Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with [ME/CFS], 2019, Yang et al

[JemPD]

Oh for God's sake why do they keep coming up with these completely ineffectual tools.
Their understanding of the conditions they're studying & how to measure their effects is just abysmal.
And the useless tools proliferate & are celebrated.

Oh and the name of it is nauseating.

 

[Sly Saint]

not quite sure if this is related; does anyone know what it is?
DDT COA #000080: PROMIS® Fatigue Item Bank for ME/CFS/SEID
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

https://www.fda.gov/drugs/ddt-coa-000080-promisr-fatigue-item-bank-mecfsseid

 

[Medfeb]

From what I can tell, this is from the FDA office that deals with qualification of tools used as outcome measures in trials. It includes a communication to Keller, the submitter, about additional steps that are needed.

This page has a little more information on the clinical outcome assessment (COA) qualification process
https://www.fda.gov/drugs/drug-deve...ome-assessments-coa-qualification-submissions

The COA process appears to have been replaced by this Drug Development Tools qualification process
https://www.fda.gov/drugs/drug-development-tool-qualification-programs/ddt-qualification-process