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 non-operative). 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. (C) 2019 Elsevier Inc. All rights reserved.