Laura M. Cascella, MA
Robotic surgery, once a futuristic notion, is well on its way to becoming commonplace in the United States. A 2016 article in Fortune notes that "Within five years, one in three U.S. surgeries — more than double current levels — is expected to be performed with robotic systems..."1
One of the driving factors in the rise of robotic surgery is patient demand; however, some patients who are eager for this new technology might not be ideal candidates due to comorbidities or other issues. Additionally, patients' expectations for robotic surgery outcomes might not align with medical evidence. Because of these factors, it is incumbent on healthcare organizations and surgeons to appropriately screen patients who are candidates for robotic surgery and to objectively discuss risks and benefits associated with this surgical technique.
Establishing Patient Selection Criteria
For both healthcare organizations and surgeons, an important strategy for managing robotic surgery risks is careful consideration of patient selection criteria. Participants in a U.S. Food and Drug Administration survey of experienced robotic surgeons felt that appropriate selection criteria played a pivotal role in successful patient outcomes. Although they noted that criteria may vary across specialties, standards were primarily based on maintaining patient safety.2
An advisory sent from the Massachusetts Board of Registration in Medicine in 2013 also emphasized the importance of establishing patient selection criteria, noting that "Careful preoperative assessment of patient risk is critical for preventing perioperative complications. Both the patient's comorbidities and the complexity of the robotic surgical case are important risk factors that should be considered."3
By developing greater awareness of potential risk factors and contraindications for robotic surgery, healthcare organizations and surgeons can create and implement patient selection guidelines and assessment protocols, as well as reinforce or improve quality measures.4 Further, documenting the assessment of patient risks in accordance with established selection criteria can help justify clinical decision-making.
Managing Patient Expectations
Another crucial risk strategy for robotic surgery is managing patients' expectations, which may prove challenging for healthcare organizations and surgeons. Because robotic surgery is fairly new and complex, direct claims about benefits and safety might be difficult to make. Also, aggressive marketing may overestimate benefits, overpromise results, and/or fail to define specific risks, leading to inflated patient perceptions.5
A study that examined robotic surgery information on 400 U.S. hospital websites concluded that hospital marketing of robots touted benefits, often ignored risks, and was strongly influenced by the manufacturer. Of the 41 percent of hospital websites that included robotic surgery information, 73 percent used manufacturer-provided stock images and text. Eighty-six percent made statements about the clinical superiority of robotic surgery, but few provided comparative data.6
The study's authors explained that "Because patients regard information on hospital websites as medical opinion of the physicians working at that hospital, hospital website information carries credibility that can influence patient choice."7 Massachusetts' robotic surgery advisory reinforced the importance of providing patients with factual information and education about their treatment options; it also encouraged hospitals to pay attention to whether their marketing efforts have influenced how they select patients.8
A careful review of advertising and marketing efforts promoting robotic surgery can assist healthcare organizations and medical staff in pinpointing potentially misleading statements and identifying opportunities for clarity. Further, strategies to implement well-defined patient selection criteria and manage patient expectations might help (a) patients make more informed decisions about their care, and (b) healthcare organizations and providers reduce the risks of medical errors, patient harm, and liability exposure.
2 U.S. Food and Drug Administration Medical Product Safety Network. (2013, November). Small sample survey — final report. Retrieved from www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/surgeryandlifesupport/computerassistedroboticsurgicalsystems/ucm374095.pdf
3 Commonwealth of Massachusetts Board of Registration in Medicine. (2013, March). Advisory on robot-assisted surgery. Retrieved from http://www.mass.gov/eohhs/docs/borim/physicians/pca-notifications/robot-assisted-surgery.pdf
4 Clark, C. (2012, April 17). Da Vinci robot surgical risks detailed. HealthLeaders Media. Retrieved from http://www.healthleadersmedia.com/page-1/TEC-279018/Da-Vinci-Robot-Surgical-Risks-Detailed
5 Langreth, R. (2013, October 8). Robot surgery damaging patients rises with marketing. Bloomberg News. Retrieved from http://www.bloomberg.com/news/2013-10-08/robot-surgery-damaging-patients-rises-with-marketing.html
6 Jin, L. X., Ibrahim, A. M., Newman, N. A., Makarov, D. V., Pronovast, P. J., & Makary, M. A. (2011). Robotic surgery claims on United States hospital websites. Journal for Healthcare Quality, 33(6), 48–52.
8 Commonwealth of Massachusetts Board of Registration in Medicine, Advisory on robot-assisted surgery.