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Developing Measurement Items for the Service Quality of Clinical Trials based on the Brady & Cronin Model (Brady & Cronin의 모델에 기반한 임상시험 서비스 질 측정 문항 개발)

  • Go-Eun Lee;Sanghee Kim;Sue Kim;Sang Hui Chu;Jeong-Ho Seok;So Yoon Kim
    • The Journal of KAIRB
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    • v.6 no.1
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    • pp.17-31
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    • 2024
  • Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.

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The Influence of MMPI Characteristics on the Outcome of Cognitive Behavioral Therapy for Panic Disorder (공황장애 환자의 다면적 인성검사 (MMPI) 특성이 인지행동치료 결과에 미치는 영향)

  • Choi, Young-Hee;Lee, Jung-Heum
    • Korean Journal of Psychosomatic Medicine
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    • v.6 no.2
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    • pp.147-154
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    • 1998
  • Objective : This study was designed to find the characteristics of MMPI that could influence the outcome of cognitive behavioral therapy(CBT) for panic disorder. Methods : 34 patients who met DSM-IV criteria for panic disorder with or without agoraphobia had completed 11 weekly sessions of cognitive behavioral therapy. All the patients were assessed with MMPI before the initiation of treatment. Five self-report measures including Beck Depression Inventory(BDI), Spielberger State-Trait Anxiety Inventory(STAI), Agoraphobic Cognition Questionnarie(ACQ), Body Sensation Questionnaire(BSQ), and Daily Anxiety Selfrating (0 - 8 scales) were also assessed as a pre- and post-treatment assessment. After the completion of treatment, patients were classified by the High End-State(HES) functioning group and the Low End-State(LES) functioning group for the data analysis. Results : 1) The LES group showed significantly higher scores in Hypochondriasis Scale(HS), Depression Scale(D), Hysterical Scale(Hy), Obsessive Scale(Pt), Schizophrenia Scale(Sc) and Validity Scale(F) of MMPI than the HES group. However, these differences gave impressions that the LES group had more severe symptoms rather than that they could be the factors influencing the outcome of CBT. 2) Though, the severity of symptoms of the LES group in the 5 measures of pre-assessment was basically higher than that of the HES group. The fact that both group showed the similar improvement between pre- and post-assessment supported the above interpretation. Conclusion : In regarding the above results, MMPI was not a proper tool that could provide the factors influencing the outcome of CBT. In the future study, the authors need to use a different tool that can find the personality characteristics more directly.

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Work Hours and Cognitive Function: The Multi-Ethnic Study of Atherosclerosis

  • Charles, Luenda E.;Fekedulegn, Desta;Burchfiel, Cecil M.;Fujishiro, Kaori;Hazzouri, Adina Zeki Al;Fitzpatrick, Annette L.;Rapp, Stephen R.
    • Safety and Health at Work
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    • v.11 no.2
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    • pp.178-186
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    • 2020
  • Background: Cognitive impairment is a public health burden. Our objective was to investigate associations between work hours and cognitive function. Methods: Multi-Ethnic Study of Atherosclerosis (MESA) participants (n = 2,497; 50.7% men; age range 44-84 years) reported hours per week worked in all jobs in Exams 1 (2000-2002), 2 (2002-2004), 3 (2004-2005), and 5 (2010-2011). Cognitive function was assessed (Exam 5) using the Cognitive Abilities Screening Instrument (version 2), a measure of global cognitive functioning; the Digit Symbol Coding, a measure of processing speed; and the Digit Span test, a measure of attention and working memory. We used a prospective approach and linear regression to assess associations for every 10 hours of work. Results: Among all participants, associations of hours worked with cognitive function of any type were not statistically significant. In occupation-stratified analyses (interaction p = 0.051), longer work hours were associated with poorer global cognitive function among Sales/Office and blue-collar workers, after adjustment for age, sex, physical activity, body mass index, race/ethnicity, educational level, annual income, history of heart attack, diabetes, apolipoprotein E-epsilon 4 allele (ApoE4) status, birth-place, number of years in the United States, language spoken at MESA Exam 1, and work hours at Exam 5 (β = -0.55, 95% CI = -0.99, -0.09) and (β = -0.80, -1.51, -0.09), respectively. In occupation-stratified analyses (interaction p = 0.040), we also observed an inverse association with processing speed among blue-collar workers (adjusted β = -0.80, -1.52, -0.07). Sex, race/ethnicity, and ApoE4 did not significantly modify associations between work hours and cognitive function. Conclusion: Weak inverse associations were observed between work hours and cognitive function among Sales/Office and blue-collar workers.

Differences of EEG and Sleep Structure in Pediatric Sleep Apnea and Controls (소아 수면무호흡증 환아와 정상 소아에서 수면구조와 뇌파 양상 차이)

  • Ahn, Young-Min;Shin, Hong-Beom;Kim, Eui-Joong
    • Sleep Medicine and Psychophysiology
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    • v.15 no.2
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    • pp.71-76
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    • 2008
  • Introduction: In this study, we compared sleep structure, EEG characteristic of pediatric obstructive sleep apnea (OSA) and normal controls which were matched in sex and age. Methods: Fifteen children (male:female=4:11) who complained snoring and were suspected to have sleep apnea and their age and sex matched normal controls (male:female=5:10) have been done nocturnal polysomnography (NPSG). Sleep parameters, sleep apnea variables and relative spectral components of EEG from NPSG have been compared between both groups. Results: Pediatric OSA group were distinguished from normal controls in terms of apnea index, respiratory disturbance index and nadir of oxyhemoglobulin desaturation. Pediatric OSA group showed increased percent of sleep stage 1, decreased rapid eye movement sleep percent and increased delta power in O1 EEG channel. However other sleep parameters and spectral powers were not different between two groups. Conclusion: In pediatric OSA group, sleep structure parameter disruption may be not prominent as the previous studies for adult OSA group because of including mild OSA data in diagnostic criteria. In addition, EEG changes might not be distinct due to low arousal index compared to adult OSA patients. We can observe general characteristics and particularity of pediatric OSA through this study.

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Pharmacotherapy for Patients Complaining With Somatic Symptoms (신체증상을 호소하는 환자의 약물치료)

  • Lee, Kyung-Kyu
    • Korean Journal of Psychosomatic Medicine
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    • v.29 no.2
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    • pp.95-101
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    • 2021
  • Patients complaining with somatic symptoms are very common in clinical practice, and are often consulted to medical department. But it is difficult to treat well. The treatment of somatic symptom disorder is multi-modal as none of the methods on their own provide a satisfactory outcome. The treatment of somatic symptoms disorders is complicated by lack of boundary, conceptual clarity, and overemphasis on psychosocial causation and effectiveness of psychological treatments. In clinical practice all classes of psychotropics are used to treat somatic symptoms disorder. Drugs such as tricyclic antidepressants, serotonin reuptake inibitors(SSRI), serotonin and noradrenalin reuptake inhibitors (SNRI), atypical antipsychotics are studied. The evidence indicates that these drugs are effective in somatic symptom disorders. All classes of antidepressants seem to be effective against somatic symptom disorders. SSRIs are more effective against hypochondriasis and body dysmorphic disorder, and SNRIs appear to be more effective than other antidepressants when pain is predominant. The author suggest that psychiatrists should know how to treat patients complaining with somatic symptoms by using not only psychotherapeutic approach but also pharmacological treatment. It will be helpful to reduce suffering and increase quality of life of these patients.

The Feasibility for Whole-Night Sleep Brain Network Research Using Synchronous EEG-fMRI (수면 뇌파-기능자기공명영상 동기화 측정과 신호처리 기법을 통한 수면 단계별 뇌연결망 연구)

  • Kim, Joong Il;Park, Bumhee;Youn, Tak;Park, Hae-Jeong
    • Sleep Medicine and Psychophysiology
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    • v.25 no.2
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    • pp.82-91
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    • 2018
  • Objectives: Synchronous electroencephalogram (EEG) and functional magnetic resonance imaging (fMRI) has been used to explore sleep stage dependent functional brain networks. Despite a growing number of sleep studies using EEG-fMRI, few studies have conducted network analysis on whole night sleep due to difficulty in data acquisition, artifacts, and sleep management within the MRI scanner. Methods: In order to perform network analysis for whole night sleep, we proposed experimental procedures and data processing techniques for EEG-fMRI. We acquired 6-7 hours of EEG-fMRI data per participant and conducted signal processing to reduce artifacts in both EEG and fMRI. We then generated a functional brain atlas with 68 brain regions using independent component analysis of sleep fMRI data. Using this functional atlas, we constructed sleep level dependent functional brain networks. Results: When we evaluated functional connectivity distribution, sleep showed significantly reduced functional connectivity for the whole brain compared to that during wakefulness. REM sleep showed statistically different connectivity patterns compared to non-REM sleep in sleep-related subcortical brain circuits. Conclusion: This study suggests the feasibility of exploring functional brain networks using sleep EEG-fMRI for whole night sleep via appropriate experimental procedures and signal processing techniques for fMRI and EEG.

The Psychological Characteristics of Women in the Obesity Clinic (비만클리닉에 내원한 여성의 심리적 특성)

  • Park, Sat-Byul;Yun, Kyu-Wol;Woo, Haing-Won
    • Korean Journal of Psychosomatic Medicine
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    • v.11 no.2
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    • pp.137-148
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    • 2003
  • Introduction: This research was performed to contract the attitude of dietary restriction and the psychological problems such as depressive mood and perceived stress and to investigate the relationship of these and obesity in women who visited the obesity clinic. Methods: During May 2001, sociodemographic variables, physical characteristics, Three Factor Eating Questionnaire(TFEQ), Symptom Check List-90-R(SCL-90-R) and Perceived Stress Scale were assessed from 150 female who visited the obesity clinics which were located at downtown, Seoul and the Hospital of Ajou University, Medical College. Hamilton depression rating scale(HDRS) was estimated by author. And then 116 female cases who filled up the questionnaire faithfully were included. Results: Obese group more than Body Mass Index(BMI) $25.0kg/m^2$ was 50% of the total subjects. BMI was increased as the age goes up(p<0.001). The frequency of unmarried cases in the under normal weight group was high rate of 48.8% while it in the obese group was 13.8%(p<0.001). There was no significant difference in the rate of smoking and alcohol drinking among subjects by BMI. There was no significant difference of TFEQ among subjects by BMI and the percent of body fat. Factor 2(r=0.27, p<0.01) and Factor 3(r=0.24, p<0.01) were significantly correlated with Global Severity Index(GSI). Only the paranoia scale among each estimated mean value of T scores of SCL-90-R by BMI was the significant difference between the overweight group and the obese group(p<0.05). T scores of scales of SCL-90-R were less than 50, but T scores of the under normal weight group and the obese group were higher than overweight group. GSI was significantly correlated with HDRS(r=0.75, p<0.01) and Perceived Stress Scale(r=0.32, p<0.01). Depressive mood in the obese group was significantly higher than non-obese group that HDRS was compared to two groups by the percent of body fat(p<0.05). Perceived Stress Scale was no significant correlation with BMI and the percent of body fat. All of the subject were in trouble of high stress. Stress affected dietary restriction owing that perceived stress had a relation with Factor 2(r=0.29, p<0.01) and Factor 3(r=0.37, p<0.01). Also, it affected psychological characteristics owing that perceived stress had a relation with the depression scale, GSI and HDRS(r=0.33, r=0.32, r=0.34, p<0.01). Conclusion: Obese women have more psychological difficulties including depression and high perceived stress, which closely related with the attitude of dietary restriction. Psychiatric intervention and aggressive assessment of psychological problems will be needed to the people who visit the obesity clinic in the future.

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Comparison of growth and neuropsychological function after treatment for hematologic and oncologic diseases in monozygotic twins (일란성 쌍생아에서 혈액 및 종양 질환 치료 후 성장 및 정신신경학적 발달에 대한 비교연구)

  • Kim, Gi Hwan;Kook, Hoon;Baek, Hee Jo;Han, Dong Kyun;Song, Eun Song;Jo, Young Kook;Choi, Ic Sun;Kim, Young Ok;Kim, Chan Jong;Woo, Young Jong;Yang, Soo Jin;Hwang, Tai Ju
    • Clinical and Experimental Pediatrics
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    • v.50 no.2
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    • pp.182-189
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    • 2007
  • Purpose : The primary purpose of this study was to evaluate the growth and neuropsychologic function following treatments for pediatric hematologic and oncologic diseases. Healthy monozygotic twins served as ideal controls for comparison to exclude possible confounding factors. Methods : Seven children treated with various hematologic and oncologic diseases were included in the study: acute lymphoblastic leukemia (ALL; n=2), Diamond-Blackfan anemia twins (n=2), and aplastic anemia (n=3). The median age at the diagnosis was 5.2 (0.3-15) years. The median duration of follow-up was 7.2 (4.9-10) years. Controls were healthy monozygotic twins. Growth was measured and the percentile channels were evaluated sequentially for patients. The K-WISC III was applied and compared in 5 pairs of patients and controls. Results : Similar growth profiles were noted for the twins. The percentiles at diagnosis was 3-10 in 3, 25-50 in 2, and 50-75 in 2 cases. All patients stayed in their growth percentiles through follow-up, except for 1 patient who became obese. For IQ tests, the mean behavioral, verbal and full scale IQ scores of patients were 88.0, 93.8, and 89.8, respectively, and those from their corresponding controls were 92.2, 97.0, and 91.7 (P>0.05). However, 2 children who were treated for ALL had lower IQ scores. Conclusion : Similar growth profiles were observed in the monozygotic twins in terms of height and weight. The IQ scores of patients were similar to those of monozygotic twins. However, prophylactic CNS-directed therapy for leukemia might adversely affect the IQ scores. A further prospective study on larger number of twins is warranted.

Regional Distribution of Cerebral Blood Flow in Childhood Measured by $^{99m}Tc-HMPAO$ SPECT : Reference Values of Semiquantitative Indices and Effect of Age ($^{99m}Tc-HMPAO$ SPECT를 이용한 어린이 국소뇌혈류의 정량적 분석 : 정량적 지표들의 참고값 및 연령에 따른 변화)

  • Kim, Sang-Eun;Lee, Dong-Soo;Chung, June-Key;Lee, Myung-Chul;Koh, Chang-Soon;Cho, Soo-Churl;Hong, Seung-Bong;Yoon, Byung-Woo;Roh, Jae-Kyu;Myung, Ho-Jin
    • The Korean Journal of Nuclear Medicine
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    • v.25 no.1
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    • pp.6-16
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    • 1991
  • Regional cerebral blood flow (rCBF) was evaluated in 12 children ranging in age from 2.7 to 10.0 yr using $^{99m}Tc-HMPAO$ SPECT. For quantitative analysis, 13 pairs of homologous regions of interest (ROIs) were created on three attenuation-corrected 18.8 mm thick transverse slices matching the cerebral cortical regions, deep gray matter, cerebellar hemisphere, and vascular territories, and the semiquantitative indices including "right to left ratio" [(mean count/voxel of homologous right ROI) / (mean count/voxel of homologous left ROI)] and "regional index"(RI) [(mean count/voxel of a ROI)/ (mean count/voxel of all ROIs of each hemisphere)] were calculated. Mean values of right to left ratios of homologous regions ranged from 0.984 to 1.028 in children under 5 yr (group 1) and from 0.982 to 1.012 in children between 5 and 10 yr (group 2), and the mean $value{\pm}2S.D.$ for each region did not exceed 11% and 12% in group 1 and group 2, respectively. There were no statistically significant differences between the RIs of the homologous right and left regions. Significant differences of RIs were found both between vascular regions (p<0.0005 for goup 1, and p=0.0001 for goup 2) and between regions of cerebral cortices (p<0.0005 for group 1, and p<0.005 for group 2) with a relatively high value in the occipital cortex and the lower values in the cerebellum and deep gray matter among the regions of cerebral cortices in both groups. There were no significant differences between the RIs of corresponding regions of group 1 and group 2, except a significantly higher value of right deep gray matter in group 2 than in group 1(p=0.0301). The RIs of the superior frontal cortex and deep gray matter showed to be positively correlated with age (superior frontal cortex; right: rs=0.5254, p=0.0814, left : rs=0.5919, p=0.0496/deep gray matter; right: rs=0.8246, p=0.0062, left: rs=0.6266, p=0.0377). The results suggest that the rCBF pattern of children approaches that of adults in an accipito-rostral direction. This time course of rCBF changes is in agreement with behavioral, neurophysiological, and anatomical alterations known to occur in the developing brain.

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Neurochemical Profile Quantification of Regional Adult Mice Brain Using: ex vivo $^1H$ High-Resolution Magic Angle Spinning NMR Spectroscopy (생체 외 조직 고 분해능 Magic Angle Spinning을 이용한 정상 Adult Mice에서의 뇌 부위별 뇌 신경화학 대사물질 정량분석)

  • Lee, Do-Wan;Woo, Dong-Cheol;Lee, Sung-Ho;Kim, Sang-Young;Kim, Goo-Young;Rhim, Hyang-Shuk;Choi, Chi-Bong;Kim, Hwi-Yool;Lee, Chang-Wook;Choe, Bo-Young
    • Progress in Medical Physics
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    • v.21 no.1
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    • pp.35-41
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    • 2010
  • The purpose of this study is to quantitate regional neurochemical profile of regional normal adult mice brain and assess regional metabolic differences by using ex vivo $^1H$ high-resolution magic angle spinning nuclear magnetic resonance spectroscopy ($^1H$ HR-MAS NMRS). The animals were matched in sex and age. The collected brain tissue included frontal cortex, temporal cortex, thalamus, and hippocampus. Quantitative 1D spectra were acquired on 40 samples with the CPMG pulse sequence (8 kHz spectral window, TR/TE = 5500/2.2 ms, NEX = 128, scan time: 17 min 20 sec). The mass of brain tissue and $D_2O$+TSP solvent were 8~14 mg and 7~13 mg. A total of 16 metabolites were quantified as follow: Acet, NAA, NAAG, tCr, Cr, tCho, Cho, GPC + PC, mIns, Lac, GABA, Glu, Gln, Tau and Ala. As a results, Acet, Cho, NAA, NAAG and mIns were showed significantly different aspects on frontal cortex, hippocampus, temporal cortex and thalamus respectively. The present study demonstrated that absolute metabolite concentrations were significantly different among four brain regions of adult mice. Our finding might be helpful to investigate brain metabolism of neuro-disease in animal model.