual, conceptual or theoretical, and operational guidance are described for each phase of the development process model.
Conclusion: This project seeks to narrow the gap between common practice and best practice of informed consent in elective aesthetic procedures. We present a development process model for creating a patient decision aid prototype to replace traditional informed consent documents. A pilot study is underway to determine the feasibility and acceptability of the development process model and decision aid prototype to replace informed consent documents for primary breast augmentation surgery. Potential implications for practice, research, education and policy are posited.
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