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  2. PROMIS - Physical Function

PROMIS - Physical Function

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Purpose

Originally created by the National Institute of Health (NIH), PROMIS is an expansive system of person-centered measures that evaluates and monitors functions, symptoms, behaviors, and feelings in a number of different domains. There are currently 122 different assessment domains organized into physical, mental, social and global health groups. There are separate assessments for adult populations. Although the assessments are broadly domain-focused, a disease-customized measurement can be created by choosing the PROMIS measures most relevant to a specific disease. It can be used with the general population and in individuals with chronic conditions.

Link to Instrument

Instrument Details

Acronym PROMIS PF

Area of Assessment

Coordination
Functional Mobility
Strength
Upper Extremity Function

Assessment Type

Patient Reported Outcomes

Cost

Free

Actual Cost

$0.00

Cost Description

Free to use short-form. CAT is available on the NIH Toolbox app with a $499.99 per year subscription fee

CDE Status

Availability
Please visit this website for more information about the instrument: http://www.nihpromis.org
Classification
Supplemental: Stroke

Populations

Stroke
Spinal Injuries
Rheumatic Disease
Non-Specific Patient Population
Joint Pain and Fractures
Chronic Pain
Cancer

Key Descriptions

  • 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.
  • PROMIS measures can be administered three ways:
    • Paper administration: Short forms and profiles are available in PDF form
    • Computer administration: Computer adaptive tests (CATs), short forms and profiles are available through the following health portal systems REDcap, Assessment Center, Epic, Assessment Center Application Programming Interface (API), and OBERD
    • App administration: Computer adaptive tests (CAT), short forms, and profiles are available from the PROMIS iPad app and the NIH Toolbox iPad app.

Number of Items

Item Bank
173 total items for CAT, however patients typically answer between 4-12 items

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.

Short forms
4, 6, 10 and 20 items banks available

Equipment Required

  • Short-form: Copy of assessment
  • CAT: App or computer program with item bank built in

Time to Administer

1-5 minutes

1-5 minutes for CAT
5-10 minutes for short form

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.

Body Part

Upper Extremity
Lower Extremity

ICF Domain

Body Function

Measurement Domain

General Health

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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Standard Error of Measurement (SEM)

Anterior Cervical Spine Surgery: (Purvis 2017, n=148, age = 54 (15) years old, 52% female, Computer Adaptive Testing (CAT))

  • SEM= 2.3

Minimally Clinically Important Difference (MCID)

Anterior Cervical Spine Surgery: (Purvis 2017, n=148, age = 54 (15) years old, 52% female, Computer Adaptive Testing (CAT))

  • MCID = 4.5

Normative Data

Anterior Cervical Discectomy and Fusion: (Khechen 2019, n=57, age = 50.1 (9.9) years old, 45.6% female, Computer Adaptive Testing (CAT))

Mean score

  • Preoperative 40.0(6.4)
  • 6 week 42.0(7.3)
  • 12 week 46.3(9.6)
  • 6 month 47.1(8.8)

Criterion Validity (Predictive/Concurrent)

Anterior Cervical Discectomy and Fusion: (Khechen, 2019; n = 57; age = 50.1 (9.9); Anterior Cervical Discectomy and Fusion)

   - Weak (r = .1-.3)

   - Moderate (r = .3-.5)

   - Strong (r = .5-1)

   - Statistically Significant P<.05

 

Outcomes

r

p

NDI

Preoperative

-0.600

<0.001

6 week

-0.617

<0.001

12 week

-0.605

<0.001

6 month

-0.723

<0.001

VAS neck

Preoperative

-0.405

0.018

6 week

-0.509

<0.001

12 week

-0.584

<0.001

6 month

-0.595

<0.001

VAS arm

Preoperative

-0.458

<0.001

6 week

-0.493

<0.001

12 week

-0.201

0.190

6 month

-0.492

<0.001

SF-12

Preoperative

0.703

<0.001

6 week

0.621

<0.001

12 week

0.761

<0.001

6 month

0.760

<0.001

Construct Validity

Anterior Cervical Discectomy and Fusion: (Khechen 2019, n=57, age = 50.1 (9.9) years old, 45.6% female, Computer Adaptive Testing (CAT))

 

  • Adequate correlation with the Neck Disability Index r= -0.723- -0.600
  • Poor to Adequate correlation with Visual Analog Scale Neck r= -0.595- -0.405
  • Poor to Adequate correlation with Visual Analog Scale Arm r= -0.492 - -0.201
  • Adequate correlation with Short Form-12 Physical Composite Score r= 0.621-0.761

 

Anterior Cervical Spine Surgery: (Purvis 2017, n=148, age = 54 (15) years old, 52% female, Computer Adaptive Testing (CAT))

  • Adequate correlation with Pain Interference r=-0.43
  • Poor correlation with Short Form 12, Mental Component Summary r=0.39
  • Adequate correlation with Neck Disability Index r=-0.55
  • Poor correlation with Generalized Anxiety Disorder 7-item scale r=-0.29
  • Adequate correlation with Personal Health Questionnaire Depression scale r=-0.44

Responsiveness

Anterior Cervical Spine Surgery: (Purvis 2017, n=148, age = 54 (15) years old, 52% female, Computer Adaptive Testing (CAT))

  • Effect Size = 0.35
  • Standard Response Mean = 0.31

Joint Pain and Fractures

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Normative Data

Joint Arthroplasty: (Kohring 2018, n=540, age = 64 (28-95) years old, 56% female, Computer Adaptive Testing (CAT))

 

Preoperative Median (IQR)

Postoperative Median (IQR)

Change Median (IQR)

Physical Function CAT T-score

39.0 (34.1-41.4)

47.1 (41.3-51.3)

8.4 (1.7-12.6)

IQR, interquartile range

Construct Validity

Joint Arthroplasty: (Kohring 2018, n=540, age = 64 (28-95) years old, 56% female, Computer Adaptive Testing (CAT))

  • Poor correlation with Press Ganey measure r=-0.13-0.02.

Non-Specific Patient Population

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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 )

 

n

Mean

SD

Median

25%

75%

Min

Max

αa

ICCb

Physical function

 

 PROMIS-57

171

46.78

9.60

46.4

39.4

59.7

27.9

59.7

0.95

0.89

 PROMIS-29

170

48.24

9.39

48.0

40.4

56.9

26.9

56.9

0.91

0.93

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 )

 

ICCb

 PROMIS-57

0.89

 PROMIS-29

0.93

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 )

 

αa

 PROMIS-57

0.95

 PROMIS-29

0.91

 

Lower Extremity Injury: (Rothrock, 2019; n=402; age=45.1 (16.9); Isolated Lower Extremity Trauma Injury)

   -Excellent Internal Consistency (. Cronbach’s Alpha = 0.96)

Criterion Validity (Predictive/Concurrent)

Concurrent Validity

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

  • Poor to excellent good correlations with the MHQ domains rangedtotal score both preoperative (UE: p=.68, p<.001, PI: p=.74, p<.001, PF: p=.33, p=.006) and postoperative from (UE: p=.65, p<.001, PI: p=.72, p<.001,  .007 - .48,  PF: p=.36, p=.002, P = .95 to <.001)
  • Poor to excellent correlations with the  BCTQ Functional Scale both  preoperative (UE: p=.74, p<.001, PI: p=.67, p<.001, PF: p=.39, p=.001) and postoperative (UE: p=.75, p<.001, PI: p=.66, p<.001, PF: p=.37, p=.002).p = .39 P = .001)
  • Poor to excellent correlations with the preoperative BCTQ Severity Scale score ( UE: p=.49, p<.001, PI: p=.69, p<.001, , PF: p=.04, p=.730). (p = .04 P = .73)

Construct Validity

Systemic Lupus Erythematosus: (Kasturi 2018, n=204, age = 20.0 (13.2) years old, 92.6% female, Computer Adaptive Test (CAT))

  • Excellent correlation with PROMIS Global Physical Health, n = 199, ρ = 0.77
  • Adequate correlation with PROMIS Global Mental Health, n = 187, ρ = 0.54

 

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 )

Domain

Principal legacy

PROMIS-57

PROMIS-29

CFI

RMSEA

Correlation coefficient

CFI

RMSEA

Correlation coefficient

PROMIS Physical function

Medical Outcomes Study Short Form 12-item questionnaire

0.93

0.058

0.806 (0.745 to 0.853)

0.99

0.051

0.789 (0.723 to 0.840)

 

 

Lower Extremity Injury: (Rothrock, 2019)

Convergent:

   - Moderate Correlation with the UCLA Activity Scale

   - High, statistically significant validity to other measures of 

     physical function (table below)

 

 

Mobility CAT

PF SF8a

PF 10

SMFA

FAAM-ADL

FAAM Sport

UCLA

Mobility CAT

 

----

0.83

 

 

0.64

 

-0.56

 

0.55

 

0.38

 

0.33

PF SF8a

0.91

----

0.80

-0.72

0.65

0.56

0.50

PF 10

0.80

0.85

----

-0.67

0.85

0.54

0.49

SMFA

-0.77

-0.83

-0.81

-------

-0.82

-0.54

-0.49

FAAM-ADL

0.84

0.87

0.82

-0.87

--------

0.53

0.27

FAAM Sport

0.77

0.82

0.80

-0.77

0.83

-------

0.50

UCLA

0.61

0.70

0.65

-0.66

0.66

0.64

-----

 

Floor/Ceiling Effects

Lower Extremity Injury: (Rothrock et al., 2019)

   -CSignificant ceiling effect was observedseen for PROMIS PFSF8a at time 2.

 

 

 

Floor – N(%)

Ceiling – N (%)

 

 

Time 1

Time 1 (retainer sample only)

Time 2

Time 1

Time 1 (retainer sample only)

Time 2

Promis PFSF8a

26 (7%)

11(9%)

0 (0%)

11 (3%)

6 (5%)

22(19%)

 

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 )

 

PROMIS-57

PROMIS-29

Floor (%)

Ceiling (%)

Floor (%)

Ceiling (%)

Physical function

3

26

1

50

Responsiveness

Lower Extremity Injury: (Rothrock et al., 2019)

  • Excellent Responsiveness demonstrated with large effect sizes (Mobility CAT effect size = 0.81, Physical Function Short Form 8a effect sizeeffect size d = 0.88) and moderate correlations with change scores.

Stroke

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Construct Validity

Stroke: (Katzan 2017, n=1102, age = 60.8 (14.9) years old, 46.2% female)

Correlation with PROMIS Global Health items

  • Adequate General Health r=0.54
  • Adequate Quality of life r=0.51
  • Adequate Physical health r=0.58
  • Adequate Mental health r=0.41
  • Adequate Social satisfaction r=0.49
  • Excellent Physical activities r=0.82
  • Adequate Pain  r=0.41
  • Adequate Fatigue  r=0.53
  • Adequate Social activities r=0.61
  • Adequate Emotional problems r=0.32
  • Adequate Mental component, T score  r=0.52
  • Adequate Physical component, T score  r=0.77

Cancer

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Content Validity

Breast Cancer: (Krohe et al., 2019; n=14; age = 66 (12.4); Advanced Breast Cancer)

  • All patients for whom data were available demonstrated understanding of the instructions and the recall period of the PROMIS (n=14/14, 100%).
  • Greater than >90% of participants demonstrated understanding of each item
  • Greater than  >90% of participants understood response to options 1-6
  • Greater than or equal to   >50% of participants understood response to options 7-10

Rheumatic Disease

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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 Physical Function 20a

546

38.7

9.4

37.3

31.8

44.1

43.7

18.8

62.5

Construct Validity

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

Correlation of PROMIS fatigue short forms with PROMIS Physical Function

PROMIS Fatigue

Physical Function

7a

r

-0.78

8a

r

-0.78

4a

r

-0.77

All p < 0.001

Chronic Pain

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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))

Scores on patient-reported outcomes at baseline and follow-up

 

Baseline (n = 198)

3 months (n = 197)

Domains as T-scores (population mean 50, sd 10) 

Mean

(SD)

Mean

(SD)

 Physical function 

40.9 

(6.7) 

40.4 

(6.3) 

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)

Test-retest reproducibility of PROMIS measures and the derived impact score

  • Adequate test-retest reliability when Patient’s pain “about the same” (n = 91), ICC=0.68 (0.56, 0.78)
  • Adequate test-retest reliability when Pain intensity rating changed within +/− 1 point (n = 98), ICC=0.70 (0.59, 0.79) 

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)

Scores on patient-reported outcomes at baseline and follow-up

 

Baseline (n = 198)

  

3 months (n = 197)

Domains as T-scores (population mean 50, sd 10) 

Mean

(SD)

Mean

(SD)

 Physical function 

40.9 

(6.7) 

40.4 

(6.3)

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)

 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

N=29

  

No

N=169

  

P *

<14

N=109

  

≥14

N=78

  

P *

Yes

N=57

  

No

N=139

  

P *

Physical function

36.0

(4.4)

41.8

(6.7)

<.001

43.2

(7.4)

38.3

(6.2)

<.001

38.5

(5.9)

41.9

(6.8)

0.001

 


Tabled figures are all means (SD).

*T-test of means. Bolded P-values are significant (<0.05)

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)

 Evidence of floor and ceiling effects (or lack thereof) in PROMIS measures and the derived impact score

 

Percent of responses

PROMIS measure

Lowest possible score

Highest possible score

Physical function 

0.5%

6.6%

Percent of responses at baseline and 3 months with the lowest and highest possible scores.

Responsiveness

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

  Responsiveness of PROMIS measures and derived impact score

 

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)

Spearman correlation coefficient

P

Mean score changes* 

3.85 

0.09 

−0.57 

−1.34 

−3.85 

−0.295 

<.0001 

Effect sizes (change/baseline SD)

0.68 

0.07 

−0.04 

−0.16 

−0.57 

 

 

Standardized response means (change/SD of change) 

0.87 

0.09 

−0.05 

−0.20 

−0.72 

 

 

*Means are T-scores with population mean of 50 unless otherwise specified. Correlations and P -values calculated on raw values.

† P -values are the same as for the mean score changes.

Cardiovascular Disease

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Normative Data

Heart Transplant Patients: (Flynn 2015, age = 52.8 (12.3) years old, 36% male, candidates for heart transplant UNOS status 1A, 1B, or 2)
PROMIS Physical Function CAT
•    Mean score before transplant: 34.9 (6.1)
•    Mean score after transplant: 42.1 (6.5)
PROMIS Physical Function Short for 10a
•    Mean score before transplant: 37.2 (5.2)
•    Mean score after transplant: 52.3 (23.2)

Internal Consistency

Heart Transplant Patients: (Flynn 2015, age = 52.8 (12.3) years old, 36% male, candidates for heart transplant UNOS status 1A, 1B, or 2)

PROMIS Physical Function Short for 10a

  • Excellent Internal reliability α=0.84-0.85

Construct Validity

Heart Transplant Patients: (Flynn 2015, age = 52.8 (12.3) years old, 36% male, candidates for heart transplant UNOS status 1A, 1B, or 2)

PROMIS Physical Function CAT

  • Excellent correlation with Kansas City Cardiomyopathy Questionnaire (KCCQ): Physical Limitation (r=0.77-0.79)
  • Adequate  correlation with 6 min walk distance (r=0.55-0.67)

PROMIS Physical Function Short for 10a

  • Excellent correlation with Kansas City Cardiomyopathy Questionnaire (KCCQ): Physical Limitation (r=0.75-0.85)

Responsiveness

Heart Transplant Patients: (Flynn 2015, age = 52.8 (12.3) years old, 36% male, candidates for heart transplant UNOS status 1A, 1B, or 2)

PROMIS Physical Function CAT

  • Effect size: 1.14 (0.63-1.95)

PROMIS Physical Function Short for 10a

  • Effect size: 1.13 (0.64-1.88)

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

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

Flynn, K.E., Dew, M.A., Lin, L., Fawzy, M., Graham, F.L., Hahn, E.A., Hays R.D., Kormos, R.L., Liu, H., McNulty, M., Weinfurt, K.P. (2015). Reliability and construct validity of PROMIS® measures for patients with heart failure who undergo heart transplant. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 24(11), 2591–2599. doi:10.1007/s11136-015-1010-y

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

Katzan, I.L., Lapin, B. (2018). PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study. Stroke, 49 (1): 147-154. doi:10.1161/STROKEAHA.117.018766

Khechen, B., Patel, D. V., Haws, B. E., Cardinal, K. L., Guntin, J. A., Ahn, J., & Singh, K. (2019). Evaluating the Concurrent Validity of PROMIS Physical Function in Anterior Cervical Discectomy and Fusion. Clinical Spine Surgery, 1. doi:10.1097/bsd.0000000000000786

Kohring, J.M., Pelt, C.E., Anderson, M.B., Peters, C.L., Gililland, J.M. (2018). Press Ganey Outpatient Medical Practice Survey Scores Do Not Correlate With Patient-Reported Outcomes After Primary Joint Arthroplasty. The Journal of Arthroplasty, 33(8):2417-2422. doi: 10.1016/j.arth.2018.03.044.

Krohe, M., Tang, D. H., Klooster, B., Revicki, D., Galipeau, N., & Cella, D. (2019). Content validity of the National Comprehensive Cancer Network – Functional Assessment of Cancer Therapy – Breast Cancer Symptom Index (NFBSI-16) and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form with advanced breast cancer patients. Health and Quality of Life Outcomes, 17(1). doi:10.1186/s12955-019-1162-5

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.

Rothrock, N. E., Kaat, A. J., Vrahas, M. S., O’Toole, R. V., Buono, S. K., Morrison, S., & Gershon, R. C. (2019). Validation of PROMIS Physical Function Instruments in Patients with an Orthopaedic Trauma to a Lower Extremity. Journal of Orthopaedic Trauma, 1. doi:10.1097/bot.0000000000001493

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/s11136 018-2058-2

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