scholarly journals Defining certainty of net benefit: a GRADE concept paper

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027445 ◽  
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.

Burst Suppression for ICP Control

2016 ◽  
Vol 32 (2) ◽  
pp. 130-139 ◽  
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.

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

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.

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

2018 ◽  
Vol 40 (38) ◽  
pp. 3182-3195 ◽  
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.

Development of Rapid Advice Guidelines for the Treatment of Coronavirus Disease 2019 with Traditional Chinese Medicine

2020 ◽  
Vol 48 (07) ◽  
pp. 1511-1521
Author(s):  
Ning Liang ◽  
Huizhen Li ◽  
Jingya Wang ◽  
Liwen Jiao ◽  
Yanfang Ma ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Observational Studies ◽  
The Body ◽  
Assessment Development ◽  
Evidence Collection ◽  
Novel Coronavirus ◽  
Grade Methodology ◽  
Evidence Based Guidelines

The worldwide spread of the 2019 novel coronavirus has become a profound threat to human health. As the use of medication without established effectiveness may result in adverse health consequences, the development of evidence-based guidelines is of critical importance for the clinical management of coronavirus disease (COVID-19). This research presents methods used to develop rapid advice guidelines on treating COVID-19 with traditional Chinese medicine (TCM). We have followed the basic approach for developing WHO rapid guidelines, including preparing, developing, disseminating and updating each process. Compared with general guidelines, this rapid advice guideline is unique in formulating the body of evidence, as the available evidence for the treatment of COVID-19 with TCM is from either indirect or observational studies, clinical first-hand data together with expert experience in patients with COVID-19. Therefore, our search of evidence not only focuses on clinical studies of treating COVID-19 with TCM but also of similar diseases, such as pneumonia and influenza. Grading of recommendations assessment, development and evaluation (GRADE) methodology was adopted to rate the quality of evidence and distinguish the strength of recommendations. The overall certainty of the evidence is graded as either high, moderate, low or very low, and to give either “strong” or “weak” recommendations of each TCM therapy. The output of this paper will produce the guideline on TCM for COVID-19 and will also provide some ideas for evidence collection and synthesis in the future development of rapid guidelines for COVID-19 in TCM as well as other areas.

scholarly journals Assessing causality in epidemiology: revisiting Bradford Hill to incorporate developments in causal thinking

2020 ◽  
Author(s):  
Michal Shimonovich ◽  
Anna Pearce ◽  
Hilary Thomson ◽  
Katherine Keyes ◽  
Srinivasa Vittal Katikireddi
Keyword(s):  
Directed Acyclic Graphs ◽  
Assessment Development ◽  
Causal Thinking ◽  
Acyclic Graphs ◽  
Statistical Heterogeneity ◽  
Bradford Hill ◽  
Grade Methodology ◽  
Negative Controls ◽  
Strength Of Association ◽  
Potential Outcomes Framework

AbstractThe nine Bradford Hill (BH) viewpoints (sometimes referred to as criteria) are commonly used to assess causality within epidemiology. However, causal thinking has since developed, with three of the most prominent approaches implicitly or explicitly building on the potential outcomes framework: directed acyclic graphs (DAGs), sufficient-component cause models (SCC models, also referred to as ‘causal pies’) and the grading of recommendations, assessment, development and evaluation (GRADE) methodology. This paper explores how these approaches relate to BH’s viewpoints and considers implications for improving causal assessment. We mapped the three approaches above against each BH viewpoint. We found overlap across the approaches and BH viewpoints, underscoring BH viewpoints’ enduring importance. Mapping the approaches helped elucidate the theoretical underpinning of each viewpoint and articulate the conditions when the viewpoint would be relevant. Our comparisons identified commonality on four viewpoints: strength of association (including analysis of plausible confounding); temporality; plausibility (encoded by DAGs or SCC models to articulate mediation and interaction, respectively); and experiments (including implications of study design on exchangeability). Consistency may be more usefully operationalised by considering an effect size’s transportability to a different population or unexplained inconsistency in effect sizes (statistical heterogeneity). Because specificity rarely occurs, falsification exposures or outcomes (i.e., negative controls) may be more useful. The presence of a dose-response relationship may be less than widely perceived as it can easily arise from confounding. We found limited utility for coherence and analogy. This study highlights a need for greater clarity on BH viewpoints to improve causal assessment.

scholarly journals A systematic overview of systematic reviews evaluating interventions addressing polypharmacy

2019 ◽  
Vol 76 (21) ◽  
pp. 1777-1787 ◽  
Author(s):  
Laura J Anderson ◽  
Jeffrey L Schnipper ◽  
Teryl K Nuckols ◽  
Rita Shane ◽  
Catherine Sarkisian ◽  
...  
Keyword(s):  
Older Adults ◽  
Systematic Reviews ◽  
Patient Centered ◽  
Assessment Development ◽  
Cochrane Database ◽  
Evidence Quality ◽  
Overview Of Systematic Reviews ◽  
Grade Methodology ◽  
The Impact ◽  
Medication Appropriateness

Abstract Purpose To systematically evaluate and summarize evidence across multiple systematic reviews (SRs) examining interventions addressing polypharmacy. Summary MEDLINE, the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects (DARE) were searched for SRs evaluating interventions addressing polypharmacy in adults published from January 2004 to February 2017. Two authors independently screened, appraised, and extracted information. SRs with Assessment of Multiple Systematic Reviews (AMSTAR) scores below 8 were excluded. After extraction of relevant conclusions from each SR, evidence was summarized and conclusions compared. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess evidence quality. Six SRs met the inclusion criteria, 4 of which used meta-analytic pooling. Five SRs focused on older adults. Four were not restricted to any specific disease type, whereas 1 focused on proton pump inhibitors and another focused on patients with severe dementia. Care settings and measured outcomes varied widely. SRs examining the impact on patient-centered outcomes, including morbidity, mortality, patient satisfaction, and utilization, found inconsistent evidence regarding the benefit of polypharmacy interventions, but most concluded that interventions had either null or uncertain impact. Two SRs assessing medication appropriateness found very low-quality evidence of modest improvements with polypharmacy interventions. Conclusion An overview of SRs of interventions to address polypharmacy found 6 recent and high-quality SRs, mostly focused on older adults, in which both process and outcome measures were used to evaluate interventions. Despite the low quality of evidence in the underlying primary studies, both SRs that assessed medication appropriateness found evidence that polypharmacy interventions improved it. However, there was no consistent evidence of any impact on downstream patient-centered outcomes such as healthcare utilization, morbidity, or mortality.

scholarly journals What are evidence-based treatment recommendations?

2011 ◽  
Vol 20 (1) ◽  
pp. 29-31 ◽  
Author(s):  
C. Barbui ◽  
A. Cipriani
Keyword(s):  
Clinical Practice ◽  
Treatment Recommendations ◽  
Evidence Based ◽  
Primary Research ◽  
Everyday Clinical Practice ◽  
Evidence Based Treatment ◽  
Assessment Development ◽  
New Methodologies ◽  
Grade Methodology

In recent years new methodologies for developing treatment recommendations that give consideration to evidence, values, preferences and feasibility issues have been developed. One of the most well-developed approaches is theGrading of Recommendations Assessment, Development and Evaluation(GRADE) methodology. This article briefly presents how this methodology may be employed to develop treatment recommendations that might constitute a permanent infrastructure between primary research and everyday clinical practice.

Consensus outcome rating for international neonatal resuscitation guidelines

2019 ◽  
Vol 105 (3) ◽  
pp. 328-330 ◽  
Author(s):  
Marya L Strand ◽  
Wendy Marie Simon ◽  
Jonathan Wyllie ◽  
Myra H Wyckoff ◽  
Gary Weiner
Keyword(s):  
Guideline Development ◽  
Neonatal Resuscitation ◽  
Group Method ◽  
Assessment Development ◽  
Liaison Committee ◽  
Resuscitation Guidelines ◽  
Numerical Rating ◽  
Neurodevelopmental Impairment ◽  
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.

scholarly journals The GRADE approach, Part 2: Evidence to decision frameworks—outlining decision-making in health

Medwave ◽  
2021 ◽  
Vol 21 (04) ◽  
pp. e8182-e8182
Author(s):  
Carlos Quilodrán ◽  
Matías Kirmayr ◽  
Bárbara Valente ◽  
Javier Pérez-Bracchiglione ◽  
Luis Garegnani ◽  
...  
Keyword(s):  
Decision Making ◽  
Resource Use ◽  
Evaluation Methodology ◽  
Adoption Process ◽  
Trade Off ◽  
Assessment Development ◽  
Extensive Information ◽  
Structured System ◽  
Grade Methodology ◽  
Grade Approach

The GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology provides a framework for assessing the certainty of the evidence and making recommendations. The Evidence to Decision Framework (EtD) is a transparent and structured system for formulating health recommendations. Once the problem is identified and the certainty of the evidence is assessed, EtD provides several criteria for formulating a recommendation. These criteria include the trade-off between benefits and harms, patients’ values and preferences, acceptability, feasibility, resource use, and impact on equity. The resulting recommendations may differ in strength (strong or weak) and direction (for or against). The process is transparent, allowing other users to adjust the framework of recommendations by modifying the criteria to fit the desired context through an adaptation-adoption process. Given the extensive information available on EtD and the GRADE methodology in general, this narrative review seeks to explain the main concepts involved in decision-making in health by using simplified and friendly descriptions, accompanied by practical examples, thus facilitating its understanding by inexperienced readers.

Sign in / Sign up

Export Citation Format

Share Document