Qualitative study exploring the views of patients and healthcare providers on current rehabilitation practices after lumbar fusion surgery.

OBJECTIVES: To explore the views of patients and healthcare providers on current rehabilitation after lumbar fusion surgery (LFS) to fuel the development of a novel rehabilitation care pathway. DESIGN: A cross-sectional, qualitative study with an interpretive descriptive design. SETTING: Academic and non-academic hospital setting in Belgium. PARTICIPANTS: 31 caregivers from (non)-academic settings and 5 patients with LFS were purposefully sampled and in-depth interviewed. RESULTS: Out of the data of all interviews, participants reported opinions on 23 thematic clusters that were expressed in a time-contingent manner from the preoperative, perioperative to postoperative phase. Afterwards, themes were mapped to the Consolidated Framework for Implementation Research, with a larger role for concepts related to the innovation, inner and individual domain. As an overarching theme, the importance of an 'individualised, patient-centred rehabilitation built on a strong therapeutic alliance with an accessible interprofessional team' was stressed for patients undergoing LFS. Specifically, participants stated that a biopsychosocial approach to rehabilitation should start in the preoperative phase and immediately be continued postoperatively. No consensus was observed for movement restrictions postoperatively. Uniform communication between the involved caregivers was considered essential for optimal therapeutic alliance and clinical outcome. The precise role and competence of each member of the interprofessional team needs, therefore, to be clearly defined, respected and discussed. An accessible case manager to guide the patient trajectory and tackle problems could further support this. Interestingly, only patients, psychologists and physiotherapists addressed return to work as an important outcome after LFS. CONCLUSIONS: This qualitative study identified key experiences and points to consider in the current and future rehabilitation pathway for LFS. Future research should incorporate these findings to build a novel rehabilitation pathway for LFS and evaluate its feasibility and cost-effectiveness. TRIAL REGISTRATION NUMBER: This study was registered at clinicaltrials.gov (NCT03427294).

Early management of adult traumatic spinal cord injury in patients with polytrauma: a consensus and clinical recommendations jointly developed by the World Society of Emergency Surgery (WSES) & the European Association of Neurosurgical Societies (EANS).

BACKGROUND: The early management of polytrauma patients with traumatic spinal cord injury (tSCI) is a major challenge. Sparse data is available to provide optimal care in this scenario and worldwide variability in clinical practice has been documented in recent studies. METHODS: A multidisciplinary consensus panel of physicians selected for their established clinical and scientific expertise in the acute management of tSCI polytrauma patients with different specializations was established. The World Society of Emergency Surgery (WSES) and the European Association of Neurosurgical Societies (EANS) endorsed the consensus, and a modified Delphi approach was adopted. RESULTS: A total of 17 statements were proposed and discussed. A consensus was reached generating 17 recommendations (16 strong and 1 weak). CONCLUSIONS: This consensus provides practical recommendations to support a clinician's decision making in the management of tSCI polytrauma patients.

An international, prospective observational study on traumatic brain injury epidemiology study protocol: GEO-TBI: Incidence.

Background: The epidemiology of traumatic brain injury (TBI) is unclear - it is estimated to affect 27-69 million individuals yearly with the bulk of the TBI burden in low-to-middle income countries (LMICs). Research has highlighted significant between-hospital variability in TBI outcomes following emergency surgery, but the overall incidence and epidemiology of TBI remains unclear. To address this need, we established the Global Epidemiology and Outcomes following Traumatic Brain Injury (GEO-TBI) registry, enabling recording of all TBI cases requiring admission irrespective of surgical treatment. Objective: The GEO-TBI: Incidence study aims to describe TBI epidemiology and outcomes according to development indices, and to highlight best practices to facilitate further comparative research. Design: Multi-centre, international, registry-based, prospective cohort study. Subjects: Any unit managing TBI and participating in the GEO-TBI registry will be eligible to join the study. Each unit will select a 90-day study period. All TBI patients meeting the registry inclusion criteria (neurosurgical/ICU admission or neurosurgical operation) during the selected study period will be included in the GEO-TBI: Incidence. Methods: All units will form a study team, that will gain local approval, identify eligible patients and input data. Data will be collected via the secure registry platform and validated after collection. Identifiers may be collected if required for local utility in accordance with the GEO-TBI protocol. Data: Data related to initial presentation, interventions and short-term outcomes will be collected in line with the GEO-TBI core dataset, developed following consensus from an iterative survey and feedback process. Patient demographics, injury details, timing and nature of interventions and post-injury care will be collected alongside associated complications. The primary outcome measures for the study will be the Glasgow Outcome at Discharge Scale (GODS) and 14-day mortality. Secondary outcome measures will be mortality and extended Glasgow Outcome Scale (GOSE) at the most recent follow-up timepoint.

Traumatic brain injury (TBI) is a significant global health problem, which affects 27­69 million people every year. After-effects of TBI commonly affect the injured individuals for years. Most patients who sustain a TBI are from developing countries. Research has shown that there are differences in patients' recovery after TBI between countries and hospitals. The causes of these differences are unclear and tackling them could improve TBI treatment worldwide. To address this need, we have recently established the Global Epidemiology and Outcomes Following Traumatic Brain Injury (GEO-TBI) registry. The international collaborative registry aims to collect data related to the causes, treatments and outcomes related to TBI patients. This data will hopefully enable future research to elucidate the causes of the recovery differences between hospitals, which could lead to improved patient outcomes. The GEO-TBI: Incidence study collects data from all TBI patients that are admitted to participating hospitals or undergo a neurosurgical operation due to TBI during a 90-day period. This study looks at the patient's recovery at discharge using the Glasgow Outcome at Discharge Scale (GODS), and at the 2-week mortality. In addition, the study also evaluates recovery at the most recent follow-up timepoint. We hope that this information will enhance our understanding on the causes, treatments, and commonness of TBI. The study results will also help local hospitals compare their treatment results to an international standard.

Early surgery versus conservative treatment in patients with traumatic intracerebral hematoma: a CENTER-TBI study.

PURPOSE: Evidence regarding the effect of surgery in traumatic intracerebral hematoma (t-ICH) is limited and relies on the STITCH(Trauma) trial. This study is aimed at comparing the effectiveness of early surgery to conservative treatment in patients with a t-ICH. METHODS: In a prospective cohort, we included patients with a large t-ICH (< 48 h of injury). Primary outcome was the Glasgow Outcome Scale Extended (GOSE) at 6 months, analyzed with multivariable proportional odds logistic regression. Subgroups included injury severity and isolated vs. non-isolated t-ICH. RESULTS: A total of 367 patients with a large t-ICH were included, of whom 160 received early surgery and 207 received conservative treatment. Patients receiving early surgery were younger (median age 54 vs. 58 years) and more severely injured (median Glasgow Coma Scale 7 vs. 10) compared to those treated conservatively. In the overall cohort, early surgery was not associated with better functional outcome (adjusted odds ratio (AOR) 1.1, (95% CI, 0.6-1.7)) compared to conservative treatment. Early surgery was associated with better outcome for patients with moderate TBI and isolated t-ICH (AOR 1.5 (95% CI, 1.1-2.0); P value for interaction 0.71, and AOR 1.8 (95% CI, 1.3-2.5); P value for interaction 0.004). Conversely, in mild TBI and those with a smaller t-ICH (< 33 cc), conservative treatment was associated with better outcome (AOR 0.6 (95% CI, 0.4-0.9); P value for interaction 0.71, and AOR 0.8 (95% CI, 0.5-1.0); P value for interaction 0.32). CONCLUSIONS: Early surgery in t-ICH might benefit those with moderate TBI and isolated t-ICH, comparable with results of the STITCH(Trauma) trial.

Comparative effectiveness of decompressive craniectomy versus craniotomy for traumatic acute subdural hematoma (CENTER-TBI): an observational cohort study.

Background: Limited evidence existed on the comparative effectiveness of decompressive craniectomy (DC) versus craniotomy for evacuation of traumatic acute subdural hematoma (ASDH) until the recently published randomised clinical trial RESCUE-ASDH. In this study, that ran concurrently, we aimed to determine current practice patterns and compare outcomes of primary DC versus craniotomy. Methods: We conducted an analysis of centre treatment preference within the prospective, multicentre, observational Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (known as CENTER-TBI) and NeuroTraumatology Quality Registry (known as Net-QuRe) studies, which enrolled patients throughout Europe and Israel (2014-2020). We included patients with an ASDH who underwent acute neurosurgical evacuation. Patients with severe pre-existing neurological disorders were excluded. In an instrumental variable analysis, we compared outcomes between centres according to treatment preference, measured by the case-mix adjusted proportion DC per centre. The primary outcome was functional outcome rated by the 6-months Glasgow Outcome Scale Extended, estimated with ordinal regression as a common odds ratio (OR), adjusted for prespecified confounders. Variation in centre preference was quantified with the median odds ratio (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). Findings: Between December 19, 2014 and December 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI of whom 336 (7%) underwent acute surgery for ASDH evacuation; 91 (27%) underwent DC and 245 (63%) craniotomy. The proportion primary DC within total acute surgery cases ranged from 6 to 67% with an interquartile range (IQR) of 12-26% among 46 centres; the odds of receiving a DC for prognostically similar patients in one centre versus another randomly selected centre were trebled (adjusted median odds ratio 2.7, p < 0.0001). Higher centre preference for DC over craniotomy was not associated with better functional outcome (adjusted common odds ratio (OR) per 14% [IQR increase] more DC in a centre = 0.9 [95% CI 0.7-1.1], n = 200). Primary DC was associated with more follow-on surgeries and complications [secondary cranial surgery 27% vs. 18%; shunts 11 vs. 5%]; and similar odds of in-hospital mortality (adjusted OR per 14% IQR more primary DC 1.3 [95% CI (1.0-3.4), n = 200]). Interpretation: We found substantial practice variation in the employment of DC over craniotomy for ASDH. This variation in treatment strategy did not result in different functional outcome. These findings suggest that primary DC should be restricted to salvageable patients in whom immediate replacement of the bone flap is not possible due to intraoperative brain swelling. Funding: Hersenstichting Nederland for the Dutch NeuroTraumatology Quality Registry and the European Union Seventh Framework Program.

Neurosurgical treatment in elderly patients with Traumatic brain injury: A 20-year follow-up study.

Introduction: Traumatic brain injury in the elderly population can have a substantial impact on patients' quality of life. In this regard, successful treatment strategies are hard to define to date. Research question: In order to facilitate further insight, this study assessed outcomes following acute subdural hematoma evacuation in patients aged ≥65 years in a large patient series. Material and methods: A manual screening of the clinical records of 2999 TBI patients aged ≥65 years, admitted to the University Hospital Leuven (Belgium) between 1999 and 2019, was performed. Results: A total of 149 patients were identified with aSDH, of whom 32 underwent early surgery, 33 underwent delayed surgery and 84 were treated conservatively. Patients who underwent early surgery had the lowest median GCS, poorest Marshall CT scores, longest hospital and ICU stay, and highest intensive care unit admission and redo surgery rates. 30-d mortality was 21.9% in patients undergoing early surgery, 3.0% in patients undergoing late surgery and 16.7% in patients who were treated conservatively. Discussion and conclusion: In conclusion, patients in whom surgery could not be delayed had the worst presentation and poorest outcomes as opposed in patients in whom delay was possible. Surprisingly, patients treated conservatively had worse outcomes than those treated with delayed surgery. These results might indicate that if the GCS at admission is still adequate, an initial strategy of waiting and seeing might be associated with better outcomes. Future prospective studies with sufficient sample size are warranted to draw more definitive conclusions on the value of early vs. late surgery in elderly patients with aSDH.

Best practice rehabilitation pathway for the management of single and double-level lumbar fusion surgery: a modified Delphi Study.

BACKGROUND: There is limited evidence to guide the rehabilitation of patients following single or double-level lumbar fusion surgery (LFS). This is reflected in extensive variability in current rehabilitation regimes and subsequent low clinical success rates, which urges a call for a consensus rehabilitation pathway. AIM: To establish consensus on the optimal pre-, peri- and postoperative rehabilitation of LFS. DESIGN: A modified Delphi Study. SETTING: Belgium and the Netherlands. POPULATION: A multidisciplinary panel of 31 experts in the field of LFS and rehabilitation participated. Nine patients validated the consensus pathway. METHODS: A three-round online Delphi questionnaire was followed by an in-person consensus meeting. In each round, experts could suggest new statements, and received group summary statistics and feedback for reconsidered statements. Consensus threshold was set at ≥75% agreement. The resulting rehabilitation pathway was validated by patients through an online questionnaire and subsequent in-person focus group. RESULTS: A total of 31 experts participated in the first online round, with 27 (87%) completing all online rounds, and 17 (55%) attending the in-person consensus meeting. Consensus was reached on 122 statements relating to pre-, peri- and postoperative rehabilitation of LFS, and validated by patients. Key components of the rehabilitation pathway included prehabilitation, education, physiotherapy in every phase, early postoperative mobilization, and little movement restrictions. Patients emphasized the need for support during the return-to-work process. CONCLUSIONS: This process resulted in 122 expert-consensus statements on best practice rehabilitation for managing LFS, validated by patients. CLINICAL REHABILITATION IMPACT: The proposed rehabilitation pathway can serve as guidance to support clinicians, reduce practice variability, and subsequently improve clinical outcomes after LFS.

Long-term outcomes after traumatic brain injury in elderly patients on antithrombotic therapy.

INTRODUCTION: Elderly patients receiving antithrombotic treatment have a significantly higher risk of developing an intracranial hemorrhage when suffering traumatic brain injury (TBI), potentially contributing to higher mortality rates and worse functional outcomes. It is unclear whether different antithrombotic drugs carry a similar risk. OBJECTIVE: This study aims to investigate injury patterns and long-term outcomes after TBI in elderly patients treated with antithrombotic drugs. METHODS: The clinical records of 2999 patients ≥ 65 years old admitted to the University Hospitals Leuven (Belgium) between 1999 and 2019 with a diagnosis of TBI, spanning all injury severities, were manually screened. RESULTS: A total of 1443 patients who had not experienced a cerebrovascular accident prior to TBI nor presented with a chronic subdural hematoma at admission were included in the analysis. Relevant clinical information, including medication use and coagulation lab tests, was manually registered and statistically analyzed using Python and R. In the overall cohort, 418 (29.0%) of the patients were treated with acetylsalicylic acid before TBI, 58 (4.0%) with vitamin K antagonists (VKA), 14 (1.0%) with a different antithrombotic drug, and 953 (66.0%) did not receive any antithrombotic treatment. The median age was 81 years (IQR = 11). The most common cause of TBI was a fall accident (79.4% of the cases), and 35.7% of the cases were classified as mild TBI. Patients treated with vitamin K antagonists had the highest rate of subdural hematomas (44.8%) (p = 0.02), hospitalization (98.3%, p = 0.03), intensive care unit admissions (41.4%, p < 0.01), and mortality within 30 days post-TBI (22.4%, p < 0.01). The number of patients treated with adenosine diphosphate (ADP) receptor antagonists and direct oral anticoagulants (DOACs) was too low to draw conclusions about the risks associated with these antithrombotic drugs. CONCLUSION: In a large cohort of elderly patients, treatment with VKA prior to TBI was associated with a higher rate of acute subdural hematoma and a worse outcome, compared with other patients. However, intake of low dose aspirin prior to TBI did not have such effects. Therefore, the choice of antithrombotic treatment in elderly patients is of utmost importance with respect to risks associated with TBI, and patients should be counselled accordingly. Future studies will determine whether the shift towards DOACs is mitigating the poor outcomes associated with VKA after TBI.

Traumatic brain injury hospitalizations in Belgium: A brief overview of incidence, population characteristics, and outcomes.

Background: There is a need for complete and accurate epidemiological studies for traumatic brain injury (TBI). Secondary use of administrative data can provide country-specific population data across the full spectrum of disease. Aim: This study aims to provide a population-based overview of Belgian TBI hospital admissions as well as their health-related and employment outcomes. Methods: A combined administrative dataset with deterministic linkage at individual level was used to assess all TBI hospitalizations in Belgium during the year 2016. Discharge data were used for patient selection and description of injuries. Claims data represented the health services used by the patient and health-related follow-up beyond hospitalization. Finally, social security data gave insight in changes to employment situation. Results: A total of 17,086 patients with TBI were identified, with falls as the predominant cause of injury. Diffuse intracranial injury was the most common type of TBI and 53% had injuries to other body regions as well. In-hospital mortality was 6%. The median length of hospital stay was 2 days, with 20% being admitted to intensive care and 28% undergoing surgery. After hospitalization, 23% had inpatient rehabilitation. Among adults in the labor force pre-injury, 72% of patients with mild TBI and 59% with moderate-to-severe TBI returned to work within 1 year post-injury. Discussion: Administrative data are a valuable resource for population research. Some limitations need to be considered, however, which can in part be overcome by enrichment of administrative datasets with other data sources such as from trauma registries.

Surgery versus conservative treatment for traumatic acute subdural haematoma: a prospective, multicentre, observational, comparative effectiveness study.

BACKGROUND: Despite being well established, acute surgery in traumatic acute subdural haematoma is based on low-grade evidence. We aimed to compare the effectiveness of a strategy preferring acute surgical evacuation with one preferring initial conservative treatment in acute subdural haematoma. METHODS: We did a prospective, observational, comparative effectiveness study using data from participants enrolled in the Collaborative European Neurotrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) cohort. We included patients with no pre-existing severe neurological disorders who presented with acute subdural haematoma within 24 h of traumatic brain injury. Using an instrumental variable analysis, we compared outcomes between centres according to treatment preference for acute subdural haematoma (acute surgical evacuation or initial conservative treatment), measured by the case-mix-adjusted percentage of acute surgery per centre. The primary endpoint was functional outcome at 6 months as rated with the Glasgow Outcome Scale Extended, which was estimated with ordinal regression as a common odds ratio (OR) and adjusted for prespecified confounders. Variation in centre preference was quantified with the median OR (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). FINDINGS: Between Dec 19, 2014 and Dec 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI, of whom 1407 (31%) presented with acute subdural haematoma and were included in our study. Acute surgical evacuation was done in 336 (24%) patients, by craniotomy in 245 (73%) of those patients and by decompressive craniectomy in 91 (27%). Delayed decompressive craniectomy or craniotomy after initial conservative treatment (n=982) occurred in 107 (11%) patients. The percentage of patients who underwent acute surgery ranged from 5·6% to 51·5% (IQR 12·3-35·9) between centres, with a two-times higher probability of receiving acute surgery for an identical patient in one centre versus another centre at random (adjusted MOR for acute surgery 1·8; p<0·0001]). Centre preference for acute surgery over initial conservative treatment was not associated with improvements in functional outcome (common OR per 23·6% [IQR increase] more acute surgery in a centre 0·92, 95% CI 0·77-1·09). INTERPRETATION: Our findings show that treatment for patients with acute subdural haematoma with similar characteristics differed depending on the treating centre, because of variation in the preferred approach. A treatment strategy preferring an aggressive approach of acute surgical evacuation over initial conservative treatment was not associated with better functional outcome. Therefore, in a patient with acute subdural haematoma for whom a neurosurgeon sees no clear superiority for acute surgery over conservative treatment, initial conservative treatment might be considered. FUNDING: The Hersenstichting Nederland (also known as the Dutch Brain Foundation), the European Commission Seventh Framework Programme, the Hannelore Kohl Stiftung (Germany), OneMind (USA), Integra LifeSciences Corporation (USA), and NeuroTrauma Sciences (USA).

Traumatic brain injury in the elderly population: a 20-year experience in a tertiary neurosurgery center in Belgium.

PURPOSE: Traumatic brain injury (TBI) rates in the elderly population are rapidly increasing worldwide. However, there are no clinical guidelines for the treatment of elderly TBI to date. This study aims at describing injury patterns and severity, clinical management, and outcomes in elderly TBI patients, which may contribute to specific prognostic tools and clinical guidelines in the future. METHODS: Clinical records of 2999 TBI patients ≥ 65 years old admitted in the University Hospital Leuven (Belgium) between 1999 and 2019 were manually screened and 1480 cases could be included. Records were scrutinized for relevant clinical data. RESULTS: The median age in the cohort was 78.0 years (IQR = 12). Falls represented the main accident mechanism (79.7%). The median Glasgow Coma Score on admission was 15 (range 3-15). Subdural hematomas were the most common lesion (28.4%). 90.1% of all patients were hospitalized and 27.0% were admitted to intensive care. 16.4% underwent a neurosurgical intervention. 11.0% of all patients died within 30 days post-TBI. Among the 521 patients with mild TBI, 28.6% were admitted to ICU and 13.1% had a neurosurgical intervention and 30-day mortality was 6.9%. CONCLUSION: Over the 20-year study period, an increase of age and comorbidities and a reduction in neurosurgical interventions and ICU admissions were observed, along with a trend to less severe injuries but a higher proportion of treatment withdrawals, while at the same time mortality rates decreased. TBI is a life-changing event, leading to severe consequences in the elderly population, especially at higher ages. Even mild TBI is associated with substantial rates of hospitalization, surgery, and mortality in elderly. The characteristics of the elderly population with TBI are subject to changes over time.

Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design.

BACKGROUND: The rapidly increasing number of elderly (≥ 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDH METHODS: In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and a midline shift > 5 mm, or a GCS < 9 with a traumatic ASDH < 10 mm and a midline shift < 5 mm without extracranial explanation for the comatose state, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024. DISCUSSION: The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered. TRIAL REGISTRATION: Nederlands Trial Register (NTR), Trial NL9012 . CLINICALTRIALS: gov, Trial NCT04648436 .

Rehabilitation to improve outcomes of lumbar fusion surgery: a systematic review with meta-analysis.

PURPOSE: To evaluate the effectiveness of rehabilitation strategies on disability, pain, pain-related fear, and return-to-work in patients undergoing lumbar fusion surgery for degenerative conditions or adult isthmic spondylolisthesis. METHODS: Six electronic databases were systematically searched for randomized controlled trials (RCTs) evaluating the effect of rehabilitation (unimodal or multimodal). The estimated effect size was calculated for interventions with homogeneous content using a random-effects model. Certainty of evidence was assessed by GRADE. RESULTS: In total, 18 RCTs, including 1402 unique patients, compared specific rehabilitation to other rehabilitation strategies or usual care. Most described indications were degenerative disc disease and spondylolisthesis. All rehabilitation interventions were delivered in the postoperative period, and six of them also included a preoperative component. Intervention dose and intensity varied between studies (ranging from one session to daily sessions for one month). Usual care consisted mostly of information and postoperative mobilization. At short term, low quality of evidence shows that exercise therapy was more effective for reducing disability and pain than usual care (standardized mean difference [95% CI]: -0.41 [-0.71; -0.10] and -0.36 [-0.65; -0.08], four and five studies, respectively). Multimodal rehabilitation consisted mostly of exercise therapy combined with cognitive behavioral training, and was more effective in reducing disability and pain-related fear than exercise therapy alone (-0.31 [-0.49; -0.13] and -0.64 [-1.11; -0.17], six and four studies, respectively). Effects disappeared beyond one year. Rehabilitation showed a positive tendency towards a higher return-to-work rate (pooled relative risk [95% CI]: 1.30 [0.99; 1.69], four studies). CONCLUSION: There is low-quality evidence showing that both exercise therapy and multimodal rehabilitation are effective for improving outcomes up to six months after lumbar fusion, with multimodal rehabilitation providing additional benefits over exercise alone in reducing disability and pain-related fear. Additional high-quality studies are needed to demonstrate the effectiveness of rehabilitation strategies in the long term and for work-related outcomes.

Generalization of fear of movement-related pain and avoidance behavior as predictors of work resumption after back surgery: a study protocol for a prospective study (WABS).

BACKGROUND: Previous studies indicated that about 20% of the individuals undergoing back surgery are unable to return to work 3 months to 1 year after surgery. The specific factors that predict individual trajectories in postoperative pain, recovery, and work resumption are largely unknown. The aim of this study is to identify modifiable predictors of work resumption after back surgery. METHODS: In this multisite, prospective, longitudinal study, 300 individuals with radicular pain undergoing a lumbar decompression will be followed until 1-year post-surgery. Prior to surgery, participants will perform a computer task to assess fear of movement-related pain, avoidance behavior, and their generalization to novel situations. Before and immediately after surgery, participants will additionally complete questionnaires to assess fear of movement-related pain, avoidance behavior, optimism, expectancies towards recovery and work resumption, and the duration and severity of the pain. Six weeks, 3 months, 6 months, and 12 months after surgery, they will again complete questionnaires to assess sustainable work resumption, pain severity, disability, and quality of life. The primary hypothesis is that (generalization of) fear of movement-related pain and avoidance behavior will negatively affect sustainable work resumption after back surgery. Second, we hypothesize that (generalization of) fear of movement-related pain and avoidance behavior, negative expectancies towards recovery and work resumption, longer pain duration, and more severe pain before the surgery will negatively affect work resumption, pain severity, disability, and quality of life after back surgery. In contrast, optimism and positive expectancies towards recovery and work resumption are expected to predict more favorable work resumption, better quality of life, and lower levels of pain severity and disability after back surgery. DISCUSSION: With the results of this research, we hope to contribute to the development of strategies for early identification of risk factors and appropriate guidance and interventions before and after back surgery. Trial registration The study was preregistered on ClinicalTrials.gov: NCT04747860 on February 9, 2021.

Identifying new predictive factors for survival after surgery for spinal metastases: an exploratory in-depth retrospective analysis.

OBJECTIVES: In selected patients with symptomatic spinal metastasis from solid tumors, surgery improves quality of life. Since selection is key, inaccurate survival prognostication may result in poor decisions and outcomes. However, most prognostic scores suffer from suboptimal external validation and subsequent mediocre performance. This warrants the ongoing search for factors that better capture the oncological status. This exploratory study aims to identify new preoperative variables that predict survival. METHODS: A retrospective analysis was conducted on 62 patients from a tertiary care referral center who underwent debulking and/or reconstruction surgery for spinal metastases between 2006 and 2018, and in whom detailed clinical, oncological, surgical and biochemical variables were collected. Univariate and multivariate analyses were performed for overall survival. RESULTS: Median survival was 13.2 months. Multivariate analysis for overall survival identified that a higher number of organs with metastases, a shorter time to progression on the last line of systemic therapy before surgery (TTPbs), low serum albumin, high alkaline phosphatase, high C-reactive peptide (CRP), presence of brain metastasis and the index spinal level located in the cervical region were independently associated with shorter survival. CONCLUSION: We confirmed previously known predictors and identified CRP and TTPbs as new variables that were strongly associated with survival. The latter variable may replace primary tumor type, as improved cancer treatments make the primary tumor type less relevant as a predictor. This study is exploratory and its findings need to be validated, preferably in large prospective multicenter studies that are aiming at improving existing models.

Guidelines for Rehabilitation and Return to Play After Cervical Surgery in a General Athletic Population: A Delphi Analysis.

OBJECTIVE: Decisions concerning the rehabilitation process and return to play (RTP) after cervical spine surgery in a general sporting population can be difficult and may be influenced by several factors. Moreover, no clear guidelines for this are currently available. The aim of this study was to create tentative guidelines for rehabilitation and RTP after cervical surgery in a general sporting population. DESIGN: Five-step Delphi analysis. SETTINGS: Primary, secondary, and tertiary medical practitioners. PARTICIPANTS: Panel of Belgian neurosurgeons, orthopedic surgeons, physiotherapists, and physical and rehabilitation medicine practitioners. ASSESSMENT: Round 1 (R1) was a brainstorm phase. A comprehensive list of answers from R1 was validated in round 2 (R2). In round 3 (R3), experts ranked these items in a chronological order. Contraindications and criteria to start each rehabilitation step were linked in round 4 (R4). In round 5 (R5), panelists ranked theses about contraindications and criteria on a 5-point Likert scale. MAIN OUTCOME MEASURES: Theses scoring ≥10% "oppose" or "strongly oppose" were rejected. RESULTS: The response rate was 100% (n = 15) for R1, 93% (n = 14) for R2, 73% (n = 11) for R3, 53% (n = 8) for R4, and 67% (n = 10) for R5. In R5, 25 theses on absolute and relative contraindications and criteria were endorsed. CONCLUSIONS: This Delphi analysis resulted in contraindications and criteria for the rehabilitation process and RTP after cervical surgery in a general athletic population. Tentative guidelines and timetable are proposed. Key messages from these guidelines are (1) Rehabilitation should start before surgery with education; (2) Rehabilitation should be patient-tailored; and (3) An unstable arthrodesis is an absolute contraindication for RTP.

How good are the outcomes of instrumented debulking operations for symptomatic spinal metastases and how long do they stand? A subgroup analysis in the global spine tumor study group database.

BACKGROUND: The benefits of surgery for symptomatic spinal metastases have been demonstrated, largely based on series of patients undergoing debulking and instrumentation operations. However, as cancer treatments improve and overall survival lengths increase, the incidence of recurrent spinal cord compression after debulking may increase. The aim of the current paper is to document the postoperative evolution of neurological function, pain, and quality of life following debulking and instrumentation in the Global Spine Tumor Study Group (GSTSG) database. METHODS: The GSTSG database is a prospective multicenter data repository of consecutive patients that underwent surgery for a symptomatic spinal metastasis. For the present analysis, patients were selected from the database that underwent decompressive debulking surgery with instrumentation. Preoperative tumor type, Tomita and Tokuhashi scores, EQ-5D, Frankel, Karnofsky, and postoperative complications, survival, EQ-5D, Frankel, Karnofsky, and pain numeric rating scores (NRS) at 3, 6, 12, and 24 months were analyzed. RESULTS: A total of 914 patients underwent decompressive debulking surgery with instrumentation and had documented follow-up until death or until 2 years post surgery. Median preoperative Karnofsky performance index was 70. A total of 656 patients (71.8%) had visceral metastases and 490 (53.6%) had extraspinal bone metastases. Tomita scores were evenly distributed above (49.1%) and below or equal to 5 (50.9%), and Tokuhashi scores almost evenly distributed below or equal to 8 (46.3%) and above 8 (53.7%). Overall, 12-month survival after surgery was 56.3%. The surgery resulted in EQ-5D health status improvement and NRS pain reduction that was maintained throughout follow-up. Frankel scores improved at first follow-up in 25.0% of patients, but by 12 months neurological deterioration was observed in 18.8%. CONCLUSION: We found that palliative debulking and instrumentation surgeries were performed throughout all Tomita and Tokuhashi categories. These surgeries reduced pain scores and improved quality of life up to 2 years after surgery. After initial improvement, a proportion of patients experienced neurological deterioration by 1 year, but the majority of patients remained stable.

The pivotal role for the multidisciplinary approach at all phases and at all levels in the national pathway for the management of low back pain and radicular pain in Belgium.

INTRODUCTION: High level evidence on management of spinal disorders is scarce, which results in guidelines being of limited practical use for practitioners. Care pathways are complex interventions intended for the mutual decision making of organization of care processes for a well-defined group of patients. The goal of this project was to design a pathway for the management of low back pain and radicular pain for national implementation in Belgium. EVIDENCE ACQUISITION: An international and Belgian study on characteristics of low back pain care pathways was performed along with a literature study and focus group interrogation. Based on essential building elements identified and a consensus approach among all relevant stakeholders in primary, hospital and reintegration care, a national pathway was constructed. The process was endorsed by the Belgian Health Care Knowledge Center, Belgian National Institute of Health and Disability Insurance and the Spine Society of Belgium. EVIDENCE SYNTHESIS: Eleven international pathways were identified, varying in implementation width from hospital-based to region/province-based. Seven Belgian pathway initiatives were detected. Notwithstanding differences, consistent building elements were identified. Three groups of caregivers, divided in primary care, hospital care and reintegration and including all relevant medical/paramedical disciplines, worked on integrating the essential building elements into a single concrete patient pathway of direct use to any caregiver and patient and based on a consensus model including reference to the 2017 Belgian adaptation of the 2016 NICE guidelines. The resulting pathways on management of low back pain and radicular pain underpin the importance of multidisciplinary teamwork. CONCLUSIONS: Essential building elements were identified from literature and established pathways and were successfully integrated in a Belgian national low back pain and radicular pain pathway using an integrative consensus approach. The pathways are consultable at www.lowbackpain.kce.be.

Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe.

INTRODUCTION: Controversy exists about the optimal treatment for patients with a traumatic acute subdural haematoma (ASDH) and an intracerebral haematoma/contusion (t-ICH). Treatment varies largely between different regions. The effect of this practice variation on patient outcome is unknown. Here, we present the protocol for a prospective multicentre observational study aimed at comparing the effectiveness of different treatment strategies in patients with ASDH and/or t-ICH. Specifically, the aims are to compare (1) an acute surgical approach to an expectant approach and (2) craniotomy to decompressive craniectomy when evacuating the haematoma. METHODS AND ANALYSIS: Patients presenting to the emergency room with an ASDH and/or an t-ICH are eligible for inclusion. Standardised prospective data on patient and injury characteristics, treatment and outcome will be collected on 1000 ASDH and 750 t-ICH patients in 60-70 centres within two multicentre prospective observational cohort studies: the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) and Neurotraumatology Quality Registry (Net-QuRe). The interventions of interest are acute surgery, defined as surgery directly after the first CT at presentation versus late or no surgery and craniotomy versus decompressive craniectomy. The primary outcome measure is the Glasgow Outcome Score-Extended at 6 months. Secondary outcome measures include in-hospital mortality, quality of life and neuropsychological tests. In the primary analysis, the effect of treatment preference (eg, proportion of patients in which the intervention under study is preferred) per hospital will be analysed with random effects ordinal regression models, adjusted for casemix and stratified by study. Such a hospital-level approach reduces confounding by the indication. Sensitivity analyses will include propensity score matching, with treatment defined on patient level. This study is designed to determine the best acute management strategy for ASDH and t-ICH by exploiting the existing between-hospital variability in surgical management. ETHICS AND DISSEMINATION: Ethics approval was obtained in all participating countries. Results of surgical management of ASDH and t-ICH/contusion will separately be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02210221 and NL 5761.