Development of the Cauda Equina Syndrome Core Outcome Set for research studies

Abstract Chapter1: Cauda Equina Syndrome (CES) is an emergency condition that requires acute intervention and can lead to permanent neurological deficit in working age adults. A Core Outcome Set (COS) is the minimum set of outcomes that should be reported in any future research study within a specific disease area. A COS for patients with CES will be developed for use in future research studies. Chapter 2&3: A systematic literature review (SLR) was performed using PRISMA guidelines to document the outcomes used in CES studies. A total of 1873 studies were identified of which 61 met the inclusion criteria. There were 737 verbatim outcome terms reported. There was significant heterogeneity in the outcomes reported for studies after surgery for CES patients. The duration from the start of the CES to the operation was also analysed in these studies. There was significant heterogeneity in the reporting and definition of the timing to intervention in CES. Chapter 4: The outcomes of importance to patients and the lived experience of CES considering its severity was elicited through semi structured qualitative interviews. A sampling frame was used, interviews were consented for, audio recorded and transcribed for thematic analysis using NVivo. Data saturation was achieved with 22 participants. Initially, 260 verbatim outcome terms were identified- 43 of which were not identified in the SLR. Further in depth analysis revealed 4 themes of 1) varying priorities of physical health, 2) a fragmented healthcare service 3) the process of adjustment, and 4) anticipatory anxiety and diminished sense of self-worth. Chapter 5: Outcomes were combined and condensed from the SLR and from the qualitative interviews with CES patients. This resulted in 37 outcomes that were rated through two rounds of an international Delphi survey. The Delphi survey included 172 participants (104 patients, 68 healthcare professionals) who completed both rounds. The results were presented at an international consensus meeting attended by 34 key stakeholders (16 patients and 18 healthcare professionals). Sixteen outcomes were chosen for inclusion in the COS. They are incontinence of urine, urinary retention, sensation of bladder fullness, faecal incontinence, physical ability to have sexual intercourse, perineal sensation, sensation in genitals, leg muscle strength, pain due to abnormal sensation of non-painful stimulus, complications, global quality of life, occupational role functioning, social functioning, ability to do daily activities, mobility and walking and low mood and depression. Chapter 6: The COS was obtained by a transparent international consensus process involving healthcare professionals and patients with CES as key stakeholders. This COS is recommended for use in CES studies as the minimum set of outcomes to be collected

Incidental intracranial meningiomas: a systematic review and meta-analysis of prognostic factors and outcomes (vol 142, pg 211, 2019)

BackgroundIncidental discovery accounts for 30% of newly-diagnosed intracranial meningiomas. There is no consensus on their optimal management. This review aimed to evaluate the outcomes of different management strategies for these tumors.MethodsUsing established systematic review methods, six databases were scanned up to September 2017. Pooled event proportions were estimated using a random effects model. Meta-regression of prognostic factors was performed using individual patient data.ResultsTwenty studies (2130 patients) were included. Initial management strategies at diagnosis were: surgery (27.3%), stereotactic radiosurgery (22.0%) and active monitoring (50.7%) with a weighted mean follow-up of 49.5 months (SD = 29.3). The definition of meningioma growth and monitoring regimens varied widely impeding relevant meta-analysis. The pooled risk of symptom development in patients actively monitored was 8.1% (95% CI 2.7-16.1). Associated factors were peritumoral edema (OR 8.72 [95% CI 0.35-14.90]) and meningioma diameter ≥ 3 cm (OR 34.90 [95% CI 5.17-160.40]). The pooled proportion of intervention after a duration of active monitoring was 24.8% (95% CI 7.5-48.0). Weighted mean time-to-intervention was 24.8 months (SD = 18.2). The pooled risks of morbidity following surgery and radiosurgery, accounting for cross-over, were 11.8% (95% CI 3.7-23.5) and 32.0% (95% CI 10.6-70.5) respectively. The pooled proportion of operated meningioma being WHO grade I was 94.0% (95% CI 88.2-97.9).ConclusionThe management of incidental meningioma varies widely. Most patients who clinically or radiologically progressed did so within 5 years of diagnosis. Intervention at diagnosis may lead to unnecessary overtreatment. Prospective data is needed to develop a risk calculator to better inform management strategies

More questions than answers to the diagnosis and management of cauda equina syndrome-Authors' reply

No abstract available

Understanding cauda equina syndrome: protocol for a UK multicentre prospective observational cohort study

IntroductionCauda equina syndrome (CES) is a potentially devastating condition caused by compression of the cauda equina nerve roots. This can result in bowel, bladder and sexual dysfunction plus lower limb weakness, numbness and pain. CES occurs infrequently, but has serious potential morbidity and medicolegal consequences. This study aims to identify and describe the presentation and management of patients with CES in the UK.Methods and analysisUnderstanding Cauda Equina Syndrome (UCES) is a prospective and collaborative multicentre cohort study of adult patients with confirmed CES managed at specialist spinal centres in the UK. Participants will be identified using neurosurgical and orthopaedic trainee networks to screen referrals to spinal centres. Details of presentation, investigations, management and service usage will be recorded. Both patient-reported and clinician-reported outcome measures will be assessed for 1 year after surgery. This will establish the incidence of CES, current investigation and management practices, and adherence to national standards of care. Outcomes will be stratified by clinical presentation and patient management. Accurate and up to date information about the presentation, management and outcome of patients with CES will inform standards of service design and delivery for this important but infrequent condition.Ethics and disseminationUCES received a favourable ethical opinion from the South East Scotland Research Ethics Committee 02 (Reference: 18/SS/0047; IRAS ID: 233515). All spinal centres managing patients with CES in the UK will be encouraged to participate in UCES. Study results will be published in medical journals and shared with local participating sites.Trial registration numberISRCTN16828522; Pre-results.</jats:sec

Presentation, management, and outcomes of cauda equina syndrome up to one year after surgery, using clinician and participant reporting: a multi-centre prospective cohort study

Background: Cauda equina syndrome (CES) results from nerve root compression in the lumbosacral spine, usually due to a prolapsed intervertebral disc. Evidence for management of CES is limited by its infrequent occurrence and lack of standardised clinical definitions and outcome measures. Methods: This is a prospective multi-centre observational cohort study of adults with CES in the UK. We assessed presentation, investigation, management, and all Core Outcome Set domains up to one year post-operatively using clinician and participant reporting. Univariable and multivariable associations with the Oswestry Disability Index (ODI) and urinary outcomes were investigated. Findings: In 621 participants with CES, catheterisation for urinary retention was required pre-operatively in 31% (191/615). At discharge, only 13% (78/616) required a catheter. Median time to surgery from symptom onset was 3 days (IQR:1–8) with 32% (175/545) undergoing surgery within 48 h. Earlier surgery was associated with catheterisation (OR:2.2, 95%CI:1.5–3.3) but not with admission ODI or radiological compression. In multivariable analyses catheter requirement at discharge was associated with pre-operative catheterisation (OR:10.6, 95%CI:5.8–20.4) and one-year ODI was associated with presentation ODI (r = 0.3, 95%CI:0.2–0.4), but neither outcome was associated with time to surgery or radiological compression. Additional healthcare services were required by 65% (320/490) during one year follow up. Interpretation: Post-operative functional improvement occurred even in those presenting with urinary retention. There was no association between outcomes and time to surgery in this observational study. Significant healthcare needs remained post-operatively. Funding: DCN Endowment Fund funded study administration. Castor EDC provided database use. No other study funding was received

Outcomes Reported After Surgery for Cauda Equina Syndrome: A Systematic Literature Review.

This is a systematic literature review following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines.To assess the outcomes reported in trials and observational studies of surgery for cauda equina syndrome (CES), and to inform the development of a core outcome set.Scoping searches revealed that there were inconsistencies in which outcomes were reported and how they were measured in research studies for patients who had undergone surgery for CES.Ovid Medline, Embase, CINAHL Plus, and trial registries were searched from January 1, 1990 to September 30, 2016 with the term "cauda equina syndrome." Inclusion and exclusion criteria were applied according to study design, diagnosis, procedure, publication date, language, and patient age. Data extracted included demographics, study design, the outcomes reported, and their definition. We also assessed variation in the use of terminology for each outcome domain.A total of 1873 articles were identified, of which 61 met the inclusion criteria. Of these, 737 outcomes reported verbatim were categorized into 20 core outcome domains and 12 subdomains with a range of 1 to 141 outcomes per outcome domain or subdomain. The most commonly reported outcomes were bladder function (70.5%), motor function (63.9%), and sensation (50.8%). Significant variation in the terms used for each outcome was documented, for example, bladder function outcome domain had 141 different terms.There is significant heterogeneity in outcomes reported for studies after surgery for CES patients. This indicates a clear need for the development of a core outcome set, which has been registered as number 824 on the COMET (Core Outcome Measure in Effectiveness Trials) database.1