Reliability of a Smartphone App to Objectively Monitor Performance Outcomes in Degenerative Cervical Myelopathy: Observational Study.

BACKGROUND: Developing new clinical measures for degenerative cervical myelopathy (DCM) is an AO Spine RECODE-DCM Research, an international and multi-stakeholder partnership, priority. Difficulties in detecting DCM and its changes cause diagnostic and treatment delays in clinical settings and heightened costs in clinical trials due to elevated recruitment targets. Digital outcome measures can tackle these challenges due to their ability to measure disease remotely, repeatedly, and more economically. OBJECTIVE: The aim of this study is to assess the reliability of the MoveMed battery of performance outcome measures. METHODS: A prospective observational study in decentralized secondary care was performed in England, United Kingdom. The primary outcome was to determine the test-retest reliability of the MoveMed performance outcomes using the intraclass correlation (ICC) of agreement . The secondary outcome was to determine the measurement error of the MoveMed performance outcomes using both the SE of the mean (SEM) of agreement and the smallest detectable change (SDC) of agreement . Criteria from the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) manual were used to determine adequate reliability (ie, ICC of agreement ≥0.7) and risk of bias. Disease stability was controlled using 2 minimum clinically important difference (MCID) thresholds obtained from the literature on the patient-derived modified Japanese Orthopaedic Association (p-mJOA) score, namely, MCID ≤1 point and MCID ≤2 points. RESULTS: In total, 7 adults aged 59.5 (SD 12.4) years who live with DCM and possess an approved smartphone participated in the study. All tests demonstrated moderate to excellent test-retest coefficients and low measurement errors. In the MCID ≤1 group, ICC of agreement values were 0.84-0.94 in the fast tap test, 0.89-0.95 in the hold test, 0.95 in the typing test, and 0.98 in the stand and walk test. SEM of agreement values were ±1 tap, ±1%-3% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively. SDC of agreement values were ±3 taps, ±4%-7% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. In the MCID ≤2 group, ICC of agreement values were 0.61-0.91, 0.75-0.77, 0.98, and 0.62, respectively; SEM of agreement values were ±1 tap, ±2%-4% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively; and SDC of agreement values were ±3-7 taps, ±7%-10% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. Furthermore, the fast tap, hold, and typing tests obtained sufficient ratings (ICC of agreement ≥0.7) in both MCID ≤1 and MCID ≤2 groups. No risk of bias factors from the COSMIN Risk of Bias checklist were recorded. CONCLUSIONS: The criteria from COSMIN provide "very good" quality evidence of the reliability of the MoveMed tests in an adult population living with DCM.

Safety and Efficacy of Surgical Implantation of Intrathecal Drug Delivery Pumps in Patients With Cancer With Refractory Pain.

BACKGROUND AND OBJECTIVES: Pain management in patients with cancer is a critical issue in oncology palliative care as clinicians aim to enhance quality of life and mitigate suffering. Most patients with cancer experience cancer-related pain, and 30%-40% of patients experience intractable pain despite maximal medical therapy. Intrathecal pain pumps (ITPs) have emerged as an option for achieving pain control in patients with cancer. Owing to the potential benefits of ITPs, we sought to study the long-term outcomes of this form of pain management at a cancer center. METHODS: We retrospectively reviewed medical records of all adult patients with cancer who underwent ITP placement at a tertiary comprehensive cancer center between 2013 and 2021. Baseline characteristics, preoperative and postoperative pain control, and postoperative complication rate data were collected. RESULTS: A total of 193 patients were included. We found that the average Numerical Rating Scale (NRS) score decreased significantly by 4.08 points (SD = 2.13, P < .01), from an average NRS of 7.38 (SD = 1.64) to an average NRS of 3.27 (SD = 1.66). Of 185 patients with preoperative and follow-up NRS pain scores, all but 9 experienced a decrease in NRS (95.1%). The median overall survival from time of pump placement was 3.62 months (95% CI: 2.73-4.54). A total of 42 adverse events in 33 patients were reported during the study period. The 1-year cumulative incidence of any complication was 15.6% (95% CI: 10.9%-21.1%) and for severe complication was 5.7% (95% CI: 3.0%-9.7%). Eleven patients required reoperation during the study period, with a 1-year cumulative incidence of 4.2% (95% CI: 2.0%-7.7%). CONCLUSION: Our study demonstrates that ITP implantation for the treatment of cancer-related pain is a safe and effective method of pain palliation with a low complication rate. Future prospective studies are required to determine the optimal timing of ITP implantation.

A Clinical Practice Guideline for Prevention, Diagnosis and Management of Intraoperative Spinal Cord Injury: Recommendations for Use of Intraoperative Neuromonitoring and for the Use of Preoperative and Intraoperative Protocols for Patients Undergoing Spine Surgery.

STUDY DESIGN: Development of a clinical practice guideline following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) process. OBJECTIVE: The objectives of this study were to develop guidelines that outline the utility of intraoperative neuromonitoring (IONM) to detect intraoperative spinal cord injury (ISCI) among patients undergoing spine surgery, to define a subset of patients undergoing spine surgery at higher risk for ISCI and to develop protocols to prevent, diagnose, and manage ISCI. METHODS: All systematic reviews were performed according to PRISMA standards and registered on PROSPERO. A multidisciplinary, international Guidelines Development Group (GDG) reviewed and discussed the evidence using GRADE protocols. Consensus was defined by 80% agreement among GDG members. A systematic review and diagnostic test accuracy (DTA) meta-analysis was performed to synthesize pooled evidence on the diagnostic accuracy of IONM to detect ISCI among patients undergoing spinal surgery. The IONM modalities evaluated included somatosensory evoked potentials (SSEPs), motor evoked potentials (MEPs), electromyography (EMG), and multimodal neuromonitoring. Utilizing this knowledge and their clinical experience, the multidisciplinary GDG created recommendations for the use of IONM to identify ISCI in patients undergoing spine surgery. The evidence related to existing care pathways to manage ISCI was summarized and based on this a novel AO Spine-PRAXIS care pathway was created. RESULTS: Our recommendations are as follows: (1) We recommend that intraoperative neurophysiological monitoring be employed for high risk patients undergoing spine surgery, and (2) We suggest that patients at "high risk" for ISCI during spine surgery be proactively identified, that after identification of such patients, multi-disciplinary team discussions be undertaken to manage patients, and that an intraoperative protocol including the use of IONM be implemented. A care pathway for the prevention, diagnosis, and management of ISCI has been developed by the GDG. CONCLUSION: We anticipate that these guidelines will promote the use of IONM to detect and manage ISCI, and promote the use of preoperative and intraoperative checklists by surgeons and other team members for high risk patients undergoing spine surgery. We welcome teams to implement and evaluate the care pathway created by our GDG.

Treatment of intramedullary spinal cord tumors: a modified Delphi technique of the North American Spine Society Section of Spine Oncology.

OBJECTIVE: Intramedullary spinal cord tumors (IMSCTs) are rare tumors with heterogeneous presentations and natural histories that complicate their management. Standardized guidelines are lacking on when to surgically intervene and the appropriate aggressiveness of resection, especially given the risk of new neurological deficits following resection of infiltrative tumors. Here, the authors present the results of a modified Delphi method using input from surgeons experienced with IMSCT removal to construct a framework for the operative management of IMSCTs based on the clinical, radiographic, and tumor-specific characteristics. METHODS: A modified Delphi technique was conducted using a group of 14 neurosurgeons experienced in IMSCT resection. Three rounds of written correspondence, surveys, and videoconferencing were carried out. Participants were queried about clinical and radiographic criteria used to determine operative candidacy and guide decision-making. Members then completed a final survey indicating their choice of observation or surgery, choice of resection strategy, and decision to perform duraplasty, in response to a set of patient- and tumor-specific characteristics. Consensus was defined as ≥ 80% agreement, while responses with 70%-79% agreement were defined as agreement. RESULTS: Thirty-six total characteristics were assessed. There was consensus favoring surgical intervention for patients with new-onset myelopathy (86% agreement), chronic myelopathy (86%), or progression from mild to disabling numbness (86%), but disagreement for patients with mild numbness or chronic paraplegia. Age was not a determinant of operative candidacy except among frail patients, who were deemed more suitable for observation (93%). Well-circumscribed (93%) or posteriorly located tumors reaching the surface (86%) were consensus surgical lesions, and participants agreed that the presence of syringomyelia (71%) and peritumoral T2 signal change (79%) were favorable indications for surgery. There was consensus that complete loss of transcranial motor evoked potentials with a 50% decrease in the D-wave amplitude should halt further resection (93%). Preoperative symptoms seldom influenced choice of resection strategy, while a distinct cleavage plane (100%) or visible tumor-cord margins (100%) strongly favored gross-total resection. CONCLUSIONS: The authors present a modified Delphi technique highlighting areas of consensus and agreement regarding surgical management of IMSCTs. Although not intended as a substitute for individual clinical decision-making, the results can help guide care of these patients. Additionally, areas of controversy meriting further investigation are highlighted.

Spine MRI Identifies Clinically Relevant Findings in Patients With Cancer Presenting With Back Pain.

STUDY DESIGN: This is a retrospective, cross-sectional study. OBJECTIVE: The primary aim was to identify the diagnostic yield of spine magnetic resonance imaging (MRI) in detecting malignant pathology in cancer patients with back pain. We also sought to evaluate the role of MRI extent ( i.e. regional vs. total) in identifying malignant pathology. SUMMARY OF BACKGROUND DATA: No prior study has systematically investigated the yield of spine MRI in a large cohort of cancer patients. METHODS: Spine MRI reports from 2017 to 2021 for back pain (acute and nonspecified chronicity) in cancer patients were reviewed to identify clinically relevant findings: malignant (1) epidural, (2) leptomeningeal, (3) intramedullary, (4) osseous disease, and (5) fracture. Logistic regression was used to evaluate the association between MRI extent and the presence of cancer-related findings. For patients with multiple MRIs, short-interval scans (≤4 mo) were evaluated to assess the yield of repeat imaging. RESULTS: At least one cancer-related finding was identified on 52% of 5989 spine MRIs ordered for back pain and 57% of 1130 spine MRIs ordered specifically for acute back pain. The most common pathology was malignant osseous disease (2545; 43%). Across all five categories, most findings (77%-89%) were new/progressive. Odds of identifying a finding were significantly higher with total versus regional spine MRIs ( P <0.001). Although only 14 patients had a positive regional MRI followed shortly by a positive total spine MRI, most of these repeat total spine MRIs (78%) identified findings outside the scope of the initial regional scan. Twenty-one patients had both computed tomography and MRI within 30 days of each other; eight (38%) had compression fractures appreciated on MRI but not on computed tomography. CONCLUSIONS: Our findings suggest imaging the total spine in cancer patients with back pain given higher odds of identifying malignant pathology and instances of capturing otherwise not visualized disease. Further work is warranted to confirm these findings.

Gender and Sex Differences in Health-related Quality of Life, Clinical Outcomes and Survival after Treatment of Metastatic Spine Disease.

STUDY DESIGN: Retrospective review of prospective, multicenter and international cohort study. OBJECTIVE: To describe the effect of gender on HRQoL, clinical outcomes and survival for patients with spinal metastases treated with either surgery and/or radiation. SUMMARY OF BACKGROUND DATA: Gender differences in health-related outcomes are demonstrated in numerous studies, with women experiencing worse outcomes and receiving lower standards of care than men, however, the influence that gender has on low health-related quality of life (HRQoL) and clinical outcomes after spine surgery remains unclear. METHODS: Patient demographic data, overall survival, treatment details, perioperative complications, and HRQoL measures including EQ-5D, pain NRS, the short form 36 version 2 (SF-36v2) and the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) were reviewed. Patients were stratified by sex, and a separate sensitivity analysis that excluded gender-specific cancers (i.e., breast, prostate, etc.) was performed. RESULTS: The study cohort included 207 female and 183 male patients, with age, smoking status, and site of primary cancer being significantly different between the two cohorts (P<0.001). Both males and females experienced significantly improved SOSGOQ2.0, EQ-5D, and pain NRS scores at all study time points from baseline (P<0.001). Upon sensitivity analysis, (gender-specific cancers removed from analysis), the significant improvement in SOSGOQ physical, mental, and social subdomains and on SF-36 domains disappeared for females. Males experienced higher rates of postoperative complications. Kaplan-Meier survival analysis of both the overall and sensitivity analysis cohorts showed females lived longer than males after treatment (P=0.001 and 0.043, respectively). CONCLUSION: Both males and females experienced significantly improved HRQoL scores after treatment, but females demonstrated longer survival and a lower complication rate. This study suggests that gender may be a prognostic factor in survival and clinical outcomes for patients undergoing treatment for spine metastases and should be taken into consideration when counseling patients accordingly.

Role of Frailty Status in Prediction of Clinical Outcomes of Traumatic Spinal Injury: A Systematic Review and Meta-Analysis.

Although many frailty tools have been used to predict traumatic spinal injury (TSI) outcomes, identifying predictors of outcomes after TSI in the aged population is difficult. Frailty, age, and TSI association are interesting topics of discussion in geriatric literature. However, the association between these variables are yet to be clearly elucidated. We conducted a systematic review to investigate the association between frailty and TSI outcomes. The authors searched Medline, EMBASE, Scopus, and Web of Science for relevant studies. Studies with observational designs that assessed baseline frailty status in individuals suffering from TSI published from inception until 26th March 2023 were included. Length of hospital stay (LoS), adverse events (AEs), and mortality were the outcomes of interest. Of the 2425 citations, 16 studies involving 37,640 participants were included. The modified frailty index (mFI) was the most common tool used to assess frailty. Meta-analysis was employed only in studies that used mFI for measuring frailty. Frailty was significantly associated with increased in-hospital or 30-day mortality (pooled odds ratio [OR]: 1.93 [1.19; 3.11]), non-routine discharge (pooled OR: 2.44 [1.34; 4.44]), and AEs or complications (pooled OR: 2.00 [1.14; 3.50]). However, no significant relationship was found between frailty and LoS (pooled OR: 3.02 [0.86; 10.60]). Heterogeneity was observed across multiple factors, including age, injury level, frailty assessment tool, and spinal cord injury characteristics. In conclusion, although there is limited data concerning using frailty scales to predict short-term outcomes after TSI, the results showed that frailty status may be a predictor of in-hospital mortality, AEs, and unfavorable discharge destination.

Health system-scale language models are all-purpose prediction engines.

Physicians make critical time-constrained decisions every day. Clinical predictive models can help physicians and administrators make decisions by forecasting clinical and operational events. Existing structured data-based clinical predictive models have limited use in everyday practice owing to complexity in data processing, as well as model development and deployment1-3. Here we show that unstructured clinical notes from the electronic health record can enable the training of clinical language models, which can be used as all-purpose clinical predictive engines with low-resistance development and deployment. Our approach leverages recent advances in natural language processing4,5 to train a large language model for medical language (NYUTron) and subsequently fine-tune it across a wide range of clinical and operational predictive tasks. We evaluated our approach within our health system for five such tasks: 30-day all-cause readmission prediction, in-hospital mortality prediction, comorbidity index prediction, length of stay prediction, and insurance denial prediction. We show that NYUTron has an area under the curve (AUC) of 78.7-94.9%, with an improvement of 5.36-14.7% in the AUC compared with traditional models. We additionally demonstrate the benefits of pretraining with clinical text, the potential for increasing generalizability to different sites through fine-tuning and the full deployment of our system in a prospective, single-arm trial. These results show the potential for using clinical language models in medicine to read alongside physicians and provide guidance at the point of care.

Carbon fiber-reinforced PEEK spinal implants for primary and metastatic spine tumors: a systematic review on implant complications and radiotherapy benefits.

OBJECTIVE: By minimizing imaging artifact and particle scatter, carbon fiber-reinforced polyetheretherketone (CF-PEEK) spinal implants are hypothesized to enhance radiotherapy (RT) planning/dosing and improve oncological outcomes. However, robust clinical studies comparing tumor surgery outcomes between CF-PEEK and traditional metallic implants are lacking. In this paper, the authors performed a systematic review of the literature with the aim to describe clinical outcomes in patients with spine tumors who received CF-PEEK implants, focusing on implant-related complications and oncological outcomes. METHODS: A systematic review of the literature published between database inception and May 2022 was performed in accordance with the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The PubMed database was queried using the terms "carbon fiber" and "spine" or "spinal." The inclusion criteria were articles that described patients with CF-PEEK pedicle screw fixation and had a minimum of 5 patients. Case reports and phantom studies were excluded. RESULTS: This review included 11 articles with 326 patients (237 with CF-PEEK-based implants and 89 with titanium-based implants). The mean follow-up period was 13.5 months, and most tumors were metastatic (67.1%). The rates of implant-related complications in the CF-PEEK and titanium groups were 7.8% and 4.7%, respectively. The rate of pedicle screw fracture was 1.7% in the CF-PEEK group and 2.4% in the titanium group. The rates of reoperation were 5.7% (with 60.0% because of implant failure or junctional kyphosis) and 4.8% (all because of implant failure or junctional kyphosis) in the CF-PEEK and titanium groups, respectively. When reported, 72.5% of patients received postoperative RT (41.0% stereotactic body RT, 30.8% fractionated RT, 25.6% proton, 2.6% carbon ion). Four articles suggested that implant artifact was reduced in the CF-PEEK group. Local recurrence occurred in 14.4% of CF-PEEK and 10.7% of titanium-implanted patients. CONCLUSIONS: While CF-PEEK harbors similar implant failure rates to traditional metallic implants with reduced imaging artifact, it remains unclear whether CF-PEEK implants improve oncological outcomes. This study highlights the need for prospective, direct comparative clinical studies.

Developing an Automated Registry (Autoregistry) of Spine Surgery Using Natural Language Processing and Health System Scale Databases.

BACKGROUND AND OBJECTIVES: Clinical registries are critical for modern surgery and underpin outcomes research, device monitoring, and trial development. However, existing approaches to registry construction are labor-intensive, costly, and prone to manual error. Natural language processing techniques combined with electronic health record (EHR) data sets can theoretically automate the construction and maintenance of registries. Our aim was to automate the generation of a spine surgery registry at an academic medical center using regular expression (regex) classifiers developed by neurosurgeons to combine domain expertise with interpretable algorithms. METHODS: We used a Hadoop data lake consisting of all the information generated by an academic medical center. Using this database and structured query language queries, we retrieved every operative note written in the department of neurosurgery since our transition to EHR. Notes were parsed using regex classifiers and compared with a random subset of 100 manually reviewed notes. RESULTS: A total of 31 502 operative cases were downloaded and processed using regex classifiers. The codebase required 5 days of development, 3 weeks of validation, and less than 1 hour for the software to generate the autoregistry. Regex classifiers had an average accuracy of 98.86% at identifying both spinal procedures and the relevant vertebral levels, and it correctly identified the entire list of defined surgical procedures in 89% of patients. We were able to identify patients who required additional operations within 30 days to monitor outcomes and quality metrics. CONCLUSION: This study demonstrates the feasibility of automatically generating a spine registry using the EHR and an interpretable, customizable natural language processing algorithm which may reduce pitfalls associated with manual registry development and facilitate rapid clinical research.

Digital Biomarkers and the Evolution of Spine Care Outcomes Measures: Smartphones and Wearables.

Over the past generation, outcome measures in spine care have evolved from a reliance on clinician-reported assessment toward recognizing the importance of the patient's perspective and the wide incorporation of patient-reported outcomes (PROs). While patient-reported outcomes are now considered an integral component of outcomes assessments, they cannot wholly capture the state of a patient's functionality. There is a clear need for quantitative and objective patient-centered outcome measures. The pervasiveness of smartphones and wearable devices in modern society, which passively collect data related to health, has ushered in a new era of spine care outcome measurement. The patterns emerging from these data, so-called "digital biomarkers," can accurately describe characteristics of a patient's health, disease, or recovery state. Broadly, the spine care community has thus far concentrated on digital biomarkers related to mobility, although the researcher's toolkit is anticipated to expand in concert with advancements in technology. In this review of the nascent literature, we describe the evolution of spine care outcome measurements, outline how digital biomarkers can supplement current clinician-driven and patient-driven measures, appraise the present and future of the field in the modern era, as well as discuss present limitations and areas for further study, with a focus on smartphones (see Supplemental Digital Content , http://links.lww.com/NEU/D809 , for a similar appraisal of wearable devices).

Perception of frailty in spinal metastatic disease: international survey of the AO Spine community.

OBJECTIVE: Frailty has not been clearly defined in the context of spinal metastatic disease (SMD). Given this, the objective of this study was to better understand how members of the international AO Spine community conceptualize, define, and assess frailty in SMD. METHODS: The AO Spine Knowledge Forum Tumor conducted an international cross-sectional survey of the AO Spine community. The survey was developed using a modified Delphi technique and was designed to capture preoperative surrogate markers of frailty and relevant postoperative clinical outcomes in the context of SMD. Responses were ranked using weighted averages. Consensus was defined as ≥ 70% agreement among respondents. RESULTS: Results were analyzed for 359 respondents, with an 87% completion rate. Study participants represented 71 countries. In the clinical setting, most respondents informally assess frailty and cognition in patients with SMD by forming a general perception based on clinical condition and patient history. Consensus was attained among respondents regarding the association between 14 preoperative clinical variables and frailty. Severe comorbidities, extensive systemic disease burden, and poor performance status were most associated with frailty. Severe comorbidities associated with frailty included high-risk cardiopulmonary disease, renal failure, liver failure, and malnutrition. The most clinically relevant outcomes were major complications, neurological recovery, and change in performance status. CONCLUSIONS: The respondents recognized that frailty is important, but they most commonly evaluate it based on general clinical impressions rather than using existing frailty tools. The authors identified numerous preoperative surrogate markers of frailty and postoperative clinical outcomes that spine surgeons perceived as most relevant in this population.

Cervicothoracic junction instrumentation strategies following separation surgery for spinal metastases.

OBJECTIVE: The cervicothoracic junction (CTJ) is a challenging region to stabilize after tumor resection for metastatic spine disease. The objective of this study was to describe the outcomes of patients who underwent posterolateral decompression and instrumented fusion (i.e., separation surgery across the CTJ for instability due to metastatic disease). METHODS: The authors performed a single-institution retrospective study of a prospectively collected cohort of patients who underwent single-approach posterior decompression and instrumented fusion across the CTJ for metastatic spine disease between 2011 and 2018. Adult patients (≥ 18 years old) who presented with mechanical instability, myelopathy, and radiculopathy secondary to metastatic epidural spinal cord compression (MESCC) of the CTJ (C7-T1) from 2011 to 2018 were included. RESULTS: Seventy-nine patients were included, with a mean age of 62.1 years. The most common primary malignancies were non-small cell lung (n = 17), renal cell (11), and prostate (8) carcinoma. The median number of levels decompressed and construct length were 3 and 7, respectively. The average operative time, blood loss, and length of stay were 179.2 minutes, 600.5 ml, and 7.7 days, respectively. Overall, 58 patients received adjuvant radiation, and median dose, fractions, and time from surgery were 27 Gy, 3 fractions, and 20 days, respectively. All patients underwent lateral mass and pedicle screw instrumentation. Forty-nine patients had tapered rods (4.0/5.5 mm or 3.5/5.5 mm), 29 had fixed-diameter rods (3.5 mm or 4.0 mm), and 1 had both. Ten patients required anterior reconstruction with poly-methyl-methacrylate. The overall complication rate was 18.8% (6 patients with wound-related complications, 7 with hardware-related complications, 1 with both, and 1 with other). For the 8 patients (10%) with hardware failure, 7 had tapered rods, all 8 had cervical screw pullout, and 1 patient also experienced rod/screw fracture. The average time to hardware failure was 146.8 days. The 2-year cumulative incidence rate of hardware failure was 11.1% (95% CI 3.7%-18.5%). There were 55 deceased patients, and the median (95% CI) overall survival period was 7.97 (5.79-12.60) months. For survivors, the median (range) follow-up was 12.94 (1.94-71.80) months. CONCLUSIONS: Instrumented fusion across the CTJ demonstrated an 18.8% rate of postoperative complications and an 11% overall 2-year rate of hardware failure in patients who underwent metastatic epidural tumor decompression and stabilization.

Long-Term Clinical Outcomes of Patients with Colorectal Cancer with Metastatic Epidural Spinal Cord Compression Treated with Hybrid Therapy (Surgery Followed by Stereotactic Body Radiation Therapy).

BACKGROUND: Hybrid therapy, consisting of separation surgery followed by stereotactic body radiation therapy, has become the mainstay treatment for radioresistant spinal metastases. Histology-specific outcomes for hybrid therapy are scarce. In clinical practice, colorectal cancer (CRC) is particularly thought to have poor outcomes regarding spinal metastases. The goal of this study was to evaluate clinical outcomes for patients treated with hybrid therapy for spinal metastases from CRC. METHODS: This retrospective study was performed at a tertiary cancer center. Adult patients with CRC spinal metastasis who were treated with hybrid therapy for high-grade epidural spinal cord or nerve root compression from 2005 to 2020 were included. Outcome variables evaluated included patient demographics, overall survival and progression-free survival, surgical and radiation complications, and clinical-genomic correlations. RESULTS: Inclusion criteria were met by 50 patients. Progression of disease occurred in 7 (14%) patients at the index level, requiring reoperation and/or reirradiation at a mean of 400 days after surgery. Postoperative complications occurred in 16% of patients, with 3 (6%) requiring intervention. APC exon 14 and 16 mutations were found in 15 of 17 patients tested and in all 3 of 7 local failures tested. Twenty patients (40%) underwent further radiation due to disease progression at other spinal levels. CONCLUSIONS: Hybrid therapy in patients with CRC resulted in 86.7% local control at 2 years after surgery, with limited complications. APC mutations are commonly present in CRC patients with spine metastases and may suggest worse prognosis. Patients with CRC spinal metastases commonly progress outside the index treatment level.

The Impact of Targetable Mutations on Clinical Outcomes of Metastatic Epidural Spinal Cord Compression in Patients With Non-Small-Cell Lung Cancer Treated With Hybrid Therapy (Surgery Followed by Stereotactic Body Radiation Therapy).

BACKGROUND: In treatment of metastatic epidural spinal cord compression (MESCC), hybrid therapy, consisting of separation surgery, followed by stereotactic body radiation therapy, has become the mainstay of treatment for radioresistant pathologies, such as non-small-cell lung cancer (NSCLC). OBJECTIVE: To evaluate clinical outcomes of MESCC secondary to NSCLC treated with hybrid therapy and to identify clinical and molecular prognostic predictors. METHODS: This is a single-center, retrospective study. Adult patients (≥18 years old) with pathologically confirmed NSCLC and spinal metastasis who were treated with hybrid therapy for high-grade MESCC or nerve root compression from 2012 to 2019 are included. Outcome variables evaluated included overall survival (OS) and progression-free survival, local tumor control in the competing risks setting, surgical and radiation complications, and clinical-genomic correlations. RESULTS: One hundred and three patients met inclusion criteria. The median OS for this cohort was 6.5 months, with progression of disease noted in 5 (5%) patients at the index tumor level requiring reoperation and/or reirradiation at a mean of 802 days after postoperative stereotactic body radiation therapy. The 2-year local control rate was 94.6% (95% CI: 89.8-99.3). Epidermal growth factor receptor (EGFR) treatment-naïve patients who initiated EGFR-targeted therapy after hybrid therapy had significantly longer OS (hazard ratio 0.47, 95% CI 0.23-0.95, P = .04) even after adjusting for smoking status. The presence of EGFR exon 21 mutation was predictive of improved progression-free survival. CONCLUSION: Hybrid therapy in NSCLC resulted in 95% local control at 2 years after surgery. EGFR treatment-naïve patients initiating therapy after hybrid therapy had significantly improved survival advantage. EGFR-targeted therapy initiated before hybrid therapy did not confer survival benefit.

Surgery for Metastatic Spinal Disease in Octogenarians and Above: Analysis of 78 Patients.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVE: Octogenarians living with spinal metastases are a challenging population to treat. Our objective was to identify the rate, types, management, and predictors of complications and survival in octogenarians following surgery for spinal metastases. METHODS: A retrospective review of a prospectively collected cohort of patients aged 80 years or older who underwent surgery for metastatic spinal tumor treatment between 2008 and 2019 were included. Demographic, intraoperative, complications, and postoperative follow-up data was collected. Cox proportional hazards regression and logistic regression were used to associate variables with overall survival and postoperative complications, respectively. RESULTS: 78 patients (mean 83.6 years) met inclusion criteria. Average operative time and blood loss were 157 minutes and 615 mL, respectively. The median length of stay was 7 days. The overall complication rate was 31% (N = 24), with 21% considered major and 7% considered life-threatening or fatal. Blood loss was significantly associated with postoperative complications (OR = 1.002; P = 0.02) and mortality (HR = 1.0007; P = 0.04). Significant associations of increased risk of death were also noted with surgeries with decompression, and cervical/cervicothoracic index level of disease. For deceased patients, median time to death was 4.5 months. For living patients, median follow-up was 14.5 months. The Kaplan-Meier based median overall survival for the cohort was 11.6 months (95% CI: 6.2-19.1). CONCLUSIONS: In octogenarians undergoing surgery with instrumentation for spinal metastases, the median overall survival is 11.6 months. There is an increased complication rate, but only 7% are life-threatening or fatal. Patients are at increased risk for complications and mortality particularly when performing decompression with stabilization, with increasing intraoperative blood loss, and with cervical/cervicothoracic tumors.

Correlation Between the Spinal Instability Neoplastic Score (SINS) and Patient Reported Outcomes.

STUDY DESIGN: International multicenter prospective observational cohort study on patients undergoing radiation +/- surgical intervention for the treatment of symptomatic spinal metastases. OBJECTIVES: To investigate the association between the total Spinal Instability Neoplastic Score (SINS), individual SINS components and PROs. METHODS: Data regarding patient demographics, diagnostics, treatment, and PROs (SF-36, SOSGOQ, EQ-5D) was collected at baseline, 6 weeks, and 12 weeks post-treatment. The SINS was assessed using routine diagnostic imaging. The association between SINS, PRO at baseline and change in PROs was examined with the Spearmans rank test. RESULTS: A total of 307 patients, including 174 patients who underwent surgery+/- radiotherapy and 133 patients who underwent radiotherapy were eligible for analyses. In the surgery+/- radiotherapy group, 18 (10.3%) patients with SINS score between 0-6, 118 (67.8%) with a SINS between 7-12 and 38 (21.8%) with a SINS between 13-18, as compared to 55 (41.4%) SINS 0-6, 71(53.4%) SINS 7-12 and 7 (5.2%) SINS 13-18 in the radiotherapy alone group. At baseline, the total SINS and the presence of mechanical pain was significantly associated with the SOSGOQ pain domain (r = -0.519, P < 0.001) and the NRS pain score (r = 0.445, P < 0.001) for all patients. The presence of mechanical pain demonstrated to be moderately associated with a positive change in PROs at 12 weeks post-treatment. CONCLUSION: Spinal instability, as defined by the SINS, was significantly correlated with PROs at baseline and change in PROs post-treatment. Mechanical pain, as a single SINS component, showed the highest correlations with PROs.

Integration of an enhanced recovery after surgery program for patients undergoing pituitary surgery.

Evidence-based enhanced recovery after surgery (ERAS) programs aim to improve patient outcomes and shorten hospital stays. The objective of this study is to describe the development, implementation, and evolution of an ERAS protocol to optimize the perioperative management for patients undergoing endoscopic skull base surgery for pituitary tumors. A systematic review of the literature was performed, best practices were discussed with stakeholders, and institutional guidelines were established and implemented. Key performance indicators (KPI) were measured and patient-reported outcome surveys were collected. The ERAS protocol was introduced successfully at our institution. We describe the process of initiation of the program and the perioperative management of our patients. We demonstrated the feasibility of integration of ERAS protocols for pituitary tumors with multidisciplinary engagement, with a particular emphasis on the use of data informatics and metrics to monitor outcomes. We expect that this approach will translate to improved quality of care for these often-complex patients.

Patient outcomes following implementation of an enhanced recovery after surgery pathway for patients with metastatic spine tumors.

BACKGROUND: Metastatic spine tumor surgery consists of palliative operations performed on frail patients with multiple medical comorbidities. Enhanced recovery after surgery (ERAS) programs involve an evidence-based, multidisciplinary approach to improve perioperative outcomes. This study presents clinical outcomes of a metastatic spine tumor ERAS pathway implemented at a tertiary cancer center. METHODS: The metastatic spine tumor ERAS program launched in April 2019, and data from January 2018 to May 2020 were reviewed. Measured outcomes included the following: hospital length of stay (LOS), time to ambulation, urinary catheter duration, time to resumption of diet, intraoperative fluid intake, estimated blood loss (EBL), and intraoperative and postoperative day 0-5 cumulative opioid use (morphine milligram equivalent [MME]). RESULTS: A total of 390 patients were included in the final analysis: 177 consecutive patients undergoing metastatic spine tumor surgery enrolled in the ERAS program and 213 consecutive pre-ERAS patients. Although the mean case durations were similar in the ERAS and pre-ERAS cohorts (265 vs. 274 min; p = .22), the ERAS cohort had decreased EBL (157 vs. 215 ml; p = .003), decreased postoperative day 0-5 cumulative mean opioid use (178 vs. 396 MME; p < .0001), earlier ambulation (mean, 34 vs. 57 h; p = .0001), earlier discontinuation of urinary catheters (mean, 36 vs. 56 h; p < .001), and shorter LOS (5.4 vs. 7.5 days; p < .0001). CONCLUSIONS: The implementation of a multidisciplinary ERAS program designed for metastatic spine tumor surgery led to improved clinical quality metrics, including shorter hospitalizations and significant reductions in opioid consumption.

Development and external validation of predictive algorithms for six-week mortality in spinal metastasis using 4,304 patients from five institutions.

BACKGROUND CONTEXT: Historically, spine surgeons used expected postoperative survival of 3-months to help select candidates for operative intervention in spinal metastasis. However, this cutoff has been challenged by the development of minimally invasive techniques, novel biologics, and advanced radiotherapy. Recent studies have suggested that a life expectancy of 6 weeks may be enough to achieve significant improvements in postoperative health-related quality of life. PURPOSE: The purpose of this study was to develop a model capable of predicting 6-week mortality in patients with spinal metastases treated with radiation or surgery. STUDY DESIGN/SETTING: A retrospective review was conducted at five large tertiary centers in the United States and Taiwan. PATIENT SAMPLE: The development cohort consisted of 3,001 patients undergoing radiotherapy and/or surgery for spinal metastases from one institution. The validation institutional cohort consisted of 1,303 patients from four independent, external institutions. OUTCOME MEASURES: The primary outcome was 6-week mortality. METHODS: Five models were considered to predict 6-week mortality, and the model with the best performance across discrimination, calibration, decision-curve analysis, and overall performance was integrated into an open access web-based application. RESULTS: The most important variables for prediction of 6-week mortality were albumin, primary tumor histology, absolute lymphocyte, three or more spine metastasis, and ECOG score. The elastic-net penalized logistic model was chosen as the best performing model with AUC 0.84 on evaluation in the independent testing set. On external validation in the 1,303 patients from the four independent institutions, the model retained good discriminative ability with an area under the curve of 0.81. The model is available here: https://sorg-apps.shinyapps.io/spinemetssurvival/. CONCLUSIONS: While this study does not advocate for the use of a 6-week life expectancy as criteria for considering operative management, the algorithm developed and externally validated in this study may be helpful for preoperative planning, multidisciplinary management, and shared decision-making in spinal metastasis patients with shorter life expectancy.