Objectives: This study aimed to explore the reasons behind the “resistance” of higher education institutions (HEIs) located in the south Manila area in creating research ethics committees (RECs). It also examined the proportion of researches in these HEIs with human participation. Methods: Research directors underwent key informant interviews while faculty researchers participated in focus group discussions. Universal sampling was employed on all researches in the schools to determine the proportion with human participants and to know if they are ethically “high risk“ or “low risk” in terms of the participants’ involvement. Results: We included ten higher education institutions in this study. Research directors and faculty researchers agreed that their school should have a REC and that studies should undergo ethical evaluation before commencement of data collection. Half of all researches were found to have human participant involvement and, after developing a tool to determine the risk level to participants, this study found that ethically high risk researches are found to represent 10% as a proportion of the total researches done in the schools. Conclusion Almost all respondents in this study agreed that RECs should be created; however, there are financial challenges that schools face in establishing RECs.
Ethics Committees

In 2003, the secretaries of the Department of Health (DOH) and the Department of Science and Technology (DOST) signed a memorandum of understanding to institutionalize the Philippine National Health Research System (PNHRS) for the management of research in the country.1 One of the groups constituted under the PNHRS was the Technical Working Group (TWG) on Ethics, which created strategies that highlight the role of ethics in a responsible health research system. Among the recommendations of the Ethics TWG was the establishment of the Philippine Health Research Ethics Board (PHREB).2 In 2006, the PHREB was formally created through DOST Special Order 2006-91 “to ensure that all phases of health research shall adhere to universal ethical principles that value the protection and promotion of the dignity of health research participants.” Since then, PHREB has become the country’s policy making body on health research ethics.2 3 In 2013, the Republic Act 10532一or the PNHRS Law一was enacted.4 The Act strengthened the mandate of PHREB to ensure protection of the welfare, rights, and safety of human research participants, and the implementing rules and regulations (IRR) of the Act specified the policies that facilitate the achievement of the PHREB mandate.5 In 2017, through DOST Special Order 2017-248, DOST established research ethics monitoring boards (REMBs) in Region I, Region VI, and Region XI to assist in the comprehensive and consistent implementation of PHREB policies at the regional level.6 The creation of PHREB in 2006 initiated several other mandates from PHREB and other agencies that implement the PNHRS. These mandates一shown in the infographic一support human research participant protection through ethical reviews of research protocols, establishment of research ethics committees, and maintenance of quality standards of these committees through accreditation. Many of these mandates are national in scope, but a few are specific to Davao Region (Region XI).
Ethics Committees, Research

Aspergillosis ; Ethics Committees, Research ; Fungi ; Humans ; Korea ; Magnetic Resonance Imaging ; Mycetoma ; Paranasal Sinuses ; Retrospective Studies ; Sinusitis

OBJECTIVES: This study investigates the current state of consuming breakfast among elementary school students residing in Malang, East Java, Indonesia, and to identify factors that influence breakfast behavior.METHODS: The research model was set up as per the health belief model, and slightly modified by adding the subjective normative factors of the theory of planned behavior. The survey was conducted from July 17 to August 15, 2017 using a questionnaire, after receiving the permission PNU IRB (2017_60_HR).RESULTS: The subjects were 77 boys (49.4%) and 79 girls (50.6%) suffering from malnutrition with anemia (21.2%) and stunting ratio of Height for Age Z Score (HAZ) (11.5%). Furthermore, moderate weakness (14.8%) and overweight and obesity (12.3%) by Body Mass Index for Age Z Score (BMIZ) were coexistent. According to the results obtained for breakfast, 21.8% did not eat breakfast before school, with 18.8% of the reasons for skipping breakfast being attributed to lack of food. Even for subjects partaking breakfast, only about 10% had a good balanced diet. The average score of behavioral intention on eating breakfast was 2.60 ± 0.58. The perceived sensitivity, perceived severity, perceived benefits, and self-efficacy of the health belief model correlated with breakfast behavior. Of these, self-efficacy (β=0.447, R²=0.200) and perceived sensitivity (β=0.373, R²=0.139) had the greatest effect on breakfast behavior. Mother was the largest impact person among children.CONCLUSIONS: In order to increase the level of breakfast behavior intention among children surveyed in Indonesia, we determined the effectiveness by focus on education which helps the children recognize to be more likely to get sick when they don't have breakfast, and increase their confidence in ability to have breakfast on their own. We believe there is a necessity to seek ways to provide indirect intervention through mothers, as well as impart direct nutrition education to children.
Anemia ; Body Mass Index ; Breakfast ; Child ; Diet ; Eating ; Education ; Ethics Committees, Research ; Female ; Growth Disorders ; Humans ; Indonesia ; Intention ; Malnutrition ; Mothers ; Obesity ; Overweight

BACKGROUND: This study aimed to provide basic data to establish a foundation for efficient operation of the organization by assessing the effects of self-efficacy and job stress (measured by self-efficacy, job demand, and job autonomy) on organizational commitment among clinical dental hygienists. METHODS: This was a cross-sectional survey study that used a self-administered questionnaire to collect data. After institutional review board approval, a survey was conducted from January to May 2017, targeting dental hygienists working in dental clinics and hospitals. The final 199 questionnaires were analyzed with PASW 18.0 for Windows (IBM Corp.). The data were analyzed using mean and/or standard deviation t-test, one-way ANOVA, and multiple regression analysis. RESULTS: The means for self-efficacy, job demand, job autonomy, and organizational commitment were 55.94±9.65, 26.55±2.29, 20.24±3.88, and 49.49±8.39, respectively. Along with self-efficacy, the other factors of organizational commitment among dental hygienists that were statistically significant included job autonomy, mean salary (2,500~2,990 thousand Korean won [KRW] and ≥3,000 thousand KRW), and employee welfare (good), which are sub-areas of the surface acting. In other words, it was found that the higher the mean salary, the better the employee welfare, the higher self-efficacy, and the higher the organizational commitment, and the explanatory power of the model was approximately 42.1%. CONCLUSION: These results suggest that the higher the self-efficacy, job autonomy, mean salary, and employee welfare, the higher the organizational commitment. In order to improve job demand among dental hygienists, it is necessary to establish an effective plan to improve job welfare, self-efficacy, and job autonomy.
Cross-Sectional Studies ; Dental Clinics ; Dental Hygienists ; Ethics Committees, Research ; Humans ; Salaries and Fringe Benefits

OBJECTIVE: To identify factors associated with non-completion of intraperitoneal with intravenous chemotherapy [IP/IV] in women with epithelial ovarian cancer (EOC). METHODS: This was an Institutional Review Board approved, retrospective cohort study in women with stage III EOC following optimal cytoreductive surgery (CRS) (<1 cm) followed by IP/IV chemotherapy from 2000–2016. Demographic, surgical, and oncologic variables were collected. Pearson χ2 test and 2 sample t-test evaluated for variables associated with IP/IV chemotherapy completion. Kaplan-Meier survival analysis was performed for progression-free survival (PFS) and overall survival (OS). RESULTS: Of 96 women, 71.9% (n=69) completed 6 cycles of IP/IV chemotherapy. The majority had high grade serous histology (n=82; 85.4%) and stage IIIC disease (n=83; 86.5%). Common reasons for IP/IV chemotherapy discontinuation were grade 3–4 gastrointestinal (n=10; 37.0%), neurologic (n=6; 22.2%), hematologic (n=3; 11.1%), renal toxicities (n=3; 11.1%) and port infections (n=3; 11.1%). Incidence of IP port complications was 20.8% (n=20). Port complications (48.0% vs. 11.6%; p<0.001) and hospitalization during chemotherapy (29.6% vs. 2.9%; p<0.001) were more frequent in patients who discontinued IP/IV chemotherapy. Patients who completed IP/IV chemotherapy had higher rates of home discharge following CRS (92.2% vs. 72.0%; p<0.01) and lower Eastern Cooperative Oncology Group (ECOG) score (0 vs. 1.0; p=0.04). There was no significant difference in PFS (p=0.51) nor OS (p=0.38) between the cohorts. CONCLUSION: In this series, the rate of IP/IV chemotherapy completion is high. Non-home discharge and higher ECOG status following CRS are associated with IP/IV chemotherapy non-completion and should be considered in treatment planning.
Chemotherapy, Adjuvant ; Cohort Studies ; Disease-Free Survival ; Drug Therapy ; Ethics Committees, Research ; Female ; Hospitalization ; Humans ; Incidence ; Infusions, Parenteral ; Ovarian Neoplasms ; Retrospective Studies

OBJECTIVES: This study aimed to measure the efficacy of different tooth-brushing methods for removing plaque in Korea. METHODS: This study was conducted with the approval of the Institutional Review Board (IRB) of the Seoul National University School of Dentistry (S-D20180021). Thirty participants aged between 19 and 30 years, who did not have periodontal disease, were enrolled in this observational study. Participants were given the same type of toothbrush and toothpaste and asked to brush their teeth as they usually would. During brushing, participants were recorded with a camcorder that was attached to a mirror. Participants were aware they were being recorded. After they had finished brushing their teeth, a dental plaque staining and oral plaque index (PI) examination was performed. The PI score was measured using the Turesky modified Quigley Hein Index. Brushing methods were classified as rolling, horizontal, vertical, circling, and oblique. Skipped surfaces were recorded separately. Following this, statistical analysis was performed using SPSS software. RESULTS: Most surfaces of the mouth were skipped. The most commonly used brushing method was the circling method, followed by the vertical, horizontal, rolling, and oblique methods. The most frequently used method on the vestibular surface was circling, with 52.92% of the oral surface skipped. The oblique brushing method had the lowest mean PI score with a mean±SD of 1.73±0.82. The mean PI score of the skipped surfaces was the highest with a mean±SD of 2.52±0.81. We also analyzed the linear mixed model considering the different lengths of time spent brushing. Both the brushing method used and the time spent brushing had a significant effect on the PI score, but no interactions between these were observed. In areas where a horizontal brushing method had been used, the PI score was significantly decreased. CONCLUSIONS: This study suggests that the horizontal brushing method is an efficient tooth-brushing method compared to the other methods. Additionally, tooth-brushing for more than 10 seconds on 3 to 4 teeth area was effective in removing dental biofilm.
Biofilms ; Dental Plaque Index ; Dental Plaque ; Dentistry ; Ethics Committees, Research ; Humans ; Korea ; Methods ; Mouth ; Observational Study ; Oral Hygiene ; Periodontal Diseases ; Seoul ; Tooth ; Toothpastes ; Video Recording

OBJECTIVE: To analyze the complications of percutaneous transthoracic needle biopsy using CT-based imaging modalities for needle guidance in comparison with fluoroscopy in a large retrospective cohort. MATERIALS AND METHODS: This study was approved by multiple Institutional Review Boards and the requirement for informed consent was waived. We retrospectively included 10568 biopsies from eight referral hospitals from 2010 through 2014. In univariate and multivariate logistic analyses, 3 CT-based guidance modalities (CT, CT fluoroscopy, and cone-beam CT) were compared with fluoroscopy in terms of the risk of pneumothorax, pneumothorax requiring chest tube insertion, and hemoptysis, with adjustment for other risk factors. RESULTS: Pneumothorax occurred in 2298 of the 10568 biopsies (21.7%). Tube insertion was required after 316 biopsies (3.0%), and hemoptysis occurred in 550 cases (5.2%). In the multivariate analysis, pneumothorax was more frequently detected with CT {odds ratio (OR), 2.752 (95% confidence interval [CI], 2.325–3.258), p < 0.001}, CT fluoroscopy (OR, 1.440 [95% CI, 1.176–1.762], p < 0.001), and cone-beam CT (OR, 2.906 [95% CI, 2.235–3.779], p < 0.001), but no significant relationship was found for pneumothorax requiring chest tube insertion (p = 0.497, p = 0.222, and p = 0.216, respectively). The incidence of hemoptysis was significantly lower under CT (OR, 0.348 [95% CI, 0.247–0.491], p < 0.001), CT fluoroscopy (OR, 0.594 [95% CI, 0.419–0.843], p = 0.004), and cone-beam CT (OR, 0.479 [95% CI, 0.317–0.724], p < 0.001) guidance. CONCLUSION: Hemoptysis occurred less frequently with CT-based guidance modalities in comparison with fluoroscopy. Although pneumothorax requiring chest tube insertion showed a similar incidence, pneumothorax was more frequently detected using CT-based guidance modalities.
Biopsy ; Biopsy, Needle ; Chest Tubes ; Cohort Studies ; Cone-Beam Computed Tomography ; Ethics Committees, Research ; Fluoroscopy ; Hemoptysis ; Image-Guided Biopsy ; Incidence ; Informed Consent ; Lung Neoplasms ; Multivariate Analysis ; Needles ; Pneumothorax ; Referral and Consultation ; Retrospective Studies ; Risk Factors

OBJECTIVE: The aim of our study was to develop and validate a convolutional neural network (CNN) architecture to convert CT images reconstructed with one kernel to images with different reconstruction kernels without using a sinogram. MATERIALS AND METHODS: This retrospective study was approved by the Institutional Review Board. Ten chest CT scans were performed and reconstructed with the B10f, B30f, B50f, and B70f kernels. The dataset was divided into six, two, and two examinations for training, validation, and testing, respectively. We constructed a CNN architecture consisting of six convolutional layers, each with a 3 × 3 kernel with 64 filter banks. Quantitative performance was evaluated using root mean square error (RMSE) values. To validate clinical use, image conversion was conducted on 30 additional chest CT scans reconstructed with the B30f and B50f kernels. The influence of image conversion on emphysema quantification was assessed with Bland–Altman plots. RESULTS: Our scheme rapidly generated conversion results at the rate of 0.065 s/slice. Substantial reduction in RMSE was observed in the converted images in comparison with the original images with different kernels (mean reduction, 65.7%; range, 29.5–82.2%). The mean emphysema indices for B30f, B50f, converted B30f, and converted B50f were 5.4 ± 7.2%, 15.3 ± 7.2%, 5.9 ± 7.3%, and 16.8 ± 7.5%, respectively. The 95% limits of agreement between B30f and other kernels (B50f and converted B30f) ranged from −14.1% to −2.6% (mean, −8.3%) and −2.3% to 0.7% (mean, −0.8%), respectively. CONCLUSION: CNN-based CT kernel conversion shows adequate performance with high accuracy and speed, indicating its potential clinical use.
Dataset ; Emphysema ; Ethics Committees, Research ; Image Processing, Computer-Assisted ; Machine Learning ; Multidetector Computed Tomography ; Retrospective Studies ; Tomography, X-Ray Computed

OBJECTIVE: According to the current guidelines, arterial hyperenhancement for diagnosis of hepatocellular carcinoma (HCC) is determined using the arterial phase only. We investigated the optimal definition of arterial hyperenhancement in patients with HCC using computed tomography (CT) and magnetic resonance imaging (MRI). MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. The requirement for informed consent was waived. Between January 2011 and September 2013, 147 consecutive patients with surgically proven HCCs with both pre-operative CT and MRI were included. Identification rates of arterial hyperenhancement on CT and magnetic resonance (MR) images using arterial phase only, dual phase (unenhanced and arterial phases), and also subtraction MR images were assessed qualitatively. RESULTS: The identification rates for arterial hyperenhancement on CT were significantly different between arterial phase and dual phase (72.8% vs. 90.5%; p < 0.001), whereas the rates were similar on MRI (91.8% vs. 93.9%; p = 0.257). The identification rate of arterial hyperenhancement in MRI increased to 98.6% using subtraction MR images. CONCLUSION: Visual comparison of arterial and unenhanced phases could be recommended instead of conventional qualitative arterial phase alone assessment to determine arterial hyperenhancement of HCCs, especially when using CT.
Carcinoma, Hepatocellular ; Diagnosis ; Ethics Committees, Research ; Humans ; Informed Consent ; Magnetic Resonance Imaging ; Retrospective Studies