European Society of Anaesthesiologists; 8th Annual Meeting with the Austrian International Congress; Vienna, Austria, 1-4 April 2000
Background and goal of study: Factors likely to influence willingness to participate in clinical research include patient age, educational status, anxiety level, and depression . We therefore evaluated the contribution of each, with the expectation that anxiety and depression would prove to be major influences.
Material and methods: With IRB approval, we asked 57 patients to participate in the study. They were aged 19-65 years. ASA I-III, and scheduled for elective surgery. Patients with malignancies or serious underlying illnesses were excluded. We initially evaluated anxiety and depression using the HADS-D scale . Subsequently, they were asked to participate in a clinical study protocol involving randomized assignment to various intra- and postoperative procedures and tests. The risks and discomforts associated with the study were explained and they were given written consent forms. The patients were given up to one hour to decide whether or not to participate; during this time they were permitted to consult family members but were told that their surgeons were unavailable. The consenting investigators were available throughout this one-hour period.
Results and discussion: The overall consent rate was 63%. Potential confounding factors including the type of operation and ASA scores were similar in patients who agreed and declined to participate in the study. Anxiety and depression scores were also comparable. There was a trend towards a lower consent rate in the younger (20-34 years, 50%) and older (50-65 years, 56%) patients than in the middle-aged group (35-49 years, 78%) (P=0.28). Educational level did not influence the participation rate.
Conclusions: Interestingly, a willingness to participate in clinical research did not correlate with anxiety or depression. Additionally, our data similarly suggest that patients of various educational backgrounds are able to make informed decisions.
1 Brit J Anaesth
2 HADS-D. Verlag Hans Huber, Bern Goettingen, Toronto Seattle, 1995.
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