Safety Of Spine Surgery Research Articles

Proposal for a complementary safety checklist for spine surgery

IntroductionOnce the World Health Oraganization (WHO) generic surgical checklist has been standardized and following the itinerary proposed, it is up to the different specialties to continue advancing in the improvement and adjustment of the checklists to their specific procedures. MethodsThrough a Failure Mode and Effects Analysis (FMEA) in which professionals from the surgical area of ​​the Torrecárdenas University Hospital, Jaén Hospital Complex and Gregorio Marañón General University Hospital participated, aspects that threaten patient safety in spine surgery and that are not included in the WHO generic surgical checklist were proposed. The authors scored each of the proposed items incrementally based on the degree of suitability. Based on the score obtained, they selected those who would be incorporated into the specific safety checklist. ResultsA total of twenty-one candidate items were proposed to be part of the specific check list. These obtained scores between 15 and 11 points. After scoring them, it was decided to include the thirteen best rated in the definitive surgical checklist, seven of them in the initial phase, two in the phase prior to the incision and another four in the final part of the checklist prior to the completion of the procedure. ConclusionsProfessionals in the surgical area of ​​Neurosurgery can identify aspects not included in the generic checklist whose non-compliance can affect patient safety in spine surgery to at least the same extent as those included in WHO checklist.It is possible to propose a specific complementary checklist for spinal surgery, responsible for collecting aspects related to safety and success in these procedures.

Does Intrawound Vancomycin Decrease Postoperative Surgical Site Infection in Spine Surgery: A Retrospective Case-control Study.

Retrospective Case-Control series. The objective of this study is to define the overall postoperative rate of surgical site infection (SSI) in patients undergoing spine surgery and examine the effects of intrawound Vancomycin on postoperative infection rates. Surgical site infections (SSI) account for 22% of all health care-associated infections. The use of intrawound Vancomycin in an attempt to reduce the incidence of postoperative SSI has not been sufficiently evaluated in the existing literature. All spine surgeries (n=19,081) from our institution were reviewed from 2003 to 2013. All cases of verified SSI were identified from the database. Cases were then matched to controls in a 1:1 fashion based on age, gender, and date of surgery (+/-30d). Patient demographics, comorbidities, estimated blood loss, duration of surgery, intrawound administration of Vancomycin, and smoking status were evaluated. At total of 316 cases of SSI after spine surgery were identified, representing an infection rate of 1.7%. The mean follow-up for cases and controls was 31.5 and 41.6 months, respectively. OR for intrawound Vancomycin was 0.44 (95% CI 0.23-0.88, P =0.019). OR for BMI greater than 30 was 1.63 (95% CI 1.04-2.56, P =0.03). In this large cohort of spine surgery patients, administration of intrawound Vancomycin was associated with a significant reduction in postoperative surgical site infections. Further studies are needed to determine appropriate dosing and application as well as long-term safety in spine surgery.

Spine Surgeon Estimation of Patient Health Literacy

Lower health literacy is associated with worse patient outcomes, yet physicians tend to overestimate patients’ health literacy. To assess spine surgeons’ ability to accurately estimate patients’ health literacy, this study administered the Newest Vital Sign (NVS) to spine surgery patients and recorded two spine surgeons’ estimations of those patients’ health literacy levels. Spine surgeons’ estimates were in moderate agreement with patients’ NVS scores, and spine surgeons tended to overestimate patients’ health literacy. Surgeons’ estimates were more accurate for patients with the following characteristics: Adequate health literacy, White, age 60 and older, and male. These findings highlight the potential for routine NVS administration to promote health equity, quality, and safety in spine surgery.

CORR Insights®: Do Community-level Disadvantages Account for Racial Disparities in the Safety of Spine Surgery? A Large Database Study Based on Medicare Claims.

CORR Insights®: Do Community-level Disadvantages Account for Racial Disparities in the Safety of Spine Surgery? A Large Database Study Based on Medicare Claims.

Do Community-level Disadvantages Account for Racial Disparities in the Safety of Spine Surgery? A Large Database Study Based on Medicare Claims.

Racial health disparities across orthopaedic surgery subspecialties, including spine surgery, are well established. However, the underlying causes of these disparities, particularly relating to social determinants of health, are not fully understood. (1) Is there a racial difference in 90-day mortality, readmission, and complication rates ("safety outcomes") among Medicare beneficiaries after spine surgery? (2) To what degree does the Centers for Disease Control and Prevention Social Vulnerability Index (SVI), a community-level marker of social determinants of health, account for racial disparities in safety outcomes? To examine racial differences in 90-day mortality, readmission, and complications after spine surgery, we retrospectively identified all 419,533 Medicare beneficiaries aged 65 or older who underwent inpatient spine surgery from 2015 to 2019; we excluded 181,588 patients with endstage renal disease or Social Security disability insurance entitlements, who were on Medicare HMO, or who had missing SVI data. Because of the nearly universal coverage of those age 65 or older, Medicare data offer a large cohort that is broadly generalizable, provides improved precision for relatively rare safety outcomes, and is free of confounding from differential insurance access across races. The Master Beneficiary Summary File includes enrollees' self-reported race based on a restrictive list of mutually exclusive options. Even though this does not fully capture the entirety of racial diversity, it is self-reported by patients. Identification of spine surgery was based on five Diagnosis Related Groups labeled "cervical fusion," "fusion, except cervical," "anterior-posterior combined fusion," "complex fusion," and "back or neck, except fusion." Although heterogeneous, these cohorts do not reflect inherently different biology that would lead us to expect differences in safety outcomes by race. We report specific types of complications that did and did not involve readmission. Although complications vary in severity, we report them as composite measures while being cognizant of the inherent limitations of making inferences based on aggregate measures. The SVI was chosen as the mediating variable because it aggregates important social determinants of health and has been shown to be a marker of high risk of poor public health response to external stressors. Patients were categorized into three groups based on a ranking of the four SVI themes: socioeconomic status, household composition, minority status and language, and housing and transportation. We report the "average race effects" among Black patients compared with White patients using nearest-neighbor Mahalanobis matching by age, gender, comorbidities, and spine surgery type. Mahalanobis matching provided the best balance among propensity-type matching methods. Before matching, Black patients in Medicare undergoing spine surgery were disproportionately younger with more comorbidities and were less likely to undergo cervical fusion. To estimate the contribution of the SVI on racial disparities in safety outcomes, we report the average race effect between models with and without the addition of the four SVI themes. After matching on age, gender, comorbidities, and spine surgery type, Black patients were on average more likely than White patients to be readmitted (difference of 1.5% [95% CI 0.9% to 2.1%]; p < 0.001) and have complications with (difference of 1.2% [95% CI 0.5% to 1.9%]; p = 0.002) or without readmission (difference of 3.6% [95% CI 2.9% to 4.3%]; p < 0.001). Adding the SVI to the model attenuated these differences, explaining 17% to 49% of the racial differences in safety, depending on the outcome. An observed higher rate of 90-day mortality among Black patients was explained entirely by matching using non-SVI patient demographics (difference of 0.00% [95% CI -0.3% to 0.3%]; p = 0.99). However, even after adjusting for the SVI, Black patients had more readmissions and complications. Social disadvantage explains up to nearly 50% of the disparities in safety outcomes between Black and White Medicare patients after spine surgery. This argument highlights an important contribution of socioeconomic circumstances and societal barriers to achieving equal outcomes. But even after accounting for the SVI, there remained persistently unequal safety outcomes among Black patients compared with White patients, suggesting that other unmeasured factors contribute to the disparities. This is consistent with evidence documenting Black patients' disadvantages within a system of seemingly equal access and resources. Research on racial health disparities in orthopaedics should account for the SVI to avoid suggesting that race causes any observed differences in complications among patients when other factors related to social deprivation are more likely to be determinative. Focused social policies aiming to rectify structural disadvantages faced by disadvantaged communities may lead to a meaningful reduction in racial health disparities. Level III, therapeutic study.

209. Does increased regional discretionary spending correlate with safety in spine surgery among Medicare beneficiaries?

<h3>BACKGROUND CONTEXT</h3> Spine surgery in Medicare patients has increased in recent years and its use is variable across geographic regions. Corresponding wide variation in costs are also well-documented. Provider care intensity, a marker for discretionary care (eg, unnecessary imaging, tests, injections, and visits), is the component of spending variation that is independent of patient severity, age, and regional pricing. It is unknown if greater provider care intensity is associated with improved safety, as we might expect from value-based care. <h3>PURPOSE</h3> To determine if increased provider care intensity was associated with safety among five Medicare cohorts undergoing spinal surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective analysis of Medicare claims, 2013-2017. <h3>PATIENT SAMPLE</h3> We included beneficiaries (age 65+) undergoing inpatient spinal surgery as defined by the Center for Medicare and Medicaid Innovation, including "cervical fusion," "fusion, except cervical," "anterior-posterior combined fusion," "complex fusion," and "back or neck surgery, except fusion." Claims included variables on age, sex and race, as well as codes from the International Classification of Diseases, used to calculate the Charlson Comorbidity Index. Regional 90-day episode costs for the five cohorts ranged from a low of $32,384 for cervical fusion to a high of $123,388 for complex fusion. <h3>OUTCOME MEASURES</h3> Safety was measured as mortality, pulmonary embolism, deep vein thrombosis, and all-cause readmission over the first 90-days following surgery. <h3>METHODS</h3> Patients were classified by the Hospital Referral Region (HRR) where surgery occurred. Regions were grouped into quintiles based on the Dartmouth Atlas End-of-Life Expenditure Index (EOL), reflecting spending variation due to practice care intensity. Multivariable regression examined the association between care intensity and our safety measures, controlling for age, sex, race, and comorbidity. To further mitigate unobserved confounding by indication, we also added year and hospital fixed-effects parameters, and applied EOL as an instrumental variable. <h3>RESULTS</h3> Within each cohort, we observed a 4-fold variation in 90-day episode cost across HRRs. Spine-specific spending was correlated with EOL quintile, confirming that spending variation is due to provider care intensity more than pricing, age, or illness severity. Greater spending across EOL quintile was not associated with improved safety, and in-fact, was associated with significantly worse outcomes in some cohorts. For example, all-cause readmission was greater in the high spending quintile relative to the low spending quintile among the "Fusion, except cervical" cohort (14.2% vs 13.1%; OR 1.10; 95% CI 1.05 – 1.20; p<0.001), the "complex fusion" cohort (28.0% vs 25.4%; OR 1.15; 95% CI 1.01 – 1.30; p=0.033), and the "cervical fusion" cohort (15.0% vs 13.6%; OR 1.12; 95% CI 1.05 – 1.20; p<0.001). Fixed effects and instrumental variable models yielded consistent results. <h3>CONCLUSIONS</h3> Wide variation in regional 90-day episode-of-care spine spending was not explained by differences in patient severity, age, or regional pricing. Hospitals in the highest spending quintile spent between $10,378 (back & neck) to $35,533 (complex fusion) more per patient than those in the lowest quintile, but increased spending did not result in enhanced safety. These findings point to inefficient and potentially wasteful use of health care resources, which should be a focus of payment reforms. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

"The Jackson Table Is a Pain in the…": A Qualitative Study of Providers' Perception Toward a Spinal Surgery Table.

The aim of this study was to define health care providers' perceptions toward prone patient positioning for spine surgery using the Jackson Table, which has not been hitherto explored. We analyzed open-ended questionnaire data and interviews conducted with the spine surgical team regarding the current process of spinal positioning/repositioning using the Jackson Table. Participants were asked to provide an open-ended explanation as to whether they think the current process of spinal positioning/repositioning is safe for the staff or patients. Follow-up qualitative interviews were conducted with 11 of the participants to gain an in-depth understanding of the challenges and safety issues related to prone patient positioning. Data analysis resulted in 6 main categories: general challenges with patient positioning, role-specific challenges, challenges with the Jackson Table and the "sandwich" mechanism, safety concerns for patients, safety concerns for the medical staff, and recommendations for best practices. This study is relevant to everyday practice for spinal surgical team members and advances our understanding of how surgical teams qualitatively view the current process of patient positioning for spinal surgery. Providers recommended best practices for using the Jackson Table, which can be achieved through standardized practice for transfer of patients, educational tools, and checklists for equipment before patient transfer and positioning. This research has identified several important practice opportunities for improving provider and patient safety in spine surgery.

Improving Safety in Spine Surgery: Reducing Perioperative Blood Loss and Transfusion Requirements

Improving Safety in Spine Surgery: Reducing Perioperative Blood Loss and Transfusion Requirements

A valid model for predicting responsible nerve roots in lumbar degenerative disease with diagnostic doubt.

ObjectiveTo construct and validate a model to predict responsible nerve roots in lumbar degenerative disease with diagnostic doubt (DD).MethodsFrom January 2009-January 2013, 163 patients with DD were assigned to the construction (n = 106) or validation sample (n = 57) according to different admission times to hospital. Outcome was assessed according to the Japanese Orthopedic Association (JOA) recovery rate as excellent, good, fair, and poor. The first two results were considered as effective clinical outcome (ECO). Baseline patient and clinical characteristics were considered as secondary variables. A multivariate logistic regression model was used to construct a model with the ECO as a dependent variable and other factors as explanatory variables. The odds ratios (ORs) of each risk factor were adjusted and transformed into a scoring system. Area under the curve (AUC) was calculated and validated in both internal and external samples. Moreover, calibration plot and predictive ability of this scoring system were also tested for further validation.ResultsPatients with DD with ECOs in both construction and validation models were around 76 % (76.4 and 75.5 % respectively). Risk factors: more preoperative visual analog pain scale (VAS) score (OR = 1.56, p < 0.01), stenosis levels of L4/5 or L5/S1 (OR = 1.44, p = 0.04), stenosis locations with neuroforamen (OR = 1.95, p = 0.01), neurological deficit (OR = 1.62, p = 0.01), and more VAS improvement of selective nerve route block (SNRB) (OR = 3.42, p = 0.02). Validation: the internal area under the curve (AUC) was 0.85, and the external AUC was 0.72, with a good calibration plot of prediction accuracy. Besides, the predictive ability of ECOs was not different from the actual results (p = 0.532).ConclusionsWe have constructed and validated a predictive model for confirming responsible nerve roots in patients with DD. The associated risk factors were preoperative VAS score, stenosis levels of L4/5 or L5/S1, stenosis locations with neuroforamen, neurological deficit, and VAS improvement of SNRB. A tool such as this is beneficial in the preoperative counseling of patients, shared surgical decision making, and ultimately improving safety in spine surgery.

Patient safety in spine surgery: regarding the wrong-site surgery.

Patient safety regarding wrong site surgery has been one of the priority issues in surgical fields including that of spine care. Since the wrong-side surgery in the DM foot patient was reported on a public mass media in 1996, the wrong-site surgery issue has attracted wide public interest as regarding patient safety. Despite the many wrong-site surgery prevention campaigns in spine care such as the operate through your initial program by the Canadian Orthopaedic Association, the sign your site program by the American Academy of Orthopedic Surgeon, the sign, mark and X-ray program by the North American Spine Society, and the Universal Protocol program by the Joint Commission, the incidence of wrong-site surgery has not decreased. To prevent wrong-site surgery in spine surgeries, the spine surgeons must put patient safety first, complying with the hospital policies regarding patient safety. In the operating rooms, the surgeons need to do their best to level the hierarchy, enabling all to speak up if any patient safety concerns are noted. Changing the operating room culture is the essential part of the patient safety concerning spine surgery.

Navigation-guided posterior fixation plus transpedicular vertebroplasty for thoracolumbar fractures

ObjectiveTo assess the outcomes of navigation-guided posterior fixation plus transpedicular vertebroplasty for thoracolumbar fractures.MethodsFrom June, 2005 through March,2009, 30 patients with thoracolumbar fracture underwent navigation-guided posterior fixation with transpedicular vertebroplasty in our department. They were 18 men and 12 women, aged from 21 to 57 years (mean,35.5 years). Three fractures occurred on T11, 11 on T12, 14 on L1, and 2 on L2.Results The follow-ups averaged 18 months ( 12 to 36 months). Of the 120 pedicle screws inserted, 110 were of degree 0, 8of degree I, 2 of degree Ⅱ, 0 of degree Ⅲ. The total good to excellent rate was 98.3％ for the screw insertion. Before operation, the average canal compromise was 37.5％ (5％ to 70％ ), the average vertebrae compression was 54. 5％ (40％ to 70％ ), and the average Cobb angle was 29. 5° ( 15.5° to 41.5°). Postoperatively the average canal compromise was 14. 3％ (0 to 20％ ), the average height of vertebrae was 91.3％ (80％ to 100％ ) and the average Cobb angle was 4. 9° ( 1. 3° to 9. 1°). The long-term follow-ups showed an average Cobb angle loss of ＜ 1° and an average vertebral height loss of ＜ 2 mm.Conclusions The navigation-guided posterior fixation plus transpedicular vertebroplasty is an effective treatment for thoracolumbar fractures. Computer-assisted navigation system enhances accuracy and further improves the safety of spine surgery, compared with just the anterior or posterior fixation. Key words: Su rgery, computer-assisted; Spil al fracture; Fracture fixation, internal; Bone graft

Blood Loss in Major Spine Surgery

Systematic review. To determine the definition and incidence of significant hemorrhage in adult spine fusion surgery, and to assess whether measures to decrease hemorrhage are effective. Significant hemorrhage and associated comorbidities in spine fusion surgery have not yet been clearly identified. Several preoperative and intraoperative techniques are currently available to reduce blood loss and transfusion requirements such as cell saver (CS), recombinant factor VIIa, and perioperative antifibrinolytic agents, such as aprotinin, tranexamic acid, and epsilon-aminocaproic acid. Their effectiveness and safety in spine surgery is uncertain. A systematic review of the English-language literature was undertaken for articles published between January 1990 and April 2009. Electronic databases and reference lists of key articles were searched to identify published studies examining blood loss in major spine surgery. Two independent reviewers assessed the quality of the literature using the Grading of Recommendations Assessment, Development, and Evaluation criteria. Disagreements were resolved by consensus. A total of 90 articles were initially screened, and 17 ultimately met the predetermined inclusion criteria. No studies were found that attempted to define significant hemorrhage in adult spine surgery. We found that there is a high level of evidence that antifibrinolytic agents reduce blood loss and the need of transfusion in adult spine surgery; however, the safety profile of these agents is unclear. There is very low evidence to support the use of CS, recombinant factor VIIa, activated growth factor platelet gel, or normovolemic hemodilution as a method to prevent massive hemorrhage in spine fusion surgery. There is no consensus definition of significant hemorrhage in adult spine fusion surgery. However, definition in the anesthesiology literature of massive blood loss is somewhat arbitrary but is commonly accepted to entail loss of 1 volume of the patient's total blood (60 mL/kg in adults) in <24 hours. On the basis of the current literature, there is little support for routine use of CS during elective spinal surgery. Concerns related to the use of aprotinin were such that our panel of experts unanimously recommended against its use in spine surgery on the basis of the reports of increased complications. With respect to the antifibrinolytics of the lysine analog class (tranexamic acid and aminocaproic acid), on the basis of the available efficacy and safety data, we recommend that they be considered as possible agents to help reduce major hemorrhage in adult spine surgery.

Methods for the Systematic Reviews on Patient Safety During Spine Surgery

Systematic review. To provide a detailed description of the methods undertaken in the systematic search and analytical summary of patient safety issues in spinal surgery, and to describe the process used to come to a clinical recommendation regarding challenges in the management of patients undergoing spine surgery. A solid understanding of complication type, incidence, risk factors, and impact is implicit to the physician's role in developing an informed patient centered decision with respect to surgical intervention. We present methods used in conducting the systematic, evidence-based reviews, and expert panel recommendations of key challenges to the spine surgical practice. It is our desire that spine surgeons will use the information from these reviews together with an understanding of their own capacities and experience to better inform patients with respect to potential treatment outcomes, safety, and life impact. A systematic search and critical review of the English language literature was undertaken for articles published on the safety of various surgical spine conditions. Citations were screened for relevance using a priori criteria, and relevant studies were critically reviewed. The strength of evidence for the overall body of literature in each topic area was determined by 2 independent reviewers considering study quality, study quantity, and consistency of results. Disagreements were resolved by consensus. Findings from studies meeting inclusion criteria were summarized. From these summaries, clinical recommendations were formulated from consensus achieved among subject experts through the Delphi process. We identified and screened 2020 citations in 13 topic areas relating to safety in spine surgery. Of these, 273 met our predetermined inclusion criteria and were used to attempt to answer specific clinical questions within each topic area. We undertook systematic reviews to establish a baseline of the current evidence on patient safety issues in spine surgery. This article reports the methods used in the reviews.