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.

Consistency of Radiological Grading of Cervical Foraminal Stenosis.

BACKGROUND: The degree of cervical foraminal stenosis on MRI scans may be measured and categorised using the Kim or modified Kim methods. These grading scales have not previously been validated in a cohort of patients awaiting surgery. OBJECTIVES: To establish the normal foraminal and root diameters as well as the consistency of inter and intra-rater grading using the Kim and modified Kim grading systems in pre-operative surgical patients. METHODS: Asymptomatic cervical nerve roots and foramina demonstrated on the pre-operative MRI scans of adult surgical patients with cervical radiculopathy were measured and categorised by six raters using the Kim and modified Kim grading methods. Repeat "second pass" measurements were made by the same assessors on the same images a minimum of one month later. RESULTS: Foraminal diameters (mm) in asymptomatic foramina were C2/C3 (mean±SD): 4.18±1.44, C3/C4 2.96±1.23, C4/C5 3.02±1.19, C5/C6 3.15±1.33, C6/C7 3.53±1.36, C7/T1 3.93±1.34. Nerve root diameters were C3 3.11±0.87, C4 2.95±0.77, C5 2.56±0.73, C6 2.26±0.76, C7 2.56±0.82, C8 3.83±0.86. Inter-rater consistency was kappa [95% CI]: Kim 0.01 [0.00, 0.03], modified Kim 0.08 [0.05, 0.10]. Intra-rater consistency was kappa [95% CI]: Kim 0.81 [0.77, 0.86], modified Kim 0.69 [0.62, 0.76]. CONCLUSION: There was poor inter-rater consistency but good intra-rater consistency when assessing the severity of foraminal stenosis on axial T2 MRI scans. Foraminal diameter was narrowest at C3/C4 and C4/C5, whereas the smallest root diameter was C5/C6. Volumetric or oblique MR may improve consistency.

Literature Review of Automated Grading Systems Utilizing MRI for Neuroforaminal Stenosis.

BACKGROUND: Cervical neural foraminal stenosis is a common and debilitating condition affecting people between the ages 40-60. Although it is established that MRI is the best method of scanning the neural foramen, the question remains whether there is a role for three-dimensional MRIs and whether it is possible to develop a computer-aided automated grading system to establish the degree of clinically relevant cervical foraminal stenosis. OBJECTIVE: The study's objective is to conduct a literature review of existing or recently developed automated grading systems for the cervical neural foramen, including volumetric MRI evaluations of the foramen. METHODS: A systematic search of Cochrane Library, Cochrane Clinical Trials, Ovid MEDLINE, EMBASE, CINAHL, ACM Digital Library and Institute of Electrical and Electronics Engineers (IEEE), and Web of Science was performed for reports examining automated systems and volumetric scanning foraminal stenosis published before 31.07.2021. RESULTS: 3971 articles were identified of which 8 were included in the study. The automated grading systems of the neural foramen focus largely on the lumbar spine with elements that may be applicable to the cervical spine. Although there are established studies on the automated grading of the lumbar spine, it is uncertain whether any of these are reproducible in the cervical spine. Visual grading systems for the cervical spine demonstrate good inter-reader reliability between radiologists and clinicians. CONCLUSION: The Park visual grading method shows strong inter-reader reliability across radiologists and clinicians despite the limited data on the correlation with neurological symptoms or surgical outcome. There is scope for further development of an automated grading system for cervical foraminal stenosis to improve the speed and consistency of image interpretation.

Increasing patient flow through neurosurgical critical care: the Leeds Improvement Method.

At Leeds General Infirmary, a busy tertiary centre for neurosurgery, there has been little visibility of the step-down status of the patients from intensive care to high dependency or from the latter to a ward bed. The only record of the current situation was limited to the paper notes of the bed managers. Furthermore, accuracy of electronic systems used for staffing levels and bed state were underused. There were gaps in information and furthermore information within the system was unreliable (together defined as 'defects'). These defects mandated bed managers' physical presence on each ward to obtain reliable data. This led to unwarranted critical care stays and resultant high rates (up to 40%) of elective operation cancellations requiring a critical care bed.The Leeds Improvement Method using principles of the Toyota Production System aimed to improve patient flow through critical care and to assess the impact on elective case activity. Problems were identified and changes were implemented over a 1-week period. The changes included measures to reduce time taken for collation of critical bed-state information and improving patient and staffing data quality collected in the electronic patient management system (EPMS) and electronic staffing record (ESR). Impact was monitored for 30 days pre-implementation and post-implementation.Following intervention, the time taken by the bed manager to gather live bed-state information decreased from 50 to 9 min; the EPMS storing correct bed-state data was improved from 71% to 0% defect; the ESR was improved from 100% to 4% defects; critical care patient step-downs occurring at night (after 20:00) improved from 80% to 20%; and the number of cancelled elective cases over a 30-day period reduced from nine to one.Implementing these organisational efficiencies can significantly improve critical care patient flow and elective case throughput.

Factors relating to working hours restriction that have impacted the professional identity of trainees in the last decade.

Ever-developing changes to the working hours of junior doctors by the European Working Time Directive, the junior doctor contract of 2019 and most recently the COVID-19 pandemic have impacted the professional identity of doctors. There has been little investigation into its influence on the multifaceted aspects of postgraduate medical training, which feeds into how trainees consider themselves professionally and the concept of professional identity or 'being a doctor'. A review of the medical, socio-political and educational literature reveals that the impact on the professional identity development of trainees is influenced by several perspectives from the trainee, trainer and the public. Gross reduction in working hours has no doubt decreased the raw volume of clinical experiences. However, to counteract this, smarter learning processes have evolved, including narrative reflection, supervised learning events, and a greater awareness of coaching and training among trainers.

Systematic review of radiological cervical foraminal grading systems.

The study design of this paper is systematic review. The purpose of this review is to evaluate the existing radiological grading systems that are used to assess cervical foraminal stenosis. The importance of imaging the cervical spine using CT or MRI in evaluating cervical foraminal stenosis is widely accepted; however, there is no consensus for standardized methodology to assess the compression of the cervical nerve roots. A systematic search of Ovid Medline databases, Embase 1947 to present, Cinahl, Web of Science, Cochrane Library, ISRCTN and WHO international clinical trials was performed for reports of cervical foraminal stenosis published before 01 February 2020. In collaboration with the University of Leeds, a search strategy was developed. A total of 6952 articles were identified with 59 included. Most of the reports involved multiple imaging modalities with standard axial and sagittal imaging used most. The grading themes that came from this systematic review show that the most mature for cervical foraminal stenosis is described by (Kim et al. Korean J Radiol 16:1294, 2015) and (Park et al. Br J Radiol 86:20120515, 2013). Imaging of the cervical nerve root canals is mostly performed using MRI and is reported using subjective terminology. The Park, Kim and Modified Kim systems for classifying the degree of stenosis of the nerve root canal have been described. Clinical application of these scoring systems is limited by their reliance on nonstandard imaging (Park), limited validation against clinical symptoms and surgical outcome data. Oblique fine cut images derived from three dimensional MRI datasets may yield more consistency, better clinical correlation, enhanced surgical decision-making and outcomes.

Is surgery more about doing than thinking?

Detailed thought, knowledge, complex analysis, reasoned judgment and professionalism all fundamentally underpin a surgeon's work and training, yet there is a popularly held view that accomplished surgeons are primarily concerned with performing procedures. A review of pedagogical, social and medical literature, together with personal reflections from the authors, shows that a surgeon's work is multi-faceted. This article discusses the technical skills of operating as a reflection of the 'tip of the iceberg' of a surgeon's cognition, the increasingly multidisciplinary strategic approach of surgeons today, the importance of surgical decision making, the influence of robotics, the role of non-medically trained staff, surgeons' role in postoperative care, adaptive expertise and the formation of professional identity. In so doing, a much wider view of a surgeon than simply 'doing' or 'thinking' is presented with implications for surgical training.