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Development and validation of two clinical prediction models to inform clinical decision-making for lumbar spinal fusion surgery for degenerative disorders and rehabilitation following surgery: Protocol for a prospective observational study
Introduction Potential predictors of poor outcome will be measured at baseline: (1) preoperatively to develop a clinical prediction model to predict which patients are likely to have favourable outcome following lumbar spinal fusion surgery (LSFS) and (2) postoperatively to predict which patients are likely to have favourable long-term outcomes (to inform rehabilitation). Methods and analysis Prospective observational study with a defined episode inception of the point of surgery. Electronic data will be collected through the British Spine Registry and will include patient-reported outcome measures (eg, Fear-Avoidance Beliefs Questionnaire) and data items (eg, smoking status). Consecutive patients (≥18 years) undergoing LSFS for back and/or leg pain of degenerative cause will be recruited. Exclusion criteria: LSFS for spinal fracture, inflammatory disease, malignancy, infection, deformity and revision surgery. 1000 participants will be recruited (n=600 prediction model development, n=400 internal validation derived model; planning 10 events per candidate prognostic factor). The outcome being predicted is an individual’s absolute risk of poor outcome (disability and pain) at 6 weeks (objective 1) and 12 months postsurgery (objective 2). Disability and pain will be measured using the Oswestry Disability Index (ODI), and severity of pain in the previous week with a Numerical Rating Scale (NRS 0–10), respectively. Good outcome is defined as a change of 1.7 on the NRS for pain, and a change of 14.3 on the ODI. Both linear and logistic (to dichotomise outcome into low and high risk) multivariable regression models will be fitted and mean differences or ORs for each candidate predictive factor reported. Internal validation of the derived model will use a further set of British Spine Registry data. External validation will be geographical using two spinal registries in The Netherlands and Switzerland. Ethics and dissemination Ethical approval (University of Birmingham ERN_17-0446A). Dissemination through peer-reviewed journals and conferences.
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... The FACS contains 20 separate items that are scored from 0 ("completely disagree") to 5 ("completely agree"), with a total possible score of 100. Five severity levels are available for clinical interpretation: subclinical (0-20), mild (21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40), moderate (41)(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60), severe (61-80), and extreme (81-100) . ...
... Also, subgroup classification of patient with chronic LBP are available, based on a multifactorial approach, including psychological factors such as anxiety, depression, functional disability, pain, and FA beliefs . Even clinical prediction models to inform clinical decision-making after some type of surgery are being developed, which includes FA . Hence, FA assessment is crucial to guide treatment in primary care. ...
Background: Pain-related fear-avoidance (FA) is a common problem affecting many patients with painful medical conditions. As there is great interest in the clinical importance of the relationship between FA and disability, several questionnaires have been developed to measure FA. The Fear-Avoidance Components Scale (FACS) is a recently developed patient-reported instrument that addresses critical issues not previously considered in previous FA-related questionnaires. The original English version of the FACS demonstrated good reliability, internal consistency, and construct, criterion, and predictive validity. Two factors were determined: General Fear Avoidance and Types of Activities That are Avoided. The aim of this study was to to translate the FACS into European-style Spanish (FACS-Sp), and validate its psychometric properties. Methods: This two-stage psychometric study included 330 subjects with various chronic musculoskeletal pain disorders. An initial translation and cross-cultural adaptation of the FACS, from English to Spanish, was performed. Then, critical psychometric properties were analysed, including internal consistency by Cronbach's α coefficients, structural validity from the Maximum Likelihood Extraction (MLE), and convergent validity by Pearson correlation with the Central Sensitization Inventory (CSI). Results: This study reports for the first time the psychometric properties of the Spanish version of the FACS. Total scores ranged from 0 to 88 points, with a mean of 30.49 (±17.18). The FACS-Sp showed a high internal consistency for factor 1 (α = 0.902) and factor 2 (α = 0.88). Factor structure was two-dimensional and supported structural validity, accounting for 48.75% of the total variance. Convergent validity analysis found a significant Pearson correlation r = 0.414. Conclusion: This study reports for the first time the psychometric properties of the Spanish version of the FACS-Sp. Psychometric properties supported the validation of FACS-Sp and ensured the conceptual equivalence with the original English version. In primary care and chronic pain rehabilitation, FA assessment is crucial for clinical decision-making and treatment guidance. The FACS-Sp offers a new measure of FA in Spanish speaking populations. Future research on the FACS-Sp should evaluate test-retest reliability, treatment responsiveness and psychometric comparisons with other translated versions.
... There is a model for predicting outcome of total knee arthroplasty albeit with only partial support for its external validity. 21,82 Also, a decision support tool for spinal fusion surgery is being developed, 85 but there is no evidence yet that implementation of risk stratification on the basis of these 2 approaches does actually improve patient outcomes. There is evidence that the STarT Back Screening Tool, which was developed for primary care, is not useful for predicting outcomes in secondary care settings, 52,65 but stratified care for LBP (matched treatment to risk profiles) has not been investigated in secondary care settings. ...
The overall quality of care for musculoskeletal pain conditions is suboptimal, partly due to a considerable evidence-practice gap. In osteoarthritis and low back pain, structured models of care exist to help overcome that challenge. In osteoarthritis, focus is on stepped care models, where treatment decisions are guided by response to treatment, and increasingly comprehensive interventions are only offered to people with inadequate response to more simple care. In low back pain, the most widely known approach is based on risk stratification, where patients with higher predicted risk of poor outcome are offered more comprehensive care. For both conditions, the recommended interventions and models of care share many commonalities and there is no evidence that one model of care is more effective than the other. Limitations of existing models of care include a lack of integrated information on social factors, comorbid conditions, and previous treatment experience, and they do not support an interplay between health care, self-management, and community-based activities. Moving forwards, a common model across musculoskeletal conditions seems realistic, which points to an opportunity for reducing the complexity of implementation. We foresee this development will use big data sources and machine-learning methods to combine stepped and risk-stratified care and to integrate self-management support and patient-centred care to a greater extent in future models of care.
Purpose This study aims to evaluate the potential of C-reactive protein to lymphocyte count ratio (CLR) for the prediction of surgical site infection (SSI) following posterior lumbar interbody fusion (PLIF) and the instrumentation of lumbar degenerative diseases. Methods In this retrospective study, we considered patients with a lumbar degenerative disease diagnosis surgically treated by the instrumented PLIF procedure from 2015 to 2021. Patient data, including postoperative early SSI and other perioperative variables, were collected from their respective hospitalization electronic medical records. The receiver operator characteristic curve was constructed to determine the optimal cut-off value for CLR, and the ability to predict SSI was evaluated by the area under the curve (AUC). According to the cut-off value, patients were dichotomized with high- or low-CLR, and between-group differences were compared using univariate analysis. The independent impact of CLR on predicting SSI was investigated by multivariate logistics regression analysis. Results A total of 773 patients were included, with 26 (3.4%) developing an early SSI post-operation. The preoperative CLR was 11.1 ± 26.1 (interquartile range, 0.4–7.5), and the optimal cut-off was 2.1, corresponding to a sensitivity of 0.856, a specificity of 0.643, and an AUC of 0.768 (95% CI, 0.737–0.797). CLR demonstrated a significantly improved prediction ability than did lymphocyte count ( P = 0.021) and a similar ability to predict an infection as C-response protein ( P = 0.444). Patients with a high CLR had a significantly higher SSI incidence than those with a low CLR (7.6% vs. 0.8%, P < 0.001). After adjustment for numerous confounding factors, CLR ≥ 2.1 was associated with an 11.16-fold increased risk of SSI, along with other significant variables, i.e., diabetes, preoperative waiting time, and surgical duration. Conclusion A high CLR exhibited an improved ability to predict incident SSI and was associated with a substantially increased risk of SSI following instrumented PLIF. After better-design studies verified this finding, CLR could potentially be a beneficial tool in surgical management.
Identification of novel markers would contribute to the individualised risk assessment and development of a risk prediction model. This study aimed to investigate the role of the C‐reactive protein to albumin ratio (CAR) in predicting surgical site infection (SSI) following instrumented posterior lumbar interbody fusion (PLIF) of lumbar degenerative diseases. This study enrolled patients who underwent PLIF and instrumentation for treatment of lumbar degenerative diseases between 2015 and 2020. Electronic medical records were inquired for data collection, with follow‐up register for identifying SSI cases. The optimal cut‐off for CAR was determined by constructing the receiver operator characteristic (ROC) curve. Patients with high‐ or low‐CAR value were compared using the univariate analyses, and the association between CAR and the risk of SSI was investigated using multivariate logistics regression analysis. A total of 905 patients were enrolled, twenty‐nine (3.2%) had developed an SSI with 72.4% occurring during index hospitalisation, and 11 (1.2%) had deep and 18 (2.0%) superficial SSIs. An SSI was associated with additional 10.7 days of index total hospital stay (P = .001). The CAR was 0–5.43 (median, 0.05), and the optimal cut‐off was 0.09 and area under the curve was 0.720 (P < .001). 336 (37.1%) patients had a CAR ≥0.09 and 22 (6.5%) developed an SSI, with a crude risk of 5.6 relative to those with a low CAR. The multivariate analyses showed CAR ≥0.09 was associated with 8.06‐fold increased risk of SSI, together with diabetes (P = .018), while hypertension was identified as a protective factor (OR, 0.34; 95%CI, 0.11–1.00, P = .049). High CAR is found to significantly predict the incident SSI following instrumented PLIF of lumbar degenerative diseases, and can be considered as a useful index in practice only after it is verified by future high‐level evidences.
Introduction Urolithiasis affects many people throughout their lives. Among the maternal population, although the morbidity of acute urolithiasis in pregnant women is unremarkable, it is the leading cause of hospitalisation during pregnancy. There is no effective clinical diagnostic tool to help doctors diagnose diseases. Our primary aim was to develop and validate a clinical prediction model based on statistical methods to predict the probability of having disease in pregnant women who visited the emergency department because of urolithiasis-induced colic. Methods and analysis We will use multivariate logistic regression analysis to build a multivariate regression linear model. A receiver operating characteristic curve plot and calibration plot will be used to measure the discrimination value and calibration value of the model, respectively. We will also use least absolute shrinkage and selection operator regression analysis combined with logistic regression analysis to select predictors and construct the multivariate regression model. The model will be simplified to an application that has been reported before, and users will only need to enter their clinical parameters so that risk probability is automatically derived. Ethics and dissemination The review and approval documents of the clinical research ethics committee have been received from the ethics committee of our hospital (The Third Affiliated Hospital of Wenzhou Medical University). We will disseminate research findings through presentations at scientific conferences and publication in peer-reviewed journals.
Background: In 2014, inpatient spinal fusion surgery had the highest aggregate cost of any inpatient surgery performed in the United States, costing 12 billion dollars. As the national health care system seeks to improve value-based care, there is increased motivation to perform surgery on an outpatient basis. To ensure improved patient outcomes with this transition, patient selection has become increasingly important to identify who would most benefit from outpatient spine fusion, for example. This demands an improved understanding of the demographics of patients who have been receiving outpatient spine fusion on which the spine surgery community can build to improve cost-effective care delivered. Methods: The Healthcare Cost and Utilization Project, State Ambulatory Surgery Databases, and Agency for Healthcare Research and Quality databases were queried for demographic data regarding all-cause outpatient spine surgery between 2012 and 2014. Outpatient surgery volume was compared with inpatient surgery volume-which was provided by the State Inpatient Databases. Results: A total of 1,164,040 spine fusion procedures were identified between 2012 and 2014, of which 132,900 procedures were performed as outpatient surgery (11.4%). Of all fusion procedures amongst 18- to 44-year-old patients, 18.4% were outpatient. A larger proportion of white patients, rather than black or Hispanic patients, underwent ambulatory procedures (12.14% vs 9.53% vs 7.46%, respectively); 16.54% of spinal fusion procedures for patients with private insurance was performed on an outpatient basis. Based on patient income, 76% of all outpatient fusions were performed on patients who live in "not low" income ZIP codes. Conclusions: There has been a gradual trend toward performing more outpatient spinal fusion procedures over the studied period. This study has also revealed unique trends in the demographics of patients who have received outpatient spine fusion during this time. Level of evidence: 3.
Purpose of review: The purpose of this systematic review is to evaluate the current literature in patients undergoing spine surgery in the cervical, thoracic, and lumbar spine to determine the available risk assessment tools to predict the patient-centered outcomes of pain, disability, physical function, quality of life, psychological disposition, and return to work after surgery. Recent findings: Risk assessment tools can assist surgeons and other healthcare providers in identifying the benefit-risk ratio of surgical candidates. These tools gather demographic, medical history, and other pertinent patient-reported measures to calculate a probability utilizing regression or machine learning statistical foundations. Currently, much is still unknown about the use of these tools to predict quality of life, disability, and other factors following spine surgery. A systematic review was conducted using PRISMA guidelines that identified risk assessment tools that utilized patient-reported outcome measures as part of the calculation. From 8128 identified studies, 13 articles met inclusion criteria and were accepted into this review. The range of c-index values reported in the studies was between 0.63 and 0.84, indicating fair to excellent model performance. Post-surgical patient-reported outcomes were identified in the following categories (n = total number of predictive models): return to work (n = 3), pain (n = 9), physical functioning and disability (n = 5), quality of life (QOL) (n = 6), and psychosocial disposition (n = 2). Our review has synthesized the available evidence on risk assessment tools for predicting patient-centered outcomes in patients undergoing spine surgery and described their findings and clinical utility.
Introduction Postoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery. Methods and analysis This is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage. Ethics and dissemination The study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases. Trial registration number ChiCTR1900025069; Pre-results.
Study design: Systematic review with meta-analysis. Objective: To conduct a systematic review and meta-analysis of current evidence evaluating the effectiveness of rehabilitation following lumbar fusion surgery (LFS). Summary of background data: LFS for the management of lower back pain, with(out) neurogenic leg pain, is increasing as the population ages. Clinical outcomes commonly lag behind surgical outcomes and 40% of patients experience significant back related disability 12 months after LFS. Identifying rehabilitation strategies to improve function and quality of life following LFS is important. Methods: A systematic review of databases were searched, including MEDLINE, CINAHL and grey literature. Studies identified were screened for inclusion by title and abstract. Full text of eligible/potentially eligible studies were evaluated against predetermined eligibility criteria. Included studies were subjected to critical appraisal and risk of bias evaluation. The GRADE approach to quality of evidence was utilised. A meta-analysis comparing usual care with 'complex rehabilitation', comprising exercise and cognitive behavioural therapy, for outcomes relating to pain, disability, fear of movement and mental health was conducted at short and longer term (<3 and >12 months post-surgery) time points. Results: Three studies were identified for the systematic review and two included in the meta-analysis (n = 237, female = 62%, mean age = 55). Low quality evidence suggests 'complex rehabilitation' provides short term improvement in disability (effect size, -0.85, 95% CI, -1.41, -0.29) and fear avoidance behaviour (-1.07, 95% CI -1.33, -0.80), compared with usual care. Low quality evidence exists favouring 'complex rehabilitation' over usual care for longer term disability (-0.84, 95% CI -1.11, -0.58) and fear avoidance behaviour (-1.40, 95% CI -1.69 to -1.12). Conclusions: A small number of low quality studies suggest 'complex rehabilitation' reduces short and long term disability and fear avoidance behaviour following LFS. More, high quality research is required to confirm the effectiveness of 'complex rehabilitation' programs. Level of evidence: 1.
The TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) Statement includes a 22-item checklist, which aims to improve the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. This explanation and elaboration document describes the rationale; clarifies the meaning of each item; and discusses why transparent reporting is important, with a view to assessing risk of bias and clinical usefulness of the prediction model. Each checklist item of the TRIPOD Statement is explained in detail and accompanied by published examples of good reporting. The document also provides a valuable reference of issues to consider when designing, conducting, and analyzing prediction model studies. To aid the editorial process and help peer reviewers and, ultimately, readers and systematic reviewers of prediction model studies, it is recommended that authors include a completed checklist in their submission. The TRIPOD checklist can also be downloaded from www.tripod-statement.org.
Object: The purpose of this study was to quantify the perioperative outcomes, complications, and costs associated with posterolateral spinal fusion (PSF) among Medicare enrollees with lumbar spinal stenosis (LSS) and/or spondylolisthesis by using a national Medicare claims database. Methods: A 5% systematic sample of Medicare claims data (2005-2009) was used to identify outcomes in patients who had undergone PSF for a diagnosis of LSS and/or spondylolisthesis. Patients eligible for study inclusion also required a minimum of 2 years of follow-up and a claim history of at least 12 months prior to surgery. Results: A final cohort of 1672 patients was eligible for analysis. Approximately half (50.7%) had LSS only, 10.2% had spondylolisthesis only, and 39.1% had both LSS and spondylolisthesis. The average age was 71.4 years, and the average length of stay was 4.6 days. At 3 months and 1 and 2 years postoperatively, the incidence of spine reoperation was 10.9%, 13.3%, and 16.9%, respectively, whereas readmissions for complications occurred in 11.1%, 17.5%, and 24.9% of cases, respectively. At 2 years postoperatively, 36.2% of patients had either undergone spine reoperation and/or received an epidural injection. The average Medicare payment was $36,230 ± $17,020, $46,840 ± $31,350, and $61,610 ± $46,580 at 3 months, 1 year, and 2 years after surgery, respectively. Conclusions: The data showed that 1 in 6 elderly patients treated with PSF for LSS or spondylolisthesis underwent reoperation on the spine within 2 years of surgery, and nearly 1 in 4 patients was readmitted for a surgery-related complication. These data highlight several potential areas in which improvements may be made in the effective delivery and cost of surgical care for patients with spinal stenosis and spondylolisthesis.
OBJECTIVE Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis. METHODS The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen’s effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO. RESULTS A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3–26.5 points for ODI, 0.04–0.3 points for EQ-5D, 0.6–4.5 points for NRS-LP, and 0.5–4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort. CONCLUSIONS The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.
The present study investigates outcomes in patients undergoing elective primary, versus revision fusion surgery for lumbar degenerative pathologies using a large population based database. 126,044 patients registered in the National Inpatient Sample (NIS) database were identified to have undergone elective fusion of the lumbar spine (Primary fusion: 94%; redo fusion: 6%) for degenerative pathologies, between 2002-2011. A multivariable logistic regression model was built adjusting for patient demographics, clinical and hospital characteristics to explore clinical outcomes and postoperative complications. The mean age of the cohort was 54.91 ± 13.98 years, and 58% were female. Multivariable regression analysis revealed patients undergoing redo lumbar fusion had a higher likelihood for an unfavorable discharge (OR:1.17; 95% CI:1.08-1.26; p<0.0001), prolonged length of stay (OR:1.80; 95% CI:1.68-1.92; p<0.0001), higher hospital charges (OR:1.60; 95% CI:1.51-1.71; p<0.0001), neurologic complications including dural tears and nerve root injuries (OR:2.06; 95% CI:1.80-2.37; p<0.0001), deep venous thrombosis (OR:2.35; 95% CI:1.76-3.14; p<0.0001), pulmonary embolism (OR:1.72; 95% CI:1.45-2.03; p<0.0001), would infections (OR:2.40; 95% CI:1.79-3.22; p<0.0001) and wound complications (OR:1.59; 95% CI:1.32-1.91; p<0.0001), and gastrointestinal complications (OR:1.23; 95% CI:1.04-1.45; p=0.016), compared to patients undergoing a primary lumbar fusion procedure. The association of a likely post-operative complication in patients undergoing revision lumbar spine fusion compared to those undergoing primary fusion procedures at the same region of the spine is quantified. Our analysis provides baseline estimates that could aid in preoperative risk stratification and as an adjunct in patient education and counseling, and policy makers for higher reimbursements for these sicker patients. Copyright © 2015 Elsevier Inc. All rights reserved.
To ascertain current surgeon practice in the United Kingdom National Health Service for the management of patients undergoing lumbar spinal fusion surgery. Descriptive survey methodology utilised an online questionnaire administered through SurveyMonkey. Eligible participants were all surgeons currently carrying out lumbar spinal fusion surgery in the National Health Service. Two previous surveys and a recent systematic review informed questions. Statistical analyses included responder characteristics and pre-planned descriptive analyses. Open question data were interpreted using thematic analysis. The response rate was 73.8%. Most surgeons (84%) were orthopaedic surgeons. Range of surgeon experience (1-15 years), number of operations performed in the previous 12 mo (4-250), and range of information used to predict outcome was broad. There was some consistency of practice: most patients were seen preoperatively; all surgeons ensured patients are mobile within 3 d of surgery; and there was agreement for the value of post-operative physiotherapy. However, there was considerable variability of practice: variability of protocols, duration of hospital stay, use of discharge criteria, frequency and timing of outpatient follow up, use of written patient information and outcome measures. Much variability was explained through patient-centred care, for example, 62% surgeons tailored functional advice to individual patients. Current United Kingdom surgeon practice for lumbar spinal fusion is described. The surgical procedure and patient population is diverse, and it is therefore understandable that management varies. It is evident that care should be patient-centred. However with high costs and documented patient dissatisfaction it is important that further research evaluates optimal management.
Study design: Descriptive survey methodology employed a SurveyMonkey online questionnaire. Objective: To evaluate UK National Health Service physiotherapy practice for lumbar spinal fusion surgery. Summary of background data: An increasing rate of surgery and high level of patient dis-satisfaction focus attention to rehabilitation of patients undergoing lumbar spinal fusion. Inconclusive, very low-quality evidence for the effectiveness of physiotherapy management after lumbar spinal fusion exists. Best practice, therefore, remains unclear. Limited comparability of outcomes and retrieval of only 2 trials reflected a lack of research and considerable heterogeneity. An evaluation of current practice is required, to inform a future trial to evaluate a best practice physiotherapy intervention. Methods: Eligible participants were all physiotherapists working with patients undergoing spinal fusion. A previous survey and recent systematic review informed questions. Statistical analyses included responder characteristics and preplanned descriptive analyses. Thematic analysis was conducted on open-ended question data. Results: The 83.5% response rate was good. Findings illustrated varied provision relating to assessment and management of patients pre- and postoperatively. Physiotherapists employed limited use of protocols or guidelines, partly attributed to the poor evidence base for this surgery. Scope of practice included exercise, advice, listing for surgery, and ordering investigations. Patient education played an important role. Patient-centered practice was important, although constraints owing to limited resources (staffing, poor evidence, base/lack of protocols) were evident. Conclusion: Current UK pre- and postoperative physiotherapy practice for lumbar spinal fusion is described. It is not clear whether patients who are seen by physiotherapists have improved outcomes, owing to variability of practice, physiotherapy being delivered in a range of locations at a range of times postoperatively, and limited use of outcome measures. The findings support the need for a randomized clinical trial evaluating effectiveness of a best practice physiotherapy management intervention. Level of evidence: 3.
Systematic review and meta-analysis of randomized controlled trials (RCTs). To evaluate the current evidence comparing lumbar fusion to non-operative management for the treatment of chronic discogenic low back pain. Discogenic low back pain is a common and sometimes disabling condition. When the condition becomes chronic and intractable, spinal fusion may play a role. A systematic review of the literature was conducted using the PubMed and CENTRAL databases. We included RCTs that compared lumbar fusion to non-operative management for the treatment of adult patients with chronic discogenic low back pain. A meta-analysis was conducted to assess the improvement in back pain based on the ODI. Five RCTs met our inclusion criteria. A total of 707 patients were divided into lumbar fusion (n=523) and conservative management (n=134). Although inclusion/exclusion criteria were relatively similar across studies, surgical techniques and conservative management protocols varied. The pooled mean difference in ODI (final ODI minus initial ODI) between the non-operative and lumbar fusion groups across all studies was -7.39 points [95% CI: -20.26, 5.47] in favor of lumbar fusion, but this difference was not statistically significant (P=0.26). Despite the significant improvement in ODI in the lumbar fusion groups in three studies, pooled data revealed no significant difference when compared to the non-operative group. Although there was an overall improvement of 7.39 points in the ODI in favor of lumbar fusion, it is unclear that this change in ODI would lead to a clinically significant difference. Prospective randomized trials comparing a specific surgical technique versus a structured physical therapy program may improve evidence quality. Until then, either operative intervention via lumbar fusion or non-operative management and physical therapy remain two acceptable treatment methods for intractable low back pain.
Chronic low back pain (cLBP) represents a major challenge to our health care systems. The relative efficacy of surgery over nonoperative treatment for the treatment of cLBP remains controversial, and little is known of the long-term comparative outcomes. To compare the clinical outcome at long-term follow-up (LTFU) of patients who were randomized with either spinal fusion or multidisciplinary cognitive-behavioral and exercise rehabilitation for cLBP. Long-term clinical follow-up of three multicenter randomized controlled trials (RCTs) of surgery (instrumented or noninstrumented fusion, stabilization) versus nonoperative treatment (multidisciplinary cognitive-behavioral and exercise rehabilitation) in Norway and the United Kingdom. A total of 473 patients with cLBP of at least 1 year's duration who were all considered candidates for spinal fusion. The primary outcome was the Oswestry Disability Index (ODIv2.1a for the United Kingdom and ODIv1 for Norway) score measured at LTFU. Secondary outcomes included visual analog scale (VAS) pain intensity, pain frequency, pain medication use, work status, EuroQol VAS for health-related quality of life, satisfaction with care, and global treatment outcome at LTFU. Patients who consented to LTFU (average 11.4 [range 8-15] years after the initial treatment) completed the outcome questionnaires. Of 473 enrolled patients, 261 (55%) completed LTFU, 140/242 patients randomized to receive surgery and 121/231 randomized to receive multidisciplinary cognitive-behavioral and exercise rehabilitation. The intention-to-treat analysis showed no statistically or clinically significant differences between treatment groups for ODI scores at LTFU (adjusted for baseline ODI, previous surgery, duration of LBP, sex, age, and smoking habit): the mean adjusted treatment effect of fusion was -0.7 points on the 0-100 ODI scale (95% confidence interval [CI], -5.5 to 4.2). An as-treated analysis similarly demonstrated no advantage of surgery (treatment effect, -0.8 points on the ODI (95% CI, -5.9 to 4.3). The results for the secondary outcomes were largely consistent with those of the ODI, showing no relevant group differences. After an average of 11 years follow-up, there was no difference in patient self-rated outcomes between fusion and multidisciplinary cognitive-behavioral and exercise rehabilitation for cLBP. The results suggest that, given the increased risks of surgery and the lack of deterioration in nonoperative outcomes over time, the use of lumbar fusion in cLBP patients should not be favored in health care systems where multidisciplinary cognitive-behavioral and exercise rehabilitation programmes are available.