Informing Core Outcome Set Development in Cauda Equina Syndrome.
Research type
Research Study
Full title
Informing the development of a Core Outcome Set for patients who have undergone surgery for Cauda Equina Syndrome.
IRAS ID
201946
Contact name
Tony Marson
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
825, Developing a Core Outcome Set in Surgery for Cauda Equina Syndrome
Duration of Study in the UK
0 years, 11 months, 2 days
Research summary
Cauda equina syndrome is the most common indication for emergency spine operation. It is caused by sudden compression of the spine in the lower back which can cause severe disability including leg weakness, bowel, bladder and sexual dysfunction. The typical cause is a “slipped” disc, which is then removed by emergency surgery. In the literature there are many studies analysing the outcomes of operating but there is significant difference in outcomes reported, and a lack of focus in long term outcomes for this condition.
With the help of patients we intend to ultimately develop a 'Core Outcome Set'(COS) for cauda equina. A COS is a minimum set of outcomes that will need to be measured by all clinical trials for this condition in the future. Its use should improve consistency of reporting in the literature allowing more statistically powerful studies to be done. This will contribute to evidenced based treatment and management protocols to be developed for this serious condition.
The currently proposed study represents the first step in our development of the COS. It will involve us conducting qualitative interviews with patients to find out the different outcomes that are important to them. No such evidence currently exists. This information will inform the subsequent steps that will be completed to develop the COS. Specifically, a Delphi survey will be conducted in which a large sample of patients and health professionals from around the UK will be presented with a list of potentially important outcomes and asked to rate their importance. Those outcomes ranking highest will then be discussed at a consensus meeting at which a final, core set of outcomes will be decided upon. The outcomes identified by patients at the interviews will inform the outcomes presented on the initial list used for the Delphi and the language used to describe them.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0587
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion