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Jeffrey C Andrews,
Holger J Schünemann,
Andrew D Oxman,
Kevin Pottie,
Joerg J Meerpohl,
Pablo Alonso Coello,
David Rind,
Victor Montori,
Juan Pablo Brito Campana,
Susan Norris,
Mahmoud Elbarbary,
Piet Post,
Mona Nasser,
Vijay Shukla,
Roman Jaeschke,
Jan Brozek, Ben Djulbegovic,
Gordon Guyatt
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ABSTRACT: In the GRADE approach, the strength of a recommendation reflects the extent to which we can be confident that the composite desirable effects of a management strategy outweigh the composite undesirable effects. This article addresses GRADE's approach to determining the direction and strength of a recommendation. The GRADE describes the balance of desirable and undesirable outcomes of interest among alternative management strategies depending on four domains, namely estimates of effect for desirable and undesirable outcomes of interest, confidence in the estimates of effect, estimates of values and preferences, and resource use. Ultimately, guideline panels must use judgment in integrating these factors to make a strong or weak recommendation for or against an intervention.
Journal of clinical epidemiology 04/2013; · 2.96 Impact Factor
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Gordon H Guyatt,
Andrew D Oxman,
Victor Montori,
Gunn Vist,
Regina Kunz,
Jan Brozek,
Pablo Alonso-Coello, Ben Djulbegovic,
David Atkins,
Yngve Falck-Ytter,
John W Williams,
Joerg Meerpohl,
Susan L Norris,
Elie A Akl,
Holger J Schünemann
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ABSTRACT: In the GRADE approach, randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down if a body of evidence is associated with a high risk of publication bias. Even when individual studies included in best-evidence summaries have a low risk of bias, publication bias can result in substantial overestimates of effect. Authors should suspect publication bias when available evidence comes from a number of small studies, most of which have been commercially funded. A number of approaches based on examination of the pattern of data are available to help assess publication bias. The most popular of these is the funnel plot; all, however, have substantial limitations. Publication bias is likely frequent, and caution in the face of early results, particularly with small sample size and number of events, is warranted.
Journal of clinical epidemiology 07/2011; 64(12):1277-82. · 2.96 Impact Factor
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Gordon H Guyatt,
Andrew D Oxman,
Gunn Vist,
Regina Kunz,
Jan Brozek,
Pablo Alonso-Coello,
Victor Montori,
Elie A Akl, Ben Djulbegovic,
Yngve Falck-Ytter,
Susan L Norris,
John W Williams,
David Atkins,
Joerg Meerpohl,
Holger J Schünemann
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ABSTRACT: In the GRADE approach, randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias. Well-established limitations of randomized trials include failure to conceal allocation, failure to blind, loss to follow-up, and failure to appropriately consider the intention-to-treat principle. More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results. Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance. Risk of bias may vary across outcomes (e.g., loss to follow-up may be far less for all-cause mortality than for quality of life), a consideration that many systematic reviews ignore. In deciding whether to rate down for risk of bias--whether for randomized trials or observational studies--authors should not take an approach that averages across studies. Rather, for any individual outcome, when there are some studies with a high risk, and some with a low risk of bias, they should consider including only the studies with a lower risk of bias.
Journal of clinical epidemiology 04/2011; 64(4):407-15. · 2.96 Impact Factor
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John D Roback,
Stephen Caldwell,
Jeff Carson,
Robertson Davenport,
Mary Jo Drew,
Anne Eder,
Mark Fung,
Marilyn Hamilton,
John R Hess,
Naomi Luban,
Jeremy G Perkins,
Bruce S Sachais,
Aryeh Shander,
Toby Silverman,
Ed Snyder,
Christopher Tormey,
John Waters, Ben Djulbegovic
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ABSTRACT: There is little systematically derived evidence-based guidance to inform plasma transfusion decisions. To address this issue, the AABB commissioned the development of clinical practice guidelines to help direct appropriate transfusion of plasma.
A systematic review (SR) and meta-analysis of randomized and observational studies was performed to quantify known benefits and harms of plasma transfusion in common clinical scenarios (see accompanying article). A multidisciplinary guidelines panel then used the SR and the GRADE methodology to develop evidence-based plasma transfusion guidelines as well as identify areas for future investigation.
Based on evidence ranging primarily from moderate to very low in quality, the panel developed the following guidelines: 1) The panel suggested that plasma be transfused to patients requiring massive transfusion. However, 2) the panel could not recommend for or against transfusion of plasma at a plasma : red blood cell ratio of 1:3 or more during massive transfusion, 3) nor could the panel recommend for or against transfusion of plasma to patients undergoing surgery in the absence of massive transfusion. 4) The panel suggested that plasma be transfused in patients with warfarin therapy-related intracranial hemorrhage, 5) but could not recommend for or against transfusion of plasma to reverse warfarin anticoagulation in patients without intracranial hemorrhage. 6) The panel suggested against plasma transfusion for other selected groups of patients.
We have systematically developed evidence-based guidance to inform plasma transfusion decisions in common clinical scenarios. Data from additional randomized studies will be required to establish more comprehensive and definitive guidelines for plasma transfusion.
Transfusion 03/2010; 50(6):1227-39. · 3.22 Impact Factor
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Cancer Treatment Reviews 12/2005; 31(7):587-9. · 6.05 Impact Factor
