Contact information
Type
Scientific
Primary contact
Dr Stirling Bryan
ORCID ID
Contact details
Health Services Management Centre
University of Birmingham
Park House
40 Edgbaston Park Road
Birmingham
B15 2RT
United Kingdom
+44 (0)121 414 4706
s.bryan@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/26/16
Study information
Scientific title
Acronym
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)
Ethics approval
Not provided at time of registration
Study design
Single centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Musculoskeletal injury
Intervention
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 radiologists 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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
No secondary outcome measures
Overall trial start date
01/01/1996
Overall trial end date
31/12/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Patients attending with knee problems in whom surgery was being considered were recruited from routine orthopaedic clinics.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
118
Participant exclusion criteria
No exclusion criteria
Recruitment start date
01/01/1996
Recruitment end date
31/12/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Services Management Centre
Birmingham
B15 2RT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2001 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11532240
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15209182
Publication citations
-
HTA monograph
Bryan S, Weatherburn G, Bungay H, Hatrick C, Salas C, Parry D, Field S, Heatley F, The cost-effectiveness of magnetic resonance imaging for investigation of the knee joint., Health Technol Assess, 2001, 5, 27, 1-95.
-
Results
Bryan S, Bungay HP, Weatherburn G, Field S, Magnetic resonance imaging for investigation of the knee joint: a clinical and economic evaluation., Int J Technol Assess Health Care, 2004, 20, 2, 222-229.