Impact of educational background on preoperative disease severity and postoperative outcomes among patients with lumbar spondylolisthesis: a Quality Outcomes Database study.

OBJECTIVE: Deficiency in patient education has been correlated with increased disease-related morbidity and decreased access to care. However, the associations between educational level, preoperative disease severity, and postoperative outcomes in patients with lumbar spondylolisthesis have yet to be explored. METHODS: The spondylolisthesis dataset of the Quality Outcomes Database (QOD)-a cohort with prospectively collected data by the SpineCORe study team of the 12 highest enrolling sites with an 81% follow-up at 5 years -was utilized and stratified for educational level. Patients were classified into three categories (high school or less, graduate, or postgraduate). Patient-reported outcome measures (PROMs) documented at baseline and follow-up included Oswestry Disability Index (ODI) score, EQ-5D in quality-adjusted life years, and numeric rating scale (NRS) scores for back and leg pain. Disease severity was measured with PROMs. Postoperatively, patients also completed the North American Spine Society assessment to measure their satisfaction with surgery. Multivariable regression analysis was used to compare education level with disease severity and postoperative outcomes. RESULTS: A total of 608 patients underwent analysis, with 260 individuals (42.8%) at an educational level of high school or less. On univariate analysis, baseline disease severity was worse among patients with lower levels of education. On multivariable regression analysis, patients with postgraduate level of education had significantly lower ODI scores (ß = -3.75, 95% CI -7.31 to -0.2, p = 0.039) compared to graduates, while the other PROMs were not associated with significant differences at baseline. Five years postoperatively, patients from various educational backgrounds exhibited similar rates of minimal clinically important differences in PROMs. Nevertheless, patients with the lowest educational level had higher ODI scores (27.1, p < 0.01), lower EQ-5D scores (0.701, p < 0.01), and higher NRS leg pain (3.0, p < 0.01) and back pain (4.0, p < 0.01) scores compared to those with graduate or postgraduate levels of education. The odds for postoperative satisfaction were also comparable between cohorts at 5 years (reference, graduate level; high school or less, OR 0.87, 95% CI 0.46-1.64, p = 0.659; postgraduate, OR 1.6, 95% CI 0.7-3.65, p = 0.262). CONCLUSIONS: Lower patient education level was associated with a greater baseline disease severity in patients with lumbar spondylolisthesis. Surgery demonstrated similar benefits irrespective of educational background; however, individuals with lower educational level reported lower outcomes overall. This emphasizes the need for enhanced health literacy to mitigate disparities for reported outcomes.

Computed tomography assessment of robotic versus fluoroscopic implant accuracy in sacroiliac joint fusion.

OBJECTIVE: Computed tomography is considered the gold-standard imaging tool to evaluate spinal implant accuracy. However, there are no studies that evaluate the accuracy of robotic sacroiliac joint (SIJ) implant placement using CT to date. The aim of this study was to compare the accuracy of implant placement on CT between robotic and fluoroscopic navigation for SIJ fusion and the subsequent complications and clinical outcomes of suboptimally placed screws. METHODS: A retrospective analysis of SIJ fusions utilizing either robotic or fluoroscopic guidance at a single institution was conducted from 2014 to 2023. Implant placement accuracy was evaluated on intra- or postoperative CT. Primary endpoints were SIJ screw placement accuracy and complications. Secondary endpoints were pain status at the first and second follow-ups and rates of 2-year revision surgery. Statistical analysis was performed using chi-square tests. RESULTS: Sixty-nine patients who underwent 78 SIJ fusions were included, of which 63 were robotic and 15 were fluoroscopic. The mean age of the cohort at the time of surgery was 55.9 ± 14.2 years, and 35 patients (50.7%) were female. There were 135 robotically placed and 34 fluoroscopically placed implants. A significant difference was found in implant placement accuracy between robotic and fluoroscopic fusion (97.8% vs 76.5%, p < 0.001). When comparing optimal versus suboptimal implant placement, no difference was found in the presence of 30-day complications (p = 0.98). No intraoperative complications were present in this cohort. No difference was found in subjective pain status at the first (p = 0.69) and second (p = 0.45) follow-ups between optimal and suboptimal implant placement. No patients underwent 2-year revision surgery. CONCLUSIONS: Use of robotic navigation was significantly more accurate than the use of fluoroscopic navigation for SIJ implant placement. Complications overall were low and not different between optimally and suboptimally placed implants. Suboptimally placed implants did not differ in degree of subjective pain improvement or rates of revision surgery postoperatively.

The Incremental Clinical Benefit of Adding Layers of Complexity to the Planning and Execution of Adult Spinal Deformity Corrective Surgery.

BACKGROUND AND OBJECTIVES: For patients with surgical adult spinal deformity (ASD), our understanding of alignment has evolved, especially in the last 20 years. Determination of optimal restoration of alignment and spinal shape has been increasingly studied, yet the assessment of how these alignment schematics have incrementally added benefit to outcomes remains to be evaluated. METHODS: Patients with ASD with baseline and 2-year were included, classified by 4 alignment measures: Scoliosis Research Society (SRS)-Schwab, Age-Adjusted, Roussouly, and Global Alignment and Proportion (GAP). The incremental benefits of alignment schemas were assessed in chronological order as our understanding of optimal alignment progressed. Alignment was considered improved from baseline based on SRS-Schwab 0 or decrease in severity, Age-Adjusted ideal match, Roussouly current (based on sacral slope) matching theoretical (pelvic incidence-based), and decrease in proportion. Patients separated into 4 first improving in SRS-Schwab at 2-year, second Schwab improvement and matching Age-Adjusted, third two prior with Roussouly, and fourth improvement in all four. Comparison was accomplished with means comparison tests and χ2 analyses. RESULTS: Sevenhundredthirty-two. patients met inclusion. SRS-Schwab BL: pelvic incidence-lumbar lordosis mismatch (++:32.9%), sagittal vertical axis (++: 23%), pelvic tilt (++:24.6%). 640 (87.4%) met criteria for first, 517 (70.6%) second, 176 (24%) third, and 55 (7.5%) fourth. The addition of Roussouly (third) resulted in lower rates of mechanical complications and proximal junctional kyphosis (48.3%) and higher rates of meeting minimal clinically important difference (MCID) for physical component summary and SRS-Mental (P < .05) compared with the second. Fourth compared with the third had higher rates of MCID for ODI (44.2% vs third: 28.3%, P = .011) and SRS-Appearance (70.6% vs 44.8%, P < .001). Mechanical complications and proximal junctional kyphosis were lower with the addition of Roussouly (P = .024), while the addition of GAP had higher rates of meeting MCID for SRS-22 Appearance (P = .002) and Oswestry Disability Index (P = .085). CONCLUSION: Our evaluation of the incremental benefit that alignment schemas have provided in ASD corrective surgery suggests that the addition of Roussouly provided the greatest reduction in mechanical complications, while the incorporation of GAP provided the most significant improvement in patient-reported outcomes.

Fit-for-Purpose Ki-67 Immunohistochemistry Assays for Breast Cancer.

New therapies are being developed for breast cancer, and in this process, some "old" biomarkers are reutilized and given a new purpose. It is not always recognized that by changing a biomarker's intended use, a new biomarker assay is created. The Ki-67 biomarker is typically assessed by immunohistochemistry (IHC) to provide a proliferative index in breast cancer. Canadian laboratories assessed the analytical performance and diagnostic accuracy of their Ki-67 IHC laboratory-developed tests (LDTs) of relevance for the LDTs' clinical utility. Canadian clinical IHC laboratories enrolled in the Canadian Biomarker Quality Assurance Pilot Run for Ki-67 in breast cancer by invitation. The Dako Ki-67 IHC pharmDx assay was employed as a study reference assay. The Dako central laboratory was the reference laboratory. Participants received unstained slides of breast cancer tissue microarrays with 32 cases and performed their in-house Ki-67 assays. The results were assessed using QuPath, an open-source software application for bioimage analysis. Positive percent agreement (PPA, sensitivity) and negative percent agreement (NPA, specificity) were calculated against the Dako Ki-67 IHC pharmDx assay for 5%, 10%, 20%, and 30% cutoffs. Overall, PPA and NPA varied depending on the selected cutoff; participants were more successful with 5% and 10%, than with 20% and 30% cutoffs. Only 4 of 16 laboratories had robust IHC protocols with acceptable PPA for all cutoffs. The lowest PPA for the 5% cutoff was 85%, for 10% was 63%, for 20% was 14%, and for 30% was 13%. The lowest NPA for the 5% cutoff was 50%, for 10% was 33%, for 20% was 50%, and for 30% was 57%. Despite many years of international efforts to standardize IHC testing for Ki-67 in breast cancer, our results indicate that Canadian clinical LDTs have a wide analytical sensitivity range and poor agreement for 20% and 30% cutoffs. The poor agreement was not due to the readout but rather due to IHC protocol conditions. International Ki-67 in Breast Cancer Working Group (IKWG) recommendations related to Ki-67 IHC standardization cannot take full effect without reliable fit-for-purpose reference materials that are required for the initial assay calibration, assay performance monitoring, and proficiency testing.

Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study.

OBJECTIVES: The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi. DESIGN: We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach. SETTING: First-level hospitals in Neno district, Malawi. PARTICIPANTS: Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers. RESULTS: Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management. CONCLUSIONS: Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings. TRIAL REGISTRATION NUMBER: PACTR202102832069874; Post-results.

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial.

OBJECTIVES: To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes. DESIGN: A 2:1 open randomised controlled feasibility trial. SETTING: Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi. PARTICIPANTS: 45 people living with type 1 diabetes (PLWT1D). INTERVENTIONS: Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education. OUTCOMES: Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life. RESULTS: Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention. CONCLUSIONS: This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Is Upper Extremity or Lower Extremity Function More Important for Patient Satisfaction? An Analysis of 24-Month Outcomes from the QOD Cervical Spondylotic Myelopathy Cohort.

STUDY DESIGN: Retrospective analysis of a prospective, multicenter registry. OBJECTIVE: To assess whether upper or lower limb mJOA improvement more strongly associates with patient satisfaction after surgery for cervical spondylotic myelopathy (CSM). SUMMARY OF BACKGROUND DATA: The modified Japanese Orthopaedic Association (mJOA) is commonly used to assess functional status in patients with CSM. Patients present with upper and/or lower extremity dysfunction, and it is unclear whether improvement in one and/or both symptoms drives postoperative patient satisfaction. METHODS: This study utilizes the prospective Quality Outcomes Database (QOD) CSM data set. Clinical outcomes included mJOA and North American Spine Society (NASS) satisfaction. The upper limb mJOA score was defined as upper motor plus sensory mJOA, and the lower limb mJOA as lower motor plus sensory mJOA. Ordered logistic regression was used to determine whether upper or lower limb mJOA was more closely associated with NASS satisfaction, adjusting for other covariates. RESULTS: Overall, 1141 patients were enrolled in the QOD CSM cohort. In all, 780 had both preoperative and 24-month mJOA scores, met inclusion criteria, and were included for analysis. The baseline mJOA was 12.1±2.7, and postoperatively, 85.6% would undergo surgery again (NASS 1 or 2, satisfied). Patients exhibited mean improvement in both upper (baseline:3.9±1.4 vs. 24 mo:5.0±1.1, P<0.001) and lower limb mJOA (baseline:3.9±1.4 vs. 24 mon:4.5±1.5, P<0.001); however, the 24-month change in the upper limb mJOA was greater (upper:1.1±1.6 vs. lower:0.6±1.6, P<0.001). Across 24-month NASS satisfaction, the baseline upper and lower limb mJOA scores were similar (pupper=0.28, plower=0.092). However, as satisfaction decreased, the 24-month change in upper and lower limb mJOA decreased as well (pupper<0.001, plower<0.001). Patients with NASS scores of 4 (lowest satisfaction) did not demonstrate significant differences from baseline in upper or lower limb mJOA (P>0.05). In ordered logistic regression, NASS satisfaction was independently associated with upper limb mJOA improvement (OR=0.81; 95% CI: 0.68-0.97; P=0.019) but not lower limb mJOA improvement (OR=0.84; 95% CI: 0.70-1.0; P=0.054). CONCLUSIONS: As the magnitude of upper and lower mJOA improvement decreased postoperatively, so too did patient satisfaction with surgical intervention. Upper limb mJOA improvement was a significant independent predictor of patient satisfaction, whereas lower limb mJOA improvement was not. These findings may aid preoperative counseling, stratified by patients' upper and lower extremity treatment expectations. LEVEL OF EVIDENCE: Level-III.

Comparing posterior cervical foraminotomy with anterior cervical discectomy and fusion in radiculopathic patients: an analysis from the Quality Outcomes Database.

OBJECTIVE: The objective of this study was to compare clinical and patient-reported outcomes (PROs) between posterior foraminotomy and anterior cervical discectomy and fusion (ACDF) in patients presenting with cervical radiculopathy. METHODS: The Quality Outcomes Database was queried for patients who had undergone ACDF or posterior foraminotomy for radiculopathy. To create two highly homogeneous groups, optimal individual matching was performed at a 5:1 ratio between the two groups on 29 baseline variables (including demographic characteristics, comorbidities, symptoms, patient-reported scores, underlying pathologies, and levels treated). Outcomes of interest were length of stay, reoperations, patient-reported satisfaction, increase in EQ-5D score, and decrease in Neck Disability Index (NDI) scores for arm and neck pain as long as 1 year after surgery. Noninferiority analysis of achieving patient satisfaction and minimal clinically important difference (MCID) in PROs was performed with an accepted risk difference of 5%. RESULTS: A total of 7805 eligible patients were identified: 216 of these underwent posterior foraminotomy and were matched to 1080 patients who underwent ACDF. The patients who underwent ACDF had more underlying pathologies, lower EQ-5D scores, and higher NDI and neck pain scores at baseline. Posterior foraminotomy was associated with shorter hospitalization (0.5 vs 0.9 days, p < 0.001). Reoperations within 12 months were significantly more common among the posterior foraminotomy group (4.2% vs 1.9%, p = 0.04). The two groups performed similarly in PROs, with posterior foraminotomy being noninferior to ACDF in achieving MCID in EQ-5D and neck pain scores but also having lower rates of maximal satisfaction at 12 months (North American Spine Society score of 1 achieved by 65.2% posterior foraminotomy patients vs 74.6% of ACDF patients, p = 0.02). CONCLUSIONS: The two procedures were found to be offered to different populations, with ACDF being selected for patients with more complicated pathologies and symptoms. After individual matching, posterior foraminotomy was associated with a higher reoperation risk within 1 year after surgery compared to ACDF (4.2% vs 1.9%). In terms of 12-month PROs, posterior foraminotomy was noninferior to ACDF in improving quality of life and neck pain. The two procedures also performed similarly in improving NDI scores and arm pain, but ACDF patients had higher maximal satisfaction rates.

Cost-effectiveness of a pediatric operating room installation in Sub-Saharan Africa.

The unmet need for pediatric surgery imposes enormous health and economic consequences globally, predominantly shouldered by Sub-Saharan Africa (SSA) where children comprise almost half of the population. Lack of knowledge about the economic impact of improving pediatric surgical infrastructure in SSA inhibits the informed allocation of limited resources towards the most cost-effective interventions to bolster global surgery for children. We assessed the cost-effectiveness of installing and running two dedicated pediatric operating rooms (ORs) in a hospital in Nigeria with a pre-existing pediatric surgical service by constructing a decision tree model of pediatric surgical delivery at this facility over a year, comparing scenarios before and after the installation of the ORs, which were funded philanthropically. Health outcomes measured in disability-adjusted life years (DALYs) averted were informed by the hospital's operative registry and prior literature. We adopted an all healthcare payor's perspective including costs incurred by the local healthcare system, the installation (funded by the charity), and patients' families. Costs were annualized and reported in 2021 United States dollars ($). The incremental cost-effectiveness ratios (ICERs) of the annualized OR installation and operation were presented. One-way and probabilistic sensitivity analyses were performed. We found that installing and operating two dedicated pediatric ORs averted 538 DALYs and cost $177,527 annually. The ICER of the ORs' installation and operation was $330 per DALY averted (95% uncertainty interval [UI] 315-336) from the all healthcare payor's perspective. This ICER was well under the cost-effectiveness threshold of the country's half-GDP per capita in 2020 ($1043) and remained cost-effective in one-way and probabilistic sensitivity analyses. Installation of additional dedicated pediatric operating rooms in Nigeria with pre-existing pediatric surgical capacity is therefore very cost-effective, supporting investment in children's global surgical infrastructure as an economically sound intervention.

Development and validation of an artificial intelligence model to accurately predict spinopelvic parameters.

OBJECTIVE: Achieving appropriate spinopelvic alignment has been shown to be associated with improved clinical symptoms. However, measurement of spinopelvic radiographic parameters is time-intensive and interobserver reliability is a concern. Automated measurement tools have the promise of rapid and consistent measurements, but existing tools are still limited to some degree by manual user-entry requirements. This study presents a novel artificial intelligence (AI) tool called SpinePose that automatically predicts spinopelvic parameters with high accuracy without the need for manual entry. METHODS: SpinePose was trained and validated on 761 sagittal whole-spine radiographs to predict the sagittal vertical axis (SVA), pelvic tilt (PT), pelvic incidence (PI), sacral slope (SS), lumbar lordosis (LL), T1 pelvic angle (T1PA), and L1 pelvic angle (L1PA). A separate test set of 40 radiographs was labeled by four reviewers, including fellowship-trained spine surgeons and a fellowship-trained radiologist with neuroradiology subspecialty certification. Median errors relative to the most senior reviewer were calculated to determine model accuracy on test images. Intraclass correlation coefficients (ICCs) were used to assess interrater reliability. RESULTS: SpinePose exhibited the following median (interquartile range) parameter errors: SVA 2.2 mm (2.3 mm) (p = 0.93), PT 1.3° (1.2°) (p = 0.48), SS 1.7° (2.2°) (p = 0.64), PI 2.2° (2.1°) (p = 0.24), LL 2.6° (4.0°) (p = 0.89), T1PA 1.1° (0.9°) (p = 0.42), and L1PA 1.4° (1.6°) (p = 0.49). Model predictions also exhibited excellent reliability at all parameters (ICC 0.91-1.0). CONCLUSIONS: SpinePose accurately predicted spinopelvic parameters with excellent reliability comparable to that of fellowship-trained spine surgeons and neuroradiologists. Utilization of predictive AI tools in spinal imaging can substantially aid in patient selection and surgical planning.

The impact of anxiety and depression on lumbar spine surgical outcomes: a Michigan Spine Surgery Improvement Collaborative study.

OBJECTIVE: The presence of depression and anxiety has been associated with negative outcomes in spine surgery patients. While it seems evident that a history of depression or anxiety can negatively influence outcome, the exact additive effect of both has not been extensively studied in a multicenter trial. The purpose of this study was to investigate the relationship between a patient's history of anxiety and depression and their patient-reported outcomes (PROs) after lumbar surgery. METHODS: Patients in the Michigan Spine Surgery Improvement Collaborative registry undergoing lumbar spine surgery between July 2016 and December 2021 were grouped into four cohorts: those with a history of anxiety only, those with a history of depression only, those with both, and those with neither. Primary outcomes were achieving the minimal clinically important difference (MCID) for the Patient-Reported Outcomes Measurement Information System Physical Function 4-item Short Form (PROMIS PF), EQ-5D, and numeric rating scale (NRS) back pain and leg pain, and North American Spine Society patient satisfaction. Secondary outcomes included surgical site infection, hospital readmission, and return to the operating room. Multivariate Poisson generalized estimating equation models were used to report incidence rate ratios (IRRs) from patient baseline variables. RESULTS: Of the 45,565 patients identified, 3941 reported a history of anxiety, 5017 reported a history of depression, 9570 reported both, and 27,037 reported neither. Compared with those who reported having neither, patients with both anxiety and depression had lower patient satisfaction at 90 days (p = 0.002) and 1 year (p = 0.021); PROMIS PF MCID at 90 days (p < 0.001), 1 year (p < 0.001), and 2 years (p = 0.006); EQ-5D MCID at 90 days (p < 0.001), 1 year (p < 0.001), and 2 years (p < 0.001); NRS back pain MCID at 90 days (p < 0.001) and 1 year (p < 0.001); and NRS leg pain MCID at 90 days (p < 0.001), 1 year (p = 0.024), and 2 years (p = 0.027). Patients with anxiety only (p < 0.001), depression only (p < 0.001), or both (p < 0.001) were more likely to be readmitted within 90 days. Additionally, patients with anxiety only (p = 0.015) and both anxiety and depression (p = 0.015) had higher rates of surgical site infection. Patients with anxiety only (p = 0.006) and depression only (p = 0.021) also had higher rates of return to the operating room. CONCLUSIONS: The authors observed an association between a history of anxiety and depression and negative outcome after lumbar spine surgery. In addition, they found an additive effect of a history of both anxiety and depression with an increased risk of negative outcome when compared with either anxiety or depression alone.

Risk factors of emergency department visits following elective cervical and lumbar surgical procedures: a multi-institution analysis from the Michigan Spine Surgery Improvement Collaborative.

OBJECTIVE: Emergency department visits 90 days after elective spinal surgery are relatively common, with rates ranging from 9% to 29%. Emergency visits are very costly, so their reduction is of importance. This study's objective was to evaluate the reasons for emergency department visits and determine potentially modifiable risk factors. METHODS: This study retrospectively reviewed data queried from the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry from July 2020 to November 2021. MSSIC is a multicenter (28-hospital) registry of patients undergoing cervical and lumbar degenerative spinal surgery. Adult patients treated for elective cervical and/or lumbar spine surgery for degenerative pathology (spondylosis, intervertebral disc disease, low-grade spondylolisthesis) were included. Emergency department visits within 90 days of surgery (outcome measure) were analyzed utilizing univariate and multivariate regression analyses. RESULTS: Of 16,224 patients, 2024 (12.5%) presented to the emergency department during the study period, most commonly for pain related to spinal surgery (31.5%), abdominal problems (15.8%), and pain unrelated to the spinal surgery (12.8%). On multivariate analysis, age (per 5-year increase) (relative risk [RR] 0.94, 95% CI 0.92-0.95), college education (RR 0.82, 95% CI 0.69-0.96), private insurance (RR 0.79, 95% CI 0.70-0.89), and preoperative ambulation status (RR 0.88, 95% CI 0.79-0.97) were associated with decreased emergency visits. Conversely, Black race (RR 1.30, 95% CI 1.13-1.51), current diabetes (RR 1.13, 95% CI 1.01-1.26), history of deep venous thromboembolism (RR 1.28, 95% CI 1.16-1.43), history of depression (RR 1.13, 95% CI 1.03-1.25), history of anxiety (RR 1.32, 95% CI 1.19-1.46), history of osteoporosis (RR 1.21, 95% CI 1.09-1.34), history of chronic obstructive pulmonary disease (RR 1.19, 95% CI 1.06-1.34), American Society of Anesthesiologists class > II (RR 1.18, 95% CI 1.08-1.29), and length of stay > 3 days (RR 1.29, 95% CI 1.16-1.44) were associated with increased emergency visits. CONCLUSIONS: The most common reasons for emergency department visits were surgical pain, abdominal dysfunction, and pain unrelated to index spinal surgery. Increased focus on postoperative pain management and bowel regimen can potentially reduce emergency visits. The risks of diabetes, history of osteoporosis, depression, and anxiety are areas for additional preoperative screening.

What is the effect of preoperative depression on outcomes after minimally invasive surgery for adult spinal deformity? A prospective cohort analysis.

OBJECTIVE: Depression has been implicated with worse immediate postoperative outcomes in adult spinal deformity (ASD) correction, yet the specific impact of depression on those patients undergoing minimally invasive surgery (MIS) requires further clarity. This study aimed to evaluate the role of depression in the recovery of patients with ASD after undergoing MIS. METHODS: Patients who underwent MIS for ASD with a minimum postoperative follow-up of 1 year were included from a prospectively collected, multicenter registry. Two cohorts of patients were identified that consisted of either those affirming or denying depression on preoperative assessment. The patient-reported outcome measures (PROMs) compared included scores on the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back and leg pain, Scoliosis Research Society Outcomes Questionnaire (SRS-22), SF-36 physical component summary, SF-36 mental component summary (MCS), EQ-5D, and EQ-5D visual analog scale. RESULTS: Twenty-seven of 147 (18.4%) patients screened positive for preoperative depression. The nondepressed cohort had an average of 4.83 levels fused, and the depressed cohort had 5.56 levels fused per patient (p = 0.267). At 1-year follow-up, 10 patients still reported depression, representing a 63% decrease. Postoperatively, both cohorts demonstrated improvement in their PROMs; however, at 1-year follow-up, those without depression had statistically better outcomes based on the EQ-5D, MCS, and SRS-22 scores (p < 0.05). Patients with depression continued to experience higher NRS leg scores at 1-year follow-up (3.63 vs 2.22, p = 0.018). After controlling for covariates, the authors found that depression significantly impacted only 1-year follow-up MCS scores (ß = 8.490, p < 0.05). CONCLUSIONS: Depressed and nondepressed patients reported similar improvements after MIS surgery, except MCS scores were more likely to improve in nondepressed patients.

Aggregation of rhodopsin mutants in mouse models of autosomal dominant retinitis pigmentosa.

Mutations in rhodopsin can cause it to misfold and lead to retinal degeneration. A distinguishing feature of these mutants in vitro is that they mislocalize and aggregate. It is unclear whether or not these features contribute to retinal degeneration observed in vivo. The effect of P23H and G188R misfolding mutations were examined in a heterologous expression system and knockin mouse models, including a mouse model generated here expressing the G188R rhodopsin mutant. In vitro characterizations demonstrate that both mutants aggregate, with the G188R mutant exhibiting a more severe aggregation profile compared to the P23H mutant. The potential for rhodopsin mutants to aggregate in vivo was assessed by PROTEOSTAT, a dye that labels aggregated proteins. Both mutants mislocalize in photoreceptor cells and PROTEOSTAT staining was detected surrounding the nuclei of photoreceptor cells. The G188R mutant promotes a more severe retinal degeneration phenotype and greater PROTEOSTAT staining compared to that promoted by the P23H mutant. Here, we show that the level of PROTEOSTAT positive cells mirrors the progression and level of photoreceptor cell death, which suggests a potential role for rhodopsin aggregation in retinal degeneration.

Cervical spondylotic myelopathy and driving abilities: defining the prevalence and long-term postoperative outcomes using the Quality Outcomes Database.

OBJECTIVE: Cervical spondylotic myelopathy (CSM) can cause significant difficulty with driving and a subsequent reduction in an individual's quality of life due to neurological deterioration. The positive impact of surgery on postoperative patient-reported driving capabilities has been seldom explored. METHODS: The CSM module of the Quality Outcomes Database was utilized. Patient-reported driving ability was assessed via the driving section of the Neck Disability Index (NDI) questionnaire. This is an ordinal scale in which 0 represents the absence of symptoms while driving and 5 represents a complete inability to drive due to symptoms. Patients were considered to have an impairment in their driving ability if they reported an NDI driving score of 3 or higher (signifying impairment in driving duration due to symptoms). Multivariable logistic regression models were fitted to evaluate mediators of baseline impairment and improvement at 24 months after surgery, which was defined as an NDI driving score < 3. RESULTS: A total of 1128 patients who underwent surgical intervention for CSM were included, of whom 354 (31.4%) had baseline driving impairment due to CSM. Moderate (OR 2.3) and severe (OR 6.3) neck pain, severe arm pain (OR 1.6), mild-moderate (OR 2.1) and severe (OR 2.5) impairment in hand/arm dexterity, severe impairment in leg use/walking (OR 1.9), and severe impairment of urinary function (OR 1.8) were associated with impaired driving ability at baseline. Of the 291 patients with baseline impairment and available 24-month follow-up data, 209 (71.8%) reported postoperative improvement in their driving ability. This improvement seemed to be mediated particularly through the achievement of the minimal clinically important difference (MCID) in neck pain and improvement in leg function/walking. Patients with improved driving at 24 months noted higher postoperative satisfaction (88.5% vs 62.2%, p < 0.01) and were more likely to achieve a clinically significant improvement in their quality of life (50.7% vs 37.8%, p < 0.01). CONCLUSIONS: Nearly one-third of patients with CSM report impaired driving ability at presentation. Seventy-two percent of these patients reported improvements in their driving ability within 24 months of surgery. Surgical management of CSM can significantly improve patients' driving abilities at 24 months and hence patients' quality of life.

Does Tighter Glycemic Control Beyond Hemoglobin A1c of 8% Improve Outcome for Lumbar Spine Surgery? A MSSIC Study.

BACKGROUND AND OBJECTIVES: Diabetes mellitus is associated with increased risk of postoperative adverse outcomes. Previous studies have emphasized the role of glycemic control in postoperative complications. This study aims to ascertain whether controlling hemoglobin A1c (HbA1c) lower than 8% preoperatively results in meaningful risk reduction or improved outcomes. METHODS: We used patient-level data from the Michigan Spine Surgery Improvement Collaborative registry, focusing on patients who underwent elective lumbar spine surgery between 2018 and 2021. The primary outcomes were length of stay and the occurrence of postoperative adverse events. Secondary outcomes included patient satisfaction, achievement of a minimum clinically important difference (MCID) of Patient-Reported Outcomes Measurement Information System-Physical Function, the EuroQol-5D and NRS of leg and back pain, and return to work. RESULTS: A total of 11 348 patients were included in this analysis. Patients with HbA1c above the thresholds before surgery had significantly higher risks of urinary retention for all 3 possible threshold values (incidence rate ratio [IRR] = 1.30, P = .015; IRR = 1.35, P = .001; IRR = 1.25, P = .011 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively). They also had longer hospital stay (IRR = 1.04, P = .002; IRR = 1.03, P = .001; IRR = 1.03, P < .001 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively) and had higher risks of developing any complication with HbA1c cutoff of 7.5% (IRR = 1.09, P = .010) and 7% (IRR = 1.12, P = .001). Diabetics with preoperative HbA1c above all 3 thresholds were less likely to achieve Patient-Reported Outcomes Measurement Information System MCID at the 90-day follow-up (IRR = .81, P < .001; IRR = .86, P < .001; IRR = .90, P = .007 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively) and less likely to achieve EuroQol-5D MCID at the 2-year follow-up (IRR = .87, P = .027; IRR = .84, P = .005 for the HbA1c cutoffs of 7.5% and 7%, respectively). CONCLUSION: Our study suggests that reducing HbA1c below 8% may have diminishing returns regarding reducing complications after spine surgery.

An Integrated 3-Dimentional Navigation System Increases the Accuracy, Efficiency, and Safety of Percutaneous Thoracolumbar Pedicle Screw Placement in Minimally Invasive Approaches: A Randomized Cadaveric Study.

STUDY DESIGN: Cadaveric study. OBJECTIVES: The purpose of this study was to compare a novel, integrated 3D navigational system (NAV) and conventional fluoroscopy in the accuracy, efficiency, and radiation exposure of thoracolumbar percutaneous pedicle screw (PPS) placement. METHODS: Twelve skeletally mature cadaveric specimens were obtained for twelve individual surgeons. Each participant placed bilateral PS at 11 segments, from T8 to S1. Prior to insertion, surgeons were randomized to the sequence of techniques and the side (left or right). Following placement, a CT scan of the spine was obtained for each cadaver, and an independent reviewer assessed the accuracy of screw placement using the Gertzbein grading system. Outcome metrics of interest included a comparison of breach incidence/severity, screw placement time, total procedure time, and radiation exposure between the techniques. Bivariate statistics were employed to compare outcomes at each level. RESULTS: A total of 262 screws (131 using each technique) were placed. The incidence of cortical breaches was significantly lower with NAV compared to FG (9% vs 18%; P = .048). Of breaches with NAV, 25% were graded as moderate or severe compared to 39% in the FG subgroup (P = .034). Median time for screw placement was significantly lower with NAV (2.7 vs 4.1 min/screw; P = .012), exclusive of registration time. Cumulative radiation exposure to the surgeon was significantly lower for NAV-guided placement (9.4 vs 134 µGy, P = .02). CONCLUSIONS: The use of NAV significantly decreased the incidence of cortical breaches, the severity of screw breeches, screw placement time, and radiation exposure to the surgeon when compared to traditional FG.

Does the number of social factors affect long-term patient-reported outcomes and satisfaction in those with cervical myelopathy? A QOD study.

OBJECTIVE: It is not clear whether there is an additive effect of social factors in keeping patients with cervical spondylotic myelopathy (CSM) from achieving both a minimum clinically important difference (MCID) in outcomes and satisfaction after surgery. The aim of this study was to explore the effect of multiple social factors on postoperative outcomes and satisfaction. METHODS: This was a multiinstitutional, retrospective study of the prospective Quality Outcomes Database (QOD) CSM cohort, which included patients aged 18 years or older who were diagnosed with primary CSM and underwent operative management. Social factors included race (White vs non-White), education (high school or below vs above), employment (employed vs not), and insurance (private vs nonprivate). Patients were considered to have improved from surgery if the following criteria were met: 1) they reported a score of 1 or 2 on the North American Spine Society index, and 2) they met the MCID in patient-reported outcomes (i.e., visual analog scale [VAS] neck and arm pain, Neck Disability Index [NDI], and EuroQol-5D [EQ-5D]). RESULTS: Of the 1141 patients included in the study, 205 (18.0%) had 0, 347 (30.4%) had 1, 334 (29.3%) had 2, and 255 (22.3%) had 3 social factors. The 24-month follow-up rate was > 80% for all patient-reported outcomes. After adjusting for all relevant covariates (p < 0.02), patients with 1 or more social factors were less likely to improve from surgery in all measured outcomes including VAS neck pain (OR 0.90, 95% CI 0.83-0.99) and arm pain (OR 0.88, 95% CI 0.80-0.96); NDI (OR 0.90, 95% CI 0.83-0.98); and EQ-5D (OR 0.90, 95% CI 0.83-0.97) (all p < 0.05) compared to those without any social factors. Patients with 2 social factors (outcomes: neck pain OR 0.86, arm pain OR 0.81, NDI OR 0.84, EQ-5D OR 0.81; all p < 0.05) or 3 social factors (outcomes: neck pain OR 0.84, arm pain OR 0.84, NDI OR 0.84, EQ-5D OR 0.84; all p < 0.05) were more likely to fare worse in all outcomes compared to those with only 1 social factor. CONCLUSIONS: Compared to those without any social factors, patients who had at least 1 social factor were less likely to achieve MCID and feel satisfied after surgery. The effect of social factors is additive in that patients with a higher number of factors are less likely to improve compared to those with only 1 social factor.

What predicts the best 24-month outcomes following surgery for cervical spondylotic myelopathy? A QOD prospective registry study.

OBJECTIVE: The aim of this study was to identify predictors of the best 24-month improvements in patients undergoing surgery for cervical spondylotic myelopathy (CSM). For this purpose, the authors leveraged a large prospective cohort of surgically treated patients with CSM to identify factors predicting the best outcomes for disability, quality of life, and functional status following surgery. METHODS: This was a retrospective analysis of prospectively collected data. The Quality Outcomes Database (QOD) CSM dataset (1141 patients) at 14 top enrolling sites was used. Baseline and surgical characteristics were compared for those reporting the top and bottom 20th percentile 24-month Neck Disability Index (NDI), EuroQol-5D (EQ-5D), and modified Japanese Orthopaedic Association (mJOA) change scores. A multivariable logistic model was constructed and included candidate variables reaching p ≤ 0.20 on univariate analyses. Least important variables were removed in a stepwise manner to determine the significant predictors of the best outcomes (top 20th percentile) for 24-month NDI, EQ-5D, and mJOA change. RESULTS: A total of 948 (83.1%) patients with 24-month follow-up were included in this study. For NDI, 204 (17.9%) had the best NDI outcome and 200 (17.5%) had the worst NDI outcome. Factors predicting the best NDI outcomes included symptom duration less than 12 months (OR 1.5, 95% CI 1.1-1.9; p = 0.01); procedure other than posterior fusion (OR 1.5, 95% CI 1.03-2.1; p = 0.03); higher preoperative visual analog scale neck pain score (OR 1.2, 95% CI 1.1-1.3; p < 0.001); and higher baseline NDI (OR 1.06, 95% CI 1.05-1.07; p < 0.001). For EQ-5D, 163 (14.3%) had the best EQ-5D outcome and 169 (14.8%) had the worst EQ-5D outcome. Factors predicting the best EQ-5D outcomes included arm pain-only complaints (compared to neck pain) (OR 1.9, 95% CI 1.3-2.9; p = 0.002) and lower baseline EQ-5D (OR 167.7 per unit lower, 95% CI 85.0-339.4; p < 0.001). For mJOA, 222 (19.5%) had the best mJOA outcome and 238 (20.9%) had the worst mJOA outcome. Factors predicting the best mJOA outcomes included lower BMI (OR 1.03 per unit lower, 95% CI 1.004-1.05; p = 0.02; cutoff value of ≤ 29.5 kg/m2); arm pain-only complaints (compared to neck pain) (OR 1.7, 95% CI 1.1-2.5; p = 0.02); and lower baseline mJOA (OR 1.6 per unit lower, 95% CI 1.5-1.7; p < 0.001). CONCLUSIONS: Compared to the worst outcomes for EQ-5D, the best outcomes were associated with patients with arm pain-only complaints. For mJOA, lower BMI and arm pain-only complaints portended the best outcomes. For NDI, those with the best outcomes had shorter symptom durations, higher preoperative neck pain scores, and less often underwent posterior spinal fusions. Given the positive impact of shorter symptom duration on outcomes, these data suggest that early surgery may be beneficial for patients with CSM.

Patient-Centered Outcomes Following Prone Lateral Single-Position Approach to Same-Day Circumferential Spine Surgery.

STUDY DESIGN: Retrospective study. OBJECTIVE: Evaluate surgical characteristics and postoperative 2-year results of the PL approach to spinal fusion. SUMMARY OF BACKGROUND DATA: Prone-lateral(PL) single positioning has recently gained popularity in spine surgery due to lower blood loss and operative time but has yet to be examined for other notable outcomes, including realignment and patient-reported measures. MATERIALS AND METHODS: We included circumferential spine fusion patients with a minimum one-year follow-up. Patients were stratified into groups based on undergoing PL approach versus same-day staged (Staged). Mean comparison tests identified differences in baseline parameters. Multivariable logistic regression, controlling for age, levels fused, and Charlson Comorbidity Index were used to determine the influence of the approach on complication rates, radiographic and patient-reported outcomes up to two years. RESULTS: One hundred twenty-two patients were included of which 72(59%) were same-day staged and 50(41%) were PL. PL patients were older with lower body mass index (both P <0.05). Patients undergoing PL procedures had lower estimated blood loss and operative time (both P <0.001), along with fewer osteotomies (63% vs. 91%, P <0.001). This translated to a shorter length of stay (3.8 d vs. 4.9, P =0.041). PL procedures demonstrated better correction in both PT (4.0 vs. -0.2, P =0.033 and pelvic incidence and lumbar lordosis (-3.7 vs. 3.1, P =0.012). PL procedures were more likely to improve in GAP relative pelvic version (OR: 2.3, [1.5-8.8]; P =0.003]. PL patients suffered lesser complications during the perioperative period and greater improvement in NRS-Back (-6.0 vs. -3.3, P =0.031), with less reoperations (0.0% vs. 4.8%, P =0.040) by two years. CONCLUSIONS: Patients undergoing PL single-position procedures received less invasive procedures with better correction of pelvic compensation, as well as earlier discharge. The prone lateral cohort also demonstrated greater clinical improvement and a lower rate of reoperations by two years following spinal corrective surgery. LEVEL OF EVIDENCE: Level-III.