Evidence map›Paper›PMID 28765246›Full record

ArticleThe Journal of rheumatology2017

The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica.

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 and 4 more

2 registry-linked trialsAbstract read
In one paragraph

Article in The Journal of rheumatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05542316 completednot on this mapstarted 2022, after this paper: background citation

Validation of the Polymyalgia Rheumatica Activity Score for Determination of Disease Activity

TypeobservationalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2022 to 2024Enrolled133ConditionsPolymyalgia Rheumatica
NCT07749547 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica: a Feasibility Randomized Clinical Trial

TypeinterventionalSponsorWashington University School of MedicineRan2026 to 2027Enrolled20ConditionsPolymyalgia Rheumatica (PMR)ArmsMovement Pattern Training (MoveTrain), Usual Care
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Sarah L MackieFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany. s.l.mackie@leeds.ac.uk.
Helen TwohigFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Lorna M NeillFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Eileen HarrisonFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Beverley SheaFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Rachel J BlackFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Tanaz A KermaniFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Peter A MerkelFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Christian D MallenFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Frank ButtgereitFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Chetan MukhtyarFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Lee S SimonFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
Catherine L HillFrom the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany.
OMERACT PMR Working Group

Funding

VCRC-VF FellowshipU54AR057319 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI MERKEL, PETER A · 2009 to 2020
$12.5M
Department of Health NIHR-CS-012-016Medical Research Council MR/N011775/1NIAMS NIH HHS U54 AR057319
6 · The paper itself

Abstract

objectiveTo inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies.

methodsDomains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary.

resultsNinety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic inflammation, pain, stiffness, and physical function. Patient's global and fatigue were considered important but not mandatory (outer core). The research agenda included psychological impact, weakness, physical activity, participation, sleep, imaging, and health-related quality of life.

conclusionThis core domain set was considered sufficiently well-defined that the next step will be to apply the OMERACT Filter 2.0 Instrument Selection Algorithm to select candidate instruments for a subsequent "deeper dive" into the data. This will allow instruments to be mapped onto each of our core domains to derive a core outcome set for PMR.

Indexed as

Clinical Trials as TopicOutcome Assessment, Health CareAntirheumatic AgentsDelphi TechniqueHumansPolymyalgia RheumaticaQuality of LifeResearch DesignAntirheumatic AgentsOMERACTOUTCOMESPOLYMYALGIA RHEUMATICA

Identifiers

PMID28765246
PMCPMC6690488

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.