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Appreciation of the informed consent procedure in a randomised trial of decompressive surgery for space occupying hemispheric infarction
- Source :
- Journal of Neurology Neurosurgery and Psychiatry, 78(10), 1124-1128. BMJ Publishing Group
- Publication Year :
- 2007
- Publisher :
- BMJ, 2007.
-
Abstract
- Background and aim: As non-randomised studies have suggested that surgical decompression may reduce mortality in patients with space occupying hemispheric infarction, randomisation may be considered unethical in controlled trials testing this treatment strategy. We studied differences in recall of information and in appreciation of the informed consent procedure between representatives included in the Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial (HAMLET) and representatives of patients participating in the randomised trial of Paracetamol (Acetaminophen) In Stroke (PAIS). Methods: 1 year after study inclusion, we contacted 30 consecutive representatives who had given informed consent for participation of their relative in HAMLET, and 30 for PAIS. Recall of trial details and appreciation of the informed consent procedure were investigated using standardised questionnaires and compared between the two groups. Results: All 30 PAIS representatives and 28 HAMLET representatives were interviewed. Participation of their relative in a clinical trial was remembered by 86% of HAMLET and 40% of PAIS representatives (p
- Subjects :
- Paper
medicine.medical_specialty
business.industry
Unconsciousness
Infarction
medicine.disease
Patient advocacy
law.invention
Clinical trial
Psychiatry and Mental health
Randomized controlled trial
law
Informed consent
medicine
Physical therapy
Surgery
Neurology (clinical)
medicine.symptom
Patient participation
business
Stroke
Subjects
Details
- ISSN :
- 00223050
- Volume :
- 78
- Database :
- OpenAIRE
- Journal :
- Journal of Neurology, Neurosurgery & Psychiatry
- Accession number :
- edsair.doi.dedup.....d55f21a1c2480ff92a59865f5f259cc2