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PURPOSE: The aim of this study was to translate and cross-culturally adapt the Core Outcome Measures Index for (COMI) into a Simplified Chinese version (COMI-SC) and to evaluate the reliability and validity of COMI-SC in patients with neck pain. METHODS: The COMI-neck was translated into Chinese according to established methods. The COMI-neck questionnaire was then completed by 122 patients with a hospital diagnosis of neck pain. Reliability was assessed by calculating Cronbach's alpha and intraclass correlation coefficient (ICC). Construct validity was assessed by correlating the COMI-neck with the Neck Pain and Disability Scale (NPDS), the Neck Disability Index (NDI), the VAS and the Short Form (36) Health Survey (SF-36). Using confirmatory factor analysis to validate the structural, convergent and discriminant validity of the questionnaire. RESULTS: The COMI-neck total scores were well distributed, with no floor or ceiling effects. Internal consistency was excellent (Cronbach's alpha = 0.861). Moderate to substantial correlations were found between COMI-neck and NPDS (r = 0.420/0.416/0.437, P < 0.001), NDI (r = 0.890, P < 0.001), VAS (r = 0.845, P < 0.001), as well as physical function (r = - 0.989, P < 0.001), physical role (r = - 0.597, P < 0.001), bodily pain (r = - 0. 639, P < 0.001), general health (r = - 0.563, P < 0.001), vitality (r = - 0.702, P < 0.001), social functioning (r = - 0.764, P < 0.001), role emotional (r = - 0.675, P < 0.001) and mental health (r = - 0.507, P < 0.001) subscales of the SF-36. An exploratory factor analysis revealed that the 3-factor loading explained 71.558% of the total variance [Kaiser-Mayer-Olkin (KMO) = 0.780, C2 = 502.82, P < 0.001]. CMIN/DF = 1.813, Tucker-Lewis index (TLI) = 0.966 (> 0.9), Comparative Fit Index (CFI) = 0.982 (> 0.9), Normed Fit Index (NFI) = 0.961 (> 0.9), RMSEA = 0.082 (< 0.5) indicating that the model fits well. CONCLUSION: COMI-neck was shown to have acceptable reliability and validity in patients with non-specific chronic neck pain and could be recommended for patients in mainland China. LEVEL OF EVIDENCE: Diagnostic: individual cross-sectional studies with consistently applied reference standard and blinding.

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INTRODUCTION: The Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) are two commonly used self-rating outcome instruments in patients with lumbar spinal disorders. No formal crosswalk between them exists that would otherwise allow the scores of one to be interpreted in terms of the other. We aimed to create such a mapping function. METHODS: We performed a secondary analysis of ODI and COMI data previously collected from 3324 patients (57 ± 17y; 60.3% female) at baseline and 1y after surgical or conservative treatment. Correlations between scores and Cohen's kappa for agreement (κ) regarding achievement of the minimal clinically important change (MCIC) score on each instrument (ODI, 12.8 points; COMI, 2.2 points) were calculated, and regression models were built. The latter were tested for accuracy in an independent set of registry data from 634 patients (60 ± 15y; 56.8% female). RESULTS: All pairs of measures were significantly positively correlated (baseline, 0.73; 1y follow-up (FU), 0.84; change-scores, 0.73). MCIC for COMI was achieved in 53.9% patients and for ODI, in 52.4%, with 78% agreement on an individual basis (κ = 0.56). Standard errors for the regression slopes and intercepts were low, indicating excellent prediction at the group level, but root mean square residuals (reflecting individual error) were relatively high. ODI was predicted as COMI × 7.13-4.20 (at baseline), COMI × 6.34 + 2.67 (at FU) and COMI × 5.18 + 1.92 (for change-score); COMI was predicted as ODI × 0.075 + 3.64 (baseline), ODI × 0.113 + 0.96 (FU), and ODI × 0.102 + 1.10 (change-score). ICCs were 0.63-0.87 for derived versus actual scores. CONCLUSION: Predictions at the group level were very good and met standards justifying the pooling of data. However, we caution against using individual values for treatment decisions, e.g. attempting to monitor patients over time, first with one instrument and then with the other, due to the lower statistical precision at the individual level. The ability to convert scores via the developed mapping function should open up more centres/registries for collaboration and facilitate the combining of data in meta-analyses.

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PURPOSE: To elucidate the minimum clinically important change (MCIC) of the physical component summary (PCS) of the Short Form-12, Oswestry Disability Index (ODI), EuroQOL-5 dimensions (EQ-5D), and the Core Outcome Measures Index (COMI) in patients aged ≥ 75 years undergoing lumbar spine surgery. METHODS: We retrospectively reviewed patients aged ≥ 75 years with degenerative lumbar spine disease who underwent lumbar spine decompression or fusion surgery within three levels between April 2017 and June 2018. We also evaluated patients aged < 75 years in the same period as reference. We evaluated the baseline and postoperative PCS, ODI, EQ-5D, and COMI scores. Patients were asked to answer an anchor question regarding health transition for MCICs using the anchor-based method. RESULTS: A total of 247 patients aged ≥ 75 years and 398 patients aged < 75 years were included for analysis. Of patients aged ≥ 75 years, 83.4% showed at least "somewhat improved" outcomes, while 91.0% of patients aged < 75 years reported this outcome. PCS change score was not adequately correlated to health transition in patients aged ≥ 75 years. Receiver operating characteristic curve analyses revealed MCICs of 17.8 for ODI, 0.18 for EQ-5D, and 1.6 for COMI in patients aged ≥ 75 years, and 12.7 for ODI, 0.19 for EQ-5D, and 2.3 for COMI in patients aged < 75 years. CONCLUSION: In patients aged ≥ 75 years, PCS may not be feasible for evaluation of health transition. The MCIC value for ODI score was higher and that for EQ-5D/COMI score was lower in patients aged ≥ 75 years, compared with those in patients aged < 75 years.

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STUDY DESIGN: Retrospective case series. OBJECTIVE: Despite numerous advances in the technology and techniques available to spinal surgeons, lumbar decompression remains the mainstay of degenerative lumbar spine surgery. It has proven efficacy in trials, but only limited evidence of advantage over conservative management in large scale systematic reviews. We collated data from a large surgically managed cohort to evaluate the patient-reported outcomes. METHODS: We performed a retrospective analysis of a prospectively populated database. Patient demographics, surgical details, and patient outcomes (Spine Tango core outcome measures index [COMI]-Low Back) were collected for 2699 lumbar decompression surgeries. RESULTS: Lumbar decompression was shown to be successful at improving leg pain (mean improvement in visual analogue scale [VAS] at 3 months = 4) and to a lesser extent, back pain (mean improvement in VAS at 3 months = 2.61). Mean improvement in COMI score was 3.15 for all-comers. Minimal clinically important improvement (MCID) in COMI score (-2 points) was achieved in 73% of patients by 2-year follow-up. Primary surgery was more effective than redo surgery: odds ratio 0.547 (95% CI 0.408-0.733, P < .001). The benefits across all outcomes were maintained for the 2-year follow-up period. Patients can be classified according to their outcome as "early responders"; achieving MCID by 3 months (61% primary vs 41% redo), "late responders"; achieving MCID by 2 years (15% vs 20%) or nonresponders (24% vs 39%). CONCLUSIONS: Lumbar decompression is effective in improving quality of life in appropriately selected patients. Patient-reported outcome measures collected routinely and collated within a registry are a powerful tool for assessing the efficacy of lumbar spine interventions and allow accurate counseling of patients perioperatively.

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PURPOSE: Vertebral osteomyelitis (VO) has a high mortality and leads to chronic pain and functional disability. Surgical treatment is often necessary. To date, little is known about the consequences of surgery on patient outcome. The aim of this study was to determine the quality of life (QoL) and mortality rates of surgically treated VO patients for a period of 2 years. METHODS: Patients with VO undergoing surgical treatment in a tertiary referral hospital from 2008 to 2015 were included prospectively. Data were collected before (T0) as well as 1 year (T1) and 2 years (T2) post-surgery. Within the European Spine Tango registry, prospective patient and QoL data were collected using validated outcome scores: Oswestry Disability Index, Short Form 36/EuroQol, Visual Analog Scale, and Core Outcome Measures Index. RESULTS: From 195 patients surgically treated for VO, QoL data were available from 136 patients at T0, 100 patients at T1, and 82 patients at T2, respectively. The 1- and 2-year mortality rates were 20% and 23%. Mainly all QoL outcome scores showed significant improvement at T1 and did not change significantly from T1 to T2. CONCLUSION: Surgical treatment of VO patients leads to significantly improved QoL. Nevertheless, QoL levels were below those of the general population. Our results underscore that spine disability questionnaires measuring QoL are mandatory to demonstrate comprehensively the severity of this entity. Our study confirms a high mortality and points out the role of VO as a potentially life-threatening condition.

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OBJECTIVE: The 6-minute walking test (6WT) is used to determine restrictions in a subject's 6-minute walking distance (6WD) due to lumbar degenerative disc disease. To facilitate simple and convenient patient self-measurement, a free and reliable smartphone app using Global Positioning System coordinates was previously designed. The authors aimed to determine normative values for app-based 6WD measurements. METHODS: The maximum 6WD was determined three times using app-based measurement in a sample of 330 volunteers without previous spine surgery or current spine-related disability, recruited at 8 centers in 5 countries (mean subject age 44.2 years, range 16-91 years; 48.5% male; mean BMI 24.6 kg/m2, range 16.3-40.2 kg/m2; 67.9% working; 14.2% smokers). Subjects provided basic demographic information, including comorbidities and patient-reported outcome measures (PROMs): visual analog scale (VAS) for both low-back and lower-extremity pain, Core Outcome Measures Index (COMI), Zurich Claudication Questionnaire (ZCQ), and subjective walking distance and duration. The authors determined the test-retest reliability across three measurements (intraclass correlation coefficient [ICC], standard error of measurement [SEM], and mean 6WD [95% CI]) stratified for age and sex, and content validity (linear regression coefficients) between 6WD and PROMs. RESULTS: The ICC for repeated app-based 6WD measurements was 0.89 (95% CI 0.87-0.91, p < 0.001) and the SEM was 34 meters. The overall mean 6WD was 585.9 meters (95% CI 574.7-597.0 meters), with significant differences across age categories (p < 0.001). The 6WD was on average about 32 meters less in females (570.5 vs 602.2 meters, p = 0.005). There were linear correlations between average 6WD and VAS back pain, VAS leg pain, COMI Back and COMI subscores of pain intensity and disability, ZCQ symptom severity, ZCQ physical function, and ZCQ pain and neuroischemic symptoms subscores, as well as with subjective walking distance and duration, indicating that subjects with higher pain, higher disability, and lower subjective walking capacity had significantly lower 6WD (all p < 0.001). CONCLUSIONS: This study provides normative data for app-based 6WD measurements in a multicenter sample from 8 institutions and 5 countries. These values can now be used as reference to compare 6WT results and quantify objective functional impairment in patients with degenerative diseases of the spine using z-scores. The authors found a good to excellent test-retest reliability of the 6WT app, a low area of uncertainty, and high content validity of the average 6WD with commonly used PROMs.

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BACKGROUND: To conduct a cross-cultural adaptation and validation of the Core Outcome Measures Index (COMI) in the Slovenian language, for use in patients with low back pain. METHODS: The English version of COMI was translated into Slovene following established guidelines. Three hundred fifty-three patients with chronic low back pain were recruited from the Orthopedic clinic department of a tertiary care teaching institution. Data quality, construct validity, responsiveness, and test-retest reliability of the COMI were assessed. RESULTS: The questionnaire was generally well accepted with no missing values. The majority of items exhibited only mild ceiling effects (below 20.0%) and somewhat more prominent floor effects, which were similar to previous studies (4.5-78.8%). Correlations with Oswestry Disability Index (ODI) were high (ρ = 0.76 between overall COMI and ODI scores), suggesting that the Slovene version of COMI had high construct validity. Additionally, the Slovene version of COMI successfully captured surgical patients' improvement in their low back problem after surgery (overall COMI score change: Z = - 9.34, p < .001, r = - 0.53) and showed acceptable test-retest reliability (ICC = 0.86). CONCLUSIONS: The Slovene version of COMI showed good psychometric properties, comparable to those of previously tested language versions. It represents a valuable instrument for the use in future domestic and multicenter clinical studies.

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Background and aims The Core Outcome Measures Index (COMI) is a short, self-reported questionnaire for assessing important outcomes in patients with low back pain (LBP). The present study was conducted to explore the responsiveness and longitudinal validity of the Persian COMI (COMI-P) in patients with non-specific chronic LBP. Methods In this prospective cohort study of patients with non-specific chronic LBP receiving physiotherapy, patients completed a booklet containing the COMI-P, Persian Functional Rating Index (FRI-P), and a visual analogue scale (VAS) for pain before and after the end of ten-sessions of physiotherapy. Patients also completed a global rating of change scale (GRCS) at the end of the physiotherapy. Responsiveness was examined by means of internal responsiveness methods [t-test, standard effect size (SES); standardized response mean (SRM), and Guyatt responsiveness index (GRI)] and external responsiveness methods [correlation with external criteria and receiver operating characteristics (ROC) curve]. Results Fifty patients with a mean age of 50.62 ± 13.8 years participated. The paired t-test showed significant changes in COMI-P scores (p < 0.001). The effect sizes for COMI-P were large (range 0.96-1.23). The score changes for the COMI-P revealed significant correlations with FRI-P (r = 0.67, p < 0.001), the VAS (r = 0.65, p < 0.001), and the GRCS (r = 0.34, p = 0.02). The COMI-P change scores showed excellent correlation with the dichotomized smallest detectable change (SDC) criterion (r = 0.83, p < 0.001). The ROC area under the curve for the COMI-P based on the dichotomized SDC criterion was perfect. The minimal clinically important change was estimated 2.15 points (sensitivity 94% and specificity 100%). Conclusions The COMI-P appears to have responsiveness and longitudinal validity in detecting changes after physiotherapy for non-specific chronic LBP. An improvement of 2.15 points in COMI-P total score is required to be interpreted as minimally clinically important change in individual patients.

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BACKGROUND: Spinal metastases are being diagnosed more frequently because of increasing life expectancies and advances in the diagnosis and therapy of primary tumours. OBJECTIVE: This aim of this study was to assess the quality of life (QoL) and functional outcomes after surgical intervention for spinal metastases in a large cohort. METHODS: A single-centre, prospective, observational study was conducted from June 2016 to February 2018. Patients treated surgically for spinal metastasis were included. Primary endpoints were the Core Outcome Measure Index (COMI), Oswestry Disability Index (ODI), and QoL questionnaire (EuroQoL-5D) scores recorded preoperatively, 6 weeks postoperatively, and 3, 6, and 12 months postoperatively. RESULTS: Ninety-two patients (mean age, 62.7 ± 12.8 years) were included. The most frequent neoplasms were multiple myeloma (n= 18; 19.6%), lung cancer (n= 16; 17.4%), prostate cancer (n= 14; 15.2%), and breast cancer (n= 11; 12.0%). During the observation period, 44.6% of patients died. The COMI score improved significantly from preoperatively (mean, 7.1; 95% CI, 6.6-7.6) to 3 months (mean, 5.5; 95% CI, 4.8-6.2; p= 0.01) and 12 months (mean, 4.6; 95% CI, 3.7-5.5; p= 0.001) postoperatively. The ODI showed a significant improvement from preoperatively (mean, 52.9; 95% CI, 48.5-57.4) to 6 weeks (mean, 43.4; 95% CI, 37.1-49.6; p= 0.03), 3 months (mean, 37.0; 95% CI, 31.0-42.9) 6 months mean, 40.5; 95% CI, 34.2-46.8; p= 0.01), and 12 months (mean, 31.9; 95% CI, 24.8-39.1; p= 0.005) postoperatively. Improvements in the COMI at 6 weeks (p= 0.05), and 6 months (p= 0.05) postoperatively were not statistically significant. QoL improved from preoperatively to 6 weeks (mean, 0.48; 95% CI, 0.38-0.59; p= 0.002), 3 months (mean, 0.50; 95% CI, 0.38-0.61; p= 0.009), and 12 months (mean, 0.61; 95% CI, 0.51-0.71; p= 0.001) postoperatively. After 6 months, the difference was not significant (p= 0.08). CONCLUSION: Short-term and long-term improvements in functional outcomes and QoL were observed after surgical treatment of spinal metastases. Surgery is a good option for patients with an estimated life expectancy of more than 3 months.

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INTRODUCTION AND STUDY DESIGN: Spinal arachnoid cyst is an uncommon entity, presenting with radiculopathy or paraparesis. These cysts are usually found in intradural extramedullary region; and the extradural region is a rare location. The exact pathogenesis in the existence of these cysts in the extradural region is still debated. In this article, we have retrospectively analyzed the clinical profile of the rare extradural arachnoid cyst (EDAC). METHODOLOGY: In this study, 19 patients of EDAC operated at our institute between January 2006 to June 2016 are analyzed. All patients with the Oswestry disability index score of >20 were managed surgically (open laminectomy and cyst excision). The clinical outcome was assessed at using 5-point satisfaction scale and McCormick grading. RESULTS: All 13 operated patients had EDACs with communication with the intradural compartment. In 11 (84.6%) patients, cyst wall was excised completely, in 2 (15.3%) patients underwent partial excision of cyst wall; dural communication was closed in all patients (n = 13). None of the patients had clinical deterioration or radiological recurrence till the last follow-up. Mean follow-up was 52.2 months (range 1-160); all patients were satisfied after surgery (median score was 3). DISCUSSION: Symptomatic EDACs account <2% of all spinal tumors. The EDACs have communication with the intradural compartment. In our article, we have discussed the approach and management of EDAC, including minimally invasive percutaneous procedures. CONCLUSION: One should aim for preoperative or intraoperative localization of dural communication and try to disconnect the extradural cyst from the intradural connection to prevent recurrence. Surgical treatment is complete excision of the cyst.

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OBJECTIVE: Sagittal imbalance and loss of lumbar lordosis are the main drivers of functional disability in adult degenerative scoliosis. The main limitations of the classic posterior lumbar interbody fusion technique are increased risk of neurological injury and suboptimal correction of the segmental lordosis. Here, the authors describe the radiological results of a modified posterior lumbar interbody fusion and compare the results with a historical cohort of patients. METHODS: Eighty-two consecutive patients underwent surgical treatment for degenerative scoliosis/kyphosis in a single tertiary referral center for complex spinal surgery. Fifty-five patients were treated using the classic multilevel posterior lumbar interbody fusion (MPLIF) technique and 27 were treated using the modified MPLIF technique to include a release of the anterior longitudinal ligament (ALL) and the annulus. A radiographic review of both series of patients was performed by two independent observers. Functional outcomes were obtained, and patients were registered in the European Spine Tango registry. RESULTS: The mean L4-5 disc angle increased by 3.14° in the classic MPLIF group and by 12.83° in MPLIF plus ALL and annulus release group. The mean lumbar lordosis increased by 15.23° in the first group and by 25.17° in the second group. The L4-S1 lordosis increased on average by 4.92° in the classic MPLIF group and increased by a mean of 23.7° in the MPLIF plus ALL release group when both L4-5 and L5-S1 segments were addressed. There were significant improvements in the Core Outcome Measures Index and EQ-5D score in both groups (p < 0.001). There were no vascular or neurological injuries observed in either group. CONCLUSIONS: The authors' preliminary results suggest that more correction can be achieved at the disc level using posterior-based ALL and annulus release in conjunction with posterior lumbar interbody fusion. They demonstrate that ALL and annulus release can be performed safely using a posterior-only approach with minimal risk of vascular injury. However, the authors recommend that this approach should only be used by surgeons with considerable experience in anterior and posterior spinal surgery.

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BACKGROUND: The patient-rated Core Outcome Measures Index (COMI) assesses the multidimensional impact of back problems on the sufferer. The brevity and comprehensibility of the tool make it practical for use in clinical and research settings. Although the COMI has been cross-culturally adapted in various languages worldwide, there is currently no Japanese version. The aim of this study was to develop a Japanese version of the COMI by: (1) performing a cross-cultural adaptation of the English version and (2) evaluating the psychometric properties of the Japanese version of the COMI in Japanese volunteers with chronic back problems. METHODS: The English version of the COMI was cross-culturally adapted for the Japanese language using established guidelines. The pre-final version was pilot-tested in five Japanese-speaking patients with low back pain (LBP) and a history of spine surgery. The psychometric properties of the Japanese COMI were tested in a group of 1052 individuals with chronic LBP (LBP ≥3 months), aged 20-69 years, who were recruited through a web-based survey. The psychometric properties that were evaluated included convergent and known-group validity, using the following reference questionnaires: EuroQol 5 Dimension, Roland Morris Disability Questionnaire, Short Form 8™ Health Survey, and the Keele STarT Back Screening Tool. RESULTS: The pre-final version of the cross-culturally adapted Japanese COMI was completed without any major problems of understanding or acceptability. For the evaluation of its psychometric properties, tests for convergent validity showed moderate correlations between COMI items and the respective reference questionnaires for symptom-specific well-being [- 0.33--0.48] and disability domains [0.48] and strong correlations (> 0.5) for the other domains and the COMI summary score. The analysis of known-group validity showed a linear trend for the COMI score in relation to prognostic risk (P < 0.001). CONCLUSIONS: The Japanese COMI retained conceptual equivalence to the original using comprehensible and acceptable Japanese expressions. We developed a Japanese version of the COMI that displayed qualities that support its convergent and known-group validity. The availability of a Japanese version of the COMI should allow for improved documentation of the care provided to patients with back problems.

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PURPOSE: Patient-rated measures are considered the gold standard for assessing the outcome of spine surgery, but there is no consensus on the appropriate timing of follow-up. Journals often demand a minimum 2-year follow-up, but the indiscriminate application of this principle may not be warranted. We examined the course of change in patient outcomes up to 5 years after surgery for degenerative spinal disorders. METHODS: The data were evaluated from 4287 consecutive patients (2287 women, 2000 men; aged 62 ± 15 years) with degenerative disorders of the thoracolumbar spine, undergoing first-time surgery at the given level between 01/01/2005 and 31/12/2011. The Core Outcome Measures Index (COMI; scored 0-10) was completed by 4012 (94%) patients preoperatively, 4008 (93%) at 3-month follow-up, 3897 (91%) at 1-year follow-up, 3736 (87%) at 2-year follow-up, and 3387 (79%) at 5-year follow-up. 2959 (69%) completed the COMI at all five time-points. RESULTS: The individual COMI change scores from preoperatively to the various follow-up time-points showed significant correlations ranging from r = 0.50 (for change scores at the earliest vs the latest follow-up) to r = 0.75 (for change scores after 12- vs 24-month follow-up). Concordance with respect to whether the minimum clinically important change score was achieved at consecutive time-points was also good (70-82%). COMI decreased significantly (p < 0.05) from preop to 3 months (by 3.6 ± 2.8 points) and from 3 to 12 months (by 0.3 ± 2.4 points), then levelled off up to 5 years (0.04-0.05 point change; p > 0.05). The course of change up to 12 months differed slightly (p < 0.05) depending on pathology/whether fusion was carried out. For patients undergoing simple decompression, 3-month follow-up was sufficient; those undergoing fusion continued to show further slight but significant change up to 12 months. CONCLUSIONS: Stable group mean COMI scores were observed for all patients from 12 months postoperatively onwards. The early postoperative results appeared to herald the longer term outcome. As such, a 'wait and see policy' in patients with a poor initial outcome at 3 months is not advocated. The insistence on a 2-year follow-up could result in a failure to intervene early to achieve better long-term outcomes.

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PURPOSE: The core outcome measures index (COMI) is a validated multidimensional instrument for assessing patient-reported outcome in patients with back problems. The aim of the present study is to translate the COMI into Dutch and validate it for use in native Dutch speakers with low back pain. METHODS: The COMI was translated into Dutch following established guidelines and avoiding region-specific terminology. A total of 89 Dutch-speaking patients with low back pain were recruited from 8 centers, located in the Dutch-speaking part of Belgium. Patients completed a questionnaire booklet including the validated Dutch version of the Roland Morris disability questionnaire, EQ-5D, the WHOQoL-Bref, the Numeric Rating Scale (NRS) for pain, and the Dutch translation of the COMI. Two weeks later, patients completed the Dutch COMI translation again, with a transition scale assessing changes in their condition. RESULTS: The patterns of correlations between the individual COMI items and the validated reference questionnaires were comparable to those reported for other validated language versions of the COMI. The intraclass correlation for the COMI summary score was 0.90 (95% CI 0.84-0.94). It was 0.75 and 0.70 for the back and leg pain score, respectively. The minimum detectable change for the COMI summary score was 1.74. No significant differences were observed between repeated scores of individual COMI items or for the summary score. CONCLUSION: The reproducibility of the Dutch translation of the COMI is comparable to that of other validated spine outcome measures. The COMI items correlate well with the established item-specific scores. The Dutch translation of the COMI, validated by this work, is a reliable and valuable tool for spine centers treating Dutch-speaking patients and can be used in registries and outcome studies.

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BACKGROUND CONTEXT: Spinal epidural lipomatosis (SEL) is a rare condition characterized by an excessive accumulation of fat tissue in the spinal canal that can have a compressive effect, leading to clinical symptoms. This condition has a distinct pathology from spinal stenosis associated with degeneration of the intervertebral discs, ligaments, and facet joints. Several different conservative and surgical treatment strategies have been proposed for SEL, but its treatment remains controversial. There is a lack of evidence documenting the success of surgical decompression in SEL, and no previous studies have reported the postoperative outcome from the patient's perspective. PURPOSE: The aim of the present study was to evaluate patient-rated outcome after surgical decompression in SEL. STUDY DESIGN: A retrospective analysis of prospectively collected data was carried out. PATIENT SAMPLE: A total of 22 patients (19 males; age: 68.2±9.9 years) who had undergone spine surgery for SEL were identified from our local Spine Surgery Outcomes Database, which includes a total of 10,028 spine surgeries recorded between 2005 and 2012. Inclusion criteria were epidural lipomatosis confirmed by preoperative magnetic resonance imaging (MRI) scans and subsequent decompression surgery without spinal fusion. OUTCOME MEASURES: The Core Outcome Measures Index (COMI) was used to assess patient-rated outcome. The COMI includes the domains pain (separate 0-10 scales for back and leg pain), back-specific function, symptom-specific well-being, general quality of life (QOL), work disability, and social disability. METHODS: The questionnaires were completed preoperatively and at 3, 12, and 24 months postoperatively. Surgical data were retrieved from the patient charts and from our local Spine Surgery Outcomes Database, which we operate in connection with the International Spine Tango Registry. Differences between pre- and postoperative scores were analyzed using paired t tests and repeated measures analysis of variance. RESULTS: At 3-months follow-up, the COMI score and scores for leg pain and back pain had improved significantly compared with their preoperative values (p<.005). The mean decrease in COMI score after 3 months was 2.6±2.4 (range: -1.3 to 6.5) points: from 7.5±1.7 (range: 3.5-10) to 4.9±2.5 (range: 0.5-9.6). A total of 11 patients (50%) had an improvement of the COMI of more than the minimal clinically important change (MCIC) score of 2.2 points. The mean decrease in leg pain after 3 months was 2.4±3.5 (-5 to 10) points. Overall, 17 patients (77.3%) reported a reduced leg pain, 12 (54.6%) of whom by at least the MCIC score of 2 points. The significant reductions from baseline in COMI and leg and back pain scores were retained up to 2 years postoperatively (p<.02). The general QOL item of the COMI improved significantly after surgery (p<.0001). Over 80% of the cohort rated their preoperative QOL as bad (n=13) or very bad (n=5), whereas 3 months after surgery, only 7 patients rated their QOL as bad, and one as very bad (36%). CONCLUSIONS: The present study is the first to demonstrate that surgical decompression is associated with a statistically significant improvement in patient-rated outcome scores in patients with symptomatic SEL, with a clinically relevant change occurring in approximately half of them. Surgical decompression hence represents a reasonable treatment option for SEL, although the reason behind the less good response in some patients needs further investigation.

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OBJECT The aim of this study was to evaluate outcome in patients undergoing surgical treatment for intradural spinal tumor using a patient-oriented, self-rated, outcome instrument and a physician-based disease-specific instrument. METHODS Prospectively collected data from 63 patients with intradural spinal tumor were analyzed in relation to scores on the multidimensional patient-rated Core Outcome Measures Index (COMI) and the physician-rated modified McCormick Scale, before and at 3 and 12 months after surgery. RESULTS There was no statistically significant difference between the scores on the modified McCormick Scale preoperatively and at the 3-month follow-up, though there was a trend for improvement (p = 0.073); however, comparisons between the scores determined preoperatively and at the 12-month follow-up, as well as 3- versus 12-month follow-ups, showed a statistically significant improvement in each case (p < 0.004). The COMI scores for axial pain, peripheral pain, and back-related function showed a significant reduction (p < 0.001) from before surgery to 3 months after surgery, and thereafter showed no further change (p > 0.05) up to 12 months postoperatively. In contrast, the overall COMI score, "worst pain," quality of life, and social disability not only showed a significant reduction from before surgery to 3 months after surgery (p < 0.001), but also a further significant reduction up to 12 months postoperatively (p < 0.001). The scores for work disability showed no significant improvement from before surgery to the 3-month follow-up (p > 0.05), but did show a significant improvement (p = 0.011) from 3 months to 12 months after surgery. At the 3- and 12-month follow-ups, 85.2% and 83.9% of patients, respectively, declared that the surgical procedure had helped/helped a lot; 95.1% and 95.2%, respectively, declared that they were satisfied/very satisfied with their care. CONCLUSIONS COMI is a feasible tool to use in the evaluation of baseline symptoms and outcome in patients undergoing surgery for intradural spinal tumor. COMI was able to detect changes in outcome at 3 months after surgery (before changes were apparent on the modified McCormick Scale) and on later postoperative follow-up. The COMI subdomains are valuable for monitoring the patient's reintegration into society and the work environment. The addition of an item that specifically covers neurological deficits may further increase the value of COMI in patients with spinal tumors.

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BACKGROUND: Lumbar Disc Herniation (LDH) and Lumbar Spinal Stenosis (LSS) are the most common diagnoses of low back and leg pain symptoms. This study aimed to cross-culturally translate, and validate the Core Outcome Measures Index (COMI) in Iran. METHODS: The translation and cross-cultural adaptation of the original questionnaire were performed in accordance with published guidelines. A total of 121 patients with LDH or LSS were asked to respond to the questionnaire at two points in time: Pre and postoperative assessments (6 months follow-up). The Oswestry Disability Index (ODI) also was completed. To test the reliability, the internal consistency was assessed by Cronbach's alpha coefficient, and validity was assessed using convergent validity. Responsiveness to change also was assessed for comparing patients' pre and postoperative scores. RESULTS: The Cronbach's alpha coefficients for the COMI at pre and postoperative assessments ranged from 0.79 to 0.82, indicating a good internal consistency. The change in the ODI after surgery was strongly correlated with change in the COMI, lending support to its good convergent validity (r = 0.79 for LDH and r = 0.77 for LSS; P < 0.001). In addition, the correlation of each item with its hypothesized subscale of the COMI showed satisfactory results suggesting, that the items had a substantial association with the subscale, representing the concept. Further analysis also indicated that the questionnaire was responsive to change (P < 0.0001). CONCLUSION: The Iranian version of COMI performed well, and the findings suggest that it is a reliable and valid measure of back pain treatment evaluation among LDH and lumbar canal stenosis patients.