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  2. PROMIS – Pain Interference

PROMIS – Pain Interference

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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 P-I

Area of Assessment

Pain

Assessment Type

Patient Reported Outcomes

Cost

Not Free

Actual Cost

$0.00

Cost Description

Short forms are free to use. NIH Toolbox app requires a subscription of $499 per year.

CDE Status

NINDS CDE Notice of Copyright
PROMIS Item Bank v1.1 - Pain Behavior
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
Joint Pain and Fractures
Arthritis

Key Descriptions

  • Usually 4-12 items for each section domain depending on which type of test is being
    performed (Short Form, CAT, or Profile)
  • Scores typically calculated as T-scores
  • 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 pain interference.

Number of Items

Item Bank: 40
Short forms: 4, 6a, 6b, 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.

Equipment Required

  • Short form or NIH toolbox app on devise

Time to Administer

1-10 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

Considerations

  • PROMIS measures can be used in the general population and with adult 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)

Anterior Cervical Spine Patients
Purvis et al, 2017; n=148; mean age = 53                  
   - MCID = -5.2

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

Mean

SD

Median

25%

75%

Min

Max

 PROMIS-57

166

50.32

10.24

49.9

40.7

55.8

40.7

77.0

 PROMIS-29

164

50.52

9.91

49.6

41.6

56.4

41.6

75.6

Test/Retest Reliability

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 )

  • Excellent test retest reliability: PROMIS-57 (ICC=0.75)
  • Excellent test retest reliability: PROMIS-29 (ICC=0.76)

Internal Consistency

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 )

  • Excellent internal consistency: PROMIS-57 α=0.99
  • Excellent internal consistency: PROMIS-29 α=0.99

Construct Validity

Systemic Lupus Erythematosus: (Kasturi et al 2018, n=204, age= 40.0 ± 13.2, outpatient, CAT)

  • Excellent convergent validity with PROMIS Global Physical Health (-0.80)
  • Adequate convergent validity with PROMIS Global Physical Health (-0.59)

Content Validity

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 )

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)

Floor/Ceiling Effects

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 )

Ceiling and floor effects of PROMIS and legacy measures

 

PROMIS-57

 

PROMIS-29

Floor (%)

Ceiling (%)

Floor (%)

Ceiling (%)

Pain interference

46

2

48

2

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 Pain Interference 8a

548

59.3

10.2

61.0

53.3

66.9

36.3

40.7

77.0

Test/Retest Reliability

Osteoarthritis

Broderick et al, 2013; n=98; mean age = 56.9                  

  • Excellent test-retest reliability (ICC = 0.83)

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

Pain Interference

7a

r

0.78

8a

r

0.75

4a

r

0.75

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

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: 60.6(5.8)
  • 3 month follow-up t-score:59.8(7.0)

Test/Retest Reliability

Adults chronic MSK pain not receiving opiates
Deyo et al, 2016; n=198; mean age = 66.5                  

  • Adequate ICC = 0.58 (n=91) for patient’s pain being “about the same” at 3 months following baseline assessment
  • Adequate ICC= 0.67 (n=98), for patient’s whose pain intensity was within 1 point of baseline values 3 months following baseline assessment.

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=0.92

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 

Pain interference 

65.0 (4.9)

59.8 (5.6)

58.6 (5.9)

63.4 (4.9)

62.7 (6.1)

59.7 (5.5)

Floor/Ceiling Effects

Adults chronic MSK pain not receiving opiates

Deyo et al, 2016; n=198; mean age = 66.5                 

  • Adequate floor/ceiling effects (3.1% of responses with the lowest possible score at baseline and 3 months, 2.6% of responses with the highest possible score at baseline and 3 months).

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)

Pain interference 

?1.03 

?0.28 

?0.08 

0.17 

0.71 

Joint Pain and Fractures

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Criterion Validity (Predictive/Concurrent)

Carpal Tunnel: (Bernstein, 2019; n=70; age = 61 range 27-86; Carpal Tunnel Syndrome)

  • Excellent correlation with Michigan Hand Questionnaire
    • Pre-operative ρ=.74
    • Post-operative ρ=.72
  • Adequate correlation with Boston Carpal Tunnel Questionnaire –Symptom Severity Scale
    • Pre-operative ρ=.69
    • Post-operative ρ=.62
  • Adequate correlation with Boston Carpal Tunnel Questionnaire –Functional Status Scale
    • Pre-operative ρ=.67
    • Post-operative ρ=.66

Responsiveness

Carpal Tunnel: (Bernstein, 2019; n=70; age = 61 range 27-86; Carpal Tunnel Syndrome)

  • Effect Size Index: 0.74 (0.39-1.08)

Bibliography

Bernstein, D. N., Houck, J. R., Mahmood, B., & Hammert, W. C. (2019). Responsiveness of the PROMIS and its Concurrent Validity with Other Region- and Condition-specific PROMs in Patients Undergoing Carpal Tunnel Release. Clinical Orthopaedics and Related Research, 1. doi:10.1097/corr.0000000000000773

Broderick, J. E., Schneider, S., Junghaenel, D. U., Schwartz, J. E., Stone, A. A. (2013). Validity and reliability of patient-reported outcomes measurement information system instruments in osteoarthritis. Arthritis Care Res (Hoboken), 65, 1625–1633.

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

Kasturi, S., Szymonifka, J., Burket, J. C., Berman, J. R., Kirou, K. A., Levine, A. B., Sammaritano, L.R., Mandl, L.A. (2018). Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus. The Journal of Rheumatology, 45(3), 397404. doi:10.3899/jrheum.170590

Purvis, T. E., Andreou, E., Neuman, B. J., Riley, L. H. III, & Skolasky, R. L. (2017). Concurrent validity and responsiveness of PROMIS health domains among patients presenting for anterior cervical spine surgery. Spine, 42(23), E1357–E1365.

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 Research, 28(3), 815-827. doi:10.1007/s11136018-2058-2

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