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  2. PROMIS-Sleep Disturbance

PROMIS-Sleep Disturbance

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Purpose

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

Link to Instrument

Acronym PROMIS S-D

Area of Assessment

Sleep

Assessment Type

Patient Reported Outcomes

Cost

Free

Actual Cost

$0.00

Cost Description

Free to use forms, NIH toolbox app costs $499 annual subscription

CDE Status

NINDS CDE Notice of Copyright
PROMIS Item Bank v1.0 - Sleep Disturbance
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

Musculoskeletal Conditions
Spinal Injuries
Mixed Populations
Mental Health
Cancer
Arthritis

Key Descriptions

  • Short Form and computer adaptive test (CAT)
  • Higher scores means more of the concept being measured. Example = more sleep disturbance

Number of Items

27 items in bank
4, 6, 8 item short forms

Time to Administer

5 minutes

Required Training

No Training

Age Ranges

Adult

18 - 64

years

Elderly Adult

+

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 adults and 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

Spinal Injuries

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Minimally Clinically Important Difference (MCID)

Lumbar Degenerative Disease Undergoing Decompression with or without Arthrodesis: (Purvis et. al., 2018. n= 231, mean age= 59 years (13))

   - PROMIS MID estimate for sleep disturbance: -6.5.

Criterion Validity (Predictive/Concurrent)

CONCURRENT

Lumbar Degenerative Disease Undergoing Decompression with or without Arthrodesis: Purvis et al, (2018)

     - Strong correlation between PROMIS anxiety, depression, fatigue, and sleep disturbance with GAD-7 (r>= 0.60).

     - Strong correlation between PROMIS anxiety, depression, fatigue, and sleep disturbance with PHQ-8 (r>=0.60)

Responsiveness

Lumbar Degenerative Disease Undergoing Decompression with or without Arthrodesis: Purvis et al, (2018)

-PROMIS sleep disturbance showed moderate responsiveness when measured by effect size

Cancer

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Normative Data

Cancer: (Leung et al. 2016, n=336, age= 57.44?±?15.71, cancer patients (mixed) from outpatient clinic setting, CAT)

  • Mean score: 51.27?±?9.51

Test/Retest Reliability

Cancer: (Leung et al. 2016, n=336, age= 57.44?±?15.71, cancer patients (mixed) from outpatient clinic setting, CAT)

  • Excellent test retest reliability (ICC=0.92)

Internal Consistency

Cancer: (Leung et al. 2016, n=336, age= 57.44?±?15.71, cancer patients (mixed) from outpatient clinic setting, CAT)

  • Excellent internal consistency (Cronbach’s Alpha: 0.842)

Mixed Populations

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Normative Data

Kidney Transplant Recipients: (Tang, et. al., 2019, n=77, 58% male, age=50.6 (17.0) years, adults who received a kidney transplant >30 pre-enrollment )

Distribution of PROMIS scores by domain (n=168)

 

Mean

SD

Median

25%

75%

Min

Max

PROMIS-57

47.62

10.53

47.3

40.4

54.3

30.5

77.6

PROMIS-29

47.54

9.76

48.4

41.1

54.2

32.0

73.3

Test/Retest Reliability

Kidney Transplant Recipients: (Tang, et. al., 2019. n= 177, mean age= 50 (17))

  • Excellent test retest reliability: PROMIS-57 (ICC=0.83)
  • Excellent test retest reliability: PROMIS-29 (ICC=0.82)

Internal Consistency

Kidney Transplant Recipients: Tang et al, (2019)

  • Excellent internal consistency: PROMIS-57 α=0.93
  • Excellent internal consistency: PROMIS-29 α=0.88

Construct Validity

Kidney Transplant Recipients: Tang et al, (2019)

     Correlation of PROMIS scores with legacy kidney transplant measures

Domain

Principal legacy

PROMIS-57

PROMIS-29

Correlation coefficient

Correlation coefficient

Pain interference

Edmonton Symptom Assessment Scale pain

0.666 (0.568 to 0.746)

0.671 (0.573 to 0.750)

Sleep disturbance

Patient Health Questionnaire (PHQ) sleep

0.682 (0.585 to 0.759)

0.683 (0.587 to 0.760)

Floor/Ceiling Effects

Kidney Transplant Recipients: (Tang et al, (2019)

PROMIS-57

  • Floor: 13% (percentage of people who reached floor effect)
  • Ceiling: 1% (percentage of people who reached ceiling effect)

Arthritis

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Normative Data

Rheumatoid Arthritis: (Bingham 2019, n=546, age = 57 (14) years old, 81% female, recruited from online patient communities, Computer Adaptive Testing (CAT))

 

N

Mean

SD

Median

25%

75%

Range

Min

Max

PROMIS Sleep Disturbance 4a

546

53.9

10.0

54.5

48.1

61.1

41.3

32.0

73.3

Construct Validity

Rheumatoid Arthritis: (Bingham 2019, n=546, age = 57 (14) years old, 81% female, recruited from online patient communities, Computer Adaptive Testing (CAT))

Correlation of PROMIS fatigue short forms with other PROMIS measures and other clinical disease indicators of RA

PROMIS Fatigue

Sleep Disturbance

7a

r

0.65

8a

r

0.63

4a

r

0.65

All p < 0.001 except *p <.005 and **p <.02

Mental Health

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Internal Consistency

Psychiatric inpatients: Strainge et al 2019; n= 95; mean age=36.61 (14.09), Short form

     -Excellent internal consistency (Cronbach’s Alpha: 0.945)

Criterion Validity (Predictive/Concurrent)

PREDICTIVE

Psychiatric inpatients: Strainge et al, (2019)

     - Positive predictive value for physical health (PHQ-15)  (PPV=

        64.5%)

     - Negative predictive value for physical health (PHQ-15)  (NPV=

        72.3%)

Musculoskeletal Conditions

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Normative Data

Chronic Musculoskeletal Pain: (Deyo 2016, n=198, age = 66.5 (8.2) years old, 62.1% female, recruited from primary care physicians’ offices, Computer Adaptive Testing (CAT))

  • Baseline t-score: 52.5 (7.6)
  • 3 month follow-up t-score: 53.2 (7.9)

Test/Retest Reliability

Chronic Musculoskeletal Pain: (Deyo 2016, n=198, age = 66.5 (8.2) years old, 62.1% female, recruited from primary care physicians’ offices, Computer Adaptive Testing (CAT))

  • Adequate test-retest reliability
    • When patients rated their pain “about the same” ICC=0.70
    • When patients intensity rating changed within±1 point ICC=0.74

Internal Consistency

Chronic Musculoskeletal Pain: (Deyo 2016, n=198, age = 66.5 (8.2) years old, 62.1% female, recruited from primary care physicians’ offices, Computer Adaptive Testing (CAT))

  • Excellent internal consistency: α=0.81

Construct Validity

Chronic Musculoskeletal Pain: (Deyo 2016, n=198, age = 66.5 (8.2) years old, 62.1% female, recruited from primary care physicians’ offices, Computer Adaptive Testing (CAT))

 

Evidence of construct validity of baseline PROMIS measures and the derived impact score

 

Worker’s compensation

 

Catastrophizing score (total)

 

Falls in previous 3 months

PROMIS measure

Yes

No

<14

≥14

Yes

No

N 

29.0

169.0 

109.0

78.0 

57.0 

139.0 

Sleep disturbance 

56.2 (5.1)

51.8 (7.8)

50.9 (8.3)

54.5 (7.9)

53.0 (8.0)

52.2 (7.5)

Floor/Ceiling Effects

Chronic Musculoskeletal Pain: (Deyo 2016, n=198, age = 66.5 (8.2) years old, 62.1% female, recruited from primary care physicians’ offices, Computer Adaptive Testing (CAT))

  • Ceiling effect: 1.8%
  • Floor Effect: 1.6%

Responsiveness

Chronic Musculoskeletal Pain: (Deyo 2016, n=198, age = 66.5 (8.2) years old, 62.1% female, recruited from primary care physicians’ offices, Computer Adaptive Testing (CAT))

Effect Size: Change in pain at 3 months compared to baseline

 

Much less (n?=?20)

A little less (n?=?23)

About the same (n?=?91)

A little worse (n?=?47)

Much worse (n?=?16)

Sleep interference 

?0.32 

0.10 

0.04 

0.17 

0.41 

Bibliography

Bingham, C O., Gutierrez, A.K., Butanis, A., Bykerk, V.P., Curtis, J.R., Leong, A., Lyddiatt, A., Nowell, W. B., Orbai, A. M., Bartlett, S.J.(2019).  PROMIS Fatigue short forms are reliable and valid in adults with rheumatoid arthritis. Journal of Patient-Reported Outcomes, 3(1):14. doi: 10.1186/s41687-019-0105-6

Deyo, R.A., Ramsey, K., Buckley, D.I., Michaels, L., Kobus, A., Eckstrom, E., Forro, V., Morris, C. (2016). Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain medicine (Malden, Mass.), 17(2), 314–324. doi:10.1093/pm/pnv046

Strainge, L., Sullivan, M.C., Blackmon, J.E., Cruess, S.E., Wheeler, D., Cruess, D.G. (2019). PROMIS-assessed sleep problems and physical health symptoms in adult psychiatric Inpatients. Health Psychology, 38 (5): 376-385. Doi: 10.1037/hea0000651

Leung, Y. W., Brown, C. , Cosio, A. P., Dobriyal, A. , Malik, N. , Pat, V. , Irwin, M. , Tomasini, P. , Liu, G. and Howell, D. (2016). Feasibility and diagnostic accuracy of the Patient‐Reported Outcomes Measurement Information System (PROMIS) item banks for routine surveillance of sleep and fatigue problems in ambulatory cancer care. Cancer, 122: 2906-2917. doi:10.1002/cncr.30134

Purvis, T. E., Neuman, B. J., Riley, L. H., & Skolasky, R. L. (2018). Discriminant Ability, Concurrent Validity, and Responsiveness of PROMIS Health Domains Among Patients With Lumbar Degenerative Disease Undergoing Decompression With or Without Arthrodesis. Spine, 43(21), 1512-1520. doi:10.1097/brs.0000000000002661

Tang, E., Ekundayo, O., Peipert, J. D., Edwards, N., Bansal, A., Richardson, C., Bartlett, S.J., Howell, D., Li, M., Cella, D., Novak, M., Mucsi, I. (2019). Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 and -29 item short forms among kidney transplant recipients. Quality of Life 嫩B研究院, 28(3), 815-827. doi:10.1007/s11136018-2058-2

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