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KMID : 0828520120160030141
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Journal of the Korean Geriatrics Society
2012 Volume.16 No. 3 p.141 ~ p.148
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How Aware Elderly Subjects are of Medical Device Clinical Trials and Their Adverse-A Survery
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Lim Chi-Yeon
Lee Ho-Jun
Kwon Bum-Sun
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Abstract
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Background: Recently, the number of clinical trials for medical devices has been increased with the development of medical device for elder subjects. However, whether or not they have the awareness and understanding in medical device clinical trials and adverse events of the devices is uncertain.
Methods: Total of 147 elder subjects (mean age 65.75±8.349; 39 males) responded to the questionnaires. Pilot study for development of questionnaires was conducted on 2009 and survey using the developed questionnaires was carried out from June to November of 2011. Questionnaires was composed of 22 items: 10 items for awareness and understanding in medical device clinical trial; 4 items for understandings of adverse events; and 8 items for demographical characteristics.
Results:. Of those responders, 62.5% subjects had participated in at least one clinical trials and had heard about the information of medical device clinical trials by doctor or newspapers or TV. And 63.16% of the responders understood the purpose of the trial was to show efficacy and safety for medical device. There were significant differences awareness in the trial by gender and life level. However there was no statistically significant difference in adverse events awareness.
Conclusions: Althogh elder subjects have been exposed to clinical trials, they didn’t receive relevant information about a medical devices clinical trials. Before the medical device products agency grants permission to carry out a trial, education or information sharing for elder subjects is needed.
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KEYWORD
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Medical device, Elder subjects, Clinical trial, Survey
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