Raising the Standard: Informed Consent

| July 1, 2020 | 0 Comments

by Cyrena Lam, MD, and Dominick Gadaleta, MD, FACS, FASMBS

Dr. Lam is a General Surgery resident at the Zucker School of Medicine at Hofstra/Northwell in New York, New York. Dr. Gadaleta is Chair, Department of Surgery, Southside Hospital; Director, Metabolic and Bariatric Surgery, North Shore University Hospital, Northwell Health, Manhasset, New York; Associate Professor of Surgery, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.

FUNDING: No funding was provided for this article.

DISCLOSURES: The authors report no conflicts of interest relevant to the content of this article.

Bariatric Times. 2020;17(7):18–19


“As the burden of indirect patient care responsibilities like electronic medical records (EMR) documentation continues to increase, surgeons must find ways to adapt without sacrificing patient care.”

Obtaining and documenting patient consent is an essential component of any preoperative process. But informed consent is far more than a signature on a piece of paper and can sometimes be difficult to accomplish.

The idea of informed consent as a necessary prerequisite to surgery was established in 1914 when, in regard to a lawsuit involving a patient who had developed gangrene of the hand after abdominal surgery, the ruling judge stated “… every human being of adult years and sound mind has a right to determine what shall be done with his body….”1

But while the need for informed consent has been well established for decades, the meaning of informed consent has, itself, undergone many evolutions since then. The initial approach to consent was the “reasonable physician standard,” in which physicians disclosed to patients only what they thought was necessary for them to know. This paternalistic approach eventually shifted to an approach aimed at establishing the “reasonable patient standard,” in which the physician disclosed to patients only what they thought any “reasonable person” would want to know. But because physicians are not always the best arbiters of their patient’s values, this approach also fell out of favor, and evolved into today’s standard for informed consent, “shared decision making,” or SDM.1

SDM entails in-depth discussion between the physician and patient, during which the physician shares all available treatment options, including associated risk and benefit information, and in turn the patient discusses with the physician his or her personal values and other pertinent information that might make one treatment more or less tolerable or preferable than the others.2 Open sharing of information allows for the ideal treatment option to make itself apparent and allows for both parties to come to a mutual decision.

Informed consent through SDM is especially pertinent in bariatric surgery, where there are many surgical options available, each with notable differences in expected weight loss, recovery time, and likelihood of postoperative complications. However, there is evidence that eligible patients who opt against bariatric surgery might be doing so based on incomplete information. In one study of adults with severe obesity who appeared to be good candidates for bariatric surgery, the majority of patients stated they were not interested in surgery, citing perceived surgical risk, concerns regarding postsurgical diet, and physical restrictions as reasons why.3

Part of the reason for these perceptions could be that SDM can be difficult to implement into clinical practice. SDM requires not only that the physician form a strong physician–patient relationship, but also that physicians know how to communicate information effectively, with time and available resources often acting as prohibitive factors.

Using decision aids can mitigate these prohibitive factors, and is a beneficial adjunct to informed consent. Decision aids provide supplemental information to patients and can be presented using several different types of media, including printed brochures, internet-based tools, video, and multimedia computer programs. Decision aids are particularly useful because they can be employed before and/or after clinical encounters, which effectively increases information sharing without increasing the amount of time spent on in-person physician–patient counseling. There is evidence to suggest that decision aids improve patient knowledge regarding options, help patients feel better informed, stimulate patients to take a more active role in decision making, and improve accurate risk perceptions.4

Internet-based decision aids are easily accessible and especially appropriate in regard to bariatric surgery, where 80 percent of the patients seeking surgery have first searched for health information online.5

The Patient Decision Aids research group from the Ottawa Hospital has designed and published numerous decision aids, which are readily available online. One such decision aid, “Should I have weight loss surgery?” was designed to assist patients contemplating bariatric surgery specifically. This decision aid is comprised of practitioner and patient testimonials, compares risks and benefits of operative versus nonoperative management, and includes an interactive component where patients are prompted to rank how they feel about particular statements, such as “I feel confident that I can make major diet and exercise changes after surgery” and “I’m not sure I can handle the diet and exercise changes I’ll need to make after surgery.” The decision aid culminates in a short quiz and a summary of the provided information, with the goal of helping the patient synthesize their thoughts.6

Video-based decision aids are a particularly attractive option because they can provide information in a format that feels familiar and accessible for patients. At one ophthalmology clinic in California, patients undergoing cataract extraction were either consented for surgery via traditional face-to-face counseling with the surgeon or shown a cataract surgery education video prior to this counseling. This four-minute video used animation to portray indications and the basic steps of the surgery. Researchers found that use of the video significantly reduced the amount of physician counseling time required to perform the informed consent.7

There is evidence that humorous video, in particular, can allow for even greater information retention. Comparing humorous and nonhumorous video-based decision aids used in the informed-consent process for a large orthodontics practice in New York, researchers found that patients who viewed the humorous video retained higher levels of information and were more likely to rewatch the video.8 The nonhumorous video was designed to mimic a routine in-office interaction and featured live actors to describe the consent in common language, while the humorous video communicated the same information but utilized animation and a script written by two experienced comedians.

Beyond video-based decision aids, there are interactive multimedia tools that have demonstrated to be effective. One such program is already being used in bariatric surgery. This computer program explains to patients the indications for surgery, steps of the procedure, and postoperative expectations in uncomplicated terms using a combination of text, schematic images, and animation. Compared to patients undergoing traditional consent, patients that had interacted with the computer program had significantly improved patient satisfaction and understanding.9 But it is important to note that development of this program was a time-consuming and labor-intensive process, which occurred over a span of three years and required the input of a surgeon, linguist, psychotherapist, graphic designer, and programmer in its production.

Special Considerations

The utility of decision aids has been made even more apparent by the current COVID-19 pandemic. The pandemic has significantly impacted the field of surgery. In mid-March, all elective surgeries were canceled in New York state, resulting in an innumerable backlog of cases. And while the tide fortunately appears to be turning, allowing us to begin to reschedule some elective procedures, there is still so much that is unknown regarding the transmission rate/rate of asymptomatic COVID-19 infection, and even less known about the true physiologic impact of COVID-19 on patients undergoing surgery/anesthesia. Given these uncertainties, obtaining truly informed consent in the COVID-19 era has proven to be a challenge. At one institution in Chicago,10 an effort was made to ensure continued informed consent with the development of a discussion guide. Essentially a decision aid, this guide was designed to be used during the “enhanced informed consent” process and outlines five topics: 1) Risk of operation for patients who test positive for COVID-19, 2) Risk of contracting coronavirus while in the hospital, 3) Challenges in coordination of care and communication due to disruption of normal hospital operations in response to the pandemic, 4) Possibility of future resource scarcity, and 5) Heightened importance of living wills or advanced directives.

While informed consent though SDM is a necessary prerequisite to all surgical procedures, it is an involved process and can be difficult to accomplish efficiently. As the burden of indirect patient care responsibilities like electronic medical records (EMR) documentation continues to increase, surgeons must find ways to adapt without sacrificing patient care. Decision aids have become an increasingly popular way to not only improve the effectiveness by which information is communicated, but also to decrease the amount of time required to do so, with good research to suggest that patients retain information better, have higher rates of satisfaction, and require less one-on-one counseling. With many media options available, there is likely a format that can work for every practice, and moving forward, we might find that decision aids become the standard of care in informed consent.


Column Editors

Anthony T. Petrick, MD, FACS, FASMBS

Dr. Petrick is Quality Director at Geisinger Surgical Institute and Director of Bariatric and Foregut Surgery at Geisinger Health System in Danville, Pennsylvania.

Dominick Gadaleta, MD, FACS, FASMBS

Dr. Gadaleta is Chair of the Department of Surgery at Southside Hospital, Director of Metabolic and Bariatric Surgery at North Shore University Hospital at Northwell Health in Manhasset, New York, and Associate Professor of Surgery at Zucker School of Medicine, Hofstra/Northwell in Hempstead, New York. 


References

  1. Markham SA, Gadaleta D. Informed Consent. In: Morton JM, Brethauer SA, DeMaria EJ (eds). Quality in Obesity treatment. Cham (Switzerland): Springer, 2019:353–364.
  2. King JS, Moulton BW. Rethinking informed consent: the case for shared medical decision-making. Am J Law Med. 2006;32(4):429–501.
  3. Wharton S, Serodio KJ, Kuk JL, et al. Interest, views and perceived barriers to bariatric surgery in patients with morbid obesity. Clin Obes. 2016;6(2):154–160.
  4. Madden K, Kleinlugtenbelt YV. Cochrane in CORR ®: decision aids for people facing health treatment or screening decisions. Clin Orthop Relat Res. 2017;475(5):1298–1304.
  5. Paolino L, Genser L, Fritsch S, et al. The web-surfing bariatic patient: the role of the internet in the decision-making process. Obes Surg. 2015;25(4):738–743.
  6. Healthwise Staff. Obesity: should I have weight-loss surgery? https://decisionaid.ohri.ca. Accessed March 25, 2020.
  7. Vo T, Ngai P, Tao J. A randomized trial of multimedia-facilitated informed consent for cataract surgery. Clin Ophthalmol. 2018;12:1427–1432.
  8. Levine TP. The effects of a humorous video on memory for orthodontic treatment consent information. Am J Orthod Dentofacial Orthop. 2020;157(2):240–244.
  9. Eggers C, Obliers R, Koerfer A, et al. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity. 2007;15(11):2866–2873.
  10. Bryan A, Milner R, Roggin K, et al. Unknown unknowns: surgical consent during the COVID-19 pandemic. Ann Surg. 2020 April 29. Online ahead of print.

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Category: Past Articles, Raising the Standard

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