Anesthesia investigators who worry about obtaining patient consent for clinical trials—on the day of surgery—finally might be able to lay those fears to rest, a new study suggests.
Obtaining same-day consent has become an issue at several medical centers around the country since the elimination of preoperative clinics due to cost constraints. Opportunities are often limited to the day of surgery, raising ethical concerns about the ability of patients to voluntarily participate in research.
“Unfortunately, the only time that we as anesthesiologists have contact with patients now is on the morning of surgery,” said Glenn Stephen Murphy, MD, lead study author and an anesthesiologist for NorthShore University HealthSystem, with several locations in Illinois. “When we have to obtain consent for clinical trials, that’s often the first opportunity that we have. … This is a problem that’s consistently raised by review boards.”
However, results from a 25-question survey completed by 200 patients participating in one of two low-risk clinical trials suggest that the patients had sufficient time and privacy to review protocols in this setting.
“The data are clear: Patients are comfortable providing consent on the morning of surgery for low-risk clinical trials,” Dr. Murphy said. The findings were presented at the 2016 World Congress of Anaesthesiologists (abstract PR523).
The two low-risk clinical trials in the study were a trial involving dexamethasone in gynecologic patients and a study examining neuromuscular monitoring in the operating room. While consent on the day of surgery was permitted for both studies, patients being recruited for the neuromuscular study were required to be contacted the day before and informed they would be approached about participating in a clinical trial.
“Our IRB [institutional review board] felt that patients might be more comfortable with consenting if they knew that they’d be approached about the clinical trial and had more time to consider participation, even if they didn’t have all the information at the time,” Dr. Murphy explained.
Of the 129 patients who completed the questionnaire, the median score for satisfaction with the consent process was 9.5 on a 0- to 10-point scale. The majority of respondents strongly agreed that being approached by a research assistant in the preoperative holding area allowed sufficient time and privacy to review the protocols. Despite the limitations imposed by the same-day consent process, patients understood the purpose, benefits and risks of the clinical trials, according to the researchers.
At least 95% of respondents were satisfied with the structure of the same-day consent process (satisfaction score, 7/10); only a small number of patients had regrets about participation, the researchers reported. They also observed no difference in responses whether patients received a preadmission telephone call or not.
“The data have also satisfied our hospital’s IRB,” Dr. Murphy said. “They’re much more comfortable using this approach to sign up patie nts for clinical studies in this setting.” He noted that his IRB has only approved this approach for low-risk clinical trials, and investigators will need to contact patients at least the day before surgery for high-risk trials.
While these responses should help assuage concerns regarding same-day consent for low-risk clinical trials, Dr. Murphy emphasized that this may not necessarily be the case for higher-risk studies. In fact, patient-reported anxiety in this study was “surprisingly low” on the morning of surgery.
“I think the low level of anxiety is a reflection of the fact that patients were undergoing lower-risk procedures,” Dr. Murphy said. “If we were investigating a new experimental drug, the results might be different.”