Methodological considerations in calculating the minimal clinically important change score for the core outcome measures index (COMI): insights from a large single-centre spine surgery registry.

INTRODUCTION: The Minimal Clinically Important Change (MCIC) is used in conjunction with Patient-Reported Outcome Measures (PROMs) to determine the clinical relevance of changes in health status. MCIC measures a change within the same person or group over time. This study aims to evaluate the variability in computing MCIC for the Core Outcome Measure Index (COMI) using different methods. METHODS: Data from a spine centre in Switzerland were used to evaluate variations in MCIC for the COMI score. Distribution-based and anchor-based methods (predictive and nonpredictive) were applied. Bayesian bootstrap estimated confidence intervals. RESULTS: From 27,003 cases, 9821 met the inclusion criteria. Distribution-based methods yielded MCIC values from 0.4 to 1.4. Anchor-based methods showed more variability, with MCIC values from 1.5 to 4.9. Predictive anchor-based methods also provided variable MCIC values for improvement (0.3-2.4), with high sensitivity and specificity. DISCUSSION: MCIC calculation methods produce varying values, emphasizing careful method selection. Distribution-based methods likely measure minimal detectable change, while non-predictive anchor-based methods can yield high MCIC values due to group averaging. Predictive anchor-based methods offer more stable and clinically relevant MCIC values for improvement but are affected by prevalence and reliability corrections.

Patient-reported outcome of lumbar decompression with instrumented fusion for low-grade spondylolisthesis: influence of pathology and baseline symptoms.

INTRODUCTION: Low-grade isthmic and degenerative spondylolisthesis (DS) of the lumbar spine are distinct pathologies but both can be treated with lumbar decompression with fusion. In a very large cohort, we compared patient-reported outcome in relation to the pathology and chief complaint at baseline. METHODS: This was a retrospective analysis using the EUROSPINE Spine Tango Registry. We included 582 patients (age 60 ± 15 years; 65% female), divided into four groups based on two variables: type of spondylolisthesis and chief pain complaint (leg pain (LP) versus back pain). Patients completed the COMI preoperatively and up to 5 years follow-up (FU), and rated global treatment outcome (GTO). Regression models were used to predict COMI-scores at FU. Pain scores and satisfaction ratings were analysed. RESULTS: All patients experienced pronounced reductions in COMI scores. Relative to the other groups, the DS-LP group showed between 5% and 11% greater COMI score reduction (p < 0.01 up to 2 years' FU). This group also performed best with respect to pain outcomes and satisfaction. Long-term GTO was 93% at the 5 year FU, compared with between 82% and 86% in the other groups. CONCLUSION: Regardless of the type of spondylolisthesis, all groups experienced an improvement in COMI score after surgery. Patients with DS and LP as their chief complaint appear to benefit more than other patients. These results are the first to show that the type of the spondylolisthesis and its chief complaint have an impact on surgical outcome. They will be informative for the consent process prior to surgery and can be used to build predictive models for individual outcome.

Anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimization.

Cage subsidence after instrumented lumbar spinal fusion surgery remains a significant cause of treatment failure, specifically for posterior or transforaminal lumbar interbody fusion. Recent advancements in computational techniques and additive manufacturing, have enabled the development of patient-specific implants and implant optimization to specific functional targets. This study aimed to introduce a novel full-scale topology optimization formulation that takes the structural response of the adjacent bone structures into account in the optimization process. The formulation includes maximum and minimum principal strain constraints that lower strain concentrations in the adjacent vertebrae. This optimization approach resulted in anatomically and mechanically conforming spinal fusion cages. Subsidence risk was quantified in a commercial finite element solver for off-the-shelf, anatomically conforming and the optimized cages, in two representative patients. We demonstrated that the anatomically and mechanically conforming cages reduced subsidence risk by 91% compared to an off-the-shelf implant with the same footprint for a patient with normal bone quality and 54% for a patient with osteopenia. Prototypes of the optimized cage were additively manufactured and mechanically tested to evaluate the manufacturability and integrity of the design and to validate the finite element model.

Are large language models valid tools for patient information on lumbar disc herniation? The spine surgeons' perspective.

Introduction: Generative AI is revolutionizing patient education in healthcare, particularly through chatbots that offer personalized, clear medical information. Reliability and accuracy are vital in AI-driven patient education. Research question: How effective are Large Language Models (LLM), such as ChatGPT and Google Bard, in delivering accurate and understandable patient education on lumbar disc herniation? Material and methods: Ten Frequently Asked Questions about lumbar disc herniation were selected from 133 questions and were submitted to three LLMs. Six experienced spine surgeons rated the responses on a scale from "excellent" to "unsatisfactory," and evaluated the answers for exhaustiveness, clarity, empathy, and length. Statistical analysis involved Fleiss Kappa, Chi-square, and Friedman tests. Results: Out of the responses, 27.2% were excellent, 43.9% satisfactory with minimal clarification, 18.3% satisfactory with moderate clarification, and 10.6% unsatisfactory. There were no significant differences in overall ratings among the LLMs (p = 0.90); however, inter-rater reliability was not achieved, and large differences among raters were detected in the distribution of answer frequencies. Overall, ratings varied among the 10 answers (p = 0.043). The average ratings for exhaustiveness, clarity, empathy, and length were above 3.5/5. Discussion and conclusion: LLMs show potential in patient education for lumbar spine surgery, with generally positive feedback from evaluators. The new EU AI Act, enforcing strict regulation on AI systems, highlights the need for rigorous oversight in medical contexts. In the current study, the variability in evaluations and occasional inaccuracies underline the need for continuous improvement. Future research should involve more advanced models to enhance patient-physician communication.

The use of the Core Yellow Flags Index for the assessment of psychosocial distress in patients undergoing surgery of the cervical spine.

BACKGROUND: Psychosocial distress (the presence of yellow flags) has been linked to poor outcomes in spine surgery. The Core Yellow Flags Index (CYFI), a short instrument assessing the 4 main yellow flags, was developed for use in patients undergoing lumbar spine surgery. This study evaluated its ability to predict outcome in patients undergoing cervical spine surgery. METHODS: Patients with degenerative spinal disorders (excluding myelopathy) operated in one centre, from 2015 to 2019, were asked to complete the CYFI at baseline and the Core Outcome Measures Index (COMI) at baseline and 3 and 12 months after surgery. The relationship between CYFI and COMI scores at baseline as well as the predictive ability of the CYFI on the COMI follow-up scores were tested using structural equation modelling. RESULTS: From 731 eligible patients, 547 (61.0 ± 12.5 years; 57.2% female) completed forms at all three timepoints. On a cross-sectional basis, preoperative CYFI and COMI scores were highly correlated (ß = 0.54, in men and 0.51 in women; each p < 0.001). CYFI added significantly and independently to the prediction of COMI at 3 months' FU in men (ß = 0.36) and 12 months' FU in men and women (both ß = 0.20) (all p < 0.001). CONCLUSION: The CYFI had a low to moderate but significant and independent association with cervical spine surgery outcomes. Implementing the CYFI in the preoperative workup of these patients could help refine outcome predictions and better manage patient expectations.

Evaluation of "appropriate use criteria" for surgical decision-making in lumbar degenerative spondylolisthesis. A controlled, multicentre, prospective observational study.

INTRODUCTION: Selecting patients with lumbar degenerative spondylolisthesis (LDS) for surgery is difficult. Appropriate use criteria (AUC) have been developed to clarify the indications for LDS surgery but have not been evaluated in controlled studies. METHODS: This prospective, controlled, multicentre study involved 908 patients (561 surgical and 347 non-surgical controls; 69.5 ± 9.7y; 69% female), treated as per normal clinical practice. Their appropriateness for surgery was afterwards determined using the AUC. They completed the Core Outcome Measures Index (COMI) at baseline and 12 months' follow-up. Multiple regression adjusting for confounders evaluated the influence of appropriateness designation and treatment received on the 12-month COMI and achievement of MCIC (≥ 2.2-point-reduction). RESULTS: As per convention, appropriate (A) and uncertain (U) groups were combined for comparison with the inappropriate (I) group. For the adjusted 12-month COMI, the benefit of surgery relative to non-surgical care was not significantly greater for the A/U than the I group (p = 0.189). There was, however, a greater treatment effect of surgery for those with higher baseline COMI (p = 0.035). The groups' adjusted probabilities of achieving MCIC were: 83% (A/U, receiving surgery), 71% (I, receiving surgery), 50% (A/U, receiving non-surgical care), and 32% (I, receiving non-surgical care). CONCLUSIONS: A/U patients receiving surgery had the highest chances of achieving MCIC, but the AUC were not able to identify which patients had a greater treatment effect of surgery relative to non-surgical care. The identification of other characteristics that predict a greater treatment effect of surgery, in addition to baseline COMI, is required to improve decision-making.

A decade of experience in over 300 surgically treated spine patients with long-term oral anticoagulation: a propensity score matched cohort study.

PURPOSE: The aim of this study was to investigate the risks and outcomes of patients with long-term oral anticoagulation (OAC) undergoing spine surgery. METHODS: All patients on long-term OAC who underwent spine surgery between 01/2005 and 06/2015 were included. Data were prospectively collected within our in-house Spine Surgery registry and retrospectively supplemented with patient chart and administrative database information. A 1:1 propensity score-matched group of patients without OAC from the same time interval served as control. Primary outcomes were post-operative bleeding, wound complications and thromboembolic events up to 90 days post-surgery. Secondary outcomes included intraoperative blood loss, length of hospital stay, death and 3-month post-operative patient-rated outcomes. RESULTS: In comparison with the control group, patients with OAC (n = 332) had a 3.4-fold (95%CI 1.3-9.0) higher risk for post-operative bleeding, whereas the risks for wound complications and thromboembolic events were comparable between groups. The higher bleeding risk was driven by a higher rate of extraspinal haematomas (3.3% vs. 0.6%; p = 0.001), while there was no difference in epidural haematomas and haematoma evacuations. Risk factors for adverse events among patients with OAC were mechanical heart valves, posterior neck surgery, blood loss > 1000 mL, age, female sex, BMI > 30 kg/m2 and post-operative PTT levels. At 3-month follow-up, most patients reported favourable outcomes with no difference between groups. CONCLUSION: Although OAC patients have a higher risk for complications after spine surgery, the risk for major events is low and patients benefit similarly from surgery.

Far Lateral Lumbar Decompression Using the Far-Lateral Approach: Patient Reported Outcome is Associated with the Involved Vertebral Level and Coronal Segmental Angle.

STUDY DESIGN: Single centre retrospective study of prospectively collected data. OBJECTIVE: Analyse factors associated with patient reported outcome after far lateral decompression surgery (FLDS) for lumbar nerve root compression using the far-lateral approach. SUMMARY OF BACKGROUND DATA: To date, no studies have investigated the influence of vertebral level, coronal segmental Cobb angle, and the nature of the compressive tissue (hard/soft) on patient reported outcome following FLDS. METHODS: Patients who had undergone FLDS between 2005 and 2020 were included. Coronal segmental angle (CSCA) was measured on preoperative, posteroanterior radiographs. Primary outcome measure was the Core Outcome Measures Index (COMI) score at 2 years' follow-up (2Y-FU). Patients who had undergone microsurgical decompression using a midline approach (MID) served as a comparator group. RESULTS: There were 148 FLDS and 463 MID patients. In both groups there was a significant improvement in COMI score from preoperative to 2Y-FU (P<0.0001), with greater improvement in patients treated at higher vertebral levels than in those treated at L5/S1 (P=0.014). Baseline COMI, ASA grade, BMI, and low back pain as the "chief complaint" all had a significant association with the 2-year COMI score. The nature of compressive tissue showed no association with COMI score at 2Y-FU. In the FLDS group, there was a statistically significant correlation between the preoperative CSCA and change in COMI score preoperatively to 2Y-FU (P<0.001). The association was retained in multiple regression analysis controlling for confounders. A one-degree increase in CSCA was associated with a 0.35-point worse COMI score at 2Y-FU (P=0.003). CONCLUSION: Treatment of far lateral nerve root compression showed overall good patient reported outcome, but with less improvement with advanced coronal segmental angulation. Modified approaches and techniques might be preferable for the level L5/S1.

Does loss to follow-up lead to an overestimation of treatment success? Findings from a spine surgery registry of over 15,000 patients.

PURPOSE: Patient-reported outcome measures (PROMs) are integral to the assessment of treatment success, but loss to follow-up (attrition) may lead to bias in the results reported. We sought to evaluate the extent, nature and implications of attrition in a long-established, single-centre spine registry. METHODS: The registry contained the data of 15,264 consecutive spine surgery patients. PROMs included the Core Outcome Measures Index (COMI) and a rating of the Global Treatment Outcome (GTO) and Satisfaction with Care. Baseline characteristics associated with returning a 12-month PROM (= "responder") were analysed (logistic regression). The 3-month outcomes of 12-month responders versus 12-month non-responders were compared (ANOVA and Chi-square). RESULTS: In total, 14,758/15,264 (97%) patients (60 ± 17y; 46% men) had consented to the use of their registry data for research. Preoperative, 3-month post-operative and 12-month post-operative PROMs were returned by 91, 90 and 86%, respectively. Factors associated with being a 12-month responder included: greater age, born in the country of the study, no private/semi-private insurance, better baseline status (lower COMI score), fewer previous surgeries, less comorbidity and no perioperative medical complications. 12-month non-responders had shown significantly worse outcomes in their 3-month PROMs than had 12-month responders (respectively, 66% vs 80% good GTO ("treatment helped/helped a lot"); 77% vs 88% satisfied/very satisfied; and 49% vs 63% achieved MCIC on COMI). CONCLUSION: Although attrition in this cohort was relatively low, 12-month non-responders displayed distinctive characteristics and their early outcomes were significantly worse than those of 12-month responders. If loss to follow-up is not addressed, treatment success will likely be overestimated, with erroneously optimistic results being reported.

Association between sagittal alignment and loads at the adjacent segment in the fused spine: a combined clinical and musculoskeletal modeling study of 205 patients with adult spinal deformity.

PURPOSE: Sagittal malalignment is a risk factor for mechanical complications after surgery for adult spinal deformity (ASD). Spinal loads, modulated by sagittal alignment, may explain this relationship. The aims of this study were to investigate the relationships between: (1) postoperative changes in loads at the proximal segment and realignment, and (2) absolute postoperative loads and postoperative alignment measures. METHODS: A previously validated musculoskeletal model of the whole spine was applied to study a clinical sample of 205 patients with ASD. Based on clinical and radiographic data, pre-and postoperative patient-specific alignments were simulated to predict loads at the proximal segment adjacent to the spinal fusion. RESULTS: Weak-to-moderate associations were found between pre-to-postop changes in lumbar lordosis, LL (r = - 0.23, r = - 0.43; p < 0.001), global tilt, GT (r = 0.26, r = 0.38; p < 0.001) and the Global Alignment and Proportion score, GAP (r = 0.26, r = 0.37; p < 0.001), and changes in compressive and shear forces at the proximal segment. GAP score parameters, thoracic kyphosis measurements and the slope of upper instrumented vertebra were associated with changes in shear. In patients with T10-pelvis fusion, moderate-to-strong associations were found between postoperative sagittal alignment measures and compressive and shear loads, with GT showing the strongest correlations (r = 0.75, r = 0.73, p < 0.001). CONCLUSIONS: Spinal loads were estimated for patient-specific full spinal alignment profiles in a large cohort of patients with ASD pre-and postoperatively. Loads on the proximal segments were greater in association with sagittal malalignment and malorientation of proximal vertebra. Future work should explore whether they provide a causative mechanism explaining the associated risk of proximal junction complications.

Factors associated with an increased risk of developing postoperative symptomatic lumbar spondylolisthesis after decompression surgery: an explorative two-centre international cohort study.

PURPOSE: Symptomatic lumbar spinal stenosis can be treated with decompression surgery. A recent review reported that, after decompression surgery, 1.6-32.0% of patients develop postoperative symptomatic spondylolisthesis and may therefore be indicated for lumbar fusion surgery. The latter can be more challenging due to the altered anatomy and scar tissue. It remains unclear why some patients get recurrent neurological complaints due to postoperative symptomatic spondylolisthesis, though some associations have been suggested. This study explores the association between key demographic, biological and radiological factors and postoperative symptomatic spondylolisthesis after lumbar decompression. METHODS: This retrospective cohort study included patients who had undergone lumbar spinal decompression surgery between January 2014 and December 2016 at one of two Spine Centres in the Netherlands or Switzerland and had a follow-up of two years. Patient characteristics, details of the surgical procedure and recurrent neurological complaints were retrieved from patient files. Preoperative MRI scans and conventional radiograms (CRs) of the lumbar spine were evaluated for multiple morphological characteristics. Postoperative spondylolisthesis was evaluated on postoperative MRI scans. For variables assessed on a whole patient basis, patients with and without postoperative symptomatic spondylolisthesis were compared. For variables assessed on the basis of the operated segment(s), surgical levels that did or did not develop postoperative spondylolisthesis were compared. Univariable and multivariable logistic regression analyses were used to identify associations with postoperative symptomatic spondylolisthesis. RESULTS: Seven hundred and sixteen patients with 1094 surgical levels were included in the analyses. (In total, 300 patients had undergone multilevel surgery.) ICCs for intraobserver and interobserver reliability of CR and MRI variables ranged between 0.81 and 0.99 and 0.67 and 0.97, respectively. In total, 66 of 716 included patients suffered from postoperative symptomatic spondylolisthesis (9.2%). Multivariable regression analyses of patient-basis variables showed that being female [odds ratio (OR) 1.2, 95%CI 1.07-3.09] was associated with postoperative symptomatic spondylolisthesis. Higher BMI (OR 0.93, 95%CI 0.88-0.99) was associated with a lower probability of having postoperative symptomatic spondylolisthesis. Multivariable regression analyses of surgical level-basis variables showed that levels with preoperative spondylolisthesis (OR 17.30, 95%CI 10.27-29.07) and the level of surgery, most importantly level L4L5 compared with levels L1L3 (OR 2.80, 95%CI 0.78-10.08), were associated with postoperative symptomatic spondylolisthesis; greater facet joint angles (i.e. less sagittal-oriented facets) were associated with a lower probability of postoperative symptomatic spondylolisthesis (OR 0.97, 95%CI 0.95-0.99). CONCLUSION: Being female was associated with a higher probability of having postoperative symptomatic spondylolisthesis, while having a higher BMI was associated with a lower probability. When looking at factors related to postoperative symptomatic spondylolisthesis at the surgical level, preoperative spondylolisthesis, more sagittal orientated facet angles and surgical level (most significantly level L4L5 compared to levels L1L3) showed significant associations. These associations could be used as a basis for devising patient selection criteria, stratifying patients or performing subgroup analyses in future studies regarding decompression surgery with or without fusion.

Management and outcome of spinal implant-associated surgical site infections in patients with posterior instrumentation: analysis of 176 cases.

PURPOSE: The management of implant-associated surgical site infections (SSI) in patients with posterior instrumentation is challenging. Evidence regarding the most appropriate treatment and the need for removal of implants is equivocal. We sought to evaluate the management and outcome of such patients at our institution. METHODS: We searched our prospectively documented databases for eligible patients with posterior spinal instrumentation, excluding the cervical spine (January 2008-June 2018). Patient files were reviewed, demographic data and treatment details were recorded. Patient-reported outcome (PRO) was assessed with the Core Outcome Measures Index (COMI) preoperatively and postoperatively at 3 and 12 months. RESULTS: A total of 170 patients underwent 210 revisions for 176 SSIs. Two-thirds presented within four weeks (105/176, 59.7%, median 22.5d, 7d-11.1y). The most common pathogens were Staphylococcus aureus (n = 79/210, 37.6%) and Staphylococcus epidermidis (n = 56/210, 26.7%). Debridement and implant retention was performed in 135/210 (64.3%) revisions and partial replacement in 62/210 (29.5%). In 28/176 SSI (15.9%), persistent infection required multiple revisions (≤ 4). Surgery was followed by intravenous and oral antimicrobial treatment (10-12w). In 139/176 SSIs (79%) with ≥ 1y follow-up, infection was cured in 115/139 (82.7%); relapse occurred in 9 (relapse rate: 5.1%). Two patients (1.4%) died. COMI decreased significantly (8.2 ± 1.5 vs. 4.8 ± 2.9, p < 0.0001) over 12 months. 72.7% of patients were (very) satisfied with their care. CONCLUSION: Patients with SSI after posterior (thoraco-)lumbo(-sacral) instrumentation can be successfully treated in most cases with surgical and specific antibiotic treatment. An interdisciplinary approach is recommended. Loose implants should be replaced. In some cases, multiple revisions may be necessary. Patient outcomes were satisfactory.

Revision surgery for incomplete resection or recurrence of cervical spine chordoma: a consecutive case series of 24 patients.

PURPOSE: Chordomas are rare tumors with an annual incidence of approximately one per million. Chordomas rarely metastasize but show a high local recurrence rate. Therefore, these patients present a major clinical challenge, and there is a paucity of the literature regarding the outcome after revision surgery of cervical spine chordomas. Available studies suggest a significantly worse outcome in revision scenarios. The purpose of this study is to analyze the survival rate, and complications of patients that underwent revision surgery for local recurrence or incomplete resection of chordoma at the craniocervical junction or at the cervical spine. METHODS: 24 consecutive patients that underwent revision surgery for cervical spine chordoma remnants or recurrence at a single center were reviewed retrospectively. We analyzed patient-specific surgical treatment strategies, complications, and outcome. Kaplan-Meier estimator was used to analyze five-year overall survival. RESULTS: Gross total resection was achieved in 17 cases. Seven patients developed dehiscence of the pharyngeal wall, being the most common long-term complication. No instability was observed. Postoperatively, four patients received proton beam radiotherapy and 12 patients had combined photon and proton beam radiotherapy. The five-year overall survival rate was 72.6%. CONCLUSION: With thorough preoperative planning, appropriate surgical techniques, and the addition of adjuvant radiotherapy, results similar to those in primary surgery can be achieved.

Development of a model to predict the probability of incurring a complication during spine surgery.

PURPOSE: Predictive models in spine surgery are of use in shared decision-making. This study sought to develop multivariable models to predict the probability of general and surgical perioperative complications of spinal surgery for lumbar degenerative diseases. METHODS: Data came from EUROSPINE's Spine Tango Registry (1.2012-12.2017). Separate prediction models were built for surgical and general complications. Potential predictors included age, gender, previous spine surgery, additional pathology, BMI, smoking status, morbidity, prophylaxis, technology used, and the modified Mirza invasiveness index score. Complete case multiple logistic regression was used. Discrimination was assessed using area under the receiver operating characteristic curve (AUC) with 95% confidence intervals (CI). Plots were used to assess the calibration of the models. RESULTS: Overall, 23'714/68'111 patients (54.6%) were available for complete case analysis: 763 (3.2%) had a general complication, with ASA score being strongly predictive (ASA-2 OR 1.6, 95% CI 1.20-2.12; ASA-3 OR 2.98, 95% CI 2.19-4.07; ASA-4 OR 5.62, 95% CI 3.04-10.41), while 2534 (10.7%) had a surgical complication, with previous surgery at the same level being an important predictor (OR 1.9, 95%CI 1.71-2.12). Respectively, model AUCs were 0.74 (95% CI, 0.72-0.76) and 0.64 (95% CI, 0.62-0.65), and calibration was good up to predicted probabilities of 0.30 and 0.25, respectively. CONCLUSION: We developed two models to predict complications associated with spinal surgery. Surgical complications were predicted with less discriminative ability than general complications. Reoperation at the same level was strongly predictive of surgical complications and a higher ASA score, of general complications. A web-based prediction tool was developed at https://sst.webauthor.com/go/fx/run.cfm?fx=SSTCalculator .

Validation of a surgical invasiveness index in patients with lumbar spinal disorders registered in the Spine Tango registry.

INTRODUCTION: Being able to quantify the invasiveness of a surgical procedure is important to weigh up its associated risks, since invasiveness governs the blood loss, operative time and likelihood of complications. Mirza et al. (Spine (Phila Pa 1976) 33:2651-2661, 2008) published an invasiveness index for spinal surgery. We evaluated the validity of a modified version of the Mirza invasiveness index (mMII), adapted for use with registry data. METHODS: A cross-sectional analysis was performed with data acquired from the Spine Tango registry including 21,634 patients. The mMII was calculated as the sum of six possible interventions on each vertebral level: decompression, fusion and stabilization either on anterior or posterior structures. The association between the mMII and blood loss, operative time and complications was evaluated using multiple regression, adjusting for possible confounders. RESULTS: The mean (± SD) mMII was 3.9 ± 5.0 (range 0-40). A 1-point increase in the mMII was associated with an additional blood loss of 12.8% (95% CI 12.6-13.0; p < 0.001) and an increase of operative time of 10.4 min (95% CI 10.20-10.53; p < 0.001). The R2 for the blood loss model was of 43% and for operative time, 47%. The mean mMII was significantly (p < 0.001) higher in patients with surgical complications (4.5 ± 5.6) and general medical complications (6.5 ± 7.0) compared to those without (3.8 ± 4.9). Our results were comparable to those reported in the original publication of Mirza et al. CONCLUSION: The mMII appeared to be a valid measure of surgical invasiveness in our study population. It can be used in predictor models and to adjust for surgical case-mix when comparing outcomes in different studies or different hospitals/surgeons in a registry.

Development of the "Core Yellow Flags Index" (CYFI) as a brief instrument for the assessment of key psychological factors in patients undergoing spine surgery.

BACKGROUND: Depression, anxiety, catastrophising, and fear-avoidance beliefs are key "yellow flags" (YFs) that predict a poor outcome in back patients. Most surgeons acknowledge the importance of YFs but have difficulty assessing them due to the complexity of the instruments used for their measurement and time constraints during consultations. We performed a secondary analysis of existing questionnaire data to develop a brief tool to enable the systematic evaluation of YFs and then tested it in clinical practice. METHODS: The following questionnaire datasets were available from a total of 932 secondary/tertiary care patients (61 ± 16 years; 51% female): pain catastrophising (N = 347); ZUNG depression (N = 453); Hospital Anxiety and Depression Scale (anxiety subscale) (N = 308); fear-avoidance beliefs (N = 761). The single item that best represented the full-scale score was identified, to form the 4-item "Core Yellow Flags Index" (CYFI). 2422 patients (64 ± 16 years; 54% female) completed CYFI and a Core Outcome Measures Index (COMI) before lumbar spine surgery, and a COMI 3 and 12 months later (FU). RESULTS: The item-total correlation for each item with its full-length questionnaire was: 0.77 (catastrophising), 0.67 (depression), 0.69 (anxiety), 0.68 (fear-avoidance beliefs). Cronbach's α for the CYFI was 0.79. Structural equation modelling showed CYFI uniquely explained variance (p < 0.001) in COMI at both the 3- and 12-month FUs (ß = 0.11 (women), 0.24 (men); and ß = 0.13 (women), ß = 0.14 (men), respectively). CONCLUSION: The 4-item CYFI proved to be a simple, practicable tool for routinely assessing key psychological attributes in spine surgery patients and made a relevant contribution in predicting postoperative outcome. CYFI's items were similar to those in the "STarT Back screening tool" used in primary care to triage patients into treatment pathways, further substantiating its validity. Wider use of CYFI may help improve the accuracy of predictive models derived using spine registry data.

Development and temporal validation of a prognostic model for 1-year clinical outcome after decompression surgery for lumbar disc herniation.

PURPOSE: Surgeons need tools to provide individualised estimates of surgical outcomes and the uncertainty surrounding these, to convey realistic expectations to the patient. This study developed and validated prognostic models for patients undergoing surgical treatment of lumbar disc herniation, to predict outcomes 1 year after surgery, and implemented these models in an online prediction tool. METHODS: Using the data of 1244 patients from a large spine unit, LASSO and linear regression models were fitted with 90% upper prediction limits, to predict scores on the Core Outcome Measures Index, and back and leg pain. Candidate predictors included sociodemographic factors, baseline symptoms, medical history, and surgeon characteristics. Temporal validation was conducted on 364 more recent patients at the same unit, by examining the proportion of observed outcomes exceeding the threshold of the 90% upper prediction limit (UPL), and by calculating mean bias and other calibration measures. RESULTS: Poorer outcome was predicted by obesity, previous spine surgery, and having basic obligatory (rather than private) insurance. In the validation data, fewer than 12% of outcomes were above the 90% UPL. Calibration plots for the model validation showed values for mean bias < 0.5 score points and regression slopes close to 1. CONCLUSION: While the model accuracy was good overall, the prediction intervals indicated considerable predictive uncertainty on the individual level. Implementation studies will assess the clinical usefulness of the online tool. Updating the models with additional predictors may improve the accuracy and precision of outcome predictions. These slides can be retrieved under Electronic Supplementary Material.

Back Pain and Its Change After Surgery in Adolescents and Young Adults With Idiopathic Scoliosis.

STUDY DESIGN: A retrospective analysis of prospectively collected data from patients aged 12-30 years, operated for AIS in our hospital from 2005 to 2014 and registered in our local patient outcomes database linked to EUROSPSINE's Spine Tango Registry. OBJECTIVES: To investigate whether in patients with AIS and notable back pain surgery is associated with significant pain relief and whether age influences outcome. SUMMARY OF BACKGROUND DATA: Few studies have investigated the association between adolescent idiopathic scoliosis and back pain and the influence of age on the relief of back pain after surgical correction of the deformity. METHODS: Preoperatively and up to two years' postoperatively, patients completed the Core Outcome Measures Index, which includes two 0-10 scales for back pain and leg/buttock pain. A score of 4/10 or more is considered "relevant pain." RESULTS: We identified 85 patients with AIS (74 (87%) females) in the database; 60 were aged 12-18 years (mean 15.5 ± 1.7 years) and 25 were 19-30 years (mean 22.5 ± 3.1 years). There were no significant differences (p > .05) between the age groups for coronal Cobb angles of the main curves or Lenke curve types, and these curves showed no correlation with pain intensity (p > .05). Back pain was correlated with age (r = 0.31, p = .004). Preoperatively, 42% patients had a back pain score of ≥4/10 (52% in adults, 38% in adolescents). Just 8% patients had a leg pain score of ≥4/10 (16% in adults, 5% in adolescents). Those with notable back pain showed a significant (p < .0001) improvement two years after surgery. However, 24% of patients with no back pain at baseline showed a worsening of pain by 2 (out of 10) points or more two years postoperatively. There was no significant difference in the extent of improvement in older and younger patients (p = .22). CONCLUSION: In patients undergoing surgery for correction of AIS, back pain is correlated with age. In those with relevant back pain at baseline, surgery is associated with a statistically significant and clinically relevant reduction of pain 24 months later, in skeletally mature young adults and adolescents alike. LEVEL OF EVIDENCE: Level III.

Correction to: Surgical growth guidance with non-fused anchoring segments in early-onset scoliosis.

The preoperative X-ray presented in Figure 1 of the original publication erroneously was not the latest radiographic image taken before the index surgery at the age of 3 years.

Surgical growth guidance with non-fused anchoring segments in early-onset scoliosis.

PURPOSE: Surgical treatment of early-onset scoliosis (EOS) requires a balance between maintained curve correction and the capacity for spinal and thoracic growth. Spinal fusion creates irreversible conditions that prevent the implementation of further treatment methods. Our hypothesis was that non-fused anchors in growth guidance show a comparable outcome as the technique described in the literature, which involves spondylodesis of the anchoring segments. METHODS: This retrospective study analysed 148 surgeries in 22 EOS patients (11 female, 11 male) over a 15-year period. Patients underwent surgery with non-fused anchors and growth guidance techniques. Scoliosis, kyphosis, growth and anchoring segments were measured. For the latter, a new measuring technique was developed. Complications were recorded and classified. RESULTS: The mean Cobb angle reduced from 73.5 ± 24.4° to 28.4 ± 16.2° (60.2 ± 22.9%, p < 0.001) at the last follow-up. Spinal growth T1-S1 and T1-T12 were 41.1 ± 23.3 mm and 24.9 ± 16.6 mm (p < 0.001), respectively. Growth at the cranial and caudal anchoring segment was 1.5 mm/segment/year and 1.9 mm/segment/year, respectively. A total of 63 complications were documented in 20 patients, with 40 requiring unplanned revision surgery. Definitive spondylodesis was performed in three patients. CONCLUSION: Patients demonstrated a significant spinal growth including the anchoring segments. A comparable correction in Cobb angle and the type of complications was noted, although the rate of device-related complications was higher. No permanent impairment was reported. The rate of device-related complications is acceptable and outweighed by the significant degree of growth preservation and more flexible and individualised treatment strategy for patients with EOS. These slides can be retrieved under Electronic Supplementary Material.