• Title/Summary/Keyword: Clinical standards

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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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Development of a Management Tool of CCD/CCR-centric Standard Clinical Document (CCD/CCR 중심의 표준진료문서 관리 도구의 개발)

  • Lee, In-Keun;Cho, Hune;Kim, Hwa-Sun
    • Journal of the Korean Institute of Intelligent Systems
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    • v.22 no.4
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    • pp.507-514
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    • 2012
  • XML-based standards such as CCD(Continuity of Care Document) and CCR(Continuity of Care Record) have been developed for representation, integration, and exchange of personal health record(PHR), and various of researches on PHR based on the standards have been conducted. These researches have developed and used CCD/CCR parsers each with their own different ways, but it can be hard to develop and update the parsers because of the structural complexity of the standards. Moreover, inter-exchange between CCD and CCR documents in the PHR-related medical information systems should be possible for the interoperability of the systems. Therefore, we proposed a designing method to develop the tools treating XML-based CCD/CCR documents. And we implemented CCD/CCR parser based on the proposed method and developed a converter from CCD to CCR using the parsers. To confirm the usefulness of the developed tool, we performed an experiment of creating CCD documents using the personal health data gathered from chronically ill patients in Kyungpook National University Hospital and of converting from the CCD documents to CCR documents.

Consolidated Standards of Reporting Trials: The Reporting Guideline for Randomized Controlled Trials (Consolidated Standards of Reporting Trials의 소개: 무작위 대조군 연구의 보고 지침)

  • Jung, Hoi-In;Kim, Hee-Eun
    • Journal of dental hygiene science
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    • v.14 no.3
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    • pp.269-275
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    • 2014
  • Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

Refutation against the Non-Scientificity Argument on Korean Medicine (한의학의 비과학성 논란에 대한 반박)

  • Chi, Gyoo Yong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.33 no.5
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    • pp.249-254
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    • 2019
  • This study is aimed to refute against medical opponent's claim that Korean medicine does not conform to the conditions of science. Analyses and refutations against a journal treatise and a Facebook column formally written for a logical criticism and attack were conducted. As an example of the logic of the knowledge production process in Chinese medicine, 8 principle theory was exemplified in the Han danasty Classics "Neijing" and "Shanghanlun" at first. The knowledge was continuously revised and accumulated historically and then completed through Ming、Cheng period. The differential diagnosis and treatment theory is a logical process of forming knowledge through the process of abduction, deduction and induction begun from "Shanghanlun" succeeded to nowadays and it is essentially equaled with the process of experimental inference by Claude Bernard. Examples of normal science status based on Kuhn's scientific standards include the theory of 8 principle, differntial diagnosis of viscera and bowel, 3 yang and 3 yin diseases of "Shanghanlun" and warm disease theory. Examples of science lost or get its normal status by refutation following Popper's standards were cold damage theory and warm disease theory respectively. This allowed Chinese medicine to follow the general principles of science that form scientific knowledge and to correspond with the demarcation standards and concepts of science. However, as one of the conditions for becoming a science, Chinese medicine is partially lacking in terms of the interpretation of text language or the accordance with modern knowledge. Therefore methods are required to supplement this lack through multi-faceted research such as literature-based, theoretical and clinical studies.

A Clinical Study for 157 Cases of CVA by Sasang Constitutional Medicine (사상의학적(四象醫學的) 중풍치험(中風治驗) 157례(例)에 대(對)한 임상적(臨床的) 연구(硏究))

  • Choi, Jae-young;Park, Seong-sik
    • Journal of Sasang Constitutional Medicine
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    • v.10 no.2
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    • pp.431-453
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    • 1998
  • 1. Background and Purpose: We intended to make the standards of CVA management of Sasang Constitutional Medicine and be helpful to understand the constitutional symptoms through a clinical study of CVA. 2. Methods: We studied 157 CVA inpatients(79 men and 78 women) who were in constitutional clinic of Dongguk Pundang Oriental Hospital during 1 year from March 1997 to February 1998. We investigated and analysed the characteristics, past histories, symptoms and progresses of patients. 3. Results: The results of constitutional analysis showed 88 Taeumin(56.1%), 48 Soyangin(30.6%) and 21 Soeumin(13.4%). The frequency of strokes was much the same between male and female and the greater part of cases were 50-70 of age. The CVA cases were classified into 119 cerebral infarction(75.8%), 11 cerebral hemorrhage(7.0%), 1 subarachnoid hemorrhage(0.6%) and 26 trasient ischemic attack. From the standards of symptom management, there were abnormality of a coated tongue(63.1%) in most cases, sleeping disorders(48.4%), excremental disorders(44.7%) and urinary disorders(36.9%) on admission. With regard to the rate of improvement in the standards of CVA management, excremental disorders improved 87.1% and emotional disorder 81.0%, swallowing disorder 78.7% and so on.

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2007 Korean National Growth Charts: review of developmental process and an outlook (2007 한국 소아 청소년 성장도표 : 개발 과정과 전망)

  • Moon, Jin Soo;Lee, Soon Young;Nam, Chung Mo;Choi, Joong-Myung;Choe, Bong-Keun;Seo, Jeong-Wan;Oh, Kyungwon;Jang, Myoung-Jin;Hwang, Seung-Sik;Yoo, Myung Hwan;Kim, Young Taek;Lee, Chong Guk
    • Clinical and Experimental Pediatrics
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    • v.51 no.1
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    • pp.1-25
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    • 2008
  • Purpose : Since 1967, The Korean Pediatric Society and Korean Government have developed Korean Growth Standards every 10 years. Last version was published in 1998. During past 40 years, Korean Growth Standards were mainly descriptive charts without any systematic nor statistical standardization. With the global epidemic of obesity, many authorities such as World Health Organization (WHO) and United States' Centers for Disease Control (CDC) have been changed their principles of growth charts to cope with the situations like ours. This article summarizes and reviews the whole developmental process of new 2007 Korean Growth Charts with discussion. Methods : With the initiative of Division of Chronic Disease Surveillance in Korea Centers for Disease Control and Prevention, we have performed new national survey for the development of new Standards in 2005 and identified marked increase of childhood obesity and plateau of secular increment of final height in late adolescents. We have developed new Growth Standards via adapting several innovative methods, including standardization of all available raw data, which were acquired in 1997 and 2005 national survey and full application of LMS method. Results : We could get new standardized charts; weight-for-age, length/height-for-age, weight-for-height, head circumference-for-age and BMI-for-age. Other non-standardized charts based on 2005 survey data were also published; waist circumference-for-age, mid-arm circumference-for-age, chest circumference-for-age and skinfold-for-age. Clinical guideline was also developed. Conclusion : Developmental process and results of new Korean Growth Charts are comparable with other internationally well-known Growth Standards, WHO 2006 Growth Standards and CDC Growth Charts. 2007 Korean Growth Charts are relevant especially in Korea and Korean ethnic groups.

Explanation and Elaboration of the Clinical Trial Guidelines for Psoriasis Using Herbal Medicine (건선 치료용 한약제제에 대한 임상시험 가이드라인 설명 및 제언)

  • Kim, Bong-Hyun;Kim, Kwan-Il;Kang, Se-Hyun;Park, Jung-Gun;Kang, Dong-Won;Nam, Hae-Jeong;Kim, Yoon-Bum;Lee, Jun-Hee;Kim, Kyu-Seok
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.31 no.2
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    • pp.40-59
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    • 2018
  • Objectives : We report on the contents and reviews of the guidelines for clinical trials of herbal medicine for psoriasis. Methods : After reviewing the existing reports, the guidelines were drafted by the writing committee on guidelines for Korean medicine clinical trial center in Kyung Hee university Korean medicine hospital. Since then, the guidelines have been consulted by the experts in diseases, clinical trials and pharmaceuticals. In addition, the guidelines have been certified by the Korean medicine clinical trial center association and Korean Medicine Ophthalmology & Otolaryngology & Dermatology Society. Results : The guidelines for clinical trials are divided into 8 categories: (1) general contents, (2) evaluation standards of effectiveness, (3) outcome valuables, (4) selection of study participants, (5) designs of clinical trials, (6) safety evaluations, (7) combination therapies in psoriasis treatment and (8) Korean medical considerations. Conclusions : There are 3 major contents for discussion: (1) obscurity of Korean medical considerations to differentiate from existing guidelines, (2) the absence of Korean version of PASI and DLQI, which are validity parameters and (3) realistic institutional problem using the herbal medicine.

Therapeutic Evaluation of a Topical Unani Formulation, Tila-i Muhāsā in Buthūr Labaniyya (Acne Vulgaris): A Randomized, Controlled Clinical Study

  • Azahar, Mohd;Uddin, Qamar;Kazmi, Munawwar Husain;Khatoon, Faiza;Husain, Nazim
    • CELLMED
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    • v.10 no.2
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    • pp.15.1-15.9
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    • 2020
  • Introduction: Buthūr Labaniyya (Acne vulgaris) is a multifactorial disorder of the pilosebaceous units characterized by non-inflammatory and inflammatory clinical lesions. Several Unani medications have been used for centuries to treat acne. Objectives: Evaluation of safety and efficacy of Tila-i Muhāsā in patients with acne vulgaris Materials and Methods: This clinical study was conducted in patients with acne vulgaris. Patients applied Tila-i Muhāsā or 5% Benzoyl Peroxide (BPO) once daily for 6 weeks. Assessment of efficacy was carried out by Global Acne Grading System (GAGS) and Patient Global Assessment (PGA) scores. In addition, overall severity of acne was evaluated on a 5-point Cook's acne grading scale using photographic standards. Assessment of safety was performed through adverse drug reactions, local dermal tolerability, vital signs, and routine laboratory investigations. Results: A total of 60 patients (30 in each group) completed 6 weeks of treatment. The mean percentage reduction in GAGS score at 6 weeks from baseline in Unani group (66.97%) and BPO group (59.09%) was statistically significant (P<0.0001). After 6 weeks of therapy, the mean percentage reduction in PGA score compared to baseline in Unani group (57.44%) and BPO group (50.23%) was statistically significant (P<0.0001). No serious adverse events were reported in both groups; however, mild adverse events occurred more frequently in BPO group (30%) compared to Unani group (10%). Conclusion: Tila-i Muhāsā was found to be effective and safe in the treatment of acne vulgaris. However, further clinical studies with larger sample size and longer duration of therapy need to be conducted.

The Evaluation of Method for Computerization of Clinical Informations of the Patients of the Department of Thoracic and Cardiovascular Surgery - About the practical method of coding and standardization of the structure of the database file(DBF) - (흉부외과환자 임상정보의 전산화 방법에 대한 고찰;데이터베이스 파일(DBF) 구조의 표준화및 코딩화 방안에 대하여)

  • Song, U-Cheol;Kim, Byeong-Ju;Hong, Gi-U
    • Journal of Chest Surgery
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    • v.25 no.10
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    • pp.989-1000
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    • 1992
  • The concepts of modern type computer are so called "General purpose, stored program and digital computer" that is proposed by Charles Babbage. ENIAC, the initial operational electronic digital computer model, was produced in 1946. During the last 50 years, an epoch-making development of the personal computer was marked. The computerization of all levels of society is going on and also computerization of the general hospital and medical college is developing. But patient data management system for clinician is not used generally. We suggest the use of computer aided data management application programs for the clinical informations of the patients of the Department of Thoracic and Cardiovascular Surgery for better management and to make best of medical informations, to co-operate with the current of this times, and to prepare against the Hospital Information Systems[HIS], actively. Also, we suggest to standardize the format and structure of database files to store the clinical data of the patients By standardization of the database files, we can integrate and relate the data of the individual department or hospital, build up the regional or national statistics of the patients easily, and promote the generation of application programs. The medical network by the communication and computer would be utilized to collect the database files. And finally, we suggest the use of code system to input and search the informations about the diagnosis and operation such as the code system of International Classfication of Disease[WHO] and the table of the classfication of operation of the Ministry of Health and Social Affairs, Korea. In this article, we tried to show the new standards, the essential items for computerization of clinical informations of the patients of the Department of Thoracic and Cardiovascular Surgery.r Surgery.

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Stem Cells in Plastic Surgery: A Review of Current Clinical and Translational Applications

  • Salibian, Ara A.;Widgerow, Alan D.;Abrouk, Michael;Evans, Gregory R.D.
    • Archives of Plastic Surgery
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    • v.40 no.6
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    • pp.666-675
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    • 2013
  • Background Stem cells are a unique cell population characterized by self-renewal and cellular differentiation capabilities. These characteristics, among other traits, make them an attractive option for regenerative treatments of tissues defects and for aesthetic procedures in plastic surgery. As research regarding the isolation, culture and behavior of stem cells has progressed, stem cells, particularly adult stem cells, have shown promising results in both translational and clinical applications. Methods The purpose of this review is to evaluate the applications of stem cells in the plastic surgery literature, with particular focus on the advances and limitations of current stem cell therapies. Different key areas amenable to stem cell therapy are addressed in the literature review; these include regeneration of soft tissue, bone, cartilage, and peripheral nerves, as well as wound healing and skin aging. Results The reviewed studies demonstrate promising results, with favorable outcomes and minimal complications in the cited cases. In particular, adipose tissue derived stem cell (ADSC) transplants appear to provide effective treatment options for bony and soft tissue defects, and non-healing wounds. ADSCs have also been shown to be useful in aesthetic surgery. Conclusions Further studies involving both the basic and clinical science aspects of stem cell therapies are warranted. In particular, the mechanism of action of stem cells, their interactions with the surrounding microenvironment and their long-term fate require further elucidation. Larger randomized trials are also necessary to demonstrate the continued safety of transplanted stem cells as well as the efficacy of cellular therapies in comparison to the current standards of care.