Feasibility of Patient-Reported Outcomes Measurement Information System (PROMIS®) computerized adaptive tests in systemic lupus erythematosus outpatients

Abstract

Objective

The aims of this study were to assess the feasibility of administering Patient-Reported Outcomes Measurement Information System (PROMIS®) computerized adaptive tests (CATs) to outpatients with systemic lupus erythematosus (SLE).

Methods

Adults with SLE were recruited during routine outpatient visits at an SLE Center of Excellence. Participants completed 14 PROMIS CATs and provided feedback on their experience. Differences in socio-demographic and clinical characteristics between participants and non-participants were evaluated.

Results

A total of 204 (86%) of 238 socioeconomically and racially diverse SLE patients completed PROMIS CATs. There were no significant differences between participants and non-participants. Time constraints were cited most frequently as reasons for non-participation. More than 75% of individuals submitted positive comments, including approval of the content and format of questions, and the survey’s promotion of self-reflection. A minority of participants cited challenges, most often related to question phrasing (8%) and technical difficulties (6%).

Conclusions

The administration of PROMIS CATs was feasible and positively received in a diverse cohort of SLE outpatients. Neither socio-demographic nor disease characteristics were significant barriers to successful completion of PROMIS CATs. PROMIS CATs have great potential for efficiently measuring important patient-centered outcomes in routine clinical care of a wide range of SLE patients.

Keywords

Outcome measures patient-reported outcomes PROMIS systemic lupus erythematosus

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References

Strand

Gladman

Isenberg

Petri

Smolen

Tugwell

. Endpoints: Consensus recommendations from OMERACT IV. Outcome Measures in Rheumatology. Lupus 2000; 9: 322–327.

US Department of Health and Human Services, Food and Drug Administration. Guidance for industry: Patient-Reported outcome measures: Use in medical product development to support labeling claims, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm193282.pdf (2009, accessed 30 August 2017).

Jolly

Garris

Mikolaitis

et al.

Development and validation of the Lupus Impact Tracker: A patient-completed tool for clinical practice to assess and monitor the impact of systemic lupus erythematosus. Arthritis Care Res (Hoboken) 2014; 66: 1542–1550.

Miedany YE, Gaafary ME, Aroussy NE, Bahlas S, Hegazi M, Palmer D, Youssef S. Toward electronic health recording: Evaluation of electronic patient reported outcome measures (e-PROMs) system for remote monitoring of early systemic lupus patients. Clin Rheumatol 2017; 36(11): 2461–2469. doi: 10.1007/s10067-017-3675-9.

Lavallee

Chenok

Love

et al.

Incorporating patient-reported outcomes into health care to engage patients and enhance care. Health Aff (Millwood) 2016; 35: 575–582.

Baumhauer

. Patient-reported outcomes—Are they living up to their potential? N Engl J Med 2017; 377: 6–9.

Centers for Medicare and Medicaid Services. Oncology care model, https://innovation.cms.gov/initiatives/Oncology-Care/ (2016, accessed 30 August 2017).

Centers for Medicare and Medicaid Services. Comprehensive care for joint replacement model, https:// innovation.cms.gov/initiatives/cjr (2016, accessed 30 August 2017).

Health Measures, Intro to PROMIS, http://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis (2016, accessed 30 August 2017).

10.

Kasturi

Szymonifka

Burket

et al.

Validity and reliability of Patient Reported Outcomes Measurement Information System computerized adaptive tests in systemic lupus erythematosus. J Rheumatol 2017; 44: 1024–1031.

11.

Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. Initial adult health item banks and first wave testing of the patient-reported outcomes measurement information system (PROMIS) network: 2005-2008. J Clin Epidemiol 2010; 63(11): 1179–1194. doi:10.1016/j.jclinepi.2010.04011.

12.

Petri

. Musculoskeletal complications of systemic lupus erythematosus in the Hopkins Lupus Cohort: An update. Arthritis Care Res 1995; 8: 137–145.

13.

Petri

Naqibuddin

Carson

et al.

Cognitive function in a systemic lupus erythematosus inception cohort. J Rheumatol 2008; 35: 1776–1781.

14.

Jolly

Katz

. Systemic lupus erythematosus: The promise of PROMIS—Is it ready for prime time in SLE? Nat Rev Rheumatol 2017; 13: 453–454.

15.

Khanna

Maranian

Rothrock

et al.

Feasibility and construct validity of PROMIS and legacy instruments in an academic scleroderma clinic—Analysis from the UCLA Scleroderma Quality of Life Study. Value Health 2012; 15: 128–134.

16.

Bartlett

Orbai

Duncan

et al.

Reliability and validity of selected PROMIS measures in people with rheumatoid arthritis. PLoS One 2015; 10: e0138543–e0138543.

17.

Hochberg

. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997; 40: 1997–1997.

18.

Ware

JE Jr

Sherbourne

. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473–483.

19.

Jolly

Pickard

Wilke

et al.

Lupus-specific health outcome measure for US patients: The LupusQoL-US version. Ann Rheum Dis 2010; 69: 29–33.

20.

Petri

Kim

Kalunian

et al.

Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005; 353: 2550–2558.

21.

Gladman

Ginzler

Goldsmith

et al.

The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for systemic lupus erythematosus. Arthritis Rheum 1996; 39: 363–369.

22.

Choi

Bae

Gupta

Rogers

Liang

. Improving participation in clinical trials of novel therapies: Going back to basics. Rheum Dis Clin North Am 2014; 40: 553–559.

23.

Costenbader

Brome

Blanch

Gall

Karlson

Liang

. Factors determining participation in prevention trials among systemic lupus erythematosus patients: A qualitative study. Arthritis Rheum 2007; 57: 49–55.

24.

Jamilloux

Sarabi

Kérever

et al.

Adherence to online monitoring of patient-reported outcomes by patients with chronic inflammatory diseases: A feasibility study. Lupus 2015; 24: 1429–1436.