The Need for Joint IRB in Multi-Clinical Trials and Searching for A Systemization Strategy for IRB Review / 의료커뮤니케이션

Purpose@#: Recently, with the development of science and technology and the expansion of research scale, the number of multicenter clinical trials involving more than one institution is increasing. Accordingly, by establishing a standard and computerized system for IRB examination, we intend to present a strategy that can be expected to shorten the examination period and reduce examination costs with an efficient examination system. @*Methods@#: The necessity of joint IRB and regulations for operation were reviewed. The points to be considered for the establishment of the e-IRB system were reviewed. @*Results@#: It confirmed that the need for a joint IRB was clear. Problems and solutions to be solved for the concrete realization of the joint IRB were presented. Functions and interlocking methods for reviewing domestic and foreign regulations and system construction were presented. @*Conclusion@#: Through this paper, it is expected that medical institutions will become aware of the importance and necessity of an efficient and flexible joint IRB in line with the rapidly changing medical industry. In fact, it is expected that it will be able to contribute to understanding the precautions on how to organize and operate a joint IRB.

Application of Point Shearwave Elastography to Breast Ultrasonography: Initial Experience Using “S-Shearwave” in Differential Diagnosis

PURPOSE@#To evaluate the optimal measurement location, cut-off value, and diagnostic performance of S-Shearwave in differential diagnosis of breast masses seen on ultrasonography (US).@*MATERIALS AND METHODS@#During the study period, 225 breast masses in 197 women were included. S-Shearwave measurements were made by applying a square region-of-interest automatically generated by the US machine. Shearwave elasticity was measured three times at four different locations of the mass, and the highest shearwave elasticity was used for calculating the optimal cut-off value. Diagnostic performance was evaluated by using the area under the receiving operator characteristic curve (AUC).@*RESULTS@#Of the 225 breast masses, 156 (69.3%) were benign and 69 (30.7%) were malignant. Mean S-Shearwave values were significantly higher for malignant masses (108.0 ± 70.0 kPa vs. 43.4 ± 38.3 kPa; p < 0.001). No significant differences were seen among AUC values at different measurement locations. With a cut-off value of 41.9 kPa, S-Shearwave showed 85.7% sensitivity, 63.9% specificity, 70.7% accuracy, and positive and negative predictive values of 51.7% and 90.8%, respectively. The AUCs for US and S-Shearwave did not show significant differences (p = 0.179).@*CONCLUSION@#S-Shearwave shows comparable diagnostic performance to that of grayscale US that can be applied for differential diagnosis of breast masses seen on US.

Reduction Plan of ‘Undeterminable’ in the Unexpected Antibody Screening by the Microcolumn Agglutination Automated Instrument / 대한수혈학회지

BACKGROUND: Among the results of an unexpected antibody screening test using IH-1000, ‘undeterminable’ results can be obtained. Repeated tests not only use reagents and consumables but also cause a turnaround time delay. Therefore, it is important to reduce the ‘undeterminable’ results and to determine the effects. METHODS: From January to early June, 2016, 2,872 cases/259,455 tests (1.11%) of ‘undeterminable’ were detected in the screening test. The factors considered to affect the ‘undeterminable’ were classified into four categories: ① reagent, ② consumables, ③ inspection environment & specimen, and ④ enhancing the equipment management. For data comparison, a chi-square test was conducted (95% confidence interval, 0.05 significant level). RESULTS: The incidence of ‘undeterminable’ cases decreased from 1.11% before management to 0.66% (P < 0.001) after Pool Cells management. The consumption of ‘LISS/Coombs Card’ decreased from 1.07% before management to 0.51% (P < 0.001) after management. By maintaining a clean inspection environment and strengthening sample management, the rate decreased from 1.11% before management to 0.66% (P < 0.001) after management. On the other hand, there was no difference in the incidence of ‘undeterminable’ between before and after IH-1000 management reinforcement. CONCLUSION: Among the factors predicted to affect the decrease in the incidence of ‘undeterminable’, the management of Pool Cells and keeping the inspection environment clean as well as improving sample management contributed the most to the reduced ‘undeterminable’. Improvements in the management of consumables, and removing dust from the inside of the equipment, had a positive impact. A continuous quality improvement theme has been adopted and it is helpful for managing and improving the predicted factors.

Bioprospecting Potential of the Soil Metagenome: Novel Enzymes and Bioactivities

The microbial diversity in soil ecosystems is higher than in any other microbial ecosystem. The majority of soil microorganisms has not been characterized, because the dominant members have not been readily culturable on standard cultivation media; therefore, the soil ecosystem is a great reservoir for the discovery of novel microbial enzymes and bioactivities. The soil metagenome, the collective microbial genome, could be cloned and sequenced directly from soils to search for novel microbial resources. This review summarizes the microbial diversity in soils and the efforts to search for microbial resources from the soil metagenome, with more emphasis on the potential of bioprospecting metagenomics and recent discoveries.

Effect of Mandibular Set Back Surgery on Volumetric Change and Bite Force of Masseter Muscle

PURPOSE: The purpose of our study was to evaluate the volume of pre- and post operative masseter muscle and bite force in mandibular prognathic patients treated with SSRO with the use of the 3D CT imaging technique and occlusal force meter. MATERIALS AND METHODS: The study group consisted of 12 patients with mandibular prognathism (5 males and 7 females) who underwent mandibular setback surgery (BSSRO) in the Department of Oral and Maxillofacial Surgery, Samsung medical center. Bite force was measured at pre op, post op 3, 6 and 12 months by occlusal force meter(GM10, Nagano Keiki, Japan) The preoperative CT examination of subjects was performed between one month prior to operation and one year after to operation. And muscle volume was measured. RESULT: As compared to preoperative measurements at 1 year postoperatively the masseter and internal pterygoid muscle volume were diminished (p0.05), internal pterygoid muscle and bite force (p>0.05). CONCLUSION: In this study, the results showed that volume and bite force of the masticatory muscles decresed significantly immediate after orthognathic surgery for mandibular set-back. However, reduction of maximum bite force disappears within 6 months after surgery.

Imaging Features of Tuberculous Mastitis: Comparison with non-Tuberculous Mastitis

PURPOSE: The purpose of this report is to evaluate the characteristic findings of tuberculosis of the breast on mammogram, sonogram, and CT and to compare the results with the imaging features of non-tuberculous mastitis. MATERIALS AND METHODS: Using mammograms and sonograms, nine cases of tuberculosis of the breast were evaluated, and for four cases, CT was used. Aspects evaluated were contour, shape and size of the lesion, homogeneity ofinternal content, and extension of the lesion from/to the adjacent organs. Diagnosis was based on aspiration,surgery, and pathologic findings including acid-fast bacillus (AFB) staining. Mammograms and sonograms of 19 patients with non-tuberculous mastitis of the breast were reviewed. RESULTS: No cases of tuberculous mastitis presented clinical evidence of acute inflammation such as fever, swelling or skin redness. Nine cases of tuberculous mastitis were seen as a distinct mass on mammogram and sonogram. Four of nine cases (44.4%) showed arelatively smooth peripheral margin on mammogram and a cold abscess form on sonogram and CT. There were other fociof tuberculosis in the chest wall, anterior mediastinum, pleural cavity or lung. Five cases demonstrated as a nodular type on US. In the non-tuberculous mastitis group, an abscess with distinct margin or direct contiguity between a breast lesion and the adjacent organ was observed neither on mammogram nor on sonogram. CONCLUSION: Inan afebrile patient, relative homogeneous density with distinct margin in the breast on mammogram and a fistulous connection or direct continuity between breast abscess form with the adjacent organ on sonogram or CT is acharacteristic feature of the tuberculous mastitis. The cold abscess type is a frequent subtypes of this entity, and must also be included.