Disease-specific patient reported outcome tools for systemic lupus erythematosus

Meenakshi Jolly, A. Simon Pickard, Joel A. Block, Kumar Rajan, Rachel A. Mikolaitis, Caitlyn T. Wilke, Roger A. Rodby, Louis Fogg, Winston Sequeira, Tammy O. Utset, Thomas F. Cash, Iona Moldovan, Emmanuel Katsaros, Perry Nicassio, Mariko L. Ishimori, Mark Kosinsky, Joan T. Merrill, Michael H. Weisman, Daniel J. Wallace

Research output: Contribution to journalArticle

64 Citations (Scopus)

Abstract

Purpose: Systemic lupus erythematosus (SLE) can significantly affect both health and non-health-related quality of life (HRQOL and non-HRQOL). However, of the existent published patient-reported outcome (PRO) tools, none were developed from US patients, an ethnically diverse population. Furthermore, these tools do not address men with SLE or assess non-HRQOL issues. Herein, we present the development and validation of the Lupus Patient-Reported Outcome tool (LupusPRO) and discuss its clinical utility and research value compared with other PRO tools currently available for SLE. Methods: Beginning with a conceptual framework, items for LupusPRO were generated using feedback from women and men with SLE. The tool underwent iterations based on patient feedback and clinimetric and psychometric analyses. Validity (content, construct, and criterion) and reliability (internal consistency and test-retest) for the 44-item LupusPRO tool are presented. Results: Consistent with the conceptual framework, items were identified that were related to HRQOL and non-HRQOL constructs. HRQOL domains included (1) lupus symptoms; (2) physical health (physical function, role physical); (3) pain-vitality; (4) emotional health (emotional function and role emotional); (5) body image; (6) cognition; (7) procreation; and (8) lupus medications. Non-HRQOL domains were (1) available social support and coping; (2) desires-goals; and (3) satisfaction with medical care. Internal consistency reliability (0.68-0.94), test-retest reliability (0.55-0.92), content, construct (r > 0.50 with SF-36), and criterion (r > -0.35 with disease activity) validity were fair to good. Conclusions: LupusPRO is a valid and reliable disease-targeted patient-reported health outcome tool that is generalizable to SLE patients in the United States of varied ethnic backgrounds and either gender.

Original languageEnglish (US)
Pages (from-to)56-65
Number of pages10
JournalSeminars in Arthritis and Rheumatism
Volume42
Issue number1
DOIs
StatePublished - Aug 1 2012
Externally publishedYes

Fingerprint

Systemic Lupus Erythematosus
Health
Body Image
Patient Reported Outcome Measures
Psychometrics
Reproducibility of Results
Social Support
Cognition
Quality of Life
Pain
Research
Population

Keywords

  • Health measurement
  • Health outcomes
  • Patient reported outcome
  • Quality of life
  • Systemic lupus erythematosus

ASJC Scopus subject areas

  • Rheumatology
  • Anesthesiology and Pain Medicine

Cite this

Jolly, M., Pickard, A. S., Block, J. A., Rajan, K., Mikolaitis, R. A., Wilke, C. T., ... Wallace, D. J. (2012). Disease-specific patient reported outcome tools for systemic lupus erythematosus. Seminars in Arthritis and Rheumatism, 42(1), 56-65. https://doi.org/10.1016/j.semarthrit.2011.12.005

Disease-specific patient reported outcome tools for systemic lupus erythematosus. / Jolly, Meenakshi; Pickard, A. Simon; Block, Joel A.; Rajan, Kumar; Mikolaitis, Rachel A.; Wilke, Caitlyn T.; Rodby, Roger A.; Fogg, Louis; Sequeira, Winston; Utset, Tammy O.; Cash, Thomas F.; Moldovan, Iona; Katsaros, Emmanuel; Nicassio, Perry; Ishimori, Mariko L.; Kosinsky, Mark; Merrill, Joan T.; Weisman, Michael H.; Wallace, Daniel J.

In: Seminars in Arthritis and Rheumatism, Vol. 42, No. 1, 01.08.2012, p. 56-65.

Research output: Contribution to journalArticle

Jolly, M, Pickard, AS, Block, JA, Rajan, K, Mikolaitis, RA, Wilke, CT, Rodby, RA, Fogg, L, Sequeira, W, Utset, TO, Cash, TF, Moldovan, I, Katsaros, E, Nicassio, P, Ishimori, ML, Kosinsky, M, Merrill, JT, Weisman, MH & Wallace, DJ 2012, 'Disease-specific patient reported outcome tools for systemic lupus erythematosus', Seminars in Arthritis and Rheumatism, vol. 42, no. 1, pp. 56-65. https://doi.org/10.1016/j.semarthrit.2011.12.005
Jolly, Meenakshi ; Pickard, A. Simon ; Block, Joel A. ; Rajan, Kumar ; Mikolaitis, Rachel A. ; Wilke, Caitlyn T. ; Rodby, Roger A. ; Fogg, Louis ; Sequeira, Winston ; Utset, Tammy O. ; Cash, Thomas F. ; Moldovan, Iona ; Katsaros, Emmanuel ; Nicassio, Perry ; Ishimori, Mariko L. ; Kosinsky, Mark ; Merrill, Joan T. ; Weisman, Michael H. ; Wallace, Daniel J. / Disease-specific patient reported outcome tools for systemic lupus erythematosus. In: Seminars in Arthritis and Rheumatism. 2012 ; Vol. 42, No. 1. pp. 56-65.
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AU - Pickard, A. Simon

AU - Block, Joel A.

AU - Rajan, Kumar

AU - Mikolaitis, Rachel A.

AU - Wilke, Caitlyn T.

AU - Rodby, Roger A.

AU - Fogg, Louis

AU - Sequeira, Winston

AU - Utset, Tammy O.

AU - Cash, Thomas F.

AU - Moldovan, Iona

AU - Katsaros, Emmanuel

AU - Nicassio, Perry

AU - Ishimori, Mariko L.

AU - Kosinsky, Mark

AU - Merrill, Joan T.

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AU - Wallace, Daniel J.

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N2 - Purpose: Systemic lupus erythematosus (SLE) can significantly affect both health and non-health-related quality of life (HRQOL and non-HRQOL). However, of the existent published patient-reported outcome (PRO) tools, none were developed from US patients, an ethnically diverse population. Furthermore, these tools do not address men with SLE or assess non-HRQOL issues. Herein, we present the development and validation of the Lupus Patient-Reported Outcome tool (LupusPRO) and discuss its clinical utility and research value compared with other PRO tools currently available for SLE. Methods: Beginning with a conceptual framework, items for LupusPRO were generated using feedback from women and men with SLE. The tool underwent iterations based on patient feedback and clinimetric and psychometric analyses. Validity (content, construct, and criterion) and reliability (internal consistency and test-retest) for the 44-item LupusPRO tool are presented. Results: Consistent with the conceptual framework, items were identified that were related to HRQOL and non-HRQOL constructs. HRQOL domains included (1) lupus symptoms; (2) physical health (physical function, role physical); (3) pain-vitality; (4) emotional health (emotional function and role emotional); (5) body image; (6) cognition; (7) procreation; and (8) lupus medications. Non-HRQOL domains were (1) available social support and coping; (2) desires-goals; and (3) satisfaction with medical care. Internal consistency reliability (0.68-0.94), test-retest reliability (0.55-0.92), content, construct (r > 0.50 with SF-36), and criterion (r > -0.35 with disease activity) validity were fair to good. Conclusions: LupusPRO is a valid and reliable disease-targeted patient-reported health outcome tool that is generalizable to SLE patients in the United States of varied ethnic backgrounds and either gender.

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