Dr Tucker's New Test Page

Dr. Douglas Tucker's Claim Comments

CLAIMS: 'Used appropriately' fMRI can provide useful information within the clinical contexts of pre-surgical mapping and disease diagnoses.

OBJECTIVE: The objective of the QIBA group is to characterize clinical uses of fMRI which are appropriate and to develop a standard of best practices (guidelines) pertaining to - paradigm development, representation, and management, - data acquisition, analysis and interpretation, and - facilities outfitting, staffing and management that will guide those clinical users (not scientists) to use fMRI in the most appropriate manner for their clinical context.

This largely boils down to answering questions generated by the usual suspects: who, what, when, where and how

• Who should be involved in these studies? This should address both the patient and the personnel conducting the study
  • For the patient, things like screening for suitability (can they follow directions? Can they actually move their fingers? Etc).
  • For personnel conducting the exam, what are the roles? For each role, what are the qualifications? Etc.
• What should be done? This should be stated in the context of goals for the study (for example, adult studies vs peds). This should include things like 'paradigm design should include measureable patient responses' so as to assess whether the patient is actually performing the task, and 'patient responses should be recorded' for obvious reasons. The fMRI exam should not be a fishing experiment -- that will lead to no good. There was lots of this discussion today cast in light of 'do I have enough data?' (When is it appropriate to trade clinical efficiency for …?)
• When should an exam be performed? There are competing technologies out there; when is fMRI the right choice? Is it a diagnostic tool? Or therapeutic management? Or something else?
• Where should it be conducted? Inpatient? Outpatient? Is 0.5T okay? Do I need a dedicated stimulation system? Is flashing the room lights okay?
• How should it be conducted? What are the steps involved? In setting up a program? Do I need dedicated personnel? Equipment? How should I conduct an exam? Is there a 'workflow' I can follow (perhaps checklists I can use to make sure I've done everything I need to do'

RATIONALE: QIBA needs to focus on use of the technology, and to standardize that practice.

• At the two extremes:
  • I think it is not appropriate for the QIBA group to validate clinical utility (indications for use, etc). That is for the professional societies (like ASFNR) to develop. QIBA should support that activity (i.e. for the proposed multi-site fMRI study, paradigms and data collection should be regimented in a manner consistent with QIBA, etc).
  • fMRI is not a quantitative procedure. It’s a big research project to try to establish fMRI as a quantitative test – nothing this group will ever solve. Trying to associate absolute measures (A Z score >= N, or activated volume >= V cc's) with a paradigm is inappropriate; it depends too much on the subject, the environment, etc.

IMO -The 'sweet spot' for QIBA lies between these ends...