The cost-effectiveness of Magnetic Resonance Imaging (MRI) for investigation of the knee joint

ISRCTN	ISRCTN17898966
DOI	https://doi.org/10.1186/ISRCTN17898966
Secondary identifying numbers	HTA 93/26/16

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 02/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stirling Bryan
Scientific

Health Services Management Centre
University of Birmingham
Park House
40 Edgbaston Park Road
Birmingham
B15 2RT
United Kingdom

Phone	+44 (0)121 414 4706
Email	s.bryan@bham.ac.uk

Study information

Study design	Single centre, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/1996
Completion date	31/12/1998

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	118
Key inclusion criteria	Patients attending with knee problems in whom surgery was being considered were recruited from routine orthopaedic clinics.
Key exclusion criteria	No exclusion criteria
Date of first enrolment	01/01/1996
Date of final enrolment	31/12/1998

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Health Services Management Centre

Birmingham
B15 2RT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	HTA monograph	01/12/2001		Yes	No
Results article	results	01/03/2004		Yes	No