Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public

Considering general public as potential patients, identifying factors that hinder public participation poses great importance, especially in a research environment where demands for clinical trial participants outpace the supply. Hence, the aim of this study was to evaluate knowledge and perception about clinical research in general public. A total of 400 Seoul residents with no previous experience of clinical trial participation were selected, as representative of population in Seoul in terms of age and sex. To minimize selection bias, every fifth passer-by was invited to interview, and if in a cluster, person on the very right side was asked. To ensure the uniform use of survey, written instructions have been added to the questionnaire. Followed by pilot test in 40 subjects, the survey was administered face-to-face in December 2014. To investigate how perception shapes behavior, we compared perception scores in those who expressed willingness to participate and those who did not. Remarkably higher percentage of responders stated that they have heard of clinical research, and knew someone who participated (both, P < 0.001) compared to India. Yet, the percentage of responders expressed willingness to participate was 39.3%, a significantly lower rate than the result of the India (58.9% vs. 39.3%, P < 0.001). Treatment benefit was the single most influential reason for participation, followed by financial gain. Concern about safety was the main reason for refusal, succeeded by fear and lack of trust. Public awareness and educational programs addressing these negative perceptions and lack of knowledge will be effective in enhancing public engaged in clinical research.

Reasons for Investigators to Participate Industry Sponsored Clinical Trials

BACKGROUND: It is getting more difficult to involve appropriate investigators in clinical trials. Knowing what investigators want from sponsor initiated clinical trials would help industry cooperate with investigators more efficiently. This study aims to describe the incentives for investigators choosing to participate or not and perform well in sponsored clinical trials. METHODS: Investigators who have participated in GSK sponsored clinical trials were interviewed face-to-face or through e-mail using the standardized questionnaire. Investigators were asked to choose five items and determine the ranking or those five items. RESULTS: Questionnaires answered by 122 investigators were collected. The top three incentives were "Academic merit" (108, 88.5 %), "Expectation of treatment potentially helpful to patient" (101, 82.8 %), and "Access to new treatments" (92, 75.4 %). The disincentives and the factors affecting an investigator's performance were analyzed separately because of the different questionnaire between investigators for medicine and vaccine. Investigators for medicine choose as disincentives "Insufficient time" (43, 61.4 %), "Difficult protocol" (41, 58.6 %), and "Adverse event concerns" (41, 58.6 %). Vaccine investigators pointed out "Limited support staff" (41, 78.8 %), "Insufficient time" (40, 76.9 %), and "Difficult blood sampling" (333, 63.5 %) as disincentives. Factors adversely affecting an investigator's performance showed similar results to those of disincentives. CONCLUSION: Investigators focused on academic curiosity and patients and insufficient time mostly inhibits them from participating and performing clinical trials. Our results would help industry cooperate with investigators more efficiently, finally making companies perform clinical trials more effectively.

The Effect of Systemic Inflammation on the Elevation of Troponin I after Percutaneous Transluminal Coronary Angioplasty with Stent in Patients with Stable Angina

BACKGROUND AND OBJECTIVES: There is growing evidence that inflammation plays an important role in atherosclerosis and in the elevation of cardiac troponin I (cTnI) after coronary intervention. The aim of this study was to evaluate the relationship between inflammatory markers and the elevation of cTnI after coronary intervention in patients with stable angina. SUBJECTS AND METHODS: Twenty-three patients who underwent successful percutaneous transluminal coronary angioplasty with stent were examined as the subjects. Serial blood samples were obtained for High Sensitivity C-reactive protein (hs-CRP), which served as markers of systemic inflammation, and cTnI. The difference of cTnI before and 24 hours after coronary intervention was defined as the gradient of cTnI. RESULTS: The mean gradient of cTnI was 1.77+/-3.4 ng/mL. The concentrations of baseline and post-procedural hs-CRP were 1.57+/-1.3 mg/L and 6.31+/-3.8 mg/L, respectively (p=0.001). There were no significant differences in the gradient of cTnI with hypertention, diabetes, smoking, and hypercholesterolemia. The variable that significantly correlated with the gradient of cTnI was the baseline hs-CRP (R2=0.374, p=0.048). CONCLUSION: Systemic inflammation correlated with periprocedural elevation of cTnI in stable angina patients. These results suggest that inflammation plays a pivotal role in the predictive value of myocardial injury after coronary intervention.

Prevalence of Antibody to Hepatitis C Virus among the Employees and their Partners in Korea / 대한산업의학회지

OBJECTIVE: This study was performed to determine the prevalence and age-adjusted prevalence of anti-HCV antibody among the employees and their partners in Korea, and whether prevalence varies with job type. METHOD: The blood serum of 29, 278 people, employees and their partners aged between 20 and 60 residing in Seoul or Kyung-gee province, were tested with Immunoradiometric Assay (IRMA) method using third generation anti-HCV serum. RESULTS: Twenty-five among the 29, 278 people tested positive; a prevalence rate of 0.9 per 1, 000 (95% CI 0.6-1.3). The prevalences of different age groups were 0, 0.5, 1.3, and 4.2 per 1, 000 among the subjects in their 20s, 30s, 40s and 50s respectively, which shows the increasing rate of prevalence with age. Age adjusted prevalence among employees was 1.3 per 1, 000. The prevalences among different kinds of job were 1.9 per 1, 000 (95% CI: 0.5~7.0) for construction, 1.7 per 1, 000 (95% CI: 0.7~3.9) for finance, and 1.2 per 1, 000 (95% CI: 0.2~6.6) for telecommunication. No significant statistical difference was found in the prevalence according to job type(p>0.05). CONCLUSIONS: Employees in Korea showed a lower prevalence rate of anti-HCV antibody than that of blood donors, health screening examinees and the general population. This result is in line with that of other studies abroad and is considered to be because employees may have lower rates of Hepatitis C risk activities, such as needle sharing, than unemployed.

B-Type Natriuretic Peptide Blood Concentrations in Differential Diagnosis of Dyspnea and its Association to 6 Minute Walk

BACKGROUND AND OBJECTIVES: This study was performed to, 1) evaluate the diagnostic value of the Brain Natriuretic Peptide (BNP), which is known to be present in the heart ventricle, for patients with dyspnea for the assessing its causes;diastolic or systolic heart failure or pulmonary disease, and 2) find if the BNP is correlated with the distance walked in 6 minutes, which is known to be a prognostic indicator for heart failure. SUBJECTS AND METHODS: Fifty-seven patients who admitted to the Kangbuk Samsung Medical Center, with the chief complaint of dyspnea, were enrolled in the study. The subjects were classified into three groups according to the causes of their dyspnea, which were systolic heart failure, diastolic heart failure and chronic obstructive pulmonary disease. The plasma BNP levels were measured by a radioimmunoassay, both at admission and discharge. The BNP levels at admission were compared among the three groups. The presence of a correlation between the distance walked in 6 minutes and the BNP at discharge were also evaluated. RESULTS: The patients group with systolic heart failure had the highest mean BNP concentration of 934.6+/-386.7 pg/mL. The other two groups had significantly lower levels of BNP. The patients group with chronic obstructive pulmonary disease had significantly lower level than the group with diastolic heart failure (33.2+/-25.6 vs. 181.8+/-222.2 pg/mL). The BNP concentrations at discharge, and the distance walked in 6 minutes, between the three groups showed no statistical significance (p=0.69). CONCLUSION: This study showed that the mean plasma BNP level was highest in the group with systolic heart failure, followed by diastolic heart failure and lastly chronic obstructive pulmonary disease. These findings suggest that diagnostic value of the plasma BNP concentration in the assessment of the causes of dyspnea. Although this study has failed to show a correlation between the plasma BNP concentration at discharge and the distance walked in 6 minutes, prospective cohort studies, with larger sample sizes, need to be performed to establish the relationship, if any.