Feasibility and Construct Validation of the Patient Reported Outcomes Measurement Information System in Systemic Vasculitis

Gunnar Tomasson; John T Farrar; David Cuthbertson; Carol A McAlear; Susan Ashdown; Peter F Cronholm; Jill Dawson; Don Gebhart; Georgia Lanier; Raashid A Luqmani; Nataliya Milman; Jacqueline Peck; Joanna C Robson; Judy A Shea; Simon Carette; Nader Khalidi; Curry L Koening; Carol A Langford; Paul A Monach; Larry Moreland; Christian Pagnoux; Ulrich Specks; Antoine G Sreih; Steven R Ytterberg; Peter A Merkel; Vasculitis Clinical Research Consortium

doi:10.3899/jrheum.171405

Feasibility and Construct Validation of the Patient Reported Outcomes Measurement Information System in Systemic Vasculitis

J Rheumatol. 2019 Aug;46(8):928-934. doi: 10.3899/jrheum.171405. Epub 2019 Mar 1.

Authors

Gunnar Tomasson^{1

2}, John T Farrar^{3

4}, David Cuthbertson^{3

4}, Carol A McAlear^{3

4}, Susan Ashdown^{3

4}, Peter F Cronholm^{3

4}, Jill Dawson^{3

4}, Don Gebhart^{3

4}, Georgia Lanier^{3

4}, Raashid A Luqmani^{3

4}, Nataliya Milman^{3

4}, Jacqueline Peck^{3

4}, Joanna C Robson^{3

4}, Judy A Shea^{3

4}, Simon Carette^{3

4}, Nader Khalidi^{3

4}, Curry L Koening^{3

4}, Carol A Langford^{3

4}, Paul A Monach^{3

4}, Larry Moreland^{3

4}, Christian Pagnoux^{3

4}, Ulrich Specks^{3

4}, Antoine G Sreih^{3

4}, Steven R Ytterberg^{3

4}, Peter A Merkel^{3

4}; Vasculitis Clinical Research Consortium

Affiliations

¹ From the Department of Epidemiology and Biostatistics, Faculty of Medicine, University of Iceland; Department of Rheumatology, and Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland; Department of Biostatistics, Epidemiology, and Informatics, and Division of Rheumatology, and Department of Family Medicine and Community Health, and Division of General Internal Medicine, University of Pennsylvania, Philadelphia; Division of Rheumatology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Biostatistics and Informatics, Department of Pediatrics, University of South Florida, Tampa, Florida; Division of Rheumatology, University of Utah, Salt Lake City, Utah; Department of Rheumatology, Cleveland Clinic, Cleveland; Ohio State University Wexner Medical Center, Columbus, Ohio; Section of Rheumatology, Boston University School of Medicine, Boston, Massachusetts; Division of Rheumatology, and Division of Pulmonology and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA; Nuffield Department of Population Health, Health Services Research Unit (HSRU), and Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Faculty of Health and Applied Sciences, University of the West of England, Bristol and School of Clinical Sciences, University of Bristol, Bristol, UK; Department of Rheumatology, University of Ottawa, Ottawa; Division of Rheumatology, Mount Sinai Hospital, Toronto; Division of Rheumatology, St. Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada. gunnar.tomasson@gmail.com.
² G. Tomasson, MD, PhD, Assistant Professor, Department of Epidemiology and Biostatistics, Faculty of Medicine, University of Iceland, and Department of Rheumatology, and Centre for Rheumatology Research, University Hospital; J.T. Farrar, MD, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania; D. Cuthbertson, MS, Department of Biostatistics and Informatics, Department of Pediatrics, University of South Florida; C.A. McAlear, MA, Division of Rheumatology, University of Pennsylvania; S. Ashdown, RN, Oxfordshire; P.F. Cronholm, MD, MSCE, Department of Family Medicine and Community Health, University of Pennsylvania; J. Dawson, MA, MSc, DPhil, SRN, SCM, Nuffield Department of Population Health (HSRU), University of Oxford; D. Gebhart, MD, Ohio State University Wexner Medical Center, Columbus; G. Lanier, Patient Research Partner, Boston; R.A. Luqmani, DM, FRCP, FRCP(E), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; N. Milman, MD, MSc, FRCPC, Department of Rheumatology, University of Ottawa; J. Peck, RN, Faculty of Health and Applied Sciences, University of the West of England, Bristol and School of Clinical Sciences, University of Bristol; J.A. Shea, PhD, Division of General Internal Medicine, University of Pennsylvania; S. Carette, MD, Division of Rheumatology, Mount Sinai Hospital; N. Khalidi, MD, Division of Rheumatology, St. Joseph's Healthcare, McMaster University; C.L. Koening, MD, Division of Rheumatology, University of Utah; C.A. Langford, MD, Department of Rheumatology, Cleveland Clinic; P.A. Monach, MD, PhD, Section of Rheumatology, Boston University School of Medicine; L. Moreland, MD, Division of Rheumatology, University of Pittsburgh; C. Pagnoux, MD, MSc, MPH, Division of Rheumatology, Mount Sinai Hospital; U. Specks, MD, Division of Pulmonology and Critical Care Medicine, Mayo Clinic College of Medicine and Science; A.G. Sreih, MD, Division of Rheumatology, University of Pennsylvania; S.R. Ytterberg, MD, Division of Rheumatology, Mayo Clinic College of Medicine and Science; P.A. Merkel, MD, MPH, Division of Rheumatology, University of Pennsylvania. gunnar.tomasson@gmail.com.
³ From the Department of Epidemiology and Biostatistics, Faculty of Medicine, University of Iceland; Department of Rheumatology, and Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland; Department of Biostatistics, Epidemiology, and Informatics, and Division of Rheumatology, and Department of Family Medicine and Community Health, and Division of General Internal Medicine, University of Pennsylvania, Philadelphia; Division of Rheumatology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Biostatistics and Informatics, Department of Pediatrics, University of South Florida, Tampa, Florida; Division of Rheumatology, University of Utah, Salt Lake City, Utah; Department of Rheumatology, Cleveland Clinic, Cleveland; Ohio State University Wexner Medical Center, Columbus, Ohio; Section of Rheumatology, Boston University School of Medicine, Boston, Massachusetts; Division of Rheumatology, and Division of Pulmonology and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA; Nuffield Department of Population Health, Health Services Research Unit (HSRU), and Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Faculty of Health and Applied Sciences, University of the West of England, Bristol and School of Clinical Sciences, University of Bristol, Bristol, UK; Department of Rheumatology, University of Ottawa, Ottawa; Division of Rheumatology, Mount Sinai Hospital, Toronto; Division of Rheumatology, St. Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
⁴ G. Tomasson, MD, PhD, Assistant Professor, Department of Epidemiology and Biostatistics, Faculty of Medicine, University of Iceland, and Department of Rheumatology, and Centre for Rheumatology Research, University Hospital; J.T. Farrar, MD, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania; D. Cuthbertson, MS, Department of Biostatistics and Informatics, Department of Pediatrics, University of South Florida; C.A. McAlear, MA, Division of Rheumatology, University of Pennsylvania; S. Ashdown, RN, Oxfordshire; P.F. Cronholm, MD, MSCE, Department of Family Medicine and Community Health, University of Pennsylvania; J. Dawson, MA, MSc, DPhil, SRN, SCM, Nuffield Department of Population Health (HSRU), University of Oxford; D. Gebhart, MD, Ohio State University Wexner Medical Center, Columbus; G. Lanier, Patient Research Partner, Boston; R.A. Luqmani, DM, FRCP, FRCP(E), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; N. Milman, MD, MSc, FRCPC, Department of Rheumatology, University of Ottawa; J. Peck, RN, Faculty of Health and Applied Sciences, University of the West of England, Bristol and School of Clinical Sciences, University of Bristol; J.A. Shea, PhD, Division of General Internal Medicine, University of Pennsylvania; S. Carette, MD, Division of Rheumatology, Mount Sinai Hospital; N. Khalidi, MD, Division of Rheumatology, St. Joseph's Healthcare, McMaster University; C.L. Koening, MD, Division of Rheumatology, University of Utah; C.A. Langford, MD, Department of Rheumatology, Cleveland Clinic; P.A. Monach, MD, PhD, Section of Rheumatology, Boston University School of Medicine; L. Moreland, MD, Division of Rheumatology, University of Pittsburgh; C. Pagnoux, MD, MSc, MPH, Division of Rheumatology, Mount Sinai Hospital; U. Specks, MD, Division of Pulmonology and Critical Care Medicine, Mayo Clinic College of Medicine and Science; A.G. Sreih, MD, Division of Rheumatology, University of Pennsylvania; S.R. Ytterberg, MD, Division of Rheumatology, Mayo Clinic College of Medicine and Science; P.A. Merkel, MD, MPH, Division of Rheumatology, University of Pennsylvania.

Abstract

Objective: The Patient Reported Outcome Measurement Information System (PROMIS) is a collection of item banks of self-reported health. This study assessed the feasibility and construct validity of using PROMIS instruments in vasculitis.

Methods: Data from a multicenter longitudinal cohort of subjects with systemic vasculitis were used. Instruments from 10 PROMIS item banks were selected with direct involvement of patients. Subjects completed PROMIS instruments using computer adaptive testing (CAT). The Medical Outcomes Study Short Form-36 (SF-36) was also administered. Cross-sectional construct validity was assessed by calculating correlations of PROMIS scores with SF-36 measures and physician and patient global scores for disease activity. Longitudinal construct validity was assessed by correlations of between-visit differences in PROMIS scores with differences in other measures.

Results: During the study period, 973 subjects came for 2306 study visits and the PROMIS collection was completed at 2276 (99%) of visits. The median time needed to complete each PROMIS instrument ranged from 40 to 55 s. PROMIS instruments correlated cross-sectionally with individual scales of the SF-36, most strongly with subscales of the SF-36 addressing the same domain as the PROMIS instrument. For example, PROMIS fatigue correlated with both the physical component score (PCS; r = -0.65) and with the mental component score (MCS; r = -0.54). PROMIS physical function correlated strongly with PCS (r = 0.81) but weakly with MCS (r = 0.29). Weaker correlations were observed longitudinally between change in PROMIS scores with change in PCS and MCS.

Conclusion: Collection of data using CAT PROMIS instruments is feasible among patients with vasculitis and has some cross-sectional and longitudinal construct validity.

Keywords: PATIENT-REPORTED OUTCOME MEASURES; VASCULITIS.

Publication types

Multicenter Study
Research Support, N.I.H., Extramural
Validation Study

MeSH terms

Adult
Aged
Anti-Inflammatory Agents / therapeutic use*
Cognition / physiology
Cross-Sectional Studies
Disability Evaluation*
Fatigue / diagnosis
Feasibility Studies
Female
Humans
Longitudinal Studies
Male
Middle Aged
Pain / diagnosis
Patient Reported Outcome Measures*
Quality of Life
Social Participation
Systemic Vasculitis / drug therapy*
Systemic Vasculitis / psychology

Substances

Anti-Inflammatory Agents

Abstract

Publication types

MeSH terms

Substances

Grants and funding