A Reporting Tool for Adapted Guidelines in Health Care: The RIGHT-Ad@pt Checklist.

BACKGROUND: Adaptation of existing guidelines can be an efficient way to develop contextualized recommendations. Transparent reporting of the adaptation approach can support the transparency and usability of the adapted guidelines. OBJECTIVE: To develop an extension of the RIGHT (Reporting Items for practice Guidelines in HealThcare) statement for the reporting of adapted guidelines (including recommendations that have been adopted, adapted, or developed de novo), the RIGHT-Ad@pt checklist. DESIGN: A multistep process was followed to develop the checklist: establishing a working group, generating an initial checklist, optimizing the checklist (through an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review, and a final assessment of adapted guidelines), and approval of the final checklist by the working group. SETTING: International collaboration. PARTICIPANTS: A total of 119 professionals participated in the development process. MEASUREMENTS: Participants' consensus on items in the checklist. RESULTS: The RIGHT-Ad@pt checklist contains 34 items grouped in 7 sections: basic information (7 items); scope (6 items); rigor of development (10 items); recommendations (4 items); external review and quality assurance (2 items); funding, declaration, and management of interest (2 items); and other information (3 items). A user guide with explanations and real-world examples for each item was developed to provide a better user experience. LIMITATION: The RIGHT-Ad@pt checklist requires further validation in real-life use. CONCLUSION: The RIGHT-Ad@pt checklist has been developed to improve the reporting of adapted guidelines, focusing on the standardization, rigor, and transparency of the process and the clarity and explicitness of adapted recommendations. PRIMARY FUNDING SOURCE: None.

The protective effect of alcohol consumption on the incidence of cardiovascular diseases: is it real? A systematic review and meta-analysis of studies conducted in community settings.

BACKGROUND: This study investigated the dose-response relationship between alcohol consumption and CVD incidence, conducting a meta-analysis of studies focusing on residents from local communities. Further, we examined whether light to moderate alcohol consumption had a protective effect on CVD incidence through a sub-group analysis. METHODS: This study conducted a meta-analysis of the relationship between alcohol consumption and CVD incidence, selecting journals published up to December 2017. The alcohol consumption level was classified into non-consumers, light (0.01-10.0 g/day), light to moderate (10.1-20.0 g/day), moderate (20.1-40.0 g/day), moderate to high (40.1-60.0 g/day), and high (> 60.0 g/day) groups. The sub-group analysis was conducted according to the number of comorbidities and age. RESULTS: Seven articles were selected in total for the meta-analysis. The mean Newcastle-Ottawa scale score was 8.14 points, suggesting studies were of high quality. There was a J-shaped dose-response relationship between alcohol consumption level and CVD incidence only in men. In general, light to moderate and moderate consumption lowered CVD incidence (Relative risk (RR) [95% confidence interval (CI)] was 0.68 [0.57-0.81] and 0.72 [0.58-0.90], respectively). In men with 3-4 comorbidities, there were no protective effects of light to moderate and moderate consumption on CVD incidence. In either groups of only men or men and women there were protective effects of light to moderate and moderate consumption on CVD incidence only in those aged between 41 and 65. DISCUSSION: We found that light to moderate and moderate alcohol consumption had a protective effect on CVD incidence, there was no protective effect either in those with at least three comorbidities or people aged 40 or younger. CONCLUSIONS: We conclude that not all local community residents experience a protective effect of light to moderate consumption on CVD incidence. As such, it is necessary to recommend a moderate amount of drinking or less for each individual.

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]). CONCLUSION: 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; I²=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; I²=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.

Clinical Practice Guideline of Acute Respiratory Distress Syndrome.

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.

Massage with or without aromatherapy for symptom relief in people with cancer.

BACKGROUND: Massage and aromatherapy massage are used to relieve cancer-related symptoms. A number of claims have been made for these treatments including reduction of pain, anxiety, depression, and stress. Other studies have not shown these benefits. OBJECTIVES: To evaluate the effects of massage with or without aromatherapy on pain and other symptoms associated with cancer. SEARCH METHODS: We searched the following databases and trials registries up to August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 7), MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), PubMed Cancer Subset, SADCCT, and the World Health Organization (WHO) ICTRP. We also searched clinical trial registries for ongoing studies. SELECTION CRITERIA: Randomised controlled studies (RCTs) reporting the effects of aromatherapy or massage therapy, or both, in people with cancer of any age. We applied no language restrictions. Comparators were massage (using carrier oil only) versus no massage, massage with aromatherapy (using carrier oil plus essential oils) versus no massage, and massage with aromatherapy (using carrier oil plus essential oils) versus massage without aromatherapy (using carrier oil only). DATA COLLECTION AND ANALYSIS: At least two review authors selected studies, assessed the risk of bias, and extracted data relating to pain and other symptoms associated with cancer, using standardised forms. We assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created two 'Summary of findings' tables. MAIN RESULTS: We included 19 studies (21 reports) of very low quality evidence with a total of 1274 participants. We included 14 studies (16 reports) in a qualitative synthesis and five studies in a quantitative synthesis (meta-analysis). Thirteen studies (14 reports, 596 participants) compared massage with no massage. Six studies (seven reports, 561 participants) compared aromatherapy massage with no massage. Two studies (117 participants) compared massage with aromatherapy and massage without aromatherapy. Fourteen studies had a high risk of bias related to sample size and 15 studies had a low risk of bias for blinding the outcome assessment. We judged the studies to be at unclear risk of bias overall. Our primary outcomes were pain and psychological symptoms. Two studies reported physical distress, rash, and general malaise as adverse events. The remaining 17 studies did not report adverse events. We downgraded the GRADE quality of evidence for all outcomes to very low because of observed imprecision, indirectness, imbalance between groups in many studies, and limitations of study design. Massage versus no-massage groupsWe analysed results for pain and anxiety but the quality of evidence was very low as most studies were small and considered at an unclear or high risk of bias due to poor reporting. Short-term pain (Present Pain Intensity-Visual Analogue Scale) was greater for the massage group compared with the no-massage group (one RCT, n = 72, mean difference (MD) -1.60, 95% confidence interval (CI) -2.67 to -0.53). Data for anxiety (State-Trait Anxiety Inventory-state) relief showed no significant difference in anxiety between the groups (three RCTs, n = 98, combined MD -5.36, 95% CI -16.06 to 5.34). The subgroup analysis for anxiety revealed that the anxiety relief for children was greater for the massage group compared with the no-massage group (one RCT, n = 30, MD -14.70, 95% CI -19.33 to -10.07), but the size of this effect was considered not clinically significant. Furthermore, this review demonstrated no differences in effects of massage on depression, mood disturbance, psychological distress, nausea, fatigue, physical symptom distress, or quality of life when compared with no massage. Massage with aromatherapy versus no-massage groupsWe analysed results for pain, anxiety, symptoms relating to the breast, and quality of life but the quality of evidence was very low as studies were generally at a high risk of bias. There was some indication of benefit in the aromatherapy-massage group but this benefit is unlikely to translate into clinical benefit. The relief of medium- and long-term pain (medium-term: one RCT, n = 86, MD 5.30, 95% CI 1.52 to 9.08; long-term: one RCT, n = 86, MD 3.80, 95% CI 0.19 to 7.41), anxiety (two RCTs, n = 253, combined MD -4.50, 95% CI -7.70 to -1.30), and long-term symptoms relating to the breast in people with breast cancer (one RCT, n = 86, MD -9.80, 95% CI -19.13 to -0.47) was greater for the aromatherapy-massage group, but the results were considered not clinically significant. The medium-term quality of life score was lower (better) for the aromatherapy-massage group compared with the no-massage group (one RCT, n = 30, MD -2.00, 95% CI -3.46 to -0.54). Massage with aromatherapy versus massage without aromatherapy groupsFrom the limited evidence available, we were unable to assess the effect of adding aromatherapy to massage on the relief of pain, psychological symptoms including anxiety and depression, physical symptom distress, or quality of life. AUTHORS' CONCLUSIONS: There was a lack of evidence on the clinical effectiveness of massage for symptom relief in people with cancer. Most studies were too small to be reliable and key outcomes were not reported. Any further studies of aromatherapy and massage will need to address these concerns.

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.

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

Since the first description of acute respiratory distress syndrome (ARDS) as a series of 12 patients in 1967 by Ashbaugh et al.1 , it still remains a major public health problem that incurs high health care costs and causes major mortality in the intensive care unit (ICU) despite improvements in outcomes in the last two decades. ARDS refers to the occurrence of severe hypoxemia that was not corrected by oxygen treatment and is characterized by heterogeneous acute lung inflammation with increased permeability of the alveolar-capillary membrane, resulting in the development of exudate within the alveolar space, damage due to activated neutrophils and cytokines, and abnormalities of surfactant and the coagulation system2 . The definition also recently changes as the Berlin criteria3 , which was modified to the original American-European Consensus Conference definitions4 and novel clinical trial designs in ARDS may anticipate a new era of successful therapies. Although over the past decades, there has been a remarkable development in the therapeutic approach and management of critically ill patients with ARDS, the mortality of patients with ARDS is unacceptably high, up to 40%5 . In Korea, it has been reported that 79 patients with ARDS were admitted to the ICUs of 28 university hospitals all over the country within 1 month, July 2009, and 45 of those patients died, resulting in a mortality rate of 57%6 . Also, until now there is no wellstated clinical practice guideline for intensivists about ARDS, especially focused on the critical care including applying mechanical ventilation until now. Herein, we report the recommendations and suggestions of how to manage mechanically ventilated patients with or without ARDS

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.

Guidelines for the diagnosis and treatment of Helicobacter pylori infection in Korea, 2013 revised edition.

The Korean College of Helicobacter and Upper Gastrointestinal Research first developed guidelines for the diagnosis and treatment of Helicobacter pylori (H. pylori) infection in 1998, and revised guidelines were proposed in 2009 by the same group. Although the revised guidelines were based on a comprehensive review of published articles and the consensus of expert opinions, the revised guidelines were not developed using an evidence-based process. The new guidelines presented in this study include specific changes regarding indication and treatment of H. pylori infection in Korea, and were developed through the adaptation process using an evidence-based approach. After systematic review of the literature, six guidelines were selected using the Appraisal of Guidelines for Research and Evaluation (AGREE) II process. A total of 21 statements were proposed with the grading system and revised using the modified Delphi method. After the guideline revisions, 11 statements about indication of test and treatment, four statements about diagnosis, and four statements about treatment of H. pylori infection were developed. The revised guidelines were reviewed by external experts before receiving official endorsement from the Korean College of Helicobacter and Upper Gastrointestinal Research, and disseminated to physicians and other medical professionals for use in clinical practice in Korea. The guidelines will continue to be updated and revised periodically.

[Guidelines for the diagnosis and treatment of Helicobacter pylori infection in Korea, 2013 revised edition].

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.

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.

[Updated guidelines 2012 for gastroesophageal reflux disease].

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.