Clinical Research Coordinators' Attitude Toward Risk-Based Monitoring.

BACKGROUND: Clinical research coordinators (CRCs) are persons who collect, record, and maintain clinical trial data in accordance with the principles of Good Clinical Practice at investigators' sites. This study was conducted to examine attitudes of clinical research coordinators (CRCs) toward risk-based monitoring (RBM) prior to full-scale implementation of RBM in Korea. METHODS: The study subjects were 607 CRCs, and data were collected using a self-reported questionnaire. Collected data were analyzed by frequency, percentage, χ2 test and Fisher exact test. RESULTS: Among CRCs, 42.3% had heard of RBM and 44.6% were found to oppose its implementation. Those opposed believed that implementation of RBM would increase the workload of CRCs and CRAs' work support for CRCs. In addition, they showed many negative opinions such as poor accuracy of test data input and failure to increase the overall quality of clinical tests. In particular, such attitudes were more noticeable in CRCs with 5 or more years of experience. CONCLUSION: Before the implementation of RBM, it is necessary to come up with administrative measures such as education for practitioners and recruitment of human resources to help CRCs properly understand RBM.

Changes in the Number and Employment Conditions of Clinical Research Coordinators in South Korea.

BACKGROUND: This study was aimed to examine the number and employment conditions of clinical research coordinators (CRCs) in Korea, with comparison to data from 2010 to identify changes. METHODS: The descriptive study examined 65 sites that participated in a survey or phone interviews among 184 sites registered as clinical trial sites by the Ministry of Food and Drug Safety, and 2 site management organizations. The data were analyzed for mean, standard deviation or median, range, frequency, and percentage. RESULTS: There were 2855 CRCs in 65 sites and 3711 CRCs nationwide, which reflected an increase of 268 people every year on average since 2010. The most common employment system (60.6%) was where CRCs were hired by sites and allocated to clinical trial departments. As for employment type, 48.5% of posts were full-time, and monthly wage payment was the most common at 54.5%. An employment/personnel management department was reported at 87.9% of sites. The average duration from hiring to resignation was 19 months. CONCLUSIONS: The number of CRCs was increased, and such an increase of CRCs was attributed to the increase of investigator-affiliated CRCs rather than site-affiliated CRCs. Though the employment conditions of CRCs have been improved, most improvements were confined to site-affiliated CRCs. It is recommended that each site have a CRC registration and management system for both site-affiliated CRCs and investigator-affiliated CRCs, standardized CRC employment guidelines, and support for CRCs to participate in the training program for the overall improvement of employment conditions of CRCs in Korea.

Factors Influencing the Health Examination in Unmarried Women.

PURPOSE: This study was to investigate factors that influence health examination for unmarried women. METHODS: A correlation study was carried out with 144 unmarried women with an age range of 35~49 years through self-administered questionnaires. This questionnaire included Health Belief Model modifying factors (demographic . sociological, structural, and cues to action variables). Data were analyzed using descriptive statistics, chi2-test, multiple logistic regression. RESULTS: The mean age of participants was 37.2+/-2.67 years. Rates for breast cancer, cervical cancer and comprehensive health examination were each 34.7%, 38.2% and 94%. In multiple logistic regression analysis, influencing factors on physical examination were age(OR=0.06, 95% CI: 0.02~0.26), personal medical insurance (OR=6.30, 95% CI: 1.60~24.82), housemate (OR=7.63, 95% CI: 2.58~22.52), exercise (OR=3.72, 95% CI: 1.37~10.12) in breast cancer examination, and age (OR=0.08, 95% CI: 0.02~0.34; OR=0.07, 95% CI: 0.01~0.85), personal medical insurance (OR=14.17, 95% CI: 2.94~68.23), sexual experiences (OR=3.38, 95% CI: 1.28~8.91), drinking (OR=2.92, 95% CI: 1.14~7.49) in cervical cancer examination. CONCLUSION: The results emphasize the necessity of preparing nursing education and intervention in consideration of associated factors which influence on the health examination in unmarried women.

[Predictors of postpartum depression: prospective cohort study].

PURPOSE: This prospective cohort study was done to investigate recall bias to antepartum variables measured at postpartum periods and predictors of postpartum depression. METHODS: Participants were 215 women who answered a self-administered questionnaire which included demographics, Postpartum Depression Predictors Inventory-Revised and Korean version of Edinburgh Postpartum Depression Scale at antepartum 36-40 weeks and postpartum 2 weeks and 6 weeks. Data were analyzed using kappa, and hierarchical multiple logistic regression. RESULTS: Agreement between antepartum variables at both antepartum and two postpartum periods was relatively high (κ=.55-.95). Postpartum depression rates were 36.3% and 36.7% at two follow-up points. In hierarchical multiple logistic regression analysis, prenatal depression (OR=4.32, 95% CI: 1.41-13.19; OR=5.19, 95% CI: 1.41-19.08), social support (OR=1.40, 95% CI: 1.18-1.66; OR=1.27, 95% CI: 1.06-1.53) and maternity blues (OR=4.75, 95% CI: 1.89-11.98; OR=4.22, 95% CI: 1.60-11.12) were commonly associated with postpartum depression at two follow-up points. Child care stress (OR=1.85, 95% CI: 1.01-3.37) was only associated with postpartum depression at 2 weeks postpartum and pregnancy intendedness (OR=1.57, 95% CI: 1.09-2.27) was only associated with postpartum depression at 6 weeks postpartum. CONCLUSIONS: The results indicate a need to apply nursing interventions such as prenatal education and counseling with families from antenatal period.

Predictive validity of the postpartum depression predictors inventory-revised.

PURPOSE: This study aimed to investigate the predictive validity of three versions of the Postpartum Depression Predictors Inventory-Revised (PDPI-R) in Korea. METHODS: A descriptive cross-sectional design with a self-administered questionnaire, including 43 items of the PDPI-R, using the Edinburgh Postpartum Depression Scale as the gold standard was used. Data were collected from 316 women within 6 weeks after childbirth in Busan, Korea, from August to November 2010. RESULTS: The postpartum depression and postpartum depressive symptom (PDS) rate was 22.5%. The area under the curve of the receiver operating characteristic curve was .882 for the prenatal version of the PDPI-R and .927 for the full version. The sensitivity and specificity were 87.3% and 85.1%, respectively, at a cutoff point of 9.5 for the full version, and 91.5% and 66.1%, respectively, at a cutoff point of 5.5 for the prenatal version. The Hosmer-Lemeshow goodness-of-fit statistics was 3.554 (p=.829) for the prenatal version and 8.305 (p=.404) for the full version; this showed a good degree of correspondence between the estimated and observed probabilities of PDS. By age, education, and socioeconomic groups, the discrimination and calibration were generally good for both the prenatal and full versions. CONCLUSION: The PDPI-R showed good predictive validity among women in Korea. It is recommended that the prenatal version of the PDPI-R be used to predict PDS for pregnant women and the full version of the PDPI-R be used for women during the postpartum period.