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

Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Studies Group working group

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)1394-1402
Number of pages9
JournalRheumatology
Volume55
Issue number8
Early online date15 Apr 2016
DOIs
Publication statusPublished - 1 Aug 2016

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Osteoarthritis
Arthritis
Research
Observational Studies
Consensus
Joints
Therapeutics
Pain
Self Efficacy
Occupations
Comorbidity
Mental Health
Chronic Disease
History
Clinical Studies
Depression

Keywords

  • Clinical trials
  • Osteoarthritis
  • Personalized medicine
  • Prognosis
  • Stratification

ASJC Scopus subject areas

  • Rheumatology
  • Pharmacology (medical)

Cite this

Harmonising data collection from osteoarthritis studies to enable stratification : Recommendations on core data collection from an Arthritis Research UK clinical studies group. / Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Studies Group working group.

In: Rheumatology, Vol. 55, No. 8, 01.08.2016, p. 1394-1402.

Research output: Contribution to journalArticle

Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Studies Group working group. / Harmonising data collection from osteoarthritis studies to enable stratification : Recommendations on core data collection from an Arthritis Research UK clinical studies group. In: Rheumatology. 2016 ; Vol. 55, No. 8. pp. 1394-1402.
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title = "Harmonising data collection from osteoarthritis studies to enable stratification: Recommendations on core data collection from an Arthritis Research UK clinical studies 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.",
keywords = "Clinical trials, Osteoarthritis, Personalized medicine, Prognosis, Stratification",
author = "Kingsbury, {Sarah R.} and Nadia Corp and Watt, {Fiona E.} and Felson, {David T.} and O'Neill, {Terence W.} and Holt, {Cathy A.} and Jones, {Richard K.} and Conaghan, {Philip G.} and Arden, {Nigel K.} and Jo Adams and Ian Appleyard and Fraser Birrell and Mike Blank and Callaghan, {Michael J.} and Jo Cumming and Chapman, {Graham J.} and Jill Halstead and Hamilton, {David F.} and Michael Hurley and Kathryn Martin and Mason, {Deborah J.} and George Nuki and Redmond, {Anthony C.} and Kathleen Reilly and Nicola Robinson and Edward Roddy and Hamish Simpson and Smith, {Toby O.} and Christine Thomas and Elaine Thomas and Jennifer Wilkinson and Elspeth Wise and {Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Studies Group working group}",
note = "The authors wish to thank Arthritis Research UK for convening the meeting as part of the Clinical Studies Group for Osteoarthritis and Crystal Diseases programme. The views of Arthritis Research UK have not influenced the content of this guideline. Funding: No specific funding was received from any bodies in the public, commercial or not-for-profit sectors to carry out the work described in this article.",
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T2 - Recommendations on core data collection from an Arthritis Research UK clinical studies group

AU - Kingsbury, Sarah R.

AU - Corp, Nadia

AU - Watt, Fiona E.

AU - Felson, David T.

AU - O'Neill, Terence W.

AU - Holt, Cathy A.

AU - Jones, Richard K.

AU - Conaghan, Philip G.

AU - Arden, Nigel K.

AU - Adams, Jo

AU - Appleyard, Ian

AU - Birrell, Fraser

AU - Blank, Mike

AU - Callaghan, Michael J.

AU - Cumming, Jo

AU - Chapman, Graham J.

AU - Halstead, Jill

AU - Hamilton, David F.

AU - Hurley, Michael

AU - Martin, Kathryn

AU - Mason, Deborah J.

AU - Nuki, George

AU - Redmond, Anthony C.

AU - Reilly, Kathleen

AU - Robinson, Nicola

AU - Roddy, Edward

AU - Simpson, Hamish

AU - Smith, Toby O.

AU - Thomas, Christine

AU - Thomas, Elaine

AU - Wilkinson, Jennifer

AU - Wise, Elspeth

AU - Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Studies Group working group

N1 - The authors wish to thank Arthritis Research UK for convening the meeting as part of the Clinical Studies Group for Osteoarthritis and Crystal Diseases programme. The views of Arthritis Research UK have not influenced the content of this guideline. Funding: No specific funding was received from any bodies in the public, commercial or not-for-profit sectors to carry out the work described in this article.

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N2 - 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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