임상시험 시행대상자설명서의 가독성 평가 = Readability of Patient
Information Leaflets in Clinical Trials
| 저자 |
최임순 ( Im Soon
Choi ), 용철순 ( Chul Soon Yong ), 이인향 ( Iyn Hyang Lee ) |
| 학술지명 |
영남대학교
약품개발연구소 연구업적집(Archives of drug research) |
| 권호사항 |
Vol.26No.-[2016]
|
| 발행처 |
영남대학교
약품개발연구소 |
| 자료유형 |
학술저널
|
| 수록면 |
91-91 |
| 언어 |
Korean |
| 발행년도 |
2016 |
| 주제어 |
Clinical
trial. Infomed consent, patient information leaflets, readability |
| 초록 |
Background:
Elements of informed consent including capacity, disclosure, understanding,
voluntariness, and permission of the participant, are all crucial for
clinical trials to be legally and ethically valid. During the informed
consent process, the patient information leaflet is an important information
source which prospective research subjects can utilize in their
decision-making. In the adequate provision of information, KGCP guideline
necessitate 20 specific items, as well as the use language that individuals
can understand. This study measures the vocabulary level of patient
information leaflets in an effort to provide an objective evaluation on the
readability of such material. Methods: The word difficulty of 13 leaflets was
quantitatively evaluated using Kim kwang Hae``s vocabulary grading framework,
which was compared to the difficulty level of words found in the 6th grade
Korean textbook. The quantitative outcomes were statistically analyzed using
chi-squared tests and linear by linear association for ordinal data. Results:
There was a statistically significant difference between the vocabulary level
and frequency of words in leaflets and the 6th Korean textbook. The leaflets
were on average 260 sentences and about roughly 15 pages long, including lay
language (easier or equal to language used in primary school) of around 12%
less: technical language of around 4.5% more. As the vocabulary grades
increase, there was a distinct difference in vocabulary level between Korean
textbook and each information leaflet (p<0.001), Conclusion: Patient
information leaflets may fail to provide appropriate information for
self-determination by clinical trial subject through the difficulty level of
its wording. Improvements in the degree of patients`` understanding and
appropriate use of information leaflets are collaboratively equipped to
strengthen patient``s autonomy and therefore guaranteeing participant``s
rights. |
|
