Criteria for selection of study | Description of criteria |
---|---|
Minimum criteria | |
Included within statutory limits of Federal Coordinating Council’s definition of CER | Is the topic included within the definition of CER detailed in the mandate of the Recovery Act? |
Stakeholder/community interest | Does the topic answer to expressed needs and preferences of patients, clinicians, and other stakeholders? |
Feasibility | Are there available databases, registries, collaborations and resources to support study design? Are data from sufficient numbers of patients available for analysis? Do the data span sufficient time to evaluate desired outcomes? |
Evidence needed | Is the modality currently being used without adequate evidence? |
Primary criteria | |
Standards for modality and implementation of test results | Are guidelines in place for the various uses of this modality? Are existing guidelines evidence-based and unbiased? Are they consistently implemented by providers? |
Potential patient harm/safety concerns | What is the potential degree of harm (e.g., anxiety, radiation exposure, unnecessary treatment) an individual may experience from use of the modality? What are potential downstream harms from incorrect diagnosis using this modality? |
Diagnostic accuracy and efficacy potential | How accurate is the modality for disease diagnosis? Does the modality offer potential for changing patient treatment path or outcome? |
Economic impact | What is the estimated total direct cost per year (increase/decrease) of the modality and downstream treatments? |
Secondary criteria | |
Severity of condition treated/diagnosed by modality | Are significant morbidity, mortality, and/or disability associated with disease? |
Pressure on payers | Is there a high degree of pressure on payers to cover this modality, even though little evidence supports its use? |
Potential or observed variation | Does payer/provider use of modality vary widely? |
Diverse populations | Is there potential to evaluate CER in diverse populations and patient sub-groups affected by disease and/or modality? |
Overlap/redundancy | Is/has similar research being/been conducted elsewhere? |
Disease burden | How many persons are affected by disease per year? What is the disease cost to society? |
CER: Comparative effectiveness research.