1. Introduction Patients with tumors affecting the spine have significant impairments in Quality of Life domains that include physical function, neural function, pain, mental health, and social roles. The literature on tumors of the spine and clinical outcomes is limited, and characterized by outcome measures that are process variables including survival, local recurrence, complications, and gross measures of function (ambulatory status, Frankel Score), with more limited use of direct patient self-assessment of their health status. Methodology Two separate literature searches were carried out. The first included the combination of key words or MESH subheadings of “quality of life,” “outcomes,” “cancer,” and/or “metastasis” with limiting factors of “human” and “English language.” The purpose of this search was to identify the HRQOL tools most commonly used in patients with metastatic disease in general, with this frequency data represented in Table 1. This initial search produced a total of 14892 articles. The second literature search included the combination of key words or MESH subheadings of “quality of life,” “outcomes,” “spine,” and/or “metastasis,” again with limiting factors of “human” and “English language.” This search initially produced 5530 articles. Only those original studies analyzing the outcomes or results of surgical management of metastatic disease of the spine were retained. In particular we tried to identify those purporting to measure “Quality of Life.” All of these abstracts were read and from this an evidentiary table for 141 studies examining HRQOL in patients with metastatic disease of the spine was compiled. Study Purpose / Questions This study addresses the following questions: Question 1 What outcome instruments have been used in the published literature to measure HRQOL in patients with cancer, and more specifically metastatic disease of the spine? The goal of this question is to provide a systematic review of the literature on measurement systems for reporting change in health-related quality of life in patients with cancer in general and in particular tumors involving the spine. The results for this question are shown in Tables 1-3. Health Related Quality of Life Outcomes in Metastatic Disease of the Spine John Street MD PhD*, Brian Lenehan MD*, Tim Ryken MD #, Sigurd Berven MD #, Charles Fisher MD* # * Combined Neurosurgical and Orthopedic Spine Program, Vancouver, BC # Spine Oncology Study Group Question 2 What currently available generic and cancer-specific outcome tools should be used to develop domains and questions for a disease-specific instrument for patients with tumors affecting the spine? The goal of this question is to provide a recommendation, based on a critical synthesis of the literature, on the domains to be included in a disease specific HRQOL tool for tumors involving the Spine The content validity of the 6 most frequently used measures of cancer related HRQOL was then established using the International Classification of Functioning Disability and Health (ICF). Concepts contained in the questionnaires were linked to the ICF, using established linkage rules described in detail by Cieza et al The reliability of the linkage process was evaluated by calculating kappa coefficients. The purpose of this kappa or correlation coefficient was to determine the face or content validity of the commonly used HRQOL outcomes tools in cancer in general. The result of this correlation or linkage analysis is represented in Table 4. Conclusions There is little consensus in the choice of outcome measures applied to patients with tumors affecting the spine. The lack of uniformity in outcome measures prevents effective combination of studies in meta- analysis and limits the value of the published literature in demonstrating the impact of operative and nonoperative management in the treatment of spinal metastatic disease. The creation of a valid and reliable spinal-oncology-specific outcome measure for use in future studies would allow greater applicability and provide a more robust measure of health-related quality of life in this complex patient population. Table 3 summarizes the use of “outcome measures” or “instruments” in the 141 studies. None of the instruments have been validated for patients with tumor affecting the spine. None of the studies selected for review provided a definition for HRQOL and none attempted to justify the use of their chosen instrument. No study presented a case for choice based on the specific needs and concerns of people with metastatic disease of the spine. There is no consensus on the use of a uniform HRQOL instrument in the literature, and significant disparity in the choice of instruments. The ability to quantify changes in health status and utility and to compare across studies in ameta-analysis is severely limited by the absence of a disease-specific outcome measure for patients with tumors affecting the spine. These 6 cancer-specific HRQOL tools have excellent content validity when directly compared to the universal WHO ICF tool. Thus domains from any of these outcome tools would be appropriate to be included in the non disease specific component of the assessment of HRQOL as it relates to patients with metastatic disease of the spine. Based on frequency of citation and on correlation with ICF, both ECOG as a cancer specific tool, and SF36 as a generic HRQOL outcome tool could be used while a disease-specific tool for metastatic disease of the spine is being developed. Results Edmonton 2010