• 제목/요약/키워드: Quality of clinical trial

검색결과 312건 처리시간 0.027초

입원과 수술시행의 적정성 평가 (An Appropriateness Evaluation of Cesarean Section, Cholecystectomy, and Admission in Pediatric Pneumonia)

  • 김창엽;안형식;이영성;권영대;김용익;신영수
    • Journal of Preventive Medicine and Public Health
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    • 제25권4호
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    • pp.413-428
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    • 1992
  • The aim of this study was to evaluate the appropriateness of some kinds of surgery and admission, such as cesarean section (C/S), cholecystectomy, and pediatric pneumonia. For appropriateness evaluation, we ourselves developed some criteria, which were included in the category of explicit and linear criteria, with the assistance of specialists of relevant clinical field. The evaluation of appropriateness was performed by two family physicians. The major findings were as follows: 1. For cesarean section, 77.6% of deliveries were determined to be 'appropriate', but the level of appropriateness was not significantly different among hospitals and between hospital groups by size. The most freqeunt indication of C/S was repeated operation, followed by cephalopelvic disproportion (CPD). The labor trials for vaginal delivery among repeated C/S and CPD cases were performed in 24.5% of pertinent deliveries. 2. About 73.8% of cholecystectomy cases was appropriate to one of the surgical indications, without significant differences among hospitals. Of surgical indications, 'sufficiently frequent and intense symptom recurrence' was the most frequent, and 'confirmed acute cholecystitis' was the second. 3. Of children admitted due to pneumonia, only 57.4% of cases satisfied admission criteria, and the level of appropriateness of admission was different among hospitals. The common reasons fur admission were 'failure to initial treatment', 'suspected bacterial pneumonia', 'young infant', etc. We could find that there were differences of quality among hospitals in some procedures, especially in the pediatric pneumonia and labor trial before C/S, which suggested that the implementation of quality assurance activiteis would be necessary in this country. In this study, we used some simple and primitive research tools and the numbers of subjects and tracer procedures were limited. So advanced studios with plentiful subjects and more representative diseases or procedures should be tried.

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방사선 치료 중인 두경부 종양 환자를 대상으로 메게이스 내복 현탁액 경구투여 후 유효성 및 안전성에 관한 다기관, 공개, 관측연구 (Multicenter, Open-Labeled, Observational Clinical Trial to Investigate the Efficacy and Safety of Oral Administration of Megace Suspension in Patients with Head and Neck Cancer During Radiotherapy)

  • 김세헌;김민식;김영모;김현수;남순열;노영수;박영학;백정환;봉정표;이강대;이용섭;정광윤;정성민;정필상;주영훈;주형로;최은창;태경;홍기환
    • 대한두경부종양학회지
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    • 제24권1호
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    • pp.57-63
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    • 2008
  • Background and Purpose:Nausea, vomiting and weight loss are common problems that are encountered in the course of cancer patient treatment who are receiving radiotherapy. In this study, we are aiming to analyze the effect of megestrol acetate on quality of life of head and neck cancer patients receiving radiotherapy, resulting from improvement of weight loss, appetite and nutritional status via multicenter, open-labeled, observational clinical trial. Material and Methods:A total of 270 patients from 10 medical institutes who are receiving radiotherapy or who have completed radiotherapy within 3 months, between February 2007 and February 2008, were selected as candidates for the study. Megestrol acetate suspension(megace) was given to the subjectives once a week for 4 weeks with the amount of 20ml(megestrol 800mg). Measurement of weight and questionnaire surveys were carried out three times: at the start of the study, 4 weeks after the start of the medication, and 4 weeks after the end of the medication, respectively. Results:The group who has received megace had a total number of 199, and control group was 70. The group who have received megace showed mean weight loss of 1kg in 8 weeks, compared with the weight loss of 5.5kg in control group, which showed that the medication was effective in reducing the amount of weight loss(P=0.027). The group who received megace had a tendency to report a reduced rate of decrease in the score of appetite, nausea and vomiting, and QOL score, but it did not have statistical significance(P>0.05). Conclusion:Megestrol acetate have reduced the degree of weight loss significantly, and it has a tendency to reduce the rate of decrease in appetite, aggravation of nausea and vomiting, and quality of life.

생쥐 초기배아와 사람의 수정란의 발생에 미치는 생식수관 상피세포의 영향에 관한 연구 (The Effects of the Epithelial Cells of Genital Tract on the Development of Mouse Early Embryos and Human Fertilized Oocytes)

  • 이호준;변혜경;김정욱;황정혜;전종영;김문규
    • Clinical and Experimental Reproductive Medicine
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    • 제21권3호
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    • pp.315-323
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    • 1994
  • Mammalian oviductal epithelial cells have been known to improve in vitro fertilization and embryonic development. Recently, co-cultured human embryos with the epithelial cells in human genital tract has been reported to improve the pregnancy rate. The purpose of the study was to investigate the effects of the epithelial cells of human genital tract on the development of mouse early embryos and human fertilized oocytes. The epithelial cells of human genital tract were collected from the fallopian tubes which were obtained during hysterectomy in fertile women and from the endometrium during endometrium biopsy. Collected human ampullary cells(HACs) and endometrial cells(HECs) were cultured for 10 days to establish primary monolayer. Second passaged HACs and HECs were obtained by trypsinization were cryopreserved in PBS with 1.5 M DMSO for later use. To investigate the effect when co-cultured with HACs and HECs, we tried to apply strict quality control on mouse embryo, from two cell to blastocyst prior to human trial. The results of quality control were as follows; In Group I (Ham's F10 with 10% FCS), Group IT (co-cultured with HACs) and Group ill (co-cultured with HECs), developmental rates to blastocyst were 63.3%(253/400), 76.0%(304/ 400),74.0%(296/400), respectively. Hatching rates were 36.8%(147/400), 41.80/0(167/400), 38.0%(152/400), respectively(p<0.05). To perform the human IVF, cryopreserved HACs were thawed at 37$^{\circ}C$ waterbath, seeded on the well dish and cultured for 48 hI'S. The pronuclear stage embryos were transferred to the seeded well dish. After 24 hRS, co-cultured embryos were examined and transferred to patient's uterus. The results of human IVF when co-cultured with HACs were that fertilization and developmental rates were 61.8% (256/414), 95.3% (244/256) as compared with 57.2% (279/488) and 94.6%(264/279) in Ham's F10 supplemented with 10% FCS(control). However, 62.9% (161/256) of co-cultured human embryos showed good embryos(no or slight fragmentation) as compared with 53.8 % (150/279) in control(p < 0.05). Pregnancy rate was 40.0% (12/30) when co-cultured with HACs whereas 30.6%(11/36) in control. In conclusions, co-culture system using HACs and HECs improved the developmental and hatching rates of mouse embryo. Also, in human IVF system when co-cultured with HACs, it improved both the quality of human embryos and the pregnancy rate.

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우리나라 노인에서 관절염과 동반 만성질환에 의한 건강관련 삶의 질 감소 효과 (Effect of Arthritis and Comorbid Chronic Conditions on Health-related Quality of Life in Korean Elderly)

  • 노지영;김순영;권인선;남해성
    • 한국산학기술학회논문지
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    • 제15권6호
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    • pp.3751-3758
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    • 2014
  • 본 연구는 제3기 국민건강영양조사 자료를 이용하여 우리나라 65세 이상 노인의 관절염과 동반 만성질환에 따른 건강관련 삶의 질(이하 HRQoL) 감소 양상을 파악하고자 하였다. 연구대상자는 7개 단일질환군(관절염, 추간판탈출증, 골다공증, 천식, 위십이지장궤양, 뇌졸중, 백내장) 1,357명, 관절염에 더하여 상기 만성질환중 하나를 추가 보유한 복합만성질환군 886명, 무질환군 465명 등 총 2,708명이었다. HRQoL 지표인 EQ-5D index를 집단 간에 비교하기 위해 공분산 분석을 실시하였고 관절염과 동반 만성질환의 교호작용을 관찰하기 위해 다중 회귀분석을 실시하였다. 남녀로 나누어 분석한 연구결과는 다음과 같다. 남성에서 연령보정 EQ-5D index 평균치가 관절염군과 유의한 차이를 보인 질환군은 단일질환군 중에는 뇌졸중군이 유일하였으며, 복합만성질환군 중에는 뇌졸중을 동반한 관절염군과 백내장 동반 관절염군이었다. 여성에서 연령보정 EQ-5D index 평균치가 관절염군과 유의한 차이를 보인 질환군은 단일질환군 중에는 천식, 뇌졸중, 백내장 등이었으며, 복합 만성질환군 중에는 골다공증 동반 관절염군, 위십이지장궤양 동반 관절염군, 뇌졸중 동반 관절염군, 백내장 동반 관절염군 등이었다. 다중 회귀분석을 실시한 결과 남성에서는 교호작용이 관찰되지 않았고, 여성에서는 관절염환자가 뇌졸중을 동반한 경우만 교호작용이 관찰되었는데 감산관계 양상을 보였다. 관절염환자에서 건강관련 삶의 질을 평가하는 경우에는 동반 만성질환의 이러한 효과를 고려하여할 것이다.

불면증 변증도구 신뢰도와 타당도 평가 및 심리검사와의 상관성에 대한 초기연구 (A Pilot Study of Evaluating the Reliability and Validity of Pattern Identification Tool for Insomnia and Analyzing Correlation with Psychological Tests)

  • 정진형;이지윤;김주연;김시연;강위창;임정화;김보경;정인철
    • 동의신경정신과학회지
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    • 제31권1호
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    • pp.1-12
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    • 2020
  • Objectives: The purpose of this study was to evaluate the reliability and validity of the instrument on pattern identification for insomnia (PIT-Insomnia) and verify the correlation between PIT-Insomnia and psychological tests. Methods: Two evaluators examined the pattern identification of the participants who met insomnia disorder diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) and took the Insomnia Severity Index (ISI) score over 15 once manually and twice using the PIT-Insomnia to measure the inter-rater and test-retest reliability. We also conducted the following surveys: the Pittsburgh Sleep Quality Index (PSQI), the Korean version of Beck's depression inventory (K-BDI), the Korean version of the State-Trait Anxiety Inventory (STAI-K), the Korean Symptom checklist-95 (KSCL-95), and the EuroQol-5 dimension (EQ-5D), to measure concurrent validity and correlation between the PTI-Insomnia and psychological tests. Results: 1. The test-retest reliability analysis of the pattern identification results showed moderate agreement, and test-retest reliability analysis of each pattern identification score showed agreements from poor to moderate. 2. The inter-rater reliability analysis of the pattern identification results via manual showed slight agreement, when analysis was performed with calibration, the inter-rater reliability analysis of the pattern identification results via manual showed fair agreement. 3. The concordance analysis between results via manual and the PIT-Insomnia showed poor agreement, when the analysis was performed with calibration, concordance analysis showed fair agreement. 4. The concordance analysis between the PIT-Insomnia and the PSQI showed positive linear correlation. 5. The concordance analysis between the PIT-Insomnia and the PSQI, K-BDI, STAI-K, KSCL-95, and EQ-5D showed that non-interaction between the heart and kidney have positive linear correlation with the K-BDI, anxiety item of KSCL-95, dual deficiency of the heart-spleen have positive linear correlation with somatization item of KSCL-95, paranoia item of KSCL-95, heart deficiency with timidity have positive linear correlation with stress vulnerability item of KSCL-95, parania item of KSCL-95, phlegm-fire harassing the heart have positive linear correlation with K-BDI, paranoia item of KSCL-95, depressed liver qi transforming into fire have positive linear correlation with the anxiety item of KSCL-95, parania item of KSCL-95, all pattern identification have negative linear correlation with EQ-5D. Conclusions: The PIT-Insomnia has moderate agreement of reliability and reflects the severity of insomnia since it has some concurrent validity with the PSQI. There are some correlations between the PTI-Insomnia with specific psychological tests, so we could suggest it can be used appropriately in the clinical situation.

화병의 불안 증상에 대한 시호가용골모려탕의 효능 임상연구 중간보고 (Interim Report about The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung)

  • 최우창;박대명;이상룡;강위창;정인철
    • 동의신경정신과학회지
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    • 제23권4호
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    • pp.133-152
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    • 2012
  • Objectives : The purpose of this study is to investigate the effect of Sihogayonggolmoryeo-tang on the anxiety of Hwa-byung. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Sihogayonggolmoryeo-tang or controlled medication for anxiety of Hwa-byung. Hamilton Anxiety Scale (HAM-A) was measured as the 1st evaluative instrument, and Korean State-Trait Anxiety Inventory (STAI-K), Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, Korean Beck's Depression Inventory (BDI-K), Korean State-Trait Anger Expression Inventory (STAXI-K), Insomnia severity Index (ISI), Instrument of Oriental Medical Evaluation for Hwa-Byung, WHO Quality of Life Avvreviated (WHOQOL-BREF), genral self-Efficacy Scale (GSES), Rosenberg Self-Esteem Inventory (SRE) and Heart Rate Variability (HRV) were also measured as the 2nd evaluative instrument before treatment. Results : Clinical characteristics-vital signs and demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, and etc, also showed similarity of distribution in both groups. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; HAM-A was measured as the first evaluative instrument, and STAI-K, Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, BDI-K, STAXI-K, ISI, Instrument of Oriental Medical Evaluation for Hwa-Byung, WHOQOL-BREF, GSES, SRE and HRV. Conclusions : We considered that establishment of the experimental group and controlled group was objective and worth conducting this research. In addition, this methodology is expected to be applied to the subsequent research. Further, we hope to make up for this study through various study and discussion.

중풍(中風) 재활(再活)의 침치료(鍼治療) 효과(效果)에 대한 고찰(考察) -최근 RCT(Randomized controlled trial) 논문을 중심으로- (The Study on the Effectiveness of Acupuncture in Stroke Rehabilitation)

  • 김정은;이재동;강성길
    • Journal of Acupuncture Research
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    • 제22권1호
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    • pp.211-221
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    • 2005
  • 본 논문은 지금까지의 침 치료와 중풍재활에 관해 쓰인 논문들을 살펴보고 그들의 연구방법, 실험과정, 결과들을 분석 평가하여 침 치료가 중풍 재활 치료에 유의함을 가지는지 알아보고자 하였다. 이를 위해 pubmed와 science direct, EBSCO를 검색하고 경희의료원 의학도서관에 소장된 비전산화 저널 자료에 대한 수기 조사를 병행하여 논문 원문 16편을 얻을 수 있었으며 다음과 같은 결론을 얻었다. 1. 검색을 통해 원문을 얻은 논문은 모두 16편이었으며, 그중 9편의 논문이 RCT논문이었다. 2. 중풍 재활치료로써 침 치료가 환자의 전반적 운동기능향상 및 일상생활과 생활의 질의 향상에 유의한 효과를 보인다고 보고한 논문이 3편이었으며, 다른 세 논문은 침 치료가 유의한 효과를 보이지 않는다고 보고하였다. 3. 중풍 후 증상인 spasticity에 대한 두 논문 중 상지의 spasticity에 관련한 논문은 침 치료가 유의하다고 보고하였으며, 하지의 spasticity에 관련한 논문은 이와 반대로 유의하지 않다고 보고하였다. 4. 침 치료와 자세조절에 관한 논문 1편은 침 치료가 중풍 후 자세 조절의 정상화를 촉진시키는데 유의하다고 보고하였다. 5. 9편의 논문 중 침 치료가 유의한 효과를 보고한 논문의 Jadad score는 2점, 2점, 1점, 1점, 1점으로 낮게 나타났으며 유의한 효과를 보이지 않는다고 보고한 논문의 Jadad score는 5 점, 5점, 3점, 1점으로 높게 나타났다.

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두통에 대한 이혈 방혈요법의 유효성 분석: 체계적 문헌고찰 및 메타분석 (Effectiveness of Auricular Blood-letting Therapy for Headaches: A Systematic Review and Meta-Analysis)

  • 이경은;박민령;이지원;황인준;이보람;서종철;권찬영
    • 동의신경정신과학회지
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    • 제34권3호
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    • pp.259-274
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    • 2023
  • Objectives: The purpose of this study was to provide clinical evidence to support the use of auricular blood-letting therapy (ABT) for headaches. Methods: Studies were identified by a comprehensive search of five databases. Randomized controlled trials (RCTs) that investigated the effects of the ABT for headaches were included. Two authors independently extracted the data and assessed the methodological quality of the included studies using Cochrane's risk-of-bias tool. If two or more studies reported the same outcome, a meta-analysis was performed. Meta-analysis results for dichotomous variables are expressed as risk ratios (RRs) and 95% confidence intervals (CIs). Results: A total of eight RCTs were included in this review. The total effective rate (TER) was the most commonly used outcome measurement. Among the eight RCTs, five were included in the metaanalysis. The TER was not statistically significantly different in the ABT group compared to the medication group (two studies, n=55, RR=1.24, 95% CI: 0.78 to 1.96, p=0.36, I2 =86%). However, the TER of the combined ABT and medication group was significantly different compared to the medication alone group (four studies, n=159, RR=1.23, 95% CI: 1.12 to 1.35, p<0.0001, I2 = 0%). Pain and mental health-related outcomes in the combined ABT and medication group were significantly different from the control groups. The methodological quality of the included RCTs was generally low. Conclusions: ABT combined with medication may be effective for treating headaches. However, the number of studies included was small, so the results were insufficient, and statistically significant effects were not confirmed for a single implementation of ABT. Thus, well-designed further studies based on the findings of this study are recommended.

불면장애에 대한 천왕보심단의 체계적 문헌 고찰 및 메타분석 연구 (Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) for Insomnia Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials)

  • 사공종원;김동희;하지원;조윤송;김보경
    • 동의신경정신과학회지
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    • 제29권4호
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    • pp.267-280
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    • 2018
  • Objectives: The objective of this study was to provide clinical evidence to support the use of a herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet (TWBXP)) for insomnia. Methods: Randomized controlled trials that verified effects of Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) treating primary insomnia were carried out. A literature search of English, Chinese, Korean databases was also performed. The selected literature were assessed by Risk of Bias (RoB). Results: The total number of selected trials was 13 RCTs. Among the 13 RCTs, 10 were meta-analyzed. The Chinese Classification of Mental Disorders-3 (CCMD-3) was frequently used as the diagnostic criteria for interventions during the analysis of the use of herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) for management of primary insomnia. As for outcome measurement, the effective rate was used. From the Meta-analysis of the studies, it was established that the insomnia cure effective rate in the TWBXP group was higher than that in the Western Medicine (WM) group (RR: 1.15, 95% CI: 1.07 to 1.24, p<0.0001, $I^2=33%$). Also, the effective rate in the TWBXP+ACU group was significantly different compared to the WM group (RR: 1.32, 95% CI: 1.13 to 1.54, p=0.0004, $I^2=0%$). The quality of the selected RCTs was low. Conclusions: Herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) is effective for treating primary insomnia. It is worth noting that this studies were of relatively poor quality. The sample sizes were also small. Therefore, further investigations into the diagnosis and treatment of insomnia are warranted.

임플란트 식립 후 초기 안정성의 변화 (Initial Changes of Implant Stability from Installation during Early Bone Healing)

  • 박찬진;김대곤;조리라
    • 구강회복응용과학지
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    • 제29권3호
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    • pp.272-279
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    • 2013
  • 골치유 기간 중 임플란트-골 계면에서 일정 수준 이상의 미세동요가 발생하게 되면 임플란트의 골유착이 방해받게 되므로 임플란트 식립 후 초기 골반응에 관해 임플란트 안정성은 하나의 지표가 된다. 본 연구의 목적은 임플란트 식립 후 전향적인 연구를 통해 초기 임플란트 안정성 변화를 추적하여 골치유 양상을 추론하고자 하였다. 총 26명의 환자에게 식립된 30개의 임플란트를 대상으로 하악골에 1회법으로 식립 직후 1주 간격으로 12주간 공진주파수분석을 시행하여 초기 안정성의 변화를 구하였으며 식립 직후와 1개월 간격으로 변연골 흡수 정도를 방사선학적 방법으로 측정하였다. 식립 직후와 각 치유기간 동안의 ISQ값 비교에서 식립 4주에서 6주사이에 골질에 따른 차이를 보였으나(P<0.05), 6주 이후에는 골질군 간에는 임플란트 안정성 변화에 차이가 없었다(P>0.05). 방사선학적 검사에서는 변연골의 차이가 관찰기간내에 유의하게 변화하지 않았다(P>0.05). 임플란트 식립 후 초기 골치유과정은 골흡수과정에 연속적인 과정으로 4주 이후 바람직한 골치유과정이 진행됨을 공진주파수분석으로 관찰할 수 있었다.