How to use QIBA Profiles

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QIBA Profiles are published at several stages of increasing maturity and confidence.

Even at the earliest publication stage, significant thought, investigation and expert opinion have already gone into each QIBA Profile, making it useful to many users already.

Profile stages are intended to communicate the stage of maturity or confidence clearly and allow users to make their own choice about what meets their needs.

Public Comment

  • Use the profile as a source of expert thinking to understand considerations that may affect your performance for this biomarker. It will help you draft or modify your current procedures, whether you are using those in research, clinical trials or clinical practice. Please consider providing feedback as public comments so they can be addressed in the Consensus Stage.
  • A Public Comment Profile was developed using data collected in a number of groundwork projects and represents the expert opinions of QIBA participants.
    • the discussion sections will tell you what QIBA experts think are the key factors that influence the quality of your biomarker values
    • the specification sections will tell you what QIBA experts think are practical behaviors to address those factors
    • the claim will give you an estimate of what QIBA experts think is achievable in terms of performance.
      • If you are assuming better performance and are not constraining more tightly, you may want to re-evaluate/re-confirm your assumptions and estimates.
  • Note that the profile contains opinions of the QIBA experts, but these opinions have not yet been vetted externally; the profile text may change during the Consensus process.

Consensus

  • Use the profile as a basis for your own biomarker procedure.
  • A Consensus Profile represents a consensus procedure based on input and comments from a broad community or experts and practitioners.
    • You should not expect any factors that have not been mentioned in the Profile
    • the discussion sections will tell you the key factors that influence the quality of your biomarker values
    • the specification sections will tell you what QIBA experts think are practical behaviors to address those factors
    • the claim will give you an estimate of what QIBA experts think is achievable in terms of performance.
  • Note that a community of people have reviewed the requirements and believe them to be practical and effective, but no site has yet generated the biomarker by following the requirements as written in the profile; requirements may be revised to address any practical issues discovered during the Technical Confirmation process.

Technically Confirmed

  • Use the profile as your biomarker procedure.
  • A Technically Confirmed profile represents a procedure that was read, executed and confirmed to be practical by several sites.
    • You should not expect any problems reading/understanding the profile
    • You should not expect any problems performing the requirements
      • Some Profile requirements let sites to choose how to achieve the stated requirement based on their current practices, preferences and equipment. This too is vetted to confirm tractable solutions were found. If you have troubles, you might contact one of the TC sites to find out what they did. And let QIBA know. If several sites had troubles, QIBA will have added some explanatory text to the profile.
  • Note that several sites have made measurements following the profile requirements and found them to be understandable and practical, but their performance was not measured or compared to the claim; requirements and the claim may be revised to address any issues discovered during the Claim Confirmation process.

Claim Confirmed

  • Use the profile as your biomarker procedure and use the claim as a reasonable estimate of your performance
  • A Claim Confirmed profile represents a procedure that executed by several sites who's performance was measured and found to match the claimed performance.
  • Note that several sites have demonstrated the claim performance by following the profile requirements, but the performance has not been (validated? statistically proven? Qualified?) in a study involving a wide range of sites; requirements and the claim may be revised to address any issues discovered during the Clinical Confirmation process.