About Tier Classified Guidelines Database
This database contains guidelines from the Genomics and Precision Health Database, sorted according to the highest evidence tier level that could be assigned to recommendations from each guideline. The sorting process is based on our previous method for classifying genomic applications (described in Clinical Pharmacology and Therapeutics, 2014), except that guideline documents rather than clinical scenarios are sorted according to evidence level. The previous Tier Table of Genomic Applications has been archived as an illustration of how the published method has been applied, however, it is no longer being updated. The purpose of both databases has been to help organize our horizon scanning results.
- FDA label requires use of test to inform choice or dose of a drug
- FDA cleared or approved companion diagnostic device
- CMS covers testing
- Clinical practice guidelines based on systematic review supports testing
- FDA label mentions biomarkers
- FDA premarket approval (PMA)
- FDA 510(k) substantially equivalent decision
- CMS coverage with evidence development
- Clinical practice guideline, not based on systematic review, supports use of test
- Clinical practice guideline finds insufficient evidence but does not discourage use of test
- Clinical practice guideline recommends dosage adjustment, but does not address testing
Frequently Asked Questions
What is, and is not, in the Tier-Classified Guidelines Database?Guidelines identified in weekly horizon scanning are included. While the Genomics and Precision Health Database of horizon scanning results classifies a guideline ‘product type’ to include: clinical, laboratory, and public health practice guidelines, summaries of guidelines and articles about guidelines, policy statements, etc., only clinical and public health practice guidelines are included in the Tier-Classified Guidelines Database. Although clinical scenarios themselves are not assigned a Tier level, at least one clinical scenario involving genetic testing must be the subject of a recommendation (either for or against use, or neither for nor against use with insufficient evidence findings) in order for a guideline to be assigned a Tier level and included in the database. In the future, it is expected that additional types of guidance, such as links to FDA drug labels and CMS coverage decisions, will be included in the database.
How are Tier Levels Assigned?Sorting is done using criteria (shown above) after reviewing titles and abstracts, and consulting the full text of articles when needed. Reviews are not rigorous, being done relatively quickly, and necessarily involve some degree of subjectivity. While some errors are likely in the process, at least two reviewers must agree on each Tier level classification. Reviewer disagreements are resolved through discussion, and additional reviewers may be called upon as needed for majority voting resolution.
What is the Practical Significance of a Tier Designation?The population of Tier 1 guidelines should be relatively enriched in genomic applications whose implementation has some support from evidence-informed processes (for example, practice guidelines based on systematic reviews, CMS coverage determinations, etc.). Tier 2 guidelines should likewise be enriched with genomic applications with there is support for implementation, but with more uncertainty, and Tier 3 with genomic applications where there are recommendations against implementation. It is important to remember that the highest Tier level is assigned to each guideline, so a Tier 1 guideline could include separate recommendations that meet criteria for Tiers 1, 2, and 3. Likewise, Tier 2 guidelines could include recommendations meeting criteria for Tiers 2 and 3.
What do the search results mean?Guidelines in the database that contain the search terms will be displayed in the search results. It is important to remember that the tier level is assigned to each guideline, NOT to the specific search terms. For example, a Tier 1 guideline has at least one recommendation that meets criteria for Tier 1, but also could include tier 2 or 3 recommendations.
DON’T rely on the overall tier level classification of the guideline for the specified search terms.