| How Aware Elderly Subjects are of Medical Device Clinical Trials and Their Adverse Events - A Survery |
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Chi Yeon Lim, Ho Jun Lee, Bum Sun Kwon |
1Department of Medicine, Dongguk University College of Medicine, Gyeongju, Korea.
2Department of Rehabilitation Medicine, Dongguk University College of Medicine, Ilsan Hospital, Goyang, Korea. bskwon@dumc.or.kr |
| 노인 대상의 의료기기 임상 시험 및 부작용에 대한 피험자의 인지도 조사 |
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임지연1, 이호준2, 권범선2 |
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동국대학교 의과대학 의학과1, 동국대학교 일산병원 재활의학교실2 |
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| Abstract |
BACKGROUND
Along with the recent greater number of medical devices for the elderly in the market, there has been a parallel increase in the number of clinical trials for these devices. It is uncertain, though, whether the target population has the awareness and understanding of these clinical trials and the possible adverse events of the devices.
METHODS
A total of 147 elderly subjects (mean age, 65.8+/-8.3 years; 39 males) responded to the questionnaire. A pilot study during the development of the questionnaire was conducted in 2009 with the actual survey taking place from June to November 2011. The questionnaire included 22 items-10 items on awareness and understanding of the clinical trial; 4 items on the understanding of adverse events; and 8 items on demographical characteristics.
RESULTS
Of the responders, 62.5% had participated in at least one clinical trial and had heard about the clinical trials through a doctor, newspaper, or television. And 63.3% of the responders understood that the purpose of the trial was to show efficacy and safety for the medical device. There were significant differences on the awareness of the trial by gender and life level. However, there was no statistically significant difference in adverse events awareness.
CONCLUSION
Although elderly subjects participate in clinical trials, it seems they do not receive enough information when involved in clinical trials of medical devices. In the future, before these trials are carried out, medical device companies need to ensure that they provide their elderly subjects with better education and information. |
| Key Words:
Medical device, Elder subjects, Clinical trial, Survey |
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