Development, validation, qualification, and dissemination of quantitative MR methods: Overview and recommendations by...

Area of Science:

• Medical Imaging
• Biophysics

Background:

• Quantitative MR (qMR) methods are increasingly important for clinical applications.
• Development and validation processes for qMR methods require clear guidelines.

Purpose of the Study:

• To provide an overview of considerations for developing, validating, qualifying, and disseminating qMR methods.
• To offer essential guidelines for trainees, researchers, and clinicians.
• To highlight potential pitfalls in qMR method dissemination.

Main Methods:

• The article frames the qMR development process around technical performance properties: bias and precision.
• Illustrative examples include liver proton-density fat fraction quantification and cardiac T1 quantification.
• Discussion covers iterative development and validation of qMR methods.

Main Results:

• Methods with low bias and high precision can be iteratively developed and validated despite confounding factors.
• Examples demonstrate the expansion of qMR methods from research to clinical settings.
• Key considerations for successful dissemination are discussed.

Conclusions:

• Establishing clear guidelines is crucial for the reliable development and validation of qMR methods.
• Successful dissemination requires careful attention to technical performance and potential challenges.
• This work supports the broader adoption of qMR in research and clinical practice.