Calculation of the minimal clinically important difference in operated patients with adult spine deformity: advantages of the ROC method and significance of prevalence in threshold selection.

PURPOSE: The Minimal Clinically Important Difference (MCID) is crucial to evaluate management outcomes, but different thresholds have been obtained in different works. Part of this variability is due to measurement error and influence of the database, both essential for calculating the MCID. The aim of this study was to introduce the association of the ROC method in the anchor-based MCID calculation for ODI, SRS-22r, and SF-36, to objectively set the threshold for the anchor-based MCID in an adult spine deformity (ASD) population. METHODS: Multicentric study based on a prospective database of consecutively operated ASD patients. An anchor question was used to assess patients' quality of life after surgery. Different approaches were used to calculate the MCID and then compared: SEM (Standard Error of Measurement), MDC (Minimal Detectable Change), and anchor-based MCID with ROC method. RESULTS: 516 patients were included. Those who responded with 6 and 7 to the anchor question were considered improved. The MCID ranges obtained with the ROC method exhibited the lowest variability. Prediction error rates ranged from 31% (SRS-22r) to 41% (SF-36 MCS). The MCID ranges spanned between 12 and 15 for ODI, 0.6 and 0.73 for SRS-22r, 6.62 and 7.41 for SF-36 PCS, and between 2.69 and 5.63 for SF-36 MCS. CONCLUSION: The ROC method proposes an MCID range with error rate, and can objectively determine the threshold for distinguishing improved and non-improved patients. As the MCID correlates with the utilized database and error of measurement, each study should compute its own MCID for each PROM to allow comparison among different publications. LEVEL OF EVIDENCE: II.

The Impact of Unplanned Reoperation Following Adult Spinal Deformity Surgery: A Prospective Longitudinal Cohort Study with 5-Year Follow-up.

BACKGROUND: The long-term impact of reoperations following adult spinal deformity (ASD) surgery is still poorly understood. Our aim was to identify the relationship between unplanned reoperation and health-related quality of life (HRQoL) gain at 2 and 5 years of follow-up. METHODS: We included patients enrolled in a prospective ASD database who underwent surgery ≥5 years prior to the start of the study and who had 2 years of follow-up data. Adverse events (AEs) leading to an unplanned reoperation, the time of reoperation occurrence, invasiveness (blood loss, surgical time, hospital stay), and AE resolution were assessed. HRQoL was measured with use of the Oswestry Disability Index, Scoliosis Research Society-22, and Short Form-36. Linear models controlling for baseline data and index surgery characteristics were utilized to assess the relationships between HRQoL gain at 2 and 5-year follow-up and the number and invasiveness of reoperations. The association between 5-year HRQoL gain and the time of occurrence of the unplanned reoperation and that between 5-year HRQoL gain and AE resolution were also investigated. RESULTS: Of 361 eligible patients, 316 (87.5%) with 2-year follow-up data met the inclusion criteria and 258 (71.5%) had 5-year follow-up data. At the 2-year follow-up, 96 patients (30.4%) had a total of 165 unplanned reoperations (1.72 per patient). At the 5-year follow-up, 73 patients (28.3%) had a total of 117 unplanned reoperations (1.60 per patient). The most common cause of reoperations was mechanical complications (64.9%), followed by surgical site infections (15.7%). At the 5-year follow-up, the AE that led to reoperation was resolved in 67 patients (91.8%). Reoperation invasiveness was not associated with 5-year HRQoL scores. The number of reoperations was associated with lesser HRQoL gain at 5 years for all HRQoL measures. The mean associated reduction in HRQoL gain per unplanned reoperation was 41% (range, 19% to 66%). Reoperations resulting in no resolution of the AE or resolution with sequelae had a greater impact on 5-year follow-up HRQoL scores than reoperations resulting in resolution of the AE. CONCLUSIONS: A postoperative, unplanned reoperation following ASD surgery was associated with lesser gain in HRQoL at 5 years of follow-up. The association did not diminish over time and was affected by the number, but not the magnitude, of reoperations. Resolution of the associated AE reduced the impact of the unplanned reoperation. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Reliability of a New Digital Tool for Photographic Analysis in Quantifying Body Asymmetry in Scoliosis.

Background: Advancements in non-ionizing methods for quantifying spinal deformities are crucial for assessing and monitoring scoliosis. In this study, we analyzed the observer variability of a newly developed digital tool for quantifying body asymmetry from clinical photographs. Methods: Prospective observational multicenter study. Initially, a digital tool was developed using image analysis software, calculating quantitative measures of body asymmetry. This tool was integrated into an online platform that exports data to a database. The tool calculated 10 parameters, including angles (shoulder height, axilla height, waist height, right and left waistline angles, and their difference) and surfaces of the left and right hemitrunks (shoulders, waists, pelvises, and total). Subsequently, an online training course on the tool was conducted for twelve observers not involved in its development (six research coordinators and six spine surgeons). Finally, 15 standardized back photographs of adolescent idiopathic scoliosis patients were selected from a multicenter image bank, representing various clinical scenarios (different age, gender, curve type, BMI, and pre- and postoperative images). The 12 observers measured the photographs at two different times with a three-week interval. For the second round, the images were randomly mixed. Inter- and intra-observer variabilities of the measurements were analyzed using intraclass correlation coefficients (ICCs), and reliability was measured by the standard error of measurement (SEM). Group comparisons were made using Student's t-test. Results: The mean inter-observer ICC for the ten measurements was 0.981, the mean intra-observer ICC was 0.937, and SEM was 0.3-1.3°. The parameter with the strongest inter- and intra-observer validity was the difference in waistline angles 0.994 and 0.974, respectively, while the highest variability was found with the waist height angle 0.963 and 0.845, respectively. No test-retest differences (p > 0.05) were observed between researchers (0.948 ± 0.04) and surgeons (0.925 ± 0.05). Conclusion: We developed a new digital tool integrated into an online platform demonstrating excellent reliability and inter- and intra-observer variabilities for quantifying body asymmetry in scoliosis patients from a simple clinical photograph. The method could be used for assessing and monitoring scoliosis and body asymmetry without radiation.

Primary Pelvic Anteversion: Definition, Relevance And History After Surgery for Adult Spine Deformity.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: To identify the best definition of primary anteverted pelvis in the setting of adult spine deformity (ASD), and to investigate whether this is a pathologic setting that requires surgical correction. SUMMARY OF BACKGROUND DATA: While pelvic retroversion has been thoroughly investigated, pelvic anteversion (AP) is a far lesser discussed topic. Four different AP definitions have been proposed, and AP has been described as a normal or pathologic entity by different authors. METHODS: All patients consulting for ASD at the five participating sites were included. Firstly, the four definitions of AP were compared with descriptive statistics (anatomic method - Pelvic Tilt <0°; Relative Pelvic Version method - RPV >5°; Roussouly method - Pelvic Incidence (PI)<50° and Sacral Slope (SS)>35°); low PT method - PT/PI <25th percentile). Secondly a subgroup analysis among operated AP patients with a two-year follow-up was performed. Complication rate, radiographic parameters and clinical scores (ODI, SF-36) were compared in a multivariate analysis between patients who did and did not maintain an AP at the 2-year follow-up. RESULTS: 1163 patients were available for the first analysis. The RPV method appeared to be the most appropriate to define AP in ASD patient. For the second analysis, data on 410 subjects were available, and most of them were young adults with idiopathic scoliosis that did not require pelvic fixation. AP patients who maintained an AP after ASD surgery presented comparable radiographic and clinical outcomes to the patients who presented a normo/retroverted pelvis after surgery. CONCLUSIONS: According to the results of the presented study, the RPV method is the most appropriate to define primary AP, which is not a pathologic condition and is most often observed in young adults with idiopathic scoliosis. Anteverted pelvis does not require direct surgical correction in this patient group.

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.

Adherence to the Obeid coronal malalignment classification and a residual malalignment below 20 mm can improve surgical outcomes in adult spine deformity surgery.

PURPOSE: Coronal balance is a major factor impacting the surgical outcomes in adult spinal deformity (ASD). The Obeid coronal malalignment (O-CM) classification has been proposed to improve the coronal alignment in ASD surgery. Aim of this study was to investigate whether a postoperative CM < 20 mm and adherence to the O-CM classification could improve surgical outcomes and decrease the rate of mechanical failure in a cohort of ASD patients. METHODS: Multicenter retrospective analysis of prospectively collected data on all ASD patients who underwent surgical management and had a preoperative CM > 20 mm and a 2-year follow-up. Patients were divided in two groups according to whether or not surgery had been performed in adherence to the guidelines of the O-CM classification and according to whether or not the residual CM was < 20 mm. The outcomes of interest were radiographic data, rate of mechanical complications and Patient-Reported Outcome Measures. RESULTS: At 2 years, adherence to the O-CM classification led to a lower rate of mechanical complications (40 vs. 60%). A coronal correction of the CM < 20 mm allowed for a significant improvement in SRS-22 and SF-36 scores and was associated with a 3.5 times greater odd of achieving the minimal clinical important difference for the SRS-22. CONCLUSION: Adherence to the O-CM classification could reduce the risk of mechanic complications 2 years after ASD surgery. Patients with a residual CM < 20 mm showed better functional outcomes and a 3.5 times greater odd of achieving the MCID for the SRS-22 score.

Rod angulation does not reflect sagittal curvature in adult spinal deformity surgery: comparison of lumbar lordosis and rod contouring.

STUDY DESIGN: A retrospective study. OBJECTIVE: Relationship between rod and spinal shape in the sagittal plane in adult spinal deformity (ASD) surgery. BACKGROUND: Corrective surgery for adult spinal deformity (ASD) involves the use of contoured rods to correct and modify the spinal curvatures. Adequate rod bending is crucial for achieving optimal correction. The correlation between rods and spinal shape in long constructs has not been reported previously. METHODS: We conducted a retrospective analysis of a prospective, multicenter database of patients who underwent surgery for ASD. The inclusion criteria were patients who underwent pelvic fixation and had an upper instrumented vertebra at or above T12. Pre- and post-operative standing radiographs were used to assess lumbar lordosis at the L4S1 and L1S1 levels. The angle between the tangents to the rod at the L1, L4, and S1 pedicles was calculated to determine the L4S1 and L1S1 rod lordosis. The difference between the lumbar lordosis (LL) and the rod lordosis (RL) was calculated as ΔL = LL-RL. The correlation between this difference (ΔL) and various characteristics was analyzed using descriptive and statistical methods. RESULTS: Eighty-three patients were included in the study, resulting in 166 analyzed differences (ΔL) between the rod and spinal lordosis. The values for rod lordosis were found to be both greater and lesser than those of the spine but were mostly lower. The range for total ΔL was -24 °-30.9 °, with a mean absolute ΔL of 7.8 ° for L1S1 (standard deviation (SD) = 6.0) and 9.1 ° for L4S1 (SD = 6.8). In 46% of patients, both rods had a ΔL of over 5 °, and over 60% had at least one rod with a ΔL difference of over 5 °. Factors found to be related to a higher ΔL included postoperative higher lumbar lordosis, presence of osteotomies, higher corrected degrees, older age, and thinner rods. Multivariate analysis correlated only higher postoperative L1S1 lordosis with higher ΔL. No correlation was found between a higher ΔL and sagittal imbalance. CONCLUSIONS: Variations between spinal and rod curvatures were observed despite the linear regression correlation. The shape of the rod does not seem to be predictive of the shape of the spine in the sagittal plane in ASD long-construct surgeries. Several factors, other than rod contouring, are involved in explaining the postoperative shape of the spine. The observed variation calls into question the fundamentals of the ideal rod concept.

Long-term opioid medication profile of European adult spinal deformity patients: minimum five years follow-up study.

BACKGROUND CONTEXT: There remains significant variability in the use of postoperative opioids. On one end, it is proven that appropriate pain control is a critical aspect of patient management; on the other end, past few decades have been associated with major increases in opioid-related overdoses and addiction treatment. We hypothesized that several pre- and postoperative risk factors affecting long-term opioid use could be identified. PURPOSE: Evaluation of factors associated with minimum 5-year postoperative opioid use following adult spinal deformity surgery. STUDY DESIGN/SETTING: Prospectively followed study group database. PATIENT SAMPLE: Adult spinal deformity patients who underwent elective spine surgery between 2009 and 2016 were included. OUTCOME MEASURES: Opioid usage or otherwise at minimum 5 years follow-up. Use of nonopioid analgesics, weak and strong opioids METHODS: Retrospective analysis of patients undergoing elective spinal deformity surgery. A total of 37 factors comprising patient characteristics, radiographic measurements, operative details, preoperative and early postoperative opioid use, and mechanical complications and revisions were analyzed. Details on identified factors were provided. RESULTS: A total of 265 patients (215F, 50M) from five sites were included. The mean follow-up duration was 68.4±11.7 (60-102) months. On average, 10.6±3.5 levels were fused. Preoperatively, 64 (24.2%) patients were using opioids. The rate of opioid users increased to 33.6% at 6 weeks and decreased to 21.5% at 6 months. During follow-up, there were patients who discontinued opioids, while others have started and/or restarted using opioids. As a result, 59 (22.3%) patients were still on opioids at the latest follow-up. Multivariate analyses showed that factors independently affecting opioid use at an average of 68 months postoperatively, in order of significance, were opioid use at sixth weeks, preoperative opioid use and opioid use at sixth months with the odds ratios of 2.88, 2.51, and 2.38 respectively. At these time points, factors such as age, number of comorbidities, tobacco use, the time of the last prior spine surgery and postoperative sagittal plane alignment affected opioid usage rates. CONCLUSIONS: Opioid usage at 6 weeks was found to be more predictive of long-term opioid use compared to preoperative use. Patients should be well informed to have realistic expectations regarding opioid use when considering adult spinal deformity surgery.

The Effect of Discharging Patients with Low Hemoglobin Levels on Hospital Readmission and Quality of Life after Adult Spinal Deformity Surgery.

STUDY DESIGN: Retrospective cohort. PURPOSE: This study aims to evaluate the impact of anemia on functional outcomes, health-related quality of life (HRQoL), and early hospital readmission (EHR) rates after adult spinal deformity (ASD) surgery at the time of discharge from the hospital. OVERVIEW OF LITERATURE: Concerns with risks of transfusion, insufficient evidence for its benefits, and the possibility of associated adverse outcomes have led to restrictive transfusion practices. Therefore, patients are discharged according to patient blood management programs that are implemented in hospitals nationwide to reduce unnecessary blood transfusions. However, not many comprehensive kinds of studies exist on the effect of postoperative anemia on functional life and complications. METHODS: Anemia severity was defined following the 2011 World Health Organization guidelines. All patients had HRQoL tests as well as complete blood counts pre- and postoperatively. EHR is the admission within 30 days of discharge and was used as the dependent parameter. RESULTS: This study comprised 225 surgically treated ASD patients with a median age of 62.0 years, predominantly women (80%). Of the 225 patients, 82, 137, and six had mild, moderate, and severe anemia at the time of discharge, respectively. Seventeen of the patients (mild [11, 64.7%]; moderate [5, 29.4%]; severe [1, 5.9%]) were readmitted within 30 days. The mean hemoglobin values were higher in readmitted patients (p=0.071). Infection was the leading cause of readmission (n=12), but a low hemoglobin level was not observed in any of these patients at the time of discharge. Except for Scoliosis Research Society-22 questionnaire, HRQoL improvements did not reach statistical significance in early readmitted patients in the first year after surgery. CONCLUSIONS: The results of this study demonstrated that the occurrence and the severity of postoperative anemia are not associated with EHR in surgically treated patients with ASD. The findings of the current research suggested that clinical awareness of the parameters other than postoperative anemia may be crucial. Thus, improvements in HRQoL scores were poor in early readmitted patients 1 year after surgery.

An age and sex matched study on the effect of obesity on the functional outcomes and complication rates in patients with adult spinal deformity undergoing primary multi-level thoracolumbar spinal fusion.

Background: The objective of this study was to determine the effect of obesity on the functional outcomes and complication rates of patients with adult spinal deformity (ASD) undergoing multi-level thoracolumbar fusion. Methods: An age and sex matched comparison of functional outcomes [Numeric Rating Scale (NRS) back and leg scores, Core Outcome Measurement Index (COMI) back scores, Scoliosis Research Society 22 (SRS22) satisfaction and total scores, Short Form 36 (SF36) general health scores, Physical Component Score (PCS), Mental Component Score (MCS), Oswestry Disability Index (ODI) (including all domains)] at 6 months, 1, 2, 3 and 4 years and the complication rates at final follow-up between obese [body mass index (BMI) >30] and normal BMI (18.5-24.9) patients undergoing more than 3 levels of thoracolumbar fusion with a minimum 2-year follow-up. Patients who had undergone any previous spinal surgery were excluded. Results: Thirty patients were included in each arm of the study. Baseline demographics, including the number of levels fused, were similar between the groups. Estimated blood loss (EBL) was higher in obese patients (1,916 vs. 1,099 mL, P=0.001), but operative time was similar (282 vs. 320 min, P=0.351). The functional outcomes and satisfaction scores were consistently poorer in the obese group at all time-points, but their satisfaction scores were similar. Obese patients had a higher complication rate (OR 3.05, P=0.038) predominantly due to dural tears and nerve root injuries, but a similar reoperation rate. Conclusions: In patients with ASD undergoing multi-level thoracolumbar fusion, obesity results in a higher blood loss, poorer sagittal correction, poorer post-operative functional scores and higher complication rates than patients with a normal BMI. However, obesity does not affect operative times, length of hospital stay or reoperation rates. Furthermore, patients with obesity have similar post-operative satisfaction scores to patients with normal BMIs.

Obeid-Coronal Malalignment Classification Is Age Related and Independently Associated to Personal Reported Outcome Measurement Scores in the Nonfused Spine.

OBJECTIVE: To evaluate Obeid-coronal malalignment (O-CM) modifiers according to age, sagittal alignment, and patient-reported outcome measures (PROMs), in the mobile spine. METHODS: Retrospective review of a prospective multicenter adult spinal deformity (ASD) database with 1,243 (402 nonoperative, 841 operative) patients with no prior fusion surgery. Patients were included if they were aged over 18 years and were affected by spinal deformity defined by one of: Cobb angle ≥ 20°, pelvic tilt ≥ 25°, sagittal vertical axis ≥ 5 cm, thoracic kyphosis ≥ 60°. Patients were classified according to the O-CM classification and compared to coronally aligned patients. Multivariate analysis was performed on the relationship between PROMs and age, global tilt (GT) and coronal malalignment (CM). RESULTS: Four hundred forty-three patients had CM of more than 2 cm compared to 800 who did not. The distribution of these modifiers was correlated to age. After multivariate analysis, using age and GT as confounding factors, we found that before the age of 50 years, 2A1 patients had worse sex life and greater satisfaction than patients without CM. After 50 years of age, patients with CM (1A1, 1A2) had worse self-image and those with 2A2, 2B had worse self-image, satisfaction, and 36-item Short Form Health Survey physical function. Self-image was the consistent determinant of patients opting for surgery for all ages. CONCLUSION: CM distribution according to O-CM modifiers is age dependent. A clear correlation between the coronal malalignment and PROMs exists when using the O-CM classification and in the mobile spine, this typically affects self-image and satisfaction. Thus, CM classified according to O-CM modifiers is correlated to PROMs and should be considered in ASD.

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.

Surgical training in spine surgery: safety and patient-rated outcome.

PURPOSE: The aim of this study was to investigate the difference in patient-reported outcomes and surgical complication rates between lumbar procedures carried out either by experienced board-certified spine surgeons (BCS) or by supervised spine surgery residents (RES) in a large Swiss teaching hospital. METHODS: This was a single-center retrospective analysis of data collected prospectively within the framework of the EUROSPINE Spine Tango Registry. It involved the data of 1415 patients undergoing first-time surgery in our institution between the years 2004 and 2016. Patients were divided into three groups based on the surgical procedure: lumbar single-level fusion (SLF), single-level decompression (SLD) for lumbar spinal stenosis and disc hernia procedures (DH). Patient-reported outcome measures (primary outcome) included the multidimensional Core Outcome Measures Index (COMI) preoperatively and 3 and 12 months postoperatively plus single items concerning satisfaction with care and global treatment outcome (GTO). Secondary outcomes included surgical variables such as blood loss, duration of surgery, complication rates and length of stay. RESULTS: There were no significant differences between the RES and BCS patient groups for most of the demographic and baseline clinical variables with the exception of age in the SLD group (p = 0.012), BMI in the DH group (p = 0.02) and leg pain in the SLF group (p = 0.03). COMI scores improved significantly after all three types of procedure (p < 0.0001) without significant difference (p > 0.05) between the patients of RES and BCS. There was no significant difference (p > 0.05) between RES and BCS patients with regard to satisfaction and GTO. There were no significant differences between RES and BCS (p > 0.05) in the surgical or medical complication rates. CONCLUSION: In the given setting, surgical training of spine surgery residents under guided supervision by board-certified spine surgeons was shown to be safe, as it was not associated with greater morbidity or mortality. Furthermore, it had no detrimental influence on patient-reported outcomes. The findings can be used to give reassurance to prospective patients that are to be operated on by supervised spine surgery residents. These slides can be retrieved under Electronic Supplementary Material.

The effect of increasing body mass index on the pain and function of patients with adult spinal deformity.

BACKGROUND: Both adult spinal deformity (ASD) and obesity are growing concerns internationally. This study therefore aims to determine the effect of increasing body mass index (BMI) on the pain and function of patients with ASD. METHODS: A retrospective review of prospectively collected data from a multicentre European database was undertaken. Initially a univariate analysis was performed on the effect of BMI on the initial presentation of functional scores in patients with ASD. The functional scores included the Numerical Rating Scale (NRS) back and leg score, Core Outcome Measures Index (COMI) back score, SRS22 total score, Short Form 36 (SF-36) [general health, physical component score (PCS) and mental component score (MCS)] and Oswestry Disability Index (ODI) score (including all domains). Subsequently a multivariate analysis controlling for age, sex, comorbidities, employment status, smoking status and radiological parameters [coronal cobb, coronal balance, sagittal balance, global tilt, and pelvic incidence minus lumbar lordosis (PI - LL) mismatch] was performed. RESULTS: A total of 1,004 patients were included in this study (166 male, 838 female). On univariate analysis a statistically significant (P<0.05) moderate correlation between NRS leg pain, ODI (walking, standing, sex life, social life and total score), SF-36 (physical component), sagittal balance, global tilt and age were recognised (P<0.05). A statistically significant low correlation was identified for all other outcomes, except coronal balance (P=0.640). On multivariate analysis BMI remained significantly related to all functional outcomes except ODI-pain and ODI-travelling (P>0.05). CONCLUSIONS: Increasing BMI has a significant adverse effect on the pain and functioning of patients with ASD. Clinicians should recognise this association and treat patients accordingly.

The impact and value of uni- and multimodal intraoperative neurophysiological monitoring (IONM) on neurological complications during spine surgery: a prospective study of 2728 patients.

PURPOSE: We compared the value of different uni- and multimodal intraoperative neurophysiological monitoring (IONM) methods on the detection of neurological complications during spine surgery. METHODS: IONM data derived from sensory spinal and cortical evoked potentials combined with continuous electromyography monitoring, motor evoked potentials and spinal recording were evaluated in relation to subsequent post-operative neurological changes. Patients were categorised based on their true-positive or true-negative post-operative neurological status. RESULTS: In 2728 consecutive patients we had 909 (33.3%) IONM alerts. We had 8 false negatives (0.3%) with post-operative radicular deficit that completely recovered within 3 months, except for one. There was no false negative for spinal cord injury. 107 were true positives, and 23 were false positives. Multimodal IONM sensitivity and specificity were 93.0% and 99.1%, respectively. The frequency of neurological complications including minor deficits was 4.2% (n = 115), of which 0.37% (n = 10) were permanent. Analysis of the single IONM modalities varied between 13 and 81% to detect neurological complications compared with 93% when using all modalities. CONCLUSION: Multimodal IONM is more effective and accurate in assessing spinal cord and nerve root function during spine surgeries to reduce both neurological complications and false-negative findings compared to unimodal monitoring. We recommend multimodal IONM in all complex spine surgeries. These slides can be retrieved from Electronic Supplementary Material.

The Influence of Diagnosis, Age, and Gender on Surgical Outcomes in Patients With Adult Spinal Deformity.

STUDY DESIGN: Retrospective review of prospectively collected data from a multicentric database. OBJECTIVES: To determine the clinical impact of diagnosis, age, and gender on treatment outcomes in surgically treated adult spinal deformity (ASD) patients. METHODS: A total of 199 surgical patients with a minimum follow-up of 1 year were included and analyzed for baseline characteristics. Patients were separated into 2 groups based on improvement in health-related quality of life (HRQOL) parameters by minimum clinically important difference. Statistics were used to analyze the effect of diagnosis, age, and gender on outcome measurements followed by a multivariate binary logistic regression model for these results with statistical significance. RESULTS: Age was found to affect SF-36 PCS (Short From-36 Physical Component Summary) score significantly, with an odds ratio of 1.017 (unit by unit) of improving SF-36 PCS score on multivariate analysis (P < .05). The breaking point in age for this effect was 37.5 years (AUC = 58.0, P = .05). A diagnosis of idiopathic deformity would increase the probability of improvement in Oswestry Disability Index (ODI) by a factor of 0.219 and in SF-36 PCS by 0.581 times (P < .05). Gender was found not to have a significant effect on any of the HRQOL scores. CONCLUSIONS: Age, along with a diagnosis of degenerative deformity, may have positive effects on the likelihood of improvement in SF-36 PCS (for age) and ODI (for diagnosis) in surgically treated patients with ASD and the breaking point of this effect may be earlier than generally anticipated. Gender does not seem to affect results. These may be important in patient counseling for the anticipated outcomes of surgery.

The impact of deep surgical site infection on surgical outcomes after posterior adult spinal deformity surgery: a matched control study.

PURPOSE: The impact of deep surgical site infection (SSI) on surgical outcomes after adult spinal deformity (ASD) surgery is still unclear. We aimed to study the morbidity of SSI in ASD and its impact on deformity correction and functional outcome. METHODS: Prospective multicenter matched-cohort study including consecutively enrolled ASD patients. Patients developing SSI were matched to similar controls in terms of age, gender, ASA, primary or revision, extent of fusion, and use of tri-columnar osteotomies. Preoperative parameters, surgical variables, and complications were recorded. Deformity parameters and Health Related Quality of Life (HRQoL) scores were obtained preoperatively and at 6, 12, and 24 months. Independent t test and Fischer's exact test were used for comparisons. RESULTS: 444 surgical ASD patients with more than 2 years of follow-up were identified. 20 sustained an acute SSI and 60 controls were accordingly matched. No differences were observed between groups in preoperative radiological and HRQoL variables confirming comparable groups. SSI patients had longer hospital stay and more mechanical complications including proximal junctional kyphosis. Infection was associated with more unrelated complications and revisions. Deformity correction was maintained equally at the different time intervals. One death was related to SSI. SSI patients had worse overall HRQoL status at 1 year and were less likely to experience improvement. However, no significant differences were recorded thereafter. CONCLUSION: SSI significantly affects the first postoperative year after posterior ASD surgery. It is associated with more complications, unrelated revisions, and worst quality of life. However it's negative impact seems to be diluted by the second postoperative year as differences in HRQoL scores between the two groups decrease. These slides can be retrieved under Electronic Supplementary material.

The assessment of complications after spine surgery: time for a paradigm shift?

BACKGROUND CONTEXT: Recent years have witnessed a shift in the assessment of spine surgical outcomes with a greater focus on the patient's perspective. However, this approach has not been widely extended to the assessment of complications. PURPOSE: The present study sought to quantify the patient-rated impact/severity of complications of spine surgery and directly compare the incidences of surgeon-rated and patient-reported complications. STUDY DESIGN: Prospective study of patients undergoing surgery for painful degenerative lumbar disorders, being operated in the Spine Center of an orthopedic hospital. PATIENT SAMPLE: A total of 2,303 patients (mean [standard deviation] age, 61.9 [15.1] years; 1,136 [49.3%] women and 1,167 [50.7%] men). PATIENTS: Core Outcome Measures Index, self-rated complications, bothersomeness of complications, global treatment outcome, and satisfaction. Surgeons: Spine Tango surgery and follow-up documentation forms registering surgical details and complications. METHODS: PATIENTS completed questionnaires before and 3 months after surgery. Surgeons documented complications before discharge and at the first postoperative follow-up, 6 to 12 weeks after surgery. RESULTS: In total, 615 out of 2,303 (27%) patients reported complications, with "bothersomeness" ratings of 1%, not at all; 22%, slightly; 26%, moderately; 34%, very; and 17%, extremely bothersome. PATIENTS most commonly reported sensory disturbances (35% of those reporting a complication) or ongoing/new pain (27%) followed by wound healing problems (11%) and motor disturbances (8%). The surgeons documented complications in 19% of patients. There was a minimal overlap regarding the presence or absence of complications in any given patient. CONCLUSIONS: Most complications reported by the patient are perceived to be at least moderately bothersome and are, hence, not inconsequential. Surgeons reported lower complication rates than the patients did, and there was only moderate agreement between the ratings of the two. As with treatment outcome, complications and their severity should be assessed from both the patient's and the surgeon's perspectives.

Comparison of patient and surgeon ratings of outcome 12 months after spine surgery: presented at the 2009 Joint Spine Section Meeting.

OBJECT: The contemporary assessment of spine surgical outcome primarily relies on patient-centered reports of symptoms and function. Such measures are considered to reduce bias compared with traditional surgeon-based outcome ratings. This study examined the agreement between patients' and surgeons' ratings of outcome 1 year after spine surgery. METHODS: The study involved 404 patients (mean age 56.6 +/- 16.4 years; 259 women, 145 men) and their treating surgeons. At baseline and 12 months postoperatively patients completed the Core Outcome Measures Index (COMI) rating pain, function, quality of life, and disability. At 12 months postoperatively, they also rated the global outcome of surgery and their satisfaction with treatment. The surgeon, blinded to the patient's evaluation, rated the global outcome of surgery as excellent, good, fair, or poor. RESULTS: Seventy-six percent of the patients who were considered by the surgeon to have an excellent or good outcome achieved the minimum clinically important difference (MCID) of a 2.2-point reduction on the COMI; 24% achieved less than the MCID. There was a significant correlation between the surgeons' and patients' global outcome ratings (Spearman rho = 0.56; p < 0.0001). The degree of absolute agreement between them was significantly influenced by surgeon seniority: senior surgeons "overrated" the outcome in 24.5% of cases (compared with patients' ratings) and "underrated" it in 17.5% of cases. Junior surgeons overrated in 7.8% of cases and underrated in 43.8% of cases (p < 0.0001). Surgeon overrating occurred significantly more frequently for patients with a poor self-rated outcome (measured as global outcome, COMI score, or satisfaction with treatment). In a multivariate model, the independent variables "senior surgeon" and "patient dissatisfaction with care" were the most significant unique predictors of surgeon overrating of the global outcome (p < 0.0001; adjusted R(2) for the model = 0.16). CONCLUSIONS: Overall, agreement between surgeon and patient was reasonably good. The majority of patients who were rated as excellent/good by the surgeons had achieved the MCID in the prospectively measured COMI score. Discrepancies in outcome ratings were influenced by surgeon seniority and patient satisfaction. For a balanced view of the surgical result, outcomes should be assessed from the perspectives of both the patient and the surgeon.

Ratings of global outcome at the first post-operative assessment after spinal surgery: how often do the surgeon and patient agree?

Patient-orientated questionnaires are becoming increasingly popular in the assessment of outcome and are considered to provide a less biased assessment of the surgical result than traditional surgeon-based ratings. The present study sought to quantify the level of agreement between patients' and doctors' global outcome ratings after spine surgery. 1,113 German-speaking patients (59.0 +/- 16.6 years; 643 F, 470 M) who had undergone spine surgery rated the global outcome of the operation 3 months later, using a 5-point scale: operation helped a lot, helped, helped only little, didn't help, made things worse. They also rated pain, function, quality-of-life and disability, using the Core Outcome Measures Index (COMI), and their satisfaction with treatment (5-point scale). The surgeon completed a SSE Spine Tango Follow-up form, blind to the patient's evaluation, rating the outcome with the McNab criteria as excellent, good, fair, and poor. The data were compared, in terms of (1) the correlation between surgeons' and patients' ratings and (2) the proportions of identical ratings, where the doctor's "excellent" was considered equivalent to the patient's "operation helped a lot", "good" to "operation helped", "fair" to "operation helped only little" and "poor" to "operation didn't help/made things worse". There was a significant correlation (Spearman Rho = 0.57, p < 0.0001) between the surgeons' and patients' ratings. Their ratings were identical in 51.2% of the cases; the surgeon gave better ratings than the patient ("overrated") in 25.6% cases and worse ratings ("underrated") in 23.2% cases. There were significant differences between the six surgeons in the degree to which their ratings matched those of the patients, with senior surgeons "overrating" significantly more often than junior surgeons (p < 0.001). "Overrating" was significantly more prevalent for patients with a poor self-rated outcome (measured as global outcome, COMI score, or satisfaction with treatment; each p < 0.001). In a multivariate model controlling for age and gender, "low satisfaction with treatment" and "being a senior surgeon" were the most significant unique predictors of surgeon "overrating" (p < 0.0001; adjusted R (2) = 0.21). Factors with no unique significant influence included comorbidity (ASA score), first time versus repeat surgery, one-level versus multilevel surgery. In conclusion, approximately half of the patient's perceptions of outcome after spine surgery were identical to those of the surgeon. Generally, where discrepancies arose, there was a tendency for the surgeon to be slightly more optimistic than the patient, and more so in relation to patients who themselves declared a poor outcome. This highlights the potential bias in outcome studies that rely solely on surgeon ratings of outcome and indicates the importance of collecting data from both the patient and the surgeon, in order to provide a balanced view of the outcome of spine surgery.