Response to Letters by Asimos and by Alper and Brown (original) (raw)
Related papers
Applying the Grades of Recommendation for Antithrombotic and Thrombolytic Therapy
Chest, 2004
This article about the grades of recommendation for antithrombotic and thrombolytic therapy is part of the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Clinicians need to know whether a recommendation is strong or weak, and about the methodological quality of the evidence underlying that recommendation. We determine the strength of a recommendation by considering the trade-off between the benefits of a treatment, on the one hand, and the risks, burdens, and costs on the other. Here, as elsewhere, we assume that a recommended treatment will increase costs (we recognize this is not always the case, but for simplicity we will continue to make this assumption). If the benefits outweigh the risks, burdens, and costs, we recommend that clinicians offer a treatment to typical patients. The uncertainty associated with the trade-off between the benefits and the risks, burdens, and costs will determine the strength of the recommendations. If we are very certain that the benefits do, or do not, outweigh the risks, burdens, and costs, we make a strong recommendation (in our formulation, Grade 1). If we are less certain of the magnitude of the benefits and the risks, burdens, and costs, and thus of their relative impact, we make a weaker Grade 2 recommendation. We grade the methodological quality of a recommendation according to the following criteria. Randomized clinical trials (RCTs) with consistent results provide evidence with a low likelihood of bias, which we classify as Grade A recommendations. RCTs with inconsistent results, or with major methodological weaknesses, warrant Grade B recommendations. Grade C recommendations come from observational studies or from a generalization from one group of patients included in randomized trials to a different, but somewhat similar, group of patients who did not participate in those trials. When we find the generalization from RCTs to be secure, or the data from observational studies overwhelmingly compelling, we choose a Grade C؉. When that is not the case, we designate methodological quality as Grade C.
Grading quality of evidence and strength of recommendations
… (Clinical research ed. …, 2004
Clinical guidelines are only as good as the evidence and judgments they are based on. The GRADE approach aims to make it easier for users to assess the judgments behind recommendations This is an abridged version; the full version is on bmj.com
Grading Strength of Recommendations and Quality of Evidence in Clinical Guidelines *
CHEST Journal, 2006
While grading the strength of recommendations and the quality of underlying evidence enhances the usefulness of clinical guidelines, the profusion of guideline grading systems undermines the value of the grading exercise. An American College of Chest Physicians (ACCP) task force formulated the criteria for a grading system to be utilized in all ACCP guidelines that included simplicity and transparency, explicitness of methodology, and consistency with current methodological approaches to the grading process. The working group examined currently available systems, and ultimately modified an approach formulated by the international GRADE group. The grading scheme classifies recommendations as strong (grade 1) or weak (grade 2), according to the balance among benefits, risks, burdens, and possibly cost, and the degree of confidence in estimates of benefits, risks, and burdens. The system classifies quality of evidence as high (grade A), moderate (grade B), or low (grade C) according to factors that include the study design, the consistency of the results, and the directness of the evidence. For all future ACCP guidelines, The College has adopted a simple, transparent approach to grading recommendations that is consistent with current developments in the field. The trend toward uniformity of approaches to grading will enhance the usefulness of practice guidelines for clinicians. (CHEST 2006; 129:174 -181)
GRADE guidelines: 3. Rating the quality of evidence
Journal of Clinical Epidemiology, 2011
This article introduces the approach of GRADE to rating quality of evidence. GRADE specifies four categoriesdhigh, moderate, low, and very lowdthat are applied to a body of evidence, not to individual studies. In the context of a systematic review, quality reflects our confidence that the estimates of the effect are correct. In the context of recommendations, quality reflects our confidence that the effect estimates are adequate to support a particular recommendation. Randomized trials begin as high-quality evidence, observational studies as low quality. ''Quality'' as used in GRADE means more than risk of bias and so may also be compromised by imprecision, inconsistency, indirectness of study results, and publication bias. In addition, several factors can increase our confidence in an estimate of effect. GRADE provides a systematic approach for considering and reporting each of these factors. GRADE separates the process of assessing quality of evidence from the process of making recommendations. Judgments about the strength of a recommendation depend on more than just the quality of evidence. Ó GRADE provides a framework for assessing quality that encourages transparency and an explicit accounting of the judgments made.
Journal of clinical epidemiology, 2016
The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) is a widely used methodology for the development of clinical practice guideline. Although its reproducibility is good for evaluating the quality of evidence, it has not been tested in context of developing recommendations. The objective of this study was to assess the reproducibility of all GRADE factors that determine the direction and strength of a recommendation among the guideline panel members with limited exposure to GRADE methodology. The study was conducted as part of the clinical practice guideline development process of American Association of Blood Banking (AABB) for the use of prophylactic versus therapeutic platelet transfusion in patients with thrombocytopenia. The results from the systematic review and meta-analysis for each question were summarized as a GRADE evidence profile. Inter-rater agreement for all GRADE factors and strength of recommendations was summarized using a weighted kappa...
Grades of Recommendation for Antithrombotic Agents
CHEST Journal, 2001
This chapter describes the system used by the American College of Chest Physicians to grade recommendations for antithrombotic and thrombolytic therapy as part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Clinicians need to know if a recommendation is strong or weak, and the methodologic quality of the evidence underlying that recommendation. We determine the strength of a recommendation by considering the balance between the desirable effects of an intervention and the undesirable effects (incremental harms, burdens, and for select recommendations, costs). If the desirable effects outweigh the undesirable effects, we recommend that clinicians offer an intervention to typical patients. The uncertainty associated with the balance between the desirable and undesirable effects will determine the strength of recommendations. If we are confident that benefits do or do not outweigh harms, burden, and costs, we make a strong recommendation in our formulation, Grade 1. If we are less certain of the magnitude of the benefits and risks, burden, and costs, and thus their relative impact, we make a weaker Grade 2 recommendation. For grading methodologic quality, randomized controlled trials (RCTs) begin as high-quality evidence (designated by "A"), but quality can decrease to moderate ("B"), or low ("C") as a result of poor design and conduct of RCTs, imprecision, inconsistency of results, indirectness, or a high likelihood for reporting bias. Observational studies begin as low quality of evidence (C) but can increase in quality on the basis of very large treatment effects. Strong (Grade 1) recommendations can be applied uniformly to most patients. Weak (Grade 2) suggestions require more judicious application, particularly considering patient values and preferences and, when resource limitations play an important role, issues of cost.
Clinical practice guidelines: the need for greater transparency in formulating recommendations
The Medical Journal of Australia, 2011
2 The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system 23 GRADE proposes that the quality of evidence associated with each outcome of importance to patients be evaluated separately. The GRADE system classifies quality of evidence into 4 levels: high, moderate, low or very low. Evidence from randomised controlled trials (RCTs) begins as high quality, but may be rated down if trials demonstrate one of five categories of limitations. Observational studies begin as low-quality evidence, but may be rated up if associated with one of three categories of special strengths. Reasons for rating down quality of evidence Risk of bias: Quality will be lower if most of the evidence from available RCTs is compromised by limitations such as: lack of allocation concealment; lack of blinding (particularly if outcome assessment is highly susceptible to bias); large losses to follow-up; failure to analyse patients in the groups to which they were randomised; premature termination for benefit; or failure to report outcomes (often those for which no effect was observed). Inconsistent results: Widely differing estimates of treatment effect across studies suggest true differences in underlying treatment effect, and if investigators fail to identify a plausible explanation, quality of evidence decreases. Variability may arise from differences in populations, interventions, or outcomes. Indirectness of evidence: In comparing effects of two active treatments, randomised head-to-head trials constitute high-quality evidence. Indirect comparisons of the magnitude of effects seen in separate placebo-controlled trials of each treatment constitute lower quality evidence. Another type of indirectness arises if there are important differences between the populations (eg, elderly v non-elderly), interventions (eg, low v high dose) and outcomes (patient-important v surrogate) measured in trials and those under consideration in the guideline. Imprecision: When studies include relatively few patients and few events and thus have wide confidence intervals, quality of evidence decreases. Publication bias: Failure to report studies that typically show no effect reduces evidence quality. Such publication bias is more likely when only a small number of trials, all funded by industry, are available. Reasons for rating up quality of evidence Large and consistent effect sizes: If several large and methodologically strong observational studies report a very large effect size and confounding is unlikely to explain all or most of the apparent benefit, quality of evidence can be rated up (eg, hip replacement in severe osteoarthritis or dialysis for end-stage renal failure). Presence of a dose-response gradient: Where intensity of intervention (eg, dose, duration, or parenteral v oral method of administration) shows a correlation with effect size, the quality of evidence may increase. Accounting for all plausible confounding: Where investigators have accounted for all plausible biases which might decrease the magnitude of an apparent effect or create a spurious effect when results show no effect, the quality of evidence increases.