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Recommendations for the conduct of efficacy trials of treatment devices for osteoarthritis: a report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group

Recommendations for the conduct of efficacy trials of treatment devices for osteoarthritis: a report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group
Recommendations for the conduct of efficacy trials of treatment devices for osteoarthritis: a report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group
Objective. There are unique challenges to designing and carrying out high-quality trials testing therapeutic devices in OA and other rheumatic diseases. Such challenges include determining the mechanisms of action of the device and the appropriate sham. Design of device trials is more challenging than that of placebo-controlled drug trials. Our aim was to develop recommendations for designing device trials.

Methods. An Arthritis Research UK study group comprised of 30 rheumatologists, physiotherapists, podiatrists, engineers, orthopaedists, trialists and patients, including many who have carried out device trials, met and (using a Delphi-styled approach) came to consensus on recommendations for device trials.

Results. Challenges unique to device trials include defining the mechanism of action of the device and, therefore, the appropriate sham that provides a placebo effect without duplicating the action of the active device. Should there be no clear-cut mechanism of action, a three-arm trial including a no-treatment arm and one with presumed sham action was recommended. For individualized devices, generalizable indications and standardization of the devices are needed so that treatments can be generalized.

Conclusion. A consensus set of recommendations for device trials was developed, providing a basis for improved trial design, and hopefully improvement in the number of effective therapeutic devices for rheumatic diseases.
1462-0324
320-326
Felson, D.T.
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Redmond, A.C.
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Chapman, G.J.
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Smith, T.O.
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Hamilton, D.F.
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Jones, R.K.
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Holt, C.A.
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Callaghan, M.J.
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Mason, D.J.
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Conaghan, P.G.
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Adams, J.
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Arden, N.
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Birrell, F.
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Cumming, J.
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Corp, N.
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Halstead, J.
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Hurley, M.
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Kingsbury, S.R.
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Martin, K.
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Nuki, G.
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O'Neill, T.
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Reilly, K.
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Robinson, N.
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Roddy, E.
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Simpson, H.
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Thomas, C.
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Watts, F.E.
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Wilkinson, J.
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Felson, D.T.
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Redmond, A.C.
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Chapman, G.J.
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Hamilton, D.F.
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Jones, R.K.
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Holt, C.A.
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Callaghan, M.J.
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Mason, D.J.
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Conaghan, P.G.
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Adams, J.
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Arden, N.
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Birrell, F.
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Cumming, J.
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Corp, N.
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Halstead, J.
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Hurley, M.
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Kingsbury, S.R.
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Martin, K.
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Nuki, G.
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Reilly, K.
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Thomas, C.
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Watts, F.E.
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Wilkinson, J.
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Wise, E.
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Felson, D.T., Redmond, A.C., Chapman, G.J., Smith, T.O., Hamilton, D.F., Jones, R.K., Holt, C.A., Callaghan, M.J., Mason, D.J., Conaghan, P.G., Adams, J., Arden, N., Birrell, F., Cumming, J., Corp, N., Halstead, J., Hurley, M., Kingsbury, S.R., Martin, K., Nuki, G., O'Neill, T., Reilly, K., Robinson, N., Roddy, E., Simpson, H., Thomas, C., Thomas, E., Watts, F.E., Wilkinson, J. and Wise, E. (2016) Recommendations for the conduct of efficacy trials of treatment devices for osteoarthritis: a report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group. Rheumatology, 55 (2), 320-326. (doi:10.1093/rheumatology/kev328). (PMID:26361882)

Record type: Article

Abstract

Objective. There are unique challenges to designing and carrying out high-quality trials testing therapeutic devices in OA and other rheumatic diseases. Such challenges include determining the mechanisms of action of the device and the appropriate sham. Design of device trials is more challenging than that of placebo-controlled drug trials. Our aim was to develop recommendations for designing device trials.

Methods. An Arthritis Research UK study group comprised of 30 rheumatologists, physiotherapists, podiatrists, engineers, orthopaedists, trialists and patients, including many who have carried out device trials, met and (using a Delphi-styled approach) came to consensus on recommendations for device trials.

Results. Challenges unique to device trials include defining the mechanism of action of the device and, therefore, the appropriate sham that provides a placebo effect without duplicating the action of the active device. Should there be no clear-cut mechanism of action, a three-arm trial including a no-treatment arm and one with presumed sham action was recommended. For individualized devices, generalizable indications and standardization of the devices are needed so that treatments can be generalized.

Conclusion. A consensus set of recommendations for device trials was developed, providing a basis for improved trial design, and hopefully improvement in the number of effective therapeutic devices for rheumatic diseases.

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More information

Accepted/In Press date: 5 August 2015
e-pub ahead of print date: 10 September 2015
Published date: 1 February 2016
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 397501
URI: http://eprints.soton.ac.uk/id/eprint/397501
ISSN: 1462-0324
PURE UUID: e9aa6699-b3fe-435a-98e7-ed04cef0614c
ORCID for J. Adams: ORCID iD orcid.org/0000-0003-1765-7060

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Date deposited: 04 Jul 2016 12:04
Last modified: 12 Nov 2019 02:00

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Contributors

Author: D.T. Felson
Author: A.C. Redmond
Author: G.J. Chapman
Author: T.O. Smith
Author: D.F. Hamilton
Author: R.K. Jones
Author: C.A. Holt
Author: M.J. Callaghan
Author: D.J. Mason
Author: P.G. Conaghan
Author: J. Adams ORCID iD
Author: N. Arden
Author: F. Birrell
Author: J. Cumming
Author: N. Corp
Author: J. Halstead
Author: M. Hurley
Author: S.R. Kingsbury
Author: K. Martin
Author: G. Nuki
Author: T. O'Neill
Author: K. Reilly
Author: N. Robinson
Author: E. Roddy
Author: H. Simpson
Author: C. Thomas
Author: E. Thomas
Author: F.E. Watts
Author: J. Wilkinson
Author: E. Wise

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