Spine Oncology Study Group Outcomes Research Articles

Patient-Reported and Clinical Outcomes of Surgically Treated Patients With Symptomatic Spinal Metastases: Results From Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO), a Prospective, Multi-Institutional and International Study.

The palliative impact of spine surgery for metastatic disease is evolving with improvements in surgical technique and multidisciplinary cancer care. The goal of this study was to prospectively evaluate long-term clinical outcomes including health-related quality-of-life (HRQOL) measures, using spine cancer-specific patient-reported-outcome (PRO) measures, in patients with symptomatic spinal metastases who underwent surgical management. The Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO, ClinicalTrials.gov identifier: NCT01825161) trial is a prospective-observational cohort study that included 10 specialist centers in North America and Europe. Patients aged 18 to 75 years who underwent surgery for spinal metastases were included. Prospective assessments included both spine tumor-specific and generic PRO tools which were collected for a minimum of 2 years post-treatment or until death. Two hundred and eighty patients (51.8% female, mean age 57.9 years) were included. At presentation, the mean Charlson Comorbidity Index was 6.0, 35.7% had neurological deficits as defined by the American Spinal Cord Injury Association scores, 47.2% had high-grade epidural spinal cord compression (2-3), and 89.6% had impending or frank instability as measured by a Spinal Instability Neoplastic Score of ≥7. The most common primary tumor sites were breast (20.2%), lung (18.8%), kidney (16.2%), and prostate (6.5%). The median overall survival postsurgery was 501 days, and the 2-year progression-free-survival rate was 38.4%. Compared with baseline, significant and durable improvements in HRQOL were observed at the 6-week, 12-week, 26-week, 1-year, and 2-year follow-up assessments from a battery of PRO questionnaires including the spine cancer-specific, validated, Spine Oncology Study Group Outcomes Questionnaire v2.0, the Short Form 36 version 2, EuroQol-5 Dimension (3L), and pain numerical rating scale score. Multi-institutional, prospective-outcomes data confirm that surgical decompression and/or stabilization provides meaningful and durable improvements in multiple HRQOL domains, including spine-specific outcomes based on the Spine Oncology Study Group Outcomes Questionnaire v2.0, for patients with metastatic spine disease.

Validation of the Russian version of Spine Oncology Study Group Outcomes Questionnaire

Introduction. Surgical intervention is the only or main component of combination treatment of the majority of malignant tumors of the spine. Pronounced pain syndrome and neurological deficit caused by spinal tumors significantly worsen disease progression, decrease patients’ quality of life.Aim. To develop a Russian-language version of a specialized questionnaire to study the quality of life of patients suffering from tumor lesions of the spine Spine Oncology Study Group Outcomes Questionnaire (SOSG-OQ).Materials and methods. In 82 patients with tumors of various parts of the spine who are treated at the N.N. Blokhin National Medical Research Center of Oncology, psychometric evaluation of the SOSG-OQ questionnaire was performed confirming its convergent validity and reliability–consistency (Cronbach’s α = 0.899).Results. Exploratory factor analysis confirmed adequacy of the questionnaire’s structure and its conformity to the basic factor model. Instruments of the validated Russian version of the SOSG-OQ questionnaire (text and data analysis instructions) for its use in clinical practice are presented. Results obtained using the new SOSG-OQ questionnaire show a significant decrease in quality of life of patients with spinal tumors. Additionally, after surgery patients described their health-related quality of life significantly higher than prior to treatment.Conclusion. Validated Russian version of the SOSG-OQ questionnaire can be recommended for application in oncological clinic for more precise and differentiated evaluation of performance status, emotional condition, experience of patients, evaluation of life circumstances associated with the disease to promote more targeted and personalized psychological care.

The Efficacy of Cervical Pedicle Screw Is Enhanced When Used With 5.5-mm Rods for Metastatic Cervical Spinal Tumor Surgery.

The cervical spine presents challenges in treating metastatic cervical spinal tumors (MCSTs). Although the efficacy of cervical pedicle screw placement (CPS) has been well established, its use in combination with 5.5-mm rods for MCST has not been reported. This study aimed to evaluate the efficacy of CPS combined with 5.5-mm rods in treating MCST and compare it with that of CPS combined with traditional 3.5-mm rods. This retrospective study analyzed 58 patients with MCST who underwent posterior cervical spinal fusion surgery by a single surgeon between March 2012 and December 2022. Data included demographics, surgical details, imaging results, numerical rating scale score for neck pain, Eastern Cooperative Oncology Group performance status, and Spine Oncology Study Group Outcomes Questionnaire responses. Preoperative Spinal Instability Neoplastic Scores were significantly higher in the 5.5-mm rod group. Greater kyphotic changes in the index vertebra were observed in the 3.5-mm rod group. Neck pain reduction was significantly better in the 5.5-mm rod group. CPS with 5.5-mm rods provides superior biomechanical stability and effectively resists forward bending momentum in posterior MCST fusion surgery. These findings support the use of 5.5-mm rods to enhance surgical outcomes.

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

Retrospective review of prospective, multicenter and international cohort study. To describe the effect of gender on HRQoL, clinical outcomes and survival for patients with spinal metastases treated with either surgery and/or radiation. 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. 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. 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). 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.

Assessing Cross-Cultural Adaptation of the Spine Oncology Study Group Outcomes Questionnaire 2.0: A Methodological Systematic Review Regard to Consensus-Based Standards for the Selection of Health Measurement Instruments Guideline.

systematic review of cross-cultural adaptation. SOSGOQ 2.0 was widely used to assess the HRQQOL of patients with spinal metastasis. Due to the lack of methodological quality assessment, it is a challenge to use the questionnaire in routine practice. This study aims to comprehensively evaluate the translation procedures and measurement attributes of SOSGOQ 2.0 according to COSMIN guidelines. The literature was reviewed adhering to the PRISMA guidelines. Each translation process and different cultural adaptation methods were classified according to the guidelines for Cross cultural Adaptation Process of Self Reporting Measures, and the methodological quality of the identified research was evaluated according to the consensus based on the selection criteria of health measurement tools. 6 publications finally met the inclusion criteria. As for the evaluation of translation procedures and cross-cultural adaptability, two adaptations did not report the detailed information in translation and cross-cultural adaptation (synthesis, back translation, review by expert committee, pre-test), factor analysis and sample size calculation were only mentioned in two studies, and only one adaptation met the minimum sample size standard. Regard to the methodological quality assessment of measurement attributes, all adaptations completed internal consistency, structural effectiveness and reliability. However, none of the adaptations reported measurement errors and only one reported response sensitivity. We found that the methodological quality of the current adaptation was uneven, and the report of measurement attribute results was not comprehensive. We recommend higher quality German, Italian and Chinese adaptation.

Cross-cultural adaptation, reliability, and validity of the Russian version of the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0).

The most validated health-related quality-of-life (HRQOL) questionnaire specific to the metastatic spine cancer population is the Spine Oncology Study Group Outcomes Questionnaire version 2 (SOSGOQ2.0). The purpose of this study was to translate and validate a Russian version of the SOSGOQ2.0. The SOSGOQ2.0 was translated into Russian and cross-culturally adapted. In this study, 64 eligible patients completed the SOSGOQ2.0_RUS along with the EQ-5D 5 Level, SF-36 quality-of-life questionnaires, and visual analog scale for pain assessment scale (VAS). Internal consistency was measured using Cronbach's alpha, in which a score of 0.65 or higher is acceptable. Test-retest reliability was evaluated by examining the intraclass correlation coefficient (ICC). Included in this study were 64 Russian-speaking patients (median age 59 years) with metastatic spine disease. The most common primary tumors were breast, kidney, and prostate cancers. The overall Cronbach's alpha was 0.87, indicating high internal consistency. The overall ICC for the SOSGOQ2.0_RUS was 0.88 (95% CI 0.81-0.93), indicating high reliability and consistency of the measure. The physical function, pain, and mental health domains of the SF-36 moderately correlated with the same domains of the SOSGOQ2.0_RUS, with correlation coefficients ranging from 0.65 to 0.71. The SOSGOQ2.0_RUS is a reliable and valid questionnaire for assessing the HRQOL in patients with metastatic spinal tumors. The questionnaire showed high internal consistency, test-retest reliability, and good construct validity when compared with other established questionnaires.

Translation and validation of the Dutch Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) to evaluate health-related quality of life in patients with symptomatic spinal metastases

BackgroundThe primary goal of palliative treatment of spinal metastases is to maintain or improve health-related quality of life (HRQOL). We translated and validated a Dutch version of The Spine Oncology Study Group Outcome Questionnaire (SOSGOQ2.0), a valid and reliable 20-item questionnaire to evaluate HRQOL in patients with spinal metastases.MethodsAfter cross-cultural translation and adaptation, the questionnaire was pre-tested in fifteen patients referred for spine surgery and/or radiotherapy. This resulted in a final questionnaire that was sent to patients for assessment of internal consistency, construct (i.e., convergent and divergent) validity, discriminative power and test-retest reliability.ResultsOverall, 147 patients (mean age 65.6 years, SD = 10.4) completed the questionnaire after a median time of 45.4 months (IQR = 18.9–72.9) after spine surgery and/or radiotherapy. Internal consistency was good for the Physical function, Pain, and Mental health domains (α = 0.87, 0.86, 0.72), but not for Social function (α = 0.04). Good convergent validity was demonstrated except for Social function (rs = 0.37 95%CI = 0.21–0.51). Discriminative power between patients with ECOG performance scores of 0–1 and 2–4 was found on all domains and Neurological function items. Test-retest reliability was acceptable for Physical function, Pain and Mental health (ICC = 0.89 95%CI = 0.81–0.94, ICC = 0.88 95%CI = 0.78–0.93, ICC = 0.68 95%CI = 0.48–0.81), whereas ICC = 0.45 (95%CI = 0.17–0.66) for Social function was below threshold. After removing item 20 from the Social function domain, internal consistency improved, and convergent validity and test-retest reliability were good.ConclusionThe Dutch version of the SOSGOQ2.0 questionnaire is a reliable and valid tool to measure HRQOL in patients with spinal metastases. Item 20 was removed to retain psychometric properties.

Cross-cultural adaptation and validation of the Chinese version of the Spine Oncology Study Group Outcomes Questionnaire.

Patients with spinal metastases always have a poor health-related quality of life (HRQoL) and disease- and treatment-related adverse outcomes. The Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) has been verified and validated in English for patients with spinal metastases but not in Chinese. This paper aimed to complete the cross-cultural adaptation of the Chinese version of the SOSGOQ, to verify its reliability and validity, and to report on the HRQoL of Chinese patients with spinal metastases. This is a single-center, prospective, observational cross-sectional study. Seventy-six patients were enrolled in this study. The SOSGOQ is made up of five HRQoL domains (physical function, neurological function, pain, mental health, social function) and post-therapy questions. The EQ-5D 3L questionnaire covers five items in mobility, self-care, usual activities, pain discomfort, and anxiety-depression, each with three answer options. The SF-36 comprises 36 items divided into eight domains. A single-center, prospective, observational cross-sectional study involving patients with spinal metastases who underwent surgery was conducted. HRQoL was evaluated using the Chinese version of the SOSGOQ, the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36), and the EuroQol 5-Dimension questionnaire (EQ-5D). Demographic, tumor, symptom, and treatment data, as well as Eastern Cooperative Oncology Group (ECOG) information, were collected. Internal consistency reliability, convergent validity, concurrent validity, and clinical validity were used to evaluate reliability. A Spearman's correlation analysis was used to analyze the relationship between variables. This study enrolled 76 patients, with a mean age of 55.8 years. The kidney was the most common primary tumor site, and the thoracic spine was the most affected. The internal consistency of the overall SOSQOQ (0.907) was higher than the EQ-5D (0.819), and all items of the SOSQOQ had a high convergent validity (>0.40). The SOSGOQ was significantly correlated with the EQ-5D in respective domains (p < 0.001) and overall score (p < 0.001), whereas the SF-36 was related to the overall SOSGOQ score and most domains. Total SOSGOG was significantly sensitive to changes in ECOG (p = 0.017), prior surgery (p = 0.001), and tumor type (p = 0.026). The SOSGOQ is a reliable and effective tool for evaluating HRQoL in patients with spinal metastases, with high sensitivity and specificity. Surgical treatment can significantly improve patients' HRQoL.

Cross-cultural adaptation and validation of simplified Chinese version of the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) 2.0 with its assessment in clinical setting

BACKGROUND CONTEXTThe treatment of spinal metastases (SM) has been significantly improved in recent years, which gives health-related quality of life (HRQOL) further significance in management of SM. The Spine Oncology Study Group Outcomes Questionnaire version 2.0 (SOSGOQ 2.0) was a specific targeted SM HRQOL criterion that was previously reported to pose good reliability and validity. However, there is no culturally adapted, reliable, and validated version of SOSGOQ 2.0 in mainland China. PURPOSEThe current study aimed to translate the SOSGOQ 2.0 in a cross-cultural fashion, before evaluating the reliability and validity of the adapted simplified Chinese version of (SC-SOSGOQ 2.0) for patients with spinal metastases (SM). STUDY DESIGN/SETTINGTranslation, cross-cultural adaptation, and validation were performed on the Chinese version of the SOSGOQ 2.0. PATIENT SAMPLEPatients who were diagnosed with metastatic spinal disease, posing at least 6-years experience of education and the ability to read and speak Chinese. OUTCOME MEASURESReliability and Validity of the SC-SOSGOQ 2.0 were measured to assess HRQOL in patients with SM. METHODSThe cross-cultural adaptation of the SOSGOQ 2.0 was conducted following international guidelines. The reliability and validity of the SC-SOSGOQ 2.0 was assessed in a multi-center, prospective observational study. The test-retest reliability was assessed by comparing the results of the first and final SC-SOSGOQ 2.0 scales, with 2 weeks apart. The discriminative, concurrent, and construct validity of the cross-culturally adapted questionnaire was individually evaluated. The relationship among the SC-SOSGOQ 2.0, SC-EQ-5D-5L and SC-SF-36 was assessed using the correlation coefficients. RESULTSOne hundred and twenty patients were included in this study. No floor or ceiling effects were observed for the SC-SOSGOQ 2.0. The Cronbach's α for domains of neurological function, pain, mental health, social function, and post-therapy were 0.825, 0.876, 0.896, 0.897, 0.943, and 0.835, respectively. The value of inter-class correlation coefficient ranged from 0.55 to 0.83, which reflected a satisfactory test-retest reliability. Concurrent assessment of criterion validity demonstrated a moderate-to-strong correlation in all domains of SC-SOSGOQ 2.0 with the SC-EQ-5D-5L (0.34–0.74) and SC-SF-36 (0.33–0.76). The best-correlated domain was physical function (0.741 in the EQ-5D-5L and 0.722 in the SF-36). CONCLUSIONSThe SC-SOSGOQ 2.0 demonstrated an excellent acceptability, score distribution, internal consistency, test-retest reliability and validity. It was therefore considered as a tool effective for evaluating HRQOL of Chinese patients with SM.

On the development of new cancer quality of life questionnaires

The article is devoted to summarizing the authors’ experience in the development of Russian-language versions of foreign quality of life questionnaires for cancer patients as well as their own questionnaires for studying various aspects of the quality of life in bone and soft tissue tumors of the musculoskeletal system. We briefly presented the results of the validation and testing of the modules of the «Cancer Quality of Life Questionnaire - Core 30» (EORTC QLQ-C30) developed by the Quality of Life Assessment Group at the European Organization for Research and Treatment of Cancer (EORTC) – «Fatigue» module (FA12), «Spiritual wellbeing» module (SWB32), «Bone Metastases» module (BM22), as well as the specialized Spine Oncology Study Group Outcomes Questionnaire (SOSG-OQ). We also presented the diagnostic tools developed by the authors’ themselves for studying the quality of life of patients with pelvic bone tumors and lower limb amputations due to cancer. The main objective of the article was to inform the scientific community, as well as practicing psycho-oncologists and oncologists about the existence of new diagnostic tools for assessing the quality of life of cancer patients. The article also outlines the prospects for development of diagnostic tools for quality of life of cancer patients.

Surgical strategy for metastatic spinal tumor patients with surgically challenging situation.

The incidence of spinal metastasis is increasing as cancer patients live longer owing to the improvement of cancer treatments. However, traditional surgery (TS) which fixates at least 2 levels above and 2 levels below the affected vertebrae is sometimes difficult to perform as it is burdensome to the patients. In this article, we introduce our experience and strategy in treating spinal metastasis, focusing particularly on challenging cases.We retrospectively reviewed the data of 110 patients who underwent spinal surgery for metastatic spinal tumors from April 2018 to March 2020. Among them, 5 patients who received anterior approach surgery were excluded. The remaining 105 patients were enrolled. In addition to TS, we also performed cervical pedicle screw, cervicothoracic junction fixation, thoracolumbar short fixation, and decompression surgery, depending on the characteristics of the tumor. The overall survival was analyzed, and the local tumor control rate was evaluated using magnetic resonance imaging. Perioperative clinical characteristics including Spine Oncology Study Group Outcomes Questionnaire, visual analog scale, Eastern Cooperative Oncology Group performance score, and Karnofsky Performance Score were also investigated.The overall survival rate was 57.9% at 1 year, and the local tumor control rate was 81.1% after surgery. There was a statistically significant difference according to the type of the tumor in the survival analysis: the overall survival rates were 72.7% for favorable tumors and 48.6% for unfavorable tumors at 12 months after surgery (P = .04). Spine Oncology Study Group Outcomes Questionnaire, visual analog scale, Eastern Cooperative Oncology Group performance score, and Karnofsky Performance Score was improved after surgery. All surgical methods, including TS, cervical pedicle screw, cervicothoracic junction fixation, thoracolumbar short fixation, and decompression surgery, showed good clinical and radiological outcomes.Optimized surgical methods show similarly good clinical outcomes in managing spinal metastasis as TS.

Adaptation and Validation of the Spine Oncology Study Group Outcomes Questionnaire in Italian Language.

Prospective observational study. The population of patients with advanced stages of cancer, including metastatic spinal disease, is growing because of better treatment options allowing for longer control of disease. The main goal of treatment for these patients is to improve or maintain their health-related quality of life (HRQOL). A spine oncology-specific outcome measure has been developed by the Spine Oncology Study Group and validated through international studies. We proposed to translate and validate the questionnaire in Italian language. The cross-cultural adaptation of the questionnaire has been performed according to guidelines previously proposed. After this process, an observational prospective study has been conducted to validate the efficacy of SOSGOQ in Italian language. SOSGOQ has been compared to SF-36 (Short Form Health Survey-36), a generic validated questionnaire to assess HRQOL. Starting from January 2020, SOSGOQ and SF-36 questionnaires were auto-administered to 150 patients affected by spinal metastases who provided written informed consent for study participation. The confirmatory factor analysis on the 4 domains examined showed a good model fit (comparative fit index, .95; RMSEA .07 (90% CI, .05-.09) and SRMR, .05), endorsing construct validity. The analysis of concurrent validity demonstrated strong correlation for physical function, pain and mental health domains with the corresponding domain scores of SF-36. The reliability across item was high with a Cronbach's alpha coefficient of .91. The statistical analysis of the results will allow to accept the Italian version of SOSGOQ as a specific and efficient tool to measure HRQOL in Italian-speaking patients affected by spinal metastases.

Patient Reported Outcomes in Metastatic Spine Disease: Concurrent Validity of PROMIS with the Spine Oncology Study Group Outcome Questionnaire.

Cross-sectional prospective study. To evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), Pain Interference (PI), and Depression domains in comparison to the Spine Oncology Study Group-Outcomes Questionnaire (SOSG-OQ) in patients with metastatic spine disease. While there remains a significant movement toward incorporating patient-reported outcome measures (PROMs) into clinical care, there are few validated PROMs for patients with metastatic spine disease. The SOSG-OQ was designed and validated for metastatic spine tumor patients. However, the use of general symptom-based PROMs, such as PROMIS domains, may reduce both patient and physician burden and improve interdisciplinary care if shown to be concurrently valid. Metastatic spine tumor patients from January 2017 to July 2021 at a single academic medical center were asked to complete PROMIS PF, PI, and Depression domains and the SOSG-OQ. Spearman correlation (p) coefficients were calculated. A total of 103 unique visits, representing 79 patients met our inclusion criteria. A majority were men (59; 57%) and Caucasian (93; 90%), and the average age was 64-years-old (range: 34-87). There were 13 different types of histologies reported, with multiple myeloma, breast cancer, and prostate cancer representing 28 (27%), 26 (25%), and 13 (13%), respectively. Additional cancers included renal cell carcinoma, lung cancer, colon cancer, thyroid cancer, large B-cell lymphoma, nonHodgkin lymphoma, esophageal cancer, plasmacytoma, metastatic paraganglioma, and metastatic spindle cell sarcoma. SOSG-OQ was strongly correlated with PROMIS PI (ρ = 0.78) and PROMIS PF (ρ = 0.71), and moderately correlated with PROMIS Depression (ρ = 0.58). PROMIS PF, PI, and Depression appear to capture similar clinical insight as the SOSG-OQ. Spine surgeons can consider using these PROMIS domains in lieu of the SOSG-OQ in metastatic spine tumor patients.

A comparison of two different surgical procedures in the treatment of isolated spinal metastasis patients with metastatic spinal cord compression: a case-control study.

The aim of the study was to compare total en bloc spondylectomy (TES) and separation surgery with postoperative stereotactic radiosurgery (SSRS) for isolated metastatic patients with spinal cord compression by assessing recurrence-free survival (RFS), overall survival (OS), postoperative complications, and quality of life scores (QoL). From October 2013 to December 2020, 52 isolated spinal metastasis patients with cord compression were selected and separated into two groups based on the surgical method used (TES group, n = 26; and SSRS group, n = 26). Indexes for evaluation included postoperative Frankel grade, postoperative ECOG-PS, RFS, OS, postoperative complications, operation time, intraoperative blood loss, and QoL. The average follow-up duration was 31.44months. There was no significant difference (P > 0.05) in postoperative complications and OS between the two groups. However, a significant difference in operation time, intraoperative blood loss, postoperative ECOG-PS, RFS, and mental health domain (6 months after surgery) was found between the two groups (P < 0.05). According to The Spine Oncology Study Group Outcomes Questionnaire assessment, the total pain and physical function domains scores were also elevated after surgery in both groups. However, no significant difference was observed between groups A and B (p = 0.450 and 0.446, respectively). TES and SSRS were efficient methods for treating solitary spinal metastasis patients with metastatic spinal cord compression. Better local tumor control and mental health were found in the TES group, and most patients felt as if they were free of spinal tumors. Compared with TES, the SSRS caused less operation-related trauma. However, there was no significant difference in OS between the two groups.

ECross-cultural adaptation of the spine oncology-specific SOSGOQ2.0 questionnaire to German language and the assessment of its validity and reliability in the clinical setting

BackgroundThe recently developed Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) was proven a valid and reliable instrument measuring health-related quality of life (HRQOL) for patients with spinal malignancies. A German version was not available.ObjectiveA cross-cultural adaptation of the SOSGOQ2.0 to the German language and its multicenter evaluation.MethodsIn a multistep process, a cross-cultural adaptation of the SOSGOQ2.0 was conducted. Subsequently, a multicenter, prospective observational cohort study was initiated to assess the reliability and validity of the German adaptation. To assess external construct validity of the cross-cultural adapted questionnaire, a comparison to the established questionnaire QLQ-C30 from the European Organisation for Research and Treatment of Cancer was conducted. Mean-difference plots were used to measure the agreement between the questionnaires in total score and by domain (deviation from mean up to 10% allowed). Further reliability and validity tests were carried out. Change to baseline was analysed 3–16 weeks later after different interventions occurred. Clinically relevant thresholds in comparison to the EORTC QLQ-C30 questionnaire were evaluated by ROC curve analysis.ResultsWe could enroll 113 patients from four different university hospitals (58 females, 55 males). Mean age was 64.11 years (sd 11.9). 80 patients had an ECOG performance status of 2 or higher at baseline. External construct validity in comparison to the EORTC QLQ-C30 questionnaire in total score and by domain was confirmed (range of deviation 4.4 to 9.0%). Good responsiveness for the domains Physical Functioning (P < .001) and Pain (P < .001) could be shown. The group mean values also displayed a difference in the domains of Social Functioning (P = .331) and Mental Health (P = .130), but not significant. The minimum clinically relevant threshold values for the questionnaire ranged from 4.0 to 7.5 points.ConclusionsAccording to our results, the cross-cultural adapted questionnaire is a reliable and valid tool to measure HRQOL in German speaking patients with spinal malignancies. Especially the domains Physical Functioning and Pain showed overall good psychometric characteristics. In this way, a generic questionnaire, such as the EORTC QLQ-C30, can be usefully supplemented by spine-specific questions to increase the overall accuracy measuring HRQOL in patients with spinal malignancies.

Dynamics of quality of life main parameters in patients with spine tumors underwent surgical treatment

In this study we analyzed the quality of life in 62 patients (35.5 % of men and 64.5 % of women; mean age 55 years) who had tumor lesions in different parts of the spine and were treated in the Department of Vertebral Surgery, N.N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia. We assessed the association between the quality of life and psychological characteristics of patients – coping strategies and personal resources. We used a general questionnaire for assessing patients’ quality of life (The Medical Outcomes Study Short Form 36 Items Health Survey) and special questionnaires for cancer patients (Quality of Life Questionnaire – Core 30, QLQ-C30), patients with tumor lesions to the spine (Spine Oncology Study Group Outcomes Questionnaire, SOSG OQ), and psychodiagnostic methods, such as Ways of Coping, Big Five, and Life-meaning Orientations. We have identified an association between the quality of life and all parameters of psychodiagnostic questionnaires, better quality of life correlated with more pronounced psychological characteristics reflecting the maturity of the individual (internality, activity, presence of meaningful goals, ability to seek social support, etc.). Lower personal maturity and poorer constructive coping strategies were associated with worse somatic symptoms and their impact on the quality of life.

P73. Evaluating the concurrent validity of PROMIS PF, PI, and depression domains with the SOSG-OQ in metastatic spine tumor patients

<h3>BACKGROUND CONTEXT</h3> While there remains a significant movement towards incorporating PROMs (patient-reported outcome measures) into clinical spine practice to improve patient-centered care, a commonly used PROM in practice remains elusive. This is especially true in the case of patients with metastatic spine disease. The SOSG-OQ (Spine Oncology Study Group-Outcomes Questionnaire) was designed and validated for metastatic spine tumor patients. The use of general symptom-based PROMs, such as PROMIS (Patient-Reported Outcomes Measurement Information System) domains, may reduce both patient and physician burden and improve interdisciplinary care if shown to be concurrently valid. <h3>PURPOSE</h3> To evaluate the concurrent validity of PROMIS PF (Physical Function), PI (Pain Interference), and Depression domains with the SOSG-OQ in patients with metastatic spine disease. <h3>STUDY DESIGN/SETTING</h3> Cross-sectional study at a single academic medical center. <h3>PATIENT SAMPLE</h3> Metastatic spine tumor patients. <h3>OUTCOME MEASURES</h3> SOSG-OQ; PROMIS PF, PI, and Depression domains. <h3>METHODS</h3> Metastatic spine tumor patients from 1/2017 to 1/2021 at a single academic medical center were asked to complete PROMIS PF, PI, and Depression domains and the SOSG-OQ. Only patients who completed both the SOSG-OQ and PROMIS instruments were included in the analysis. Spearman correlation (ρ) coefficients were calculated, and the absolute value of each correlation was taken for ease of analysis. Patients missing a single question in the SOSG-OQ were excluded from the correlation analysis of the corresponding section. Significance was set at p<0.05. <h3>RESULTS</h3> A total of 73 unique visits, representing 55 patients met our inclusion criteria. A majority were men (39; 53%) and Caucasian (66; 91%), and the average age was 64 years (range: 34-87). There were 11 different types of tumors reported, with multiple myeloma, breast cancer, and lung cancer representing 22 (30%), 21 (29%), and 7 (9.6%), respectively. Additional cancers included prostate, colon, renal cell, thyroid, esophageal, non-Hodgkin's lymphoma, large B cell lymphoma, and metastatic spindle cell sarcoma. SOSG-OQ was strongly correlated with PROMIS PI (ρ = 0.83, p<0.0001; n = 68) and moderately correlated with both PROMIS PF (ρ = 0.76, p<0.0001; n = 68) and PROMIS Depression (ρ = 0.65, p<0.0001; n = 68). <h3>CONCLUSIONS</h3> PROMIS PF, PI, and Depression appear to capture similar clinical insight as the SOSG-OQ. Thus, spine surgeons can consider using these PROMIS domains in lieu of the SOSG-OQ in metastatic spine tumor patients. This is important for establishing broader, more interdisciplinary clinical care for this complex patient population, as PROMIS domains are symptom-based and can also be used by oncologists and other health care providers to deliver improved care. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Calculating Utilities From the Spine Oncology Study Group Outcomes Questionnaire: A Necessity for Economic and Decision Analysis.

General population utility valuation study. The aim of this study was to develop a technique for calculating utilities from the Spine Oncology Study Group Outcomes Questionnaire v2.0 (SOSGOQ2.0). The ability to calculate quality-adjusted life-years (QALYs) for metastatic spine disease would enhance treatment decision-making and facilitate economic analysis. QALYs are calculated using utilities. Using a hybrid concept-retention and factorial analysis shortening approach, we first shortened the SOSGOQ2.0 to eight items (SOSGOQ-8D). This was done to lessen the cognitive burden of the utility valuation exercise. A general population sample of 2730 adults was then asked to evaluate 12 choice sets based on SOSGOQ-8D health states in a Discrete Choice Experiment. A utility scoring rubric was then developed using a mixed multinomial-logit regression model. We were able to reduce the SOSGOQ2.0 to an SOSGOQ-8D with a mean error of 0.003 and mean absolute error of 3.078 compared to the full questionnaire. The regression model demonstrated good predictive performance and was used to develop a utility scoring rubric. Regression results revealed that participants did not regard all SOSGOQ-8D items as equally important. We provide a simple technique for converting the SOSGOQ2.0 to utilities. The ability to evaluate QALYs in metastatic spine disease will facilitate economic analysis and patient counseling. We also quantify the importance of individual SOSGOQ-8D items. Clinicians should heed these findings and offer treatments that maximize function in the most important items.Level of Evidence: 3.

Validity and reliability of the Thai version of the Spine Oncology Study Group Outcomes Questionnaire version 2.0 to assess Quality of Life in Patients with Spinal Metastasis

Background ContextThe Spine Oncology Study Group Outcomes Questionnaire version 2.0 (SOSGOQ2.0) is a spinal metastasis (SM)-specific quality of life (QoL) questionnaire that was previously reported to have good reliability and validity. There is currently no Thai version of the SOSGOQ 2.0. (TH-SOSGOQ2.0). PurposeTo assess the psychometric properties of the TH-SOSGOQ 2.0. Study Design/SettingCross-sectional study. Faculty of Medicine Siriraj Hospital, Mahidol University. Patient SamplePatients who were confirmed diagnosis of metastatic spinal disease, age 18 to 75 years, and having already undergone surgery and/or radiotherapy for the treatment of spinal metastasis. Outcome MeasuresValidity and reliability of the TH-SOSGOQ 2.0 to assess QoL in Patients with SM. MethodsUsing the forward-backward translation technique, the SOSGOQ2.0 was translated into Thai language to create the TH-SOSGOQ2.0. SM patients were prospectively enrolled and evaluated for patient QoL using both the TH-SOSGOQ2.0 and the EQ-5D-5L (Thai version) at baseline and 3 months after treatment. Construct validity was assessed using multi-trait scaling analysis, confirmatory factor analysis, and correlation with EQ-5D-5L. Test-retest reliability was assessed in a subgroup of patients who took the TH-SOSGOQ2.0 two times one week apart. ResultsSixty-eight patients (mean age: 57 years; 30 males, 38 females) were included. The Cronbach's alpha values for the total score, physical function, neurological function, pain, mental health, social function, and post-therapy domains were 0.87, 0.89, 0.91, 0.84, 0.82, 0.75, and 0.85, respectively. Good reliability was demonstrated (interclass correlation coefficient range: 0.70-0.84), except for the social function domain (0.60). Regarding concurrent validity, the TH-SOSGOQ2.0 domains demonstrated moderate to good correlation with the corresponding EQ-5D-5L 9 (Thai version) domains (range: -0.32 to -0.78). Physical function was the most well-correlated domain with the EQ-5D-5L (Thai version) (-0.77). ConclusionsTH-SOSGOQ2.0 demonstrated good reliability and validity for assessing QoL in Thai SM patients.

Predicting postoperative quality-of-life outcomes in patients with metastatic spine disease: who benefits?

Symptomatic spinal metastasis occurs in around 10% of all cancer patients, 5%-10% of whom will require operative management. While postoperative survival has been extensively evaluated, postoperative health-related quality-of-life (HRQOL) outcomes have remained relatively understudied. Available tools that measure HRQOL are heterogeneous and may emphasize different aspects of HRQOL. The authors of this paper recommend the use of the EQ-5D and Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ), given their extensive validation, to capture the QOL effects of systemic disease and spine metastases. Recent studies have identified preoperative QOL, baseline functional status, and neurological function as potential predictors of postoperative QOL outcomes, but heterogeneity across studies limits the ability to derive meaningful conclusions from the data. Future development of a valid and reliable prognostic model will likely require the application of a standardized protocol in the context of a multicenter study design.