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Grades of Recommendation
James G. Wright, MD, MPH, FRCSC; Thomas A. Einhorn, MD; James D. Heckman, MD
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The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2005 Sep 01;87(9):1909-1910. doi: 10.2106/JBJS.8709.edit
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Surgeons use the literature to determine the best treatment for their patients. Although practice can be changed by a single study, we often find multiple studies more convincing. The appropriate literature can be identified in many ways. First, we can search the literature ourselves. However, this takes a lot of time and the search may not be comprehensive. Second, we can identify meta-analyses or systematic overviews, which collect and combine studies together to assemble a larger sample size in order to provide greater precision around treatment effects. However, meta-analyses pose many methodologic challenges and are not always available. Finally, we can use review articles such as the Current Concepts Reviews published by The Journal as a source for treatment recommendations. The difficulty with review articles is uncertainty about the quality of the recommendations they contain.
In this issue, The Journal introduces the latest in a series of changes to help surgeons appraise the literature to make the best decisions with and for their patients. In June 2000, The Journal featured a new section called Evidence-Based Orthopaedics1. On a quarterly basis, structured abstracts derived from high-quality evidence from journals other than JBJS are published with a commentary from a clinical expert. This section provides the latest and highest-quality evidence for orthopaedic surgeons. In January 2003, The Journal began publishing a Levels of Evidence rating at the end of the abstract for every clinical article2. This system rates the quality of the evidence with use of five levels that are based on the study methods. Levels of Evidence ratings provide a measure of the quality of clinical articles published in JBJS.
With this issue, The Journal extends the evidence-based approach to selected Current Concepts Reviews by applying Grades of Recommendation to selected treatments discussed in the reviews. Authors writing Current Concepts Review articles are encouraged to provide definitive and explicit recommendations regarding the care of patients. Definitive recommendations are most appropriate either when there is minimal disagreement among clinicians or when the evidence is consistent and of high quality. If authors choose to make their recommendations explicit, they should be formatted in a standard way. Recommendations must be included in a separate table entitled "Recommendations for Care." Authors should base their recommendations on a complete evaluation of the appropriate literature. Support for recommendations regarding treatment, diagnosis, or prognosis are based on JBJS Levels of Evidence (www.ejbjs.org/misc/public/instrux.shtml#levels; last accessed February 9, 2005). Levels of Evidence ratings for multiple studies addressing a clinical care recommendation are to be summarized with use of Grades of Recommendation. A Grade of Recommendation is to be attached to each recommendation in the table entitled "Recommendations for Care." Grade-A recommendations are based on consistent Level-I studies. Grade-B recommendations are based on consistent Level-II or III evidence. Grade-C recommendations represent either conflicting evidence or are based on Level-IV or V evidence. A grade of I indicates that there is insufficient evidence to make a treatment recommendation (Table I).
 
Anchor for JumpAnchor for JumpTABLE I  Grades of Recommendation for Summaries or Reviews of Orthopaedic Surgical Studies
Grade Description
A Good evidence (Level-I studies with consistent findings) for or against recommending intervention.
B Fair evidence (Level-II or III studies with consistent findings) for or against recommending intervention.
C Conflicting or poor-quality evidence (Level-IV or V studies) not allowing a recommendation for or against intervention.
I There is insufficient evidence to make a recommendation.
Grades of Recommendation have been used most commonly in the development of practice guidelines. In this process, organizations assemble all of the appropriate literature on a clinical question. The quality of the literature is appraised with use of Levels of Evidence. Finally, the overall quality of the literature is summarized together as a Grade of Recommendation. The JBJS Grades of Recommendation, modified from previously published Grades (www.ahrq.gov/clinic/uspstfix.htm; last accessed February 9, 2005), were developed by a consensus group that included representation from the American Academy of Orthopaedic Surgeons, The Journal of Bone and Joint Surgery (American and British editions), and Clinical Orthopaedics and Related Research.
Using Grades of Recommendation will improve the review articles published by JBJS in two ways. First, the review articles will provide explicit treatment recommendations for surgeons. Second, Grades of Recommendation will guide surgeons as to whether they should definitely (Grade A) or probably (Grade B) change their practice. Finally, by using this system, we also will know those things that we do not know. In some clinical situations the surgeon will not have good evidence, or even any evidence at all, upon which to make an important decision, and in such cases the decision will have to be made with the surgeon relying heavily upon professional judgment alone.
We look forward to your feedback on this important initiative.
Wright JG, Swiontkowski MF. Introducing a new journal section: evidence-based orthopaedics. J Bone Joint Surg Am.2000;82: 759.82759  2000 
 
Wright JG, Swiontkowski MF, Heckman JD. Introducing levels of evidence to the journal. J Bone Joint Surg Am.2003;85: 1-3.851  2003  [PubMed][CrossRef]
 

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Anchor for JumpAnchor for JumpTABLE I  Grades of Recommendation for Summaries or Reviews of Orthopaedic Surgical Studies
Grade Description
A Good evidence (Level-I studies with consistent findings) for or against recommending intervention.
B Fair evidence (Level-II or III studies with consistent findings) for or against recommending intervention.
C Conflicting or poor-quality evidence (Level-IV or V studies) not allowing a recommendation for or against intervention.
I There is insufficient evidence to make a recommendation.

References

Wright JG, Swiontkowski MF. Introducing a new journal section: evidence-based orthopaedics. J Bone Joint Surg Am.2000;82: 759.82759  2000 
 
Wright JG, Swiontkowski MF, Heckman JD. Introducing levels of evidence to the journal. J Bone Joint Surg Am.2003;85: 1-3.851  2003  [PubMed][CrossRef]
 
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These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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James G. Wright, M.D., MPH, FRCSC
Posted on March 10, 2006
Revised Grades of Recommendation for Summaries or Reviews of Orthopaedic Surgical Studies
The Hospital for Sick Children, 555 University Ave., Rm 1254, Toronto, ON M5G 1X8, CANADA

To The Editor:

Grades of recommendation, introduced to readers of The Journal in September 2005, (1), are a method of summarizing the quality of the literature. Grades of Recommendation are used in practice guidelines and in review articles to summarize the evidence on clinical questions.

In response to concerns raised by some that the designation of a Grade-C recommendation was not sufficiently clear, we revised the definition to read: “poor-quality evidence (Level-IV or V studies with consistent findings) for or against recommending intervention.” The amended Grades of Recommendation are presented in Table I. We hope that this minor revision will make the Grades of Recommendation even easier for authors to use.

TABLE I Grades of Recommendation for Summaries or Reviews of Orthopaedic Surgical Studies

A Good evidence (Level-I studies with consistent findings) for or against recommending intervention
B Fair evidence (Level-II or III studies with consistent findings) for or against recommending intervention
C Poor-quality evidence (Level-IV or V studies with consistent findings) for or against recommending intervention
I There is insufficient or conflicting evidence not allowing a recommendation for or against intervention

References:

1. Wright JG, Einhorn TA, Heckman, JD. Grades of Recommendation. J Bone Joint Surg Am. 2005;87:1909-10

James G. Wright, M.D., MPH, FRCSC
Posted on September 30, 2005
Drs. Wright, Einhorn, and Heckman respond to Dr. Rama
The Journal of Bone & Joint Surgery, Needham, MA 02492

Dr. Rama states that Grades of Recommendation are “simple and useful for the busy clinician”. He is also correct that Grades of Recommendation are built on Levels of Evidence and, thus, are complementary to the efforts of JBJS to promote evidence-based orthopaedics. We appreciate Dr. Rama’s support for Evidence-based Orthopedics and the changes to JBJS.

In response to Dr. Rama’s specific comments, he first points out that if randomized trials have not been performed, then treatment recommendations arising from those studies cannot be Grade A. We agree.

Second, he correctly emphasizes that randomized trials, like all research studies can be generalized only to the specific study population. As such, any treatment recommendations must consider the study populations of interest and extrapolation beyond those studies would constitute expert opinion or Level V Evidence.

Thirdly, he points out that intermediate outcomes such as bacterial counts cannot be extrapolated to other endpoints such as surgical site infection. This is not an issue of Levels of Evidence or Grades of Recommendation but inappropriately extending results beyond conclusions specific to the study.

Finally, he comments on the difficulty of balancing risks and benefits of surgical procedures when evaluating the outcomes of surgical therapy. Although differing valuations of outcomes of surgical trials may lead to contradictory grades, more likely the trials themselves will have contradictory conclusions and hence require consistent Grade C Recommendations.

We thank Dr. Rama for his comments and look forward to wider adoption of Grades of Recommendation wherever orthopaedic review articles are published.

Krishna Reddi Boddu Siva Rama
Posted on September 10, 2005
Grades of Recommendations
R No: 636, Orthopaedic Biomechanics, Mechanical Engineering,Imperial College, London SW7 2AZ

To the Editor:

The recent introduction of “Grades of Recommendations” for review articles by The Journal is greatly appreciated (1). Such a simple classification will be very useful for a busy orthopaedic surgeon in obtaining guidance about treatment recommendations. Moreover, such a grading standardizes the conclusions of the authors of review articles.

However, the proposed grading system is merely an extrapolation of the ‘JBJS Levels of Evidence’ (2). Henceforth, a few words of caution are necessary for readers before assimilating the grades of recommendation into clinical practice.

First, although randomized controlled trials are widely accepted as the gold standard for obtaining the highest level of evidence, such trials may not be feasible in all instances (3). For example, we may never obtain "Level-I" evidence for the effectiveness of laminar air flow theatres in reducing the infections in major joint arthroplasties and so the grade of recommendation for such an intervention may never be ‘A’ in the proposed grading system.

The second issue is generalizability of the evidence. Results of the randomized controlled trials conducted in a narrow group of patients cannot always be generalized to the wider population. It is essential to clearly define the specific settings and the particular groups of the patients to which the grades of recommendation are applicable.

The third issue is the directness of the evidence. For example, a rise in the bacterial count in the operative field may not necessarily prove an increased risk of infection. It is advisable to provide the directness of the evidence also while stating the grades of recommendations.

Finally, irrespective of the level of evidence and its consistency, a judgment about the balance between the benefits and harms of an intervention must influence the type of recommendation in some instances, and so the recommendation may be more subjective or author dependent. This means that consistent findings of Level-I studies have the potential to lead to contradictory recommendations of high grade (grade A) by different authors.

Such limitations should always be considered by readers while interpreting these grades of recommendations. Nevertheless, this initiative of The Journal in extending its evidence based approach is highly acclaimed.

References:

1. Wright J, Einhorn T, Heckman J. Grades of recommendation. J Bone Joint Surg Am. 2005;87(9):1909-10.

2. http://www.ejbjs.org/misc/public/instrux.shtml#levels (accessed on September 8, 2005)

3. McLeod RS, Wright JG, Solomon MJ, Hu X, Walters BC, Lossing A. Randomized controlled trials in surgery: Issues and problems. Surgery. 1996;119(5):483-6.

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