• 한국임상약학회지
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• 제26권1호
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• pp.33-39
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• 2016

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 $6^{th}$ 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.

• 한국임상약학회지
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• 제26권3호
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• pp.254-263
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• 2016

Objective: Written information could be helpful for senior population to adhere to complex medication therapies, but must be well prepared and empirically assessed to achieve such end. We purposed to develop a drug information leaflet for senior citizens by applying 'performance-based user-testing.' Methods: We employed a user-testing, a mixed method to figure difficulties out with patients' leaflets from the user perspective. The cycle made of test and revision can be repeated as necessary. We recruited senior citizens with age of 65 or above who were taking antihypertensive medications at the point of participating and excluded the elderly who suffered illiteracy. We firstly rectified a drug information leaflet of antihypertensive medications for the general public distributed by the Korean authority based on focus group interviews (9 participants). The revised leaflets were tested four times with 8~12 participants in each round (40 seniors in total). We targeted to develop a leaflet which more than 80% of participants understood 10 key information. Main outcomes measures were to be able to find information and be able to understand information. This study was approved by the Yeungnam University Research Ethics Committee. Results: Focus group interviews identified difficulties with small font of words, professional language, long information, and a poor structure. The leaflet was revised and in the first round questionnaire found problems with 4/10 information points; interviews disclosed all but one (normal blood pressure range) were ill-understood. The second round questionnaire and interview found fewer problems but the comprehensiveness of participants was still poor in several points. For the third and fourth rounds we revised the leaflets in the individual-targeted manner. Finally, the fourth round showed all key information found and understood by at least 80% of participants except one question about drug name. Conclusion: The drug leaflets need to be developed in a personalized mode for the seniors. There was a limit for Korean seniors to understand nonproprietary name of their drugs because they used to producers' trade names which the Korean health system predominantly works with.

• 한국임상약학회지
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• 제26권1호
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• pp.6-12
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• 2016

Objective: This study aimed to explore the readability and comprehensibility of the drug information on a patient leaflet for the senior by employing performance-based user-testing. Methods: We included 36 elderly (65 years old or older) as the senior group (intervention group) and 36 adults (40~59 years old) as the adult group (control). We developed a questionnaire to test if participants could access to drug information. After completing a questionnaire, the participant was interviewed about their understanding over the patient leaflet. We performed t-test, ${\chi}^2$-test or Fisher's exact test to examine differences between two groups in primary outcomes. Results: The senior were less likely able to find information (78%) than the adult (91%); they were much less likely able to understand information (42%) than the adult (69%). While we found differences between the ability of finding and understanding drug information in both groups, the senior group had greater difficulties in understanding all kinds of drug information. They had significant difficulties to remember information after reading the patient leaflet and frequently failed to find proper information even though they were allowed to access freely to the leaflet during interviewing. Conclusion: To secure safe and effective use of drugs for the senior, it is necessary to develop drug leaflets for the senior.

• 한국임상약학회지
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• 제27권3호
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• pp.171-177
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• 2017

Objective: The study purpose was to develop a drug information leaflet for the elderly and to evaluate it with performance-based user-testing. Methods: We performed a stratified randomized controlled trial. We recruited 62 elderly patients with age of 65 or above who were taking antidiabetic medications at the point of participating and excluded those who suffered illiteracy. We randomly allocated them into the intervention group with a leaflet for the elderly and the control group with a leaflet for the general public. Main outcome measures were to 'be able to find information' and to 'be able to understand information.' We measured outcome variables by employing performance-based user-testing and analyzed data to find any differences between two groups with t-tests, chi-squared tests or Fisher's exact tests accordingly. Results: More participants in the intervention group understood how to store their medications than those in the control group (intervention group 93% vs. control group 70%; p=0.02). There were no significant differences in other information items between two groups. Mostly 'being able to understand information' was lower than 'being able to find information.' The gaps between two outcome variables were about 10% in the intervention group and about 18% in the control group. The lowest understanding was observed in information relating to drug names and their potential adverse events. Conclusion: Without providing personalized drug information, it might be hard for the elderly to improve their drug knowledge even with leaflets that were developed specifically for the elderly.

• 대한간호학회지
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• 제44권5호
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• pp.581-591
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• 2014

Purpose: This study was conducted to develop a self-management program using goal setting for patients after a stroke. The program was based on a theory-based Goal setting and Action Planning framework (G-AP), and the effectiveness of the program was examined. Methods: A non-equivalent control group pretest-posttest design was used. The experimental group (n=30) received the self-management program using goal setting based on the G-AP over 7 weeks. The education was delivered individually with a specifically designed stroke workbook. The control group (n=30) received only patient information leaflets about stroke. Results: There were significant differences between the two groups. Stroke knowledge, self-efficacy, and health behavior compliance were significantly higher (all p<.001), and hospital anxiety (p<.001) and depression (p<.001) were significantly lower in the experimental group compared to the control group. Conclusion: This self-management program using goal setting based on a G-AP was found to be useful and beneficial for patients in stroke rehabilitation settings.