Informed Consent: The Ultimate Standard of Care
According to a published paper about Informed Consent by the National Institutes of Health, https://www.ncbi.nlm.nih.gov/books/NBK430827/
Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion:
(1) the nature of the procedure
(2) the risks and benefits and the procedure
(3) reasonable alternatives
(4) risks and benefits of alternatives
(5) assessment of the patient's understanding of elements 1 through 4.
It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider. The provider must make a recommendation and provide their reasoning for said recommendation.
Our vision at GPAC ~ Global Patient Advocacy Coalition is to make sure that every patient is given the proper safety information to make an educated and informed decision about their specific medical procedure. GPAC founders are advocates for breast reconstruction and augmentation for the reason that they were deeply affected by and were specifically harmed by breast implants. Like so many others, they were also not given the proper information to make an informed, educated decision specifically on their breast surgeries.
Above is a survey asking breast implant patients if they had received information or discussion from their plastic surgeon about the surgery that they had consented to. Out of the 5022 patients surveyed, 84% of patients were not given the information brochure or booklet printed by the breast implant manufacturer. Out of the 5026 responses from the patients surveyed, 84% felt that they were not given enough time and information to make an informed decision about having breast surgery. Out of 5029 responses, 96.1% did not feel they understood the risks, maintenance, and complications associated with having breast implants.
With results like this, why is there so much pushback in the medical communities to giving patients the tools that they need to make an informed decision?
As GPAC started to work with other advocates, we realized that the problem is not just in breast reconstruction or breast implant surgery consent. Surgeons are lightly glossing over adverse events and not giving proper informed consent, a problem that exists in most medical procedures, implanted medical devices, or physician-recommended pharmaceuticals. GPAC's mission became to ensure through legislation that extensive informed consent is given to every patient having any medical procedure, implanted medical devices, or recommended pharmaceuticals.
GPAC's first mission was to implement legislation for Breast Implant Informed Consent. Our first law passed in Arizona and became effective on January 1st, 2022.
GPAC collaborated with ASPS-The American Society of Plastic Surgeons, and produced a consensus patient checklist. This checklist was created with the patient as the main focus. GPAC and ASPS worked diligently and were conscientious about making sure the language was thorough and easy to comprehend, using language that all patients will understand. Ensuring all information is included is important in making such a major medical decision. The plan is to make this model legislation duplicatable so that it can be used in the many specialties that are lacking in patient informed consent.
If you are interested in being part of the solution, join us at GPAC, the Global Patient Advocacy Coalition, where we are working globally with practitioners, patient advocates, medical societies, and regulatory agencies. Please join us by liking and subscribing to our website, monthly newsletter, social media, blog, and YouTube pages to be informed of the projects that we are working on to ensure patient safety, improve the standard of care, and the awareness of adverse effects to patients.