Imperial Orthopaedic Score Validation
Research type
Research Study
Full title
Imperial Orthopaedic Score Validation
IRAS ID
288281
Contact name
Justin Cobb
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 3 months, 30 days
Research summary
The title of research is "Imperial Orthopaedic Score Validation Study." This is a mixed study design consisting of qualitative focus group, expert opinion (Delphi methodology), and quantitative cohort study. The aims of the research are two-fold. Firstly, to develop a robust questionnaire that captures patients’ experiences before and after hip or knee replacement surgery and overcomes the existing floor and ceiling effect associated with existing measures. Secondly, to validate this questionnaire, exploring construct validity and criterion related validity.
There are three outcome measures. Firstly a questionnaire capturing patients’ experience with joint mobility that overcomes the existing floor and ceiling effect limitations of current measures. Second outcome measure is construct validity – how the new questionnaire compares to similar measures such as the Oxford Hip and Knee Score and/or EQ5D. The last outcome measure is criterion-related validity – whether the new questionnaire is predictive of patient outcomes following surgery.
The study population consists of patient focus groups, health professional experts and main study patient participants. Patient focus groups will run at two different phases (scoping and design) for a total of 30-40 participants. In addition, 20 health professional experts will help to validate the questionnaire during the design phase. Finally 250-500 patients planned to have knee or hip replacement surgery will take part in the validation of the novel questionnaire. There is no treatment. The intervention is the administration of a novel questionnaire amongst patients undergoing elective hip or knee joint replacement surgery.
Study duration is 40 months from Ethics approval to develop and validate the questionnaire. Subject to successful completion of the project, there is a possibility of longer follow up with patients. Data and all appropriate documentation will be stored for up to 20 years after the completion of the study, including the follow-up period.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0276
Date of REC Opinion
11 Jan 2022
REC opinion
Further Information Favourable Opinion