One or more of the following:

• Clear evidence of harm or ineffectiveness for the current DHI version
• The DHI is not clinically appropriate, per advice of clinical subject matter experts.
• The risk balance is unfavorable due to safety concerns, per subject matter experts.
• There are unaddressed concerns regarding misleading or false claims.

All of the following:

• Very low or low-quality evidence (per GRADE definitions; “very low” includes no evidence)
• Low clinical risk or well-managed risk with appropriate clinical rationale
• Plausibility of clinically meaningful impact relative to usual care (or an alternate, relevant comparator) OR noninferior clinical outcomes with plausible improvement in a domain such as access, health equity, user experience, or cost. Clinically meaningful impact is defined by an effect size magnitude at or above a minimal clinically important difference, as established in credible guidelines and/or peer-reviewed literature.

All of the following:

• Meets or exceeds all criteria for Actionability Level 1
• Low-to-moderate quality evidence (per GRADE definitions). Real-world evidence may be included.
• No or minimal uncertainty (per GRADE) around value to stakeholders (often patients and their families)

Acceptable or likely acceptable (per GRADE) to stakeholders

All of the following:

• Meets or exceeds all criteria for Actionability Levels 1-2
• Moderate-to-high quality evidence (per GRADE). Real-world evidence may be included.

All of the following:

• Meets or exceeds all criteria for Actionability Levels 1-3
• Two or more high-quality RCTs support efficacy and safety
• Preferred: One or more RCTs have 3rd-party data monitoring and analysis
• Preferred: Real-world evidence of safety and effectiveness