Developing a Core Outcome Set for Cauda Equina Syndrome
Research type
Research Study
Full title
Developing a Core Outcome Set for Cauda Equine Syndrome. Phase 2: The Delphi Process and Consensus Meeting.
IRAS ID
235208
Contact name
Nisaharan Srikandarajah
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
1 years, 1 months, 31 days
Research summary
Cauda Equina Syndrome (CES) is a neurological emergency. It is most likely caused by a “slipped disc” at the lower end of the spine. It can lead to permanent disability in young working age adults such as leg weakness, bladder, bowel and sexual dysfunction. CES is the most common indication for an emergency spine operation. We have performed a review of the literature, which showed that there is significant difference in the way CES studies choose, define and assess outcomes. It is difficult and methodologically unsound to collate these results together to decide on a robust management plan for these patients. Unfortunately, this is what is currently being done. Ultimately, we intend to develop a “core outcome set” for CES patients who have undergone surgery. This is the minimum set of outcomes that must be measured and reported in all research studies in a healthcare condition. We interviewed patients in the first phase of this study (IRAS 201946, REC 16/SC/0587) and found that there were many outcomes relating to quality of life that were not mentioned in the medical literature. We intend to combine the outcomes from the literature review and the patient interviews to make a comprehensive list. Key Stakeholders such as CES patients, healthcare professionals and researchers will then be asked to prioritise, which outcomes are most important through two to three rounds of a Delphi questionnaire process. The outcomes will then be discussed at a consensus meeting in person to decide on the final outcomes to be included in the core outcome set. Over time this will standardise the outcomes reported and assessed in this condition and this will contribute to evidenced based treatment and management protocols to be developed for this serious condition.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0022
Date of REC Opinion
12 Mar 2018
REC opinion
Further Information Favourable Opinion