|
|
 |
 |
|
|
| Flexible consent procedures improve stroke trial recruitment |
|
16 February 2006
Flexible consent procedures, including waiver of consent in extenuating circumstances, facilitates the recruitment of a wider variety of patients to stroke trials, investigators claim.
The coordinators of the Third International Stroke Trial (IST-3) - a large-scale, international, randomised trial of intravenous thrombolysis in acute ischaemic stroke - explain that the ideal method of recruitment is to obtain written consent from the stroke patient. If, however, the patient is unable to write, they may give witnessed verbal consent, they say. In circumstances where a patient is unable to give informed consent, the physicians may seek assent (surrogate consent) from the patient's relatives and, in some countries, under "exceptional circumstances," waiver of consent is permitted.
Written consent was obtained for 71 of the first 300 stroke patients recruited to IST-3, and witnessed verbal consent was used for 30. However, assent from relatives had to be sought for 197 patients, and a waiver of consent was used in two cases where neither consent nor assent could be obtained. In general, patients with more severe strokes were less likely to be able to provide informed consent, especially those with left hemisphere lesions.
"Research on emergency medical treatments is necessary in stroke patients who are unable to give consent due to the nature of their stroke," the researchers stress in the journal Cerebrovascular Diseases. "Without studying them, we would be unable to move forward and provide an evidence base for giving these groups of people such acute treatments in emergency settings when time is limited and decisions have to be made very quickly."
Dr Ingrid Kane (Western General Hospital, Edinburgh, UK) and colleagues conclude that the flexible range of consent procedures adopted for IST-3 has permitted the recruitment of a wider variety of stroke patients than used in previous trials. "This is an area where there is scope to develop still better tools to improve the process of informed consent in acutely ill people," they comment.
Reference:
Cerebrovasc Dis 2006; 21 (5-6): 348-352.
 Back to selection |
|
 |
|
|
|
