Evidence map›Paper›PMID 36709309›Full record

ArticleTrials2023

Developing an Outcome Measures in Rheumatology (OMERACT) Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT): core domain set study protocol.

Lara S Chapman, Anthony C Redmond, Caroline A Flurey, Pamela Richards, Toby O Smith, John B Arnold, Dorcas Beaton, Philip G Conaghan, Yvonne M Golightly, Marian T Hannan and 7 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
4.6field-weighted citation impact, top 6% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
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

17 authors at 10 institutions in 4 countries.

Lara S ChapmanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID http://orcid.org/0000-0002-4207-2809
Anthony C RedmondLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Caroline A FlureyDepartment of Health and Social Sciences, Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.
Pamela RichardsOMERACT Patient Research Partner, Bristol, UK.
Toby O SmithWarwick Clinical Trials Unit, University of Warwick, Warwick, UK.
John B ArnoldIIMPACT in Health, Allied Health & Human Performance Unit, University of South Australia, Adelaide, Australia.
Dorcas BeatonInstitute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, University of Toronto, Toronto, ON, Canada.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Yvonne M GolightlyThurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Marian T HannanHinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Catherine HofstetterOMERACT Patient Research Partner, Toronto, ON, Canada.
Lara J MaxwellFaculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Hylton B MenzSchool of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC, Australia.
Beverley SheaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Peter TugwellDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.
Philip HelliwellLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Heidi J SiddleLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. H.Siddle@leeds.ac.uk.
University of Leeds · GBUniversity of Ottawa · CABeth Israel Deaconess Medical Center · USLa Trobe University · AUOttawa Hospital · CAUniversity of North Carolina at Chapel Hill · USUniversity of South Australia · AUUniversity of the West of England · GBUniversity of Toronto · CAUniversity of Warwick · GB

Funding

National Institute for Health and Care Research ICA-SCL-2018-04-ST2-004National Institute for Health and Care Research NIHR302173
6 · The paper itself

Abstract

backgroundFoot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure).

methodsCOMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake.

conclusionsThis protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains.

trial registrationThis study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081.

Indexed as

Musculoskeletal DiseasesRheumatologyAnkleDelphi TechniqueHumansMuscular DiseasesOutcome Assessment, Health CareResearch DesignTreatment OutcomeAnkleConsensusCore outcome setFootMusculoskeletalOutcome measuresRheumatology

Identifiers

PMID36709309
PMCPMC9883911
OpenAlexW4318334776

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.