The Effects of Peri-Operative Adverse Events on Clinical and Patient-Reported Outcomes After Surgery for Degenerative Cervical Myelopathy: An Observational Cohort Study from the Canadian Spine Outcomes and Research Network.

BACKGROUND AND OBJECTIVES: There is a lack of data examining the effects of perioperative adverse events (AEs) on long-term outcomes for patients undergoing surgery for degenerative cervical myelopathy. We aimed to investigate associations between the occurrence of perioperative AEs and coprimary outcomes: (1) modified Japanese Orthopaedic Association (mJOA) score and (2) Neck Disability Index (NDI) score. METHODS: We analyzed data from 800 patients prospectively enrolled in the Canadian Spine Outcomes and Research Network multicenter observational study. The Spine AEs Severity system was used to collect intraoperative and postoperative AEs. Patients were assessed at up to 2 years after surgery using the NDI and the mJOA scale. We used a linear mixed-effect regression to assess the influence of AEs on longitudinal outcome measures as well as multivariable logistic regression to assess factors associated with meeting minimal clinically important difference (MCID) thresholds at 1 year. RESULTS: There were 167 (20.9%) patients with minor AEs and 36 (4.5%) patients with major AEs. The occurrence of major AEs was associated with an average increase in NDI of 6.8 points (95% CI: 1.1-12.4, P = .019) and reduction of 1.5 points for mJOA scores (95% CI: -2.3 to -0.8, P < .001) up to 2 years after surgery. Occurrence of major AEs reduced the odds of patients achieving MCID targets at 1 year after surgery for mJOA (odds ratio 0.23, 95% CI: 0.086-0.53, P = .001) and for NDI (odds ratio 0.34, 95% CI: 0.11-0.84, P = .032). CONCLUSION: Major AEs were associated with reduced functional gains and worse recovery trajectories for patients undergoing surgery for degenerative cervical myelopathy. Occurrence of major AEs reduced the probability of achieving mJOA and NDI MCID thresholds at 1 year. Both minor and major AEs significantly increased health resource utilization by reducing the proportion of discharges home and increasing length of stay.

Effectiveness of prophylactic intranasal photodynamic disinfection therapy and chlorhexidine gluconate body wipes for surgical site infection prophylaxis in adult spine surgery.

BACKGROUND: Current measures to prevent spinal surgical site infection (SSI) lack compliance and lead to antimicrobial resistance. We aimed to examine the effectiveness of bundled preoperative intranasal photodynamic disinfection therapy (nPDT) and chlorhexidine gluconate (CHG) body wipes in the prophylaxis of spine SSIs in adults, as well as determine our institutional savings attributable to the use of this strategy and identify adverse events reported with nPDT-CHG. METHODS: We performed a 14-year prospective observational interrupted time-series study in adult (age > 18 yr) patients undergoing emergent or elective spine surgery with 3 time-specific cohorts: before rollout of our institution's nPDT-CHG program (2006-2010), during rollout (2011-2014) and after rollout (2015-2019). We used unadjusted bivariate analysis to test for temporal changes across patient and surgical variables, and segmented regression to estimate the effect of nPDT-CHG on the annual SSI incidence rates per period. We used 2 models to estimate the cost of nPDT-CHG to prevent 1 additional SSI per year and the annual cumulative cost savings through SSI prevention. RESULTS: Over the study period, 13 493 patients (mean 964 per year) underwent elective or emergent spine surgery. From 2006 to 2019, the mean age, mean Charlson Comorbidity Index (CCI) score and mean Spine Surgical Invasiveness Index (SSII) score increased from 48.4 to 58.1 years, from 1.7 to 2.6, and from 15.4 to 20.5, respectively (p < 0.001). Unadjusted analysis confirmed a significant decrease in the annual number (74.6 to 26.8) and incidence (7.98% to 2.67%) of SSIs with nPDT-CHG (p < 0.001). After adjustment for mean age, mean CCI score and mean SSII score, segmented regression showed an absolute reduction in the annual SSI incidence rate of 3.36% per year (p < 0.001). The estimated annual cost to prevent 1 additional SSI per year was about $1350-$1650, and the estimated annual cumulative cost savings were $2 484 856-$2 495 016. No adverse events were reported with nPDT-CHG. CONCLUSION: Preoperative nPDT-CHG administration is an effective prophylactic strategy for spinal SSIs, with significant cost savings. Given its rapid action, minimal risk of antimicrobial resistance, broad-spectrum activity and high compliance rate, preoperative nPDT-CHG decolonization should be the standard of care for all patients undergoing emergent or elective spine surgery.

The Role of Frailty and Sarcopenia in Predicting Major Adverse Events, Length of Stay and Reoperation Following En Bloc Resection of Primary Tumours of the Spine.

STUDY DESIGN: Retrospective observational cohort study. OBJECTIVE: En bloc resection for primary tumours of the spine is associated with a high rate of adverse events (AEs). The objective was to explore the relationship between frailty/sarcopenia and major perioperative AEs, length of stay (LOS), and unplanned reoperation following en bloc resection of primary spinal tumours. METHODS: This is a unicentre study consisting of adult patients undergoing en bloc resection for a primary spine tumor. Frailty was calculated with the modified frailty index (mFI) and spine tumour frailty index (STFI). Sarcopenia was quantified with the total psoas area/vertebral body area ratio (TPA/VB) at L3 and L4. Univariable regression analysis was used to quantify the association between frailty/sarcopenia and major perioperative AEs, LOS and unplanned reoperation. RESULTS: 95 patients met the inclusion criteria. The mFI and STFI identified a frailty prevalence of 3% and 18%. Mean CT TPA/VB ratios were 1.47 (SD ± .05) and 1.83 (SD ± .06) at L3 and L4. Inter-observer reliability was .93 and .99 for CT and MRI L3 and L4 TPA/VB ratios. Unadjusted analysis demonstrated sarcopenia and mFI did not predict perioperative AEs, LOS or unplanned reoperation. Frailty defined by an STFI score ≥2 predicted unplanned reoperation for surgical site infection (SSI) (P < .05). CONCLUSIONS: The STFI was only associated with unplanned reoperation for SSI on unadjusted analysis, while the mFI and sarcopenia were not predictive of any outcome. Further studies are needed to investigate the relationship between frailty, sarcopenia and perioperative outcomes following en bloc resection of primary spinal tumors.

Generic versus disease-specific adverse event reporting: a comparison of the NSQIP and SAVES databases for the identification of acute care adverse events in adult spine surgery.

OBJECTIVE: The accurate identification and reporting of adverse events (AEs) is crucial for quality improvement. A myriad of AE systems are utilized. There is a lack of understanding of the differences between prospective versus retrospective, disease-specific versus generic, and point-of-care versus chart-abstracted systems. The objective of this study was to compare the benefits and limitations between the prospective, disease-specific, point-of-care Spine Adverse Events Severity System (SAVES) and the retrospective, generic, and chart-abstracted National Surgical Quality Improvement Program (NSQIP) for the identification and reporting of AEs in adult patients undergoing spinal surgery. METHODS: The authors conducted an observational ambidirectional cohort study of adult patients undergoing spine surgery other than for trauma between 2011 and 2019 in a quaternary spine center. Patients were identified using Current Procedural Terminology codes in the NSQIP database and matched using unique medical record numbers to their corresponding record in SAVES. The incidence of AEs and per-patient AEs as recorded in NSQIP and SAVES was the primary outcome of interest. Comparable AEs were identified by matching NSQIP AEs to equivalent ones in SAVES. Chi-square tests were used to test for significant differences in the incidence of overall and comparable AEs between the databases. RESULTS: There were 2198 patients identified in NSQIP, of whom 2033 also had complete records in SAVES. SAVES identified 5342 individual AEs in 1484 patients (73%) compared with 1291 individual AEs in 807 patients (39.7%) with the NSQIP database (p < 0.001). SAVES identified 250 intraoperative and 422 postoperative spine-specific AEs that NSQIP did not record. NSQIP captured a greater number of AEs beyond 30 days, including prolonged length of stay > 30 days, unplanned readmission, unplanned reoperation, and death later than 30 days after surgery compared with SAVES. CONCLUSIONS: SAVES captures a greater incidence of peri- and intraoperative spine-specific AEs than NSQIP, while NSQIP identifies a greater number of AEs beyond 30 days. While a prospective, disease-specific, point-of-care AE system such as SAVES is specific for guiding quality improvement in spine surgery, it incurs greater time and financial costs. Conversely, a retrospective, generic, and chart-abstracted system such as NSQIP provides equivocal cross-institutional comparability with reduced time and financial costs. Specific contextual and aim-specific needs should guide the choice and implementation of an AE system.

Patient's expectations of surgery for lumbar degenerative spondylolisthesis: analysis by type of surgery and patient factors from the Canadian Spine Outcomes and Research Network (CSORN).

BACKGROUND CONTEXT: Preoperative expectations influence postoperative outcomes. Patients with lumbar degenerative spondylolisthesis have especially high expectations of pain relief and overall functional well-being compared to patients with lumbar stenosis. PURPOSE: The primary objective was to analyze preoperative expectations of lumbar DS patients with respect to the type of surgery proposed (decompression vs decompression and fusion). Secondarily, we aimed to assess the associations between preoperative expectations and patient and clinical factors as well as postoperative expectations fulfillment. STUDY DESIGN/SETTING: Patients were prospectively enrolled in a multicenter, prospective cohort study evaluating the assessment and management of degenerative spondylolisthesis utilizing the infrastructure of the Canadian Spine Outcomes and Research Network (CSORN) surgical registry. PATIENT SAMPLE: Patients with a diagnosis of degenerative spondylolisthesis with symptoms of neurogenic claudication or radiculopathy with or without back pain, unresponsive to nonoperative management over at least 3 months were included. Patients who underwent decompression, decompression and posterolateral fusion or decompression and interbody fusion at Canadian spine centers between January 2015 and September 2021 were included. OUTCOME MEASURES: The North American Spine Society Lumbar Spine Questionnaire was utilized for expectations measurement. The expectation questionnaire was completed following consent and before surgery and at 1 year. METHODS: Expectations for pain relief and improvements in overall functional well-being were rated on a scale of 0 to 100. Preoperative expectation in terms of pain relief and functional well-being score were calculated. Multivariate linear regression was used to evaluate the association between expected preoperative patient factors and pain relief and functional well-being. The factors associated with the most important expectation were evaluated using multivariable multinomial logistic regression. RESULTS: Three hundred fifty-two patients were included with 100 patients undergoing decompression and 252 patients also undergoing fusion. The seven items of preoperative expectations did not differ between the procedure groups nor did expected change. The mean pain relief and overall functional well-being expectation scores did not significantly differ between procedures. Higher expectations were associated with having more comorbidities [ß=-2.0 (SE 0.8), p=.020], being physically active [ß=8.4 (SE 3.2), p=.010] and having more leg pain [ß=1.6 (SE 0.7), p=.015]. Better perceived physical health measured by SF12 PCS was associated with lower expectation of pain relief [ß= -0.4 (SE 0.2), p=.039] and functional well-being [ß=-0.84 (SE 0.2), p=.001]. Better perceived mental health measured by SF12 MCS was associated with lower expectation of functional well-being [ß=-0.8 (SE 0.2), p=.001]. Postoperative expectations fulfillment did not differ between procedures. CONCLUSION: Preoperative expectations in terms of pain relief and functional well-being were similar between the two most common procedures performed, decompression ± fusion. Secondarily, higher preoperative expectations were associated with greater pain, disability and being physically active. Expectations fulfillment did not differ between procedures.

Patient, clinical, surgical, and institutional factors associated with length of stay in scheduled degenerative thoracolumbar spine surgery: National Multicenter Cohort Analysis from the Canadian Spine Outcomes and Research Network.

OBJECTIVE: Length of stay (LOS) is a contributor to costs and resource utilization. The primary goal of this study was to identify patient, clinical, surgical, and institutional variables that influence LOS after elective surgery for thoracolumbar degenerative pathology. The secondary objective was to examine variability in LOS and institutional strategies used to decrease LOS. METHODS: This is a retrospective study of prospectively collected data from a multicentric cohort enrolled in the Canadian Spine Outcomes and Research Network (CSORN) between January 2015 and October 2020 who underwent elective thoracolumbar surgery (discectomy [1 or 2 levels], laminectomy [1 or 2 levels], and posterior instrumented fusion [up to 5 levels]). Prolonged LOS was defined as LOS greater than the median. Logistic regression models were used to determine factors associated with prolonged LOS for each procedure. A survey was sent to the principal investigators of the participating healthcare institutions to understand institutional practices that are used to decrease LOS. RESULTS: A total of 3700 patients were included (967 discectomies, 1094 laminectomies, and 1639 fusions). The median LOSs for discectomy, laminectomy, and fusion were 0.0 (IQR 1.0), 1.0 (IQR 2.0), and 4.0 (IQR 2.0) days, respectively. On multivariable analysis, predictors of prolonged LOS for discectomy were having more leg pain, higher Oswestry Disability Index (ODI) scores, symptom duration more than 2 years, having undergone an open procedure, occurrence of an adverse event (AE), and treatment at an institution without protocols to reduce LOS (p < 0.05). Predictors of prolonged LOS for laminectomy were increased age, living alone, higher ODI scores, higher BMI, open procedures, longer operative time, AEs, and treatment at an institution without protocols to reduce LOS (p < 0.05). For posterior instrumented fusion, predictors of prolonged LOS were older age, living alone, more comorbidities, higher ODI scores, longer operative time, AEs, and treatment at an institution without protocols to reduce LOS (p < 0.05). The laminectomy group had the largest variability in LOS (SD 4.4 days, range 0-133 days). Three hundred fifty-four patients (22%) had an LOS above the 75th percentile. Ten institutions (53%) had either Enhanced Recovery After Surgery or standardized protocols in place. CONCLUSIONS: Among the factors identified in this study, worse baseline ODI scores, experiencing AEs, and treatment at an institution without protocols aimed at reducing LOS were predictive of prolonged LOS in all surgical groups. The laminectomy group had the largest variability in LOS.

Pattern of neurological recovery in persons with an acute cervical spinal cord injury over the first 14 days post injury.

Introduction: Following a traumatic spinal cord injury (SCI) it is critical to document the level and severity of injury. Neurological recovery occurs dynamically after injury and a baseline neurological exam offers a snapshot of the patient's impairment at that time. Understanding when this exam occurs in the recovery process is crucial for discussing prognosis and acute clinical trial enrollment. The objectives of this study were to: (1) describe the trajectory of motor recovery in persons with acute cervical SCI in the first 14 days post-injury; and (2) evaluate if the timing of the baseline neurological assessment in the first 14 days impacts the amount of motor recovery observed. Methods: Data were obtained from the Rick Hansen Spinal Cord Injury Registry (RHSCIR) site in Vancouver and additional neurological data was extracted from medical charts. Participants with a cervical injury (C1-T1) who had a minimum of three exams (including a baseline and discharge exam) were included. Data on the upper-extremity motor score (UEMS), total motor score (TMS) and American Spinal Injury Association (ASIA) Impairment Scale (AIS) were included. A linear mixed-effect model with additional variables (AIS, level of injury, UEMS, time, time2, and TMS) was used to explore the pattern and amount of motor recovery over time. Results: Trajectories of motor recovery in the first 14 days post-injury showed significant improvements in both TMS and UEMS for participants with AIS B, C, and D injuries, but was not different for high (C1-4) vs. low (C5-T1) cervical injuries or AIS A injuries. The timing of the baseline neurological examination significantly impacted the amount of motor recovery in participants with AIS B, C, and D injuries. Discussion: Timing of baseline neurological exams was significantly associated with the amount of motor recovery in cervical AIS B, C, and D injuries. Studies examining changes in neurological recovery should consider stratifying by severity and timing of the baseline exam to reduce bias amongst study cohorts. Future studies should validate these estimates for cervical AIS B, C, and D injuries to see if they can serve as an "adjustment factor" to control for differences in the timing of the baseline neurological exam.

The measurements of frailty and their possible application to spinal conditions: a systematic review.

BACKGROUND CONTEXT: Frailty is associated with an increased risk of postoperative adverse events (AEs) within the surgical spine population. Multiple frailty tools have been reported in the surgical spine literature. However, the applicability of these tools remains unclear. PURPOSE: Primary objective is to appraise the construct, feasibility, objectivity, and clinimetric properties of frailty tools reported in the surgical spine literature. Secondary objectives included determining the applicability and the most sensitive surgical spine population for each tool. STUDY DESIGN: Systematic Review. PATIENT SAMPLE: Studies reporting the use of a clinical frailty tool with a defined methodology in the adult surgical population (age ≥18 years). OUTCOME MEASURES: Postoperative adverse events (AEs) including mortality, major and minor morbidity, length of stay (LOS), unplanned readmission and reoperation, admission to the Intensive Care Unit (ICU), and adverse discharge disposition; postoperative patient-reported outcomes (health-related quality of life (HRQoL), functional, cognitive, and symptomatic); radiographic outcomes; and postoperative frailty trajectory. METHODS: This systematic review was registered with PROSPERO: CRD42019109045. Publications from January 1950 to December 2020 were identified by a comprehensive search of PubMed, Ovid, and Embase, supplemented by manual screening. Studies reporting and validating a frailty tool in the surgical spine population with a measurable outcome were included. Each tool and its clinimetric properties were evaluated using validated criteria and definitions. The applicability of each tool and its most sensitive surgical spine population was determined by panel consensus. Bias was assessed using the Newcastle-Ottawa Scale. RESULTS: 47 studies were included in the final qualitative analysis. A total of 14 separate frailty tools were identified, in which 9 tools assessed frailty according to the cumulative deficit definition, while 4 instruments utilized phenotypic or weighted frailty models. One instrument assessed frailty according to the comprehensive geriatric assessment (CGA) model. Twelve measures were validated as risk stratification tools for predicting postoperative AEs, while 1 tool investigated the effect of spine surgery on postoperative frailty trajectory. The modified frailty index (mFI), 5-item mFI, adult spinal deformity frailty index (ASD-FI), FRAIL Scale, and CGA had the most positive ratings for clinimetric properties assessed. CONCLUSIONS: The assessment of frailty is important in the surgical decision-making process. Cumulative deficit and weighted frailty instruments are appropriate risk stratification tools. Phenotypic tools are sensitive for capturing the relationship between spinal pathology, spine surgery, and prehabilitation on frailty trajectory. CGA instruments are appropriate screening tools for identifying health deficits susceptible to improvement and guiding optimization strategies. Studies are needed to determine whether spine surgery and prehabilitation are effective interventions to reverse frailty.

Development of a machine learning algorithm for predicting in-hospital and 1-year mortality after traumatic spinal cord injury.

BACKGROUND CONTEXT: Current prognostic tools such as the Injury Severity Score (ISS) that predict mortality following trauma do not adequately consider the unique characteristics of traumatic spinal cord injury (tSCI). PURPOSE: Our aim was to develop and validate a prognostic tool that can predict mortality following tSCI. STUDY DESIGN: Retrospective review of a prospective cohort study. PATIENT SAMPLE: Data was collected from 1245 persons with acute tSCI who were enrolled in the Rick Hansen Spinal Cord Injury Registry between 2004 and 2016. OUTCOME MEASURES: In-hospital and 1-year mortality following tSCI. METHODS: Machine learning techniques were used on patient-level data (n=849) to develop the Spinal Cord Injury Risk Score (SCIRS) that can predict mortality based on age, neurological level and completeness of injury, AOSpine classification of spinal column injury morphology, and Abbreviated Injury Scale scores. Validation of the SCIRS was performed by testing its accuracy in an independent validation cohort (n=396) and comparing its performance to the ISS, a measure which is used to predict mortality following general trauma. RESULTS: For 1-year mortality prediction, the values for the Area Under the Receiver Operating Characteristic Curve (AUC) for the development cohort were 0.84 (standard deviation=0.029) for the SCIRS and 0.55 (0.041) for the ISS. For the validation cohort, AUC values were 0.86 (0.051) for the SCIRS and 0.71 (0.074) for the ISS. For in-hospital mortality, AUC values for the development cohort were 0.87 (0.028) and 0.60 (0.050) for the SCIRS and ISS, respectively. For the validation cohort, AUC values were 0.85 (0.054) for the SCIRS and 0.70 (0.079) for the ISS. CONCLUSIONS: The SCIRS can predict in-hospital and 1-year mortality following tSCI more accurately than the ISS. The SCIRS can be used in research to reduce bias in estimating parameters and can help adjust for coefficients during model development. Further validation using larger sample sizes and independent datasets is needed to assess its reliability and to evaluate using it as an assessment tool to guide clinical decision-making and discussions with patients and families.

The impact of frailty on patient-reported outcomes after elective thoracolumbar degenerative spine surgery.

OBJECTIVE: Frailty has been shown to be a risk factor of perioperative adverse events (AEs) in patients undergoing various types of spine surgery. However, the relationship between frailty and patient-reported outcomes (PROs) remains unclear. The primary objective of this study was to determine the impact of frailty on PROs of patients who underwent surgery for thoracolumbar degenerative conditions. The secondary objective was to determine the associations among frailty, baseline PROs, and perioperative AEs. METHODS: This was a retrospective study of a prospective cohort of patients older than 55 years who underwent surgery between 2012 and 2018. Data and PROs (collected with EQ-5D, Physical Component Summary [PCS] and Mental Component Summary [MCS] of SF-12, Oswestry Disability Index [ODI], and numeric rating scales [NRS] for back pain and leg pain) of patients treated at a single academic center were extracted from the Canadian Spine Outcomes and Research Network registry. Frailty was calculated using the modified frailty index (mFI), and patients were classified as frail, prefrail, and nonfrail. A generalized estimating equation (GEE) regression model was used to assess the association between baseline frailty status and PRO measures at 3 and 12 months. RESULTS: In total, 293 patients with a mean ± SD age of 67 ± 7 years were included. Of these, 22% (n = 65) were frail, 59% (n = 172) were prefrail, and 19% (n = 56) were nonfrail. At baseline, the three frailty groups had similar PROs, except PCS (p = 0.003) and ODI (p = 0.02) were worse in the frail group. A greater proportion of frail patients experienced major AEs than nonfrail patients (p < 0.0001). However, despite the increased incidence of AEs, there was no association between frailty and postoperative PROs (scores on EQ-5D, PCS and MCS, ODI, and back-pain and leg-pain NRS) at 3 and 12 months (p ≥ 0.05). In general, PROs improved at 3 and 12 months (with most patients reaching the minimum clinically important difference for all PROs). CONCLUSIONS: Although frailty predicted postoperative AEs, mFI did not predict PROs of patients older than 55 years with degenerative thoracolumbar spine after spine surgery.

National adverse event profile after lumbar spine surgery for lumbar degenerative disorders and comparison of complication rates between hospitals: a CSORN registry study.

OBJECTIVE: Previous works investigating rates of adverse events (AEs) in spine surgery have been retrospective, with data collection from administrative databases, and often from single centers. To date, there have been no prospective reports capturing AEs in spine surgery on a national level, with comparison among centers. METHODS: The Spine Adverse Events Severity system was used to define the incidence and severity of AEs after spine surgery by using data from the Canadian Spine Outcomes and Research Network (CSORN) prospective registry. Patient data were collected prospectively and during hospital admission for those undergoing elective spine surgery for degenerative conditions. The Spine Adverse Events Severity system defined minor and major AEs as grades 1-2 and 3-6, respectively. RESULTS: There were 3533 patients enrolled in this cohort. There were 85 (2.4%) individual patients with at least one major AE and 680 (19.2%) individual patients with at least one minor AE. There were 25 individual patients with 28 major intraoperative AEs and 260 patients with 275 minor intraoperative AEs. Postoperatively there were 61 patients with a total of 80 major AEs. Of the 487 patients with minor AEs postoperatively there were 698 total AEs. The average enrollment was 321 patients (range 47-1237 patients) per site. The rate of major AEs was consistent among sites (mean 2.9% ± 2.4%, range 0%-9.1%). However, the rate of minor AEs varied widely among sites-from 7.9% to 42.5%, with a mean of 18.8% ± 9.7%. The rate of minor AEs varied depending on how they were reported, with surgeon reporting associated with the lowest rates (p < 0.01). CONCLUSIONS: The rate of major AEs after lumbar spine surgery is consistent among different sites but the rate of minor AEs appears to vary substantially. The method by which AEs are reported impacts the rate of minor AEs. These data have implications for the detection and reporting of AEs and the design of strategies aimed at mitigating complications.

The Effect of Perioperative Adverse Events on Long-Term Patient-Reported Outcomes After Lumbar Spine Surgery.

BACKGROUND: Perioperative adverse events (AEs) lead to patient disappointment and greater costs. There is a paucity of data on how AEs affect long-term outcomes. OBJECTIVE: To examine perioperative AEs and their impact on outcome after lumbar spine surgery. METHODS: A total of 3556 consecutive patients undergoing surgery for lumbar degenerative disorders enrolled in the Canadian Spine Outcomes and Research Network were analyzed. AEs were defined using the validated Spine AdVerse Events Severity system. Outcomes at 3, 12, and 24 mo postoperatively included the Owestry Disability Index (ODI), 12-Item Short-Form Health Survey (SF-12) Physical (PCS) and Mental (MCS) Component Summary scales, visual analog scale (VAS) leg and back, EuroQol-5D (EQ5D), and satisfaction. RESULTS: AEs occurred in 767 (21.6%) patients, and 85 (2.4%) patients suffered major AEs. Patients with major AEs had worse ODI scores and did not reach minimum clinically important differences at 2 yr (no AE: 25.7 ± 19.2, major: 36.4 ± 19.1, P < .001). Major AEs were associated with worse ODI scores on multivariable linear regression (P = .011). PCS scores were lower after major AEs (43.8 ± 9.5, vs 37.7 ± 20.3, P = .002). On VAS leg and back and EQ5D, the 2-yr outcomes were significantly different between the major and no AE groups (<0.01), but these differences were small (VAS leg: 3.4 ± 3.0 vs 4.0 ± 3.3; VAS back: 3.5 ± 2.7 vs 4.5 ± 2.6; EQ5D: 0.75 ± 0.2 vs 0.64 ± 0.2). SF12 MCS scores were not different. Rates of satisfaction were lower after major AEs (no AE: 84.6%, major: 72.3%, P < .05). CONCLUSION: Major AEs after lumbar spine surgery lead to worse functional outcomes and lower satisfaction. This highlights the need to implement strategies aimed at reducing AEs.

Effectiveness of silver alloy-coated silicone urinary catheters in patients with acute traumatic cervical spinal cord injury: Results of a quality improvement initiative.

Patients with acute traumatic cervical spinal cord injury (ATCSCI) have an increased risk of catheter-associated urinary tract infection (CAUTI). The effectiveness of silver alloy-coated silicone urinary catheters (SACC) in preventing CAUTI in ATCSCI is unknown and was the objective of this study. We performed a quality improvement initiative in an attempt to reduce CAUTI in patients undergoing spine surgery at a single quaternary center. Prior to July 2015, all patients received a latex indwelling catheter (LIC). All patients with ATCSCI with limited hand function (AIS A,B, or C) received a SACC. Incidence of CAUTI, microbiology, duration of infection, antibiotic susceptibility, and catheter-associated adverse events were recorded prospectively. We studied 3081 consecutive patients over the three years, of whom 302 (9.8%) had ATCSCI; 63% of ATCSCI patients were ASIA Impairment Scale (AIS) A or B. The overall rate of CAUTI was 19% (585/3081), and was 38% (116/302) in patients with ATCSCI. Of 178 ATCSCI patients with LIC, 100 (56%) developed a CAUTI compared with 28 of 124 (23%) patients with SACC (p < 0.05). Poly-microbial and gram-positive infection was more common in LIC than in SACC (p < 0.05). Median duration of infection was 9 days in SACC group and 12 days in LIC group (p = 0.08). Resistance to trimethoprim (p < 0.001) and ciprofloxacin (p < 0.05) were more common in LIC group. There was no difference in catheter-associated adverse events or length of stay between the groups. This quality improvement initiative illustrates the effectiveness of antiseptic silver alloy-coated silicone urinary catheters in patients with ATCSCI. In our population, the use of SACC reduces the incidence and the complexity of CAUTI.

Effect of Frailty on Outcome after Traumatic Spinal Cord Injury.

Frailty negatively affects outcome in elective spine surgery populations. This study sought to determine the effect of frailty on patient outcome after traumatic spinal cord injury (tSCI). Patients with tSCI were identified from our prospectively collected database from 2004 to 2016. We examined effect of patient age, admission Total Motor Score (TMS), and Modified Frailty Index (mFI) on adverse events (AEs), acute length of stay (LOS), in-hospital mortality, and discharge destination (home vs. other). Subgroup analysis (for three age groups: <60, 61-75, and 76+ years), and multi-variable analysis was performed to investigate the impact of age, TMS, and mFI on outcome. For the 634 patients, the mean age was 50.3 years, 77% were male, and falls were the main cause of injury (46.5%). On bivariate analysis, mFI, age at injury, and TMS were predictors of AEs, acute LOS, and in-hospital mortality. After statistical adjustment, mFI was a predictor of LOS (p = 0.0375), but not of AEs (p = 0.1428) or in-hospital mortality (p = 0.1245). In patients <60 years of age, mFI predicted number of AEs, acute LOS, and in-hospital mortality. In those aged 61-75, TMS predicted AEs, LOS, and mortality. In those 76+ years of age, mFI no longer predicted outcome. Age, mFI, and TMS on admission are important determinants of outcome in patients with tSCI. mFI predicts outcomes in those <75 years of age only. The inter-relationship of advanced age and decreased physiological reserve is complex in acute tSCI, warranting further study. Identifying frailty in younger patients with tSCI may be useful for peri-operative optimization, risk stratification, and patient counseling.

Perioperative adverse events following surgery for primary bone tumors of the spine and en bloc resection for metastases.

OBJECTIVE: Surgical treatment of primary bone tumors of the spine and en bloc resection for isolated metastases are complex and challenging. Operative care is fraught with complications, though the true incidence and predictors of adverse events (AEs), length of stay (LOS), and mortality in this population remain poorly understood. The primary objective of this study was to describe the incidence and predictors of perioperative AEs in these patients. Secondary objectives included the determination of the incidence and predictors of admission to the intensive care unit (ICU), unanticipated reoperation during the same admission, hospital LOS, and mortality. METHODS: In this retrospective analysis of prospectively collected data, the authors included consecutive patients at a single quaternary care referral center (January 1, 2009, to September 30, 2018) who underwent either surgery for a primary bone tumor of the spine or an en bloc resection for an isolated spinal metastasis. Information on perioperative AEs, demographic data, primary tumor histology, neurological status, surgical variables, pathological margins, Enneking appropriateness, LOS, ICU stay, reoperation during the same admission period, and in-hospital mortality was collected prospectively in the institutional database. The modified frailty score was extracted retrospectively. RESULTS: One hundred thirteen patients met the inclusion criteria: 98 with primary bone tumors and 15 with isolated metastases. The cohort was 59% male, and the mean age was 49 years (SD 19 years). Overall, 79% of the patients experienced at least 1 AE. The median number of AEs per patient was 2 (IQR 0-4 AEs), and the median LOS was 16 days (IQR 9-32 days). No in-hospital deaths occurred in the cohort. Thirty-two patients (28%) required an ICU stay and 19% underwent an unanticipated second surgery during their admission. A longer surgical duration was associated with a higher likelihood of AEs (OR 1.21/hour, 95% CI 1.06-1.37, p = 0.005), longer ICU stay (OR 1.35/hour, 95% CI 1 1.20-1.52, p < 0.001), and reoperation (OR 1.001/hour, 95% CI 1.0003-1.003, p = 0.012). Longer hospital LOS was independently predicted by older age, female sex, upper cervical and sacral location of the tumor, surgical duration, preoperative neurological deficit, presence of AEs, and higher modified frailty index score. CONCLUSIONS: Surgeries for primary bone tumors and en bloc resection for metastatic tumors are associated with a high incidence of perioperative AEs. Surgical duration predicts complications, reoperation, LOS, and ICU stay.

Decision tree analysis to better control treatment effects in spinal cord injury clinical research.

OBJECTIVE: The aim of this study was to use decision tree modeling to identify optimal stratification groups considering both the neurological impairment and spinal column injury and to investigate the change in motor score as an example of a practical application. Inherent heterogeneity in spinal cord injury (SCI) introduces variation in natural recovery, compromising the ability to identify true treatment effects in clinical research. Optimized stratification factors to create homogeneous groups of participants would improve accurate identification of true treatment effects. METHODS: The analysis cohort consisted of patients with acute traumatic SCI registered in the Vancouver Rick Hansen Spinal Cord Injury Registry (RHSCIR) between 2004 and 2014. Severity of neurological injury (American Spinal Injury Association Impairment Scale [AIS grades A-D]), level of injury (cervical, thoracic), and total motor score (TMS) were assessed using the International Standards for Neurological Classification of Spinal Cord Injury examination; morphological injury to the spinal column assessed using the AOSpine classification (AOSC types A-C, C most severe) and age were also included. Decision trees were used to determine the most homogeneous groupings of participants based on TMS at admission and discharge from in-hospital care. RESULTS: The analysis cohort included 806 participants; 79.3% were male, and the mean age was 46.7 ± 19.9 years. Distribution of severity of neurological injury at admission was AIS grade A in 40.0% of patients, grade B in 11.3%, grade C in 18.9%, and grade D in 29.9%. The level of injury was cervical in 68.7% of patients and thoracolumbar in 31.3%. An AOSC type A injury was found in 33.1% of patients, type B in 25.6%, and type C in 37.8%. Decision tree analysis identified 6 optimal stratification groups for assessing TMS: 1) AOSC type A or B, cervical injury, and age ≤ 32 years; 2) AOSC type A or B, cervical injury, and age > 32-53 years; 3) AOSC type A or B, cervical injury, and age > 53 years; 4) AOSC type A or B and thoracic injury; 5) AOSC type C and cervical injury; and 6) AOSC type C and thoracic injury. CONCLUSIONS: Appropriate stratification factors are fundamental to accurately identify treatment effects. Inclusion of AOSC type improves stratification, and use of the 6 stratification groups could minimize confounding effects of variable neurological recovery so that effective treatments can be identified.

Pseudarthrosis in adult and pediatric spinal deformity surgery: a systematic review of the literature and meta-analysis of incidence, characteristics, and risk factors.

We conducted a systematic review with meta-analysis and qualitative synthesis. This study aims to characterize pseudarthrosis after long-segment fusion in spinal deformity by identifying incidence rates by etiology, risk factors for its development, and common features. Pseudarthrosis can be a painful and debilitating complication of spinal fusion that may require reoperation. It is poorly characterized in the setting of spinal deformity. The MEDLINE, EMBASE, and Cochrane databases were searched for clinical research including spinal deformity patients treated with long-segment fusions reporting pseudarthrosis as a complication. Meta-analysis was performed on etiologic subsets of the studies to calculate incidence rates for pseudarthrosis. Qualitative synthesis was performed to identify characteristics of and risk factors for pseudarthrosis. The review found 162 articles reporting outcomes for 16,938 patients which met inclusion criteria. In general, the included studies were of medium to low quality according to recommended reporting standards and study design. Meta-analysis calculated an incidence of 1.4% (95% CI 0.9-1.8%) for pseudarthrosis in adolescent idiopathic scoliosis, 2.2% (95% CI 1.3-3.2%) in neuromuscular scoliosis, and 6.3% (95% CI 4.3-8.2%) in adult spinal deformity. Risk factors for pseudarthrosis include age over 55, construct length greater than 12 segments, smoking, thoracolumbar kyphosis greater than 20°, and fusion to the sacrum. Choice of graft material, pre-operative coronal alignment, post-operative analgesics, and sex have no significant impact on fusion rates. Older patients with greater deformity requiring more extensive instrumentation are at higher risk for pseudarthrosis. Overall incidence of pseudarthrosis requiring reoperation is low in adult populations and very low in adolescent populations.

Validation of the Oswestry Disability Index for pain and disability in arthrogryposis multiplex congenita.

OBJECTIVE: Chronic musculoskeletal pain and disability is common in adults with arthrogryposis multiplex congenita (AMC), but validated outcome measures of its related disability are lacking. This study aimed to determine the content and construct validity of the Oswestry Disability Index (ODI) for an AMC-appropriate low-back and lower-extremity pain-related disability questionnaire. METHODS: A mixed methods approach was used to investigate the nature of AMC-related low-back and lower-extremity pain and disability. We included 50 adults with AMC from an international arthrogryposis study. Participants completed 5 pain and disability questionnaires and an interview. Content and construct validity of the ODI in the AMC population was assessed by the proportion of participants who stated ODI domains during the open-ended interview and by R2 values and Pearson's correlation coefficients (r-values), respectively. RESULTS: The content and construct validity of the ODI were considered moderate to high for measuring low-back pain and lower-extremity disability in the adult AMC population. Participants independently identified many activities of daily living (67%), such as walking, standing, personal care, sitting, lifting and sleeping, already included in the ODI. R2 values were>0.25 for all 3 measures, demonstrating the strength of construct validity of the ODI in individuals with AMC. CONCLUSION: The ODI is a valid outcome tool for low-back and lower-extremity pain-related disability for patients with AMC. Upper-extremity issues were not addressed by the ODI, which will be further addressed in future research.

Evaluation of a Clinical Protocol to Assess and Diagnose Neuropathic Pain During Acute Hospital Admission: Results From Traumatic Spinal Cord Injury.

OBJECTIVES: A clinical protocol was developed for clinicians to routinely assess and initiate treatment for patients with neuropathic pain (NP) in an acute care setting. The objectives of this study were to: (1) determine the incidence and onset of NP in patients with traumatic spinal cord injury during acute care and (2) describe how the implementation of a clinical protocol impacts the assessment and diagnosis of NP. MATERIALS AND METHODS: The study was a cohort analysis with a pre-post-test utilizing a historical control. Data were retrospectively collected from a patient registry and charts. Participants were randomly selected in cohort 1 (control) and cohort 2 (NP clinical protocol). RESULTS: The incidence of NP was 56% without significant difference between the cohorts (P=0.3). Onset of NP was 8 days (SD=14) across the study and >85% of the participants with NP were diagnosed within 2 weeks. Participants with incomplete injuries had a significant earlier onset than participants with complete injuries (6.2±12.8, 10.9±15.8 d; P=0.003). The mean number of days from hospital admission to initial assessment decreased with use of the NP clinical protocol (3.7±5.7 d; P=0.02). DISCUSSION: This study demonstrates a high incidence and early onset of NP in traumatic spinal cord injury during acute hospital care, with an earlier emergence in participants with incomplete injury. The NP clinical protocol ensured continuous assessment and documentation of NP while decreasing the time to an initial screen, but did not impact diagnosis.

The Economic Burden of Urinary Tract Infection and Pressure Ulceration in Acute Traumatic Spinal Cord Injury Admissions: Evidence for Comparative Economics and Decision Analytics from a Matched Case-Control Study.

Secondary complications of spinal cord injury (SCI) are a burden to affected individuals and the rest of society. There is limited evidence of the economic burden or cost of complications in SCI populations in Canada, however, which is necessary for comparative economic analyses and decision analytic modeling of possible solutions to these common health problems. Comparative economic analyses can inform resource allocation decisions, but the outputs are only as good as the inputs. In this article, new evidence of the excess or incremental costs of urinary tract infection (UTI) and pressure ulceration (PU) in acute traumatic SCI from an exploratory case series analysis of admissions to a Level I specialized Canadian spine facility (2008-2013) is presented. Participants in a national SCI registry were case-control matched (1:1) on the predicted probability of experiencing UTI or PU during initial acute SCI admission. The excess costs of UTI and PU are estimated as the mean of the differences in total direct acute SCI admission costs (length of stay, accommodation, nursing, pharmacy) from the perspective of the admitting facility between participants matched or paired on demographic and SCI characteristics. Even relatively minor UTI and PU, respectively, added an average of $7,790 (standard deviation [SD] $6,267) and $18,758 (SD $27,574) to the direct cost of acute SCI admission in 2013 Canadian dollars (CAD). This case series analysis established evidence of the excess costs of UTI and PU in acute SCI admissions, which will support decision-informing analyses in SCI.