H |
Key Question
What evidence of safety or assessment of potential harms is available ?
• Pre-market evidence ?
• Post-market evidence ?
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Examples of What to Include
Review FDA submissions . Also review harm assessments in published data , if available ( e . g ., observational studies and RCTs ). Consider reviewing harms in additional locations ( see node O ).
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Dates / Timeframes for Data Source |
Comments |
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I |
What is the assessment of the balance of harms vs . benefits ? |
Review the evidence available to summarize the risks and benefits related to the product . Summarize risk / benefit from patient , provider , and system-level perspectives . |
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J |
Is it equivalent or superior to established alternatives ( standard of care )? |
Describe the context of the study performance . What were the standards of care when the product was reviewed ? Does the study evaluate compliance with these standards of care ? |
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K |
Is there a demonstrated impact when the product is used alone or as part of a bundle ? |
Is this device or product evaluated in addition to bundle elements or in place of one of the bundle elements ? Is the impact measurable or reported outside of this bundle ? |
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L |
Are the findings generalizable to a product class at the time the evidence is reviewed ? |
e . g ., active ingredients , mechanism of action , product design , instructions for use , etc . |
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M |
Does evidence support generalizability across settings , environments , populations ? |
Is the harm and benefit assessment the same across patients , outbreak and non-outbreak settings , etc .? Is it the same across neonatal and adult populations ? |
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N |
What are the resource implications ? |
Include human , materials , education and training , and financial costs ( including purchase , repair , maintenance ). |