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

Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)320-326
Number of pages7
JournalRheumatology
Volume55
Issue number2
Early online date10 Sep 2015
DOIs
Publication statusPublished - Feb 2016

Fingerprint

Osteoarthritis
Arthritis
Equipment and Supplies
Research
Rheumatic Diseases
Clinical Studies
Equipment Design
Placebo Effect
Physical Therapists
Therapeutics
Placebos

Keywords

  • Brace
  • Clinical trials
  • Devices
  • Efficacy
  • Orthoses
  • Osteoarthritis
  • Recommendations

ASJC Scopus subject areas

  • Rheumatology
  • Pharmacology (medical)

Cite this

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. / Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group.

In: Rheumatology, Vol. 55, No. 2, 02.2016, p. 320-326.

Research output: Contribution to journalArticle

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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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author = "Felson, {David T.} and Redmond, {Anthony C.} and Chapman, {Graham J.} and Smith, {Toby O.} and Hamilton, {David F.} and Jones, {Richard K.} and Holt, {Cathy A.} and Callaghan, {Michael J.} and Mason, {Deborah J.} and Conaghan, {Philip G.} and J. Adams and Arden, {N. K.} and F. Birrell and J. Cumming and N. Corp and J. Halstead and M. Hurley and Kingsbury, {S. R.} and K. Martin and G. Nuki and T. O'Neill and K. Reilly and N. Robinson and E. Roddy and H. Simpson and C. Thomas and E. Thomas and Watt, {F. E.} and J. Wilkinson and E. Wise and {Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group}",
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