Clinical Validity of the PROMIS® Fatigue Item Bank across Diverse Clinical Samples, 2016, Cella et al

Andy

Andy

Senior Member (Voting rights)
Abstract
Objective
To evaluate the comparability and responsiveness of PROMIS Fatigue Item Bank across six chronic conditions.

Study Design and Setting
Individuals (n=1,430) with chronic obstructive pulmonary disease (COPD; n=125), chronic heart failure (CHF; n=60), chronic back pain (n=218), major depressive disorder (MDD; n=196), rheumatoid arthritis (RA; n=521), and cancer(n=310) completed assessments from the PROMIS fatigue item bank at baseline and a clinically-relevant follow-up. The cancer and arthritis samples were followed in observational studies; the other four groups were enrolled immediately prior to a planned clinical intervention. All participants completed global ratings of change at follow-up. Linear mixed effects models and standardized response means were estimated to examine clinical validity and responsiveness to change.

Results
All patient groups reported more fatigue than the general population (range = 0.2 – 1.29 SD worse). The four clinical groups with pre-treatment baseline data experienced significant improvement in fatigue at follow-up (effect size range= 0.25 to 0.91). Individuals reporting better overall health usually experienced larger fatigue changes than those reporting worse overall health.

Conclusion
The results support the PROMIS fatigue measures’s responsiveness to change in six different chronic conditions. In addition, these results support the ability of the PROMIS fatigue measures to compare differences in fatigue across a range of chronic conditions, thereby enabling comparative effectiveness research.

Paywall, https://www.jclinepi.com/article/S0895-4356(16)00149-9/fulltext
Open access, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4902759/
 
Having tried it, it's yet another useless tool. Only 4 questions, they are oddly phrased and do not add anything more than a simple 0-100 scale would. Actually it's less than that because it uses arbitrary qualifiers instead of numbers.

I don't see the point in doing this, it adds absolutely nothing. This is a waste of people's time.

This, except for questionnaires and unlike technical standards they are useless, but this:

standards.png
 
The PROMIS Fatigue instrument (PROMIS Short Form v1.0 - Fatigue 7a) has been evaluated in CDC's ME/CFS multi-site study and reported in this 2019 Yang paper. I understand it's being advanced in FDA qualification studies as an outcome measure for ME but don't know the status of those studies.

Yang claimed this PROMIS Fatigue instrument is responsive to change and has "minimal to almost no ceiling/floor effects." But these statements underplay/ignore significant limitations in the proxy measures of functional limitations used to evaluate this instrument in the study. The authors acknowledge these limitations in the limitations section but the points don't make it into the conclusion.

Details:
The paper concludes:
Study findings support the reliability and validity of PROMIS F-SF as a measure of fatigue for ME/CFS and lend support to the drug development tool submission for qualifying this measure to evaluate therapeutic effect in ME/CFS clinical trials, which is an important step toward developing FDA-approved treatment for this debilitating illness.​
In the discussion, it also stated
The PROMIS F-SF showed strong reliability and validity to assess fatigue outcome for ME/CFS participants by demonstrating good internal consistency, minimal to almost no floor/ceiling effects at the total score level, good known- groups validity with medium-to-large effect sizes, and acceptable responsiveness to change with small-to-medium effect sizes​

The proxy measures of functional impairment used to evaluate responsiveness to change and ceiling/floor effects included hours of vertical "feet-on-the-floor" activity (as opposed to just sitting up in bed) and hours of horizontal (feet up) activity. The maximum allowable value recorded for each was 15 or more hours - that is. a bedbound patient would be recorded as >15 hours horizontal/day, the same as someone who spent 16 hours horizontal a day.

The Yang limitations section acknowledges that 50% of the ME/CFS participants in the study had "the worst possible functional status at baseline” and that the study was unable to distinguish between stable status and a worsening. The authors acknowledged the need to identify other severity indicators with minimal floor/ceiling effects. The paper also acknowledges that the most severe patients were not likely to be in CDC's multisite study.

Note - to find the PROMIS Short Form v1.0 - Fatigue 7a, search for domain=fatigue on this page and then select fatigue 7a from the second page of search results
 
In these days of electronic wearables and apps for easily recording daily symptoms and activity levels, I think there is no excuse for using an easily manipulated subjective fatigue questionnaire to assess functional capacity and state of health in PWME. To use questions about how tired I feel as a proxy for my hours of upright activity which itself is a proxy for functional capacity which is itself only part of ME/CFS is misleading and unacceptable.
 
Medfeb said:
The PROMIS Fatigue instrument (PROMIS Short Form v1.0 - Fatigue 7a) has been evaluated in CDC's ME/CFS multi-site study and reported in this 2019 Yang paper. I understand it's being advanced in FDA qualification studies as an outcome measure for ME but don't know the status of those studies.

Yang claimed this PROMIS Fatigue instrument is responsive to change and has "minimal to almost no ceiling/floor effects." But these statements underplay/ignore significant limitations in the proxy measures of functional limitations used to evaluate this instrument in the study. The authors acknowledge these limitations in the limitations section but the points don't make it into the conclusion.

Details:
The paper concludes:
Study findings support the reliability and validity of PROMIS F-SF as a measure of fatigue for ME/CFS and lend support to the drug development tool submission for qualifying this measure to evaluate therapeutic effect in ME/CFS clinical trials, which is an important step toward developing FDA-approved treatment for this debilitating illness.​
In the discussion, it also stated
The PROMIS F-SF showed strong reliability and validity to assess fatigue outcome for ME/CFS participants by demonstrating good internal consistency, minimal to almost no floor/ceiling effects at the total score level, good known- groups validity with medium-to-large effect sizes, and acceptable responsiveness to change with small-to-medium effect sizes​

The proxy measures of functional impairment used to evaluate responsiveness to change and ceiling/floor effects included hours of vertical "feet-on-the-floor" activity (as opposed to just sitting up in bed) and hours of horizontal (feet up) activity. The maximum allowable value recorded for each was 15 or more hours - that is. a bedbound patient would be recorded as >15 hours horizontal/day, the same as someone who spent 16 hours horizontal a day.

The Yang limitations section acknowledges that 50% of the ME/CFS participants in the study had "the worst possible functional status at baseline” and that the study was unable to distinguish between stable status and a worsening. The authors acknowledged the need to identify other severity indicators with minimal floor/ceiling effects. The paper also acknowledges that the most severe patients were not likely to be in CDC's multisite study.

Note - to find the PROMIS Short Form v1.0 - Fatigue 7a, search for domain=fatigue on this page and then select fatigue 7a from the second page of search results
Click to expand...
Our discussion thread on this is here, Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with [ME/CFS], 2019, Yang et al
 
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