Spine Adverse Events Severity System Research Articles

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.

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. 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. 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). 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.

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.

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. 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. 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. 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.

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

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. 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. 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). 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.

P.219 The effect of peri-operative adverse events on long-term patient reported outcomes after lumbar spine surgery

Background: Peri-operative adverse events (AE) lead to patient disappointment and greater costs. There is a paucity of data on how AEs affect long-term outcomes. The purpose of this study is to examine peri-operative AEs and their impact on outcome after lumbar spine surgery. Methods: 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 months post-operatively included the Owestry Disability Index (ODI), SF-12 Physical (PCS) and Mental (MCS) scales, visual analog scale (VAS) leg and back, Euroqol-5D (EQ5D), and satisfaction. Results: Adverse events occurred in 767 (21.6%) patients, 85 (2.4%) suffered major AEs. Patients with major AEs had worse OD (physical disability) scores and did not reach minimum clinically important differences at 2 years (no AE 25.7±19.2, major: 36.4±19.1, p&lt;0.001). Major AEs were associated with worse ODI (physical disability) scores on multivariable linear regression (p=0.011). Conclusions: Major AEs after lumbar spine surgery lead to worse functional outcomes and lower satisfaction. This highlights the need to implement strategies aimed at reducing adverse events.

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

Perioperative adverse events (AEs) lead to patient disappointment and greater costs. There is a paucity of data on how AEs affect long-term outcomes. To examine perioperative AEs and their impact on outcome after lumbar spine surgery. 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. 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±3.0vs 4.0±3.3; VAS back: 3.5±2.7vs 4.5±2.6; EQ5D: 0.75±0.2vs 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). 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.

Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury-Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study.

Adverse events (AEs) are common during care in patients with traumatic spinal cord injury (tSCI). Increased risk of AEs is linked to patient factors including pre-existing comorbidities. Our aim was to examine the relationships between patient factors and common post-injury AEs, and identify potentially modifiable comorbidities. Adults with tSCI admitted to a Level I acute specialized spine center between 2006 and 2014 who were enrolled in the Rick Hansen SCI Registry (RHSCIR) and had AE data collected using the Spine Adverse Events Severity system were included. Patient demographic, neurological injury, and comorbidities data were obtained from RHSCIR. Potentially modifiable comorbidities were grouped into health-related conditions, substance use/withdrawal, and psychiatric conditions. Negative binomial regression and multiple logistic regression were used to model the impact of patient factors on the number of AEs experienced and the occurrence of the five previously identified common AEs, respectively. Of the 444 patients included in the study, 24.8% reported a health-related condition, 15.3% had a substance use/withdrawal condition, 8% reported having a psychiatric condition; and 79.3% experienced one or more AEs. Older age (p = 0.004) and more severe injuries (p < 0.001) were nonmodifiable independent variables significantly associated with increased AEs. The AEs experienced by patients were urinary tract infections (42.8%), pneumonia (39.2%), neuropathic pain (31.5%), delirium (18.2%), and pressure ulcers (11.0%). Risk of delirium increased in those with substance use/withdrawal; and pneumonia risk increased with psychiatric comorbidities. Opportunity exists to develop clinical algorithms that include these types of risk factors to reduce the incidence and impact of AEs.

P39 - Morbidity and Mortality of Major Adult Spinal Surgery: An Ambispective Cohort Analysis of 977 Patients

BACKGROUND CONTEXT: Patients admitted at our institution with lumbar spinal stenosis from January 2009 to December 2015 were identified. Patients with full spine adverse events severity system (SAVES) data were included.

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES?

Physicians have consistently shown poor adverse-event reporting practices in the literature and yet they have the clinical acumen to properly stratify and appraise these events. The Spine Adverse Events Severity System (SAVES) and Orthopaedic Surgical Adverse Events Severity System (OrthoSAVES) are standardized assessment tools designed to record adverse events in orthopaedic patients. These tools provide a list of prespecified adverse events for users to choose from-an aid that may improve adverse-event reporting by physicians. The primary objective was to compare surgeons' adverse-event reporting with reporting by independent clinical reviewers using SAVES Version 2 (SAVES V2) and OrthoSAVES in elective orthopaedic procedures. This was a 10-week prospective study where SAVES V2 and OrthoSAVES were used by six orthopaedic surgeons and two independent, non-MD clinical reviewers to record adverse events after all elective procedures to the point of patient discharge. Neither surgeons nor reviewers received specific training on adverse-event reporting. Surgeons were aware of the ongoing study, and reported adverse events based on their clinical interactions with the patients. Reviewers recorded adverse events by reviewing clinical notes by surgeons and other healthcare professionals (such as nurses and physiotherapists). Adverse events were graded using the severity-grading system included in SAVES V2 and OrthoSAVES. At discharge, adverse events recorded by surgeons and reviewers were recorded in our database. Adverse-event data for 164 patients were collected (48 patients who had spine surgery, 51 who had hip surgery, 34 who had knee surgery, and 31 who had shoulder surgery). Overall, 99 adverse events were captured by the reviewers, compared with 14 captured by the surgeons (p < 0.001). Surgeons adequately captured major adverse events, but failed to record minor events that were captured by the reviewers. A total of 93 of 99 (94%) adverse events reported by reviewers required only simple or minor treatment and had no long-term adverse effect. Three patients experienced adverse events that resulted in use of invasive or complex treatment that had a temporary adverse effect on outcome. Using SAVES V2 and OrthoSAVES, independent reviewers reported more minor adverse events compared with surgeons. The value of third-party reviewers requires further investigation in a detailed cost-benefit analysis. Level II, therapeutic study.

Incidence, Impact, and Risk Factors of Adverse Events in Thoracic and Lumbar Spine Fractures: An Ambispective Cohort Analysis of 390 Patients

Background Context Adverse events (AEs) in thoracic and lumbar spine fractures are common but little is known about the type of AEs that are specific to this population. Further, very little is known about the incidence and clinical impact of these AEs on patients in the presence of traumatic spinal cord injury (TSCI) and whether they are treated operatively or nonoperatively. Purpose To determine the incidence of AEs in patients with thoracic or lumbar spine fractures treated both operatively and nonoperatively and determine their impact on length of stay (LOS). Secondly, determine the difference in incidence of AEs in both neurologically intact and compromised patients. Study Design/Setting Ambispective cohort study at a quaternary referral center. Patient Sample Patients admitted at our institution with thoracic or lumbar fractures from January 2009 to December 2013 were identified. Patients with full spine adverse events severity system data (SAVES) were included. Outcome Measures Number and type of AEs collected from SAVES were assessed. Impact of AE on acute LOS was also determined. Materials and Methods No funding was received or used in this study. Data on intra-, pre-, and postoperative AEs were prospectively collected using the SAVES data collection. Logistic regression was used to model the likelihood of experiencing at least one AE based on patient characteristics. The impact of the total number of AEs experienced by a patient and that of each of the most common AEs on LOS was determined using Poisson regression. Results A total of 390 patients were included in final analysis. Total, 276 patients (70.8%) were treated operatively. Overall 140 patients (36%) experienced neurological deficit as a result of their initial injury. AEs occurred in operatively treated patients 56% of the time and only 13% of the time in the nonoperative group. The presence of neurological deficit increased the risk of AEs especially in high thoracic (T1–T6) trauma increasing the odds of having an adverse event by 12.1 ( p &lt; 0.0001). The most common AEs were urinary tract infections (UTIs) (19.7%), neuropathic pain (12.3%), pneumonias (11.8%), delirium (10.5%), and ileus (6.2%). LOS increased significantly with pneumonia ( p &lt; 0.0001) and delirium ( p = 0.0001). Conclusions The presence of neurological injury and the need for operative fixation of thoracic or lumbar injuries leads to a greater risk of adverse events. Only pneumonia and delirium consistently increase LOS.

Intraoperative Cone Beam CT (O-Arm) and Stereotactic Navigation (StealthStation) System in Complex Adult Spine Surgery: Early Experience and Learning Curve

Introduction Computer-assisted navigation and intraoperative imaging systems have been shown to improve pedicle screw accuracy in a variety of instrumented spine surgeries. There is limited data evaluating the clinical learning curve for surgeons and its relationship to patient outcomes when using intraoperative navigation and imaging systems. We examined the clinical learning curve and patient outcomes of using O-Arm and StealthStation for six fellowship-trained spine surgeons at our institution, a single quaternary referral center, from 2009 to 2013. Materials and Methods This ambispective study examined 231 surgical cases where O-arm and StealthStation were used to facilitate pedicle instrumentation. The learning curve was determined by examining the year-by-year total operative time and blood loss, operative time and blood loss per surgical level, and the incidence of surgery-related adverse events. Adverse events were prospectively collected using the spine adverse events severity system (SAVES). Results O-arm and StealthStation were acquired at our institution in late 2008 and all spine surgeons were using this navigation system by the beginning of 2009. A total of 231 patients had screws placed using the O-arm and StealthStation between January 1, 2009 and December 31, 2012. There were 430 screws placed in 27 cases in 2009, 556 screws in 54 cases in 2010, 674 screws in 59 cases in 2011, and 758 screws in 75 cases in 2012, p &lt; 0.05. The average estimated blood loss (EBL) decreased from 1,229 mL in 2009 to 907 mL in 2012, p &lt; 0.05. The EBL per case per number of levels instrumented decreased from 5.72 mL in 2008 to 2.39 mL in 2012, p &lt; 0.05. Mean operating time decreased from 407 minutes to 378 minutes from 2009 to 2012, p &lt; 0.05. The number of misplaced screws per case decreased from 0.78 to 0.54 from 2009 to 2012, p &lt; 0.05. There were no significant differences in incidences of dural tear, surgical site infection, or other surgical adverse events during the study period. Conclusion Our results demonstrate that there is a learning curve to the use of intraoperative CT-based navigation, as measured by OR time, intraoperative blood loss, and screw malposition. There were no significant differences in surgical adverse events during this learning period.

Adverse events in surgically treated cervical spondylopathic myelopathy: a prospective validated observational study.

Prospective observational study. Using validated tools to accurately identify and quantify incidence of and risks for inpatient adverse events (AEs) associated with surgical management of cervical spondylopathic myelopathy (CSM) with the goal of assisting physicians and patients in decision making. To identify patient-/disease-/technique-specific, independent risk factors for developing AEs perioperatively and affecting length of stay for patients treated surgically for CSM. Previous studies have reported an overall perioperative complication rate between 15.6% and 18.52%. A total of 104 patients underwent surgery for CSM in our academic quaternary referral center. The average age was 60.3 years (range, 34-86 yr) with a male preponderance (n = 77, 74%). The severity of myelopathy and significant comorbidities was measured and was in keeping with previously assessed populations. Surgical approach was anterior-alone (39.4%), posterior-alone (55.8%), or combined (4.8%) surgery. Inpatient AE data were collected in a rigorous, contemporaneous fashion using the previously validated Spine Adverse Events Severity System (SAVES) tool. A total AE rate of 42.3% was documented in surgically managed patients with CSM (intraoperative = 13.5%, postoperative = 37.5%). Statistically significant risk factors for postoperative AEs were identified, including number of comorbidities (P = 0.012), anterior surgical approach (P = 0.003), and number of levels operated on (P = 0.031). Multiple risk factors for length of stay were also identified, including number of AEs (P < 0.0001), Nurick Score (P < 0.0001), number of levels operated on (P = 0.006), and occurrence of deep wound infection (P < 0.0001). We report higher perioperative AE rates than previously recognized, due to the use of a validated, rigorous data collection tool. Multiple novel patient/disease severity/surgical factors with high statistical significance on perioperative AEs have been identified. 3.

Incidence, impact, and risk factors of adverse events in thoracic and lumbar spine fractures: an ambispective cohort analysis of 390 patients

Background contextAdverse events (AEs) in thoracic and lumbar spine fractures are common, but little is known about the type of AEs that are specific to this population. Furthermore, very little is known about the incidence and clinical impact of these AEs on patients in the presence of traumatic spinal cord injury and whether they are treated operatively or nonoperatively. PurposeThe purpose of this study was to determine primarily the incidence of AEs in patients with thoracic or lumbar spine fractures treated both operatively and nonoperatively and their impact on length of stay (LOS) and secondarily the difference in the incidence of AEs in both neurologically intact and compromised patients. Study design/settingThis is an ambispective cohort study at a quaternary referral center. Patient samplePatients admitted at our institution with thoracic or lumbar fractures from January 2009 to December 2013 were identified. Patients with full Spine Adverse Events Severity System (SAVES) data were included. Outcome measuresNumber and type of AEs collected from SAVES were assessed. Impact of AE on acute LOS was also determined. MethodsData on intraoperative, preoperative, and postoperative AEs were prospectively collected using the SAVES data collection. Logistic regression was used to model the likelihood of experiencing at least one AE based on the patient characteristics. The impact of the total number of AEs experienced by a patient and that of each of the most common AEs on LOS was determined using Poisson regression. ResultsThree hundred and ninety patients were included in the final analysis. Two hundred and seventy-six patients (70.8%) were treated operatively. One hundred and forty patients (36%) experienced neurologic deficit as a result of their initial injury. Adverse events occurred 56% of the time in the operatively treated patients and only 13% of the time in the nonoperative group. The presence of neurologic deficit increased the risk of AEs especially in high thoracic (T1–T6) trauma increasing the odds of having an AE by 12.1 (p<.0001). The most common AEs were urinary tract infections (19.7%), neuropathic pain (12.3%), pneumonias (11.8%), delirium (10.5%), and ileus (6.2%). Length of hospital stay increased significantly with pneumonia (p<.0001) and delirium (p=.0001). ConclusionsThe presence of neurologic injury and the need for operative fixation of thoracic or lumbar injuries lead to a greater risk of AEs. Only pneumonia and delirium consistently increase LOS.

Adverse events in emergency oncological spine surgery: a prospective analysis.

Most descriptions of spine surgery morbidity and mortality in the literature are retrospective. Emerging prospective analyses of adverse events (AEs) demonstrate significantly higher rates, suggesting underreporting in retrospective and prospective studies that do not include AEs as a targeted outcome. Emergency oncological spine surgeries are generally palliative to reduce pain and improve patients' neurology and health-related quality of life. In individuals with limited life expectancy, AEs can have catastrophic implications; therefore, an accurate AE incidence must be considered in the surgical decision-making process. The purpose of this study was to determine the true incidence of AEs associated with emergency oncological spine surgery. The authors carried out a prospective cohort study in a quaternary care referral center that included consecutive patients admitted between January 1, 2009, and December 31, 2012. Inclusion criteria were all patients undergoing emergency surgery for metastatic spine disease. AE data were reported and collected on standardized AE forms (Spine AdVerse Events Severity System, version 2 [SAVES V2] forms) at weekly dedicated morbidity and mortality rounds attended by attending surgeons, residents, fellows, and nursing staff. A total of 101 patients (50 males, 51 females) met the inclusion criteria and had complete data. Seventy-six patients (76.2%) had at least 1 AE, and 11 patients (10.9%) died during their admission. Intraoperative surgical AEs were observed in 32% of patients (9.9% incidental durotomy, 16.8% blood loss > 2 L). Transient neurological deterioration occurred in 6 patients (5.9%). Infectious complications in this patient population were significant (surgical site 6%, other 50.5%). Delirium complicated the postoperative period in 20.8% of cases. When evaluated in a rigorous prospective manner, metastatic spine surgery is associated with a higher morbidity rate than previously reported. This AE incidence must be considered by the patient, oncologist, and surgeon to determine appropriate management and preventative strategies to reduce AEs in this fragile patient population.

Reliability of the spine adverse events severity system (SAVES) for individuals with traumatic spinal cord injury.

Test-retest analysis. To determine the intra- and inter-rater reliability of the Spine Adverse Events Severity System for Spinal Cord Injury (SAVES-SCI) in patients with traumatic SCI. Quaternary care spine program in Vancouver, Canada. Ten hypothetical patient cases were developed. The cases were completed by 10 raters (seven physicians, one nurse, one physiotherapist and one researcher) who were asked to identify and grade the severity of adverse events using SAVES-SCI twice with 1-week interval. Intra- and inter-rater reliability were calculated using kappa statistics and intraclass correlation coefficients (ICC). Intra-rater reliability for both identifying and grading AEs were high with all AEs (kappa greater than 0.6) except for bone implant, diathermy burn, massive blood loss, myocardial infarction, neurological deterioration, pressure ulcer, return to operating room and tracheostomy requirement. The inter-rater reliability measured with ICC were all above 0.6 for identifying and grading intraoperative, pre and postoperative AEs and consequences of SCI. The SAVES-SCI demonstrated acceptable intra-and inter-rater reliability for a majority of the AEs. Further clarification and definition of some of the AEs as well as provision of sample training cases for clinicians would assist in reducing measurement errors. The SAVES-SCI is a useful tool to assess and capture AEs in patients with acute traumatic SCI.

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI

Background contextAdverse events (AEs) with significant resultant morbidity are common during the acute hospital care of patients with traumatic spinal cord injury (TSCI). The Rick Hansen SCI Registry (RHSCIR) collects Canada-wide data on patients with TSCI, such as sociodemographic, injury, diagnosis, intervention, and health outcome details. These data contribute to an evidence base for informing best practice and improving SCI care. As the RHSCIR captures data on patients from prehospital to community phases of care, it is an invaluable resource for providing information on health outcomes resulting from TSCI, including outcomes related to AEs. PurposeTo determine the incidence and types of AEs occurring in patients with TSCI during acute care and the impact on length of stay (LOS) and health-related quality of life (HRQOL). Study design/settingProspective cohort study at an academic quaternary referral center. Patient samplePatients with TSCI discharged from our institution between 2008 and 2010 were identified using the RHSCIR. The RHSCIR includes patients admitted to one of the participating centers across Canada, who have been clinically diagnosed with an acute TSCI or classified as AIS A, B, C, D, or cauda equina. Outcome measuresAcute-phase LOS and HRQOL were assessed for impact resulting from the number and type of AEs experienced. Health-related quality of life was determined using the short-form 36 (SF-36) physical and mental component summary scores and functional independence measure. MethodsData related to patients' injury, diagnoses, hospital admission, and SF-36 scores were obtained from the local RHSCIR. Data on intra-, pre-, and postoperative AEs were collected prospectively using the Spine Adverse Events Severity System data collection system, documenting all AEs experienced by each patient. Multivariate analyses were performed to determine whether patient and injury characteristics were associated with the number and type of AEs experienced and whether these were associated with LOS and HRQOL determined on follow-up. ResultsOne hundred seventy-one patients with TSCI were included, 81.3% were men and mean age at injury was 47.2±20.3 years. Adverse events occurred in 77.2% of patients, 14.6% experienced an intraoperative and 73.7% experienced a pre/postoperative event. The most frequent pre/postoperative AEs were urinary tract infections (UTIs) (32.2%), pneumonias (32.8%), neuropathic pain (15.2%), decubitus ulcers (14.6%), and delirium (18.7%). Length of stay was significantly affected by decubitus ulcers, delirium, pneumonias, and UTIs (p<.01), increasing 1.7 (UTIs) to 2.2 (decubitus ulcers) times compared with patients without the specific AEs. Health-related quality of life was not affected by acute care AEs but rather those identified at 1-year follow-up. ConclusionsThis prospective study found that more than 77% of patients with TSCI sustain an AE during acute hospital care, significantly higher than previously reported. We demonstrate the utility of a dedicated AE collection system and the effect of these events on health status.

Use of the Spine Adverse Events Severity System (SAVES) in patients with traumatic spinal cord injury. A comparison with institutional ICD-10 coding for the identification of acute care adverse events

Observational cohort comparison. To compare the previously validated Spine Adverse Events Severity system (SAVES) with International Classification of Diseases, Tenth Revision codes (ICD-10) codes for identifying adverse events (AEs) in patients with traumatic spinal cord injury (TSCI). Quaternary Care Spine Program. Patients discharged between 2006 and 2010 were identified from our prospective registry. Two consecutive cohorts were created based on the system used to record acute care AEs; one used ICD-10 coding by hospital coders and the other used SAVES data prospectively collected by a multidisciplinary clinical team. The ICD-10 codes were appropriately mapped to the SAVES. There were 212 patients in the ICD-10 cohort and 173 patients in the SAVES cohort. Analyses were adjusted to account for the different sample sizes, and the two cohorts were comparable based on age, gender and motor score. The SAVES system identified twice as many AEs per person as ICD-10 coding. Fifteen unique AEs were more reliably identified using SAVES, including neuropathic pain (32 × more; P<0.001), urinary tract infections (1.4 × ; P<0.05), pressure sores (2.9 × ; P<0.001) and intra-operative AEs (2.3 × ; P<0.05). Eight of these 15 AEs more frequently identified by SAVES significantly impacted length of stay (P<0.05). Risk factors such as patient age and severity of paralysis were more reliably correlated to AEs collected through SAVES than ICD-10. Implementation of the SAVES system for patients with TSCI captured more individuals experiencing AEs and more AEs per person compared with ICD-10 codes. This study demonstrates the utility of prospectively collecting AE data using validated tools.

Morbidity and mortality of major adult spinal surgery. A prospective cohort analysis of 942 consecutive patients

To date, most reports on the incidence of adverse events (AEs) in spine surgery have been retrospective and dependent on data abstraction from hospital-based administrative databases. To our knowledge, there have been no previous rigorously performed prospective analysis of all AEs occurring in the entire population of patients presenting to an academic quaternary referral center. To determine the mortality and true incidence and severity of morbidity (major and minor, medical and surgical) in adults undergoing complex spinal surgery, both trauma and elective, in a quaternary referral center. To examine the influence of the introduction of a dedicated weekly multidisciplinary rounds, and a formal abstraction tool, on the recording of this prospective perioperative morbidity data. To examine the validity and inter- and intraobserver reliability of a dedicated Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool. Ours is an academic quaternary referral center serving a population of 4.5 million people. Beginning in April 2008, a spine-specific AE-recording instrument, entitled SAVES V2, was introduced at our center for reporting, categorization, and classification of AEs. The use of this system remains an ongoing prospective study. All adult patients admitted to the spine service of a quaternary referral center for a 12-month period. A validity and an inter- and intraobserver reliability examination of the SAVES V2 system, as used at our institution. Morbidity and inhospital deaths, unplanned second surgeries during index admission, wound infections requiring reoperation, and readmissions during the same calendar year. We also examined in detail all intraoperative and nonsurgical postoperative AEs, as well as hospital length of stay (LOS). Data on all patients undergoing surgery over a 12-month period were prospectively collected using a perioperative morbidity abstraction tool at weekly dedicated mortality and morbidity rounds. This tool allows identification of each specific AE and grades the severity. Before the introduction of this system, and using the hospital inpatient database, our documented perioperative morbidity rate (major and minor, medical and surgical) was 23%. Diagnosis, operative data, hospital data, major and minor complications both medical and surgical, and deaths were recorded. One hundred percent of all patients discharged from the unit had complete data available for analysis. Nine hundred forty-two patients with an age range of 16 to 90 years (mean, 54 years; mode, 38 years) were identified. There were 552 males and 390 females. Around 58.5% of patients had undergone elective surgery. Thirty percent of patients were American Spinal Injury Association class D or worse on admission. The average LOS was 13.5 days (range, 1-221 days). Eight hundred twenty-two (87%) patients had at least one documented complication. Thirty-nine percent of these adversely affected hospital LOS. There were 14 mortalities during the study period. The rate of intraoperative surgical complication was 10.5% (4.5% incidental durotomy and 1.9% hardware malposition requiring revision and 2.2% blood loss >2 L). The incidence of postoperative complication was 73.5% (wound complications, 13.5%; delerium, 8%; pneumonia, 7%; neuropathic pain, 5%; dysphagia, 4.5%; and neurological deterioration, 3%). Major spinal surgery in the adult is associated with a high incidence of intra- and postoperative complications. We identified a very high rate of previously unrecognized postoperative complications, which adversely affect LOS. Without strict adherence to a prospective data collection system, the true complexity of this surgery may be greatly underestimated.

Spine Adverse Events Severity System (SAVES-V 2): Multicenter Development and Inter-Intra Observer Reliability Assessment

In the surgical literature the definition of an adverse event (AE), the severity of an AE and the reporting of AEs are at best inconsistent. Consequently valid comparison of AEs within or among specialties or surgical centers for the same or different procedures is often impossible.

Spine Adverse Events Severity System

A prospective validation study, preliminary single-center report. The purpose of this study was to assess the content validity and interobserver reliability of a simple severity classification system for adverse events (AEs) associated with spinal surgery. In the surgical literature what is defined as an AE, the severity of an AE, and the reporting of AEs are variable. Consequently, valid comparison of AEs within or among specialties or surgical centers for the same or different procedures is often impossible. Since 2002, a Spine Adverse Events Severity system (SAVES) has been locally developed and prospectively used. AEs were graded as I (requires none/minimal treatment, minimal effect [<1-2 days] on length of stay [LOS]), II (requires treatment and/or increases LOS [3-7 days] with no long-term sequelae), III (requires treatment and/or increased LOS [>7 days] with long-term sequelae [>6 months]), and IV (death). Content validity of the grading system was assessed using the hospital chart abstraction (current defacto gold standard) compared with the SAVES from 200 randomly selected patients. Interobserver reliability was assessed in consecutive operative cases for 1 spine surgeon during a 1-year period (2006) using 3 raters (staff surgeon, fellow, and/or resident). The prospectively administered form reported a higher number of surgical AEs (n = 43 vs. n = 30) and a similar number of medical AEs (n = 31 vs. n = 27). Compared with the chart, the AE form displayed substantial agreement for number (70%; weighted Kappa [wK] = 0.60) and type (75%; wK = 0.67) of AE. The interobserver reliability was near perfect (kappa = 0.8) for the actual grade of AE and moderate (kappa = 0.5) for the criteria behind the grading (i.e., clinical effect of the AE or the effect of the AE on LOS or both). The result of this study demonstrates improved capture of surgical AEs using SAVES. Excellent interobserver reliability between surgeons at different level of training was demonstrated with minimal education or training regarding the use of SAVES.