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

Journal article


Kingsbury, SR, Corp, N, Watt, FE, Felson, DT, O'Neill, TW, Holt, CA, Jones, RK, Conaghan, PG, Arden, NK, Adams, J, Appleyard, I, Birrell, F, Blank, M, Callaghan, MJ, Cumming, J, Chapman, GJ, Halstead, J, Hamilton, DF, Hurley, M, Martin, K, Mason, DJ, Nuki, G, Redmond, AC, Reilly, K, Robinson, N., Roddy, E, Simpson, H, Smith, TO, Thomas, C, Thomas, E, Wilkinson, J and Wise, E (2016). Harmonising data collection from osteoarthritis studies to enable stratification: Recommendations on core data collection from an Arthritis Research UK clinical studies group. Rheumatology (United Kingdom). 55 (8), pp. 1394-1402. https://doi.org/10.1093/rheumatology/kew201
AuthorsKingsbury, SR, Corp, N, Watt, FE, Felson, DT, O'Neill, TW, Holt, CA, Jones, RK, Conaghan, PG, Arden, NK, Adams, J, Appleyard, I, Birrell, F, Blank, M, Callaghan, MJ, Cumming, J, Chapman, GJ, Halstead, J, Hamilton, DF, Hurley, M, Martin, K, Mason, DJ, Nuki, G, Redmond, AC, Reilly, K, Robinson, N., Roddy, E, Simpson, H, Smith, TO, Thomas, C, Thomas, E, Wilkinson, J and Wise, E
Abstract

© The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. 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.

KeywordsHumans; Rheumatic Diseases; Rheumatology; Age Factors; Needs Assessment; Adolescent; Adult; Child; Adolescent Health Services; Continuity of Patient Care; Quality of Health Care; United States; Female; Male; Young Adult; Adolescent; Adolescent Health Services; Adult; Age Factors; Child; Continuity of Patient Care; Female; Humans; Male; Needs Assessment; Quality of Health Care; Rheumatic Diseases; Rheumatology; United States; Young Adult; arthritis; predictors; data collection; Clinical Sciences; Immunology; Public Health And Health Services; Arthritis & Rheumatology
Year2016
JournalRheumatology (United Kingdom)
Journal citation55 (8), pp. 1394-1402
PublisherOxford University Press (OUP)
ISSN1462-0324
Digital Object Identifier (DOI)https://doi.org/10.1093/rheumatology/kew201
Publication dates
Print15 Apr 2016
Print01 Aug 2016
Publication process dates
Deposited03 Jul 2017
Accepted15 Mar 2016
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