GRADE guidelines: 11. making an overall rating of confidence in effect estimates for a single outcome and for all outcomes
McMaster University1, Norwegian Institute of Public Health2, University of Florida3, University of Oxford4, United States Department of Veterans Affairs5, University of Basel6, Mayo Clinic7, University Hospital of Basel8, Harvard University9, University at Buffalo10, University of Freiburg11, Agency for Healthcare Research and Quality12, Oregon Health & Science University13, Case Western Reserve University14
TL;DR: Although this rating system represents discrete steps on an ordinal scale, it is helpful to view confidence in estimates as a continuum, and the final rating of confidence may differ from that suggested by separate consideration of each domain.
About: This article is published in Journal of Clinical Epidemiology.The article was published on 2013-02-01. It has received 556 citations till now. The article focuses on the topics: Confidence interval.
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TL;DR: The PRISMA-P checklist as mentioned in this paper provides 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol, as well as a model example from an existing published protocol.
Abstract: Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potentially prompt collaboration. Evidence documenting the existence of selective reporting and excessive duplication of reviews on the same or similar topics is accumulating and many calls have been made in support of the documentation and public availability of review protocols. Several efforts have emerged in recent years to rectify these problems, including development of an international register for prospective reviews (PROSPERO) and launch of the first open access journal dedicated to the exclusive publication of systematic review products, including protocols (BioMed Central's Systematic Reviews). Furthering these efforts and building on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, an international group of experts has created a guideline to improve the transparency, accuracy, completeness, and frequency of documented systematic review and meta-analysis protocols--PRISMA-P (for protocols) 2015. The PRISMA-P checklist contains 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol.This PRISMA-P 2015 Explanation and Elaboration paper provides readers with a full understanding of and evidence about the necessity of each item as well as a model example from an existing published protocol. This paper should be read together with the PRISMA-P 2015 statement. Systematic review authors and assessors are strongly encouraged to make use of PRISMA-P when drafting and appraising review protocols.
9,361 citations
University of Alabama at Birmingham1, American University of Beirut2, Tufts Medical Center3, Beth Israel Deaconess Medical Center4, University of California, Los Angeles5, Washington University in St. Louis6, University of California, San Diego7, University of Nebraska Medical Center8, Mayo Clinic9, University of Minnesota10, NorthShore University HealthSystem11, Duke University12, American College of Rheumatology13
TL;DR: To develop a new evidence‐based, pharmacologic treatment guideline for rheumatoid arthritis (RA), a large number of patients with RA are referred to a single clinic for treatment with these medications.
Abstract: Objective
To develop a new evidence-based, pharmacologic treatment guideline for rheumatoid arthritis (RA).
Methods
We conducted systematic reviews to synthesize the evidence for the benefits and harms of various treatment options. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to rate the quality of evidence. We employed a group consensus process to grade the strength of recommendations (either strong or conditional). A strong recommendation indicates that clinicians are certain that the benefits of an intervention far outweigh the harms (or vice versa). A conditional recommendation denotes uncertainty over the balance of benefits and harms and/or more significant variability in patient values and preferences.
Results
The guideline covers the use of traditional disease-modifying antirheumatic drugs (DMARDs), biologic agents, tofacitinib, and glucocorticoids in early (<6 months) and established (≥6 months) RA. In addition, it provides recommendations on using a treat-to-target approach, tapering and discontinuing medications, and the use of biologic agents and DMARDs in patients with hepatitis, congestive heart failure, malignancy, and serious infections. The guideline addresses the use of vaccines in patients starting/receiving DMARDs or biologic agents, screening for tuberculosis in patients starting/receiving biologic agents or tofacitinib, and laboratory monitoring for traditional DMARDs. The guideline includes 74 recommendations: 23% are strong and 77% are conditional.
Conclusion
This RA guideline should serve as a tool for clinicians and patients (our two target audiences) for pharmacologic treatment decisions in commonly encountered clinical situations. These recommendations are not prescriptive, and the treatment decisions should be made by physicians and patients through a shared decision-making process taking into account patients’ values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.
2,083 citations
Teikyo University1, Hiroshima University2, Niigata University3, University of Tsukuba4, Saitama Medical University5, Tokyo Medical and Dental University6, University of Tokyo7, Japanese Foundation for Cancer Research8, Kyorin University9, Kyoto University10, National Defense Medical College11, Dokkyo Medical University12, Tohoku University13, Tokyo Metropolitan Komagome Hospital14, Osaka Medical College15, Kurume University16, International University of Health and Welfare17, Toho University18
TL;DR: The English version of the JSCCR Guidelines 2016 is presented, which can be used as a tool for treating colorectal cancer in actual clinical practice settings and as a guide to obtaining informed consent from patients and choosing the method of treatment for each patient.
Abstract: Colorectal cancer is a major cause of death in Japan, where it accounts for the largest number of deaths from malignant neoplasms in women and the third largest number in men. Many new treatment methods have been developed over the last few decades. The Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2010 for the treatment of colorectal cancer (JSCCR Guidelines 2010) have been prepared to show standard treatment strategies for colorectal cancer, to eliminate disparities among institutions in terms of treatment, to eliminate unnecessary treatment and insufficient treatment, and to deepen mutual understanding between health-care professionals and patients by making these Guidelines available to the general public. These Guidelines have been prepared by consensuses reached by the JSCCR Guideline Committee, based on a careful review of the evidence retrieved by literature searches and in view of the medical health insurance system and actual clinical practice settings in Japan. Therefore, these Guidelines can be used as a tool for treating colorectal cancer in actual clinical practice settings. More specifically, they can be used as a guide to obtaining informed consent from patients and choosing the method of treatment for each patient. As a result of the discussions held by the Guideline Committee, controversial issues were selected as Clinical Questions, and recommendations were made. Each recommendation is accompanied by a classification of the evidence and a classification of recommendation categories based on the consensus reached by the Guideline Committee members. Here we present the English version of the JSCCR Guidelines 2010.
1,709 citations
Vanderbilt University1, McMaster University2, National Institute for Health and Care Excellence3, University of Florida4, Case Western Reserve University5, Peninsula College of Medicine and Dentistry6, University Medical Center Freiburg7, University Hospital of Basel8, Harvard University9, University at Buffalo10
TL;DR: The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to classifying the direction and strength of recommendations is described, separated into strong and weak.
1,009 citations
University of Alabama at Birmingham1, American University of Beirut2, Tufts Medical Center3, Beth Israel Deaconess Medical Center4, University of California, Los Angeles5, Washington University in St. Louis6, University of California, San Diego7, University of Nebraska Medical Center8, Mayo Clinic9, University of Minnesota10, NorthShore University HealthSystem11, Duke University12, American College of Rheumatology13
TL;DR: To develop a new evidence‐based, pharmacologic treatment guideline for rheumatoid arthritis (RA), a large number of patients with RA are referred to a single clinic for treatment with these medications.
Abstract: To develop a new evidence‐based, pharmacologic treatment guideline for rheumatoid arthritis (RA).
875 citations
Additional excerpts
...critical for the comparison between interventions (14)....
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TL;DR: The approach of GRADE to rating quality of evidence specifies four categories-high, moderate, low, and very low-that are applied to a body of evidence, not to individual studies.
5,228 citations
McMaster University1, University Hospital of Basel2, Autonomous University of Barcelona3, Mayo Clinic4, University at Buffalo5, University of South Florida6, Case Western Reserve University7, Oregon Health & Science University8, Duke University9, United States Department of Veterans Affairs10, University Medical Center Freiburg11
TL;DR: 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.
2,059 citations
McMaster University1, University Hospital of Basel2, Autonomous University of Barcelona3, Harvard University4, Mayo Clinic5, Karolinska University Hospital6, Duke University7, Liverpool School of Tropical Medicine8, Case Western Reserve University9, University Medical Center Freiburg10, Centre for Mental Health11, Vanderbilt University12
TL;DR: It is suggested that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision and rating down the quality of evidence is required if clinical action would differ if the upper versus the lower boundary of the CI represented the truth.
1,844 citations
McMaster University1, Norwegian Institute of Public Health2, University of Basel3, University of London4, Oregon Health & Science University5, Autonomous University of Barcelona6, Bond University7, University at Buffalo8, University of Florida9, Health Canada10, Medical Research Council11, Case Western Reserve University12
TL;DR: Credibility is increased if subgroup effects are based on a small number of a priori hypotheses with a specified direction; subgroup comparisons come from within rather than between studies; tests of interaction generate low P-values; and have a biological rationale.
1,535 citations
McMaster University1, Mayo Clinic2, University Hospital of Basel3, Autonomous University of Barcelona4, University of South Florida5, United States Department of Veterans Affairs6, Case Western Reserve University7, Duke University8, University Medical Center Freiburg9, Oregon Health & Science University10, University at Buffalo11
TL;DR: 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.
1,295 citations