Guidelines for Safe Drug Use / 대한내과학회지

Background/Aims@#In Korea, medications are available by prescription from a physician, or can be purchased over-the-counter (OTC) without a prescription. Education regarding both prescribed and OTC drugs is important to minimize side effects and avoid drug abuse. The risk of side effects due to polypharmacy is increasing due to the growing number of elderly patients with comorbidities. @*Methods@#There are various clinical guidelines for physicians, but it is difficult for patients and their caregivers to find published guidelines regarding drug use. In this regard, experts from nine subspecialties of internal medicine, geriatric medicine, and guideline development methodology formed a working group to develop guidelines for safe drug use under the Clinical Practice Guidelines Committee of the Korean Association of Internal Medicine. @*Results@#The main contents of this guideline are 1) safe and effective drug administration, 2) the proper use of analgesics (acetaminophen and nonsteroidal anti-inflammatory drugs), 3) the proper use of tranquilizers and sleeping pills to prevent drug abuse, 4) points to be aware of when taking multiple medications. @*Conclusions@#The guidelines were developed for patients and their caregivers to understand the general principles and precautions for drug use, including commonly used painkillers, mood stabilizers, sleeping pills, and polypharmacy. These guidelines could also be used as educational materials for physicians, nurses, and healthcare workers to educate patients and their caregivers.

Guidelines for Safe Drug Use / 대한내과학회지

Background/Aims@#In Korea, medications are available by prescription from a physician, or can be purchased over-the-counter (OTC) without a prescription. Education regarding both prescribed and OTC drugs is important to minimize side effects and avoid drug abuse. The risk of side effects due to polypharmacy is increasing due to the growing number of elderly patients with comorbidities. @*Methods@#There are various clinical guidelines for physicians, but it is difficult for patients and their caregivers to find published guidelines regarding drug use. In this regard, experts from nine subspecialties of internal medicine, geriatric medicine, and guideline development methodology formed a working group to develop guidelines for safe drug use under the Clinical Practice Guidelines Committee of the Korean Association of Internal Medicine. @*Results@#The main contents of this guideline are 1) safe and effective drug administration, 2) the proper use of analgesics (acetaminophen and nonsteroidal anti-inflammatory drugs), 3) the proper use of tranquilizers and sleeping pills to prevent drug abuse, 4) points to be aware of when taking multiple medications. @*Conclusions@#The guidelines were developed for patients and their caregivers to understand the general principles and precautions for drug use, including commonly used painkillers, mood stabilizers, sleeping pills, and polypharmacy. These guidelines could also be used as educational materials for physicians, nurses, and healthcare workers to educate patients and their caregivers.

The effect of alcohol dose on the development of hypertension in Asian and Western men: systematic review and meta-analysis

Background/Aims@#There are inconsistencies in the effects of low to moderate dose alcohol consumption on the development of hypertension in adult men. We hypothesized that a region-specific effect might participate in this heterogeneity. @*Methods@#We conducted a systematic review and meta-analysis to evaluate the effect of alcohol dose on hypertension incidence using contemporary data through December 2017. Subjects were categorized according to their level of alcohol consumption as non-drinkers (reference) and low- (0.01 to 20.0 g/day), moderate- (20.1 to 40.0 g/day), moderate- to high- (40.1 to 60.0 g/day), and high-dose (> 60.0 g/day) drinkers. We defined hypertension as a blood pressure ≥ 140/90 mmHg and/or the use of anti- hypertensive drugs. @*Results@#In total, 11 articles (seven Asian and four Western) were selected for our analysis. Among Asian men, a significantly elevated risk was observed even in the low alcohol dose group in comparison with the group with no alcohol consumption, and the risk increased in a dose-dependent manner (pooled relative risks [95% confidence intervals (CI)]: 1.25 [1.13 to 1.38], 1.48 [1.27 to 1.72], 1.75 [1.43 to 2.15], and 1.78 [1.51 to 2.09]). Among Western men, a similar dose-response relationship was noted in general (p for subgroup difference > 0.1), but a significantly elevated risk was evident only in the high-dose group (pooled relative risks [95% CI]: 1.22 [0.85 to 1.74], 1.57 [0.90 to 2.75], 1.47 [0.44 to 4.91], and 1.49 [1.02 to 2.18]). @*Conclusions@#Even low doses of alcohol can lead to the development of hypertension, particularly in Asian men. Our findings could serve as additional evidence for developing an appropriate preventive strategy in each region.

Effectiveness of Exercise Intervention in Reducing Body Weight and Glycosylated Hemoglobin Levels in Patients with Type 2 Diabetes Mellitus in Korea: A Systematic Review and Meta-Analysis

BACKGROUND: This study aimed to assess the effectiveness of exercise intervention in reducing body weight and glycosylated hemoglobin (HbA1c) level in patients with type 2 diabetes mellitus (T2DM) in Korea. METHODS: Cochrane, PubMed, Embase, KoreaMed, KMbase, NDSL, KCI, RISS, and DBpia databases were used to search randomized controlled trials and controlled clinical trials that compared exercise with non-exercise intervention among patients with non-insulin-treated T2DM in Korea. The effectiveness of exercise intervention was estimated by the mean difference in body weight changes and HbA1c level. Weighted mean difference (WMD) with its corresponding 95% confidence interval (CI) was used as the effect size. The pooled mean differences of outcomes were calculated using a random-effects model. RESULTS: We identified 7,692 studies through literature search and selected 23 articles (723 participants). Compared with the control group, exercise intervention (17 studies) was associated with a significant decline in HbA1c level (WMD, −0.58%; 95% CI, −0.89 to −0.27; I 2=73%). Although no significant effectiveness on body weight was observed, eight aerobic training studies showed a significant reduction in body weight (WMD, −2.25 kg; 95% CI, −4.36 to −0.13; I 2=17%) in the subgroup analysis. CONCLUSION: Exercise significantly improves glycemic control; however, it does not significantly reduce body weight. Aerobic training can be beneficial for patients with non-insulin-treated T2DM in Korea.

Determinants Used to Justify the Strength of Recommendations among Korean Clinical Practice Guidelines

BACKGROUND: A standardized systematic approach to grade evidence and the strength of recommendations is important for guideline users to minimize bias and help interpret the most suitable decisions at the point of care. The study aims to identify and classify determinants used to make judgement for the strength of recommendations among 56 Korean clinical practice guidelines (CPGs), and explore strong recommendations based on low quality of evidence. METHODS: Determinants used in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach among 34 CPGs which have reported both strength of recommendations and level of evidence were reviewed. RESULTS: Five of 34 CPGs (14.7%) considered quality of evidence, benefits and harms, patients' values and preferences, and costs. And 24 of 34 CPGs (70.6%) considered both magnitude of effect and feasibility as additional determinants. Judgement table was not widely provided for use to translate evidence into recommendations. Eighty-two of 121 recommendations (67.8%, ranged 20.0% to 100.0%) among 11 CPGs using the same judgement scheme showed ‘strong’ strength of recommendations based on low or very low quality of evidence. Among 5 paradigmatic situations that justify strong recommendations based on low or very low evidence, situation classified as ‘potential equivalence, one option clearly less risky or costly’ was 87.8% for 82 strong recommendations. Situation classified as ‘uncertain benefit, certain harm’ was 4.9%. CONCLUSION: There is a need to introduce and systematize an evidence-based grading system. Using judgement table to justify the strength of recommendations and applying the 5 paradigmatic situations mentioned above is also recommended in the near future.

Methodological Quality Appraisal of 27 Korean Guidelines Using a Scoring Guide Based on the AGREE II Instrument and a Web-based Evaluation

This study evaluated the methodological quality of CPGs using the Korean AGREE II scoring guide and a web-based appraisal system and was conducted by qualified appraisers. A total of 27 Korean CPGs were assessed under 6 domains and 23 items on the AGREE II instrument using the Korean scoring guide. The domain scores of the 27 guidelines were as following: the mean domain score was 82.7% (median 84.7%, ranging from 55.6% to 97.2%) for domain 1 (scope and purpose); 53.4% (median 56.9%, ranging from 11.1% to 95.8%) for domain 2 (stakeholder involvement); 63.0% (median 71.4%, ranging from 13.5% to 90.6%) for domain 3 (rigor of development); 88.9% (median 91.7%, ranging from 58.3% to 100.0%) for domain 4 (clarity of presentation); 30.1% (median 27.1%, ranging from 3.1% to 67.7%) for domain 5 (applicability); and 50.2% (median 58.3%, ranging from 0.0% to 93.8%) for domain 6 (editorial independence). Three domains including scope and purpose, rigor of development, and clarity of presentation were rated at more than 60% of the scaled domain score. Three domains including stakeholder involvement, applicability, and editorial independence were rated at less than 60% of the scaled domain score. Finally, of the 27 guidelines, 18 (66.7%) were rated at more than 60% of the scaled domain score for rigor of development and were categorized as high-quality guidelines.

Clinical Practice Guideline of Acute Respiratory Distress Syndrome / 결핵및호흡기질환

There is no well-stated practical guideline for mechanically ventilated patients with or without acute respiratory distress syndrome (ARDS). We generate strong (1) and weak (2) grade of recommendations based on high (A), moderate (B) and low (C) grade in the quality of evidence. In patients with ARDS, we recommend low tidal volume ventilation (1A) and prone position if it is not contraindicated (1B) to reduce their mortality. However, we did not support high-frequency oscillatory ventilation (1B) and inhaled nitric oxide (1A) as a standard treatment. We also suggest high positive end-expiratory pressure (2B), extracorporeal membrane oxygenation as a rescue therapy (2C), and neuromuscular blockage for 48 hours after starting mechanical ventilation (2B). The application of recruitment maneuver may reduce mortality (2B), however, the use of systemic steroids cannot reduce mortality (2B). In mechanically ventilated patients, we recommend light sedation (1B) and low tidal volume even without ARDS (1B) and suggest lung protective ventilation strategy during the operation to lower the incidence of lung complications including ARDS (2B). Early tracheostomy in mechanically ventilated patients can be performed only in limited patients (2A). In conclusion, of 12 recommendations, nine were in the management of ARDS, and three for mechanically ventilated patients.

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

The Korean Society of Neurogastroenterology and Motility first published guidelines for chronic constipation in 2005 and was updated in 2011. Although the guidelines were updated using evidence-based process, they lacked multidisciplinary participation and did not include a diagnostic approach for chronic constipation. This article includes guidelines for diagnosis and treatment of chronic constipation to realistically fit the situation in Korea and to be applicable to clinical practice. The guideline development was based upon the adaptation method because research evidence was limited in Korea, and an organized multidisciplinary group carried out systematical literature review and series of evidence-based evaluations. Six guidelines were selected using the Appraisal of Guidelines for Research & Evaluation (AGREE) II process. A total 37 recommendations were adopted, including 4 concerning the definition and risk factors of chronic constipation, 8 regarding diagnoses, and 25 regarding treatments. The guidelines are intended to help primary physicians and general health professionals in clinical practice in Korea, to provide the principles of medical treatment to medical students, residents, and other healthcare professionals, and to help patients for choosing medical services based on the information. These guidelines will be updated and revised periodically to reflect new diagnostic and therapeutic methods.

Clinical Practice Guideline of Acute Respiratory Distress Syndrome / 대한중환자의학회지

There is no well-stated practical guideline for mechanically ventilated patients with or without acute respiratory distress syndrome (ARDS). We generate strong (1) and weak (2) grade of recommendations based on high (A), moderate (B) and low (C) grade in the quality of evidence. In patients with ARDS, we recommend low tidal volume ventilation (1A) and prone position if it is not contraindicated (1B) to reduce their mortality. However, we did not support high-frequency oscillatory ventilation (1B) and inhaled nitric oxide (1A) as a standard treatment. We also suggest high positive end-expiratory pressure (2B), extracorporeal membrane oxygenation as a rescue therapy (2C), and neuromuscular blockage for 48 hours after starting mechanical ventilation (2B). The application of recruitment maneuver may reduce mortality (2B), however, the use of systemic steroids cannot reduce mortality (2B). In mechanically ventilated patients, we recommend light sedation (1B) and low tidal volume even without ARDS (1B) and suggest lung protective ventilation strategy during the operation to lower the incidence of lung complications including ARDS (2B). Early tracheostomy in mechanically ventilated patients can be performed only in limited patients (2A). In conclusion, of 12 recommendations, nine were in the management of ARDS, and three for mechanically ventilated patients.

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition / 대한내과학회지

The Korean Society of Neurogastroenterology and Motility first published guidelines for chronic constipation in 2005 and was updated in 2011. Although the guidelines were updated using evidence-based process, they lacked multidisciplinary participation and did not include a diagnostic approach for chronic constipation. This study includes guidelines for diagnosis and treatment of chronic constipation to realistically fit the situation in Korea and to be applicable to clinical practice. The guideline development was based upon the adaptation method because research evidence was limited in Korea, and an organized multidisciplinary group carried out systematical literature review and series of evidence-based evaluations. Six guidelines were selected using the Appraisal of Guidelines for Research & Evaluation II process. A total 37 recommendations were adopted, including 4 concerning the definition and risk factors of chronic constipation, 8 regarding diagnoses, and 25 regarding treatments. The guidelines are intended tohelp primary physicians and general health professionals in clinical practice in Korea, to provide the principles of medical treatment to medical students, residents, and other healthcare professionals, and to help patients for choosing medical services based on the information. These guidelines will be updated and revised periodically to reflect new diagnostic and therapeutic methods.

Clinical Practice Guideline of Acute Respiratory Distress Syndrome / 대한구급학회지

There is no well-stated practical guideline for mechanically ventilated patients with or without acute respiratory distress syndrome (ARDS). We generate strong (1) and weak (2) grade of recommendations based on high (A), moderate (B) and low (C) grade in the quality of evidence. In patients with ARDS, we recommend low tidal volume ventilation (1A) and prone position if it is not contraindicated (1B) to reduce their mortality. However, we did not support high-frequency oscillatory ventilation (1B) and inhaled nitric oxide (1A) as a standard treatment. We also suggest high positive end-expiratory pressure (2B), extracorporeal membrane oxygenation as a rescue therapy (2C), and neuromuscular blockage for 48 hours after starting mechanical ventilation (2B). The application of recruitment maneuver may reduce mortality (2B), however, the use of systemic steroids cannot reduce mortality (2B). In mechanically ventilated patients, we recommend light sedation (1B) and low tidal volume even without ARDS (1B) and suggest lung protective ventilation strategy during the operation to lower the incidence of lung complications including ARDS (2B). Early tracheostomy in mechanically ventilated patients can be performed only in limited patients (2A). In conclusion, of 12 recommendations, nine were in the management of ARDS, and three for mechanically ventilated patients.

Development of Quality Management Systems for Clinical Practice Guidelines in Korea

This study introduces the Clinical practice guidelines (CPGs) appraisal system by the Korean Academy of Medical Sciences (KAMS). Quality management policies for CPGs vary among different countries, which have their own cultures and health care systems. However, supporting developers in guideline development and appraisals using standardized tools are common practices. KAMS, an organization representing the various medical societies of Korea, has been striving to establish a quality management system for CPGs, and has established a CPGs quality management system that reflects the characteristics of the Korean healthcare environment and the needs of its users. KAMS created a foundation for the development of CPGs, set up an independent appraisal organization, enacted regulations related to the appraisals, and trained appraisers. These efforts could enhance the ability of each individual medical society to develop CPGs, to increase the quality of the CPGs, and to ultimately improve the quality of the information available to decision-makers.

Developing a Scoring Guide for the Appraisal of Guidelines for Research and Evaluation II Instrument in Korea: A Modified Delphi Consensus Process

Korea has a relatively short history in the development and use of clinical practice guidelines (CPGs). Additionally, it has been difficult to employ the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument due to the lack of consensus and the presence of differences in Korean medical settings and in the Korean socio-cultural environment. An AGREE II scoring guide was therefore developed to reduce differences among evaluators using the same tool. In consideration of the importance of using a quantitative measure of satisfaction with the elements described in the AGREE II manual, a final draft was developed through a Delphi consensus process. Ninety-two draft scoring guides for anchor points 1, 3, 5, and 7 (full score) in 23 items were developed. Consensus was defined as agreement among at least 70% of the raters. Agreement on 88 draft scoring guidelines was reached in the first Delphi round, and agreement for the remaining four was achieved in the second round. The development of an AGREE II scoring guide in this study is expected to contribute to improving the CPG environment.

Guidelines for the Diagnosis and Treatment of Helicobacter pylori Infection in Korea, 2013 Revised Edition / 대한소화기학회지

Since the Korean College of Helicobacter and Upper Gastrointestinal Research has first developed the guideline for the diagnosis and treatment of Helicobacter pylori infection in 1998, the revised guideline was proposed in 2009 by the same group. Although the revised guideline was made by comprehensive review of previous articles and consensus of authoritative expert opinions, the evidence-based developmental process was not applied in the revision of the guideline. This new guideline has been revised especially in terms of changes in the indication and treatment of H. pylori infection in Korea, and developed by the adaptation process as evidence-based method; 6 guidelines were retrieved by systematic review and the Appraisal of Guidelines for Research and Evaluation (AGREE) II process, 21 statements were made with grading system and revised by modified Delphi method. After revision, 11 statements for the indication of test and treatment, 4 statements for the diagnosis and 4 statements for the treatment have been developed, respectively. The revised guideline has been reviewed by external experts before the official endorsement, and will be disseminated for usual clinical practice in Korea. Also, the scheduled update and revision of the guideline will be made periodically.

Updated Guidelines 2012 for Gastroesophageal Reflux Disease / 대한소화기학회지

In 2010, a Korean guideline for the management of gastroesophageal reflux disease (GERD) was made by the Korean Society of Neurogastroenterology and Motility, in which the definition and diagnosis of GERD were not included. The aim of this guideline was to update the clinical approach to the diagnosis and management of GERD in adult patients. This guideline was developed by the adaptation process of the ADAPTE framework. Twelve guidelines were retrieved from initial queries through the Appraisal of Guidelines for Research & Evaluation II process. Twenty-seven statements were made as a draft and revised by modified Delphi method. Finally, 24 consensus statements for the definition (n=4), diagnosis (n=7) and management (n=13) of GERD were developed. Multidisciplinary experts participated in the development of the guideline, and the external review of the guideline was conducted at the finalization phase.

Trends in the development of and emerging tasks of clinical practice guidelines in Korea

Clinical practice guidelines (CPGs) have been developed by the members of the Korean Academy of Medical Science (KAMS) under the limited financial support of the Ministry of Health & Welfare and partnership organizations including the 11 Clinical Research Centers of the National Evidence-based Healthcare Collaborating Agency (NECA) in Korea. The Korean Medical Guideline Information Center (KoMGi), a database of evidence-based CPGs, opened on January, 2008, and it is a very useful nationwide dissemination tool of CPGs for health professionals. The following is a summary of emerging tasks related to CPGs in Korea. First, a strategy for efficient partnership between the private sector and government should be formulated and executed. Second, budget preparation and planning of financial support is needed for developing and disseminating evidence-based CPGs. Third, development of Korean-specific methodology is needed and technical support should be provided. Fourth, an educational training program should be developed for core confidence of guideline development groups. Fifth, to share current information and accelerate the dissemination of CPGs, the functions of Guideline Information Center should be reorganized and utilized. To develop highly applicable evidence-based CPGs, multidisciplinary communication and active participation among professional societies is desired.

Trend analysis of grading systems for level of evidence and strength of recommendation

When clinicians or healthcare professionals are to make decisions, they can judge the quality of evidence and reliability of recommendations by 'Level of evidence' and 'Grade of recommendation'. Because of this, the step of grading evidence and recommendations is very important in developing clinical practice guidelines. The objective of this study was to identify the various grading systems and criteria of the clinical practice guidelines. We reviewed 101 guidelines from the National Guideline Clearinghouse Database and chose 66 sets of guidelines to analyze in terms of the grading systems for level of evidence and strength of recommendation. The grading systems for 'Level of evidence' were classified into 4 types by criteria such as study design, study quality, consistency, limitations, strength of evidence, and validity. Type II was the most common evidence grading system applied by 12 organizations (37.5%) and 30 sets of guidelines (45.5%). The grading systems for 'Grade of recommendation' were classified into 4 types by criteria such as level/quality of evidence, strength of recommendations, study quality, consistency, applicability, balance between benefit and harm, and effectiveness/usefulness. Type I was the most common recommendation grading system applied by 9 organizations (33.4%) and 23 sets of guidelines (40.4%). A formal grading system based on consistent and clear approaches is needed because the process of grading work can be subjective when clinical practice guideline users are making decisions. It is necessary for clinical practice guideline developers to have a common criterion so that they can judge the grade of evidence and recommendations objectively in the development of clinical practice guidelines.

Tools for assessing quality and risk of bias by levels of evidence

Tools for assessing methodological quality or risk of bias in randomized controlled trials (RCTs) and non-randomized studies (NRS) were reviewed. The van Tulder scale and Cochrane's assessment of risk of bias are the two most useful methodological quality evaluation tools for RCTs. Cochrane's tool includes sequence generation, allocation of sequence concealment, blinding, incomplete outcome data, selective outcome reporting, and other potential sources of bias. The Cochrane Collaboration Group recommends the Downs and Black instrument and the Newcastle-Ottawa Scale for evaluating the quality of NRS. In conclusion, this study offers useful information to physicians about tools for assessing the quality of evidence in clinical guidelines. Further research is needed to provide an essential core for evidence-based decision making regarding levels and/or grades of recommendations.

Predictors of Successful Control for Selfishness, Dishonesty, Resentment, and Fear (SDRF) among Korean Alcoholics Anonymous Members / 예방의학회지

OBJECTIVES: To examine predictors of successful control for selfishness, dishonesty, resentment, and fear(SDRF) among Korean Alcoholics Anonymous(AA) members. METHODS: This study was a cross-sectional study. The study group included members from 18 different AA groups which were enrolled in the Korean AA Association in 1998. 207 out of 300 self administered questionnaires were completed by AA members (response rate 69.0%). Alcoholics who attended AA meetings were divided into two groups according to their self reported level of success in SDRF control; one with very successful experience after AA participation and the other with little or no success. In this study, the general characteristics, AA activities, relapse experience, and degree of effort exerted for SDRF control were compared between two groups. In order to study predictors of successful SDRF control after joining AA, 4 logistic regression analyses were performed for each of the 4 SDRF indices. RESULTS: The proportion of those reporting a very successful experience was 19.9% for selfishness, 20.7% for dishonesty, 25.5% for resentment, and 24.7% for fear. After control for the effect of general characteristics, the practice of the 12th step(taking alcoholics to an AA meeting after conveying messages) was found to be a significant predictor for the successful control of both selfishness(OR=6.04) and the dishonesty(OR=7.77). And individuals making every effort for SDRF control showed more successful control of selfishness(OR=4.10), dishonesty(OR=4.01), and fear(OR=34.89). CONCLUSIONS: Bivariate and multivariate analyses demonstrated that especially practicing the 12th step and making every effort themselves, may help alcoholics to control SDRF successfully after joining AA.