Plain English Summary
Not provided at time of registration
Trial website
http://www.york.ac.uk/healthsciences/centres/trials/damask/dam2.htm
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0001133 (P/Care init)
Study information
Scientific title
Acronym
DAMASK (Direct Access to Magnetic resonance imaging: Assessment for Suspect Knees)
Study hypothesis
Each year 15% of all patients consult General Practitioners (GPs) for musculo-skeletal disorders. Examination of the knee is now one of the commonest musculo-skeletal applications of Magnetic Resonance Imaging (MRI). There is evidence that MRI allows accurate assessment of meniscal and ligamentous injuries of the knee. With explicit clinical indications in selected patients it can avoid an expensive invasive arthroscopy, reducing the waiting times for those who do need one. However, whether management using MRI affects patients quality of life has not been rigorously evaluated. Hence there is uncertainty about whether recommending open access MRI to avoid hospital referral is appropriate. This reflects wide variation both in GPs access to, and use of MRI, and in associated costs. Thus the question whether patients presenting to GPs with continuing knee problems should be referred for an MRI scan or directly to an orthopaedic surgeon is crucial to patient management and outcome, and thus to cost-effectiveness.
Hypothesis:
1. To evaluate:
a. whether the early use of MRI through open access affects subsequent diagnosis and management
b. whether it improves patient outcomes
c. whether it reduces net costs to the NHS, patients and society
2. To explore patient and practitioner preferences for open access to MRI and to investigate the generalisability of results obtained from the three experimental sites in York, Wrexham and Aberdeen
By including Cardiff, where direct access to MRI has been available for eight years, we shall study the effect of such access on the case mix of GP referrals for direct MRI and referrals to the orthopaedics department.
Ethics approval
The trial protocol was designed to comply with the Declaration of Helsinki as adopted by the World Medical Association. UK Northern and Yorkshire Multi-Centre Research Ethics Committee approved the protocol (reference number MREC/1/3/59).
Study design
Multicentre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Knee problems
Intervention
All general practice staff are invited to a training session about the appropriate use of MRI and interpretation of findings.
Within practices individual participants will be randomised between:
1. The local radiology department for an MRI scan - depending on the result of the scan the GP might then refer the participant to be seen by an orthopaedic surgeon; and
2. The local orthopaedic department for a consultation with the specialist - depending on the result of this visit, the surgeon might then send the participant for an MRI scan.
To ensure that the evaluation covers events up to and including arthroscopy we shall follow patients from random allocation for 24 months using questionnaires asking about their general health and experience of knee pain. Economic analyses will compare benefits to participants with costs to both the NHS and participants themselves.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure is the change in the physical functioning sub-scale of the Short Form 36-item questionnaire (SF-36) at six months. A change of 6.75 points on the scale has been agreed as being clinically significant.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
03/01/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. People aged between 18 and 55
2. Suspected internal derangement of the knee suggesting meniscal or ligamentous patello-femoral joint-pain
3. Continuing symptoms at least six weeks after the initial consultation during the study period despite conservative treatment (e.g., analgesics, physiotherapy or tubigrip)
4. GP is considering orthopaedic or MRI referral
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
500
Participant exclusion criteria
1. The GP judges that urgent orthopaedic referral is necessary at the initial consultation
2. Suspected osteoarthritis or other non-traumatic arthropathy
3. Isolated patello-femoral joint pain
4. Previous MRI scan within this episode of care
5. Previous surgical intervention (excluding diagnostic arthroscopy) on the same knee
6. Contraindications to the use of MRI, for example pacemaker, intra-cranial aneurysm clips, or orbital metallic foreign body
7. Patients who reside in Orkney or Shetland
Recruitment start date
03/01/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Health Sciences and Clinical Evaluation
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
Heslington
York
YO10 5DD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0001133)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17040558
2. 2007 results re influence of MRI on GP's decision in http://www.ncbi.nlm.nih.gov/pubmed/17688756
3. 2008 results re effectiveness of GP's access to MRI in http://www.ncbi.nlm.nih.gov/pubmed/19000393
4. 2008 results re cost-effectiveness of MRI in http://www.ncbi.nlm.nih.gov/pubmed/19000394
5. 2010 participant feedback survey results in http://www.ncbi.nlm.nih.gov/pubmed/21122094
Publication citations
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Protocol
Brealey SD, Atwell C, Bryan S, Coulton S, Cox H, Cross B, Fylan F, Garratt A, Gilbert FJ, Gillan MG, Hendry M, Hood K, Houston H, King D, Morton V, Orchard J, Robling M, Russell IT, Torgerson D, Wadsworth V, Wilkinson C, The DAMASK trial protocol: a pragmatic randomised trial to evaluate whether GPs should have direct access to MRI for patients with suspected internal derangement of the knee., BMC Health Serv Res, 2006, 6, 133, doi: 10.1186/1472-6963-6-133.
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Participant feedback survey results
Brealey S, Andronis L, Dennis L, Atwell C, Bryan S, Coulton S, Cox H, Cross B, Fylan F, Garratt A, Gilbert F, Gillan M, Hendry M, Hood K, Houston H, King D, Morton V, Robling M, Russell I, Wilkinson C, Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey., Trials, 2010, 11, 116, doi: 10.1186/1745-6215-11-116.
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Brealey SD, , Influence of magnetic resonance of the knee on GPs' decisions: a randomised trial., Br J Gen Pract, 2007, 57, 541, 622-629.
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Effectiveness of GP access to magnetic resonance imaging of the knee: a randomised trial., Br J Gen Pract, 2008, 58, 556, e1-8; discussion 774, doi: 10.3399/bjgp08X342651.
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Cost-effectiveness of magnetic resonance imaging of the knee for patients presenting in primary care., Br J Gen Pract, 2008, 58, 556, e10-6, doi: 10.3399/bjgp08X342660.