HelpDesk Answers Evaluating the Evidence (Strength of Recommendations) Corey Lyon, D.O. University of Colorado

Objectives Gain an understanding for use of Strength of Recommendations (SOR) Exposure to the algorithm for assigning a SOR Practice assigning a SOR to a clinical recommendation

Strength of Recommendation (SOR) A recommendation for clinical practice based on a body of evidence Takes into account the level of evidence of individual studies Type of outcomes measured (patient-oriented or disease-oriented) This is a straightforward, comprehensive, user friendly grading system. Created by family physicians to be used in the family medicine literature.

Critical Components of an HDA Clinical Question Evidence Based Answer (35-75 words, with SOR grade) Evidence Summary (250-350 words) References (100-200 words, with LOEs) Handout #1 – example manuscript Note that the Evidence Based Answer needs to have a SOR assigned to it, which shows the reader what type of evidence the answer is drawn upon. 4

Strength of Recommendations All Help Desk Answers need a SOR grade, which is based on the body of evidence from the Evidence Based Summary Assigning a SOR to your clinical answer guides readers on the strength of the recommendation based on the available evidence In your Evidence Based Answer, every SOR needs an explanatory phrase explaining why the grade was given For example; “SOR A, based on 2 RCTs with consistent findings”

Strength of Recommendation –Definitions The Evidence-based Answer is assigned a Strength of Recommendation (SORT) grade, followed by an explanatory phrase. HDAs use AAFP’s patient centered method of grading the answer. http://www.jfponline.com/Pages.asp?AID=1635 Instruct attendees to turn to the SOR chart in the author handbook http://www.jfponline.com/Pages.asp?AID=1635 6

Algorithm for determining the strength of recommendation based on a body evidence

SOR Example 1 – Assign the SOR Assign a SOR to this Recommendation: “Mechanical intervention with a back brace is effective for low back pain.” This recommendation is based on a Cochrane review of 7 clinical trials that are consistent in their support of a mechanical intervention for low back pain, but the trials were poorly designed (ie, unblinded, nonrandomized, or with allocation to groups unconcealed). SOR A SOR B SOR C ASK GROUP TO TURN TO THE SORT DIAGRAM IN THE AUTHOR’S HANDBOOK 8 8

SOR Example 1 – Assign the SOR Assign a SOR to this Recommendation: “Mechanical intervention with a back brace is effective for low back pain.” This recommendation is based on a Cochrane review of 7 clinical trials that are consistent in their support of a mechanical intervention for low back pain, but the trials were poorly designed (ie, unblinded, nonrandomized, or with allocation to groups unconcealed). SOR A SOR B – consistent, but lower quality trials SOR C ASK GROUP TO TURN TO THE SORT DIAGRAM IN THE AUTHOR’S HANDBOOK 9 9

SOR Example 2 – Assign the SOR Recommendation: “Drug A is an effective treatment in pulmonary fibrosis.” This recommendation is based on a meta-analysis of 9 high-quality clinical trials of the use of this new Drug A in the treatment of pulmonary fibrosis. Two of the studies find harm, 2 find no benefit, and 5 show some benefit. The strength of recommendation in favor of this drug would be? SOR A SOR B SOR C 10 10

SOR Example 2 – Assign the SOR Recommendation: “Drug A is an effective treatment in pulmonary fibrosis.” This recommendation is based on a meta-analysis of 9 high-quality clinical trials of the use of this new Drug A in the treatment of pulmonary fibrosis. Two of the studies find harm, 2 find no benefit, and 5 show some benefit. The strength of recommendation in favor of this drug would be? SOR A SOR B – High quality trials with inconsistent results SOR C 11 11

SOR Example 3 – Assign the SOR Recommendation: “Drug A increases the forced expiratory volume in 1 second (FEV1) and peak flow rate in patients with an acute asthma exacerbation.” This recommendation is based on a RCT of good quality, however, data on symptom improvement is lacking. The strength of recommendation in favor of using this drug is? SOR A SOR B SOR C 12 12

SOR Example 3 – Assign the SOR Recommendation: “Drug A increases the forced expiratory volume in 1 second (FEV1) and peak flow rate in patients with an acute asthma exacerbation.” This recommendation is based on a RCT of good quality, however, data on symptom improvement is lacking. The strength of recommendation in favor of using this drug is? SOR A SOR B SOR C – Disease oriented evidence 13 13

SOR example 4 - Assign the SOR Recommendation: “Vitamin E should not routinely be used to prevent heart disease” An observational study suggested cardiovascular benefit from vitamin E, but this recommendation against using vitamin E is from 2 separate large, well-designed RCT with a diverse patient population which showed no benefit, and actually showed more harm. The strength of this recommendation would be? SOR A SOR B SOR C

SOR example 4 - Assign the SOR Recommendation: “Vitamin E should not routinely be used to prevent heart disease” An observational study suggested cardiovascular benefit from vitamin E, but this recommendation against using vitamin E is from 2 separate large, well-designed RCT with a diverse patient population which showed no benefit, and actually showed more harm. The strength of this recommendation would be? SOR A- based on 2 RCTs with consistent findings SOR B SOR C

Summary Assigning a SOR to a recommendation guides readers on the strength of the recommendation based on the body of evidence An A recommendation is based on consistent, good quality patient oriented evidence A B recommendation is based one inconsistent, or limited quality patient oriented evidence A C recommendation is based on consensus, disease-oriented evidence, or opinion

Summary (cont.) All Help Desk Answers need a SOR grade, with an explanatory phrase explaining why the grade was given For example; (SOR A, based on a systematic review of RCT) The SOR can be assigned by using the SOR algorithm based on a body of evidence

Reference Ebell M, Siwek J, Weiss B, Woolf S, Susman J, Ewigman B, Bowman M. Strength of Recommendation Taxonomy (SORT): A Patient-Centered Approach to Grading Evidence in the Medical Literature. American Family Physician, Feb 2004;69(3); 548-556