Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity?
OBJECTIVE
To investigate how patients included in trials on treatment in the early phase of acute myocardial infarction experience the consent procedure.


METHODS
A combined qualitative and quantitative interview concerning the patients' knowledge of the trial, their feelings about being asked to participate, and their attitudes towards the consent procedure.


METHODS
Tertiary referral centre.


METHODS
31 patients who had given written informed consent for their participation in randomised intervention trials of acute myocardial infarction.


RESULTS
The patients interviewed had only fragmentary knowledge about the trial they were involved in. Most considered that reading and signing a consent form was an unwanted or unnecessary procedure. Instead, they would have preferred to have been given concise verbal information about the study. Most were willing to allow a physician to decide for them in the event of their being too ill to be asked about their participation.


CONCLUSIONS
Patients who are asked to participate in intervention trials in the early phase of acute myocardial infarction often appear to lack sufficient knowledge to reach an autonomous choice. There were problems and disadvantages associated with the process of obtaining written informed consent in this particular situation, especially regarding the need for the patient to sign a consent form during the acute phase of the disease.
Agård
A
A
Department of Medicine, Sahlgrens University Hospital, SE-413 45 Gothenburg, Sweden. anders.agard@telia.com
Hermerén
G
G
Herlitz
J
J
D000077284:Abciximab; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D001294:Attitude to Health; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use; D007258:Informed Consent; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic; D000077785:Tenecteplase; D015912:Thrombolytic Therapy / Q000379:methods; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase; D000077284:Abciximab