Outcomes Measured in Polymyalgia Rheumatica and Measurement Properties of Instruments Considered for the OMERACT Core Outcome Set: A Systematic Review

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: h.j.twohig@keele.ac.uk. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.