A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group

Rachel J Black^{1

2}, Joanna C Robson^{3

4}, Susan M Goodman^{3

4}, Elizabeth Hoon^{3

4}, Lana Y H Lai^{3

4}, Lee S Simon^{3

4}, Eileen Harrison^{3

4}, Lorna Neill^{3

4}, Pam Richards^{3

4}, Linda M Nelsen^{3

4}, J Michael Nebesky^{3

4}, Sarah L Mackie^{3

4}, Catherine L Hill^{3

4}

Affiliations

¹ From the Discipline of Medicine, School of Public Health, The University of Adelaide; Rheumatology Unit, The Royal Adelaide Hospital, Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, Australia; Faculty of Health and Applied Sciences, University of the West of England; University of Bristol, Bristol; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; PMR & GCA UK North East, Kibblesworth; PMR and GCA Scotland, Berwickshire, Foulden, UK; Hospital for Special Surgery, New York, New York; SDG LLC, Cambridge, Massachusetts; Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, Pennsylvania, USA; F. Hoffmann-Roche Ltd., Basel, Switzerland. rachel.black2@sa.gov.au.
² R.J. Black, MBBS, PhD Candidate, Consultant Rheumatologist, Clinical Lecturer, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer in Rheumatology, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant, University Hospitals Bristol UK National Health Service Trust, and Faculty of Health and Applied Sciences, University of the West of England; S.M. Goodman, MD, Associate Professor of Clinical Medicine, Hospital for Special Surgery; E. Hoon, PhD, Arthritis SA Florey Research Fellow, School of Public Health, The University of Adelaide; L.Y. Lai, MSc, PhD Candidate, Board Certified Pharmacotherapy Specialist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; L.S. Simon, MD, Principal, SDG LLC; E. Harrison, BSc (Hons Physiology), OMERACT Patient Research Partner, PMR and GCA UK North East; L. Neill, BSc (Hons Nat Phil), OMERACT Patient Research Partner, PMR and GCA Scotland; P. Richards, HNC (Business Studies), OMERACT Patient Research Partner, University of Bristol; L.M. Nelsen, MHS, Director, Patient Focused Outcomes, Value Evidence and Outcomes, GlaxoSmithKline; J.M. Nebesky, MD, Senior Medical Director, F. Hoffmann-La Roche Ltd.; S.L. Mackie, PhD, Associate Clinical Professor, Honorary Consultant Rheumatologist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; C.L. Hill, MD, Clinical Professor, Consultant Rheumatologist, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital, and Rheumatology Unit, The Queen Elizabeth Hospital. rachel.black2@sa.gov.au.
³ From the Discipline of Medicine, School of Public Health, The University of Adelaide; Rheumatology Unit, The Royal Adelaide Hospital, Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, Australia; Faculty of Health and Applied Sciences, University of the West of England; University of Bristol, Bristol; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; PMR & GCA UK North East, Kibblesworth; PMR and GCA Scotland, Berwickshire, Foulden, UK; Hospital for Special Surgery, New York, New York; SDG LLC, Cambridge, Massachusetts; Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, Pennsylvania, USA; F. Hoffmann-Roche Ltd., Basel, Switzerland.
⁴ R.J. Black, MBBS, PhD Candidate, Consultant Rheumatologist, Clinical Lecturer, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer in Rheumatology, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant, University Hospitals Bristol UK National Health Service Trust, and Faculty of Health and Applied Sciences, University of the West of England; S.M. Goodman, MD, Associate Professor of Clinical Medicine, Hospital for Special Surgery; E. Hoon, PhD, Arthritis SA Florey Research Fellow, School of Public Health, The University of Adelaide; L.Y. Lai, MSc, PhD Candidate, Board Certified Pharmacotherapy Specialist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; L.S. Simon, MD, Principal, SDG LLC; E. Harrison, BSc (Hons Physiology), OMERACT Patient Research Partner, PMR and GCA UK North East; L. Neill, BSc (Hons Nat Phil), OMERACT Patient Research Partner, PMR and GCA Scotland; P. Richards, HNC (Business Studies), OMERACT Patient Research Partner, University of Bristol; L.M. Nelsen, MHS, Director, Patient Focused Outcomes, Value Evidence and Outcomes, GlaxoSmithKline; J.M. Nebesky, MD, Senior Medical Director, F. Hoffmann-La Roche Ltd.; S.L. Mackie, PhD, Associate Clinical Professor, Honorary Consultant Rheumatologist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; C.L. Hill, MD, Clinical Professor, Consultant Rheumatologist, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital, and Rheumatology Unit, The Queen Elizabeth Hospital.

PMID: 28365575
DOI: 10.3899/jrheum.161083

Free article

A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group

Rachel J Black et al. J Rheumatol. 2017 Nov.

Free article

. 2017 Nov;44(11):1754-1758.

doi: 10.3899/jrheum.161083. Epub 2017 Apr 1.

Authors

Affiliations

¹ From the Discipline of Medicine, School of Public Health, The University of Adelaide; Rheumatology Unit, The Royal Adelaide Hospital, Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, Australia; Faculty of Health and Applied Sciences, University of the West of England; University of Bristol, Bristol; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; PMR & GCA UK North East, Kibblesworth; PMR and GCA Scotland, Berwickshire, Foulden, UK; Hospital for Special Surgery, New York, New York; SDG LLC, Cambridge, Massachusetts; Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, Pennsylvania, USA; F. Hoffmann-Roche Ltd., Basel, Switzerland. rachel.black2@sa.gov.au.
² R.J. Black, MBBS, PhD Candidate, Consultant Rheumatologist, Clinical Lecturer, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer in Rheumatology, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant, University Hospitals Bristol UK National Health Service Trust, and Faculty of Health and Applied Sciences, University of the West of England; S.M. Goodman, MD, Associate Professor of Clinical Medicine, Hospital for Special Surgery; E. Hoon, PhD, Arthritis SA Florey Research Fellow, School of Public Health, The University of Adelaide; L.Y. Lai, MSc, PhD Candidate, Board Certified Pharmacotherapy Specialist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; L.S. Simon, MD, Principal, SDG LLC; E. Harrison, BSc (Hons Physiology), OMERACT Patient Research Partner, PMR and GCA UK North East; L. Neill, BSc (Hons Nat Phil), OMERACT Patient Research Partner, PMR and GCA Scotland; P. Richards, HNC (Business Studies), OMERACT Patient Research Partner, University of Bristol; L.M. Nelsen, MHS, Director, Patient Focused Outcomes, Value Evidence and Outcomes, GlaxoSmithKline; J.M. Nebesky, MD, Senior Medical Director, F. Hoffmann-La Roche Ltd.; S.L. Mackie, PhD, Associate Clinical Professor, Honorary Consultant Rheumatologist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; C.L. Hill, MD, Clinical Professor, Consultant Rheumatologist, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital, and Rheumatology Unit, The Queen Elizabeth Hospital. rachel.black2@sa.gov.au.
³ From the Discipline of Medicine, School of Public Health, The University of Adelaide; Rheumatology Unit, The Royal Adelaide Hospital, Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, Australia; Faculty of Health and Applied Sciences, University of the West of England; University of Bristol, Bristol; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; PMR & GCA UK North East, Kibblesworth; PMR and GCA Scotland, Berwickshire, Foulden, UK; Hospital for Special Surgery, New York, New York; SDG LLC, Cambridge, Massachusetts; Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, Pennsylvania, USA; F. Hoffmann-Roche Ltd., Basel, Switzerland.
⁴ R.J. Black, MBBS, PhD Candidate, Consultant Rheumatologist, Clinical Lecturer, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer in Rheumatology, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant, University Hospitals Bristol UK National Health Service Trust, and Faculty of Health and Applied Sciences, University of the West of England; S.M. Goodman, MD, Associate Professor of Clinical Medicine, Hospital for Special Surgery; E. Hoon, PhD, Arthritis SA Florey Research Fellow, School of Public Health, The University of Adelaide; L.Y. Lai, MSc, PhD Candidate, Board Certified Pharmacotherapy Specialist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; L.S. Simon, MD, Principal, SDG LLC; E. Harrison, BSc (Hons Physiology), OMERACT Patient Research Partner, PMR and GCA UK North East; L. Neill, BSc (Hons Nat Phil), OMERACT Patient Research Partner, PMR and GCA Scotland; P. Richards, HNC (Business Studies), OMERACT Patient Research Partner, University of Bristol; L.M. Nelsen, MHS, Director, Patient Focused Outcomes, Value Evidence and Outcomes, GlaxoSmithKline; J.M. Nebesky, MD, Senior Medical Director, F. Hoffmann-La Roche Ltd.; S.L. Mackie, PhD, Associate Clinical Professor, Honorary Consultant Rheumatologist, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; C.L. Hill, MD, Clinical Professor, Consultant Rheumatologist, Discipline of Medicine, The University of Adelaide, and Rheumatology Unit, The Royal Adelaide Hospital, and Rheumatology Unit, The Queen Elizabeth Hospital.

PMID: 28365575
DOI: 10.3899/jrheum.161083

Abstract

Objective: The need for a standardized instrument to measure the effect of glucocorticoid (GC) therapy has been well documented in the literature. The aim of the first GC Special Interest Group was to define a research agenda around the development of a patient-reported outcome measure (PROM) in this area.

Methods: The results of a background literature search and the preliminary results of a pilot survey and 2 qualitative studies were presented to facilitate the development of a research agenda.

Results: It was agreed that there was a need for a data-driven PROM that identified both positive and negative effects of GC therapy to be used across all inflammatory indications for systemic GC use in adults. A research agenda was developed, consisting of further qualitative work to assess the effect of GC across different groups including various indications for GC use, different age groups, different dosages, and duration of treatment.

Conclusion: There was agreement on the need for a PROM in this area and a research agenda was set.

Keywords: ADVERSE EFFECTS; GLUCOCORTICOIDS; OUTCOMES.

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A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group

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A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group

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