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  2. PROMIS Pediatric - Fatigue

PROMIS Pediatric - Fatigue

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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

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: .

See  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)

Populations

Pediatric Disorders

Key Descriptions

  • 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.

Time to Administer

5 minutes

Required Training

No Training

Age Ranges

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

Pediatric Disorders

back to Populations

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 (rpool) between pediatric PROMIS short forms and legacy measure subscalesa

Legacy measures

Fatigue

 

SLEDAI‐2K

0.11

 

BILAG

0.08

 

MD‐global

0.08

 

SDI

?0.01

 

Functional Disability Inventory

0.62

 

PedsQL‐GC

  

 

-Summary score

?0.78

 

-Physical function

?0.70

 

-Emotional function

?0.67

 

-Social function

?0.54

 

-School function

?0.71

 

PedsQL‐RM

  

 

-Summary score

?0.74

 

-Pain and hurt

?0.72

 

-Daily activity

?0.53

 

-Treatment

?0.51

 

-Worry

?0.53

 

-Communication

?0.49

 

SMILEY

  

 

-Summary score

0.28

 

-Effect on self

0.39

 

-Limitations

0.03

 

-Social

?0.54

 

-Burden of childhood‐onset SLE

0.36

 

C‐HAQ

  

 

-Summary score

0.42

 

-Dressing/grooming

0.42

 

-Arising

0.46

 

-Eating

0.38

 

-Walking

0.36

 

-Hygiene

0.43

 

-Reach

0.46

 

-Play

0.53

 

-Grip

0.44

 

CHQ‐PF50

  

 

-Psychosocial summary score

?0.36

 

-Physical summary score

?0.37

 

-Physical functioning

?0.35

 

-Bodily pain

?0.41

 

-General health perception

?0.25

 

-搁辞濒别/蝉辞肠颈补濒‐辫丑测蝉颈肠补濒

?0.28

 

-搁辞濒别/蝉辞肠颈补濒‐别尘辞迟颈辞苍补濒/产别丑补惫颈辞谤补濒

?0.35

 

-厂别濒蹿‐别蝉迟别别尘

?0.35

 

-Mental health

?0.37

 

-Behavior

?0.25

 

-Mental health

?0.37

 
  • a Values are the pooled correlation coefficients (rpool) 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

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