Aims: To explore the conformity of patient recruitment with recommended informed consent procedures among patients who were invited to participate in a clinical study at a general teaching hospital, and to examine the association between consent procedures and the patients’ decision to participate.
Design and Methods: All inpatients discharged during a 1-month period were invited to complete a mailed survey in which they reported whether they were invited to participate in a study and whether 13 recommended elements of informed consent actually occurred.
Results: Among 1303 respondents, 265 (20.3%) reported
that they had been invited to participate in a study, and 191 (72.1%) accepted. While the majority of potential participants were fully informed LCL161 manufacturer about practical issues related to the study (e.g. what their participation would consist in), <50% were informed of possible risks or benefits, and only 20% about the origin of the study funds. Only 60% reported satisfactory answers to items assessing the overall information process (e.g. explanations were easy to understand). Older and sicker patients reported lower levels of conformity
selleck chemical with informed consent procedures, as did patients who refused to participate in a study.
Conclusions: Our results confirm that informed consent procedures fail to meet standards for many patients. In particular, consent information should be adapted to the needs of older and sicker patients. Improving the quality of informed consent may increase patients’ participation in clinical research.”
“Objective: Distal cerebral embolization is a known complication of carotid interventions. We prospectively investigated click here whether subclinical microembolization seen on postoperative magnetic resonance imaging (MRI) leads to cognitive deficits in patients undergoing carotid revascularization procedures.
Methods: Patients undergoing carotid interventions and eligible for MRI scanning were recruited. Among 247 patients who received preoperative and postoperative MRI evaluations, 51 also completed neuropsychologic testing before and at 1 month after their procedure. Cognitive evaluation included the
Rey Auditory Verbal Learning Test (RAVLT) for memory evaluation and the Mini-Mental State Examination (MMSE) for general cognitive impairment screening.
Results: The 51 patients (all men), comprising 16 with carotid artery stenting (CAS) and 35 with carotid endarterectomy (CEA), were a mean age of 71 years (range, 54-89 years). Among them, 27 patients (53%) were symptomatic preoperatively, including 11 who had prior stroke and 16 who had prior preoperative transient ischemic attack symptoms. Most patients had significant medical comorbidities, including hypertension (96%), diabetes (31.3%), coronary artery disease (47%), and chronic obstructive pulmonary disease (15.7%). Two patients (4%) had prior ipsilateral CEA and eight had contralateral carotid occlusion (15.7%).