Attitudes and considerations of patients with ST-elevation myocardial infarction toward participation in randomized clinical trials

Abstract

Background Limited evidence is available on attitudes and considerations of ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) toward participation in randomized clinical trials (RCTs). Therefore, we investigated the ability of these patients to decide participation in RCTs. Methods This was a questionnaire-based study. Over a 9-month period, we approached and invited 100 consecutive STEMI patients who were asked to participate in at least one RCT during primary PCI. Patients were asked to fill out self-administered questionnaires concerning demographic data as well as attitudes and considerations toward participation in RCTs. Results Patients had a mean (SD) age of 61 (12) years, and most were male (82%). With a response rate of 96%, a total of 94% accepted participation in at least one RCT. Most patients (78%) reported to understand the information on participation in RCTs at an acceptable to satisfactory level, and 83% reported that they were given the possibility to ask additional questions during the decision-making process. Few patients (2%) reported that they felt pressured to participate. Most patients (83%) reported that they participated to help clinical research, and 85% of patients would be willing to participate in future RCTs. It did not seem that the total number of RCTs that patients participated in was of significant importance. Conclusions Patients with STEMI undergoing primary PCI had positive attitudes and considerations toward participation in RCTs despite their acute medical condition and the emergency environment. The overall self-assessed ability of patients to make a decision about participation in RCTs was good.