Patient-reported outcomes in Primary Spinal Intradural Tumours: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVES: Primary Spinal Intradural Tumours (PSITs) are rare pathologies that can significantly impact quality of life. This study aimed to review patient reported outcomes (PROs) in PSITs. METHODS: A systematic search of Pubmed and Embase was performed to identify studies measuring PROs in adults with PSITs. PRO results were categorised as relating to Global, Physical, Social, or Mental health. Outcomes were summarised descriptively. RESULTS: Following review of 2382 records, 11 studies were eligible for inclusion (737 patients). All studies assessed surgically treated patients. Schwannoma was the commonest pathology (n = 190). 7 studies measured PROs before and after surgery, the remainder assessed only post-operatively. For eight studies, PROs were obtained within 12 months of treatment. 21 PRO measurement tools were used across included studies, of which Euro-Qol-5D (n = 8) and the pain visual/numerical analogue scale (n = 5) were utilised most frequently. Although overall QoL is lower than healthy controls in PSITs, improvements following surgery were found in Extramedullary tumours (EMT) in overall physical, social, and mental health. Similar improvements were not significant across studies of Intramedullary tumours (IMT). Overall QoL and symptom burden was higher in IMT patients than in brain tumour patients. No studies evaluated the effect of chemotherapy or radiotherapy. CONCLUSION: Patients with PSITs suffer impaired PROs before and after surgery. This is particularly true for IMTs. PRO reporting in PSITs is hindered by a heterogeneity of reporting and varied measurement tools. This calls for the establishment of a standard set of PROs as well as the use of registries.

Identification and Assessment of Outcome Measurement Instruments in Cauda Equina Syndrome: A Systematic Review.

STUDY DESIGN: This was a systematic review of surgically managed Cauda Equina Syndrome (CES) Outcome Measurement Instruments (OMI). OBJECTIVE: A core outcome set (COS) defines agreed outcomes which should be reported as a minimum in any research study for a specific condition. This study identified OMIs used in the wider CES literature and compare these to the established CESCOS. METHODS: To identify measurement methods and instruments in the CES surgical outcome evidence base, a systematic review was performed. Medline, Embase and CINAHL plus databases were queried. In addition, a secondary search for validation studies of measurement instruments in CES was undertaken. Identified studies from this search were subject to the COSMIN risk of bias assessment. RESULTS: In total, 112 studies were identified investigating surgical outcomes for CES. The majority (80%, n = 90) of these OMI studies were retrospective in nature and only 55% (n = 62) utilised a measurement method or instrument. The remaining 50 studies used study specific definitions for surgical outcomes defined within their methods. Of the 59 measurement instruments identified, 60% (n = 38 instruments) were patient reported outcome measures. Only one validated instrument was identified, which was a patient reported outcome measure. The validated instrument was not used in any study identified in the initial search (to identify measurement instruments). CONCLUSIONS: This review highlights the wide heterogeneity of measurement instruments used in surgically managed CES research. Subsequently, there is need for consensus agreement on which instrument or instruments should be used to measure each core outcome for CES surgical outcomes.

Results from an expedited spinal nerve root block clinic at a UK tertiary neurosurgical centre.

STUDY DESIGN: Retrospective Observational Study. INTRODUCTION: Lumbar radicular pain has a prevalence of 3-5%. Level 1 evidence has demonstrated equivalence between surgical and injection treatment. We assess the outcomes from a transforaminal epidural steroid injection clinic in a tertiary neuroscience referral centre. METHODS: We performed an analysis of data from consecutive patients entered into a new internal referral database between August 2018 to May 2021. Radicular pain was classified as one of "first presentation" or "recurrence". Outcomes were obtained from follow up clinic letters and recorded in a binary manner of "positive result" or "negative result". Spinal pathology was documented from radiology reports and MRI images. RESULTS: We analysed 208 patients referred to the clinic. Excluding those who improved to a point of not requiring treatment, and those who underwent surgical intervention, 119 patients undergoing injection were included, of which 14 were lost to follow-up. 68 % of patients had a positive result from injection. Subgroup analysis demonstrated good outcomes for both hyperacute (<6 weeks) and chronic (>12 months). Contained disk pathologies had better outcomes than uncontained. There was no difference in outcomes across grades of compression, but previous same level surgery was associated with poorer response rates. CONCLUSIONS: There is a high rate of natural resolution of symptoms in patients with LSRP. In those where pain persists, TFESI is a valuable first line treatment modality. This study suggests the efficacy of TFESI is potentially independent of grade of stenosis and chronicity of symptoms. Contained disc pathologies respond better than uncontained.

Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT.

Background: Posterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking. Objective: The primary objective was to investigate whether or not posterior cervical foraminotomy is superior to anterior cervical discectomy in improving clinical outcome. Design: This was a Phase III, unblinded, prospective, United Kingdom multicentre, parallel-group, individually randomised controlled superiority trial comparing posterior cervical foraminotomy with anterior cervical discectomy. A rapid qualitative study was conducted during the close-down phase, involving remote semistructured interviews with trial participants and health-care professionals. Setting: National Health Service trusts. Participants: Patients with symptomatic unilateral cervical brachialgia for at least 6 weeks. Interventions: Participants were randomised to receive posterior cervical foraminotomy or anterior cervical discectomy. Allocation was not blinded to participants, medical staff or trial staff. Health-care use from providing the initial surgical intervention to hospital discharge was measured and valued using national cost data. Main outcome measures: The primary outcome measure was clinical outcome, as measured by patient-reported Neck Disability Index score 52 weeks post operation. Secondary outcome measures included complications, reoperations and restricted American Spinal Injury Association score over 6 weeks post operation, and patient-reported Eating Assessment Tool-10 items, Glasgow-Edinburgh Throat Scale, Voice Handicap Index-10 items, PainDETECT and Numerical Rating Scales for neck and upper-limb pain over 52 weeks post operation. Results: The target recruitment was 252 participants. Owing to slow accrual, the trial closed after randomising 23 participants from 11 hospitals. The qualitative substudy found that there was support and enthusiasm for the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial and randomised clinical trials in this area. However, clinical equipoise appears to have been an issue for sites and individual surgeons. Randomisation on the day of surgery and processes for screening and approaching participants were also crucial factors in some centres. The median Neck Disability Index scores at baseline (pre surgery) and at 52 weeks was 44.0 (interquartile range 36.0-62.0 weeks) and 25.3 weeks (interquartile range 20.0-42.0 weeks), respectively, in the posterior cervical foraminotomy group (n = 14), and 35.6 weeks (interquartile range 34.0-44.0 weeks) and 45.0 weeks (interquartile range 20.0-57.0 weeks), respectively, in the anterior cervical discectomy group (n = 9). Scores appeared to reduce (i.e. improve) in the posterior cervical foraminotomy group, but not in the anterior cervical discectomy group. The median Eating Assessment Tool-10 items score for swallowing was higher (worse) after anterior cervical discectomy (13.5) than after posterior cervical foraminotomy (0) on day 1, but not at other time points, whereas the median Glasgow-Edinburgh Throat Scale score for globus was higher (worse) after anterior cervical discectomy (15, 7, 6, 6, 2, 2.5) than after posterior cervical foraminotomy (3, 0, 0, 0.5, 0, 0) at all postoperative time points. Five postoperative complications occurred within 6 weeks of surgery, all after anterior cervical discectomy. Neck pain was more severe on day 1 following posterior cervical foraminotomy (Numerical Rating Scale - Neck Pain score 8.5) than at the same time point after anterior cervical discectomy (Numerical Rating Scale - Neck Pain score 7.0). The median health-care costs of providing initial surgical intervention were £2610 for posterior cervical foraminotomy and £4411 for anterior cervical discectomy. Conclusions: The data suggest that posterior cervical foraminotomy is associated with better outcomes, fewer complications and lower costs, but the trial recruited slowly and closed early. Consequently, the trial is underpowered and definitive conclusions cannot be drawn. Recruitment was impaired by lack of individual equipoise and by concern about randomising on the day of surgery. A large prospective multicentre trial comparing anterior cervical discectomy and posterior cervical foraminotomy in the treatment of cervical brachialgia is still required. Trial registration: This trial is registered as ISRCTN10133661. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 21. See the NIHR Journals Library website for further project information.

Cervical brachialgia is pain that starts in the neck and passes down into the arm. Although most people with cervical brachialgia recover quickly, in some patients pain persists, and in 15% of patients pain is so severe that they are unable to work. In the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial, we investigated two neck surgeries used to treat this problem: posterior cervical foraminotomy (surgery from the back of the neck) and anterior cervical discectomy (surgery from the front of the neck). This trial aimed to find out if one of them is better than the other at relieving pain and more cost-effective for the National Health Service. We assessed patients' quality of life 1 year after their surgery and how their pain changed over the course of the year. We also measured the number of complications patients had in the first 6 weeks after their operation. Recruitment was slow and so the trial was stopped early, after only 23 patients from 11 hospitals had been randomly allocated to the two surgery groups. We had planned to recruit 252 participants to the trial; the number of participants we were able to recruit in practice was too small to enable us to determine which surgery is better at relieving pain. To find out why the trial had struggled to recruit, we asked hospital staff and participants about their experiences. We found that hospital staff sometimes struggled to organise everything needed to randomise patients on the day of surgery. Some staff also found it difficult to randomise patients as they had an opinion on which surgery they thought the patient should receive. The data collected in the trial will still be useful to help design future research. Finding out which surgery is better at relieving pain remains important, and the data we have collected will support answering this question in future.

A Systematic Review and Meta-Analysis of Vertebral Artery Injury After Cervical Spine Trauma.

STUDY DESIGN: Systematic Review and Meta-Analysis. OBJECTIVE: Identify the incidence, mechanism of injury, investigations, management, and outcomes of Vertebral Artery Injury (VAI) after cervical spine trauma. METHODS: A systematic review and meta-analysis were conducted in accordance with the PRISMA guidelines (PROSPERO-ID CRD42021295265). Three databases were searched (PubMed, SCOPUS, Google Scholar, CINAHL PLUS). Incidence of VAI, investigations to diagnose (Computed Tomography Angiography, Digital Subtraction Angiography, Magnetic Resonance Angiography), stroke incidence, and management paradigms (conservative, antiplatelets, anticoagulants, surgical, endovascular treatment) were delineated. Incidence was calculated using pooled proportions random effects meta-analysis. RESULTS: A total of 44 studies were included (1777 patients). 20-studies (n = 503) included data on trauma type; 75.5% (n = 380) suffered blunt trauma and 24.5% (n = 123) penetrating. The overall incidence of VAI was .95% (95% CI 0.65-1.29). From the 16 studies which reported data on outcomes, 8.87% (95% CI 5.34- 12.99) of patients with VAI had a posterior stroke. Of the 33 studies with investigation data, 91.7% (2929/3629) underwent diagnostic CTA; 7.5% (242/3629) underwent MRA and 3.0% (98/3629) underwent DSA. Management data from 20 papers (n = 475) showed 17.9% (n = 85) undergoing conservative therapy, anticoagulation in 14.1% (n = 67), antiplatelets in 16.4% (n = 78), combined therapy in 25.5% (n = 121) and the rest (n = 124) managed using surgical and endovascular treatments. CONCLUSION: VAI in cervical spine trauma has an approximate posterior circulation stroke risk of 9%. Optimal management paradigms for the prevention and management of VAI are yet to be standardized and require further research.

Definition and surgical timing in cauda equina syndrome-An updated systematic review.

STUDY DESIGN: Systematic review. OBJECTIVES: To conduct a systematic review identifying existing definitions of cauda equina syndrome (CES) and time to surgery in the literature for patients with CES. METHODS: A systematic review was conducted in accordance with the PRISMA statement. Ovid Medline, Embase, CINAHL Plus, and trial registries were searched from October 1st, 2016, to 30th December 2022, and combined with articles identified from a previous systematic review by the same authors (studies published 1990-2016). RESULTS: A total of 110 studies (52,008 patients) were included. Of these only 16 (14.5%) used established definitions in defining CES, including Fraser criteria (n = 6), British Association of Spine Surgeons (BASS) (n = 5), Gleave and MacFarlane (n = 2), and other (n = 3). Most reported symptoms were urinary dysfunction (n = 44, 40%%), altered sensation in the perianal region (n = 28, 25.5%) and bowel dysfunction (n = 20, 18.2%). Sixty-eight (61.8%) studies included details on time to surgery. There was an increase in percentage of studies defining CES published in the last 5 years compared to ones from 1990-2016 (58.6% vs 77.5.%, P = .045). CONCLUSIONS: Despite Fraser recommendations, substantial heterogeneity exists in reporting of CES definitions, and a start point for time to surgery, with most authors using self-defined criteria. A consensus is required to define CES and time to surgery, to allow consistency in reporting and study analysis.

Predicting patient-reported outcomes following lumbar spine surgery: development and external validation of multivariable prediction models.

BACKGROUND: This study aimed to develop and externally validate prediction models of spinal surgery outcomes based on a retrospective review of a prospective clinical database, uniquely comparing multivariate regression and random forest (machine learning) approaches, and identifying the most important predictors. METHODS: Outcomes were change in back and leg pain intensity and Core Outcome Measures Index (COMI) from baseline to the last available postoperative follow-up (3-24 months), defined as minimal clinically important change (MCID) and continuous change score. Eligible patients underwent lumbar spine surgery for degenerative pathology between 2011 and 2021. Data were split by surgery date into development (N = 2691) and validation (N = 1616) sets for temporal external validation. Multivariate logistic and linear regression, and random forest classification and regression models, were fit to the development data and validated on the external data. RESULTS: All models demonstrated good calibration in the validation data. Discrimination ability (area under the curve) for MCID ranged from 0.63 (COMI) to 0.72 (back pain) in regression, and from 0.62 (COMI) to 0.68 (back pain) in random forests. The explained variation in continuous change scores spanned 16%-28% in linear, and 15%-25% in random forests regression. The most important predictors included age, baseline scores on the respective outcome measures, type of degenerative pathology, previous spinal surgeries, smoking status, morbidity, and duration of hospital stay. CONCLUSIONS: The developed models appear robust and generalisable across different outcomes and modelling approaches but produced only borderline acceptable discrimination ability, suggesting the need to assess further prognostic factors. External validation showed no advantage of the random forest approach.

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol.

INTRODUCTION: Degenerative cervical myelopathy (DCM) is a common and disabling condition of symptomatic cervical spinal cord compression secondary to degenerative changes in spinal structures leading to a mechanical stress injury of the spinal cord. RECEDE-Myelopathy aims to test the disease-modulating activity of the phosphodiesterase 3/phosphodiesterase 4 inhibitor Ibudilast as an adjuvant to surgical decompression in DCM. METHODS AND ANALYSIS: RECEDE-Myelopathy is a multicentre, double-blind, randomised, placebo-controlled trial. Participants will be randomised to receive either 60-100 mg Ibudilast or placebo starting within 10 weeks prior to surgery and continuing for 24 weeks after surgery for a maximum of 34 weeks. Adults with DCM, who have a modified Japanese Orthopaedic Association (mJOA) score 8-14 inclusive and are scheduled for their first decompressive surgery are eligible for inclusion. The coprimary endpoints are pain measured on a visual analogue scale and physical function measured by the mJOA score at 6 months after surgery. Clinical assessments will be undertaken preoperatively, postoperatively and 3, 6 and 12 months after surgery. We hypothesise that adjuvant therapy with Ibudilast leads to a meaningful and additional improvement in either pain or function, as compared with standard routine care. STUDY DESIGN: Clinical trial protocol V.2.2 October 2020. ETHICS AND DISSEMINATION: Ethical approval has been obtained from HRA-Wales.The results will be presented at an international and national scientific conferences and in a peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN Number: ISRCTN16682024.

Predictors of Pain and Disability Outcomes Following Spinal Surgery for Chronic Low Back and Radicular Pain: A Systematic Review.

OBJECTIVES: Success rates of spinal surgeries to treat chronic back pain are highly variable and useable prognostic indicators are lacking. We aimed to identify and evaluate preoperative predictors of pain and disability after spinal surgery for chronic low back/leg pain. METHODS: Electronic database (01/1984-03/2021) and reference searches identified 2622 unique citations. Eligible studies included adults with chronic low back/leg pain lasting ≥3 months undergoing first elective lumbar spine surgery, and outcomes defined as change in pain (primary)/disability (secondary) after ≥3 months. We included 21 reports (6899 participants), 7 were judged to have low and 14 high risks of bias. We performed narrative synthesis and determined the quality of evidence (QoE). RESULTS: Better pain outcomes were associated with younger age, higher education, and no spinal stenosis (low QoE); lower preoperative pain, fewer comorbidities, lower pain catastrophizing, anxiety and depression (very low QoE); but not with symptom duration (moderate QoE), other sociodemographic factors (low QoE), disability, or sensory testing (very low QoE). More favorable disability outcomes were associated with preoperative sensory loss (moderate QoE); lower job-related resignation and neuroticism (very low QoE); but not with socioeconomic factors, comorbidities (low QoE), demographics, pain, or pain-related psychological factors (very low QoE). DISCUSSION: In conclusion, absence of spinal stenosis potentially predicts greater pain relief and preoperative sensory loss likely predicts reduction in disability. Overall, QoE for most identified associations was low/very low.

Systematic Review and Meta-Analysis of Predictors of Return to Work After Spinal Surgery for Chronic Low Back and Leg Pain.

Spinal surgeries to treat chronic low back pain (CLBP) have variable success rates, and despite the significant personal and socioeconomic implications, we lack consensus for prognostic factors. This systematic review and meta-analysis evaluated the evidence for preoperative predictors of return to work (RTW) after spinal surgery for CLBP. We searched electronic databases and references (January 1984 to March 2021), screened 2,622 unique citations, and included 8 reports (5 low and 3 high risk-of-bias) which involved adults with ≥3 months duration of CLBP with/without leg pain undergoing first elective lumbar surgery with RTW assessed ≥3 months later. Narrative synthesis and meta-analysis where possible found that individuals less likely to RTW were older (odds ratio [OR] = .58; 95% confidence interval [CI]: 0.46-0.72), not working before surgery, had longer sick leave (OR = .95; 95% CI: 0.93-0.97), higher physical workload, legal representation (OR = .61; 95% CI: 0.53-0.71), psychiatric comorbidities and depression (moderate quality-of-evidence, QoE), and longer CLBP duration and opioid use (low QoE), independent of potential confounders. Low quality and small number of studies limit our confidence in other associations. In conclusion, RTW after spinal surgery for CLBP likely depends on sociodemographic and affective psychological factors, and potentially also on symptom duration and opioid use. PERSPECTIVE: This systematic review and meta-analysis synthesizes and evaluates existing evidence for preoperative predictors of return to work after spinal surgery for chronic low back pain. Demonstrated associations between return to work and sociodemographic, health-related, and psychological factors can inform clinical decision-making and guide further research.

Surgical microdiscectomy versus transforaminal epidural steroid injection in patients with sciatica secondary to herniated lumbar disc (NERVES): a phase 3, multicentre, open-label, randomised controlled trial and economic evaluation.

BACKGROUND: The optimal invasive treatment for sciatica secondary to herniated lumbar disc remains controversial, with a paucity of evidence for use of non-surgical treatments such as transforaminal epidural steroid injection (TFESI) over surgical microdiscectomy. We aimed to investigate the clinical and cost-effectiveness of these options for management of radicular pain secondary to herniated lumbar disc. METHODS: We did a pragmatic, multicentre, phase 3, open-label, randomised controlled trial at 11 spinal units across the UK. Eligible patients were aged 16-65 years, had MRI-confirmed non-emergency sciatica secondary to herniated lumbar disc with symptom duration between 6 weeks and 12 months, and had leg pain that was not responsive to non-invasive management. Participants were randomly assigned (1:1) to receive either TFESI or surgical microdiscectomy by an online randomisation system that was stratified by centre with random permuted blocks. The primary outcome was Oswestry Disability Questionnaire (ODQ) score at 18 weeks. All randomly assigned participants who completed a valid ODQ at baseline and at 18 weeks were included in the analysis. Safety analysis included all treated participants. Cost-effectiveness was estimated from the EuroQol-5D-5L, Hospital Episode Statistics, medication usage, and self-reported resource-use data. This trial was registered with ISRCTN, number ISRCTN04820368, and EudraCT, number 2014-002751-25. FINDINGS: Between March 6, 2015, and Dec 21, 2017, 163 (15%) of 1055 screened patients were enrolled, with 80 participants (49%) randomly assigned to the TFESI group and 83 participants (51%) to the surgery group. At week 18, ODQ scores were 30·02 (SD 24·38) for 63 assessed patients in the TFESI group and 22·30 (19·83) for 61 assessed patients in the surgery group. Mean improvement was 24·52 points (18·89) for the TFESI group and 26·74 points (21·35) for the surgery group, with an estimated treatment difference of -4·25 (95% CI -11·09 to 2·59; p=0·22). There were four serious adverse events in four participants associated with surgery, and none with TFESI. Compared with TFESI, surgery had an incremental cost-effectiveness ratio of £38 737 per quality-adjusted life-year gained, and a 0·17 probability of being cost-effective at a willingness-to-pay threshold of £20 000 per quality-adjusted life-year. INTERPRETATION: For patients with sciatica secondary to herniated lumbar disc, with symptom duration of up to 12 months, TFESI should be considered as a first invasive treatment option. Surgery is unlikely to be a cost-effective alternative to TFESI. FUNDING: Health Technology Assessment programme of the National Institute for Health Research (NIHR), UK.

Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT.

BACKGROUND: Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforaminal epidural steroid injection, are often reserved for failed conservative treatment. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of microdiscectomy with transforaminal epidural steroid injection for the management of radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of < 12 months' duration. INTERVENTIONS: Patients were randomised to either (1) microdiscectomy or (2) transforaminal epidural steroid injection. DESIGN: A pragmatic, multicentre, randomised prospective trial comparing microdiscectomy with transforaminal epidural steroid injection for sciatica due to prolapsed intervertebral disc with < 1 year symptom duration. SETTING: NHS services providing secondary spinal surgical care within the UK. PARTICIPANTS: A total of 163 participants (aged 16-65 years) were recruited from 11 UK NHS outpatient clinics. MAIN OUTCOME MEASURES: The primary outcome was participant-completed Oswestry Disability Questionnaire score at 18 weeks post randomisation. Secondary outcomes were visual analogue scores for leg pain and back pain; modified Roland-Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals. Cost-effectiveness and quality of life were assessed using the EuroQol-5 Dimensions, five-level version; Hospital Episode Statistics data; medication usage; and self-reported cost data at 12-weekly intervals. Adverse event data were collected. The economic outcome was incremental cost per quality-adjusted life-year gained from the perspective of the NHS in England. RESULTS: Eighty-three participants were allocated to transforaminal epidural steroid injection and 80 participants were allocated to microdiscectomy, using an online randomisation system. At week 18, Oswestry Disability Questionnaire scores had decreased, relative to baseline, by 26.7 points in the microdiscectomy group and by 24.5 points in the transforaminal epidural steroid injection. The difference between the treatments was not statistically significant (estimated treatment effect -4.25 points, 95% confidence interval -11.09 to 2.59 points). Nor were there significant differences between treatments in any of the secondary outcomes: Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland-Morris score and Core Outcome Measures Index score up to 54 weeks. There were four (3.8%) serious adverse events in the microdiscectomy group, including one nerve palsy (foot drop), and none in the transforaminal epidural steroid injection group. Compared with transforaminal epidural steroid injection, microdiscectomy had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained and a probability of 0.17 of being cost-effective at a willingness to pay threshold of £20,000 per quality-adjusted life-year. LIMITATIONS: Primary outcome data was invalid or incomplete for 24% of participants. Sensitivity analyses demonstrated robustness to assumptions made regarding missing data. Eighteen per cent of participants in the transforaminal epidural steroid injection group subsequently received microdiscectomy prior to their primary outcome assessment. CONCLUSIONS: To the best of our knowledge, the NErve Root Block VErsus Surgery trial is the first trial to evaluate the comparative clinical effectiveness and cost-effectiveness of microdiscectomy and transforaminal epidural steroid injection. No statistically significant difference was found between the two treatments for the primary outcome. It is unlikely that microdiscectomy is cost-effective compared with transforaminal epidural steroid injection at a threshold of £20,000 per quality-adjusted life-year for sciatica secondary to prolapsed intervertebral disc. FUTURE WORK: These results will lead to further studies in the streamlining and earlier management of discogenic sciatica. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04820368 and EudraCT 2014-002751-25. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 24. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Sciatica or pain related to nerve irritation travelling down the leg is common in young working adults and most likely to be caused by a 'slipped' (prolapsed) disc. Although the majority of cases get better on their own and within 4­6 weeks, a significant group of patients struggle with disabling symptoms sometimes beyond 1 year. Consequently, patients struggle to maintain their home and working lives. Many treatments are available for sciatica, but simpler treatments (e.g. pain tablets, physiotherapy and changing one's lifestyle) are often not very effective and patients have often tried all of them by the time they are seen in hospital to have tests, such as scans, done. Surgery to remove part of the disc is recommended in cases where the pain is accompanied by severe weakness in one or both legs, or where doctors think that nerves may be damaged because patients have bladder, bowel and sexual functioning difficulties (i.e. red flag symptoms). Surgery works well in alleviation of referred leg pain and also to relieve pressure on a physically compressed nerve that may be showing clinical sign of injury/weakness. An alternative to surgery is to inject a mixture of anaesthetic and steroid close to the site of the disc injury and nerve, but at the moment we do not know whether or not these injections work in the long term. They are cheaper and less invasive, with fewer risks than surgery, such as from anaesthetic or infection. WHAT DID OUR STUDY INVESTIGATE?: This study compared the usefulness of surgery with injections for patients who have had sciatica for < 1 year and who have tried simple remedies but are still in pain. Patients were allocated to have either surgery or the injection. Symptoms (e.g. pain) were assessed after 18 weeks. WHAT DID WE FIND?: We found that there was no significant difference between surgery and injection at the primary end point. Surgery was not significantly different from injection in terms of clinical outcome and was not cost-effective compared with injection. OUR CONCLUSION AND RECOMMENDATION: Given the cost of surgery and the risks to patients, we suggest that further studies should be carried out to explore whether or not all patients with sciatica due to a slipped disc should be considered suitable for an injection, unless there is a good reason not to.

Primary lumbar decompression using ultrasonic bone curette compared to conventional technique.

PURPOSE: The ultrasonic bone curette (Bone Scalpel) is a novel technique in neurosurgery for bony dissection. This study aimed to evaluate its use against conventional techniques for primary lumbar decompression. MATERIALS AND METHODS: This study was a retrospective cohort comparison, using Spine Tango Registry data. All patients undergoing a primary procedure for lumbar decompression secondary to degenerative disease during a 2-year period (2014-2016) were identified, split into age and gender matched cohorts utilising either bone scalpel or conventional techniques intra-operatively. RESULTS: Ninety-three patients were identified within each cohort, which did not differ significantly in terms of age, gender, BMI, number of operative vertebral levels or seniority of the principal surgeon. The incidence of intra-operative blood loss >100 ml was significantly reduced within the bone scalpel cohort (16.1% bone scalpel, 34.4% conventional, p = 0.04). There was no difference in the incidence of iatrogenic dural breach (9.7% bone scalpel, 16.1% conventional, p = 0.27). There was no significant difference in pre-operative Core Outcomes Measures Index (COMI) between the cohorts (7.91 bone scalpel, 8.02 conventional, p = 0.67) and both cohorts demonstrated a significant reduction in mean COMI at 24 months (bone scalpel p = 0.004, conventional p = <0.001). No difference in mean COMI existed between either cohort at any point across the 24-month post-operative period (p = 0.18). CONCLUSIONS: The use of ultrasonic bone curette for primary lumbar decompression is associated with reduced intra-operative blood loss compared to conventional techniques, alongside a comparable safety profile and equivalent patient reported outcomes.

Cauda Equina Syndrome Core Outcome Set (CESCOS): An international patient and healthcare professional consensus for research studies.

BACKGROUND: 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 by a research study within a specific disease area. There is significant heterogeneity in outcome reporting for CES, which does not allow data synthesis between studies. The hypothesis is that a COS for CES can be developed for future research studies using patients and healthcare professionals (HCPs) as key stakeholders. METHODS AND FINDINGS: Qualitative semi-structured interviews with CES patients were audio-recorded, transcribed and analysed using NVivo to identify the outcomes of importance. These were combined with the outcomes obtained from a published systematic literature review of CES patients. The outcomes were grouped into a list of 37, for rating through two rounds of an international Delphi survey according to pre-set criteria. The Delphi survey had an overall response rate of 63% and included 172 participants (104 patients, 68 HCPs) from 14 countries who completed both rounds. Thirteen outcomes reached consensus at the end of the Delphi survey and there was no attrition bias detected. The results were discussed at an international consensus meeting attended by 34 key stakeholders (16 patients and 18 HCPs) from 8 countries. A further three outcomes were agreed to be included. There was no selection bias detected at the consensus meeting. There are 16 outcomes in total in the CESCOS. DISCUSSION: This is the first study in the literature that has determined the core outcomes in CES using a transparent international consensus process involving healthcare professionals and CES patients as key stakeholders. This COS is recommended as the most important outcomes to be reported in any research study investigating CES outcomes and will allow evidence synthesis in CES.

Protocol for the development of a core outcome set for cauda equina syndrome: systematic literature review, qualitative interviews, Delphi survey and consensus meeting.

INTRODUCTION: Cauda equina syndrome (CES) is a serious neurological condition most commonly due to compression of the lumbosacral nerve roots, which can result in significant disability. The evidence for acute intervention in CES is mainly from retrospective studies. There is heterogeneity in the outcomes chosen for analysis in these studies, which makes it difficult to synthesise the data across studies. This study will develop a core outcome set for use in future studies of CES, engaging with key stakeholders and using transparent methodology. This will help ensure that relevant outcomes are used in future and will facilitate attempts to summarise data across studies in systematic reviews. METHODS AND ANALYSIS: A systematic literature review will document all the outcomes for CES after surgery mentioned in the literature. The qualitative interviews with patients with CES will be semistructured, audio recorded, transcribed and thematically analysed with the use of NVivo V.10 to identify outcomes and determine the themes described. The outcomes from the literature review and patient interviews will be combined and prioritised to determine what the most important outcomes are in CES research studies to patients and healthcare professionals. The prioritisation will be done through a two-round iterative Delphi survey and a consensus meeting. This process will decide the core outcome set for patients with CES. ETHICS AND DISSEMINATION: REC and HRA approval was obtained on the 6/12/16 for the qualitative interviews from South Central-Hampshire A REC. REC reference 16/SC/0587. REC and HRA approval was obtained on 26/3/18 for the Delphi process and consensus meeting from North West-Greater Manchester Central REC. REC reference was 18/NW/0022. The final core outcome set will be published and freely available. TRIAL REGISTRATION NUMBER: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 824.

Comparison of clinical outcomes in anterior cervical discectomy versus foraminotomy for brachialgia.

AIM: The choice between anterior cervical discectomy & fusion (ACD) or posterior cervical foraminotomy (PCF) for the treatment of cervical brachialgia is controversial. This study aimes to compare clinical outcomes between these two operative inteventions for brachialgia. METHODS: Retrospective review of prospectively collected data was performed. Patients receiving a primary ACD or PCF to treat brachialgia, in a single tertiary neurosurgical unit were included. Surgical details, and patient reported outcomes (COMI-Neck questionnaire) were extracted from a prospectively maintained spinal procedure database. Minimum clinically important difference (MCID) was defined as a change in COMI score of -2 at 12 months. The student t-test, Chi-square test, and linear regression were used to compare groups. RESULTS: Between June 2011 ad February 2016 there were 634 ACD procedures (Median age 49; 321 Male), and 54 PCF procedures (Median age 50; 37 Male) perfomed for brachialgia. Age, ASA and pre-operative COMI were similar between the groups (p > .05). Complete outcome data was recorded at twelve months in 312 ACD and 36 PCF patients. Both ACD and PCF were associated with an improvement in COMI at 3 and 12 months (all p < .01). Mean change in COMI at 3 months was -2.38 for ACD, versus -2.31 for PCF (p = .88); at twelve months it was -2.94 for ACD, versus -2.67 for PCF (p = .55). MCID was seen in 59% of ACD cases, versus 58% of PCF cases at twelve months (p = .91). CONCLUSION: There was no significant difference between outcomes in the ACD and PCF groups. This is supportive of published literature. The proposed multicenter RCTs may inform further.

Intracranial Hypertension Secondary to Cervical Dural Arteriovenous Fistula.

Idiopathic intracranial hypertension (IIH) is a disease of mainly unknown etiology. Latest theories as to the pathogenesis have postulated a final common pathway of cerebral venous hypertension secondary to venous outflow impairment leading to decreased cerebrospinal fluid absorption. We present the case of a 42-year-old female who was treated for several years for headache and for approximately 12 months for IIH until appropriate imaging showed a right-sided cervical dural arteriovenous fistula (AVF) at the level of C4. The patient's IIH symptoms resolved following surgical excision of the fistula. We suggest that the cranial venous outflow impairment secondary to the cervical AVF was responsible for intracranial hypertension and that complete investigation of IIH patients should include imaging of the neck vasculature.

Nerve root block versus surgery (NERVES) for the treatment of radicular pain secondary to a prolapsed intervertebral disc herniation: study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Sciatica is a common condition reported to affect over 3% of the UK population at any time and is often caused by a prolapsed intervertebral disc (PID). Although the duration and severity of symptoms can vary, pain persisting beyond 6 weeks is unlikely to recover spontaneously and may require investigation and treatment. Currently, there is no specific care pathway for sciatica in the National Health Service (NHS), and no direct comparison exists between surgical microdiscectomy and transforaminal epidural steroid injection (TFESI). The NERVES (NErve Root block VErsus Surgery) trial aims to address this by comparing clinical and cost-effectiveness of surgical microdiscectomy and TFESI to treat sciatica secondary to a PID. METHODS/DESIGN: A total of 163 patients were recruited from NHS out-patient clinics across the UK and randomised to either microdiscectomy or TFESI. Adult patients (aged 16-65 years) with sciatic pain endured for between 6 weeks and 12 months are eligible if their symptoms have not been improved by at least one form of conservative (non-operative) treatment and they are willing to provide consent. Patients will be excluded if they present with neurological deficit or have had previous surgery at the same level. The primary outcome is patient-reported disability measured using the Oswestry Disability Questionnaire (ODQ) score at 18 weeks post randomisation and secondary outcomes include disability and pain scales using numerical pain ratings, modified Roland-Morris and Core Outcome Measures Index at 12-weekly intervals, and patient satisfaction at 54 weeks. Cost-effectiveness and quality of life (QOL) will be assessed using the EQ-5D-5 L and self-report cost data at 12-weekly intervals and Hospital Episode Statistics (HES) data. Adverse event data will be collected. Analysis will follow the principle of intention-to-treat. DISCUSSION: NERVES is the first trial to evaluate the comparative clinical and cost-effectiveness of microdiscectomy to local anaesthetic and steroid administered via TFESI. The results of this research may facilitate the development of an evidence-based treatment strategy for patients with sciatica. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN04820368 . Registered on 5 June 2014. EudraCT EudraCT2014-002751-25. Registered on 8 October 2014.

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

STUDY DESIGN: This is a systematic literature review following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. OBJECTIVE: 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. SUMMARY OF BACKGROUND DATA: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. LEVEL OF EVIDENCE: 1.