Sarah R. Kingsbury
Harmonising data collection from osteoarthritis studies to enable stratification: recommendations on core data collection from an Arthritis Research UK clinical studies group
Kingsbury, Sarah R.; Corp, Nadia; Watt, Fiona E.; Felson, David T.; O�Neill, Terence W.; Holt, Cathy A.; Jones, Richard K.; Conaghan, Philip G.; Arden, Nigel K.; Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Studies Group working group
Authors
Nadia Corp
Fiona E. Watt
David T. Felson
Terence W. O�Neill
Cathy A. Holt
Richard K. Jones
Philip G. Conaghan
Nigel K. Arden
Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Studies Group working group
Abstract
Objective. Treatment of OA by stratifying for commonly used and novel therapies will likely improve the range of effective therapy options and their rational deployment in this undertreated, chronic disease. In order to develop appropriate datasets for conducting post hoc analyses to inform approaches to stratification for OA, our aim was to develop recommendations on the minimum data that should be recorded at baseline in all future OA interventional and observational studies.
Methods. An Arthritis Research UK study group comprised of 32 experts used a Delphi-style approach supported by a literature review of systematic reviews to come to a consensus on core data collection for OA studies.
Results. Thirty-five systematic reviews were used as the basis for the consensus group discussion. For studies with a primary structural endpoint, core domains for collection were defined as BMI, age, gender, racial origin, comorbidities, baseline OA pain, pain in other joints and occupation. In addition to the items generalizable to all anatomical sites, joint-specific domains included radiographic measures, surgical history and anatomical factors, including alignment. To demonstrate clinical relevance for symptom studies, the collection of mental health score, self-efficacy and depression scales were advised in addition to the above.
Conclusions. Currently it is not possible to stratify patients with OA into therapeutic groups. A list of core and optional data to be collected in all OA interventional and observational studies was developed, providing a basis for future analyses to identify predictors of progression or response to treatment.
Journal Article Type | Article |
---|---|
Acceptance Date | Mar 15, 2015 |
Online Publication Date | Apr 15, 2016 |
Publication Date | 2016-08 |
Deposit Date | Nov 9, 2020 |
Publicly Available Date | Nov 12, 2020 |
Journal | Rheumatology |
Print ISSN | 1462-0324 |
Electronic ISSN | 1462-0332 |
Publisher | Oxford University Press |
Peer Reviewed | Peer Reviewed |
Volume | 55 |
Issue | 8 |
Pages | 1394-1402 |
DOI | https://doi.org/10.1093/rheumatology/kew201 |
Keywords | osteoarthritis, clinical trials, stratification, prognosis, personalized medicine |
Public URL | http://researchrepository.napier.ac.uk/Output/2698531 |
Files
Harmonising data collection from osteoarthritis studies to enable stratification: recommendations on core data collection from an Arthritis Research UK clinical studies group
(191 Kb)
PDF
Publisher Licence URL
http://creativecommons.org/licenses/by/4.0/
Copyright Statement
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
You might also like
Downloadable Citations
About Edinburgh Napier Research Repository
Administrator e-mail: repository@napier.ac.uk
This application uses the following open-source libraries:
SheetJS Community Edition
Apache License Version 2.0 (http://www.apache.org/licenses/)
PDF.js
Apache License Version 2.0 (http://www.apache.org/licenses/)
Font Awesome
SIL OFL 1.1 (http://scripts.sil.org/OFL)
MIT License (http://opensource.org/licenses/mit-license.html)
CC BY 3.0 ( http://creativecommons.org/licenses/by/3.0/)
Powered by Worktribe © 2024
Advanced Search