|
ISRCTN
|
ISRCTN17898966
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The cost-effectiveness of Magnetic Resonance Imaging (MRI) for investigation of the knee joint
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
HTA 93/26/16
|
|
Study hypothesis
|
This study considered the role of Magnetic Resonance Imaging (MRI) in the diagnosis of knee injuries in a District General Hospital (DGH) setting. The principal objective was to identify whether the use of MRI had a major impact on the clinical management of patients presenting with chronic knee problems, in whom surgery was being considered, whether it reduced overall costs and whether it improved patient outcome.
In addition, the research:
1. Explored the 'diagnostic accuracy' of initial clinical investigation of the knee by an orthopaedic trainee, consultant knee specialist and consultant radiologist
2. Considered the variability and diagnostic accuracy of interpretations of knee MRI investigations between radiologists
3. Measured the strength of preference for the potential diagnostic/therapeutic impact of knee MRI (i.e. the avoidance of surgery)
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Single centre, randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Musculoskeletal injury
|
|
Participants - inclusion criteria
|
Patients attending with knee problems in whom surgery was being considered were recruited from routine orthopaedic clinics.
|
|
Participants - exclusion criteria
|
No exclusion criteria
|
|
Anticipated start date
|
01/01/1996
|
|
Anticipated end date
|
31/12/1998
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
118
|
|
Interventions
|
The research was based on a single-centre randomised controlled trial conducted at Kent and Canterbury Hospital.
Patients were randomised to:
1. Investigation using an MRI scan (MRI trial arm), or
2. Investigation using arthroscopy (no-MRI trial arm)
Investigation of diagnostic accuracy:
For the investigation of diagnostic accuracy of initial clinical investigation, the sample comprised 114 patients recruited in a separate study conducted at St Thomas’ Hospital. The sample was drawn from patients presenting at the Accident and emergency Department with an acute knee injury. All study patients received an MRI scan, but initial diagnosis was made without access to the scan or the radiologist’s report. After 12 months, all clinical notes and MRI scans of study patients were reviewed and a final ‘reference standard’ diagnosis for each patient was reached. Comparison was made between the diagnosis recorded by each clinician (i.e. orthopaedic trainee, knee specialist and consultant radiologist) and the reference diagnosis.
Investigation of the generalisability of results:
For this substudy, the MRI images from 80 patients (recruited at St Thomas’ Hospital) were interpreted independently by seven consultant radiologists at DGHs and the St Thomas’ Hospital MRI radiologist. For each area of the knee, the level of agreement (measured using weighted kappa) between the responses of the eight radiologists and the reference standard diagnosis was assessed.
Investigation of preferences:
The investigation of potential patient preferences for the diagnostic/therapeutic impact of MRI was explored using a discrete choice conjoint measurement research design. Choices involved selecting between two alternative scenarios described using four attributes, and data were collected from 585 undergraduate sports science students and analysed using a random-effects probit model.
|
|
Primary outcome measure(s)
|
The study investigated the benefits of knee MRI at two levels:
1. Diagnostic/therapeutic impact (i.e. avoidance of surgery)
2. Patient outcome (using the 36-item Short Form questionnaire [SF-36] and the EuroQoL quality-of-life measurement instruments [EQ-5D]); quality of life was assessed at baseline and at 6 and 12 months
Costs were assessed from the perspectives of the NHS and patients. All analyses were by intention to treat.
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
|
|
Publications
|
2001 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11532240
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15209182
|
|
Contact name
|
Dr
Stirling
Bryan
|
|
Address
|
Health Services Management Centre
University of Birmingham
Park House
40 Edgbaston Park Road
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B15 2RT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)121 414 4706
|
|
Fax
|
+44 (0)121 414 7051
|
|
Email
|
s.bryan@bham.ac.uk
|
|
Sponsor
|
Department of Health (UK)
|
|
Address
|
Quarry House
Quarry Hill
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 7UE
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1132 545 843
|
|
Email
|
Sheila.Greener@doh.gsi.gov.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/en/index.htm
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
02/09/2009
|
|
Date ISRCTN assigned
|
25/04/2003
|
