INFORMED CONSENT IN ACUTE ST Elevation MYOCARDIAL INFARCTION

Research is crucial for the development of treatment guidelines. Informed consent is an essential component to ensure the ethical integrity of research. An ideal informed consent should meet three requirements; disclosure of adequate information about the study, subjects understand the information provided, and voluntariness to give consent.. The nature of acute myocardial infarction (AMI) presents special challenges to obtain ideal informed consent. Literature suggest that most patients who consent to clinical trials remember the main information about the studies, however their degree of understanding and perceived comprehension was subjective and often questionable. Majority of patients prefer a summary of verbal information and do not read the written material provided to them prior to making decisions. However limited data is available in the literature addressing this issue with multiple remaining gaps of knowledge. The objective of Patients Acceptance and Comprehension to Written and Verbal Consent (PAC-VC) study was to compare patients’ perspectives and understanding to verbal and written consents in acute myocardial infarction trials. PAC-VC recruited patients from AMI RCTs: Remote ischemic conditioning in ST-Elevation myocardial infarction research (REMCON-STEMI), Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI (COMPLETE) and routine aspiration ThrOmbecTomy with PCI versus PCI ALone in patients with STEMI undergoing primary PCI (TOTAL). REMCON used verbal script delivered by paramedics during enrollment to obtain a verbal ascent. Once the patients have received their treatment and stabilized, a written consent is obtained by a research nurse within 72 hours. TOTAL and COMPLETE studies utilized the standard written consents in their recruitment. PAC-VC consisted of two comparison arms, specifically verbal and written arms. Total of 18 patients were recruited from the three ongoing clinical AMI trials. The verbal ascent arm enrolled 12 patients from REM-CON STEMI trial. The written consent arm enrolled 6 patients from TOTAL and COMPLETE studies. Assessment questionnaires were administered within 72 hours following the initial recruitment to the original trials to test patient understanding and comprehension, in addition to their perspectives to the consent process. PAC-VC study found that in the written consent arm only 33.3% of patients read the written information in its entirety. The majority of study participants 75% of patients of the verbal arm and 100% of the written arm did not believe that written information is very important to make the final decision. However, 25% of verbal and 16.7% of written arms wanted that written information to be presented during the consent process. Indeed, participants from the verbal ascent still wanted to have written information be part of the consent process. In addition, the majority of patients of the written consent 83.3% vs only 50% of the verbal ascent felt pressured during the consent process. Patient responses showed that patients with verbal ascent had an adequate understanding to most components of informed consent and comparable to those of written consent. We concluded that in order to improve the quality of consent, focus should be more on methods of information delivery, and that the information included should concentrate on the content rather than the quantity. In addition, it has been proposed that perhaps more time be provided to patients to discuss the information presented, as this may have an effect on patients’ recollection.