Evidence map›Paper›PMID 26361882›Full record

ReviewRheumatology (Oxford, England)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.

David T Felson, Anthony C Redmond, Graham J Chapman, Toby O Smith, David F Hamilton, Richard K Jones, Cathy A Holt, Michael J Callaghan, Deborah J Mason, Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group and 1 more

Open access · bronzeAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Rheumatology (Oxford, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 2 countries.

David T FelsonArthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK, Clinical Epidemiology Unit, School of Medicine, Boston University, Boston, USA, david.felson@manchester.ac.uk.
Anthony C RedmondLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
Graham J ChapmanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
Toby O SmithSchool of Health Sciences, University of East Anglia, Norwich.
David F HamiltonSchool of Clinical Sciences, University of Edinburgh, Edinburgh.
Richard K JonesSchool of Health Sciences, University of Salford, Lancashire.
Cathy A HoltSchool of Engineering, Cardiff University and Arthritis Research UK Biomechanics and Bioengineering Centre and.
Michael J CallaghanArthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK.
Deborah J MasonCardiff School of Biosciences, Cardiff University, Cardiff, UK.
Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
University of Leeds · GBVersus Arthritis · GBCardiff University · GBNIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversity of East Anglia · GBUniversity of Edinburgh · GBUniversity of Manchester · GBUniversity of Salford · GB

Funding

Arthritis Research UK 19996Department of Health PDA/03/07/047Medical Research Council MR/L01629X/1
6 · The paper itself

Abstract

objectiveThere 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.

methodsAn 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.

resultsChallenges 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.

conclusionA 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.

Indexed as

ConsensusClinical Trials as TopicHumansOrthopedic ProceduresOsteoarthritis, KneeUnited Kingdombraceclinical trialsdevicesefficacyorthosesosteoarthritisrecommendations

Identifiers

PMID26361882
PMCPMC5854040
OpenAlexW2102108151

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.