신의료기술 안전성·유효성 검증을 위한 체계적문헌 고찰

이선희,최원정 대한의사협회 2012 대한의사협회지 Vol.55 No.3

We used a systematic review to evaluate the safety and effectiveness of a new health technology in Korea. The results of the systematic review are being used by the Health Insurance Review and Assessment Service when the Ministry of Health and Welfare introduces new medical technology. The purpose of this study is to introduce this systematic review, which is the main methodology for evaluating the safety and effectiveness of new medical technology, and to share our experience of performing a systematic review to guide the reader in performing a systematic literature review accurately and easily. This paper presents the process of new health technology evaluation using a systematic review. A systematic review involves collecting current available evidence of health technology systematically. According to the evaluation process, in the first meeting of sub-committee, we develop a systematic review protocol including PICO and criteria for inclusion/exclusion. In the second meeting of sub-committee, we search comprehensively for appropriate literature according to the clinical question and to select in a clear and reproducible method. We also assess study quality, considering the internal validity and external validity of the selected literature, and make a table of extracted data. In the third meeting of subcommittee,we extract general information, study characteristics information, and study outcome information, and synthesize the outcomes. In the forth meeting of sub-committee, we finalize the conclusions based on synthesizing the studies. After the subcommittees’ assessments, the results are presented to the Committee for New Health Technology. Finally, we report this result to the Ministry of Health and Welfare. The systematic review is useful for helping policymakers make decisions about the introduction of new health technology based on evidence. It enables people to minimize confusion due to weak evidence for health technology. In case of domestically developed technology and technology for rare disease, it is difficult assess health technology due to a lack of evidence, so assessing raw data (charts, results of clinical trials) is needed in addition to a systematic review. Furthermore, the government should support clinical studies to develop evidence on new health technologies with potential benefit, and the introduction of a conditional coverage decision in the new health technology assessment system is necessary to deal with uncertainty.

Status quo of systematic reviews published in high-impact journals in Korea: A study focused on protocol registration and GRADE use

Han Mi Ah,김성중,Hwang Eu Chang,Jung Jae Hung 한국역학회 2022 Epidemiology and Health Vol.44 No.-

OBJECTIVES: This study investigated the status quo of systematic reviews published in major journals in Korea from the perspective of protocol registration and adopting the grading of recommendation, assessment, development and evaluation (GRADE) system. METHODS: We examined systematic reviews published in Korea’s top 15 medical journals from 2018 to 2021. Teams of two reviewers assessed the study eligibility criteria and extracted data independently and in duplicate. We collected the information on study characteristics, protocol registration, GRADE use of reviews included, and reviewed the “Instructions to Authors” of the selected journals to assess any guidance related to systematic reviews. RESULTS: Out of the 126 identified reviews, 18 (14.3%) reported that they registered or published their protocol. Only 5 (4.0%) rated the certainty of evidence; and all 5 used the GRADE system. Only 6 of 15 journals mentioned systematic reviews in their “Instructions for Authors.” Six journals endorsed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for systematic review reporting; however, 2 were mandatory, 3 were recommended, and 1 was unclear. None of the journals included mentioned protocol registration or certainty of evidence in their authors’ guidelines. CONCLUSIONS: Overall, the proportion of prior protocol registration of systematic reviews and adoption of the GRADE approach to rate the certainty of evidence was very low. Our study highlights the adherence to the systematic review standards of medical journals in Korea, including a prior protocol registration and certainty of evidence assessment. Our review helps improve the quality of systematic reviews in Korea.

STRICTA 권장안에 기초한 침 연구방법론의 적절성 평가 - 새로운 평가지수를 이용한 5편 Systematic Review와 그 대상인 58편 무작위대조시험의 고찰 -

김우영,이승덕,임병묵,김갑성 대한침구의학회 2007 대한침구의학회지 Vol.24 No.5

Backgraounds : Recent studies provide the evidences that the efficacy of acupuncture may be no better than placebo or inconclusive. These results are very different from those of the actual clinical situations in many acupuncture medical institutions. Objectives : The present study was designed to evaluate the influencing factors which affect the efficacy of acupuncture scale(FEAS) as the methodological assessment tool of acupuncture for examining acupuncture interventions and to demonstrate the importance of it in randomized controlled trials of acupuncture. Data sources : Electronic data were retrieved from NDSL, Pubmed, sciencedirect, LWW, OVID, Black- Well Synergy, Wiley Interscience, EBSCO HOST, springer, PML, and Kluwer. No electronic data were collected from MEDLIS and MEDLAS. Study selection : The inclusion criteria were five systematic reviews included in Alberta study and all randomized controlled trials obtained from their references. Study analysis : The acupuncture rationale, methods of stimulation, treatment regimen, and the prac- titioner’s background were rated by FEAS, and the scores were compared with those by other methodo- logical assessment tools. Results : The number of positive conclusions of high-rank RCTs by FEAS was the same as or higher than that of high-rank RCTs by other methodological assessment tools. Conclusions : We have analysed 5 systematic reviews and their objectives 58 RCTs using FEAS. Prac- titioner’s background has been described slightly in some reviews and studies. It may directly influence the effectiveness of acupuncture negatively in the systematic reviews. Backgraounds : Recent studies provide the evidences that the efficacy of acupuncture may be no better than placebo or inconclusive. These results are very different from those of the actual clinical situations in many acupuncture medical institutions. Objectives : The present study was designed to evaluate the influencing factors which affect the efficacy of acupuncture scale(FEAS) as the methodological assessment tool of acupuncture for examining acupuncture interventions and to demonstrate the importance of it in randomized controlled trials of acupuncture. Data sources : Electronic data were retrieved from NDSL, Pubmed, sciencedirect, LWW, OVID, Black- Well Synergy, Wiley Interscience, EBSCO HOST, springer, PML, and Kluwer. No electronic data were collected from MEDLIS and MEDLAS. Study selection : The inclusion criteria were five systematic reviews included in Alberta study and all randomized controlled trials obtained from their references. Study analysis : The acupuncture rationale, methods of stimulation, treatment regimen, and the prac- titioner’s background were rated by FEAS, and the scores were compared with those by other methodo- logical assessment tools. Results : The number of positive conclusions of high-rank RCTs by FEAS was the same as or higher than that of high-rank RCTs by other methodological assessment tools. Conclusions : We have analysed 5 systematic reviews and their objectives 58 RCTs using FEAS. Prac- titioner’s background has been described slightly in some reviews and studies. It may directly influence the effectiveness of acupuncture negatively in the systematic reviews.

Which is More Important in Useful Online Review? Heuristic-Systematic Model Perspective

정희정,이현애,정남호,구철모 한국지식경영학회 2018 지식경영연구 Vol.19 No.4

Hotel consumers tend to rely on online reviews to reduce the risk to hotel products when they book hotel rooms because hotel products are high-risk products due to their intangibility. However, the development of ICT has caused information load, and it is an important issue to be perceived as useful information to consumer because a large amount of information complicates the decision making process of consumers. Drawn from Heuristic-Systematic Model(HSM), the present study explored the role of heuristic a nd systematic c ues composing an online review i nfluencing consumers’ perception of hotel online reviews. More specifically, this study identified reviewers’ identity, level of the reviewer, review star ratings, and attached hotel photo as heuristic cue, while review length, cognitive level of review and negativity in review as systematic cues. The binary logistic regression was adopted for analysis. This study found that only systematic cues of online review were found to affect the usefulness of it. Moreover, we preceded further study examining the moderating effect of seasonality in the relationships between systematic cues and usefulness.

유용한 온라인 리뷰에서 어느 것이 더 중요한가? 휴리스틱-체계적 모델 관점

정희정 ( Hee Chung Chung ),이현애 ( Hyunae Lee ),정남호 ( Namho Chung ),구철모 ( Chulmo Koo ) 한국지식경영학회 2018 지식경영연구 Vol.19 No.4

Hotel consumers tend to rely on online reviews to reduce the risk to hotel products when they book hotel rooms because hotel products are high-risk products due to their intangibility. However, the development of ICT has caused information load, and it is an important issue to be perceived as useful information to consumer because a large amount of information complicates the decision making process of consumers. Drawn from Heuristic-Systematic Model(HSM), the present study explored the role of heuristic and systematic cues composing an online review influencing consumers’ perception of hotel online reviews. More specifically, this study identified reviewers’ identity, level of the reviewer, review star ratings, and attached hotel photo as heuristic cue, while review length, cognitive level of review and negativity in review as systematic cues. The binary logistic regression was adopted for analysis. This study found that only systematic cues of online review were found to affect the usefulness of it. Moreover, we preceded further study examining the moderating effect of seasonality in the relationships between systematic cues and usefulness.

코크란 체계적 문헌고찰 내의 침구치료 임상근거 현황고찰

김건형,노승희,이명수,양기영,신병철,김재규,이병렬 대한침구의학회 2011 대한침구의학회지 Vol.28 No.4

Objectives : The aim of this study is to overview the current status of Cochrane systematic review of acupuncture. Methods : Published Cochrane systematic reviews and protocols for evaluating acupuncture and/or moxibustion were searched by the terms ‘acupuncture’ and ‘moxibustion’ in Issue 1, Cochrane Library, 2011. Only reviews or protocols that regarded acupuncture or moxibustion as primary methods of intervention in their reviews were included. Data regarding first author national affiliation, intervention and disease, as well as the number of reviews or protocols that included Korean, Chinese, or Japanese databases in search strategies were obtained. Results : We found 92 hits at screening, and 59 studies were eligible for this review. Included interventions were acupuncture (n=56), auricular acupuncture (n=2), and moxibustion (n=1) for various diseases and conditions. The number of publications of Cochrane systematic reviews or protocols increased gradually from 2002 to 2011. First authors’ affiliations were located in China (n=32), Australia (n=8), UK (n=7), Canada (n=4), U.S. (n=4), Germany (n=2), Norway, (n=1) and Korea (n=1). 44, four and four Cochrane reviews adopted Chinese, Korean and Japanese databases, respectively. Conclusions : Search strategies in a substantial number of Cochrane reviews or protocols for acupuncture and moxibustion heavily relied on Chinese databases. Korean databases were underused in existing Cochrane reviews and protocols, and Korean authors were much less involved in the Cochrane systematic reviews or protocols than Chinese authors. Further studies need to be conducted in order to incorporate evidence of acupuncture reported in Korean databases into the Cochrane systematic reviews.

Patient- and family-centered care interventions for improving the quality of health care: A review of systematic reviews

Park, Myonghwa,Giap, Thi-Thanh-Tinh,Lee, Mihyun,Jeong, Hyun,Jeong, Miri,Go, Younghye Elsevier 2018 International journal of nursing studies Vol.87 No.-

<P><B>Abstract</B></P> <P><B>Background</B></P> <P>Patient- and family-centered care interventions are increasingly being implemented in various settings for improving the quality of health care. However, the huge amounts of information coming from both primary studies and reviews on patient- and family-centered care interventions have made it difficult to identify and use the available evidence effectively.</P> <P><B>Objectives</B></P> <P>This review aimed to synthesize and evaluate the evidence from published systematic reviews on the effects of patient- and family-centered care interventions. It also aimed to assess the quality of the systematic reviews in order to formulate recommendations for improving the quality of future systematic reviews.</P> <P><B>Design</B></P> <P>Review of systematic reviews.</P> <P><B>Data sources</B></P> <P>Six databases were searched for relevant published reviews that assessed patient- and family-centered care interventions and were reported on in English in peer-reviewed journals up to September 18, 2017. The reference lists of all selected publications were also used to identify additional eligible studies.</P> <P><B>Review methods</B></P> <P>Reviewers independently selected reviews, extracted data, and assessed the methodological quality of the included reviews using A MeaSurement Tool to Assess Systematic Reviews (AMSTAR) checklist. These results were presented and discussed among researchers to resolve disagreements and reach a consensus. A narrative approach was adopted to pool the constituent elements of interventions. The review protocol was registered with PROSPERO (registration number CRD42017080427).</P> <P><B>Results</B></P> <P>Twenty-eight reviews published between 2011 and 2017 met the inclusion criteria. The interventions targeted the patients, their family members, and the health-care. The interventions involved the following core outcomes: Regarding patients, they were improving knowledge about their health, increasing skills to manage self-care behaviors, enhancing satisfaction, increasing quality of life, and reducing admissions, readmissions, and length of the hospital stay. Regarding family members, they were reducing the intensity of stress, anxiety, depression, and increasing the satisfaction and relationship with health-care providers. Regarding health-care providers, the interventions could improve job satisfaction and confidence, quality of care, and reduce stress and burnout. The overall methodological quality of the 28 reviews was moderate, with a mean AMSTAR score of 6.79 (SD 1.45).</P> <P><B>Conclusion</B></P> <P>This review has provided evidence for the effects of patient- and family-centered care interventions applied to diverse patients, family members, and health-care providers. The evidence indicates that patient- and family-centered care could be a critical approach for improving the quality of health care. Additionally, the quality of future reviews needs to be improved in order to produce reliable evidence in the current era of evidence-based practice.</P>

체계적 문헌고찰 연구의 개요 및 체육학 분야의 적용사례

조정환(Junghwan Cho),송금주(Geumju Song) 한국체육측정평가학회 2015 한국체육측정평가학회지 Vol.17 No.3

체계적인 문헌고찰은 특정 연구 질문에 대한 답을 도출하기 위해 일차연구들을 구체적인 적격 기준(eligibility criteria) 에서 검토함으로서 실증적 근거들을 종합하려는 연구방법이다. 근거들을 종합하는 과정에서 명확하고 체계적인 방법을 적용하여 연구결과의 비뚤림(bias)을 최소화함으로써 제시된 문제에 대한 신뢰로운 해답을 얻고자 하는 데 있다. 과학적 근거에 기반을 둔 처치의 중요성에서 출발한 근거중심의학(evidence-based medicine)의 핵심적 연구방법이며, 오늘날에는 임상의료 보건정책뿐 아니라 사회과학 정책개발 평가에서도 주요한 연구방법으로 강조되고 있다. 최근 체육학분야에서도 근거기반의 체육정책 및 프로그램 개발평가의 필요성이 제기된 바(조정환, 2013) 있다. 갈수록 정책의 개발과 평가에서 타당한 연구방법의 중요성이 그만큼 강조된다는 의미이다. 체육학 분야에서는 그동안 소수의 체계적 문헌고찰 사례가 보고된 바 있지만 다수 연구자들에게 익숙하지 않은 연구방법이라 여겨진다. 본 고찰의 목적은 체계적문헌고찰 수행 방법에 대한 개요를 소개하고, 코크란 그룹(Cochrane group)에서 보고한 체육학 관련 체계적 문헌고찰들을 검토하여 국내 체육학 연구자들이 좀 더 쉽게 체계적 문헌고찰을 이해하고 수행하는데 도움을 주고자 한다. A systematic review is a research method to review all the empirical evidence that meets pre-defined eligibility criteria to answer a particular research question and provides reliable findings via explicit and systematic research process (identification, critical appraisal, and synthesis of evidence) aimed at minimizing bias. For this reason, the systematic review has played a critical role in evidence-based medicine and also used in policy development and evaluation area of social science as a major research methodology. Recently, physical education and sport science area also has started to discuss the need of systematic review for developing and evaluating physical education programs and policies, and a few systematic reviews have been published; however, it is still unfamiliar research methodology in the majority of researchers in the area. Therefore, the purpose of this review study is to provide a brief introduction about how to conduct systematic review and to introduce Cochrane systematic reviews with topics of physical education and sport science. This review study would provide helpful information for researchers in physical eduction and sport science area, Korea to understand the methodology of systematic review.

A Content Analysis of the Trends in Vision Research With Focus on Visual Search, Eye Movement, and Eye Track

Ye Lim Rhie,Ji Hyoun Lim,Myung Hwan Yun 대한인간공학회 2014 大韓人間工學會誌 Vol.33 No.1

Objective: This study aims to present literature providing researchers with insights on specific fields of research and highlighting the major issues in the research topics. A systematic review is suggested using content analysis on literatures regarding "visual search", "eye movement", and "eye track". Background: Literature review can be classified as "narrative" or "systematic" depending on its approach in structuring the content of the research. Narrative review is a traditional approach that describes the current state of a study field and discusses relevant topics. However, since literatures on specific area cover a broad range, reviewers inherently give subjective weight on specific issues. On the contrary, systematic review applies explicit structured methodology to observe the study trends quantitatively. Method: We collected meta-data of journal papers using three search keywords: visual search, eye movement, and eye track. The collected information contains an unstructured data set including many natural languages which compose titles and abstracts, while the keyword of the journal paper is the only structured one. Based on the collected terms, seven categories were evaluated by inductive categorization and quantitative analysis from the chronological trend of the research area. Results: Unstructured information contains heavier content on "stimuli" and "condition" categories as compared with structured information. Studies on visual search cover a wide range of cognitive area whereas studies on eye movement and eye track are closely related to the physiological aspect. In addition, experimental studies show an increasing trend as opposed to the theoretical studies. Conclusion: By systematic review, we could quantitatively identify the characteristic of the research keyword which presented specific research topics. We also found out that the structured information was more suitable to observe the aim of the research. Chronological analysis on the structured keyword data showed that studies on "physical eye movement" and "cognitive process" were jointly studied in increasing fashion. Application: While conventional narrative literature reviews were largely dependent on authors" instinct, quantitative approach enabled more objective and macroscopic views. Moreover, the characteristics of information type were specified by comparing unstructured and structured information. Systematic literature review also could be used to support the authors" instinct in narrative literature reviews.

A Systematic Review of Randomized Controlled Trials of Antibiotic Use in Diabetic Foot Ulcer Infections: Focus on Clinical Cure

Pratama Vincent,Risni Hindun Wilda,Yunir Em,Sauriasari Rani 대한감염학회 2022 Infection and Chemotherapy Vol.54 No.1

Background The use of antibiotics in diabetic foot ulcer infections (DFUI) is essential in reducing morbidity. Optimal administration of antibiotics can improve clinical outcomes and reduce the risk of antibiotic resistance. This study aims to review the efficacy, in terms of clinical cure, of various regimens and the duration of antibiotic administration in DFUI patients, based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The efficacy based on microbiological response is also reviewed as the secondary outcome. Materials and Methods We used three databases, namely PubMed, Scopus, and ScienceDirect, to search for randomized controlled trials (RCTs) in patients with DFUI who required antibiotics. Results A total of 16 studies were included in the systematic review. The study locations and bacterial patterns varied, with the most common pathogen being Staphylococcus aureus. Most studies did not demonstrate a significant difference in clinical cure and pathogen eradication, either in the comparison between systemic and topical antibiotics or in the duration of administration. Some studies had similar characteristics and were analyzed to conclude. These studies showed that ertapenem had comparable efficacy to piperacillin/tazobactam. Similar results were also conducted from studies of piperacillin-tazobactam+amoxicillin-clavulanic acid vs. moxifloxacin. Conclusion Most studies have heterogeneous characteristics, possibly due to differences in research location. Therefore, there is no strong evidence to recommend a specific antibiotic with the highest efficacy. However, since all included studies are RCTs, this review provides a good summary in considering antibiotic choices when treating DFUI patients. Background The use of antibiotics in diabetic foot ulcer infections (DFUI) is essential in reducing morbidity. Optimal administration of antibiotics can improve clinical outcomes and reduce the risk of antibiotic resistance. This study aims to review the efficacy, in terms of clinical cure, of various regimens and the duration of antibiotic administration in DFUI patients, based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The efficacy based on microbiological response is also reviewed as the secondary outcome. Materials and Methods We used three databases, namely PubMed, Scopus, and ScienceDirect, to search for randomized controlled trials (RCTs) in patients with DFUI who required antibiotics. Results A total of 16 studies were included in the systematic review. The study locations and bacterial patterns varied, with the most common pathogen being Staphylococcus aureus. Most studies did not demonstrate a significant difference in clinical cure and pathogen eradication, either in the comparison between systemic and topical antibiotics or in the duration of administration. Some studies had similar characteristics and were analyzed to conclude. These studies showed that ertapenem had comparable efficacy to piperacillin/tazobactam. Similar results were also conducted from studies of piperacillin-tazobactam+amoxicillin-clavulanic acid vs. moxifloxacin. Conclusion Most studies have heterogeneous characteristics, possibly due to differences in research location. Therefore, there is no strong evidence to recommend a specific antibiotic with the highest efficacy. However, since all included studies are RCTs, this review provides a good summary in considering antibiotic choices when treating DFUI patients.