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Legal and Regulatory Issues in Genetic Information Discrimination - Focusing on Overseas Regulatory Trends and Domestic Implications - (유전정보 차별금지의 법적문제 - 외국의 규율 동향과 그 시사점을 중심으로 -)

  • Yang, Ji Hyun;Kim, So Yoon
    • The Korean Society of Law and Medicine
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    • v.18 no.1
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    • pp.237-264
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    • 2017
  • With the onset of the Human Genome Project, social concerns about 'genetic information discrimination' have been raised, but the problem has not yet been highlighted in Korea. However, non-medical institutions' genetic testing which is related to disease prevention could be partially allowed under the revised "Bioethics and Safety Act" from June 30, 2016. In the case of one domestic insurance company, DTC genetic testing was provided for the new customer of cancer insurance as a complimentary service, which made the social changes related to the recognition of the genetic testing. At a time when precision medicine is becoming a new standard for medical care, discipline on genetic information discrimination has become a problem that can not be delayed anymore. Article 46 and 67 of the Bioethics Act stipulate the prohibition of discrimination on grounds of genetic information and penalties for its violation. However, these broad principles alone can not solve the problems in specific genetic information utilization areas such as insurance and employment. The United States, Canada, the United Kingdom, and Germany have different regulations that prohibit genetic information based discrimination. In the United States, Genetic Information Non-Discrimination Act takes a form that adds to the existing law about the prohibition of genetic information discrimination. In addition, the range of genetic information includes the results of genetic tests of individuals and their families, including "family history". Canada has recently enacted legislation in 2017, expanding coverage to general transactions of goods or services in addition to insurance and employment. The United Kingdom deals only with 'predictive genetic testing results of individuals'. In the case of insurance, the UK government and Association of British Insurers (ABI) agree to abide by a policy framework ('Concordat') for cooperation that provides that insurers' use of genetic information is transparent, fair and subject to regular reviews; and remain committed to the voluntary Moratorium on insurers' use of predictive genetic test results until 1 November 2019, and a review of the Concordat in 2016. In the case of employment, The ICO's 'Employment Practices Code (2011)' is used as a guideline. In Germany, Human Genetic Examination Act(Gesetz ${\ddot{u}}ber$ genetische Untersuchungen bei Menschen) stipulates a principle ban on the demand for genetic testing and the submission of results in employment and insurance. The evaluation of the effectiveness of regulatory framework, as well as the form and scope of the discipline is different from country to country. In light of this, it would be desirable for the issue of genetic information discrimination in Korea to be addressed based on the review of related regulations, the participation of experts, and the cooperation of stakeholders.

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Evaluation of Standardized Uptake Value applying Prompt Gamma Correction on 68Ga-DOTATOC PET/CT Image (68Ga-DOTATOC PET/CT에서 Prompt Gamma Correction을 적용한 SUV의 평가)

  • Yoon, Seok Hwan
    • Journal of the Korean Society of Radiology
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    • v.12 no.1
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    • pp.1-7
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    • 2018
  • $^{68}Ga$ was eluted from a $^{68}Ge/^{68}Ga$ radionuclide generator. $^{68}Ga$ decays into $^{68}Zn$, with a half life=67.8min. The decay is 88.9 % by ${\beta}$+ and 11.1 % by EC. The main ${\beta}$+ decay (87.7 %) is to the ground level of $^{68}Zn$ and it is a pure positron emission branch. A small fraction decays ${\beta}$+ (1.2 %) into an excited level of $^{68}Zn$, which promptly decays into the ground level with a ${\gamma}$ (1.077 Mev). This can constitute prompt gamma contamination in the PET data, if the 1.077 Mev ${\gamma}$ has a scatter interaction in the patient, and generates a lower energy ${\gamma}$ in coincidence with the positron annihilation pair. The purpose of this study was to evaluate standardized uptake value(SUV) before and after applying prompt gamma rays correction on $^{68}Ga$-DOTATOC PET/CT image. Fifty patient underwent PET/CT 1 hour after injection of the $^{68}Ga$-DOTATOC. The SUVmax and SUVmean of lesions and normal tissues (Pituitary, Lung, Liver, Spleen, Kidney, Intestine) were evaluated before and after applying prompt gamma correction on $^{68}Ga$-DOTATOC PET/CT image. Additionally, the SUVmax of each lesions and SUVmean of the soft tissues were measured on images. and target to background ratios (TBR) were calculated as quantitative indices. Among 15 patients, 25 of lesions (Pancreas, Liver, Thoracic Spine, Brain) with increased uptake on $^{68}Ga$-DOTATOC PET/CT image. SUVmax and SUVmean were increased in lesion site and normal tissue after prompt gamma rays correction. TBR was $51.51{\pm}49.28$ and $55.50{\pm}53.12$ before and after prompt gamma rays correction, respectively. (p<0.0001)

The Effects of Image Quality due to Scattering X-ray according to increasing Patient Thickness (피사체 두께에 따른 산란선 발생이 화질에 미치는 영향)

  • Park, Ji-Koon;Yang, Sung-Woo;Jun, Jae-Hoon;Cho, Su-Yeon;Kim, Kyo-Tae;Heo, Ye-Ji;Kang, Sang-Sik
    • Journal of the Korean Society of Radiology
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    • v.11 no.7
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    • pp.671-677
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    • 2017
  • In this study, scattering factors affecting the quality of medical images were quantitatively analyzed and investigated. MCNPX simulation was conducted by using ANSI phantom, made of tissue equivalent materials, to calculate the scattering ratio occurred by the increase of the object thickness. Then, the result of the simulation was compared with the result of actual radiation measurement. In addition, we evaluated the image quality by the RMS evaluation, RSD and NPS analysis using X-ray images acquired with increasing object thickness. Furthermore, the scattering ratio was analyzed by increasing the thickness of acrylic phantom on chest phantom. The result showed that the scattering ratio was increased to 57.2%, 62.4%, and 66.8% from 48.9%, respectively, when the acrylic phantom thickness was increased by 1 inch from 6.1 inches. The results of MCNPX simulation and the actual measured scattering dose showed similar results. Also, as a result of RMS measurement from acquired x-ray images, the standard deviation decreased as the object thickness increased. However, in the RSD analysis considering the average incident dose, the results were increased from 0.028 to 0.039, 0.051, 0.062 as the acrylic phantom thickness was increased from 6.1 inches to 7.1 inch, 8.1 inch, and 9.1 inch, respectively. It can be seen that the increase of the scattering effect due to the increase of the object thickness reduces the SNR. Also, the NPS results obtained by measuring scattered radiation incident on the detector resulted in the increase of the noise as the object thickness increased.

Evaluating The Radioprotective Effect of Avocado Peel Extracts upon Rat Exposed to 6 MV X-Ray (6 MV X-ray에 피폭된 흰쥐에 대한 아보카도 껍질 추출물의 방사선방호효과 평가)

  • Kim, Jang-Oh;Shin, Ji-Hye;Jung, Do-Young;Jeon, Chan-hee;Lee, Ji-Eun;Lee, Yoon-Ji;Min, Byung-In
    • Journal of the Korean Society of Radiology
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    • v.14 no.5
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    • pp.553-561
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    • 2020
  • In this study aims to investigate the radiation protection effect of avocado peel extracts on the Sprague-Dawely rats. 52 male rats were randomly classified into 4 groups. NC Group was a normal control group, PA Group was a group injected avocado peel extracts, IR Group was irradiated group, and lastly PA+IR Group was set as an irradiated group after injected of avocado peel extracts. Avocado peel extract was administered orally at 200 mg/kg once a day for 14 days before irradiation, and the radiation dose was systemically irradiated with 6 MV X-ray of 7 Gy. On the 4 and 21 days after irradiation, the experimental animals were sacrificed to evaluate the change in blood cell composition, spleen index, and histopathological evaluation of the liver and small intestine. As a result, the PA+IR Group showed a significantly greater recovery of lymphocytes(p<0.01), red blood cells(p<0.01), and platelets(p<0.05) than the IR Group. It was also confirmed that the activation of Superoxide Dismutase(SOD) was further increased. Histopathologically, observed that nuclei aggregation and cytoplasmic expansion were slightly reduced in the PA+IR Group in the liver. and the damage was significantly reduce(p<0.01) in the change of villi length due to damage to the small intestine cells. Based on the above results, avocado peel extract can be expected to act as a radiation protection agent that can reduce damage to blood cells and major organs caused by irradiation.

Analysis of Cost Structures of National R&D Programs for Effective National R&D Management (국가연구개발 정률예외사업의 원가구조분석을 통한 합리적인 사업관리방안)

  • Cho, Seong-Pyo;Ha, Seok-Tae;Hwang, Myung-Ku
    • Journal of Technology Innovation
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    • v.25 no.2
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    • pp.153-179
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    • 2017
  • Korean government has granted fixed indirect cost rates to several exceptional R&D programs which is lower than the predetermined rate by the government. It has been needed to evaluate the validity of exceptional R&D programs and determine the optimal indirect costs rate of the programs. This study analyzes the cost structure and explores drivers of indirect costs of exceptional R&D programs and evaluates the validity of current indirect costs rates. Finally, we propose the formulas for indirect costs rates of exceptional R&D programs. We analyze the cost structure of the exceptional R&D programs. Equipments and material costs are 50% in infra building program. Scholarship to students is 43% in HRD program. Equipments and material costs are 50% and R&D activity costs are 31% in international R&D program. Main cost components of evaluation program are salary(37%), R&D execution costs(21%) and R&D activity costs(19%). We propose three formulas of indirect costs for exceptional programs. 1) The cost items with exceptionally large amount are excluded in the base of formula for indirect costs. 2) Fixed indirect cost rate is applied for specific R&D programs. 3) Upper bound is set for the cost items with exceptionally large amount in the calculation of indirect costs rate. Our proposal is expected to contribute to the improvement of the efficiency of national R&D programs.

Degenerative Joint Disease After Medial Patellar Luxation Repair in Dogs with or Without Trochleoplasty (개의 슬개골 내측 탈구 교정술에서 활차성형술의 유무에 따른 퇴행성 변화)

  • Yoon, Dae-Young;Kang, Byung-Jae;Kim, Yongsun;Lee, Seung Hoon;Rhew, Daeun;Kim, Wan Hee;Kweon, Oh-Kyeong
    • Journal of Veterinary Clinics
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    • v.32 no.1
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    • pp.22-27
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    • 2015
  • We evaluated outcomes of dogs surgically treated for grade 2 or 3 medial patellar luxation (MPL) with and without trochleoplasty. A retrospective study of 63 dogs with grade 2 or 3 MPL surgically treated with or without trochleoplasty was performed. Results of radiographic evaluation were expressed numerically as degenerative joint disease score and were compared between the groups with and without trochleoplasty. The study included 7 (7/68, 10.3%) cases of reluxation and 1 case of tibial tuberosity transposition implant failure. Reluxation and complications requiring additional surgery were confirmed in 3 cases (3/47, 6.4%) in trochleoplasty group and in 1 case (1/21, 4.8%) in nontrochleoplasty group. The nontrochleoplasty group showed a shorter recovery time than the trochleoplasty group (P < 0.05). There was a significant difference in degenerative joint disease scores over time between the groups, with nontrochleoplasty group having lower scores (P < 0.05). This study suggests that surgical treatment without trochleoplasty results in favorable outcomes compared to treatment with trochleoplasty. It is not mandatory to exclude trochleoplasty when performing surgery for grade 2 or 3 MPL, but we propose that surgical treatment without trochleoplasty is one option when choosing a combination of surgical techniques.

Bioequivalence Evaluation of Two Cefquinome 2.5% Injectable Products in Piglets (돼지에서 두 가지 Cefquinome 2.5% 제제의 생물학적 동등성 평가)

  • Song, In-Bae;Kim, Tae-Won;Lee, Hong-Gee;Kim, Myoung-Seok;Hwang, Youn-Hwan;Park, Byung-Kwon;Lim, Jong-Hwan;Yun, Hyo-In
    • Journal of Veterinary Clinics
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    • v.29 no.3
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    • pp.233-236
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    • 2012
  • Cefquinome, a fourth generation cephalosporin, has been solely used for veterinary medicine and has a broad antibacterial spectrum against gram-negatives and gram-positives being very stable to ${\beta}$-lactamases. This study was conducted to evaluate the bioequivalence of two cefquinome 2.5% products in piglets. Plasma cefquinome concentrations were analyzed by liquid chromatography-mass spectrometry (LC/MS). Mean maximum concentration ($C_{max}$) of test product ($Cequus^{(R)}$) and reference product ($Cobactan^{(R)}$) were $4.34{\pm}0.58$ and $4.22{\pm}0.47{\mu}g/mL$, and mean area under the concentration time curve ($AUC_{0{\rightarrow}{\infty}}$) values were $10.43{\pm}1.96$ and $10.25{\pm}2.98{\mu}g{\cdot}h/mL$, respectively. The 90% confidence intervals for the ratio of $C_{max}$ (0.941-1.115), and $AUC_{0{\rightarrow}{\infty}}$ (0.927-1.172) values for the test and reference products were within the acceptable bioequivalence limit of 0.80-1.25. It is concluded that two commercial cefquinome injectable solutions are bioequivalent in their extent of drug absorption in piglets.

Cell-type Specific Activation of MAPKs in the Progression of Gastric Ulcer in Rats (위궤양의 진행에 있어 MAPKs의 세포특이적 활성)

  • Yu, Ri;Kwon, Young Sam;Oh, Tae-Ho;Kim, Tae-Hwan;Park, Sang-Joon
    • Journal of Veterinary Clinics
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    • v.30 no.5
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    • pp.339-345
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    • 2013
  • Mitogen-activated protein kinases (MAPKs) are a family of central signaling molecules that respond to numerous stimuli and are known to participate in processes of cell survival and death. However, it is not clear on data for cell-type specific activation of MAPKs in the progression of gastric ulcer. In the present study, we assessed how MAPKs localized at various cell types during the progression of gastric ulcer induced by ibuprofen. Gastric ulcer was induced by the repeated treatment of 200 mg/kg ibuprofen with 8 hrs interval in a day. Animals were sacrificed at 24 hrs, 48 hrs, and 72 hrs after oral treatment of ibuprofen and gastric tissues were subjected to immunohistochemical and immunoblotting evaluation. Immunoreactivity of phospho-extracellular signal-regulated kinase (p-ERK) was mainly expressed at the proliferating zone of gastric mucosa in control rats. But, these signals for p-ERK were highly shifted from cells of proliferating zone to parietal cells of the basal regions 24 hrs after treatment of ibuprofen. p-ERK signal was strongly expressed in epithelial cells adjacent to ulcer margin and new capillary and infiltrated inflammatory cells within granulation tissue of the ulcer base above 48 hrs after treatment of ibuprofen. While, phospho-c-Jun $NH_2$ terminal kinase (p-JNK) was mainly localized to the nuclei of the surface epithelial cells and the glandular epithelial cells in early gastric injury. Also, p-JNK was often observed as a scattered pattern in different regions of gastric mucosa with early gastric injury. Gradually, signal of p-JNK was strongly stained in infiltrated inflammatory cells and fibroblasts within severe ulcer base. Phospho-p38 (p-p38) MAPK was observed as scattered pattern within connective tissues of gastric mucosa. Especially, p-p38 MAPK showed strong signal in infiltrated macrophages within ulcer base. These results show that each MAPK has a specific role in various cell types during the progression of gastric ulcer.

A Study on groundwater and pollutant recharge in urban area: use of hydrochemical data

  • Lee, Ju-Hee;Kwon, Jang-Soon;Yun, Seong-Taek;Chae, Gi-Tak;Park, Seong-Sook
    • Proceedings of the Korean Society of Soil and Groundwater Environment Conference
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    • 2004.09a
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    • pp.119-120
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    • 2004
  • Urban groundwater has a unique hydrologic system because of the complex surface and subsurface infrastructures such as deep foundation of many high buildings, subway systems, and sewers and public water supply systems. It generally has been considered that increased surface impermeability reduces the amount of groundwater recharge. On the other hand, leaks from sewers and public water supply systems may generate the large amounts of recharges. All of these urban facilities also may change the groundwater quality by the recharge of a myriad of contaminants. This study was performed to determine the factors controlling the recharge of deep groundwater in an urban area, based on the hydrogeochemical characteristics. The term ‘contamination’ in this study means any kind of inflow of shallow groundwater regardless of clean or contaminated. For this study, urban groundwater samples were collected from a total of 310 preexisting wells with the depth over 100 m. Random sampling method was used to select the wells for this study. Major cations together with Si, Al, Fe, Pb, Hg and Mn were analyzed by ICP-AES, and Cl, N $O_3$, N $H_4$, F, Br, S $O_4$and P $O_4$ were analyzed by IC. There are two groups of groundwater, based on hydrochemical characteristics. The first group is distributed broadly from Ca-HC $O_3$ type to Ca-C1+N $O_3$ type; the other group is the Na+K-HC $O_3$ type. The latter group is considered to represent the baseline quality of deep groundwater in the study area. Using the major ions data for the Na+K-HC $O_3$ type water, we evaluated the extent of groundwater contamination, assuming that if subtract the baseline composition from acquired data for a specific water, the remaining concentrations may indicate the degree of contamination. The remainder of each solute for each sample was simply averaged. The results showed that both Ca and HC $O_3$ represent the typical solutes which are quite enriched in urban groundwater. In particular, the P$CO_2$ values calculated using PHREEQC (version 2.8) showed a correlation with the concentrations of maior inorganic components (Na, Mg, Ca, N $O_3$, S $O_4$, etc.). The p$CO_2$ values for the first group waters widely ranged between about 10$^{-3.0}$ atm to 10$^{-1.0}$ atm and differed from those of the background water samples belonging to the Na+K-HC $O_3$ type (<10$^{-3.5}$ atm). Considering that the p$CO_2$ of soil water (near 10$^{-1.5}$ atm), this indicates that inflow of shallow water is very significant in deep groundwaters in the study area. Furthermore, the P$CO_2$ values can be used as an effective parameter to estimate the relative recharge of shallow water and thus the contamination susceptibility. The results of our present study suggest that down to considerable depth, urban groundwater in crystalline aquifer may be considerably affected by the recharge of shallow water (and pollutants) from an adjacent area. We also suggest that for such evaluation, careful examination of systematically collected hydrochemical data is requisite as an effective tool, in addition to hydrologic and hydrogeologic interpretation.ion.ion.

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Middle School Students' Perception of Body Image and Allowance for Plastic Surgery (중학생의 신체상 지각수준과 성형수술 허용도)

  • Bae, Jin-Ju;Park, Young-Soo
    • The Journal of Korean Society for School & Community Health Education
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    • v.5
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    • pp.25-42
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    • 2004
  • This study set out to investigate the relations between middle school students' perception of body image and their allowance for plastic surgery, to understand their perception of body image and desire for plastic surgery, and provide some data needed to warn against reckless plastic surgery and guide the students effectively. For those purposes, an examination was conducted of the relationships between the individual characteristics and perception levels of body image, the individual characteristics and allowance for plastic surgery, and perception levels of body image and allowance for plastic surgery. The subjects were drawn from sour middle schools located in two regions of Gyeonggi Province. Total 922 boys and girls were surveyed on a questionnaire, which was developed based on the pretest of previous literature, reviewed for appropriateness, and tested for reliability and reasonableness. The body image on the five scale was greater as the perception level was higher. The allowance for plastic surgery was also greater as the scores were more. The findings were as follows: First, the relationships between individual characteristics and perception levels of body image were examined. The third graders showed the highest perception level, being followed by the first and second graders. The girls were more perceptive than the boys, and those who were extrovert were more perceptive than those who were introvert. Those students whose parents earned 2 million won or more a month and who adapted themselves to the environmental changes had a higher perception level. In a word, the girls from the middle class that were well adapted, felt happy, and were extrovert had a higher perception level of body image. Second, the connections between individual characteristics and allowance for plastic surgery were investigated. The third graders were the most admissive of plastic surgery, followed by the second and first graders. That is, the upper graders were more admissive of plastic surgery. In addition, the girls were more admissive than the boys, and those who were extrovert were more than those who were introvert. There were no significant differences according to the monthly income of the parents, grades, adaptability to surroundings, and happiness, which results almost resembled the findings of a study conducted on adults. Third, there were negative correlations found between the perception levels of body image and the allowance for plastic surgery. To elaborate, the higher the perception levels were, the lower the allowance was, and vice versa. As for the items, the subjects showed more allowance for plastic surgery when they scored less in the item of caring about appearance, importance of looking pretty to others, and efforts to improve appearance. When they had a low value of body and easily felt tired, they were highly acceptive of plastic surgery. The allowance for plastic surgery was also great when their perception was much of how healthy they felt, how important they felt about their bodies, how they were satisfied with their current appearances, how they evaluated the appearance of others, how much they were satisfied physically, and how much demanding they were for physical changes. Meanwhile, there were no correlations between the allowance and physical attraction, the degree for one's activities to be hindered, and sickness. In short, the demand for plastic surgery was 41% for the girls and 20.2% for the boys. Just as the study on adults reported, those who had a low or negative perception of body image were more acceptive of plastic surgery. The middle school students were generally positive about their bodies with the lowest perception level at 2.91 and the highest at 3.21. Their individual allowance for plastic surgery was related to their individual body images, which were in turn affected by the mass communication, surrounding environments, and social values. Thus it's necessary for the entire society to try to improve or change the overall perception. Helping measures should be taken so that the students can form right sense of values about their bodies, avoid the obsession with appearance and appearance-based evaluation, and exercise righteous criteria against humans beings and things. In conclusions, the following suggestions were made: they need to develop such questionnaires or tools as can measure the body image of teens and fit the reality. Moreover, body image improvement programs should be more diverse and more applicable to teens. Despite the consistent reports that prove the correlations between body image and plastic surgery, there has been little effort to apply such factors as experience of the life of the disabled, volunteer activities for the disabled and at the hospitals, and others that can induce changes to body image to the body image improvement programs. In the future, comparative research should be carried out on body image and plastic surgery.

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