The Eastern Association of the Surgery of Trauma approach to practice management guideline development using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology

The International Liaison Committee on Resuscitation uses the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) working group method to evaluate the quality of evidence and the strength of treatment recommendations. This method requires guideline developers to use a numerical rating of the importance of each specified outcome. There are currently no uniform reporting guidelines or outcome measures for neonatal resuscitation science. We describe consensus outcome ratings from a survey of 64 neonatal resuscitation guideline developers representing seven international resuscitation councils. Among 25 specified outcomes, 10 were considered critical for decision-making. The five most critically rated outcomes were death, moderate-severe neurodevelopmental impairment, blindness, cerebral palsy and deafness. These data inform outcome rankings for systematic reviews of neonatal resuscitation science and international guideline development using the GRADE methodology.

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A living WHO guideline on drugs to prevent covid-19

BMJ ◽

10.1136/bmj.n526 ◽

2021 ◽

pp. n526

Author(s):

François Lamontagne ◽

Thomas Agoritsas ◽

Reed Siemieniuk ◽

Bram Rochwerg ◽

Jessica Bartoszko ◽

...

Keyword(s):

Systematic Review ◽

Guideline Development ◽

Meta Analysis ◽

World Health ◽

Policy And Practice ◽

Assessment Development ◽

Research Priority ◽

Health Organization ◽

Almost All ◽

Drug Interventions

Abstract Clinical question What is the role of drugs in preventing covid-19? Why does this matter? There is widespread interest in whether drug interventions can be used for the prevention of covid-19, but there is uncertainty about which drugs, if any, are effective. The first version of this living guideline focuses on the evidence for hydroxychloroquine. Subsequent updates will cover other drugs being investigated for their role in the prevention of covid-19. Recommendation The guideline development panel made a strong recommendation against the use of hydroxychloroquine for individuals who do not have covid-19 (high certainty). How this guideline was created This living guideline is from the World Health Organization (WHO) and provides up to date covid-19 guidance to inform policy and practice worldwide. Magic Evidence Ecosystem Foundation (MAGIC) provided methodological support. A living systematic review with network analysis informed the recommendations. An international guideline development panel of content experts, clinicians, patients, an ethicist and methodologists produced recommendations following standards for trustworthy guideline development using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Understanding the new recommendation The linked systematic review and network meta-analysis (6 trials and 6059 participants) found that hydroxychloroquine had a small or no effect on mortality and admission to hospital (high certainty evidence). There was a small or no effect on laboratory confirmed SARS-CoV-2 infection (moderate certainty evidence) but probably increased adverse events leading to discontinuation (moderate certainty evidence). The panel judged that almost all people would not consider this drug worthwhile. In addition, the panel decided that contextual factors such as resources, feasibility, acceptability, and equity for countries and healthcare systems were unlikely to alter the recommendation. The panel considers that this drug is no longer a research priority and that resources should rather be oriented to evaluate other more promising drugs to prevent covid-19. Updates This is a living guideline. New recommendations will be published in this article and signposted by update notices to this guideline. Readers note This is the first version of the living guideline for drugs to prevent covid-19. It complements the WHO living guideline on drugs to treat covid-19. When citing this article, please consider adding the update number and date of access for clarity.

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Burst Suppression for ICP Control

Journal of Intensive Care Medicine ◽

10.1177/0885066615593939 ◽

2016 ◽

Vol 32 (2) ◽

pp. 130-139 ◽

Cited By ~ 1

Author(s):

Frederick A. Zeiler ◽

Eva Akoth ◽

Lawrence M. Gillman ◽

Michael West

Keyword(s):

Reference Lists ◽

Burst Suppression ◽

Suppressive Therapy ◽

Cochrane Library ◽

Infection Rates ◽

Assessment Development ◽

Severe Hypotension ◽

Grade Methodology ◽

Clinical Trials Registry ◽

The Impact

Background: The goal of our study was to perform a systematic review of the literature to determine the effect that burst suppression has on intracranial pressure (ICP) control. Methods: All articles from MEDLINE, BIOSIS, EMBASE, Global Health, Scopus, Cochrane Library, the International Clinical Trials Registry Platform (inception to January 2015), reference lists of relevant articles, and gray literature were searched. The strength of evidence was adjudicated using both the Oxford and the Grading of Recommendation Assessment Development and Education (GRADE) methodology. Results: Seven articles were considered for review. A total of 108 patients were studied, all receiving burst suppression therapy. Two studies failed to document a decrease in ICP with burst suppression therapy. There were reports of severe hypotension and increased infection rates with barbiturate-based therapy. Etomidate-based suppressive therapy was linked to severe renal dysfunction. Conclusions: There currently exists both Oxford level 2b and GRADE C evidence to support that achieving burst suppression reduces ICP, and also has no effect on ICP, in severe traumatic brain injury. The literature suggests burst suppression therapy may be useful for ICP reduction in certain cases, although these situations are currently unclear. In addition, the impact on patient functional outcome is unclear. Further prospective study is warranted.

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Invited commentary on “Management of simple and retained hemothorax: A practice management guideline from the Eastern Association for the Surgery of Trauma”

The American Journal of Surgery ◽

10.1016/j.amjsurg.2021.01.014 ◽

2021 ◽

Author(s):

Amanda Hambrecht ◽

Cherisse Berry

Keyword(s):

Practice Management ◽

Management Guideline ◽

Retained Hemothorax

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Management of rhabdomyolysis: A practice management guideline from the Eastern Association for the Surgery of Trauma

The American Journal of Surgery ◽

10.1016/j.amjsurg.2021.11.022 ◽

2021 ◽

Author(s):

Jaswin S. Sawhney ◽

George Kasotakis ◽

Anna Goldenberg ◽

Stuart Abramson ◽

Christopher Dodgion ◽

...

Keyword(s):

Practice Management ◽

Management Guideline

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Practice Guideline Summary: Sudden Unexpected Death in Epilepsy Incidence Rates and Risk Factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society

Epilepsy Currents ◽

10.5698/1535-7511.17.3.180 ◽

2017 ◽

Vol 17 (3) ◽

pp. 180-187 ◽

Cited By ~ 25

Author(s):

Cynthia Harden ◽

Torbjörn Tomson ◽

David Gloss ◽

Jeffrey Buchhalter ◽

J. Helen Cross ◽

...

Keyword(s):

Risk Factors ◽

Guideline Development ◽

Evaluation Process ◽

Incidence Rates ◽

Sudden Unexpected Death ◽

Dissemination And Implementation ◽

Seizure Freedom ◽

High Confidence ◽

Unexpected Death ◽

Assessment Development

Objective: To determine the incidence rates of sudden unexpected death in epilepsy (SUDEP) in different epilepsy populations and address the question of whether risk factors for SUDEP have been identified. Methods: Systematic review of evidence; modified Grading Recommendations Assessment, Development and Evaluation process for developing conclusions; recommendations developed by consensus. Results: Findings for incidence rates based on 12 Class I studies include the following: SUDEP risk in children with epilepsy (aged 0–17 years) is 0.22/1,000 patient-years (95% CI 0.16–0.31) (high confidence in evidence). SUDEP risk increases in adults to 1.2/1,000 patient-years (95% CI 0.64–2.32) (low confidence in evidence). The major risk factor for SUDEP is the occurrence of generalized tonic-clonic seizures (GTCS); the SUDEP risk increases in association with increasing frequency of GTCS occurrence (high confidence in evidence). Recommendations: Level B: Clinicians caring for young children with epilepsy should inform parents/guardians that in 1 year, SUDEP typically affects 1 in 4,500 children; therefore, 4,499 of 4,500 children will not be affected. Clinicians should inform adult patients with epilepsy that SUDEP typically affects 1 in 1,000 adults with epilepsy per year; therefore, annually 999 of 1,000 adults will not be affected. For persons with epilepsy who continue to experience GTCS, clinicians should continue to actively manage epilepsy therapies to reduce seizures and SUDEP risk while incorporating patient preferences and weighing the risks and benefits of any new approach. Clinicians should inform persons with epilepsy that seizure freedom, particularly freedom from GTCS, is strongly associated with decreased SUDEP risk.

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Ebola Hemorrhagic Fever: Recent Update On Disease Status, Current Therapies And Advances In Treatment

Journal of Pharmaceutical Technology Research and Management ◽

10.15415/jptrm.2017.52013 ◽

2017 ◽

Vol 5 (2) ◽

pp. 217-234

Author(s):

Jaskaran Singh ◽

Thapa Komal ◽

Sandeep Arora ◽

Amarjot Kaur ◽

Thakur Gurjeet Singh

Keyword(s):

Ebola Virus ◽

Hemorrhagic Fever ◽

Disease Status ◽

Clinical Test ◽

Assessment Development ◽

Hiv Virus ◽

The World ◽

New Guidelines ◽

Virus Zika ◽

Grade Methodology

Swiftly growing viruses are a major intimidation to human health. Such viruses are extremely pathogenic like Ebola virus, influenza virus, HIV virus, Zika virus etc . Ebola virus, a type of Filovirus, is an extremely infectious, single-stranded ribonucleic acid virus that infects both humans and apes, prompting acute fever with hemorrhagic syndrome. The high infectivity, severity and mortality of Ebola has plagued the world for the past fifty years with its first outbreak in 1976 in Marburg, Germany, and Frankfurt along with Belgrade and Serbia. The world has perceived about 28,000 cases and over 11,000 losses. The high lethality of Ebola makes it a candidate for use in bioterrorism thereby arising more concern. New guidelines have been framed for providing best possible care to the patients suffering from Ebola virus i.e Grading of Recommendation Assessment, Development And Evaluation (GRADE) methodology to develop evidence-based strategy for the treatment in future outbreak of Ebola virus. No drugs have been approved, while many potent drugs like rVSV-EBOV, Favipiravir, ZMapp are on clinical test for human safety. In this review we will discover and discuss perspective aspects that lead to the evolution of different Ebola variants as well as advances in various drugs and vaccines for treatment of the disease.

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Defining certainty of net benefit: a GRADE concept paper

BMJ Open ◽

10.1136/bmjopen-2018-027445 ◽

2019 ◽

Vol 9 (6) ◽

pp. e027445 ◽

Cited By ~ 8

Author(s):

Brian S Alper ◽

Peter Oettgen ◽

Ilkka Kunnamo ◽

Alfonso Iorio ◽

Mohammed Toseef Ansari ◽

...

Keyword(s):

Health Effects ◽

Net Benefit ◽

Assessment Development ◽

Grade Methodology ◽

Cost Equity

Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility.

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2019 sickle cell disease guidelines by the American Society of Hematology: methodology, challenges, and innovations

Blood Advances ◽

10.1182/bloodadvances.2019000931 ◽

2019 ◽

Vol 3 (23) ◽

pp. 3945-3950 ◽

Cited By ~ 3

Author(s):

M. Hassan Murad ◽

Robert I. Liem ◽

Eddy S. Lang ◽

Elie A. Akl ◽

Joerg J. Meerpohl ◽

...

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Guideline Development ◽

A Priori ◽

Cell Transplant ◽

Cell Disease ◽

Hematopoietic Stem ◽

Assessment Development ◽

Cerebrovascular Complications ◽

American Society

Abstract The American Society of Hematology (ASH) convened 5 guideline panels to develop clinical practice recommendations addressing 5 management areas of highest importance to individuals living with sickle cell disease: pain, cerebrovascular complications, pulmonary and kidney complications, transfusion, and hematopoietic stem cell transplant. Panels were multidisciplinary and consisted of patient representatives, content experts, and methodologists. The Mayo Clinic Evidence-Based Practice Center conducted systematic reviews based on a priori selected questions. In this exposition, we describe the process used by ASH, including the GRADE approach (Grades of Recommendations, Assessment, Development and Evaluation) for rating certainty of the evidence and the GRADE Evidence to Decision Framework. We also describe several unique challenges faced by the guideline panels and the specific innovations and solutions used to address them, including a curriculum to train patients to engage in guideline development, dealing with the opioid crisis, and working with indirect and noncomparative evidence.

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European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism

European Heart Journal ◽

10.1093/eurheartj/ehy649 ◽

2018 ◽

Vol 40 (38) ◽

pp. 3182-3195 ◽

Cited By ~ 44

Author(s):

Christian Pristipino ◽

Horst Sievert ◽

Fabrizio D’Ascenzo ◽

Jean Louis Mas ◽

Bernhard Meier ◽

...

Keyword(s):

Patent Foramen Ovale ◽

Interdisciplinary Approach ◽

Conclusive Evidence ◽

Position Paper ◽

Foramen Ovale ◽

Management Options ◽

Level Of Evidence ◽

Assessment Development ◽

Therapeutic Procedures ◽

Grade Methodology

Abstract The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published. This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO. In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales. Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism. For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials. This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.

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