The Cauda Equina Syndrome Early Recognition (CESER) Study: a mixed-methods study to improve diagnosis of cauda equina syndrome in the Emergency Department
Cauda equina syndrome (CES)
The study is a multi-centre prospective diagnostic cohort study. The study will recruit up to 2000 patients with suspected CES from approximately 12 trial locations in the UK. Participants with confirmed CES will be followed up on throughout the course of their assessment, management, and recovery. A record check will be completed for participants who do not have CES. Patients will be identified in a consultant-led, 24-hour service at the major A&E of participating hospitals. Research staff will identify and flag any potentially eligible patients and briefly introduce the idea of the study to the patients. Participants will then be approached about the study for the informed consent discussions by a member of the local research team or a clinician in the ED, such as the doctor designated to undertake their clinical assessment. Once eligibility has been confirmed by the clinical team, the patient will be informed of the study and given access to the Patient Information Sheet (PIS). If happy to proceed, the patient will sign an electronic informed consent form (ICF). Participants will be registered by the site research team using an online system. Baseline data will be collected after the participant has consented and been registered. Data will be entered into an online system by the participant, assessing clinician, and local research team. All participants will complete questionnaires at baseline. Follow-up will be completed at 6 weeks, 6 months and 12 months by participants with confirmed CES through electronic, paper or telephone questionnaires. Patient experience of symptoms, diagnosis and emergency care will be sought through qualitative interviews with up to 30 participants recruited from the study. All patients who consent to take part in the cohort study will be informed of the qualitative study at a later time point and will have time to consider whether they would like to take part in this aspect of the trial. Those who are interested in taking part i
1. They are aged 18 years or over 2. They have a suspected diagnosis of CES, defined by a clinician who routinely assesses such patients and considers it appropriate to organise an MRI to confirm or exclude this diagnosis 3. They are willing and able to give informed consent
1. The MRI scan for suspected cauda equina compression had been undertaken before the clinical assessment 2. There is a suspected spinal fracture 3. There is evidence that the patient will be unable to adhere to trial procedures or participate in follow-up, including life expectancy of less than 12 months