• Title/Summary/Keyword: Quality of clinical trial

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Diagnosis and Management of Gastroesophageal Reflux Disease in Infants and Children: from Guidelines to Clinical Practice

  • Gonzalez Ayerbe, Jeaneth Indira;Hauser, Bruno;Salvatore, Silvia;Vandenplas, Yvan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.22 no.2
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    • pp.107-121
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    • 2019
  • The diagnosis and management of gastro-esophageal reflux (GER) and GER disease (GERD) in infants and children remains a challenge. Published guidelines and position papers, along with Embase, MEDLINE, and the Cochrane Database were reviewed and summarized with the intent to propose a practical approach and management of GER and GERD for healthcare providers and to standardize and improve the quality of care for infants and children. For this purpose, 2 algorithms were developed, 1 for infants <12 months of age and the other for older children. None of the signs and symptoms of GER and GERD are specific and there is no gold standard diagnostic test or tool. Nutritional management is recommended as a first-line approach in infants, while in children, a therapeutic trial with antacid medication is advised for early management. The practical recommendations from this review are intended to optimize the management of GER in infants and older children and reduce the number of investigations and inappropriate use of medication.

Chinese Medicine including Chuna Manual Therapy for Osteoarthritis : A Systematic Review (골관절염에 대한 추나요법을 포함한 중의학치료의 효과 : 체계적 문헌 고찰)

  • Kim, Han-Kyul;Gwon, Tae-U;Kim, Byung-Jun
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.13 no.1
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    • pp.11-21
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    • 2018
  • Objectives: To evaluate the evidence supporting the effectiveness and safety of Chinese medicine, including Chuna manual therapy, for the treatment ofosteoarthritis. Methods: We conducted a search of 8 electronic databases(Pubmed, Web of Science, EMBASE, Cochrane Library, CAJ, KISTI, NDSL, and RISS) to find all randomized controlled clinical trials that discuss Chuna manual therapy forosteoarthritis till May 2018. Results: Our inclusion criteria selected 7eligible RCTs involving 633 participants. The meta-analysis of 6 studies showed positive results for the useof Chinese medicine, including Chuna manual therapy, for treating knee osteoarthritis. There was no evidence of worsening symptoms or any adverse events. Conclusions: Our systematic review found favorable evidence regardingthe effectiveness of Chinese medicine, including Chuna manual therapy, for treating knee osteoarthritis. However, our systematic review had several limitations owingto the low quality of original articles andadditionalclinical trials would be necessary for stronger evidence.

Chuna Manual Therapy for Premature Infants: A Literature Review (조산아의 추나 치료에 대한 문헌 고찰)

  • Ju-Chan Cho;Hye-Jin Park;In Heo
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.18 no.2
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    • pp.23-29
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    • 2023
  • Objectives This study aimed to explore literature evidence regarding Chuna manual therapy for premature infants and determine its applicability. Methods Eight electronic databases were searched, and randomized control trials (RCTs) applying Chuna manual therapy to premature infants were sought. The Cochrane risk of bias tool was employed to assess the methodological quality of each RCT. Results Two RCTs met the inclusion criteria and were subjected to analysis. Each study compared the usual care group with the pediatric Chuna group. The results indicated improvements in nutritional status, a reduction in hospitalization days, and enhancements in growth indicators. Conclusions Chuna manual therapy is worth applying to premature infants. However, evidence is limited due to a lack of well-designed RCTs. More qualified clinical trials are needed to obtain stronger evidence.

Cost-effectiveness Analysis of Bojungikgitang and Banhabaekchulchonmatang in Chronic Tinnitus Patients (이명증에 대한 보중익기탕과 반하백출천마탕의 비용효과 분석 연구)

  • Kim, Nam-Kwen;Oh, Yong-Leol;Seo, Eun-Sung;Lee, Dong-Hyo
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.23 no.1
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    • pp.260-269
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    • 2010
  • Background : Bojungikgitang(BJT) and Banhabaekchulchonmatang(BBT) are known to treat the tinnitus patients, which were registered Korean National Health Insurance coverage lists. Objective : Few studies have evaluated economic benefits of both herbal medicines. This research is to investigate the cost-effectiveness of Bojungikgitang(BJT) and Banhabaekchulchonmatang(BBT) in chronic tinnitus patients over nineteen years old. Method : We built the decision tree model of chronic tinnitus and executed the deterministic analysis and threshold sensitivity analysis based on randomized clinical trial. Effectiveness was measured in quality-adjusted life-years(QALYs), and costs were in 2009 KRW(South Korean Currency). The perspective is societal, time horizon is 10 weeks, and Korean willingness to pay threshold is assumed to 20,000,000KRW. Results : In the base case analysis, BJT treatment resulted is better outcomes as low cost, so BJT is dominant medicine and BBT is dominated. But both cost per QALYs (BJT is 3,120,339KWN per QALY, BBT is 3,505,780KWN per QALY) are lower than the threshold, that could be covered by Korean National Health Insurance(KNHI). Conclusion : This study results showed that BJT was more cost-effective than BBT treating tinnitus patients for 10 weeks, and the cost per QALYs of both alternatives were lower than Korean national threshold.

Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data

  • Fuchs, Charles S.;Muro, Kei;Tomasek, Jiri;Van Cutsem, Eric;Cho, Jae Yong;Oh, Sang-Cheul;Safran, Howard;Bodoky, Gyorgy;Chau, Ian;Shimada, Yasuhiro;Al-Batran, Salah-Eddin;Passalacqua, Rodolfo;Ohtsu, Atsushi;Emig, Michael;Ferry, David;Chandrawansa, Kumari;Hsu, Yanzhi;Sashegyi, Andreas;Liepa, Astra M.;Wilke, Hansjochen
    • Journal of Gastric Cancer
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    • v.17 no.2
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    • pp.132-144
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    • 2017
  • Purpose: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. Materials and Methods: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. Results: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. Conclusions: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.

A Trial for Development of Health Profile (KHP 1.0) to Measure the Self-Perceived Health Status of Korean (한국인의 자가평가 건강수준 측정도구(KHP 1.0) 개발)

  • Yang, Jin-Sun;Chun, Jin-Ho
    • Journal of Preventive Medicine and Public Health
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    • v.36 no.1
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    • pp.11-23
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    • 2003
  • Objectives : The 1990s has seen advances in the conceptualization of self-perceived health status which has important roles for individual health and the quality of life. Many types of standardized questionnaires have been developed with the current wide use of SF-36, NHP, andEuroQol. However, the outcomes of these tools may be different with regard to regional, cultural and emotional backgrounds. The purpose of this study was to trial the development of a Korean Health Profile (KHP 1.0) to measure the self-perceived health stati of Koreans. Methods : The KHP 1.0 was designed on the basis of the Medical Outcome Study Form 36 (SF-36), the Nottingham Health Profile (NHP), and the EuroQOL. It was composed of 9 scales; physical functioning, role limitation-physical, pain, general health, energy, social isolation, sleep, role limitation-emotional, and e-motional health. Self-reported chronic disease conditions, and the Zung's Self-Rating Depression Scale (SDS), were also checked for the evaluation of clinical validity. This study was conducted, from December 2000 to January 2001, on 800 middle-aged parents, with four high school students, with 100 retest sets being conducted two weeks later. From the 800 subjects there were 588 complete responses (effective response 73.5%). The reliability of the test-retest results, and the factor analysis on the validity of the KHP 1.0 components, were evaluated using the SPSS (ver 10.0) software. Results : The reliability of the KHP 1.0 was good with Cronbach's alpha (>0.6), test-retest correlation coefficients (>0.5), but with no significant differences from the paired t-test. From the psychometric validity tests, the 9 scales of the KHP 1.0 were divided into two components; physical and mental, and trimmed to the established model with 55% of the total variance, with the exception of role limitation-emotional. The clinical validity on the basis of the comparison for the four characteristic groups; healthy, physical conditions only, mental conditions only, and physical and mental conditions were also good. Conclusions : The KHP 1.0 appears to be a valid measurement tool of self-perceived health stati of Koreans, although there are limitations, i.e. sample size was too small, a limited number of middle-aged subjects, and it was based on unconfirmed diagnoses, etc. Therefore, further study is required to standardize the assessment.

A Clinical Study of Electroacupuncture and Auricular Acupuncture for Abdominal Pain Relief in Patients with Pancreatitis: A Pilot Study (췌장염 환자의 복통 호전을 위한 전침 및 이침 치료 예비 임상연구 프로토콜)

  • Kang, Ha Ra;Lee, Yeon Sun;Kim, Hye Ryeon;Kim, Eun Jung;Kim, Kyung Ho;Kim, Kap Sung;Jung, Chan Yung;Lee, Jun Kyu
    • Korean Journal of Acupuncture
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    • v.34 no.1
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    • pp.47-55
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    • 2017
  • Objectives : The purpose of this study is to evaluate the feasibility of further acupuncture research as an effective alternative and safe treatment for abdominal pain control in patients with pancreatitis. Methods and Results : This study is an open-label, assessment-blind, parallel designed pilot clinical trial. Thirty participants will be assigned to the acupuncture group(n=15) and usual care group(n=15). All patients will receive the conventional standard-of-care(SOC) therapy, but only the experimental group will receive acupuncture therapy six times a week, and the duration of acupuncture therapy will be held up to 12 weeks or until the pains are to be resolved. For the conventional SOC therapy, painkiller will be given. In treatment group, the subjects will receive the identical SOC therapy in combination with electroacupuncture therapy on twelve acupuncture points(LI4, PC6, SP6, GB39, ST36, ST37), and auricular acupuncture therapy on five auricular acupuncture points(Sympathetic, Shen Men, Abdomen, Pancreas gall, and Spleen). The primary outcome will be measured using the visual analogue scale(VAS), and the secondary outcome will be measured using the painkiller demand, quality of life index and severity of pancreatitis by abdominal computed tomography(CT). Assessments will be made at baseline and at week 1, 4, 8 and 12. Results of abdominal CT will be evaluated at baseline and at week 12. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for abdominal pain in patients with pancreatitis.

Occupational Therapy for Community Mobility in Stroke Patients : Systematic review (뇌졸중 환자의 지역사회이동을 위한 작업치료 중재: 체계적 고찰)

  • Jo, Eun-Ju;Kam, Kyung-Yoon;Chang, Moon-Young
    • The Journal of Korean society of community based occupational therapy
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    • v.8 no.3
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    • pp.77-89
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    • 2018
  • Objective : The purpose of this study was to analyze occupational therapy intervention on the community mobility for stroke patients, and to provide evidence of intervention in the clinical fields. Methods : A systematic review was executed according to the PRISMA checklist. The accessed database was PubMed, EMBASE, Cochrane Library (CENTRAL), ProQuest Dissertations & thesis (PQDT), RISS, and KoreaMed. We included the articles published from 2005 to September 2018. RoBANS checklist was used to evaluate the quality of the articles. Included articles, totally eight, were categorized according to the type of intervention. Results : The study design of the literature was varied from two-group randomized trial, quasi-experimental study, case-control trial, one group pre-post comparison study, and cross-sectional study. In the evidence level, 6 articles were included in level II (75%). The percentage of low risk of bias in each article ranged from 52.5%~87.5%. Four studies (50%) provided intervention based on virtual reality or virtual environment. The three (37.5%) provided intervention based on the protocol, and the other (12.5%) did wheelchair training. All studies reported significant effects of the intervention. Conclusion : This systematic review provided evidences to use proper intervention in the clinical fields. Various type of studies should be conducted to prove the effect of occupational therapy intervention for community mobility.

Korean Nurses Knowledge Concerning Vaginal Birth After Cesarean(VBAC) and its Educational Material (제왕절개 기왕력이 있는 질 분만(VBAC)에 관한 간호사의 인식정도와 교육안)

  • Park Sang-Ju;Choi Kyung-Sook
    • The Journal of Korean Academic Society of Nursing Education
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    • v.5 no.2
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    • pp.267-284
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    • 1999
  • The purpose of this study are 1. Evaluate the degree of knowledge of Vaginal Birth After Cesarean(VBAC) of Korean nurses. 2. To gather and develop educational material for VBAC. The sample was surveyed Korean Nurses knowledge about VBAC, from November 1998 through March 1999. For the data analysis, the SPSS computer program percentage and frequency were used for descriptive statistics. The x2 and the t-test were used to compare the results of the two sample groups. Open questions asked in the survey were sorted out by content, then displayed in chart form. For the education material, the Internet was the main source of information. Information on the Internet was provided by professional doctors and prenatal educational nurses. The results of the survey are as follows: 1. Out of 97 Nurses 15.3% answered that cesarean deliveries do not need to be performed after previous cesarean sections : however. 46.4% answered that cesarean sections must be performed after previous cesarean sections. 2. Of the nurses surveyed 14% had no knowledge or had never heard of VBAC. 3 Nurses did not have questions from patients concerning VBAC was 34.7%. This led to the conclusion that patients either do not have knowledge about VBAC or patients have no interest in the trial of labor. 4, Nurses indicated that their information about VBAC originated from other people's experiences (31%), Nursing School (25%), Media information (9%), and through literature review (6%). This data led to the conclusion that the knowledge about VBAC may not be extensive enough to counsel and guide patients who are willing to endure the trial of labor. 5. Nurses preferred hospital education programs to develop their knowledge concerning VBAC. Based upon survey, the conclusion was made that General Nurses and Maternity Nurses did not have knowledge about VBAC success rates and the possibility of a trial of labor. In order for nurses to help patients make decisions concerning VBAC, nurses have to gam more knowledge through hospital educational programs. Further more, the study suggests that through hospital educational programs, the possibility and importance of VBAC must be emphasized to nurses who work in maternity areas. Second, through prenatal educational programs, the possibility and importance of VBAC must be explained and emphasized to patients who had previous cesarean sections. Third, the clinical pathways of VBAC need to be developed. Fourth, each hospital needs to develop multi-disciplinary teams, consis-ting of obstetricians, risk management/quality management, staff registered nurses, and the director for perinatal services. This team can review cesarean section rates and help to increase the practice of VBAC.

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