• Title/Summary/Keyword: Responder

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Survey of Conflict of Interest in the Clinical Research for IRB Members and Researchers (임상시험심사위원회 위원과 연구자를 대상으로 임상연구에서 이해상충에 대한 설문조사연구)

  • Maeng, Chi Hoon;Kang, Su Jin;Lee, Sun Ju;Yim, Hyeon Woo;Choe, Byung-in;Shin, Im Hee;Huh, Jung-Sik;Kwon, Ivo;Yoo, Soyoung;Lee, Mi-Kyung;Shin, Hee-Young;Kim, Duck-An
    • The Journal of KAIRB
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    • v.2 no.1
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    • pp.23-31
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    • 2020
  • Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

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Difference of Short Term Survival in Patients with ARDS According to Responsiveness to Alveolar Recruitment (급성호흡곤란증후군 환자에서 폐포모집술의 반응에 따른 초기 예후의 차이)

  • Kim, Ho Cheol;Cho, Dae Hyun;Kang, Gyoung Woo;Park, Dong Jun;Lee, Jong Deok;Hwang, Young Sil
    • Tuberculosis and Respiratory Diseases
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    • v.56 no.3
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    • pp.280-288
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    • 2004
  • Background : Lung protective strategies, using low tidal volume in ARDS, improve survival rate in ARDS. However, low tidal volume ventilation may promote alveolar de-recruitment. Therefore, alveolar recruitment is necessary to maintain arterial oxygenation and to prevent repetitive opening and closure of collapsed alveoli in lung protective strategies. There has been a recent report describing improvement in arterial oxygenation with use of recruitment maneuver. However, impact of recruitment on outcome of ARDS is unknown. We evaluated whether short-term survival difference existed in patients with ARDS, who were performed alveolar recruitment maneuver(ARM) and prone position, according to response of alveolar recruitment or not. Methods : All patients who were diagnosed with ADRS and received mechanical ventilation were included. ARM were sustained inflation($35-45cmH_2O$ CPAP for 30-40 sec.) or increasing level of PEEP. If these methods were ineffective, alveolar recruitment with prone position was done for at least 10 hours. $P_aO_2/FiO_2$(P/F) ratio was determined before and at 0.5 and 2 hours after ARM. We defined a responder if the P/F ratio was increased over 50% of baseline value. We compared 10-days and 30-days survival rate between responders and non-responders. Results : 20 patients(M:F=12:8, $63{\pm}14age$) were included. Among them, 12 patients were responders and 8 patients were non-responders. In responders, P/F ratio was increased from $92{\pm}25mmHg$ to $244{\pm}85mmHg$. In non-responders, P/F ratio increased from $138{\pm}37mmHg$ to $163{\pm}60mmHg$. Among non-responders, P/F ratio was improved over 50% in 2 patients after prone position. Overall, 14 patients were responders after ARM and prone position. The 10-days and 30-days survival rate in responders was significantly higher than in non-responders(86%, 57% in responders and 33%, 0% in non-responders)(p<0.05). There was no significant difference between responders and non-responders in age($71{\pm}11$, $60{\pm}14$), lung injury score($2.8{\pm}0.2$, $2.9{\pm}0.45$), simplified acute physiology score(SAPS) II ($35{\pm}4.6$, $34{\pm}5.7$), positive end-positive pressure level($15.6{\pm}1.9cmH_2O$, $14.5{\pm}2.1cmH_2O$). Conclusion : ARM may improve arterial oxygenation in some patients with ARDS. These responders in patients with ARDS showed significant higher 10-days and 30-days survival rate than non-responders patients with alveolar recruitment.

Product Community Analysis Using Opinion Mining and Network Analysis: Movie Performance Prediction Case (오피니언 마이닝과 네트워크 분석을 활용한 상품 커뮤니티 분석: 영화 흥행성과 예측 사례)

  • Jin, Yu;Kim, Jungsoo;Kim, Jongwoo
    • Journal of Intelligence and Information Systems
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    • v.20 no.1
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    • pp.49-65
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    • 2014
  • Word of Mouth (WOM) is a behavior used by consumers to transfer or communicate their product or service experience to other consumers. Due to the popularity of social media such as Facebook, Twitter, blogs, and online communities, electronic WOM (e-WOM) has become important to the success of products or services. As a result, most enterprises pay close attention to e-WOM for their products or services. This is especially important for movies, as these are experiential products. This paper aims to identify the network factors of an online movie community that impact box office revenue using social network analysis. In addition to traditional WOM factors (volume and valence of WOM), network centrality measures of the online community are included as influential factors in box office revenue. Based on previous research results, we develop five hypotheses on the relationships between potential influential factors (WOM volume, WOM valence, degree centrality, betweenness centrality, closeness centrality) and box office revenue. The first hypothesis is that the accumulated volume of WOM in online product communities is positively related to the total revenue of movies. The second hypothesis is that the accumulated valence of WOM in online product communities is positively related to the total revenue of movies. The third hypothesis is that the average of degree centralities of reviewers in online product communities is positively related to the total revenue of movies. The fourth hypothesis is that the average of betweenness centralities of reviewers in online product communities is positively related to the total revenue of movies. The fifth hypothesis is that the average of betweenness centralities of reviewers in online product communities is positively related to the total revenue of movies. To verify our research model, we collect movie review data from the Internet Movie Database (IMDb), which is a representative online movie community, and movie revenue data from the Box-Office-Mojo website. The movies in this analysis include weekly top-10 movies from September 1, 2012, to September 1, 2013, with in total. We collect movie metadata such as screening periods and user ratings; and community data in IMDb including reviewer identification, review content, review times, responder identification, reply content, reply times, and reply relationships. For the same period, the revenue data from Box-Office-Mojo is collected on a weekly basis. Movie community networks are constructed based on reply relationships between reviewers. Using a social network analysis tool, NodeXL, we calculate the averages of three centralities including degree, betweenness, and closeness centrality for each movie. Correlation analysis of focal variables and the dependent variable (final revenue) shows that three centrality measures are highly correlated, prompting us to perform multiple regressions separately with each centrality measure. Consistent with previous research results, our regression analysis results show that the volume and valence of WOM are positively related to the final box office revenue of movies. Moreover, the averages of betweenness centralities from initial community networks impact the final movie revenues. However, both of the averages of degree centralities and closeness centralities do not influence final movie performance. Based on the regression results, three hypotheses, 1, 2, and 4, are accepted, and two hypotheses, 3 and 5, are rejected. This study tries to link the network structure of e-WOM on online product communities with the product's performance. Based on the analysis of a real online movie community, the results show that online community network structures can work as a predictor of movie performance. The results show that the betweenness centralities of the reviewer community are critical for the prediction of movie performance. However, degree centralities and closeness centralities do not influence movie performance. As future research topics, similar analyses are required for other product categories such as electronic goods and online content to generalize the study results.