Surveying a third of its approximately 50-member clinical staff, the interventional radiology practice of an academic medical center has identified four challenges to securing informed consent from patients or their medical decision-makers:
- limited procedural experience/knowledge by the clinician in charge of the consenting process;
- unclear division of responsibilities among faculty, trainees and nurses;
- inconsistent approaches to assessing capacity and surrogate decision making; and
- wide variation in patients’ baseline understandings.
The Journal of Radiology Nursing published the study online May 9.
Lead author Sara Silberstein, MD, of Albany Medical College in New York and senior author Eric Keller, MD, of Stanford University in California note that IR clinicians are duty-bound to make sure patients understand a given procedure’s benefits, risks and alternatives.
Their survey’s final respondent cohort consisted of 17 clinicians—three faculty, two residents, one fellow, four nurses and seven technologists—whose years of experience ranged from one to 40 years.
The team’s overall conclusion: Barriers to consistently obtaining patients’ informed consent “seem to stem from a lack of shared understanding about consent processes and responsibilities, highlighting an important area for quality improvement in IR that would benefit from a larger multipractice investigation of consent practices.”
Fleshing out each of the four challenges in some detail, Silberstein and Keller report:
1. The most appropriate clinician to inform a patient is not always the consenting clinician.
Various team members noted that how well the consenting provider understands the procedure is an important factor in the informed consent process. Interviewees indicated junior trainees often obtain consent although they may have limited experience with the procedure.”
2. Clinicians (faculty, trainees and nurses) tend to believe it’s their responsibility to ensure consent is obtained and documented.
For example, a nurse may feel that the ultimate responsibility is that of the IR faculty but that the nurse is responsible for ensuring proper documentation and assessing patient understanding and further questions immediately before the procedure. Conversely, faculty felt it was their responsibility, and trainees felt it was their or their attending’s role. Technologists’ perceptions varied, as some thought the responsibility fell on specific individuals while others said it was the responsibility of the entire team.”
3. Criteria for assessing capacity and surrogate decision-making are inconsistently applied.
The ‘alert and oriented times three’ description was commonly cited as a proxy for decision-making capacity. When asked what happens if a patient lacks capacity, many providers cited the need for two-physician consent in emergent cases, an acceptable practice adopted by certain states and institutions, including the environment in which this study was conducted. When referencing nonemergent cases, responses varied, especially regarding the process for selection of a healthcare proxy.”
4. Variability abounds in patients’/proxies’ baseline understanding, what information to disclose and how best to do so.
Several clinicians noted that the underlying content of the informed consent discussion is often more important than signing the consent form. Some also cited the ‘reasonable patient standard’ as a minimum requirement of the informed consent process. However, interviewees described multiple factors affecting the quality of these discussions, including misconceptions from information found online or told to the patient by referring clinicians, the type of procedure, the setting in which informed consent conversations take place (e.g. inpatient vs. outpatient), how much independent research a patient does and how they interpret information from different sources.”
Silberstein and Keller acknowledge that these challenges are not unique to IR. However, radiology in general and possibly IR in particular may be more obscure than other medical specialties at the level of the general public, they note.
“Adjusting for decision makers’ variable needs and preferences can be challenging, particularly when time is limited, but one potential intervention is using decision aids” such as handouts, videos or other informational tools that “present balanced information about a procedure in patient-friendly language and can improve decision-maker understanding and satisfaction.”
Reference:
Sara Silberstein, MD, MS, MPP, and Eric Keller, MD, MA, “Barriers to Informed Consent in Interventional Radiology: A Pilot Study.” Journal of Radiology Nursing, May 9, 2022. DOI: https://doi.org/10.1016/j.jradnu.2022.03.006
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Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.