Helen Twohig1, Claire Owen2, Sara Muller3, Christian D Mallen4, Caroline Mitchell5, Samantha Hider4, Catherine Hill6, Beverley Shea7, Sarah L Mackie8. 1. H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; h.j.twohig@keele.ac.uk. 2. C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia. 3. H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. 4. C.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. 5. C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK. 6. C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia. 7. B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada. 8. S.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.
Abstract
OBJECTIVE: To systematically identify the outcome measures and instruments used in clinical studies of polymyalgia rheumatica (PMR) and to evaluate evidence about their measurement properties. METHODS: Searches based on the MeSH term "polymyalgia rheumatica" were carried out in 5 databases. Two researchers were involved in screening, data extraction, and risk of bias assessment. Once outcomes and instruments used were identified and categorized, key instruments were selected for further review through a consensus process. Studies on measurement properties of these instruments were appraised against the COSMIN-OMERACT (COnsensus-based Standards for the selection of health Measurement Instruments-Outcome Measures in Rheumatology) checklist to determine the extent of evidence supporting their use in PMR. RESULTS: Forty-six studies were included. In decreasing order of frequency, the most common outcomes (and instruments) used were markers of systemic inflammation [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)], pain [visual analog scale (VAS)], stiffness (duration in minutes), and physical function (elevation of upper limbs). Instruments selected for further evaluation were ESR, CRP, pain VAS, morning stiffness duration, and the Health Assessment Questionnaire. Five studies evaluated measurement properties of these instruments, but none met all of the COSMIN-OMERACT checklist criteria. CONCLUSION: Measurement of outcomes in studies of PMR lacks consistency. The critical patient-centered domain of physical function is poorly assessed. None of the candidate instruments considered for inclusion in the core outcome set had high-quality evidence, derived from populations with PMR, on their full range of measurement properties. Further studies are needed to determine whether these instruments are suitable for inclusion in a core outcome measurement set for PMR.
OBJECTIVE: To systematically identify the outcome measures and instruments used in clinical studies of polymyalgia rheumatica (PMR) and to evaluate evidence about their measurement properties. METHODS: Searches based on the MeSH term "polymyalgia rheumatica" were carried out in 5 databases. Two researchers were involved in screening, data extraction, and risk of bias assessment. Once outcomes and instruments used were identified and categorized, key instruments were selected for further review through a consensus process. Studies on measurement properties of these instruments were appraised against the COSMIN-OMERACT (COnsensus-based Standards for the selection of health Measurement Instruments-Outcome Measures in Rheumatology) checklist to determine the extent of evidence supporting their use in PMR. RESULTS: Forty-six studies were included. In decreasing order of frequency, the most common outcomes (and instruments) used were markers of systemic inflammation [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)], pain [visual analog scale (VAS)], stiffness (duration in minutes), and physical function (elevation of upper limbs). Instruments selected for further evaluation were ESR, CRP, pain VAS, morning stiffness duration, and the Health Assessment Questionnaire. Five studies evaluated measurement properties of these instruments, but none met all of the COSMIN-OMERACT checklist criteria. CONCLUSION: Measurement of outcomes in studies of PMR lacks consistency. The critical patient-centered domain of physical function is poorly assessed. None of the candidate instruments considered for inclusion in the core outcome set had high-quality evidence, derived from populations with PMR, on their full range of measurement properties. Further studies are needed to determine whether these instruments are suitable for inclusion in a core outcome measurement set for PMR.
Authors: Carlos Enrique Toro-Gutiérrez; Carlos A Cañas; Rubén D Mantilla; Santiago Beltrán; Vivian Pastrana-Gonzalez; Milly J Vecino; Mónica Rodriguez-Jimenez; Manuel Rojas Journal: J Transl Autoimmun Date: 2021-08-21
Authors: Thomas E Bolhuis; Diane Marsman; Frank H J van den Hoogen; Alfons A den Broeder; Nathan den Broeder; Aatke van der Maas Journal: BMC Rheumatol Date: 2022-08-02