PROMIS Fatigue

Last Updated

November 01, 2018

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Center for Smart Use of Technologies to Assess Real World Outcomes (C-STAR)

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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

Instrument Details

Area of Assessment

General Health
Sleep

Assessment Type

Patient Reported Outcomes

Cost

Free

Actual Cost

$0.00

Cost Description

Free to use, however use on NIH Toolbox requres subscription of $499.99 per year

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)

Musculoskeletal Conditions

Spinal Injuries

Osteoarthritis

Mixed Populations

Arthritis

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

Item Bank: 95

Short forms: 4, 6, 7 (weekly), 7 (daily) 8, 13

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.

Paper forms or digital forms (such as NIH Toolbox)

5-15 minutes

Required Training

No Training

Adult

18 - 64

years

Elderly Adult

65 +

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 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

Minimally Clinically Important Difference (MCID)

Anterior Cervical Spine Patients

Purvis et al, 2017; n=148; mean age = 53

MCID = -5.8

Normative Data

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

Distribution of PROMIS Fatigue 7a, 8a, and 4a scores

	N	Mean	SD	Median	25%	75%	Range	Min	Max
PROMIS Fatigue 7a	548	58.0	11.5	58.7	50.1	66.4	53.3	29.4	82.7
PROMIS Fatigue 8a	548	58.6	11.6	60.1	50.5	67.3	44.6	33.1	77.7
PROMIS Fatigue 4a	546	58.0	11.6	58.9	48.6	66.6	42.1	33.7	75.8

Mean PROMIS fatigue scores by patient descriptors of symptom severity and indicators of RA disease activity

	N	Mean	SD	N	Mean	SD	N	Mean	SD	N	Mean	SD
Descriptors	None	Mild	Moderate	Severe
Fatigue 7a	47	38.8	6.4	135	48.6	6.4	127	59.6	6.1	39	69.7	4.9
Fatigue 8a	47	36.3	5.1	135	49.2	5.3	127	61.1	4.9	39	71.4	4.7
Fatigue 4a	47	36.8	5.0	135	48.4	5.5	125	60.4	5.1	39	71.1	4.6
CDAI	Remission	Low	Moderate	High
Fatigue 7a	80	46.3	8.4	132	52.0	9.6	94	58.4	10.7	34	62.7	8.4
Fatigue 8a	80	46.7	8.8	132	52.5	9.7	94	59.3	11.2	34	64.5	8.4
Fatigue 4a	80	46.3	8.7	131	51.9	9.8	93	58.6	11.0	34	63.9	8.5

Mean values in the same row are significantly different from each other at p <.05

Test/Retest Reliability

Rheumatoid Arthritis

Clifton et al; n=348; mean age = 57

Excellent ICC: 7a and 8a = 0.93; 7a and 4a = 0.91; 8a and 4a = .98

Construct Validity

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

Correlations among PROMIS fatigue 7a, 8a, 4a, Rand Vitality and 10-point fatigue scores

	Fatigue 8a	Fatigue 4a	Rand36	Fatigue NRS	7d Fatigue
Fatigue 7a	r	0.94	0.91	0.86	0.85	0.86
N	548	546	388	347	546
Fatigue 8a	r		0.98	0.87	0.88	0.93
N	549	388	351	546
Fatigue 4a	r		0.86	0.88	0.96
N	387	348	544
Rand-36 Vitality	r		0.81	0.82
N	344	387
Fatigue NRS (0-10)	r		0.87
N	345

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

PROMIS Fatigue	Physical Function	Participation	Pain Interference	Sleep Disturbance	Anxiety	Depression	TJC28	SJC28	MD	Patient	CDAI	ESR	CRP (mg/L)
7a	r	-0.78	-0.81	0.78	0.65	0.63	0.67	0.34	0.19	0.32	0.59	0.47	0.21*	0.17*
N	546	548	548	546	546	546	345	346	343	547	340	219	254
8a	r	-0.78	-0.78	0.75	0.63	0.60	0.64	0.37	0.21	0.34	0.57	0.50	0.23	0.15**
N	546	548	548	546	546	546	345	346	343	547	340	219	254
4a	r	-0.77	-0.77	0.75	0.65	0.59	0.63	0.37	0.22	0.35	0.56	0.50	0.22	0.15**
N	546	546	546	546	546	546	343	344	341	545	338	219	252

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

Floor/Ceiling Effects

Rheumatoid Arthritis

Clifton et al; n=348; mean age = 57

>=15% of people at either end was considered evidence of an effect

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

There was no evidence of floor or ceiling effects using PROMIS SF lookup tables. On the 7a, 1% had scores at the lowest (29.4) and highest (83.2) levels, based on PROMIS SF lookup tables. On the 8a, 6% were at the lowest (33.1) and 7% at the highest (77.7), while on the 4a 7% scores at the lowest (33.7) and 10% at the highest (75.8), well below the threshold of 15% for evidence of floor and ceiling effects.

Normative Data

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

Distribution of PROMIS Fatigue 7a, 8a, and 4a scores

	N	Mean	SD	Median	25%	75%	Range	Min	Max
PROMIS Fatigue 7a	548	58.0	11.5	58.7	50.1	66.4	53.3	29.4	82.7
PROMIS Fatigue 8a	548	58.6	11.6	60.1	50.5	67.3	44.6	33.1	77.7
PROMIS Fatigue 4a	546	58.0	11.6	58.9	48.6	66.6	42.1	33.7	75.8

Mean PROMIS fatigue scores by patient descriptors of symptom severity and indicators of RA disease activity

	N	Mean	SD	N	Mean	SD	N	Mean	SD	N	Mean	SD
Descriptors	None	Mild	Moderate	Severe
Fatigue 7a	47	38.8	6.4	135	48.6	6.4	127	59.6	6.1	39	69.7	4.9
Fatigue 8a	47	36.3	5.1	135	49.2	5.3	127	61.1	4.9	39	71.4	4.7
Fatigue 4a	47	36.8	5.0	135	48.4	5.5	125	60.4	5.1	39	71.1	4.6
CDAI	Remission	Low	Moderate	High
Fatigue 7a	80	46.3	8.4	132	52.0	9.6	94	58.4	10.7	34	62.7	8.4
Fatigue 8a	80	46.7	8.8	132	52.5	9.7	94	59.3	11.2	34	64.5	8.4
Fatigue 4a	80	46.3	8.7	131	51.9	9.8	93	58.6	11.0	34	63.9	8.5

Mean values in the same row are significantly different from each other at p <.05

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=169)

	Mean	SD	Median	25%	75%	Min	Max
PROMIS-57	49.61	10.94	49.2	41.0	57.5	33.1	77.8
PROMIS-29	49.22	10.68	48.6	43.1	57.0	33.7	75.8

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=0.77)
Excellent test retest reliability: PROMIS-29 (ICC=0.72)

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=0.97
Excellent internal consistency: PROMIS-29 α=0.94

Patients with Heart Failure that Undergo Heart Transplant

Flynn et al, 2015; n=48; mean age = 51.8

Excellent internal consistency (Promis Fatigue 7a Cronbach's Alpha = 0.91) at baseline.
Adequate internal consistency (Cronbach’s Alpha=0.77) at follow-up.

Construct Validity

Patients with Heart Failure that Undergo Heart Transplant

Flynn et al, 2015; n=48; mean age = 51.8

Correlation, r^a (95% Confidence Interval)

Measure

Baseline

Follow-up

Change

PROMIS Fatigue CAT

KCCQ Fatigue 05

0.74 (0.53, 0.84)

0.59 (0.33, 0.73)

0.70 (0.48, 0.81)

KCCQ Fatigue 06

0.83 (0.57, 0.90)

0.59 (0.38, 0.75)

0.69 (0.49, 0.81)

SF-36 Vitality

0.74 (0.53, 0.87)

0.78 (0.62, 0.87)

0.77 (0.61, 0.86)

6-Minute Walk Distance

0.59 (0.29, 0.78)

0.22 (0.14, 0.61)

0.45 (0.14, 0.68)

PROMIS Fatigue Short Form-7a

KCCQ Fatigue 05

0.83 (0.69, 0.90)

0.55 (0.29, 0.72)

0.72 (0.52, 0.82

KCCQ Fatigue 06

0.84 (0.70, 0.91)

0.55 (0.30, 0.70)

0.63 (0.43, 0.76)

SF-36 Vitality

0.77 (0.62, 0.87)

0.76 (0.61, 0.86)

0.76 (0.61, 0.85)

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

Adequate convergent validity with PROMIS Global Physical Health (-0.65)
Adequate convergent validity with PROMIS Global Physical Health (-0.60)

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
Fatigue	Edmonton Symptom Assessment Scale tiredness	0.722 (0.636 to 0.790)	0.725 (0.640 to 0.792)

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 (%)
Fatigue	15	1	18	2

Test/Retest Reliability

Cancer

Leung et al; n=336; mean age = 57.44

Excellent test-retest reliability for the PROMIS Fatigue Scale (ICC = 0.94)

Test/Retest Reliability

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

Excellent ICC = 0.85

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: 53.8(8.8)
3 month follow-up t-score: 53.9 (9.2)

Test/Retest Reliability

Adults chronic MSK pain not receiving opiates
Deyo et al, 2016; n=198; mean age = 66.56

Adequate ICC * 95% CI = 0.68 (n=91) for patient’s pain being “about the same” at 3 months following baseline assessment.-
Adequate ICC= 0.76 (n=98), for patient’s whose pain intensity was within 1 point of baseline values 3 months following baseline assessment.

Internal Consistency

Adults chronic MSK pain not receiving opiates
Deyo et al, 2016; n=198; mean age = 66.56

Excellent internal consistency (Chronbach's alpha = 0.94)

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
Fatigue	59.2 (8.7)	52.8 (8.5)	51.3 (8.3)	57.4 (9.3)	56.9 (8.7)	52.6 (8.6)

Floor/Ceiling Effects

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

Adequate floor/ceiling effects (4.4% of participants responses with lowest possible score at baseline and 3 months, 2.3% of responses with highest possible score at baseline and 3 months).

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
Fatigue	4.4	2.3

Percent of responses at baseline and 3 months with the lowest and highest possible scores. Bolded values are those exceeding 10%.

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)
Fatigue	−0.37	0.20	0.05	−0.05	0.14

Bibliography

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

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), 397 404. doi:10.3899/jrheum.170590

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., 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

Last Updated

Expertise, Instruction and Mentorship

Upcoming Stroke Course

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)

Normative Data

Test/Retest Reliability

Construct Validity

Floor/Ceiling Effects

Normative Data

Test/Retest Reliability

Internal Consistency

Construct Validity

Content Validity

Floor/Ceiling Effects

Ceiling and floor effects of PROMIS and legacy measures

Test/Retest Reliability

Test/Retest Reliability

Normative Data

Test/Retest Reliability

Internal Consistency

Construct Validity

Floor/Ceiling Effects

Responsiveness

Bibliography

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