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Hayes Rating
The Hayes Rating system, developed by Winifred S. Hayes, Inc., reflects the strength and direction of the evidence regarding a medical technology (procedure, test, device, biologic, drug, intervention, process, or program), including safety and efficacy, impact on health outcomes and patient management, indications for use, and patient selection criteria compared with the standard treatment/testing. Hayes Ratings are scaled A through D1 and D2 and are defined as follows:
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A
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Established benefit. Published evidence shows conclusively that safety and impact on health outcomes are comparable to or better than standard treatment/testing. Long-term safety and impact on health outcomes have been established, and other important questions concerning application of the technology have been answered. Drugs, biologics, and devices with an A rating have FDA approval, but not necessarily for the specific clinical application(s) under consideration. |
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B
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Some proven benefit. Published evidence indicates that safety and impact on health outcomes are at least comparable to standard treatment/testing. However, there are outstanding questions regarding long-term safety and impact on health outcomes, clinical indications, contraindications, optimal treatment/testing parameters, and/or effects in different patient subpopulations. Drugs, biologics, and devices with a B rating have FDA approval, but not necessarily for the specific clinical application(s) under consideration. |
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C
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Potential but unproven benefit. Some published evidence suggests that safety and impact on health outcomes are at least comparable to standard treatment/testing. However, substantial uncertainty remains about safety and/or impact on health outcomes because of poor-quality studies, sparse data, conflicting study results, and/or other concerns. |
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D1
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No proven benefit. Published evidence shows that the technology does not improve health outcomes or patient management for the reviewed application(s) or is unsafe. |
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D2
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Insufficient evidence. There is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management. |
NOTE: Reports published before August 2011 may contain a D Rating, which represents a combined D1/D2 Rating. In these reports, there is accompanying text that clarifies whether the D Rating is based on evidence of lack of benefit and/or safety issues, or whether there is insufficient evidence to assess either benefit or safety.
