PROMIS Pediatric - Fatigue

Last Updated

November 01, 2018

Purpose

Domain focused, self-reported and parent-reported measures of global, physical, mental, and social health for children in the general population and those living with a chronic condition.

Link to Instrument

Instrument Details

Area of Assessment

Sleep
General Health

Assessment Type

Patient Reported Outcomes

Cost

Free

Actual Cost

$0.00

Cost Description

Free for short forms, $499.99 annual subscription for NIH toolbox

CDE Status

Availability

The instrument is freely available here: PROMIS website.

See General Page for currently available PROMIS Bank CDE Details.

Classification

Supplemental - Highly Recommended: Stroke, Congenital Muscular Dystrophy (CMD) in studies of psychosocial functioning, quality-of-life, outcome, and long-term adjustment studies.

Supplemental: Traumatic Brain Injury (TBI), Amyotrophic Lateral Sclerosis (ALS), Chiari I Malformation (CM), Epilepsy, Friedreich's Ataxia (FA), Headache, Huntington's Disease (HD), Mitochondrial Disease (Mito), Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromuscular Diseases (NMD), Duchenne/Becker Muscular Dystrophy (DMD/BMD), Spinal Muscular Atrophy (SMA), Parkinson's Disease (PD), Stroke, and Spinal Cord Injury (SCI), and Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH)

Exploratory: Cerebral Palsy (CP) Myotonic Muscular Dystrophy (DM) and Facioscapulohumeral Muscular Dystrophy (FSHD) and Sport-Related Concussion (SRC)

*Headache specific subtest recommendations : Anxiety (Adult/Pediatric), Depression (Adult/Pediatric), Sleep (Adult)

Pediatric Disorders

Usually 4-12 items for each section domain depending on which type of test is being
performed (Short Form, CAT, or Profile)
Minimum and maximum scores depends on the form being used
Scoring: Item-levels are scored numerically for an individual's response to each question. PROMIS recommends the best way to find the total raw score is using
the free HealthMeasures Scoring Service
(https://www.assessmentcenter.net/ac_scoringservice) or a tool that can automatically
calculate scores. Scores can also be added up by hand to find the total raw score.
Then the raw score is converted to a T-score using the table in the Appendix of the link
below. This standardizes the score with a mean of 50 and standard deviation of 10.
Being above or below the standard deviation could be desirable or undesirable based on the domain being measured.
Higher scores means more of the concept being measured. Example = more fatigue

Number of Items

Pediatric
• Item bank: 25
• Short form: 10
Parent proxy report for pediatric patients
• Item bank: 23
• Short form: 8
Computer adaptive tests (CAT)
Items dynamically selected for administration from the item bank based on respondent’s previous answer. Usually between 4-12 items or questions.

5 minutes

Required Training

No Training

Preschool Children

2 - 5

years

Child

6 - 12

years

Adolescent

13 - 17

years

Instrument Reviewers

Holly O’Hearn, SPT

Jensyn Bradley SPT, ATC, LAT

Chi-Lun Chiao, SPT

Holt McPherson, SPT

Kenna Peters, SPT

Corinne Woodbine, SPT

Duke University, School of Medicine, Division of Physical Therapy.

ICF Domain

Body Function

Measurement Domain

General Health

Considerations

PROMIS measures can be used in the general population and with pediatric populations with a chronic condition(s)
PROMIS measures have a larger range of measurement than most conventional measures, decreasing floor and ceiling effects as a result
PROMIS measures have fewer items than conventional measures, thereby decreasing respondent burden. When used as computer adaptive tests, PROMIS measures usually require 4-6 items for precise measurement of health-related constructs
Translations: The assessments are available via PDF in Spanish and can be obtained in other languages by contacting translations@Healthmeasures.net

Minimally Clinically Important Difference (MCID)

Nephrotic Syndrome: Selewski et al, 2017; n=127; Age Range=8-17; Severity= active nephrotic syndrome

MID = 3

Pediatric PROMIS Domain	Adjacent Categories	Mean MID (SD) for pwJIA
Fatigue
Mild Problems	4 (3.44)
Moderate Problems	3.65 (3.56)
Severe Problems	5.43 (3.32)

Cut-Off Scores

Juvenile Idiopathic Arthritis: (Morgan et al 2017; n=4; Age Range=15-20; Severity = no problems/mild problems, mild/moderate problems, moderate/severe problems)

Pediatric PROMIS Domain	Adjacent Categories	Pediatric patients with JIA Classifications
Fatigue	No Problems	<45
Mild Problems	45-60
Moderate Problems	61-70
Severe Problems	>70

Normative Data

Diverse Pedatric Sample

Dewitt et al, 2011; n=3048; age=8-17; Diverse Sample of Pediatric Patients

- Mean (SD) Pediatric PROMIS = 50 (10)

Nephrotic Syndrome: Selewski et al, 2017; n=127; Age Range=8-17; Severity= active nephrotic syndrome

Baseline
- Mean score (n=127): 49.6 (12.6)
Event visit [occurred after remission or 3-months post baseline]
- Mean score (n=112): 43.4 (12.7)
Final visit [12-months post-baseline]
- Mean score (n=90): 43.3 (13.4)

Cancer

Macpherson et al, 2018; n=96; Age= 8-18; recently diagnosed with cancer and receiving chemotherapy, short form adolescent and children form respectively

Baseline mean score: 53 and 51.3
Count nadir mean score: 53.7 and 51.4
End of round 1 of chemotherapy mean score: 46.7 and 48.4

Test/Retest Reliability

General population: (Varni et al, 2014; n=331; age= 12.1; General Pediatrics)

Excellent test-retest Reliability for short form (ICC = .76)
Excellent test-retest Reliability for CAT (ICC = .80)

Internal Consistency

Cancer: Macpherson et al, 2018, n=96; Age= 8-18; recently diagnosed with cancer and receiving chemotherapy:

- Excellent Internal Consistency

Cronbach Alpha

	T1	T2	T3
PROMIS-C	0.94	0.93	0.94
PROMIS-A	0.96	0.96	0.96

General: (Varni et al, 2014)

Excellent Internal Consistency (Cronbach’s Alpha= 0.87)

Childhood-Onset Systemic Lupus Erythematosus (SLE)

Jones, 2017; n=100 (at visit baseline); Age=15.8 (2.2)

Excellent internal consistency for PROMIS-Short Form pooled across all visits: (Cronbach’s Alpha = 0.97)

Criterion Validity (Predictive/Concurrent)

Cancer: Macpherson et al, 2018, n=96; Age= 8-18; recently diagnosed with cancer and receiving chemotherapy:

- Concurrent Validity: Consistently strong correlation with the legacy

fatigue measures across all three collection points between the FS-A and the PROMIS measure and moderate to strong between the FS-C and the PROMIS measure.

Fatigue Scale-Child

Fatigue Scale-Adolescent

Measure	N	Correlation	P	N	Correlation	P
PROMIS T1	28	0.65	0.0002	58	0.85	<0.0001
PROMIS T2	24	0.88	<0.0001	52	0.9	<0.0001
PROMIS T3	26	0.75	<0.0001	52	0.89	<0.0001

Construct Validity

Nephrotic Syndrome: Selewski et al, 2017; n=127; Age Range=8-17; Severity= active nephrotic syndrome

- Adequate correlation with Peds QL Physical Functioning (ρ=-.65)
- Adequate correlation with Peds QL Emotional Functioning (ρ=-.57)
- Poor correlation with Peds QL Social Functioning (ρ=-.48)
- Adequate correlation with Peds QL School Functioning (ρ=-.59)
- Adequate correlation with overall health-related QOL (ρ=-.73)

Childhood-Onset Systemic Lupus Erythematosus (SLE)

Jones, 2017; n=100 (at visit baseline); Age=15.8 (2.2)

Bivariate correlation (r_pool) between pediatric PROMIS short forms and legacy measure subscalesa

Legacy measures	Fatigue
SLEDAI‐2K	0.11
BILAGb	0.08
MD‐globalc	0.08
SDId	−0.01
Functional Disability Inventory	0.62e
PedsQL‐GC
-Summary score	−0.78e
-Physical function	−0.70e
-Emotional function	−0.67e
-Social function	−0.54e
-School function	−0.71e
PedsQL‐RM
-Summary score	−0.74e
-Pain and hurt	−0.72e
-Daily activity	−0.53e
-Treatment	−0.51e
-Worry	−0.53e
-Communication	−0.49e
SMILEY
-Summary score	0.28
-Effect on self	0.39e
-Limitations	0.03
-Social	−0.54e
-Burden of childhood‐onset SLE	0.36e
C‐HAQ
-Summary score	0.42e
-Dressing/grooming	0.42e
-Arising	0.46e
-Eating	0.38e
-Walking	0.36e
-Hygiene	0.43e
-Reach	0.46e
-Play	0.53e
-Grip	0.44e
CHQ‐PF50
-Psychosocial summary score	−0.36e
-Physical summary score	−0.37e
-Physical functioning	−0.35e
-Bodily pain	−0.41e
-General health perception	−0.25
-Role/social‐physical	−0.28
-Role/social‐emotional/behavioral	−0.35e
-Self‐esteem	−0.35e
-Mental health	−0.37e
-Behavior	−0.25
-Mental health	−0.37e

^a Values are the pooled correlation coefficients (r_pool) across visits (n = 280 patient visits). PROMIS = Patient‐Reported Outcomes Measurement Information System; SLEDAI‐2K = Systemic Lupus Erythematosus Disease Activity Index 2000; BILAG = British Isles Lupus Assessment Group index; MD‐global = physician global disease assessment; SDI = Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; PedsQL‐GC = Pediatric Quality of Life Generic Core Scale 4.0; PedsQL‐RM = Pediatric Quality of Life Rheumatology Module 3.0; SMILEY = Simple Measure of Impact of Lupus Erythematosus in Youngsters; C‐HAQ = Childhood Health Assessment Questionnaire; CHQ‐PF50 = Child Health Questionnaire with 50 questions.
^b Scoring: A = 12, B = 8, C = 1, D = 0, E = 0.
^c On a 10‐point Likert scale, where 0 = inactive disease.
^d Range 0–47, where 0 = absence of damage.
^e P < 0.001 and r > 0.30.

Floor/Ceiling Effects

General: (Varni et al, 2014)

Domains in which higher scores indicate higher functioning (Peer relations, Mobility, and Upper Extremity) display a ceiling effect.
Domains in which higher scores indicate lower functioning have a floor effect

Responsiveness

General population: (Varni et al, 2014; n=331; age= 12.1; General Pediatrics)

Effect size: -0.14 to -0.10

Bibliography

Dewitt, E.M., Stucky, B.D., Thissen, D., Irwin, D.E., Langer, M., Varni, J.W., Lai, J.S., Yeatts, K.B., Dewalt, D.A. (2011). Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: Built using item response theory. Journal of Clinical Epidemiology, 64(7), 794-804. doi:10.1016/j.jclinepi.2010.10.012

Jones, J.T., Carle, A.C., Wootton, J., Liberio, B., Lee, J., Schanberg, L.E., Ying, J., Dewitt, E.M., Brunner, H.I. (2017). Validation of Patient-Reported Outcomes Measurement Information System Short Forms for Use in Childhood-Onset Systemic Lupus Erythematosus. Arthritis care & research, 69(1), 133–142. doi:10.1002/acr.22927

Macpherson, C. F., Wang, J., DeWalt, D. A., Stern, E. D., Jacobs, S., & Hinds, P. S. (2018). Comparison of Legacy Fatigue Measures With the PROMIS Pediatric Fatigue Short Form. Oncology Nursing Forum, 45(1), 106+. Retrieved from https://link-galegroup-com.proxy.lib.duke.edu/apps/doc/A544711043/AONE?u=duke_perkins&sid=AONE&xid=49f27c4f

Morgan, E.M., Mara, C.A., Huang, B., Barnett, K., Carle, A.C., Farrell, J.E., Cook, K.F. (2017). Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers. Quality of Life Research, 26(3), 565–586. doi:10.1007/s11136-016-1468-2

Selewski, D. T., Troost, J. P., Cummings, D., Massengill, S. F., Gbadegesin, R. A., Greenbaum, L. A.,Shatat, I.F., Cai, Y., Kapur, G., Herbert, D., Somers, M.J., Trachtman, H., Pais, P., Seifert, M.E., Goebel, J., Sethna, C.B., Mahan, J.D., Gross, H.E., Herreschoff, E. Liu, Y., Carlozzi, N.E., Reeve, B.B., Dewalt, D. A., Gipson, D. S. (2017). Responsiveness of the PROMIS® measures to changes in disease status among pediatric nephrotic syndrome patients: a Midwest pediatric nephrology consortium study. Health and Quality of Life Outcomes, 15(1), 166. doi:10.1186/s12955-017-0737-2

Varni, J. W., Magnus, B., Stucky, B. D., Liu, Y., Quinn, H., Thissen, D., Gross, H.E., Huang, I.C.,Dewalt, D. A. (2014). Psychometric properties of the PROMIS pediatric scales: Precision, stability, and comparison of different scoring and administration options. Quality of Life Research, 23(4), 1233-43. doi:http://dx.doi.org.proxy.lib.duke.edu/10.1007/s11136-013-0544-0

Last Updated

Purpose

Link to Instrument

Area of Assessment

Assessment Type

Cost

Actual Cost

Cost Description

CDE Status

Number of Items

Required Training

Instrument Reviewers

ICF Domain

Measurement Domain

Considerations

Minimally Clinically Important Difference (MCID)

Cut-Off Scores

Normative Data

Test/Retest Reliability

Internal Consistency

Criterion Validity (Predictive/Concurrent)

Construct Validity

Floor/Ceiling Effects

Responsiveness

Bibliography

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