Mladen Djurasovic, Steven D. Glassman, John R. Dimar II, Charles H. Crawford III, Kelly R. Bratcher and Leah Y. Carreon
Clinical studies use both disease-specific and generic health outcomes measures. Disease-specific measures focus on health domains most relevant to the clinical population, while generic measures assess overall health-related quality of life. There is little information about which domains of the Oswestry Disability Index (ODI) are most important in determining improvement in overall health-related quality of life, as measured by the 36-Item Short Form Health Survey (SF-36), after lumbar spinal fusion. The objective of the study is to determine which clinical elements assessed by the ODI most influence improvement of overall health-related quality of life.
A single tertiary spine center database was used to identify patients undergoing lumbar fusion for standard degenerative indications. Patients with complete preoperative and 2-year outcomes measures were included. Pearson correlation was used to assess the relationship between improvement in each item of the ODI with improvement in the SF-36 physical component summary (PCS) score, as well as achievement of the SF-36 PCS minimum clinically important difference (MCID). Multivariate regression modeling was used to examine which items of the ODI best predicted achievement for the SF-36 PCS MCID. The effect size and standardized response mean were calculated for each of the items of the ODI.
A total of 1104 patients met inclusion criteria (674 female and 430 male patients). The mean age at surgery was 57 years. All items of the ODI showed significant correlations with the change in SF-36 PCS score and achievement of MCID for the SF-36 PCS, but only pain intensity, walking, and social life had r values > 0.4 reflecting moderate correlation. These 3 variables were also the dimensions that were independent predictors of the SF-36 PCS, and they were the only dimensions that had effect sizes and standardized response means that were moderate to large.
Of the health dimensions measured by the ODI, pain intensity, walking, and social life best predicted improvement in overall health-related quality of life, as measured using the SF-36 PCS.
Mladen Djurasovic, Katlyn E. McGraw, Kelly Bratcher, Charles H. Crawford III, John R. Dimar II, Rolando M. Puno, Steven D. Glassman, R. Kirk Owens II and Leah Y. Carreon
The goal of this study was to determine efficacy and cost-effectiveness of Cell Saver in 2- and 3-level lumbar decompression and fusion.
Patients seen at a tertiary care spine center who were undergoing a posterior 2- or 3-level lumbar decompression and fusion were randomized to have Cell Saver used during their surgery (CS group, n = 48) or not used (No Cell Saver [NCS] group, n = 47). Data regarding preoperative and postoperative hemoglobin and hematocrit, estimated blood loss, volume of Cell Saver blood reinfused, number of units and volume of allogeneic blood transfused intraoperatively and postoperatively, complications, and costs were collected. Costs associated with Cell Saver use were calculated based on units of allogeneic blood transfusions averted.
Demographics and surgical parameters were similar in both groups. The mean estimated blood loss was similar in both groups: 612 ml in the CS group and 742 ml in the NCS group. There were 53 U of allogeneic blood transfused in 29 patients in the NCS group at a total blood product cost of $67,688; and 38 U of allogeneic blood transfused in 16 patients in the CS group at a total blood cost of $113,162, resulting in a cost of $3031 per allogeneic blood transfusion averted using Cell Saver.
Cell Saver use produced lower rates of allogeneic transfusion but was found to be more expensive than using only allogeneic blood for 2- and 3-level lumbar degenerative fusions. This increased cost may be reasonable to patients who perceive that the risks associated with allogeneic transfusions are unacceptable.
■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III.
Y. Raja Rampersaud, Paul A. Anderson, John R. Dimar II, Charles G. Fisher and on behalf of the Spine Trauma Study Group and Degenerative Spine Study Group
Reporting of adverse events (AEs) in spinal surgery uses inconsistent definitions and severity grading, making it difficult to compare results between studies. The Spinal Adverse Events Severity System, version 2 (SAVES-V2) aims to standardize the classification of spine surgery AEs; however, its inter- and intraobserver reliability are unknown. The objective of this study was to assess inter- and intraobserver reliability of the SAVES-V2 grading system for assessing AEs in spinal surgery.
Two multinational, multicenter surgical study groups assessed surgical case vignettes (10 trauma and 12 degenerative cases) for AE occurrence by using SAVES-V2. Thirty-four members of the Spine Trauma Study Group (STSG) and 17 members of the Degenerative Spine Study Group (DSSG) participated in the first round of case vignettes. Six months later, the same case vignettes were randomly reorganized and presented in an otherwise identical manner. Inter- and intraobserver agreement on the presence, severity, number, and type of AE, as well as the impact of the AE on length of stay (LOS) were assessed using intraclass correlation (ICC), Cohen's kappa value, and the percentage of participants in agreement.
Agreement on the presence of AEs ranged from 97% to 100% in the 2 groups. Severity classification showed substantial interobserver (ICC = 0.75 for both groups) and intraobserver (ICC = 0.70 in DSSG, 0.71 in STSG) agreement. Judgments on the number of AEs showed high interobserver agreement and moderate intraobserver agreement in both groups. Both the STSG and DSSG had high intraobserver agreement on the type of AE; interobserver agreement for AE type was high in the STSG and fair in the DSSG. Agreement on impact of the AE on LOS was excellent in the DSSG and fair in the STSG.
There was good agreement on the presence, severity, and number of AEs in both trauma and degenerative cases in using the SAVES-V2. This grading system is a simple, reliable tool for identifying and capturing AEs in spinal surgery.
Leah Y. Carreon, Mladen Djurasovic, John R. Dimar II, R. Kirk Owens II, Charles H. Crawford III, Rolando M. Puno, Kelly R. Bratcher, Katlyn E. McGraw and Steven D. Glassman
Studies have shown that anxious or depressed patients may have poorer outcomes after lumbar fusion. These conclusions were drawn from questionnaires specifically designed to measure anxiety and depression. The objective of this study is to determine if responses to the EQ-5D anxiety/depression domain or the items used to calculate the 36-Item Short-Form Health Survey (SF-36) Mental Component Summary (MCS) can predict outcomes after lumbar fusion surgery.
Patients enrolled in the National Neurosurgery Quality and Outcomes Database from a single center with 1-year follow-up were identified. The outcomes collected include the Oswestry Disability Index (ODI), EQ-5D, SF-36, and the back- and leg-pain numeric rating scales (range 0–10). Linear regression modeling was performed to predict the 1-year ODI scores using the EQ-5D anxiety/depression domain and the 14 items used to calculate SF-36 MCS.
Complete data were available for 312 (88%) of 353 eligible patients. The mean patient age was 58.5 years, 175 (56%) patients were women, and 52 patients were smokers. After controlling for other factors, the item in the SF-36 that asks “Have you felt downhearted and depressed?” is the strongest predictor of the 1-year ODI score (r2 = 0.191; p = 0.000) and 1-year EQ-5D score (r2 = 0.205; p = 0.000). Neither the EQ-5D anxiety/depression domain nor the diagnoses of anxiety or depression were predictors of 1-year outcomes.
Patient responses to SF-36 item “Have you felt downhearted and depressed?” account for 20% of the variability of the 1-year ODI and EQ-5D scores and can be used by clinicians to screen for anxiety or depression in patients prior to lumbar fusion surgery. Clinicians may offer psychological support to these patients preoperatively in order to improve treatment outcomes.
Borys V. Gvozdyev, Leah Y. Carreon, Christopher M. Graves, Stephanie A. Riley, Katlyn E. McGraw, R. Joseph Head, John R. Dimar II and Steven D. Glassman
Patient-reported outcomes (PROs) such as the Oswestry Disability Index (ODI) and EuroQol-5D (EQ-5D) are widely used to evaluate treatment outcomes following spine surgery for degenerative conditions. The goal of this study was to use the Charlson Comorbidity Index (CCMI) as a measure of general health status, for comparison with standard PROs.
The authors examined serial CCMI scores, complications, and PROs in 371 patients treated surgically for degenerative lumbar spine conditions who were enrolled in the Quality and Outcomes Database from a single center. The cohort included 152 males (41%) with a mean age of 58.7 years. Patients with no, minor, or major complications were compared at baseline and at 1 year postoperatively.
Minor complications were observed in 177 patients (48%), and major complications in 34 (9%). There were no significant differences in preoperative ODI, EQ-5D, or CCMI among the 3 groups. At 1 year, there was a significantly greater deterioration in CCMI in the major complication group (1.03) compared with the minor (0.66) and no complication groups (0.44, p < 0.006), but no significant difference in ODI or EQ-5D.
Despite equivalent improvements in PROs, patients with major complications actually had greater deterioration in their general health status, as evidenced by worse CCMI scores. Because CCMI is predictive of medical and surgical risk, patients who sustained a major complication now carry a greater likelihood of adverse outcomes with future interventions, including subsequent spine surgery. Although PRO scores are a key metric, they fail to adequately reflect the potential long-term impact of major perioperative complications.