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Harmonising data collection from osteoarthritis studies to enable stratification: recommendations on core data collection from an Arthritis Research UK clinical studies group

Harmonising data collection from osteoarthritis studies to enable stratification: recommendations on core data collection from an Arthritis Research UK clinical studies group
Harmonising data collection from osteoarthritis studies to enable stratification: recommendations on core data collection from an Arthritis Research UK clinical studies group
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.
1462-0324
Kingsbury, S.R.
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Corp, N.
34d73ed4-d585-4c28-9ec5-2d2a9bd6401b
Watt, F.E.
158783f0-f07b-4717-a45e-406275930d5f
Felson, D.T.
c2a29bad-b77b-49fa-aee1-94cd21e23ccc
O'Neill, T.W.
688d84bf-f76f-4777-a3e1-65c6e5526365
Holt, C.A.
72eaa96f-a18c-4495-bc97-17d5d90fb290
Jones, R.K.
0d7737d9-04b7-4bab-bd6f-f5f673951ebd
Conaghan, P.G.
fcfa7b96-7335-4cab-a643-faa6e400b47d
Arden, Nigel
23af958d-835c-4d79-be54-4bbe4c68077f
Kingsbury, S.R.
7fd057c5-5aed-4cf6-b6b2-7f0b92842618
Corp, N.
34d73ed4-d585-4c28-9ec5-2d2a9bd6401b
Watt, F.E.
158783f0-f07b-4717-a45e-406275930d5f
Felson, D.T.
c2a29bad-b77b-49fa-aee1-94cd21e23ccc
O'Neill, T.W.
688d84bf-f76f-4777-a3e1-65c6e5526365
Holt, C.A.
72eaa96f-a18c-4495-bc97-17d5d90fb290
Jones, R.K.
0d7737d9-04b7-4bab-bd6f-f5f673951ebd
Conaghan, P.G.
fcfa7b96-7335-4cab-a643-faa6e400b47d
Arden, Nigel
23af958d-835c-4d79-be54-4bbe4c68077f

Kingsbury, S.R., Corp, N., Watt, F.E., Felson, D.T., O'Neill, T.W., Holt, C.A., Jones, R.K., Conaghan, P.G. and Arden, Nigel (2016) Harmonising data collection from osteoarthritis studies to enable stratification: recommendations on core data collection from an Arthritis Research UK clinical studies group. Rheumatology. (doi:10.1093/rheumatology/kew201). (PMID:27084310)

Record type: Article

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.

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Accepted/In Press date: 15 March 2016
e-pub ahead of print date: 15 April 2016
Organisations: Faculty of Medicine

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Local EPrints ID: 397265
URI: http://eprints.soton.ac.uk/id/eprint/397265
ISSN: 1462-0324
PURE UUID: eae66c7a-4a01-4152-aca0-0d1cde03325d

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Date deposited: 27 Jun 2016 08:24
Last modified: 19 Jul 2019 19:56

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Contributors

Author: S.R. Kingsbury
Author: N. Corp
Author: F.E. Watt
Author: D.T. Felson
Author: T.W. O'Neill
Author: C.A. Holt
Author: R.K. Jones
Author: P.G. Conaghan
Author: Nigel Arden

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