• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• Korean Circulation Journal
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• v.52 no.1
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• pp.1-33
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• 2022

In primary prevention for cardiovascular diseases, there are significant barriers to adherence including freedom from symptoms, long latency for therapeutic benefits, life-long duration of treatment, and need for combined lifestyle changes. However, to implement more systematic approaches, the focus on adherence improvement needs to be shifted away from patient factors to the effects of the treatment team and healthcare system. In addition to conventional educational approaches, more patient-oriented approaches such as patient-centered clinical communication skills, counseling using motivational strategies, decision-making by patient empowerment, and a multi-disciplinary team approach should be developed and implemented. Patients should be involved in a program of self-monitoring, self-management, and active counseling. Because most effective interventions on adherence improvement demand greater resources, the health care system and educational or training system of physicians and healthcare staff need to be supported for systematic improvement.

• The Korean Journal of Nuclear Medicine
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• v.33 no.2
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• pp.143-151
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• 1999

Purpose: Dermatolymphangioadenitis (DLA) is a common and serious complication of lymphedema which deteriorates lymphatic function. The purpose of this study was to assess the risk of DLA by lymphos-cintigraphy in patients with lower extremity lymphedema. Materials and Methods: The subjects were 59 edematous lower extremities of 50 patients without previous episode of DLA and 12 lower extremities of 6 controls. Whole body images were acquired 1 min and 2 hr after subcutaneous injection of 37 MBq of Tc-99m-antimony sulfide colloid into interdigital spaces of both feet before therapy for lymphedema. The lymphosintigraphic and clinical variables were compared between groups with or without occurrence of DLA during clinical follow up. Results: There were 20 episodes of DLA in 12 extremities during clinical follow-up (19 :6 months). On univariate analysis, there were significant differences in ilioinguinal lymph node uptake, uptake pattern of main lymphatic vessel, clinical stage and therapy compliance between the two groups. After multivariate analysis, only the uptake pattern of main lymphatic vessel and therapy compliance fore confirmed to be independent variables. In other words, non-visualized main lymphatic vessel and poor compliance to therapy were more frequent in extremities with subsequent occurrence of DLA. Conclusion: Lymphoscintigraphy can be used to predict the risk of DLA and may thus be helpful for determining the initial therapeutic plan in patients with lower extremity lymphedema.

• Korean Journal of Psychosomatic Medicine
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• v.16 no.1
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• pp.52-58
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• 2008

Objectives : Antidepressants are prescribed by not only psychiatrists but also general practitioners. However, patients' negative attitude and stigma against antidepressants are major obstacles to prescribe antidepressants in nonpsychiatric outpatient departments. We, therefore, examined patients' attitude toward antidepressant in medical and surgical group outpatient in Korea. Methods : Short item questionnaire was applied to medical group and surgical group outpatients who consented to this survey in a Korean university hospital. 100 medical and 100 surgical outpatients were surveyed. The questionnaire contained sociodemographic information, previous recognition of antidepressant, and general attitude toward attidepressants. Results : Of the 212 recipients, exclusive of erroneous and missing ones, we analyzed 200 recipients. 1) We found negative attitude toward antidepressants among both medical and surgical outpatients. 2) Medical group outpatients are answered more' antidepressants cause physically ill. 3) The persons who didn't take previously antidepressants showed more negative attitudes. 4) The most reason why they refuse to take antidepressants is concerns of side effects of antidepressants. Conclusion : There are highly negative attitude toward antidepressants between medical and surgical group outpatients. Study findings suggest the need for an active education on antidepressants to nonpsychiatric outpatients to maximize their therapeutic effect and compliance.

• The Journal of the Korea Contents Association
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• v.16 no.11
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• pp.499-509
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• 2016

This study was undertaken to investigate the factors that influence post-traumatic growth in patients with breast cancer. The study subjects were 100 outpatients with breast cancer who visited the outpatient clinic of a university hospital. The instruments used for this study were Korean Post-traumatic Inventory (K-PTGI), Modified Medical Outcomes Study Social Support Survey (mMOS-SS), Self-Efficacy Scale for Self-Management of Breast Cancer (SESSM-B) and Cancer Coping Questionnaire (CCQ). The data were analyzed by t-test, ANOVA, Pearson-correlation coefficient, and stepwise multiple regression using SPSS/WIN 21.0. The mean score of post-traumatic growth was $3.4{\pm}0.9$ out of 5. Post traumatic growth had statistically significant correlation with social support, breast cancer self-management self-efficacy, and coping behavior. In stepwise multiple regression analysis, post-traumatic growth was significantly influenced by therapeutic compliance related self-efficacy and positive reframing coping behavior and it was account for 29% of the total variance. These results suggest that these influencing factors should be considered in developing the nursing intervention to improve the post-traumatic growth in patient with breast cancer.

• Journal of The Korean Society of Inherited Metabolic disease
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• v.20 no.2
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• pp.37-43
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• 2020

Phenylketonuria is the most prevalent disorder caused by an inborn error in aminoacid metabolism. It results from mutations in the phenylalanine hydroxylase (PAH) gene. If untreated or late treated, results in profound and irreversible mental disability. Newborn screening test identify patients with phenylketouria. The early initiation of a phenylalanine restricted diet very soon prevents most of the neuropsychiatric complications. However, the diet therapy is difficult to maintain and compliance is poor, especially in adolescents and adulthood. Since 2015, American Medical College of Medical Genetics and Genomics (ACMG) recommended more strong restrictive diet therapy for target blood level of phenylalanine (<360 umol/L). For over four decades the only treatment was a very restrictive low phenylalanine diet. This changed in 2007 with the approval of cofactor therapy (Tetrahydrobiopterin, BH4) which is effective in up to 30% of patients. Data from controlled clinical trials with sapropterin dihydrochloride indicate a similar occurrence of all-cause adverse events with this treatment and placebo. Large neutral aminoacids (LNAA) competes with phenylalanine for transport across the blood-brain-barrier and have a beneficial effect on executive functioning. A new therapy has just been approved that can be effective in most patients with PAH deficiency regardless of their degree of enzyme deficiency or the severity of their phenotype. Phenylalanine ammonia lyase (PAL-PEG) was approved in the USA by FDA in May of 2018 for adult patients with uncontrolled blood phenylalanine concentrations on current treatment. Nucleic acid therapy (therapeutic mRNA or gene therapy) is likely to provide longer term solutions with few side effects.

• Therapeutic Science for Rehabilitation
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• v.12 no.1
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• pp.7-22
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• 2023

Objective : This study aimed to confirm the research characteristics and quality of single-subject literature among domestic studies that applied interactive metronome (IM) intervention. Methods : Regarding literature search, 11 single-subject studies using IM were selected from an online database from January 2011 to June 2022. Moreover, the general characteristics and quality of the research method were analyzed. Results : The qualitative level of the analyzed literature was above the moderate level. However, intervention blindness and reliability showed low compliance. The ABA design accounted for the largest proportion of methods. Most of the study participants had attention deficit hyperactivity disorder. Attention, balance, bilateral coordination, and timing were checked as dependent variables. The IM-SFT was used most frequently as an evaluation method. The mediation session applied more than 8-10 interventions for 3-11 weeks. The intervention results in all studies indicated functional improvement after intervention. Conclusion : It might be necessary to expand the application of IM interventions to diverse diseases. In addition, there is a need to study the effect on the participants' quality of life and changes in daily life along with dependent variables such as attention and balance

• Korean Journal of Biological Psychiatry
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• v.3 no.2
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• pp.277-287
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• 1996

Objective : It has been proposed that cognition and related aspects of mental functioning are decreased in depression as well as in alcoholism. The objective of the study was to compare behavioral side effects of paroxetine and amitriptyline in depressed patients accompanied by alcoholism. The focused comparisons were drug effects concerning psychomotor performance, cognitive function, sleep and daytime sleepiness during the first 2 weeks of treatment. Methods : After an alcohol detoxification period(3 weeks) and a washout period(1 week), a total of 20 male inpatients with alcohol use disorder (DSM-IV), who also had a major depressive episode(DSM-IV), were treated double-blind with paroxetine 20mg/day(n=10) or amitriptyline 25mg/day(n=10) for 2 weeks. All patients were required to have a scare of at least 18 respectively on bath the Hamilton Rating Scale far Depression(HAM-D) and Beck Depression Inventory(BDI) at pre-drug baseline. Patients randomized to paroxetine received active medication in the morning and placebo in the evening whereas those randomized to amitriptyline received active medication in the evening and placebo in the morning. All patients performed the various tasks in a test battery at baseline and at days 3, 7 and 14. The test battery included : critical flicker fusion threshold for sensory information processing capacity : choice reaction time for gross psychomotor performance : tracking accuracy and latency of response to peripheral stimulus as a measure of line sensorimotor co-ordination and divided attention : digit symbol substitution as a measure of sustained attention and concentration. To rate perceived sleep and daytime sleepiness, 10cm line Visual analogue scales were employed at baseline and at days 3, 7 and 14. The subjective rating scales were adapted far this study from Leeds sleep Evaluation Questionnaire and Epworth Sleepiness Scale. In addition a comprehensive side effect assessment, using the UKU side effect rating scale, was carried out at baseline and at days 7 and 14. The efficacy of treatment was evaluated using HAM-D, BDI and clinical global impression far severity and improvement at days 7 and 14. Results : The pattern of results indicated thai paroxetine improved performance an mast of the lest variables and also improved sleep with no effect on daytime sleepiness aver the study period. In contrast, amitriptyline produced disruption of performance on same tests and improved sleep with increased daytime sleepiness in particular at day 3. On the UKU side effect rating scale, mare side effects were registered an amitriptyline. The therapeutic efficacy was observed in favor of paroxetine early in day 7. Conclusion : These results demonstrated thai paroxetine in much better than amitriptyline for the treatment of depressed patients accompained by alcoholism at least in terms of behavioral safety and tolerability, furthermore the results may assist in explaining the therapeutic outcome of paroxetine. For example, and earlier onset of antidepressant action of paroxetine may be caused by early improved cognitive function or by contributing to good compliance with treatment.

• Journal of Chest Surgery
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• v.31 no.12
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• pp.1172-1182
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• 1998

Background: Primary goal of anticoagulation treatment in patients with mechanical heart valve is the effective prevention of thromboembolism and safe avoidance of bleeding as well. Material and Method: Two-hundred and nine patients with the St. Jude Medical prosthesis operated on between 1984 and 1995, for mitral(MVR 122), aortic(AVR 39) and double mitral and aortic valve replacement(DVR 48) respectively, were studied on the practically achieved levels of anticoagulation and the clinical outcomes. Patients were on Coumadin and followed up by monthly visit to outpatient clinic for examination and prothrombin time measurement to adjust the International Normalized Ratios(INRs) within the low-intensity target range between 1.5 and 2.5. Result: A total anticoagulation follow-up period was 1082.0 patient- years(mean 62.1 months) and INRs of 10,205 measurements were available for evaluation. The accomplished INRs among the replacement groups were not significantly different and only 65% of INRs were within the target range. And, in individual patients, only 37% of patients had INRs included within the target range in more than 70% of tests during follow-up period. The levels of INRs in patients with atrial fibrillation, which was found in 57% of patients, were definitely higher than the ones measured in patients with regular rhythm(p<0.001). Thromboembolisms were experienced by 15 patients with the incidence of 1.265%/patient- year(MVR 1.412%, AVR 0.462% and DVR 1.531%/patient-year) and major bleeding by 4 patients with the incidence of 0.337%/patient-year(MVR 0.424%, AVR none and DVR 0.383%/patient-year). Frequent as well as prolonged missing of prothrombin time tests was the main risk factor strongly associated with the thromboembolic complications(odds ratio 1.99). The proportion of INRs within target range of less than 60% in individual patient was the highly significant risk factor of both thromboembolic and overall embolic and bleeding complications(p<0.004 and p<0.002 respectively). Conclusion: In conclusion, the low-intensity therapeutic target range of INRs was adequate in patients with AVR and in sinus rhythm. However, the patients with replacement of the mitral valve were more likely to require higher target range of INRs, especially in the presence of atrial fibrillation, to achieve the practical levels of anticoagulation enough to prevent thromboembolic complications effectively. For the higher therapeutic target range of INRs between 2.0∼3.0, further accumulation of clinical evidences are required. It is highly desirable to improve the patients' compliance under continuous instructions in visiting outpatient clinic and in taking daily Coumadin without omission and to keep INRs consistently within optimal range with tight control for minimization of chances and of periods of exposure to the risk of complications. And, particularly, patients with high risk of complications and with wide fluctuation of INRs should be better managed with frequent monitoring anticoagulation levels.

• Korean Journal of Psychosomatic Medicine
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• v.25 no.1
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• pp.46-55
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• 2017

Objectives : Outpatient treatment orders refer to a mandatory social program in which mentally ill persons are ordered by the court to participate in specified outpatient treatment programs. This study aimed to investigate the factors that affect outpatient treatment orders and adherence to outpatient treatment in mental health patients. Methods : A survey on outpatient treatment orders and adherence to outpatient treatment was conducted on 60 psychiatrists between October and November 2016. The questionnaire items were drafted based on a literature review, and they were then evaluated by 3 psychiatrists and 1 law school professor before being finalized. Answers from the respondents were analyzed using descriptive statistics, and the median, maximum, and minimum values of the effectiveness scores of outpatient treatment orders were calculated. Results : Among the 60 psychiatrists, 45(75.0%) were aware of outpatient treatment orders; however, only 2 out of the 45(4.0%) had actually used the program in the last 12 months. The subjective effectiveness was very low, with only 40 points out of 100. Furthermore, of the readmitted patients, 37.7% had received continued outpatient treatment, whereas 53.1% chose to quit the outpatient treatment programs, meaning that the number of dropouts was higher. Among the discharged patients, approximately two-thirds were receiving continued treatment. With regard to follow-up for dropouts, majority of the responses were either "Not taking any action"(n=27) or "Not following up"(n=15). Only two respondents answered "Contact the community mental health promotion center," meaning that this response was very rare. Meanwhile, when asked about efficient measures to be implemented for dropouts, a vast majority of the respondents(n=30) selected the answer "Work with the community mental health promotion center." Conclusions : The outpatient treatment orders currently being administered were found to be ineffective, and the associated adherence to outpatient treatment was also found to be extremely poor. Hence, the effectiveness of the therapeutic interventions could benefit from institutional as well as administrative improvements. Community mental health promotion centers are expected to have an important role in the future.