Toby Helliwell1, Elisabeth Brouwer1, Colin T Pease1, Rodney Hughes1, Catherine L Hill1, Lorna M Neill1, Serena Halls1, Lee S Simon1, Christian D Mallen1, Maarten Boers1, John R Kirwan1, Sarah L Mackie1. 1. From the Department of Primary Care Sciences, Keele University, Staffordshire, UK; Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, The Netherlands; Department of Rheumatology, Leeds Teaching Hospitals ( UK) National Health Service (NHS) Trust, Leeds, UK; Department of Rheumatology Ashford and St. Peter's Hospitals NHS Foundation Trust, Chertsey, Surrey, UK; Rheumatology Unit, The Queen Elizabeth Hospital, University of Adelaide, Woodville, South Australia; PMR-GCA Scotland, Forest Lodge, Foulden, Berwickshire, UK; University of the West of England, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; SDC LLC, Cambridge, Massachusetts, USA; Department of Primary Care Sciences, Keele University, Staffordshire, UK; Departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; UK National Institute for Health Research (NIHR)-Leeds Biomedical Research Unit, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.T. Helliwell, MRCGP, MMedSci, Department of Primary Care Sciences, Keele University; E. Brouwer, MD, PhD, Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center; C.T. Pease, MD, FRCP, Department of Rheumatology, Leeds Teaching Hospitals NHS Trust; R. Hughes, MA, MD, FRCP, Department of Rheumatology Ashford and St. Peter's Hospitals NHS Foundation Trust; C.L. Hill, MBBS, MD, MSc, FRACP, Staff Specialist, Rheumatology Unit, Queen Elizabeth Hospital, University of Adelaide; L.M. Neill, BSc, CPhys, MInstP, Trustee and Secretary, PMR-GCA Scotland; S. Halls, MSc, BSc, University of the West of England, Academic Rheumatology Unit, Bristol Royal Infirmary; L.S. Simon, MD, SDC LLC; C.D. Mallen, BMBS, PhD, FRCGP, Department of Primary Care Sciences, Keele University;
Abstract
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review. METHODS: A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress. RESULTS: Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft core domain set reasonable. The literature review identified 28 studies for full review. Measurement instruments for each proposed domain were identified. Clinicians are highly aware of glucocorticoid-related adverse effects, but there is relatively little evidence about their true prevalence and severity, especially in PMR. CONCLUSION: A provisional core domain set, presented for clinical trials in PMR, comprises acute phase markers, physical function, death, glucocorticoid-related adverse events, and development of giant cell arteritis. Measurement instruments are suggested that may cover each domain, but these require formal validation for clinical trials in PMR.
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review. METHODS: A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress. RESULTS: Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft core domain set reasonable. The literature review identified 28 studies for full review. Measurement instruments for each proposed domain were identified. Clinicians are highly aware of glucocorticoid-related adverse effects, but there is relatively little evidence about their true prevalence and severity, especially in PMR. CONCLUSION: A provisional core domain set, presented for clinical trials in PMR, comprises acute phase markers, physical function, death, glucocorticoid-related adverse events, and development of giant cell arteritis. Measurement instruments are suggested that may cover each domain, but these require formal validation for clinical trials in PMR.
Authors: Sarah L Mackie; Helen Twohig; Lorna M Neill; Eileen Harrison; Beverley Shea; Rachel J Black; Tanaz A Kermani; Peter A Merkel; Christian D Mallen; Frank Buttgereit; Chetan Mukhtyar; Lee S Simon; Catherine L Hill Journal: J Rheumatol Date: 2017-08-01 Impact factor: 4.666
Authors: Sara Muller; Samantha L Hider; Toby Helliwell; Sarah Lawton; Kevin Barraclough; Bhaskar Dasgupta; Irena Zwierska; Christian D Mallen Journal: Arthritis Res Ther Date: 2016-09-07 Impact factor: 5.156
Authors: Toby Helliwell; Sara Muller; Samantha L Hider; Irena Zwierska; Sarah Lawton; Jane Richardson; Christian Mallen Journal: Br J Gen Pract Date: 2018-11 Impact factor: 5.386
Authors: Maatla Tshimologo; Toby Helliwell; Samantha Hider; Christian Mallen; Sara Muller Journal: Prim Health Care Res Dev Date: 2018-08-08 Impact factor: 1.458
Authors: J A Prior; S Muller; T Helliwell; S L Hider; K Barraclough; B Dasgupta; C D Mallen Journal: Prim Health Care Res Dev Date: 2019-05-14 Impact factor: 1.458