2025 Brazilian guidelines for the management of neuromyelitis optica spectrum disorder in adults and children.

Application of the 2015 neuromyelitis optica spectrum disorders diagnostic criteria in a cohort of Chinese patients

Methodology for clinical practice guidelines for the management of arteriovenous access

To provide a review and commentary of various systems that grade the strength of a body of evidence for evaluating health care recommendations. A PubMed literature review was conducted between the years 2000 and 2013 using the following key words: evidence, grading systems, health care decisions, evidence quality, GRADE, and GRADE Working Group. The search focused on guidelines, review articles, and descriptive articles from prominent journals. A total of 50 articles were reviewed, of which 24 were selected for inclusion. Selected articles prior to the year 2000 were included strictly for background information. Articles were included based on the reputation of the journal or publishing body and whether the content addresses the objective of this review. A large number of varying grading systems exist, and some use numerical grading while others use prose recommendations. These systems help clinicians decipher the evidence; however, evaluating a multitude of grading systems, which are not only inconsistent but also contain their own inherent strengths and weaknesses, makes evaluation complex. Clinicians face a challenge when deciding which of these grading systems to use. The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) Working Group began in 2000 as an informal collaboration of people with an interest in addressing the shortcomings of present grading systems in health care. Many international organizations have adopted and/or endorsed the GRADE system or modified it for use in practice. Nevertheless, the true effectiveness of the system as a universal methodology for grading evidence still remains to be validated. To date, there has not been any literature-based proof of its validity; therefore, further research should be conducted in this area.

BackgroundSymptomatic slow-acting drugs (SYSADOA) have been largely studied over the last decade. The objective of this study is to prepare a document providing recommendations for the use of SYSADOA in osteoarthritis (OA).MethodsThe following interventions were taken into consideration: avocado/soybean unsaponifiables, chondroitin sulfate, diacereine, glucosamine sulfate, hyaluronic acid, oral calcitonin, risedronate, strontium ranelate. Recommendations were based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. The GRADE system is based on a sequential assessment of the quality of evidence, followed by assessment of the balance between benefits versus downsides and subsequent judgment about the strength of recommendations.ResultsChondroitin sulfate, diacereine, glucosamine sulfate, avocado/soybean unsaponifiables and hyaluronic acid have demonstrated pain reduction and physical function improvement with very low toxicity, with moderate to high quality evidence. Even if pre-clinical data and some preliminary in vivo studies have suggested that oral calcitonin and strontium ranelate could be of potential interest in OA, additional well-designed studies are needed.ConclusionIn the benefit/risk ratio, the use of chondroitin sulfate, diacereine, glucosamine sulfate, avocado/soybean unsaponifiables and hyaluronic acid could be of potential interest for the symptomatic management of OA.

Short transverse myelitis (STM; <3 vertebral segments) is considered noncharacteristic of neuromyelitis optica (NMO) spectrum disorders (NMOSDs). Nonappreciation of the potential for STM to occur in NMOSD may lead to increased disability from delay in diagnosis and appropriate treatment. To determine the frequency of short lesions at the initial myelitis manifestation of NMOSD and to compare the demographic, clinical, and radiological characteristics of aquaporin-4-IgG (AQP4-IgG) seropositive and seronegative STM. We reviewed the records and images of patients at the Mayo Clinic who were identified as AQP4-IgG positive from 1996 to 2014. Inclusion criteria were first STM episode, magnetic resonance imaging performed 90 days or less from symptom onset, spinal cord T2-hyperintense lesion less than 3 vertebral segments, AQP4-IgG seropositivity, and a final diagnosis of NMO or NMOSD. Patients with an initial longitudinally extensive transverse myelitis were excluded (n = 151). Patients with STM who were seronegative for AQP4-IgG among an Olmsted County population-based cohort of inflammatory demyelinating disorders of the central nervous system were used as a control group. Delay to diagnosis in months, clinical and radiological characteristics, and disability measured by ambulatory status. Twenty-five patients who were AQP4-IgG seropositive with an initial STM represented 14% of initial myelitis episodes among patients with NMOSD. The STM episode was defined as the first manifestation of NMOSD in 10 patients (40%) preceded by optic neuritis in 13 patients (52%) and preceded by a nausea and vomiting episode in 2 patients (8%). In comparison with the excluded patients with NMOSD who had an initial longitudinally extensive transverse myelitis, delay to diagnosis/treatment was greater when initial lesions were short (P = .02). In AQP4-IgG-positive STM cases, subsequent myelitis episodes were longitudinally extensive in 92%. Attributes more common in patients with AQP4-IgG-positive STM than in 27 population-based patients with AQP4-IgG-negative STM included the following: nonwhite race/ethnicity; tonic spasms; coexisting autoimmunity; magnetic resonance imaging (central cord lesions, T1 hypointensity, and a brain inconsistent with multiple sclerosis); and cerebrospinal fluid (oligoclonal bands lacking). Short transverse myelitis is not uncommon in NMOSD and, when it is present, delays diagnosis and treatment. Clinical and radiological characteristics identified in this study may help select patients with STM who are at the highest risk for an NMOSD. Short transverse myelitis does not exclude consideration of AQP4-IgG testing or NMOSD diagnosis.

This Part describes the process of creating the 2015 American Heart Association (AHA) Guidelines Update for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC), informed by the 2015 International Consensus on CPR and ECC Science With Treatment Recommendations (CoSTR) publication.1,2 The process for the 2015 International Liaison Committee on Resuscitation (ILCOR) systematic review is quite different when compared with the process used in 2010.1–3 For the 2015 systematic review process, ILCOR used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) (www.gradeworkinggroup.org) approach to systematic reviews and guideline development. For the development of this 2015 Guidelines Update, the AHA used the ILCOR reviews as well as the AHA definition of Classes of Recommendation (COR) and Levels of Evidence (LOE) (Table 1). This Part summarizes the application of the ILCOR GRADE process to inform the creation of 2015 Guidelines Update, and the process of assigning the AHA COR and LOE. View this table: Table 1. Applying Class of Recommendations and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care* ### Grading of Recommendations Assessment, Development, and Evaluation The 2015 CoSTR summarizes the published scientific evidence that was identified to answer specific resuscitation questions. ILCOR uses the GRADE system to summarize evidence and determine confidence in estimates of effect as well as to formulate treatment recommendations. GRADE is a consensus-crafted tool in wide use by many professional societies and reference organizations, including the American College of Physicians, the American Thoracic Society, and the Cochrane Collaboration, as well as the Centers for Disease Control and the World Health Organization. The choice of the GRADE approach was based on its increasingly ubiquitous use, practicality, and unique features. To our knowledge, the ILCOR evidence review process represents the largest application of the GRADE system in a healthcare-related review. GRADE is a system to review evidence to determine …

Michael R. Lucey, Norah Terrault, Lolu Ojo, J. Eileen Hay, James Neuberger, Emily Blumberg, and Lewis W. Teperman Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI; Gastroenterology Division, Department of Medicine, University of California San Francisco, San Francisco, CA; Division of Nephrology, Department of Medicine, University of Michigan, Ann Arbor, MI; Mayo Clinic, Rochester, MN; Liver Unit, Queen Elizabeth Hospital, Birmingham, United Kingdom; Division of Infectious Diseases, University of Pennsylvania School of Medicine, Philadelphia, PA; and Department of Surgery, NYU Transplant Associates, New York, NY

Guidelines report the quality of the evidence used when formulating recommendations to ensure transparency and allow end-users to assess the estimates of effect that underlie the recommendation. The aim of this study was to investigate the differences in grading of evidence quality between the Scottish Intercollegiate Guideline Network (SIGN) model and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. The GRADE system was used to create evidence profiles for recommendations from a guideline that used the SIGN method to assess the quality of evidence. Scores were allocated to the quality assessment in its GRADE and SIGN forms, so that the difference between the two methods could be quantified. The SIGN grading system led to quality ratings of the evidence of high and moderate but using the GRADE system, the majority of ratings were graded as low or very low. All of the recommendations were graded as higher quality by SIGN than by GRADE. The points' difference ranged from one to three points (maximum difference possible was four points). The most common reasons for downgrading evidence were "study limitations", "imprecision"' and "publication bias". "Indirectness" and "inconsistency" were rarely selected as reasons to downgrade the evidence. The GRADE and SIGN methods produce varying estimates of the quality of evidence.

The quality of evidence in Chinese meta-analyses needs to be improved

Background: The method of systematic reviews/meta-analyses (SRs/MAs) has been widely used in acute kidney injury (AKI) studies. However, it is not quite clear about the quality of the evidence and existing problems. Objectives: To grade the evidence quality of published SRs/MAs of AKI by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system, understand the current situation of evidence rating and analyze the possible problems. Methods: Researchers systematically searched for articles about SRs/MAs of AKI published in the following four Chinese databases and four English databases, including Chinese Biomedicine Literature Database, Wanfang Database, China National Knowledge Internet Database, VIP Database, Pubmed, EMBASE, the Cochrane Library and Web of Science. Results: Totally, 81 SRs/MAs were included in this study and the overall quality of evidence was not satisfactory. The number of literatures of low and very low evidence quality was 33 (40.7%) and 41 (50.6%), respectively. Limitation was the main factor which caused the quality of research evidence degrading (92.6%), and other degradation factors were inconsistency (56.8%), publication bias (44.4%), indirectness (35.8%) and imprecision (32.1%). The quality of evidence for AKI has been significantly improved after the publication of the GRADE system in 2004. Conclusions: Since 2004 when the GRADE system was published, the quality of evidence of AKI has been increased clearly. But quality of AKI evidence of SRs/MAs for intervention is still not satisfactory. Limitation and inconsistency were two major factors leading to degradation.

Centrally-located transverse myelitis would facilitate the differentiation of NMOSD and MOG-AD from MS

This study applied the grading of recommendations assessment, development and evaluation(GRADE) system and the integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine(Eff-iEC) to evaluate the evidence for 12 commonly used Chinese patent medicines for the treatment of osteoporosis, which are frequently recommended in guidelines or expert consensuses. The results showed that Xianling Gubao Capsules/Tablets were rated as C(low-level evidence) according to the GRADE system, and as BA~+B~+(intermediate evidence) according to the Eff-iEC system. Jintiange Capsules were rated as C(low-level evidence) by the GRADE system, and as AA~+B(high-level evidence) by the Eff-iEC system. Gushukang Granules/Capsules were rated as C(low-level evidence) by GRADE system, and as BA~+B~+(intermediate evidence) by Eff-iEC system. Zuogui Pills were rated as C(low-level evidence) by GRADE system, and as AA~(++)B~+(high-level evidence) by Eff-iEC system. Qianggu Capsules were rated as D(extremely low-level evidence) by GRADE system, and as AA~+B~+(high-level evidence) by Eff-iEC system. Zhuanggu Zhitong Capsules were rated as D(extremely low-level evidence) by GRADE system, and as BA~+B(intermediate evidence) by Eff-iEC system. Jingui Shenqi Pills were rated as D(extremely low-level evidence) by GRADE system, and as AA~+B(high-level evidence) by Eff-iEC system. Quanduzhong Capsules were rated as D(extremely low-level evidence) by GRADE system, and as AD~+B~+(low-level evidence) by Eff-iEC system. Epimedium Total Flavones Capsules were rated as D(extremely low-level evidence) by GRADE system, and as AAB~+(high-level evidence) by Eff-iEC system. Yougui Pills were rated as D(extremely low-level evidence) by GRADE system, and as AA~(++)B~(+ )(high-level evidence) by Eff-iEC system. Qigu Capsules were rated as D(extremely low-level evidence) by GRADE system, and as BB~+B(intermediate evidence) by Eff-iEC system. Liuwei Dihuang Pills were rated as C(low-level evidence) by GRADE system, and as AA~(++)B~+(high-level evidence) by Eff-iEC system. Overall, the Eff-iEC system provides a more comprehensive assessment of the effectiveness evidence for traditional Chinese medicine(TCM) than the GRADE system. However, it still has certain limitations that hinder its wider promotion and application. In terms of clinical evidence evaluation, both the Eff-iEC and GRADE systems reflect that the current clinical research quality on Chinese patent medicines for the treatment of osteoporosis is generally low. High-quality clinical trials are still needed in the future to further validate clinical efficacy.

In 2016, NHS England published the commissioning policy on Bone Conducting Hearing Devices (BCHDs). This policy was informed by updated evidence on the clinical and cost-effectiveness of BCHDs as well as by the 2013 Bone Anchored Hearing Aid (BAHA) policy. Commissioning policies set the criteria for service delivery and therefore have a major impact on the care received by patients. It is important that stakeholders have a good appreciation of the available evidence informing policy, as this will promote engagement both with the policy and with future research leading on from the policy. In this article, we provide stakeholders with a transparent and pragmatic assessment of the quality of the body of evidence available to inform current BCHD national policy. (i) A systematic review of the literature on BCHDs published since the development of the 2013 policy was performed in September 2016, adhering to PRISMA recommendations. The search terms used were as follows bone conduction; bone conducting; bone anchor; BAHA; Bone Anchored Hearing Aid; Bone Conducting Hearing Device; BCHD; Bone Conducting Hearing Implant; BCHI; Sophono; Bonebridge; Soundbite; Ponto; Hearing aid; implant; device; hearing device. Publications that could inform current BCHD policy were included. The quality of included articles was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. (ii) The quality of evidence referenced by the 2013 BAHA policy was assessed using the GRADE system. (i) Of the 2576 publications on BCHDs identified by the systematic search, 39 met the inclusion criteria for further analysis. Using the GRADE criteria, the quality of evidence was classified as of 'very low quality'. (ii) The 2013 BAHA policy was informed by 14 references. The GRADE system classifies the quality of evidence that informed the policy as of 'very low quality'. The GRADE system defines the body of evidence available to inform current national BCHD policy as of 'very low quality'. There is an urgent need for high-quality research to help make informed policy decisions about the care of patients with hearing loss. An (inter)national registry of BCHDs could address this need.

GRADE, Grading of Recommendations Assessment, Development, and Evaluation; HCC, hepatocellular carcinoma; LDLT, living donor liver transplantation; LT, liver transplantation. In less than 30 years, liver transplantation (LT) has rapidly developed from a highly experimental and controversial procedure to one of the most successful stories in medicine. Nowadays, LT is a widely accepted treatment for select patients with hepatocellular carcinoma (HCC). Historically, HCC was a dismal disease amenable only to palliative therapies; a number of curative alternatives, including liver resection, locoregional therapies, and LT, have emerged. This evolution is associated with dramatic improvements in imaging techniques and the implementation of surveillance programs, which have facilitated the detection of many HCCs at an earlier stage when an effective treatment is feasible.1 In this context, LT is considered an optimal strategy that addresses both the underlying disease and the cancer, and HCC is currently the indication for LT in 25% and 35% of all cases in Europe and the United States, respectively.2, 3 The need to obtain the optimal benefit from the limited number of available organs has prompted the maintenance of stringent selection criteria so that only those patients with early HCC, who have the highest likelihood of achieving long-term survival after LT, are listed. The indications for LT and the allocation of donor organs are, therefore, closely scrutinized by all LT stakeholders. An international consensus conference on LT for HCC was held in Zurich, Switzerland on December 2-4, 2010. The aims of this conference were as follows: (1) establishing the state of the art for indications for LT in patients with HCC and (2) providing internationally accepted statements and guidelines for LT programs. This conference was endorsed and financially supported by 10 major international societies focusing on liver diseases or LT: the American Association for the Study of Liver Diseases, the American Society of Transplant Surgeons, the European Association for the Study of the Liver, the European-African Hepato-Pancreato-Biliary Association, the European Liver and Intestine Transplant Association, the International Hepato-Pancreato-Biliary Association, the International Liver Cancer Association, the International Liver Transplantation Society, the Transplantation Society, and the Liver and Gastrointestinal Disease Foundation. The University of Zurich also provided financial support for this conference. For this purpose, a novel format for the consensus conference, which was based on the Danish model, was developed.4 The organizing committee identified 19 specific questions, and these questions were grouped into 5 topics (Table 1). Nineteen working groups were created to address these questions; each group was composed of 4 to 6 experts from various fields of medicine, including surgery, gastroenterology, radiology, oncology, pathology, patient representation, health insurance, statistics, and ethics. These experts were selected on the basis of their scientific and clinical records, and their mission was to prepare evidence-based papers and draft recommendations. They were asked to follow the Oxford classification for levels of evidence5 (Table 2). Nine people from a variety of clinical and academic fields (not including any fields involving LT or HCC) were appointed to a jury, and this jury reviewed the submitted papers, commented on them, and made the final recommendations. As in the Danish model, the essential rule was that the final recommendations were to be drawn by the jury and not by the experts!4 Eighteen months before the conference in Zurich, the various topics and the progression of the groups' work were extensively discussed with the organizing committee and the members of the jury. For example, 3 workshops were held during 2009 and 2010 (2 at the annual meeting of the American Association for the Study of Liver Diseases in Boston and 1 at the meeting of the European Association for the Study of the Liver in Vienna); there, the chairs or representatives from each working group met with the organizing committee and the jury president or vice-president to evaluate and discuss the status of their work. Consequently, most papers, including the recommendations from the working groups, were assessed in advance by the jury. Most often, revisions were made to these papers before the conference. Approximately 300 attendees from 5 continents were present at the consensus conference in Zurich. The chair of each working group delivered a 15-minute presentation that covered each specific question, and this was followed by questions first from the jury and then from the audience. Before the conference, the members of the jury used the experts' texts to prepare some proposals for final recommendations that answered the 19 specific questions. These proposals were discussed during the conference, and they were modified at that time in response to the discussions. Afterwards, the audience was polled anonymously with an electronic voting system to determine the strength of each recommendation; the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system for decision making6 was used (Fig. 1). The jury met independently after the meeting to produce final recommendations, which were based on the papers submitted by the experts, the discussions, and the vote of the audience during the conference. GRADE system.6 The strength of each recommendation was determined by the vote of the audience and the jury. A committee was then established to write the consensus text. This writing committee was composed of the president, the vice-president, and a statistician from the jury as well as 3 members of the organizing committee. This text will be published in The Lancet Oncology.7 General considerations: diagnosis. Indications for LT. Bridging therapy, down-staging, and monitoring on the waiting list. Living donor liver transplantation (LDLT). Monitoring after LT. The first part of the conference focused on the survival goals for LT in patients with HCC and on the tools for establishing the diagnosis of HCC.8-11 Posttransplant survival was a matter of debate. The experts proposed lowering the 5-year survival rate to 50% because of patients' personal benefits from LT. However, because of the shortage of donor organs and for consistency with the statement that the results of LT within the Milan criteria are the benchmarks, the jury concluded that LT should be reserved for HCC patients who have a predicted 5-year survival rate comparable to that of non-HCC patients. For the diagnosis of HCC, the jury endorsed the algorithm of the American Association for the Study of Liver Diseases, which is based on state-of-the-art cross-sectional imaging techniques (computed tomography or magnetic resonance imaging). In the second part of the conference, the experts focused on the indications for LT and on the possible expansion of the accepted criteria for LT for HCC.12-17 Mazzaferro et al.12 provided an exhaustive review of the literature and analyzed 90 studies, which covered 15 years of experience with the Milan criteria. Germani et al.13 conducted a meta-analysis of 101 studies and assessed the effects of staging HCC with the size and number of nodules on posttransplant recurrence and survival. They concluded that the diameter of the largest nodule or the total diameter of all nodules is the best outcome predictor. This conclusion agrees with recent Organ Procurement and Transplantation Network data, which suggest that the total tumor volume and the alpha-fetoprotein level could be useful for selecting HCC patients for LT.18 Freeman's group16 addressed the issue of using extended criteria (ie, criteria beyond the Milan criteria). Although evidence has accumulated for good outcomes for some patients beyond the Milan criteria, no definitive recommendations could be made. These strategies should be considered according to the local situation of each transplant center (ie, the availability of donor organs and the mortality rate for patients on the waiting list). Treatment on the waiting list and the down-staging of larger HCCs were the topics of the third part of the conference.19-21 This group of experts supported the concept of down-staging, although the indications and the criteria for defining success still need to be standardized. Not surprisingly, none of the locoregional therapies showed any superiority. As for treatment on the waiting list, no therapy was recommended for United Network for Organ Sharing T1 tumors. For United Network for Organ Sharing T2 tumors, the experts suggested bridging strategies for patients likely to wait longer than 6 months to prevent the development of contraindications during the waiting period. All therapies were extensively discussed, and a marginal advantage was shown for radiofrequency ablation. The fourth part, which dealt with the use of LDLT for HCC patients, triggered some controversial debates among the experts, the audience, and the jury.22-24 They discussed ethical concerns with the double equipoise describing the balance between the recipient's survival benefit with or without LDLT and the risks of morbidity and mortality for the donor. Five years after the publication of the findings of the Vancouver forum,25 it is well accepted that patients with HCC within the Milan criteria should be offered LDLT as a treatment option. On the other hand, the question of offering LDLT to HCC patients beyond the accepted criteria raised many questions. There were arguments from experts in favor of donor protection and from experts who instead focused on the patient's benefit (the issue of organ sharing does not apply to LDLT). Finally, the jury decided not to make any formal recommendations about the use of LDLT for HCC patients beyond the Milan criteria. Each transplant center should determine a clear policy with rigorous safeguards and inform the community about the expected outcomes. Finally, the fifth part of the conference focused on management after LT and paid special attention to the risk of HCC recurrence after LT.26-28 The experts investigated whether immunosuppression regimens have an impact on HCC recurrence and whether they should be adapted in such an oncological context. Adjuvant therapies were also evaluated for their potential to reduce tumor recurrence post-LT and improve long-term survival. Finally, the different therapeutic options and their indications for HCC recurrence were discussed. Overall, this consensus conference format led to objective evaluations of the most controversial topics in the field of LT for HCC by an independent jury. To the best of our knowledge, this is the first time that this format has been used in this field, in which strong opinions or dogmatic beliefs are usually difficult to challenge. The results of this effort are compiled in this special issue, which provides up-to-date information for the consensus text to be published in The Lancet Oncology.7

Limited systematic reviews exist to evaluate the effects of motivational interviewing (MI) on children's anthropometric factors. This review examined the effects of MI interventions for children and/or parents on children's anthropometric factors and included moderation analyses and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, we searched Cochrane Library, PubMed, CINAHL, EMBASE, PsycINFO, Sociological Abstracts, SPORTDiscus, Education Resources Information Center, and Web of Science in December 2020. A two-step double screening approach was applied: (1) screening titles and abstracts, and (2) screening full-text articles obtained in step 1. At each step, discussion occurred until reaching consensus. The Cochrane risk-of-bias tool was used to evaluate risk of bias, and GRADE system was applied to assess overall quality of evidence. We performed meta-analyses using the Comprehensive Meta-Analysis software. A total of 2209 records were found, and 45 eligible articles were retained. MI interventions had a pooled effect of -0.15 on body mass index (BMI; 95% confidence interval [CI]: -0.24 to -0.06), -0.36 on waist circumference (WC; 95% CI: -0.71 to -0.01) and -0.22 on percent body fat (95% CI: -0.41 to -0.03). Child baseline weight status and percent low-income families were identified as significant intervention moderators. According to the GRADE assessment, the quality of evidence on BMI percentile, BMI z-score and percent body fat was moderate, while quality on BMI and WC was low. In conclusion, culturally appropriate clinic- or home-based MI interventions with adequate duration, dose and active parental involvement are promising in reducing anthropometrics among children.