Prospective validation of a clinical prediction score for survival in patients with spinal metastases: the New England Spinal Metastasis Score.

BACKGROUND CONTEXT: The New England Spinal Metastasis Score (NESMS) was proposed as an intuitive and accessible prognostic tool for predicting survival in patients with spinal metastases. We designed an appropriately powered, prospective, longitudinal investigation to validate the NESMS. PURPOSE: To prospectively validate the NESMS. STUDY DESIGN: Prospective longitudinal observational cohort study. PATIENT SAMPLE: Patients, aged 18 and older, presenting for treatment with spinal metastatic disease. OUTCOME MEASURES: One-year mortality (primary); 6-month mortality and mortality at any time point following enrollment (secondary). METHODS: The date of enrollment was set as time zero for all patients. The NESMS was assigned based on data collected at the time of enrollment. Patients were prospectively followed to one of two predetermined end-points: death, or survival at 365 days following enrollment. Survival was visually assessed with Kaplan-Meier curves and then analyzed using multivariable logistic regression, followed by Bayesian regression to assess for robustness of point estimates and 95% confidence intervals (CI). RESULTS: This study included 180 patients enrolled between 2017 and 2018. Mortality within 1-year occurred in 56% of the cohort. Using NESMS 3 as the referent, those with a score of 2 had significantly greater odds of mortality (odds ratio 7.04; 95% CI 2.47, 20.08), as did those with a score of 1 (odds ratio 31.30; 95% CI 8.82, 111.04). A NESMS score of 0 was associated with perfect prediction, as 100% of individuals with this score were deceased at 1-year. Similar determinations were encountered for mortality at 6-months and overall. CONCLUSIONS: This study validates the NESMS and demonstrates its utility in prognosticating survival for patients with spinal metastatic disease, irrespective of selected treatment strategy. This is the first study to prospectively validate a prognostic utility for patients with spinal metastases. The NESMS can be directly applied to patient care, hospital-based practice and health-care policy.

Clinician Experiences in Treatment Decision-Making for Patients with Spinal Metastases: A Qualitative Study.

BACKGROUND: Effective management of metastatic disease requires multidisciplinary input and entails high risk of disease-related and treatment-related morbidity and mortality. The factors that influence clinician decision-making around spinal metastases are not well understood. We conducted a qualitative study that included a multidisciplinary cohort of physicians to evaluate the decision-making process for treatment of spinal metastases from the clinician's perspective. METHODS: We recruited operative and nonoperative clinicians, including orthopaedic spine surgeons, neurosurgeons, radiation oncologists, and physiatrists, from across North America to participate in either a focus group or a semistructured interview. All interviews were audiorecorded and transcribed verbatim. We then performed a thematic analysis using all of the available transcript data. Investigators sequentially coded transcripts and identified recurring themes that encompass overarching patterns in the data and directly bear on the guiding study question. This was followed by the development of a thematic map that visually portrays the themes, the subthemes, and their interrelatedness, as well as their influence on treatment decision-making. RESULTS: The thematic analysis revealed that numerous factors influence provider-based decision-making for patients with spinal metastases, including clinical elements of the disease process, treatment guidelines, patient preferences, and the dynamics of the multidisciplinary care team. The most prominent feature that resonated across all of the interviews was the importance of multidisciplinary care and the necessity of cohesion among a team of diverse health-care providers. Respondents emphasized aspects of care-team dynamics, including effective communication and intimate knowledge of team-member preferences, as necessary for the development of appropriate treatment strategies. Participants maintained that the primary role in decision-making should remain with the patient. CONCLUSIONS: Numerous factors influence provider-based decision-making for patients with spinal metastases, including multidisciplinary team dynamics, business pressure, and clinician experience. Participants maintained a focus on shared decision-making with patients, which contrasts with patient preferences to defer decisions to the physician, as described in prior work. CLINICAL RELEVANCE: The results of this thematic analysis document the numerous factors that influence provider-based decision-making for patients with spinal metastases. Our results indicate that provider decisions regarding treatment are influenced by a combination of clinical characteristics, perceptions of patient quality of life, and the patient's preferences for care.

Laboratory markers as useful prognostic measures for survival in patients with spinal metastases.

BACKGROUND CONTEXT: Laboratory values have been found to be useful predictive measures of survival following surgery. The utility of laboratory values for prognosticating outcomes among patients with spinal metastases has not been studied. PURPOSE: To determine the prognostic capacity of laboratory values at presentation including white blood cell count, serum albumin and platelet-lymphocyte ratio (PLR) in patients with spinal metastases. STUDY DESIGN: Retrospective review of records from two tertiary care centers (2005-2017). PATIENT SAMPLE: Patients, aged 40 to 80, who received operative or nonoperative management for spinal metastases. OUTCOME MEASURES: Survival, complications, or hospital readmissions within 90 days of treatment and a composite measure for treatment failure accounting for changes in ambulatory function and mortality at 6 months following presentation. METHODS: Multivariable Cox proportional hazard regression analysis was used to analyze the relationship between laboratory values and length of survival, adjusting for confounders. Multivariable logistic regression was used in analyses related to 6-month and 1-year mortality, complications, readmissions, and treatment failure. A scoring rubric was developed based on the performance of laboratory values in the multivariable tests. Internal validation was performed using a bootstrap simulation that consisted of sampling with replacement and 1,000 replications. RESULTS: We included 1,216 patients. Thirty-seven percent of patients received a surgical intervention and 63% were treated nonoperatively. Median survival for the cohort as a whole was 255 days (interquartile range 93-642 days). The PLR (hazard ratio [HR] 1.53; 95% confidence interval [CI] 1.29, 1.80; p<.001) and albumin (HR 0.54; 95% CI 0.45, 0.64; p<.001) were significantly associated with survival, whereas WBC count (HR 1.08; 95% CI 0.86, 1.36; p=.50) was not associated with this outcome. Similar findings were encountered for 6-month and 1-year mortality as well as the composite measure for treatment failure. The PLR and albumin performed well in our scoring rubric and findings were preserved in the bootstrapping validation. CONCLUSIONS: Individuals with low serum albumin and elevated PLR should be advised regarding the impact of these laboratory markers on outcomes including survival, irrespective of treatments received. An effort should also be made to optimize nutrition and PLR, if practicable, before treatment to minimize the potential for development of adverse events.

Design of the prospective observational study of spinal metastasis treatment (POST).

BACKGROUND CONTEXT: There are several prognostic scores available that intend to inform decision-making for patients with spinal metastases. Many of these have not been found to reliably predict survival across the continuum of care. Recently, our group developed the New England Spinal Metastasis Score (NESMS). While the NESMS demonstrated many of the necessary attributes of a useful prediction tool, it has yet to be validated prospectively. PURPOSE: To describe the prospective observational study of spinal metastasis treatment (POST). This investigation examined the performance of the NESMS, compared its predictive capacity with other scoring systems and determined its ability to identify patients who benefit the most from surgery. STUDY DESIGN: Prospective observational study at two medical centers. PATIENT SAMPLE: Patients age 18 and older with spinal metastases involving the spine. OUTCOME MEASURES: Survival, post-treatment morbidity and health-related quality of life outcomes. METHODS: The POST study assessed patients at baseline and at 1-month, 3-month, 6-month, and 12-month time-points. During the baseline assessment patient demographics, past medical history and assessment of co-morbidities, surgical history, primary tumor histology, and ambulatory status were recorded along with the designated treatment strategy (eg, operative or nonoperative). The NESMS and other predictive scores for each patient were calculated based on baseline data. Study-specific surveys administered at all time-points consisted of the EuroQuol 5-Dimension and Short-Form (SF)-12, Visual Analog Scale (VAS) for pain, and PROMIS assessment of global health. RESULTS: Two hundred patients were enrolled in POST from 2017 to 2019. Patients were followed to one of the two predetermined study end-points (ie, mortality, or completion of the 12-month follow-up). Survival was considered the principle dependent variable. Post-treatment morbidity and health-related quality of life outcomes were considered secondarily. Analyses, by aim, relied on Cox proportional hazards regression, repeated measures logistic regression, propensity score matching and multivariable logistic regression. CONCLUSION: The POST's findings are anticipated to provide evidence regarding the prognostic capabilities of the NESMS as well as that of other popular grading schemes for survival, post-treatment complications and physical as well as mental function.

Non-operative management of spinal metastases: A prognostic model for failure.

OBJECTIVES: To describe patient-specific characteristics associated with non-operative failure leading to surgery. PATIENTS AND METHODS: We conducted a retrospective review of patients treated for spinal metastases from 2005 to 2017. We deemed patients as failures if they were treated non-operatively and then received a surgical intervention within one year of starting a non-operative regimen. We used multivariable Poisson regression to identify factors associated with non-operative failure. We conducted internal validation using bootstrapping with 1000 replications. RESULTS: We identified 1205 patients with spinal metastases, of whom 834 were initially treated non-operatively and constituted the analytic sample. Of these 77 (9%) went on to have surgery within 1-year of presentation and were deemed non-operative treatment failures. We identified vertebral body collapse and/or pathologic fracture (adjusted Risk Ratio [RR] 1.75; 95% Confidence Interval [CI] 1.11, 2.76) and neurologic signs or symptoms at presentation (RR 1.90; 95% CI 1.19, 3.03) as factors independently associated with an increased risk of non-operative failure. Platelet-lymphocyte ratio >155, a marker for inflammatory state, was also associated with an increased risk of failure (RR 2.32; 95% CI 1.15, 4.69). Failure rates among those with 0, 1, 2 or all three of these risk factors were 5%, 7%, 12% and 20%, respectively (p = 0.004). CONCLUSION: We found that 9% of patients with spinal metastases initially treated non-operatively received surgery within 1-year of commencing care. The likelihood of surgery increased with the number of risk factors. These results can be used in counseling and shared decision making at the time of initial presentation.

Prognosticating outcomes and survival for patients with lumbar spinal metastases: Results of a bayesian regression analysis.

OBJECTIVES: To assess the impact of surgical intervention on survival, ambulatory capacity, complications and readmissions following treatment for lumbar metastases. PATIENTS AND METHODS: We identified all adult patients treated for lumbar metastases between 2005-2017. To limit the potential for inherent bias to influence determinations, we used principal component analysis to identify confounders to be included in multivariable testing. Multivariable logistic regression was performed, followed by Bayesian analysis to generate conservative estimates of effect size and 95% confidence intervals (CI). In a sensitivity test, analyses were repeated in a population where patients who died before they could initiate treatment were excluded. RESULTS: In the period under study, we identified 571 patients who met inclusion criteria. Twenty-one percent of the cohort received a surgical intervention. Bayes regression indicated surgical intervention was independently associated with decreased mortality at 6-months (odds ratio [OR] 0.49; 95% CI 0.34, 0.68) and 1-year (OR 0.63; 95% CI 0.51, 0.76), along with lower odds of being non-ambulatory at 6-months following presentation (OR 0.29; 95% CI 0.18, 0.45). Surgery was also associated with increased odds of complications (OR 1.60; 95% CI 1.24, 2.06) and readmissions (OR 1.37; 95% CI 1.09, 1.72). Numerous clinical characteristics were found to be associated with the outcomes of interest including serum albumin, lung metastases and vertebral body collapse. CONCLUSIONS: Given the favorable outcomes associated with the incorporation of surgery as a component of treatment, we believe that such interventions may be considered part of the treatment approach in patients with lumbar metastases.

Disparities in Rates of Surgical Intervention Among Racial and Ethnic Minorities in Medicare Accountable Care Organizations.

OBJECTIVE: To assess the effect of Accountable Care Organizations (ACOs) on the use of surgical services among racial and ethnic minorities. BACKGROUND: Health reform efforts were expected to reduce healthcare disparities. The impact of ACOs on existing disparities in access to surgical care remains unknown. METHODS: We used national Medicare data (2009-2014) to compare rates of surgery among white, African American, Hispanic, and Asian Medicare beneficiaries for coronary artery bypass grafting, colectomy, total hip arthroplasty, hip fracture repair, and lumbar spine surgery. We performed a pre-post difference in differences analysis between African American, Hispanic, and Asian patients receiving surgical care in ACO and non-ACO organizations before and after the implementation of ACOs. The time period 2009 to 2011 was considered the pre-ACO period, and 2012 to 2014 the post-ACO period. RESULTS: Rates of surgical intervention in the ACO cohort were significantly lower (P < 0.001) as compared to non-ACOs for whites, African Americans, Hispanics, and Asians in both the pre- and post-ACO periods. There was no significant difference in the adjusted change in the rate of surgical interventions among minority patients as compared to whites in ACOs and non-ACOs between 2009 to 2011 and 2012 to 2014. The odds of receiving surgical intervention were lowest for minority patients in ACOs during the post-ACO period (P < 0.001). CONCLUSIONS: We found persistent differences in the use of surgery among racial and ethnic minorities between the time periods 2009 to 2011 and 2012 to 2014. These disparities were not impacted by the formation of ACOs. Programs that specifically incentivize ACOs to improve surgical access for minorities may be necessary.

Does Orthopaedic Outpatient Care Reduce Emergency Department Utilization After Total Joint Arthroplasty?

BACKGROUND: Emergency department (ED) visits after elective surgical procedures are a potential target for interventions to reduce healthcare costs. More than 1 million total joint arthroplasties (TJAs) are performed each year with postsurgical ED utilization estimated in the range of 10%. QUESTIONS/PURPOSES: We asked whether (1) outpatient orthopaedic care was associated with reduced ED utilization and (2) whether there were identifiable factors associated with ED utilization within the first 30 and 90 days after TJA. METHODS: An analysis of adult TRICARE beneficiaries who underwent TJA (2006-2014) was performed. TRICARE is the insurance program of the Department of Defense, covering > 9 million beneficiaries. ED use within 90 days of surgery was the primary outcome and postoperative outpatient orthopaedic care the primary explanatory variable. Patient demographics (age, sex, race, beneficiary category), clinical characteristics (length of hospital stay, prior comorbidities, complications), and environment of care were used as covariates. Logistic regression adjusted for all covariates was performed to determine factors associated with ED use. RESULTS: We found that orthopaedic outpatient care (odds ratio [OR], 0.73; 95% confidence interval [CI], 0.68-0.77) was associated with lower odds of ED use within 90 days. We also found that index hospital length of stay (OR, 1.07; 95% CI, 1.04-1.10), medical comorbidities (OR, 1.16; 95% CI, 1.08-1.24), and complications (OR, 2.47; 95% CI, 2.24-2.72) were associated with higher odds of ED use. CONCLUSIONS: When considering that at 90 days, only 3928 patients sustained a complication, a substantial number of ED visits (11,486 of 15,414 [75%]) after TJA may be avoidable. Enhancing access to appropriate outpatient care with improved discharge planning may reduce ED use after TJA. Further research should be directed toward unpacking the situations, outside of complications, that drive patients to access the ED and devise interventions that could mitigate such behavior. LEVEL OF EVIDENCE: Level III, therapeutic study.

Outpatient Spine Clinic Utilization is Associated With Reduced Emergency Department Visits Following Spine Surgery.

STUDY DESIGN: Review of TRICARE claims (2006-2014) data to assess Emergency Department (ED) utilization following spine surgery. OBJECTIVE: The aim of this study was to determine utilization rates and predictors of ED utilization following spine surgical interventions. SUMMARY OF BACKGROUND DATA: Visits to the ED following surgical intervention represent an additional stress to the healthcare system. While factors associated with readmission following spine surgery have been studied, drivers of postsurgical ED visits, including appropriate and inappropriate use, remain underinvestigated. METHODS: TRICARE claims were queried to identify patients who had undergone one of three common spine procedures (lumbar arthrodesis, discectomy, decompression). ED utilization at 30- and 90 days was assessed as the primary outcome. Outpatient spine surgical clinic utilization was considered the primary predictor variable. Multivariable logistic regression was used to adjust for confounders. RESULTS: Between 2006 and 2014, 48,868 patients met inclusion criteria. Fifteen percent (n = 7183) presented to the ED within 30 days postdischarge. By 90 days, 29% of patients (n = 14,388) presented to an ED. The 30- and 90-day complication rates were 6% (n = 2802) and 8% (n = 4034), respectively, and readmission rates were 5% (n = 2344) and 8% (n = 3842), respectively. Use of outpatient spine clinic services significantly reduced the likelihood of ED utilization at 30 [odds ratio (OR) 0.48; 95% confidence interval (95% CI) 0.46-0.53] and 90 days (OR 0.55; 95% CI 0.52-0.57). CONCLUSION: Within 90 days following spine surgery, 29% of patients sought care in the ED. However, only one-third of these patients had a complication recorded, and even fewer were readmitted. This suggests a high rate of unnecessary ED utilization. Outpatient utilization of spine clinics was the only factor independently associated with a reduced likelihood of ED utilization. LEVEL OF EVIDENCE: 3.