Amanda L Porter1, James Ebot2, Karen Lane3, Lesia H Mooney4, Amy M Lannen5, Eugene M Richie6, Rachel Dlugash3, Steve Mayo3, Thomas G Brott7, Wendy Ziai8, William D Freeman9,10,11, Daniel F Hanley3. 1. Department of Neurology, Mayo Clinic Alix School of Medicine, Mayo Clinic, Jacksonville, FL, USA. 2. Department of Neurologic Surgery, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. 3. Brain Injury Outcomes (BIOS) Division, Johns Hopkins University, Baltimore, MD, USA. 4. Department of Nursing, Mayo Clinic, Jacksonville, FL, USA. 5. J. Wayne and Delores Barr Weaver Simulation Center, Mayo Clinic, Jacksonville, FL, USA. 6. Department of Critical Care Medicine, Mayo Clinic, Jacksonville, FL, USA. 7. Department of Neurology, Mayo Clinic, Jacksonville, FL, USA. 8. Department of Neurology, Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA. 9. Department of Neurologic Surgery, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. freeman.william1@mayo.edu. 10. Department of Neurology, Mayo Clinic, Jacksonville, FL, USA. freeman.william1@mayo.edu. 11. Department of Critical Care Medicine, Mayo Clinic, Jacksonville, FL, USA. freeman.william1@mayo.edu.
Abstract
BACKGROUND: The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments. METHODS: To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (clinicaltrials.gov, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor-patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared. RESULTS: During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion. CONCLUSION: The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.
BACKGROUND: The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments. METHODS: To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (clinicaltrials.gov, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor-patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared. RESULTS: During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion. CONCLUSION: The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.
Entities:
Keywords:
Best practice; Consent; Randomized controlled trial; Simulation
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