Hayes Rating
The Hayes Rating, a proprietary rating system, reflects the strength and direction of the evidence regarding the safety and efficacy of a medical technology (procedure, test, device, biologic, or drug), its impact on health outcomes, indications for use, patient selection criteria, and comparison with other technologies. The ratings are scaled A through D and are defined as follows:
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A
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Established benefit. A high level of positive published evidence regarding safety and efficacy supports use of the technology for the cited application(s). Drugs, biologics, and devices with an A rating have FDA approval, but not necessarily for the specific clinical application. |
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B
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Some proven benefit. A moderate level of positive published evidence regarding safety and efficacy supports use of the technology for the cited application(s). Further research is required to fully clarify clinical indications, contraindications, treatment parameters, comparison with other technologies, and/or impact on health outcomes. Drugs, biologics, and devices with a B rating have FDA approval, but not necessarily for the specific clinical application. |
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C
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Potential but unproven benefit. Some positive published evidence regarding safety and/or efficacy support use of the technology for the cited application(s), but a beneficial impact on health outcomes has not been proven because data are sparse and the level of evidence is low, or data are inconsistent or conflicting. |
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D
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No proven benefit and/or not safe. This rating conveys one of two conclusions: (1) The technology has been shown to be unsafe and/or published evidence does not show that its use improves health outcomes; or (2) The research regarding use of the technology is so limited that an appraisal of safety and efficacy cannot be made. |