Work

Preceding the procedure: Medical devices and shared decision making

Year: 2012

Type: article

Abstract: Carl Thomas is a man in his early fifties with osteoarthritis of the hip. He and his orthopedic surgeon, Dr. Jones, discuss various treatment options and ultimately decide on total hip replacement (THR). Dr. Jones reviews the procedure with him and confirms that he understands his options. Then Mr. Thomas signs the surgical consent form. This discussion appears to include all the elements of informed consent, but several ethical questions linger beneath the surface. Dr. Jones discussed the risks and benefits of total hip replacement in some detail to help Mr. Thomas decide whether or not to have surgery, but should Mr. Thomas also have participated in the decision about the specific implant to be used? This article teases out the ethical issues underlying the choice of a medical device for surgical procedures, using the example of total joint arthroplasty to illustrate the interactions between surgeons and their patients. We highlight shortcomings in the current regulatory process that result in a thin evidence base on which to anchor these technical decisions, and we note the potential for decisions to be influenced by the surgeon’s personal beliefs and possible conflicts of interest. We suggest that the informed consent process could be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values. The Table highlights the most salient aspects of the conversations that we suggest occur between surgeons and their patients. We focus our discussion around the example of total joint replacement, but these issues are generalizable to decisions about non-orthopedic devices such as cardiac pacemakers, stents, and implantable defibrillators, as well as innovative, technically complex, and potentially risky non-surgical therapies like biologic agents for rheumatic conditions.

Source: Arthritis Care & Research

DOI: 10.1002/acr.21826

Authors: Julian J. Prokopetz, Jeffrey N. Katz, Elena Losina, Thomas S. Thornhill, John Wright, Lisa Soleymani Lehmann

Institutions: Brigham and Women's Hospital, Harvard University, Boston University

Language: English

Topic: Ethics and bioethics in healthcare

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funders: National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Research Resources