• 시스템엔지니어링학술지
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• 제19권1호
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• pp.29-38
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• 2023

Independent Safety Assessment (ISA) is a third-party assessment that is to confirm that the system satisfies the safety requirements in the defined operational context. The process of this assessment often brings about many complex arguments that should be supported by evidence and justification. The communication between arguments and evidence is of the most importance in the context of safety case. This study illustrates how NOR-STA can be used for ISA process, showing the effective structure of safety compliance. The study outlines the steps to breaks down the top goal into many elements such as arguments, sub-goals, justification, context and assumptions. It concludes that the evidence-based safety conformance process utilizing NOR-STA provides a more effective and systematic representation of the independent safety assessment process in conformance cases.

• Journal of Korean Dental Science
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• 제3권2호
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• pp.34-39
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• 2010

In our daily practice, we think about the diagnosis of our patient and get into a situation wherein we have to make a clinical decision. Diagnosis and treatment come from the knowledge and experiences that each dentist should have, but sometimes, we can have doubts on our decisions. "On what evidence did I make such decision? Was that really right?" Drawing our attention these days as a possible answer to this question, evidence-based dentistry seeks to apply the best available evidence gained from the scientific method to medical decision making. To make a good decision, the strength of evidence is assessed. Specifically, randomized controlled trial, systematic review, and meta-analysis are considered the highest level of evidence; cohort study, case control study, case series, animal study, bench test, and biological plausibility follow. With the approach of evidence-based dentistry, we can make objective, scientifically sound clinical decisions. It is also patient-oriented, incorporating clinical experiences and stressing good judgments; thorough and comprehensive, it uses transparent methodology. That is the reason evidence-based dentistry can be better than other assessment methods when we make a clinical decision in modern dentistry.

• Urogenital Tract Infection
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• 제13권3호
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• pp.45-50
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• 2018

The Institute of Medicine in its report "Clinical Practice Guidelines we can trust" defined standards for clinical practice guidelines. However, many guidelines continue to rely on expert opinion and lack a formal framework for moving from evidence to recommendations. These guidelines may or may not be labeled as "consensus statements" and do not meet contemporary standards for guideline documents we would refer to as "evidence-based". Therefore, the Grading of Recommendations Assessment, Development and Evaluation working group developed a novel, rigorous and transparent approach to grading certainty (quality) of evidence. In addition, it created a system for "moving from evidence to decisions", for example for the development of evidence-based guidelines. In this article, we aim to introduce this approach to appraising the certainty of relevant evidence and estimate the benefits and detriments of health care interventions within the larger context of evidence-based medicine.

• 보건의료기술평가
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• 제6권2호
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• pp.81-87
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• 2018

With the recent change of healthcare environment including rapid technological development, evidences are more and more important and necessary to support relevant policies in health technology assessment to provide safe and effective health services, utilizing medical resources efficiently. Despite of the emphasis on the importance of real world data and real world evidence in health care research, current infrastructure supporting clinical research is considerably weak due to absence of legal and institutional basis. However, in accordance with the Article 26 of the Health and Medical Technology Promotion Act, there is a limited legal apparatus that can be used only in public data with other dataset for the purpose of healthcare technology assessment at the National Evidence-based Collaborating Agency. Although the use of linked data from various sources was often required in the field of clinical research, it was not yet working well due to insufficient environmental conditions. In order to support the decision-making of medical practice and health care policies, data-linking platform for clinical research is needed. If the legal system that can link up to the data of the private institutions without violating the significant value such as the protection of private informations is established, it will be a decisive foundation reinforcing the researches and policy making processes for the improvement of the national health care system.

• The Korean Journal of Pain
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• 제28권2호
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• pp.75-87
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• 2015

Background: Lumbar discogenic pain without pain mediated by a disc herniation, facet joints, or the sacroiliac joints, is common and often results in chronic, persistent pain and disability. After conservative treatment failure, injection therapy, such as an epidural injection, is frequently the next step considered in managing discogenic pain. The objective of this systematic review is to determine the efficacy of lumbar epidural injections in managing discogenic pain without radiculopathy, and compare this approach to lumbar fusion or disc arthroplasty surgery. Methods: A systematic review of randomized trials published from 1966 through October 2014 of all types of epidural injections and lumbar fusion or disc arthroplasty in managing lumbar discogenic pain was performed with methodological quality assessment and grading of evidence. The level of evidence was based on the grading of evidence criteria which, was conducted using 5 levels of evidence ranging from levels I to V. Results: Based on a qualitative assessment of the evidence for both approaches, there is Level II evidence for epidural injections, either caudal or lumbar interlaminar. Conclusions: The available evidence suggests fluoroscopically directed epidural injections provide long-term improvement in back and lower extremity pain for patients with lumbar discogenic pain. There is also limited evidence showing the potential effectiveness of surgical interventions compared to nonsurgical treatments.

• The Korean Journal of Pain
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• 제34권3호
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• pp.346-368
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• 2021

Background: Recalcitrant disc herniation may result in chronic lumbar radiculopathy or sciatica. Fluoroscopically directed epidural injections and other conservative modalities may provide inadequate improvement in some patients. In these cases, percutaneous neurolysis with targeted delivery of medications is often the next step in pain management. Methods: An evidence-based system of methodologic assessment, namely, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used. Multiple databases were searched from 1966 to January 2021. Principles of the best evidence synthesis were incorporated into qualitative evidence synthesis. The primary outcome measure was the proportion of patients with significant pain relief and functional improvement (≥ 50%). Duration of relief was categorized as short-term (< 6 months) and long-term (≥ 6 months). Results: This assessment identified one high-quality randomized controlled trial (RCT) and 5 moderate-quality non-randomized studies with an application of percutaneous neurolysis in disc herniation. Overall, the results were positive, with level II evidence. Conclusions: Based on the present systematic review, with one RCT and 5 non-randomized studies, the evidence level is II for percutaneous neurolysis in managing lumbar disc herniation.

• 대한간호학회지
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• 제41권6호
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• pp.768-779
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• 2011

Purpose: This study was designed to adapt a surgical wound care algorithm that is used to provide evidence-based surgical wound care in a critical care unit. Methods: This study used, the 'ADAPTE process', an international clinical practice guideline development method. The -'Bonnie Sue wound care algorithm' - was used as a draft for the new algorithm. A content validity index (CVI) targeting 135 critical care nurses was conducted. A 5-point Likert scale was applied to the CVI test using a statistical criterion of .75. Results: A surgical wound care algorithm comprised 9 components: wound assessment, infection control, necrotic tissue management, wound classification by exudates and depths, dressing selection, consideration of systemic factors, wound expected outcome, reevaluate non-healing wounds, and special treatment for non-healing wounds. All of the CVI tests were ${\leq}$.75. Compared to existing wound care guidelines, the new wound care algorithm provides precise wound assessment, reliabilities of wound care, expands applicability of wound care to critically ill patients, and provides evidence and strength of recommendations. Conclusion: The new surgical wound care algorithm will contribute to the advancement of evidence-based nursing care, and its use is expected as a nursing intervention in critical care.

• Advances in Traditional Medicine
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• 제8권2호
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• pp.103-110
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• 2008

Herbal medicine is the use of medicinal plants for prevention and treatment of diseases: it ranges from traditional and popular medicines of every country to the use of standardized and tritated herbal extracts. Generally cultural rootedness enduring and widespread use in a traditional medical system may indicate safety, but also efficacy of treatments, especially in herbal medicine where tradition is almost completely based on remedies containing active principles at very low and ultra low concentrations or relying on magical-energetic principles. The efficacy and safety assessments of medicines, whether modern or herbal, invariably encounter challenges or problems during the course of pre-clinical and clinical research. Some of the challenges in evidence-based herbal medicinal research are unique, and the researcher must be cognizant of them in order to safeguard the quality of the data obtained. Key challenges are: the quality of raw materials; appropriateness of biological/pharmacological activity assessment methodology, and data interpretation; standardization methodology; pharmacokinetics and bioavailability of active constituents and metabolites; clinical dosage formulation/production; and clinical study designs and outcome measures.

• 보건의료기술평가
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• 제1권1호
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• pp.22-26
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• 2013

Objectives: Balancing benefits and risks through the drug life cycle has been discussed for many decades. The objective of this study was to review the processes and tools currently proposed for benefit-risk assessment of medicinal drugs. It aimed to establish scientific and efficient drug safety management system based on the synthetic analysis of benefit-risk evidence. Methods: We conducted a review of exiting literatures published by regulatory agencies or initiatives. Not only quantitative methodologies but also qualitative method were compared to understand their key characteristics for the benefit and risk assessment of drugs. Results: Recently, benefit-risk assessments have more structured approaches to decision making as part of regulatory science. Regulatory agencies such as European Medicines Agency, FDA have prepared plans to apply benefit-risk assessment to regulatory decision making. Also many initiatives such as IMI (Innovative Medicine Initiative) have conducted research and published reports about benefit-risk assessment. For benefit-risk assessment, four kinds of methods are necessary. Frameworks such as BRAT (Benefit Risk Action Team) framework, PrOACT-URL provide guidance for the whole process of decision-making. Metrics are measurements of risk benefit. The estimation techniques are methods to synthesis and combine evidences from various sources. The utility survey techniques are necessary to explicit preferences of various outcome from stakeholders. Conclusion: There is the lack of widely accepted, validated model for benefit-risk assessment. Nor there is an agreement among academia, industry, and government on methods for the quantitative valuation. It is also limited by available evidence and underlying assumptions. Nevertheless, benefit-risk assessment is fundamental to improve transparency, consistency and predictability for decision making through the structured systematic approaches.

• 임상간호연구
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• 제26권2호
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• pp.154-163
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• 2020

Purpose: The aim of this study was to develop an evidence-based guideline for stoma management providing institutional policy, assessment, complications and follow-up care. Methods: The guideline adaptation manual consisting of 23 steps developed by the National Evidence-Based Healthcare Collaborating Agency was used for this study. It presents an overview of the process used to develop the guideline and lists specific recommendations from the guideline. Results: It provides 55 recommendations that include the following 8 topics: 1) Organization and policy recommendations, 2) Preoperative nursing; Ostomy education, stoma site marking, 3) Ostomy formation, 4) Postpoperative nursing; education, assessment, high output stoma management, 5) Selection of ostomy products, 6) Colostomy irrigation, 7) Stomal and peristomal complications, 8) Follow-up care after discharge. Conclusion: The guideline can be used to address stoma management in hospital settings. The intent of the guideline is to provide information that will assist healthcare providers to manage adult patients with ostomies, prevent or decrease complications, and improve patients' outcomes.