• Title/Summary/Keyword: observational clinical study

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Study on Compliance in Sleep Life Log: Observational Cohort Study (수면 라이프로그 순응도에 대한 연구)

  • Su-Min Seo;Young-Hwa Baek;Si-Woo Lee;Hyun-Chul Jang
    • Journal of Society of Preventive Korean Medicine
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    • v.27 no.1
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    • pp.89-98
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    • 2023
  • Objectives : This study collected sleep information by wearable device in the Korean medicine Daejeon citizen cohort (KDCC). It was measured based on the sleep record information measured by wearing a Fitbit, and the possibility of clinical use was examined for compliance with objective sleep collection. Based on compliance, the possibility of clinical use was examined. Methods : After surveying personal information and PSQI(Pittsburgh Sleep Quality Index), sleep information was collected by Fitbit for 14 days. Compliance was measured based on sleep record information by Fitbit. Compliance was analyzed by sex, age, BMI(Body Mass Index), and sleep group(deep/poor). Results : The number of participants was 730, and the compliance was 94.3%, and the compliance group was 675(92.5%). The age of the participants varied from 30 to 60 years old, and the average age was 46±6.7 years. There were 218 males and 512 females. Young people have high compliance. Males are more compliance than females. As the BMI score decreased in the 30s, the compliance was higher. The underweight group in all age groups had 100 compliance. The underweight group was all female. The low compliance groups were that 30 years males (obesity level2), 50 years females (overweight group), and 50 years females (obesity level2). There was no significant difference in compliance between deep sleep group and poor sleep group. In deep sleep group, females showed higher compliance. In poor sleep group, males showed higher compliance. The average duration of Fitbit usage among participants was 20.1 days. The compliant group wore the device for an average of 21.3 days, while the non-compliant group wore it for only 5.2 days. Of the compliant group, 86.9% (73.8% of all participants) continued to wear the Fitbit after the recommended 14-day period, and 50.8% wore it for more than 20 days. Conclusions : This study showed the possibility of adaptation for wearing a Fitbit for collecting objective sleep information. It is judged that the compliance is high because it was worn for more than 13.2 days out of the 14 days required. It is considered meaningful because the compliance was measured based on the sleep information by Fitbit, not the questionnaire. As the data on objective sleep time is collected automatically, we believe that the burden on participants after the study period is not significant for a certain period. Compliance may be even higher for cohorts related to illnesses and with doctor's orders, rather than for the general population.

Clinical Results of Drug-Coated Balloon Treatment in a Large-Scale Multicenter Korean Registry Study

  • Sang Yeub Lee;Yun-Kyeong Cho;Sang-Wook Kim;Young-Joon Hong;Bon-Kwon Koo;Jang-Whan Bae;Seung-Hwan Lee;Tae Hyun Yang;Hun Sik Park;Si Wan Choi;Do-Sun Lim;Soo-Joong Kim;Young Hoon Jeong;Hyun-Jong Lee;Kwan Yong Lee;Eun-Seok Shin;Ung Kim;Moo Hyun Kim;Chang-Wook Nam;Seung-Ho Hur;Doo-Il Kim; Stent Failure Research Group (SFR) Drug coated balloon (DCB) registry investigators
    • Korean Circulation Journal
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    • v.52 no.6
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    • pp.444-454
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    • 2022
  • Background and Objectives: The aim of this study was to demonstrate the efficacy and safety of treatment with drug-coated balloon (DCB) in a large real-world population. Methods: Patients treated with DCBs were included in a multicenter observational registry that enrolled patients from 18 hospitals in Korea between January 2009 and December 2017. The primary outcome was target lesion failure (TLF) defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically indicated target lesion revascularization at 12 months. Results: The study included 2,509 patients with 2,666 DCB-treated coronary artery lesions (1,688 [63.3%] with in-stent restenosis [ISR] lesions vs. 978 [36.7%] with de novo lesions). The mean age with standard deviation was 65.7±11.3 years; 65.7% of the patients were men. At 12 months, the primary outcome, TLF, occurred in 179 (6.7%), 151 (8.9%), 28 (2.9%) patients among the total, ISR, and de novo lesion populations, respectively. A history of hypertension, diabetes, acute coronary syndrome, previous coronary artery bypass graft, reduced left ventricular ejection fraction, B2C lesion and ISR lesion were independent predictors of 12 months TLF in the overall study population. Conclusions: This large multicenter DCB registry study revealed the favorable clinical outcome of DCB treatment in real-world practice in patient with ISR lesion as well as small de novo coronary lesion.

Assessing the Prevalence of Recurrent Neck and Shoulder Pain in Korean High School Male Students: A Cross-sectional Observational Study

  • Koh, Min-Jung;Park, Sun-Young;Woo, Young-Sun;Kang, Sung-Hyun;Park, Sang-Hoon;Chun, Hye-Jung;Park, Eun-Jung
    • The Korean Journal of Pain
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    • v.25 no.3
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    • pp.161-167
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    • 2012
  • Background: Neck and shoulder pain (NSP) is fairly common in adolescents, which is associated with a high prevalence of NSP found during adulthood as well; therefore, its significance during adolescence should not be underestimated. We surveyed the prevalence of recurrent NSP, lifestyle, and risk factors in Korean high school students, and examined the influence of recurrent NSP on the quality of life. Methods: Nine hundred thirty one male students (16-19 years old) from two academic high schools in Seoul were included in this study. The survey consisted of a questionnaire to assess the prevalence of recurrent NSP, with questions regarding having an occurrence more than once a week, characteristics of NSP, activity and lifestyle of the students, and the risk factors for recurrent NSP. A 36-item Short Form questionnaire was also examined. Results: We found that 44.3% of the high school students surveyed had recurrent NSP (more than once a week) and the overall prevalence of NSP was 79.1%. The average sitting time was $10.2{\pm}2.7$ h/day. 59.0% did not sit straight, 14.7% used assisting devices during reading, and 11.9% answered that they stretched regularly. Found from their self assessed health, frequent fatigue and frequent depressed mood presented significant associations with the higher prevalence of recurrent NSP. Conclusions: Korean high school students had a high prevalence of recurrent NSP. Clinical attention is needed for the prevention and resolution of recurrent NSP found in high school students.

Effect of Observation Window at Peripheral Intravenous Catheter Site on Early Recognition of Infiltration among Hospitalized Children (아동의 말초정맥관 삽입 부위 관찰창 확보가 침윤조기감지에 미치는 효과)

  • Jeong, Ihn Sook;Park, Soon Mi;Park, Kyung Ju
    • Journal of Korean Academy of Nursing
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    • v.46 no.4
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    • pp.534-541
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    • 2016
  • Purpose: The aim of this study was to identify the effect of an observation window (OW) at peripheral intravenous (IV) catheter sites on early detection of IV infiltration among hospitalized children. Methods: This was a retrospective observational study with history control group design. Participants were children who had IV infiltration after peripheral catheterization when hospitalized from January to May, 2014 and January to May, 2015 at a children's hospital located in Yangsan city, Korea. The 193 patients, who were hospitalized from January to May, 2014 formed the control group and did not have OW, and the 167 patients, who were hospitalized from January to May, 2015 formed the window group and had OW. Data were analyzed using ${\chi}^2$-test, independent samples t-test and multiple logistic regression. Results: First stage IV infiltration was 39.5% for the window group and 25.9% for the control group, which was significantly different (p=.007). The likelihood of $2^{nd}$ stage and above IV infiltration decreased by 44% in the window group, which was significantly different (p=.014). Conclusion: OW at the peripheral IV catheter site was found to be an effective measure in early recognition of IV infiltration. Considering the effect of OW, we recommend that nurses should make an OW with transparent dressing during stabilization of the IV catheter site in hospitalized children in clinical settings.

Prevalence of Menstrual Disorders according to Body Mass Index and Lifestyle Factors: The National Health Insurance Service-National Health Screening Cohort in Korea, 2009~2016 (체질량 지수와 생활습관에 따른 한국 가임 여성의 월경장애 유병률과 변화 추이: 국민건강보험공단 국가건강검진(2009~2016) 자료 활용)

  • Park, SoMi;Yoon, Tae Woong;Kang, Dae Ryong;Chung, ChaeWeon
    • Journal of Korean Academy of Nursing
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    • v.50 no.3
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    • pp.401-410
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    • 2020
  • Purpose: This study was performed to identify the prevalence of menstrual disorders in Korean women based on body mass index (BMI) and lifestyle factors, by utilizing the Korean National Health Insurance Database. Methods: A retrospective observational study design was used for the secondary data analysis. Data of women aged 15 to 49 years who were diagnosed with menstrual disorders were extracted from The National Health Insurance Service-National Health Screening Cohort in Korea from 2009 to 2016. The age-standardized prevalence rate of menstrual disorders was calculated using SAS version 9.4, and a Chi-square test and Cochran-Armitage test were performed. Results: In total, 2,219,445 cases were extracted from the database. The prevalence of menstrual disorders significantly increased from 8.6% to 11.6% (Z=135.16, p for trend <.001) over the past eight years. In particular, it was higher in underweight women than in women with normal weight across all years (Z=-4.18~-14.72, p<.001). Moreover, statistically significant differences in the prevalence of menstrual disorders were found to be associated with drinking and smoking in all years and with physical activity levels in part (p<.05~.001). Conclusion: These findings present compelling evidence on the prevalence of menstrual disorders based on a national database. Since the prevalence of menstrual disorders has steadily increased and differs based on BMI and lifestyle factors, educational and clinical interventions are necessary to promote risk awareness and appropriate behavioral changes among Korean women.

Evaluation of prolonged pain in preterm infants with pneumothorax using heart rate variability analysis and EDIN (Échelle Douleur Inconfort Nouveau-Né, neonatal pain and discomfort scale) scores

  • Buyuktiryaki, Mehmet;Uras, Nurdan;Okur, Nilufer;Oncel, Mehmet Yekta;Simsek, Gulsum Kadioglu;Isik, Sehribanu Ozluer;Oguz, Serife Suna
    • Clinical and Experimental Pediatrics
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    • v.61 no.10
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    • pp.322-326
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    • 2018
  • Purpose: The EDIN scale (${\acute{E}}chelle$ Douleur Inconfort Nouveau-$N{\acute{e}}$, neonatal pain and discomfort scale) and heart rate variability has been used for the evaluation of prolonged pain. The aim of our study was to assess the value of the newborn infant parasympathetic evaluation (NIPE) index and EDIN scale for the evaluation of prolonged pain in preterm infants with chest tube placement due to pneumothorax. Methods: This prospective observational study assessed prolonged pain in preterm infants with a gestational age between 33 and 35 weeks undergoing installation of chest tubes. Prolonged pain was assessed using the EDIN scale and NIPE index. Results: There was a significant correlation between the EDIN scale and NIPE index (r=-0.590, P=0.003). Prolonged pain is significantly more severe in the first 6 hours following chest tube installation (NIPE index: 60 [50-86] vs. 68 [45-89], P<0.002; EDIN score: 8 [7-11] vs. 6 [4-8], P<0.001). Conclusion: Prolonged pain can be accurately assessed with the EDIN scale and NIPE index. However, evaluation with the EDIN scale is time-consuming. The NIPE index can provide instantaneous assessment of prolonged and continuous pain.

Body composition: A predictive factor of cycle fecundity

  • Kayatas, Semra;Boza, Aysen;Api, Murat;Kurt, Didar;Eroglu, Mustafa;Arinkan, Sevcan Arzu
    • Clinical and Experimental Reproductive Medicine
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    • v.41 no.2
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    • pp.75-79
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    • 2014
  • Objective: To study the effect of body composition on reproduction in women with unexplained infertility treated with a controlled ovarian hyperstimulation and intrauterine insemination programme. Methods: This prospective observational study was conducted on 308 unexplained infertile women who were scheduled for a controlled ovarian hyperstimulation and intrauterine insemination programme and were grouped as pregnant and non-pregnant. Anthropometric measurements were performed using TANITA-420MA before the treatment cycle. Body composition was determined using a bioelectrical impedance analysis system. Results: Body fat mass was significantly lower in pregnant women than in non-pregnant women ($15.61{\pm}3.65$ vs. $18.78{\pm}5.97$, respectively) (p=0.01). In a multiple regression analysis, body fat mass proved to have a stronger association with fecundity than the percentage of body fat, body mass index, or the waist/hip ratio (standardized regression coefficient${\geq}0.277$, t-value ${\geq}2.537$; p<0.05). The cut-off value of fat mass, which was evaluated using the receiver operating characteristics curve, was 16.65 with a sensitivity of 61.8% and a specificity of 70.2%. Below this cut-off value, the odds of the pregnancy occurrence was found to be 2.5 times more likely. Conclusion: Body fat mass can be predictive for pregnancy in patients with unexplained infertility scheduled for a controlled ovarian hyperstimulation and intrauterine insemination programme.

Prealbumin and Retinol Binding Proteins Are Not Usable for Nutrition Follow-Up in Pediatric Intensive Care Units

  • Tekguc, Hakan;ozel, Deniz;Sanaldi, Huriye;Akbas, Halide;Dursun, Oguz
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.21 no.4
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    • pp.321-328
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    • 2018
  • Purpose: Feeding children is a problem in pediatric intensive care units (PICU) and it is difficult to know the correct amount. The purpose of this study is to evaluate if prealbumin or retinol binding proteins (RBP) are effective relative to daily enteral nutrition, without being affected by severity of diseases or infections and can be used to follow up nutritional amount. Methods: This is a prospective observational study that includes 81 patients admitted to PICU in Akdeniz University with estimated duration >72 hours, age between 1 month and 8 years. Daily calorie and protein intake were calculated and prealbumin, RBP and C-reactive protein (CRP) levels were measured on the first, third, fifth and seventh mornings. Results: We find moderate correlation between daily calorie intake and prealbumin levels (r=0.432, p<0.001), RBP levels and daily protein intake (r=0.330, p<0.001). When we investigated the relationship between changes of prealbumin, RBP, CRP, calorie and protein intake during intensive care stay, we found that increase of Prealbumin and RBP levels are explained by decrease of CRP levels (r=-0.546 and -0.645, p<0.001) and not with increase of nourishment. Conclusion: Even adjusted for PRISM3, age and CRP, prealbumin and RBP are correlated with last 24 hours' diet. However, it is not convenient to use as a follow up biomarker because increase of their levels is related with decrease of CRP levels.

Reliability and validity of rehabilitative ultrasound images obtained using a hands-free fixed probe in measuring the muscle structures of the tibialis anterior and the gastrocnemius

  • Choi, Mun-Sang;Shin, Jang-Hoon;Park, Hye-Kang;Lee, Wan-Hee
    • Physical Therapy Rehabilitation Science
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    • v.8 no.4
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    • pp.194-201
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    • 2019
  • Objective: This study aimed to investigate the reliability and validity of muscle thickness (MT) and pennation angle (PA) measurements of the ankle muscle, including the tibialis anterior (TA) and the medial gastrocnemius (MGCM), using a hands-free fixed probe and to compare it with the conventional linear probe. Design: Observational inter-rater reliability study. Methods: Thirty-three healthy subjects (20 male, 13 female) were included. In all subjects, ultrasound images were acquired from the TA and MGCM using a hands-free fixed probe and a conventional linear probe in random sequence by two examiners at two time-points within a 7-day interval. MT and PA were calculated on the taken images. Intra-class correlation coefficients (ICC), 95% confidence intervals, standard error of measurement and the Pearson's correlation coefficient were used to estimate reliability and validity. And also, Bland-Altman plots were generated for a visual representation of MT and PA at the TA and MGCM. Results: The ICC for all intra-rater reliability was 0.943 to 0.995 and that for all inter-rater reliability was 0.928 to 0.993, indicating excellent reliability. A significantly high correlation was observed between MT and PA at the TA and MGCM with use of the hands-free fixed probe and the conventional linear probe (r>0.938; p<0.001). Conclusions: The hands-free fixed probe provided excellent images for measurement of the MT and PA of the TA and MGCM and is a useful device for making clinical measurements of muscle structure without grasping of the probe.

Contributing Factors for the Registration Rates within Emergency Department Based Post-suicidal Care Program (자살시도 후 생존 퇴원한 환자에서 지역정신건강센터 등록 요인 분석 - 응급실 기반 자살시도자 관리시스템 자료 중심으로 -)

  • Kim, Dong-Ki;Chun, Byeong Jo;Moon, Jong Mi;Cho, Yong Soo;Bae, Kyung-Yeol;Kim, Hyun Jung;Kim, Mi Jin
    • Journal of The Korean Society of Clinical Toxicology
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    • v.14 no.1
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    • pp.54-59
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    • 2016
  • Purpose: This study was conducted to investigate the independent factors associated with the registration rate for the community-based post suicidal care program in the emergency department (ED). Methods: This prospective observational study was conducted between January and September 2015 at the academic ED in the tertiary urban hospital. The variables examined included gender, age, address, type of insurance, history of previous psychiatric disease, suicide methods, number of previous attempts, CES-D (The Center for Epidemiologic Studies-Depression Scale), and disposition at ED. Univariate and multivariate logistic regression analysis were conducted to identify factors affecting the registration rate for the community-based post suicidal care program. Results: Overall, 331 suicides were investigated, 61 (18.4%) of which were registered in the post-suicide care program. Factors such as a intervention by psychiatric physician (OR: 3.287, 95%; CI: 1.207-9.624) and levels of depression by CES-D score of 16-24 (OR: 3.635; CI: 1.055-12.526) were significantly correlated with registration for the program. Conclusion: The registration rate for the community-based post suicidal care program was influenced by frequent intervention by a psychiatric physician and levels of depression by CES-D score of 16-24.

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