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Abstract Number: 2624

Preliminary Content Validation of the Patient Reported Outcomes Measurement Information System (PROMIS) Short Forms in People Living with Rheumatoid Arthritis

Anna Kristina Gutierrez1, Michelle Jones2, Susan J. Bartlett1,3,4 and Clifton O. Bingham III2, 1Division of Rheumatology, Johns Hopkins University, Baltimore, MD, 2Johns Hopkins University, Baltimore, MD, 3Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, MD, 4Medicine , Divisions of Clinical Epidemiology, Rheumatology, Respirology, McGill University, Montreal, QC, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: patient-reported outcome measures and rheumatoid arthritis (RA), PRO, PROMIS

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Session Information

Date: Tuesday, November 10, 2015

Session Title: Rheumatoid Arthritis - Clinical Aspects Poster Session III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: The process of patient reported outcome (PRO) validation requires demonstration that the concept being measured and the patient experience of the corresponding symptom or impact are aligned. The NIH Patient Reported Outcomes Measurement Information System (PROMIS) provides standardized measures across the illness continuum of domains of physical, mental, and social health. Whether items contained within PROMIS item banks and short forms (SF) are felt to be relevant to people living with rheumatoid arthritis (RA) has not been previously reported.

Methods: We administered surveys to RA patients (pts) seen for routine care in an academic rheumatology practice. Routine clinical (MD global, joint count, pt global, pain, and fatigue VAS) and demographic data were collected. Surveys included PROMIS SFs for Physical Function (PF) 20a; Pain Interference (PI) 8a, Fatigue 7a and 8a, Ability to Participate in Social Roles and Activities 8a (PSRA), and Depression 8a. Pts also completed the PROMIS Profile 29 v 2.0, which contains 4 item assessments for these domains. For each domain, patients rated the relevance of items within the SF to their disease experience and the importance of the symptom to their disease.  We also queried how much patients were able to separate their overall symptom experience from that due to RA (e.g., “How much of your fatigue is due to your RA?”). Mean PROMIS T-scores were calculated.

Results: Fifty two pts (86.5% female, 88.5% Caucasian, 31% HS education or less) were surveyed with a mean (SD) age of 52.5 (13.5) yrs, disease duration of 14.7 (11.4) yrs, and CDAI 9.7 (15). PROMIS T-scores were similar using SF of different lengths, though the magnitude of difference was greatest for the PF measures. RA patients had worse PF, PI, and Fatigue that exceeded 0.4SD from the general population norm of 50 (Table 1).  More than 60% of respondents reported that the SF items in a domain completely or mostly reflected their experience due to their RA. For PF and PSRA almost half of patients considered both their symptom in general and their symptom due to RA when answering items (55.8 and 48.1%). When answering items on PI, 51.9% were thinking only of their RA. However, most (>88 %) would not have responded differently to the questions if instead asked “due to their RA”.  Most patients attribute problems with PF and PI to their RA, but not problems with sleep, emotional health, or PSRA. Most patients (>75%) considered all domains very important. Almost all (>85%) did not feel that additional questions needed to be asked regarding these symptoms.

Conclusion: These results provide preliminary evidence of the content validity in terms of importance and relevance of selected PROMIS domains and SF items from the perspective of people living with RA. Additional studies in a broader group of pts are needed.

Table 1. PROMIS short form T-scores for each domain.

Domain/Symptom

Short   Form

Physical Function (PF)

4a

20a

43.9 (10.2)

41.9 (11.5)

Pain Interference (PI)

4a

8a

56.3 (9.8)

55.9 (9.9)

Fatigue

4a

7a

8a

54.1 (13.4)

54.5 (11.3)

54.5 (13.5)

Ability to Participate in Social   Roles and Activities (PSRA)

4a

8a

48.9 (10.5)

48.8 (11.1)

Depression

4a

8a

51.1 (10.7)

50.2 (11.5)

Anxiety 4a

50.3 (10.5)

Sleep 4a

51.4 (9.8)

Legacy PROs

Mean (SD)

Patient Global VAS

34 (29.9)

Pain VAS

3.8 (3.5)

Fatigue VAS

4.5 (4)


Disclosure: A. K. Gutierrez, None; M. Jones, None; S. J. Bartlett, PCORI, 2; C. O. Bingham III, NIH, 2,PCORI, 2.

To cite this abstract in AMA style:

Gutierrez AK, Jones M, Bartlett SJ, Bingham CO III. Preliminary Content Validation of the Patient Reported Outcomes Measurement Information System (PROMIS) Short Forms in People Living with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/preliminary-content-validation-of-the-patient-reported-outcomes-measurement-information-system-promis-short-forms-in-people-living-with-rheumatoid-arthritis/. Accessed January 17, 2021.
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