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Abstract Background The number of surgical trials is increasing but such trials can be complex to deliver and pose specific challenges. A multi-centre, Phase III, RCT comparing Posterior Cervical Foraminotomy versus Anterior Cervical Discectomy and Fusion in the Treatment of Cervical Brachialgia (FORVAD Trial) was unable to recruit to target. A rapid qualitative study was conducted during trial closedown to understand the experiences of healthcare professionals who participated in the FORVAD Trial, with the aim of informing future research in this area. Methods Semi-structured interviews were conducted with 18 healthcare professionals who had participated in the FORVAD Trial. Interviews explored participants’ experiences of the FORVAD trial. A rapid qualitative analysis was conducted, informed by Normalisation Process Theory. Results Four main themes were generated in the data analysis: (1) individual vs. community equipoise; (2) trial set-up and delivery; (3) identifying and approaching patients; and (4) timing of randomisation. The objectives of the FORVAD trial made sense to participants and they supported the idea that there was clinical or collective equipoise regarding the two FORVAD interventions; however, many surgeons had treatment preferences and lacked individual equipoise. The site which had most recruitment success had adopted a more structured process for identification and recruitment of patients, whereas other sites that adopted more “ad hoc” screening strategies struggled to identify patients. Randomisation on the day of surgery caused both medico-legal and practical concerns at some sites. Conclusions Organisation and implementation of a surgical trial in neurosurgery is complex and presents many challenges. Sites often reported low recruitment and discussed the logistical issues of conducting a complex surgical RCT. Future trials in neurosurgery may need to offer more flexibility and time during set-up to maximise opportunities for larger recruitment numbers. Rapid qualitative analysis informed by Normalisation Process Theory was able to quickly identify key issues with trial implementation so rapid qualitative analysis may be a useful approach for teams conducting qualitative research in trials. Trial registration ISRCTN, ISRCTN reference: 10,133,661. Registered 23rd November 2018.

Summary: Background: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement has improved the quality of reporting of randomised trial protocols. Extensions to the SPIRIT statement are needed to address specific issues of trial protocol reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in protocols of clinical trials of implantable neurostimulation devices are common. The SPIRIT-iNeurostim extension is a new reporting guideline for randomised controlled trial protocols evaluating implantable neurostimulation devices. Methods: SPIRIT-iNeurostim was developed using the EQUATOR methodological framework including a literature review and expert consultation to generate an initial list of candidate items. The candidate items were included in a two-round Delphi survey, discussed at an international consensus meeting (42 stakeholders including healthcare professionals, methodologists, journal editors and industry representatives from the United States, United Kingdom, Netherlands and other countries), and refined through a checklist pilot (18 stakeholders). Findings: The initial extension item list included 42 candidate items relevant to SPIRIT-iNeurostim. We received 132 responses in the first round of the Delphi survey and 99 responses in the second round. Participants suggested an additional 14 candidate items for SPIRIT-iNeurostim during the first round of the survey, and those achieving initial consensus were discussed at the consensus meeting. The SPIRIT-iNeurostim extension includes 5 new checklist items, including one item for reporting the neurostimulation intervention comprising a separate checklist of 14 items. Interpretation: The SPIRIT-iNeurostim extension will help to promote increased transparency, clarity, and completeness of reporting trial protocols evaluating implantable neurostimulation devices. It will assist journal editors, peer-reviewers, and readers to better interpret the appropriateness and generalisability of the methods used for a planned clinical trial. Funding: Abbott, Boston Scientific Corp., Mainstay Medical, Medtronic Ltd, Nevro Corp., and Saluda Medical.

Objective To estimate the cost-effectiveness of craniotomy, compared with decompressive craniectomy (DC) in UK patients undergoing evacuation of acute subdural haematoma (ASDH).Design Economic evaluation undertaken using health resource use and outcome data from the 12-month multicentre, pragmatic, parallel-group, randomised, Randomised Evaluation of Surgery with Craniectomy for Patients Undergoing Evacuation-ASDH trial.Setting UK secondary care.Participants 248 UK patients undergoing surgery for traumatic ASDH were randomised to craniotomy (N=126) or DC (N=122).Interventions Surgical evacuation via craniotomy (bone flap replaced) or DC (bone flap left out with a view to replace later: cranioplasty surgery).Main outcome measures In the base-case analysis, costs were estimated from a National Health Service and Personal Social Services perspective. Outcomes were assessed via the quality-adjusted life-years (QALY) derived from the EuroQoL 5-Dimension 5-Level questionnaire (cost-utility analysis) and the Extended Glasgow Outcome Scale (GOSE) (cost-effectiveness analysis). Multiple imputation and regression analyses were conducted to estimate the mean incremental cost and effect of craniotomy compared with DC. The most cost-effective option was selected, irrespective of the level of statistical significance as is argued by economists.Results In the cost-utility analysis, the mean incremental cost of craniotomy compared with DC was estimated to be −£5520 (95% CI −£18 060 to £7020) with a mean QALY gain of 0.093 (95% CI 0.029 to 0.156). In the cost-effectiveness analysis, the mean incremental cost was estimated to be −£4536 (95% CI −£17 374 to £8301) with an OR of 1.682 (95% CI 0.995 to 2.842) for a favourable outcome on the GOSE.Conclusions In a UK population with traumatic ASDH, craniotomy was estimated to be cost-effective compared with DC: craniotomy was estimated to have a lower mean cost, higher mean QALY gain and higher probability of a more favourable outcome on the GOSE (though not all estimated differences between the two approaches were statistically significant).Ethics Ethical approval for the trial was obtained from the North West—Haydock Research Ethics Committee in the UK on 17 July 2014 (14/NW/1076).Trial registration number ISRCTN87370545.

The first issue of Research in Learning Technology (RLT) was published in 1993. Over 30 years, the journal has comprised an informal research and development facility for new ideas and practices in technology enhanced learning. This paper takes nine published articles from RLT: the three most downloaded in the period January 2021 – March 2023 (but published at any time); the three most downloaded articles published from January 2021 to March 2023; and the three most cited articles published from January 2018 to March 2023. The aim is to identify different areas of current interest and influence, different areas of practice, and different scholarly approaches. The authors are the journal’s current editorial team. This paper identifies diversity of technology enhanced learning-related subject matter and different approaches, too, but with ongoing interest in efficacy and in the ‘how’ of technology enhanced learning: how technology can be applied to truly enhance learning, comprising an approachable community, generating influence.

Background Chronic subdural haematoma is a collection of ‘old blood’ and its breakdown products in the subdural space and predominantly affects older people. Surgical evacuation remains the mainstay in the management of symptomatic cases. Objective The Dex-CSDH (DEXamethasone in Chronic SubDural Haematoma) randomised trial investigated the clinical effectiveness and cost-effectiveness of dexamethasone in patients with a symptomatic chronic subdural haematoma. Design This was a parallel, superiority, multicentre, pragmatic, randomised controlled trial. Assigned treatment was administered in a double-blind fashion. Outcome assessors were also blinded to treatment allocation. Setting Neurosurgical units in the UK. Participants Eligible participants included adults (aged ≥ 18 years) admitted to a neurosurgical unit with a symptomatic chronic subdural haematoma confirmed on cranial imaging. Interventions Participants were randomly assigned in a 1 : 1 allocation to a 2-week tapering course of dexamethasone or placebo alongside standard care. Main outcome measures The primary outcome was the Modified Rankin Scale score at 6 months dichotomised to a favourable (score of 0–3) or an unfavourable (score of 4–6) outcome. Secondary outcomes included the Modified Rankin Scale score at discharge and 3 months; number of chronic subdural haematoma-related surgical interventions undertaken during the index and subsequent admissions; Barthel Index and EuroQol 5-Dimension 5-Level utility index score reported at discharge, 3 months and 6 months; Glasgow Coma Scale score reported at discharge and 6 months; mortality at 30 days and 6 months; length of stay; discharge destination; and adverse events. An economic evaluation was also undertaken, during which the net monetary benefit was estimated at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year. Results A total of 748 patients were included after randomisation: 375 were assigned to dexamethasone and 373 were assigned to placebo. The mean age of the patients was 74 years and 94% underwent evacuation of their chronic subdural haematoma during the trial period. A total of 680 patients (91%) had 6-month primary outcome data available for analysis: 339 in the placebo arm and 341 in the dexamethasone arm. On a modified intention-to-treat analysis of the full study population, there was an absolute reduction in the proportion of favourable outcomes of 6.4% (95% confidence interval 11.4% to 1.4%; p = 0.01) in the dexamethasone arm compared with the control arm at 6 months. At 3 months, the between-group difference was also in favour of placebo (−8.2%, 95% confidence interval −13.3% to −3.1%). Serious adverse events occurred in 60 out of 375 (16.0%) in the dexamethasone arm and 24 out of 373 (6.4%) in the placebo arm. The net monetary benefit of dexamethasone compared with placebo was estimated to be –£97.19. Conclusions This trial reports a higher rate of unfavourable outcomes at 6 months, and a higher rate of serious adverse events, in the dexamethasone arm than in the placebo arm. Dexamethasone was also not estimated to be cost-effective. Therefore, dexamethasone cannot be recommended for the treatment of chronic subdural haematoma in this population group. Future work and limitations A total of 94% of individuals underwent surgery, meaning that this trial does not fully define the role of dexamethasone in conservatively managed haematomas, which is a potential area for future study. Trial registration This trial is registered as ISRCTN80782810. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/15/02) and is published in full in Health Technology Assessment; Vol. 28, No. 12. See the NIHR Funding and Awards website for further award information. Plain language summary Chronic subdural haematoma is one of the most common conditions managed in adult neurosurgery and mainly affects older people. It is an ‘old’ collection of blood and blood breakdown products found on the surface of the brain. Surgery to drain the liquid collection is effective, with most patients improving. Given that inflammation is involved in the disease process, a commonly used steroid, dexamethasone, has been used alongside surgery or instead of surgery since the 1970s. However, there is no consensus or high-quality studies confirming the effectiveness of dexamethasone for the treatment of chronic subdural haematoma. This study was designed to determine the effectiveness of adding dexamethasone to the normal treatment for patients with a symptomatic chronic subdural haematoma. The benefit of adding dexamethasone was measured using a disability score called the Modified Rankin Scale, which can be divided into favourable and unfavourable outcomes. This was assessed at 6 months after entry into the study. In total, 748 adults with a symptomatic chronic subdural haematoma treated in neurosurgical units in the UK participated. Each participant had an equal chance of receiving either dexamethasone or a placebo because they were assigned randomly. Neither the patients nor the investigators knew who received dexamethasone and who received placebo. Most patients in both groups had an operation to drain the haematoma and experienced significant functional improvement at 6 months compared with their initial admission to hospital. However, patients who received dexamethasone had a lower chance than patients who received placebo of favourable recovery at 6 months. Specifically, 84% of patients who received dexamethasone had recovered well at 6 months, compared with 90% of patients who received placebo. There were more complications in the group that received dexamethasone. This trial demonstrates that adding dexamethasone to standard treatment reduced the chance of a favourable outcome compared with standard treatment alone. Therefore, this study does not support the use of dexamethasone in treating patients with a symptomatic chronic subdural haematoma. Scientific summary Background Chronic subdural haematoma (CSDH) is a common neurological disorder predominantly affecting older people, affecting approximately 5000 people aged over 65 years in the UK each year. Its incidence is increasing owing to an ageing population, alongside the growing use of antithrombotic agents. The majority of CSDHs do not cause symptoms and are managed conservatively. In those that do cause symptoms, surgical evacuation remains the mainstay of management, which achieves a good recovery in approximately 80% of patients. The remaining 10–20% of patients may suffer a recurrence, requiring further surgery. Additional and alternative measures to surgery are sought to improve outcomes in this patient group. Inflammation has been implicated in the pathogenesis of CSDHs, which suggests a role for anti-inflammatory medications, such as steroids. Therefore, steroids may serve as a useful adjunct or even alternative to surgery. However, to date, there is a lack of high-quality evidence in the form of a randomised clinical trial or meta-analysis. This trial investigates the clinical effectiveness of a steroid, dexamethasone, in patients with symptomatic CSDH. Objectives Primary objective The primary objective of the trial was to determine the clinical effectiveness of a 2-week course of dexamethasone for adult patients with a symptomatic CSDH, assessed by comparing the rate of favourable outcomes [defined as a Modified Rankin Scale (mRS) score of 0–3] at 6 months after randomisation between the treatment and the control arm. This outcome was reviewed centrally by a clinically trained investigator blinded to treatment allocation. Secondary objectives The secondary objectives were to compare the following outcomes between the treatment and the control arm of the trial: number of CSDH-related surgical interventions undertaken during the index admission number of CSDH-related surgical interventions undertaken during subsequent admissions in the follow-up period Glasgow Coma Scale (GCS) score at discharge from the neurosurgical unit (NSU) and at 6 months Modified Rankin Scale score at discharge from the NSU and at 3 months Barthel Index score at discharge from the NSU and at 3 and 6 months mortality (30 days and 6 months) EuroQol-5 Dimensions, five-level version (EQ-5D-5L), utility index at discharge from the NSU and at 3 and 6 months length of stay in the NSU discharge destination from the NSU length of stay in secondary care rates of adverse events (AEs). An economic evaluation was also undertaken to estimate the cost-effectiveness of dexamethasone compared with placebo. Tertiary objectives Postoperative recurrence is a tertiary outcome measure and is defined as a symptomatic recurrence requiring reoperation of a previously evacuated ipsilateral CSDH. Methods Trial design The Dex-CSDH (DEXamethasone in Chronic SubDural Haematoma) trial is a multicentre, pragmatic, clinical phase III, randomised, double-blind, placebo-controlled trial of a tapering 2-week course of dexamethasone in patients with a symptomatic CSDH. The pragmatic design meant that the trial ran in parallel with standard clinical care, with the only difference being the addition of the trial drug (dexamethasone) or placebo. Intervention Two-week tapering course of dexamethasone (with matching placebo as the control). Participants Participants were screened for eligibility from 23 NSUs across the UK, with the admitting neurosurgical team determining eligibility for participation. Participants were adult patients aged ≥ 18 years with a symptomatic CSDH confirmed on cranial imaging (computerised tomography or magnetic resonance imaging of the brain). The patient or their legal representative had to provide informed consent. In the absence of a legal representative, an independent healthcare professional provided authorisation for enrolment. Patients were excluded in the presence of any of the following criteria: presence of a condition for which steroids are clearly contraindicated patients who are (or within 1 month of) receiving regular oral or intravenous glucocorticoid steroids (this did not include inhaled or topical steroids, nor did it include those receiving a single intraoperative dose of dexamethasone for anti-emesis) previous enrolment in this trial for a prior episode time interval from time of admission to the NSU to first dose of trial medication exceeded 72 hours chronic subdural haematoma in the presence of a cerebrospinal fluid shunt severe lactose intolerance or a known hypersensitivity to dexamethasone or other excipients a history of psychotic disorders unwillingness to take products containing gelatine. Patients who were screened but not included in the study were recorded on a screening log and reported centrally, with both the number of failures and the reasons for failure to recruit to the trial documented. Trial procedures Patients were managed in NSUs in accordance with standard practice. In the UK, this typically includes burr hole evacuation with the use of a subdural drain for most symptomatic patients. The decision for surgery or active monitoring was made on an individual patient basis by the blinded admitting clinical team in conjunction with the patient, in keeping with the pragmatic nature of the trial. Enrolment in the trial took place irrespective of the decision to operate and the timing of surgical intervention. Patients were randomised in 1 : 1 allocation using a computer-generated randomisation schedule, stratified by site using permuted blocks of random sizes (two or four). An interactive web-based response system was used to allocate treatment packs of 62 overencapsulated 2-mg dexamethasone tablets or 62 identical placebo capsules. The enrolled participants, clinical and research team and outcome assessors were blinded to the treatment allocation. The assigned treatment was administered as part of the routine drug round by the ward nurses. Oral administration was the preferred option, but administration via a nasogastric tube was offered to those unable to swallow. The latter method required opening of the capsules for crushing of the contents, allowing potential unblinding of the ward nurse. Therefore, the content of any opened capsules was not documented in the patient notes to maintain the blinding of the neurosurgeons and research staff. Trial drug compliance was recorded through inpatient drug charts during admission or by completion of a medication diary. Data were collected at baseline (on admission to the neurosurgical department) as part of routine standard of care, on discharge from the acute NSU, at 30 days, at 3 months and at 6 months. Patients were monitored in line with routine clinical practice until discharge, and at 3 and 6 months, to score clinical outcomes. Sample size This sample size was calculated with the following assumptions: a favourable outcome rate of 80–85% in the control arm and allowing for up to 15% loss to follow-up. A target sample size of 750 patients was needed to detect an increase in favourable outcome rate from 80–85% to 88–93%, with a power of 81–92% at the 5% significance level (two sided). An 8% increase in the rate of favourable outcome (mRS score of 0–3) at 6 months represents a clinically important treatment effect. Statistical analysis Data were analysed in accordance with the prespecified statistical analysis plan that was agreed prior to unblinding of data. Outcome data were analysed using a modified intention-to-treat analysis (all patients were included as randomised, except for those who withdrew consent for participation in the trial and those lost to follow-up). The primary outcome (mRS score at 6 months) was dichotomised into favourable (0–3) or unfavourable (4–6) outcomes. Primary analysis estimated the absolute difference between the intervention arm and the control arm in the proportions achieving a favourable outcome. A normal approximation was used to produce 95% confidence intervals (CIs) and a two-sided p-value testing the null hypothesis of no difference. Secondary analysis included a logistic regression and proportional odds logistic regression of the original mRS score adjusting for baseline covariates of age and Glasgow Coma Scale (GCS) score. Economic evaluation In the base-case analysis, costs were estimated over the 6-month trial period from an NHS and a Personal Social Services perspective. Outcomes were quality-adjusted life-years (QALYs) derived from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at NSU discharge and at the 3- and 6-month follow-ups. Analyses were undertaken to estimate the mean incremental cost and effect, and enable the net monetary benefit (NMB) (a negative score indicates that the intervention is not estimated to be cost-effective) to be calculated, along with the cost-effectiveness acceptability curve (CEAC) (probability that dexamethasone was cost-effective). NMB and CEAC values at a willingness-to-pay threshold of £20,000 per QALY are reported. Results Primary outcome An outcome of mRS score of 0–3 occurred in 286 out of 341 patients (83.9%) in the dexamethasone arm and 306 out of 339 patients (90.3%) in the placebo arm at 6 months (difference −6.4%, 95% CI −11.4% to −1.4%; p = 0.01). After adjustment for prespecified covariates (age > 70 years and GCS score on admission), the odds ratio (OR) of a favourable outcome with dexamethasone was 0.55 (95% CI 0.33 to 0.91; p = 0.022), favouring placebo. Secondary outcomes Modified Rankin Scale at discharge and 3 months At 3 months, 268 out of 322 patients (83.2%) in the dexamethasone arm and 298 out of 326 patients (91.4%) in the placebo arm had a favourable outcome, for a between-group difference of −8.2% (95% CI −13.3% to −3.1%) in favour of the placebo arm. There was no significant difference in mRS score between the two arms at discharge [255/318 (80.2%) in the dexamethasone arm and 263/316 (83.2%) in the placebo arm for a difference of −3.0% (95% CI −9.1% to 3.0%)]. Mortality At discharge, 8 out of 375 patients (2.1%) in the dexamethasone arm and 2 out of 373 patients (0.5%) in the placebo arm had died (OR 4.08, 95% CI 1.01 to 27.2). At 6 months, 30 out of 341 patients (8.8%) in the dexamethasone arm and 17 out of 339 patients (5.0%) in the placebo arm had died (OR 1.83, 95% CI 0.99 to 3.45). Number of chronic subdural haematoma-related surgical interventions undertaken The number of surgical interventions undertaken during the index admission or during subsequent admissions during the follow-up period was similar in both arms. However, in the subset of patients who received surgery, repeat surgery for recurrence of the CSDH was performed in 6 out of 349 patients (1.7%) in the dexamethasone arm and in 25 out of 350 patients (7.1%) in the placebo arm. EuroQol-5 Dimensions, five-level version, utility index (at discharge and at 3 and 6 months) The mean EQ-5D-5L, utility index scores were compared. At discharge, the difference was −0.03 (95% CI −0.07 to 0.01), favouring placebo. At 3 months, the difference was −0.07 (95% CI −0.12 to −0.02), favouring placebo. At 6 months, the difference was −0.03 (95% CI −0.09 to 0.02), favouring placebo. Glasgow Coma Scale (at discharge and at 6 months) Glasgow Coma Scale was grouped into scores of 9–12 and 13–15. The percentage of patients with a score of 13–15 was similar at discharge (99.7% in the placebo arm vs. 99.2% in the dexamethasone arm). Insufficient data at 6 months prevented analysis. Barthel Index (at discharge and at 3 and 6 months) No significant difference was seen between the placebo arm and the dexamethasone arm at discharge, 3 months or 6 months. Length of stay in the neurosurgical unit The mean length of stay was 9.03 days in the placebo arm and 9.32 days in the dexamethasone arm. Length of stay in secondary care The mean length of stay was 13.0 days in the dexamethasone arm and 13.7 days in the placebo arm, with no significant difference between the two arms (0.95, 95% CI 0.835 to 1.09; p = 0.467). Discharge destination from the neurosurgical unit No significant difference was observed between the placebo arm and the dexamethasone arm when comparing discharge destinations. Rates of adverse events The odds of an adverse event of special interest were greater in the dexamethasone arm than in the placebo arm (OR 3.40, 95% CI 1.81 to 6.85). Similarly, the odds of a serious adverse event occurring were greater in the dexamethasone arm than in the placebo arm (OR 2.49, 95% CI 1.54 to 4.15). Economic evaluation The mean incremental cost for dexamethasone was estimated to be −£143.73 (95% CI −£1793 to £1505), with a QALY of −0.012 (95% CI −0.027 to 0.003), compared with placebo. The associated NMB of dexamethasone compared with placebo was −£97.19, with an estimated 46% probability of being cost-effective. Conclusions Implications for healthcare Dexamethasone for the treatment of symptomatic CSDH resulted in a lower proportion of favourable outcomes, as measured with the mRS, and a larger number of AEs than placebo. This treatment regime was also not estimated to be cost-effective (based on the NMB). Therefore, dexamethasone is not recommended in the treatment of CSDH. Implications for research The results of our literature review indicate that this study is the first multicentre randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of dexamethasone in the management of symptomatic CSDH. It provides evidence to inform the role of dexamethasone in this condition. Trial registration This trial is registered as ISRCTN80782810. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/15/02) and is published in full in Health Technology Assessment; Vol. 28, No. 12. See the NIHR Funding and Awards website for further award information.

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. Plain language summary 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. Scientific summary Background As people age, degenerative disease affects the intervertebral discs, facet joints and ligamentum flavum in the cervical spine. Consequently, the nerve root foramina may change shape and the nerve roots become compressed, causing a syndrome called cervical radiculopathy. Cervical radiculopathy is characterised by neck pain and cervical brachialgia, with the symptom of pain originating in the neck and radiating down into the upper arm. The reported incidence of cervical brachialgia is 1.79 cases per 1000 per year, with > 110,000 cases of brachialgia annually in the UK. Cervical brachialgia typically affects people aged 40–60 years, with up to 15% of patients unable to work because of the pain. In most patients, brachialgia is self-resolving with conservative management strategies. However, if symptoms persist 6 weeks to 3 months after onset, two of the available surgical techniques used (in the UK) to treat cervical brachialgia are posterior cervical foraminotomy (PCF) and anterior cervical discectomy (ACD). The most common and current standard operation is ACD, approaching from the front of the neck. The procedure is effective, but there is a high incidence of significant, potentially permanent, complications, including dysphagia and hoarse voice, which can be devastating to a patient’s quality of life. Alternatively, PCF can be undertaken from the back of the neck. Unlike ACD, PCF avoids risk to the structures in front of the spine including the carotid artery, sympathetic trunk, recurrent laryngeal nerve, larynx and pharynx, but may result in higher levels of postoperative neck pain and a greater need for revision surgery. Controversy therefore exists over which procedure is superior for the treatment of cervical brachialgia, and the decision on which procedure to use is frequently left to surgeon preference. The posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia (FORVAD) trial aimed to robustly compare the two procedures, with the ambition of providing definitive evidence that would guide surgical decision-making for patients with cervical brachialgia symptoms requiring surgical intervention. Objectives The primary objective of the trial was to determine whether PCF is superior to ACD in terms of improving clinical outcome, as measured by the Neck Disability Index (NDI) at 52 weeks post operation, among patients with persistent cervical brachialgia for whom conservative management has failed. The secondary objectives were comparison of the two surgeries in terms of NDI score, patient-reported neck and upper-limb pain, dysphagia and globus, hoarse voice symptoms, incidence of revision surgery, cost effectiveness over 52 weeks post operation, the extent and severity of a patient’s spinal cord functional impairment, and incidence of surgical complications up to 6 weeks post operation. The exploratory objectives were to explore the impact of variations in the optional surgical components of PCF (open or minimal-access surgery) and ACD (surgery with or without a plate) on NDI and EuroQol-5 Dimensions, three-level version (EQ-5D-3L) scores. Design The FORVAD trial was a UK multicentre, Phase III, parallel-group, superiority, individually randomised controlled trial comparing the clinical effectiveness and cost effectiveness of PCF with those of ACD among patients experiencing symptomatic unilateral cervical brachialgia for at least 6 weeks, with confirmed nerve root compression on magnetic resonance imaging or computerised tomography myelography. Neither participants nor medical or clinical trial staff in the FORVAD trial were blinded to the treatment allocated. The trial incorporated an internal pilot phase to assess the feasibility of trial delivery against prespecified recruitment criteria. Participants were randomised (1 : 1) to receive PCF or ACD via minimisation incorporating a random element, with minimisation factors of centre, duration of upper-limb symptoms and smoking status. Participants were followed up in clinic at day 1 and 6 weeks post operation, and by post at 12, 26, 39 and 52 weeks post operation. The target sample size was 252 participants (126 per trial arm). This number was required to have 90% power to detect the minimum clinically important difference of 10% (5 points) in the change in NDI score at 52 weeks post operation, assuming a between-patient standard deviation of 23 units, two-sided 5% significance level and 10% loss to follow-up. For the analysis of the primary outcome measure, it was intended to use a multilevel linear regression model incorporating random effects with respect to centre, and adjusting for baseline (day 0) NDI score and minimisation factors (duration of upper limb symptoms and smoking status). The statistical analysis plan was amended prior to final analysis of the data to account for the restricted sample size owing to the early closure of the trial and was limited to descriptive summaries. Setting The trial aimed to recruit from 15 NHS hospitals throughout the UK. Participating surgeons were expected to perform both trial procedures and were required to have performed a minimum of 10 of each surgical procedure and to have completed a bespoke training package on the e-brain platform [www.ebrain.net (accessed 25 April 2022)]. Participants Patients were eligible to participate if they had been diagnosed with unilateral cervical brachialgia that had persisted for at least 6 weeks, resultant from single-level nerve entrapment, and conservative management had previously failed. Patients with cervical myelopathy, spinal cord compression or who had previously had cervical spine surgery were excluded. Eligibility waivers were not granted in this trial. Interventions Pre-operative investigations and preparation were as per individual site protocol. Participants received either PCF or ACD. Minimal- and open-access techniques were permitted for PCF. For ACD, the choice of fusion material and the decision to use a plate were left to surgeon discretion. Postoperative care was also as per individual site protocol. Main outcome measures The primary outcome measure was the patient-reported percentage NDI score at 52 weeks post operation. Secondary patient-reported outcomes (collected at baseline; at days 1 and 6; and at 12, 26, 39 and 52 weeks post operation) were collected using the Numerical Rating Scale–Neck Pain (NRS-NP), the Numerical Rating Scale–Arm Pain (NRS-AP), the validated PainDETECT, the Eating Assessment Tool-10 items (EAT-10), the Glasgow–Edinburgh Throat Scale (GETS) and the Voice Handicap Index-10 items (VHI-10) tools. Secondary clinical outcomes included a restricted version of the American Spinal Injury Association (ASIA) assessment scale, intraoperative and postoperative complications, incidence of reoperations within 52 weeks of operation and assessment of hoarse voice from additional voice recordings collected from randomly selected participants using the grade, roughness, breathiness, asthenia and strain scoring system. Exploratory outcomes included whether participants receiving PCF received minimal- or open-access surgery, and whether participants receiving ACD received surgery with or without a plate. Patient-reported outcomes were recorded using the EQ-5D-3L, which, alongside collected health resource use data, informed cost-effectiveness analysis. Results Owing to slower than expected accrual, the trial closed to recruitment after randomising 23 participants, 14 to PCF and 9 to ACD, from 11 sites. Therefore, results from the trial should be interpreted with caution because of the small sample size. The median NDI scores at baseline and 52 weeks were 44.0 [interquartile range (IQR) 36.0–62.0] and 25.3 (IQR 20.0–42.0) in the PCF group, respectively, indicating a reduction (improvement) from baseline. In the ACD group, the median scores at baseline and 52 weeks were 35.6 (IQR 34.0–44.0) and 45.0 (IQR 20.0–57.0), respectively. Unlike the PCF group, NDI scores did not appear to improve from baseline in the ACD group. For the NRS-NP and NRS-AP, there was an initial increase from baseline in neck pain score on day 1 post operation in both groups [median 5.5 (IQR 4.0–8.0) at baseline to 8.5 (IQR 6.0–10.0) at 1 day post operation in the PCF group; median 5.0 (IQR 4.0–7.0) at baseline to 7.0 (IQR 4.0–9.0) at 1 day post operation in the ACD group]. Neck pain decreased after day 1 in both treatment groups; at 52 weeks, the median scores were 4.0 (IQR 2.0–5.0) in the PCF group and 5.0 (IQR 3.0–7.0) in the ACD group. In both groups, arm pain improved on day 1 [median 3.0 (IQR 2.0–8.0) in the PCF group; median 4.0 (IQR 0.5–5.0) in the ACD group] and reached its lowest level 12 weeks post operation [median 3.0 (IQR 2.0–8.0) in the PCF group; median 2.5 (IQR 0.0–5.0) in the ACD group]. Thereafter, arm pain deteriorated (increased), but remained below baseline [median 5.0 (IQR 2.0–7.0) in the PCF group and median 5.0 (IQR 3.0–6.0) in the ACD group at 52 weeks]. PainDETECT category scores fluctuated over the postoperative period in the PCF group, but reduced over time in the ACD group, suggesting that in the ACD group a higher proportion of the participants had developed nociceptive, rather than neuropathic, pain. The ASIA score remained unchanged in both treatment groups over the 6-week assessment period. For the EAT-10 and the VHI-10 outcomes, the ACD group had worse outcomes at day 1 [median EAT-10 scores of 0.0 (IQR 0.0–4.0) in the PCF group and 13.5 (IQR 3.5–16.0) in the ACD group, and median VHI-10 scores of 0.0 (IQR 0.0–2.0) in the PCF group and 2.0 (IQR 0.5–8.5) in the ACD group], after which the two groups are comparable. However, the median GETS score was worse in the ACD group postoperatively, although the IQRs in each treatment group overlap at all time points except day 1. Five postoperative complications were reported in five participants throughout the trial, all occurring in the ACD group. Reported complications included two instances of dysphagia and three ‘other’ complications: ‘wound infection’, ‘urinary retention’ and ‘wound redness stitches overnight’. No serious or unexpected serious complications, deaths or reoperations were reported. The health economics and qualitative study The revised aims of the cost-effectiveness analysis were to describe the costs of the surgical interventions, health-care service use and participant out-of-pocket expenditures, and the productivity costs of losses associated with the surgery and its consequences. Responses to the EQ-5D-3L questionnaire of generic health-related quality of life and the rate of data completion are summarised. All costs are based on 2019/20 prices and are presented without discounting, as the time horizon of the analysis is 52 weeks. The costs of the intervention were heavily influenced by outliers in the PCF group, resulting in mean health-care costs of initial surgery, including devices, operation and hospital stay, of £2745 [95% confidence interval (CI) £2344 to £3147] for the PCF group (n = 12) and £4295 (95% CI £3436 to £5154) for the ACD group (n = 8). The corresponding median costs were £2622 (IQR £2402–2824) for participants undergoing PCF and £4423 (IQR £3849–4821) for participants undergoing ACD. These costs were driven by the time in theatre, which was a mean of 30 minutes (median 45 minutes) shorter for PCF (mean 61 minutes, median 52 minutes, IQR 49–60 minutes) than for ACD (mean 91 minutes, median 100 minutes, IQR 75–109 minutes). Results aggregated up to week 6 are presented owing to high attrition thereafter. The mean costs from the NHS and Personal Social Services perspective were £2716 (95% CI £2345 to £3087) for the PCF group and £4133 (95% CI £3099 to £5167) for the ACD group; the median costs were £2634 (IQR £2444–2741) and £4214 (IQR £3602–4994) for the PCF and ACD groups, respectively. The mean per-patient costs to society were £4608 (95% CI £2514 to £6703) for the PCF group and £5015 (95% CI £2286 to £7743) for the ACD group; the median costs were £4097 (IQR £2448–6591) and £4143 (IQR £4126–4284) for the PCF and ACD groups, respectively. At baseline, severe problems with anxiety and depression were more common, and pain and discomfort according to the EQ-5D-3L classification system was more severe in the PCF group than in the ACD group, resulting in mean utility scores of 0.291 (95% CI 0.07 to 0.51) and 0.595 (95% CI 0.40 to 0.78) for PCF and ACD, respectively. The corresponding median scores were 0.210 (IQR –0.01 to 0.60) and 0.689 (IQR 0.66–0.69). This is likely to have played a role in the larger observed gains from baseline in postoperative EuroQol-5 Dimensions (EQ-5D) scores for participants in the PCF group than in the ACD group [median change at 6 weeks of 0.10 (IQR 0.00–0.13) and 0.02 (IQR –0.03 to 0.06), respectively]. A rapid qualitative study was conducted during trial close-down to understand the experiences of health-care professionals and participants who participated in the FORVAD trial and why recruitment had been challenging, with the aim of informing future research in this area. Semistructured interviews were conducted with 18 health-care professionals (research nurses and surgeons) and two participants who had participated in the FORVAD trial. Interviews explored participants’ experiences of the FORVAD trial and their reasons for taking part, and staff experiences of recruiting to the FORVAD trial and neurosurgery trials in general. Interviews were audio-recorded and transcribed verbatim. Transcripts were analysed using rapid qualitative analysis. There was no single key factor that limited recruitment, and several themes were identified as common to all sites. Surgeons at participating sites supported the trial, and recognised collective clinical equipoise; however, many had preferences for one or the other procedure, linked to their usual practice. Organisation of the trial recruitment pathway varied, with some sites choosing to direct potentially eligible patients to dedicated clinics and other sites taking a more ad hoc approach. In the FORVAD trial, the dedicated clinic approach appeared to contribute to more eligible patients being identified and recruited, although staff at other sites explained that dedicated clinics did not fit easily with their clinical pathways. Randomisation on the day of surgery presented ethical and organisational challenges, and, where possible, should be avoided in future surgical trials. Organisation and implementation of a surgical trial in neurosurgery are complex and present many challenges. Future trials in neurosurgery should identify aspects of the protocol where it is possible to offer flexibility and ensure early multidisciplinary involvement at sites to maximise the effective integration of trial and clinical pathways. Conclusions The data suggest that PCF may be associated with better outcomes, fewer complications and lower cost, but the trial recruited slowly and was closed early. As a consequence, the trial is underpowered and definitive conclusions cannot be drawn. Trial recruitment was impaired by the lack of individual equipoise and concern about randomising on the day of surgery. A large prospective multicentre trial comparing ACD and PCF 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.

Screening trials of spinal cord stimulation (SCS) prior to full implantation of a device are recommended by expert guidelines and international regulators. The current study sought to estimate the budget impact of a screening trial of SCS and the costs or savings of discontinuing the use of a screening trial. A budget impact analysis was performed considering a study population that reflects the size and characteristics of a patient population with neuropathic pain in England eligible for SCS. The perspective adopted was that of the NHS with a 5-year time horizon. The base case analysis indicate that a no screening trial strategy would result in cost-savings to the NHS England of £400,000–£500,000 per year. Sensitivity analyses were conducted to evaluate different scenarios. If ≥5% of the eligible neuropathic pain population received a SCS device, cost-savings would be >£2.5 million/year. In contrast, at the lowest assumed cost of a screening trial (£1,950/patient), a screening trial prior to SCS implantation would be cost-saving. The proportion of patients having an unsuccessful screening trial would have to be ≥14.4% for current practice of a screening trial to be cost-saving. The findings from this budget impact analysis support the results of a recent UK multicenter randomized controlled trial (TRIAL-STIM) of a policy for the discontinuation of compulsory SCS screening trials, namely that such a policy would result in considerable cost-savings to healthcare systems.

Background: This paper describes the first case in the literature of Prototheca wickerhamii infection causing intracerebral lesions. Case Report: A 55 year old female presented with progressive neurology and multiple lesions on brain MRI scanning. Initial histology from a brain biopsy was reported to show changes compatible with toxoplasmosis. There was no evidence of immunocompromise and this diagnosis was felt to be unlikely. A specialist infectious disease histopathology opinion was requested and results were reported as consistent with protothecosis. Repeat biopsy grew Prototheca wickerhamii confirming the diagnosis. Antimicrobial susceptibility testing was arranged but was challenging to interpret due to lack of clinical break points for this species. A number of treatments were trialled but stopped due to toxicity, antimicrobial resistance on testing or lack of efficacy. Eventually treatment with liposomal amphotericin B was given for 18 months. Two years after treatment ceased the patient remains stable and appears cured of infection. Conclusion: This case highlights Prototheca spp. as a rare cause of central nervous system infection and reports the first case of intracerebral lesions caused by Prototheca wickerhamii. Lack of evidence for treatment, antifungal drug toxicity, difficulties with antimicrobial susceptibility and drug tissue penetration were a challenge. Also demonstrated is the importance of a specialist opinion, in this case histopathology, which ultimately determined the diagnosis.

Abstract Background Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions. Methods Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis. Discussion This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015. Dex-CSDH trial protocol version 3, 27 Apr 2017. This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.

Abstract Background The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. Methods/design The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. Allocation will be stratified by centre and minimised on patient age (≥ 65 or

Background: Pain of lumbar facet-joint origin is a common cause of low back pain in adults and may lead to chronic pain and disability, with associated health and socioeconomic implications. The socioeconomic burden includes an inability to return to work resulting in loss of productivity in addition to direct and indirect health-care utilisation costs. Lumbar facet-joints are paired synovial joints between the superior and inferior articular processes of consecutive lumbar vertebrae and between the fifth lumbar vertebra and the sacrum. Facet-joint pain is defined as pain that arises from any structure that is part of the facet-joints, including the fibrous capsule, synovial membrane, hyaline cartilage and bone. This pain may be treated by intra-articular injections with local anaesthetic and steroid, although this treatment is not standardised. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. Because of the lack of high-quality, robust clinical evidence, the National Institute for Health and Care Excellence (NICE) guidelines on the management of chronic low back pain [NICE. Low Back Pain in Adults: Early Management. Clinical guideline (CG88). London: NICE; 2009] did not recommend the use of spinal injections despite their perceived potential to reduce pain intensity and improve rehabilitation, with NICE calling for further research to be undertaken. The updated guidelines [NICE. Low Back Pain and Sciatica in Over 16s: Assessment and Management. NICE guideline (NG59). London: NICE; 2016] again do not recommend the use of spinal injections. Objectives: To assess the feasibility of carrying out a definitive study to evaluate the clinical effectiveness and cost-effectiveness of lumbar facet-joint injections compared with a sham procedure in patients with non-specific low back pain of > 3 months’ duration. Design: Blinded parallel two-arm pilot randomised controlled trial. Setting: Initially planned as a multicentre study involving three NHS trusts in the UK, recruitment took place in the pain and spinal orthopaedic clinics at Barts Health NHS Trust only. Participants: Adult patients referred by their GP to the specialist clinics with non-specific low back pain of at least 3 months’ duration despite NICE-recommended best non-invasive care (education and one of a physical exercise programme, acupuncture or manual therapy). Patients who had already received lumbar facet-joint injections or who had had previous back surgery were excluded. Interventions: Participants who had a positive result following a diagnostic test (single medial branch nerve blocks) were randomised and blinded to receive either intra-articular lumbar facet-joint injections with steroids (intervention group) or a sham procedure (control group). All participants were invited to attend a group-based combined physical and psychological (CPP) programme. Main outcome measures: In addition to the primary outcome of feasibility, questionnaires were used to assess a range of pain-related (including the Brief Pain Inventory and Short-Form McGill Pain Questionnaire version 2) and disability-related (including the EuroQol-5 Dimensions five-level version and Oswestry Low Back Pain Questionnaire) issues. Health-care utilisation and cost data were also assessed. The questionnaire visits took place at baseline and at 6 weeks, 3 months and 6 months post randomisation. The outcome assessors were blinded to the allocation groups. Results: Of 628 participants screened for eligibility, nine were randomised to receive the study intervention (intervention group, n = 5; sham group, n = 4), six completed the CPP programme and eight completed the study. Limitations: Failure to achieve our expected recruitment targets led to early closure of the study by the funder. Conclusions: Because of the small number of participants recruited to the study, we were unable to draw any conclusions about the clinical effectiveness or cost-effectiveness of intra-articular lumbar facet-joint injections in the management of non-specific low back pain. Although we did not achieve the target recruitment rate from the pain clinics, we demonstrated our ability to develop a robust study protocol and deliver the intended interventions safely to all nine randomised participants, thus addressing many of the feasibility objectives. Future work: Stronger collaborations with primary care may improve the recruitment of patients earlier in their pain trajectory who are suitable for inclusion in a future trial. Trial registration: EudraCT 2014-003187-20 and Current Controlled Trials ISRCTN12191542. 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. 21, No. 74. See the NIHR Journals Library website for further project information.

Following publication of the original article [1], we have been notified that the final specification of randomisation implemented in the study is slightly different to that stated in the protocol and needs to be corrected as follows:

After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled.

The purpose of this paper is to examine how recent regulatory changes, and the on-going effects of the global economic crisis, have affected legal services in England and Wales, and asks if there are, consequently, “too many lawyers”. The Legal Services Act 2007 introduced new regulatory priorities, placing greater emphasis on competition within a market for legal services, and introducing “Alternative Business Structures”, which enable non-lawyers to own or manage bodies providing legal services, or to carry out reserved legal activities within a licensed body. The paper speculates about the effects of a changing market, illustrated with emerging examples. Whether or not there are too many lawyers depends on who is regarded as a lawyer, what tasks a lawyer should carry out, the structure of the market for legal services, and the needs of legal "consumers". El objetivo de este artículo es analizar cómo los cambios recientes en la regulación y los efectos continuados de la crisis económica global, han afectado a los servicios legales en Inglaterra y Gales, y cuestiona si, consecuentemente, hay “demasiados abogados”. La ley conocida como “Legal Services Act 2007” introdujo nuevas prioridades reguladoras, otorgando mayor énfasis a la competencia en el mercado de los servicios legales, e introduciendo “Estructuras Alternativas de Negocio”, lo que permitía, sin ser abogado, poseer o gestionar empresas de servicios legales, o desarrollar actividades legales reservadas a un órgano colegiado. El artículo especula sobre los efectos de un mercado cambiante, a través de ejemplos emergentes. Si hay demasiados abogados o no, depende de lo que se entiende como abogado, las tareas que un abogado debería desarrollar, la estructura del mercado de servicios legales, y las necesidades de los “consumidores” legales.

This special issue is the fifth devoted to Open Educational Resources (OER) and the fourth to be drawn from papers presented at the annual UK-based OER conference. For this special issue, the editors selected papers from the OER14 conference, held in Newcastle in April 2014. The main conference theme was ‘Building communities of open practice’ with further themes on MOOCs and open courses; academic practice, development and pedagogy; open policy, research, scholarship and access; and students as users and co-creators. As open education matures it will be the communities we develop that make a difference to the success (or failure) of transforming education through openness. The five chosen papers in this special issue exemplify one facet of building communities of open practice – how people may, in theory and in practice, be included in or excluded from such communities despite the potential of the openness on offer.