Core Outcome Measures Index Score Research Articles

Methodological considerations in calculating the minimal clinically important change score for the core outcome measures index (COMI): insights from a large single-centre spine surgery registry.

The Minimal Clinically Important Change (MCIC) is used in conjunction with Patient-Reported Outcome Measures (PROMs) to determine the clinical relevance of changes in health status. MCIC measures a change within the same person or group over time. This study aims to evaluate the variability in computing MCIC for the Core Outcome Measure Index (COMI) using different methods. Data from a spine centre in Switzerland were used to evaluate variations in MCIC for the COMI score. Distribution-based and anchor-based methods (predictive and nonpredictive) were applied. Bayesian bootstrap estimated confidence intervals. From 27,003 cases, 9821 met the inclusion criteria. Distribution-based methods yielded MCIC values from 0.4 to 1.4. Anchor-based methods showed more variability, with MCIC values from 1.5 to 4.9. Predictive anchor-based methods also provided variable MCIC values for improvement (0.3-2.4), with high sensitivity and specificity. MCIC calculation methods produce varying values, emphasizing careful method selection. Distribution-based methods likely measure minimal detectable change, while non-predictive anchor-based methods can yield high MCIC values due to group averaging. Predictive anchor-based methods offer more stable and clinically relevant MCIC values for improvement but are affected by prevalence and reliability corrections.

Impact of Gender-Specific Physiological activities on Bone Density and Spinal Alignment Post-Spinal Stabilization Surgery Affecting Quality of Life

Background: The rate of spinal stabilization surgery has increased in recent years among both males and females due to ineffective activities impacting their quality of life, work-disability, and social-disability. Aim: This study aimed to determine the impact of such activities on bone density and spinal alignment after spinal stabilization surgery within the context of Bursa, Turkey. Method: A sample of 450 patients, who had undergone spinal surgery, was included, 210 of which were females and 240 were males. These patients had suffered from different ailments including spinal stenosis, degenerative spondylolisthesis and disc herniation. In order to attain the required outcomes, Core Outcome Measures Index (COMI) was measured before and after (one year) operation. This test measured various positive and negative outcomes post-spinal stabilization surgery including improvement in degree of pain and back function, quality of life, degree of work-disability and social-disability, over a period of 12-months. Patients' satisfaction level with therapy was also measured using a 5-point Likert scale while parametric statistics provided the relationship among variables. Results: The results obtained show that females with all pathologies had worse COMI scores significantly (p < 0.05) as compared to males. However, no significant differences were observed after the operation within the context of gender (p > 0.05). However, 72% of females and 71% of males received minimal clinically important change (MCIC) score of 2.2 for COMI. Hence, gender showed insignificant relationship with MCIC, since females did not show any significant satisfaction level as compared to males concerning their post-operative health outcomes. Conclusion: The study recommends to emphasize on improving therapeutic and surgical measures aiming at attaining significant satisfaction levels after surgery.

The use of the Core Yellow Flags Index for the assessment of psychosocial distress in patients undergoing surgery of the cervical spine.

Psychosocial distress (the presence of yellow flags) has been linked to poor outcomes in spine surgery. The Core Yellow Flags Index (CYFI), a short instrument assessing the 4 main yellow flags, was developed for use in patients undergoing lumbar spine surgery. This study evaluated its ability to predict outcome in patients undergoing cervical spine surgery. Patients with degenerative spinal disorders (excluding myelopathy) operated in one centre, from 2015 to 2019, were asked to complete the CYFI at baseline and the Core Outcome Measures Index (COMI) at baseline and 3 and 12months after surgery. The relationship between CYFI and COMI scores at baseline as well as the predictive ability of the CYFI on the COMI follow-up scores were tested using structural equation modelling. From 731 eligible patients, 547 (61.0 ± 12.5years; 57.2% female) completed forms at all three timepoints. On a cross-sectional basis, preoperative CYFI and COMI scores were highly correlated (β = 0.54, in men and 0.51 in women; each p < 0.001). CYFI added significantly and independently to the prediction of COMI at 3months' FU in men (β = 0.36) and 12months' FU in men and women (both β = 0.20) (all p < 0.001). The CYFI had a low to moderate but significant and independent association with cervical spine surgery outcomes. Implementing the CYFI in the preoperative workup of these patients could help refine outcome predictions and better manage patient expectations.

Cross-cultural adaptation, validation and establishment of the minimal clinically important change score of the European Portuguese core outcome measures index in patients with lumbar degenerative spine disease.

The core outcome measures index (COMI) for the back is a questionnaire that evaluates five domains and has been translated into several languages and validated for different populations. We aimed to translate, cross-culturally adapt and validate it in European Portuguese for use in patients with degenerative lumbar disease. Additionally, we aimed to establish the minimal clinically important change score (MCIC). The translation and cultural adaptation were done according to published guidelines. Patients awaiting surgery at a neurosurgical center completed the COMI, Oswestry Disability Index (ODI), EQ-5D questionnaires and a pain visual analog scale (VAS). To evaluate COMI's reproducibility, patients completed the questionnaire twice within two weeks, preoperatively, in addition to answering a transition question. The MCIC was determined by analysis of postoperative changes in total COMI score, using the anchor method, with a question ascertaining surgical outcome as perceived by the patient. The first set of questionnaires was answered by 108 patients and the second, by 98 patients. COMI's construct validity was confirmed by demonstrating the hypothesized correlation between each domain's score (Spearman Rho > 0.4) and the corresponding questionnaire score (ODI, EQ-5D and VAS) and through adequate correlation (Spearman > 0.6) between COMI's total score and ODI and EQ-5D total scores. Intraclass correlation coefficients between each domain and COMI's total score were > 0.8. The MCIC was calculated as 2.1. The cross-culturally adapted COMI questionnaire is a valid clinical assessment tool for European Portuguese-speaking patients with degenerative lumbar disease, with an MCIC of 2.1 points.

Lumbar Decompression Using the Far-Lateral Approach: Patient-Reported Outcome is Associated With the Involved Vertebral Level and Coronal Segmental Angle.

A single-centre retrospective study of prospectively collected data. Analyse factors associated with the patient-reported outcome after far lateral decompression surgery (FLDS) for lumbar nerve root compression using the far-lateral approach. To date, no studies have investigated the influence of vertebral level, coronal segmental Cobb angle, and the nature of the compressive tissue (hard or soft) on the patient-reported outcome following FLDS. Patients who had undergone FLDS between 2005 and 2020 were included. Coronal segmental angle (CSCA) was measured on preoperative, posteroanterior radiographs. The primary outcome measure was the core outcome measures index (COMI) score at two years' follow-up (2Y-FU). Patients who had undergone microsurgical decompression using a midline approach served as a comparator group. There were 148 FLDS and 463 midline approach patients. In both groups, there was a significant improvement in the COMI score from preoperative to 2Y-FU ( P <0.0001), with greater improvement in patients treated at higher vertebral levels than in those treated at L5/S1 ( P =0.014). Baseline COMI, American Society of Anesthesiologists grade, body mass index, and low back pain as the "chief complaint" all had a significant association with the two-year COMI score. The nature of compressive tissue showed no association with the COMI score at 2Y-FU. In the FLDS group, there was a statistically significant correlation between the preoperative CSCA and the change in COMI score preoperatively to 2Y-FU ( P <0.001). The association was retained in the multiple regression analysis, controlling for confounders. A one-degree increase in CSCA was associated with a 0.35-point worse COMI score at 2Y-FU ( P =0.003). Treatment of far lateral nerve root compression showed an overall good patient-reported outcome, but with less improvement with advanced CSCA. Modified approaches and techniques might be preferable for levels L5/S1.

Patient-reported outcomes 1 and 2years after transforaminal thoracic interbody fusion (TTIF).

Retrospective Cohort Study with prospectively collected data. Transforaminal interbody fusion was initially designed for the lumbar spine. A similar approach was later introduced for the thoracic spine (TTIF). Here we report the surgical technique and the Core Outcome Measures Index (COMI) at 1-year and 2-year follow-ups, as well as the sagittal radiographic kyphosis correction of TTIF, achieved at 1year and the latest follow-up. All TTIF procedures from 2012 to 2020 were included. COMI scores were collected preoperatively and at 1- and 2-year follow-ups. The sagittal angle between the upper and lower endplates at the segment where TTIF was performed was measured on preoperative, 1-year postoperative, and last available radiographs. Seventy-nine TTIF procedures were performed for 64 patients (36% males; mean age 67.5 (SD 15.3) years). COMI score reduced from a mean value of 8.1 (SD 1.4) preoperatively to 4.7 (SD 2.7) at 1-year follow-up and 4.7 (SD 2.7) at 2-year follow-up. The mean correction of segmental kyphosis was 10.8 (SD 7.3, p < 0.0001) degrees at 1-year follow-up and 9.3 (SD 7.0, p < 0.0001) degrees at the final follow-up 3.4 (SD 1.4) years after the operation. Kaplan-Meier analysis for reoperations showed a 5-year survival of 91% (95% CI 0.795-1) for primary TTIF operations and survival of 77% (95% CI 0.651-0.899) for TTIFs performed after earlier fusion operations. TTIF is a feasible procedure in the thoracic spine. Kyphosis correction of approximately 10° was maintained at 1-year and final follow-up. Over 69% at 1-year and 61% at 2-year follow-up achieved MCID for COMI.

Quality of Life with Respect to Surgically Treated Vertebral Osteomyelitis and Degenerative Spondylolisthesis.

Vertebral osteomyelitis (VO) and degenerative spondylolisthesis (SL) are 2 commonly treated spinal conditions. Therefore, in the presented work, the quality of life after surgical therapy of these 2 entities is compared using established scores.In a monocentric study, all patients with VO and SL were prospectively enrolled using the Spine Tango Registry. Surgical procedures included one- or two-stage fusion of the affected segments. Quality of life was assessed using the Core Outcome Measures Index (COMI) and the Oswestry Disability Index (ODI) at time points t0 (0 months), t1 (12 months), and t2 (24 months). Statistical analysis was performed using SPSS. The level of significance was set at 5%.52 patients with VO and 48 patients with SL were included in the analysis. There were no significant differences in age and gender distribution. The length of stay in the SL group was significantly shorter (p<0.001). ODI at time t0 was significantly higher in the VO group (p<0.001), whereas COMI scores did not differ significantly (p=0.155). At time points t1 and t2, the differences between the VO and SL groups were not significantly different for either the ODI score (p=0.176; p=0.250) or the COMI score (p=0.682; p=0.640).Postoperative quality of life scores after lumbar fusion surgery in SL and VO are comparable despite different indications and medical conditions. In both groups, similar quality of life with in patient with chronic back pain was achieved. This should be considered for the preoperative assessment, as well as for the indication for surgery in SL.

Determining threshold values for success after surgical treatment of lumbar spondylodiscitis using quality of life scores.

This study aimed to determine threshold values of validated quality of life (QoL) scores, including Oswestry Disability Index (ODI) and Core Outcome Measures Index (COMI), for predicting a successful outcome following surgical treatment of lumbar spondylodiscitis (LS). Patients with lumbar spondylodiscitis (LS) undergoing surgery in a tertiary referral hospital were included prospectively from 2008-2019. Data were collected both before surgery (T0) and one year after surgery (T1). QoL was measured using ODI and COMI. The successful clinical outcome was defined by the combination of the following four criteria: no recurrence of spondylodiscitis, back pain ≤4 on visual analogue scale or relief of ≥3 points, absence of LS-related neurological deficit, and radiological fusion of the affected segment. For subgroup analysis, group 1 consisted of patients with a favorable treatment outcome (meeting all four criteria), while group 2 included patients with unfavorable treatment outcome (meeting ≤3 criteria). Ninety-two LS patients (median age = 66 years; age range = 57-74) were analyzed. QoL scores improved significantly. Threshold values for the ODI and COMI were calculated at 35 and 4.2 points, respectively. The area under curve for the ODI was 0.856 (95%-CI 0.767- 0.945; P<0.001) and 0.839 (95% CI-0.749-0.928; P<0.001) for the COMI score. Eighty percent of patients achieved a favorable outcome. Objective measurement and evaluation of successful surgical treatment of spondylodiscitis require defined thresholds of quality of life scores. We were able to define such thresholds for Oswestry Disability Index and Core Outcome Measures Index. These can be useful to assess clinically relevant changes and therefore allow a more precise estimation of the post-surgical outcome. Level II, Prognostic study.

Does loss to follow-up lead to an overestimation of treatment success? Findings from a spine surgery registry of over 15,000 patients.

Patient-reported outcome measures (PROMs) are integral to the assessment of treatment success, but loss to follow-up (attrition) may lead to bias in the results reported. We sought to evaluate the extent, nature and implications of attrition in a long-established, single-centre spine registry. The registry contained the data of 15,264 consecutive spine surgery patients. PROMs included the Core Outcome Measures Index (COMI) and a rating of the Global Treatment Outcome (GTO) and Satisfaction with Care. Baseline characteristics associated with returning a 12-month PROM (= "responder") were analysed (logistic regression). The 3-month outcomes of 12-month responders versus 12-month non-responders were compared (ANOVA and Chi-square). In total, 14,758/15,264 (97%) patients (60 ± 17y; 46% men) had consented to the use of their registry data for research. Preoperative, 3-month post-operative and 12-month post-operative PROMs were returned by 91, 90 and 86%, respectively. Factors associated with being a 12-month responder included: greater age, born in the country of the study, no private/semi-private insurance, better baseline status (lower COMI score), fewer previous surgeries, less comorbidity and no perioperative medical complications. 12-month non-responders had shown significantly worse outcomes in their 3-month PROMs than had 12-month responders (respectively, 66% vs 80% good GTO ("treatment helped/helped a lot"); 77% vs 88% satisfied/very satisfied; and 49% vs 63% achieved MCIC on COMI). Although attrition in this cohort was relatively low, 12-month non-responders displayed distinctive characteristics and their early outcomes were significantly worse than those of 12-month responders. If loss to follow-up is not addressed, treatment success will likely be overestimated, with erroneously optimistic results being reported.

Effect of angular correction during posterior instrumentation of spinal fractures on postoperative outcomes and quality of life.

Posterior instrumentation using pedicle screws and rods is the most commonly used technique for the treatment of thoracolumbar fractures of the spine. The procedure aims to restore the neurologic and biomechanical functions of the spine and allows for early mobilization and rapid reintegration into society. It is unclear whether the magnitude of correction has an effect on postoperative outcomes. We aimed to determine whether the magnitude of sagittal angular correction during posterior instrumentation of the spine had an effect on postoperative quality of life, pain and function outcomes as measured using the EQ5D-3L and the Core Outcome Measures Index (COMI) instruments. We also aimed to quantify the correlation between EQ5D-3L and COMI scores. We analyzed the pre- and postoperative radiographs of 52 patients who underwent percutaneous pedicle screw placement for thoracolumbar fractures, as well as their self-reported EQ5D-3L and COMI quality of life, pain and functional outcome scores. Regression models were constructed to estimate the effect that the magnitude of Cobb angle correction had on postoperative outcomes. We also estimated the correlation between EQ5D-3L and COMI scores. The median EQ5D-3L TTO score was 0.9 (range, -0.1 to 1). The median COMI score was 3.1 (range, 0 to 10). There was no significant effect of the magnitude of correction on EQ5d-3L TTO scores (p= 0.3379; R= 0.36) or on COMI scores (p= 0.3379; R= 0.15). Age and bone mineral density were not found to be significant predictors of outcome (p= 0.05). There was a strong correlation between the EQ5D-3L TTO and COMI scores (r=-0.62). The magnitude of Cobb angle correction during pedicle screw instrumentation of thoracolumbar fractures did not influence quality of life, pain or function outcomes. There was good correlation between EQ5D-3L TTO scores and COMI scores.

Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT.

Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforaminal epidural steroid injection, are often reserved for failed conservative treatment. To compare the clinical effectiveness and cost-effectiveness of microdiscectomy with transforaminal epidural steroid injection for the management of radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of < 12 months' duration. Patients were randomised to either (1) microdiscectomy or (2) transforaminal epidural steroid injection. A pragmatic, multicentre, randomised prospective trial comparing microdiscectomy with transforaminal epidural steroid injection for sciatica due to prolapsed intervertebral disc with < 1 year symptom duration. NHS services providing secondary spinal surgical care within the UK. A total of 163 participants (aged 16-65 years) were recruited from 11 UK NHS outpatient clinics. The primary outcome was participant-completed Oswestry Disability Questionnaire score at 18 weeks post randomisation. Secondary outcomes were visual analogue scores for leg pain and back pain; modified Roland-Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals. Cost-effectiveness and quality of life were assessed using the EuroQol-5 Dimensions, five-level version; Hospital Episode Statistics data; medication usage; and self-reported cost data at 12-weekly intervals. Adverse event data were collected. The economic outcome was incremental cost per quality-adjusted life-year gained from the perspective of the NHS in England. Eighty-three participants were allocated to transforaminal epidural steroid injection and 80 participants were allocated to microdiscectomy, using an online randomisation system. At week 18, Oswestry Disability Questionnaire scores had decreased, relative to baseline, by 26.7 points in the microdiscectomy group and by 24.5 points in the transforaminal epidural steroid injection. The difference between the treatments was not statistically significant (estimated treatment effect -4.25 points, 95% confidence interval -11.09 to 2.59 points). Nor were there significant differences between treatments in any of the secondary outcomes: Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland-Morris score and Core Outcome Measures Index score up to 54 weeks. There were four (3.8%) serious adverse events in the microdiscectomy group, including one nerve palsy (foot drop), and none in the transforaminal epidural steroid injection group. Compared with transforaminal epidural steroid injection, microdiscectomy had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained and a probability of 0.17 of being cost-effective at a willingness to pay threshold of £20,000 per quality-adjusted life-year. Primary outcome data was invalid or incomplete for 24% of participants. Sensitivity analyses demonstrated robustness to assumptions made regarding missing data. Eighteen per cent of participants in the transforaminal epidural steroid injection group subsequently received microdiscectomy prior to their primary outcome assessment. To the best of our knowledge, the NErve Root Block VErsus Surgery trial is the first trial to evaluate the comparative clinical effectiveness and cost-effectiveness of microdiscectomy and transforaminal epidural steroid injection. No statistically significant difference was found between the two treatments for the primary outcome. It is unlikely that microdiscectomy is cost-effective compared with transforaminal epidural steroid injection at a threshold of £20,000 per quality-adjusted life-year for sciatica secondary to prolapsed intervertebral disc. These results will lead to further studies in the streamlining and earlier management of discogenic sciatica. Current Controlled Trials ISRCTN04820368 and EudraCT 2014-002751-25. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 24. See the NIHR Journals Library website for further project information.

Minimum clinically important change for outcome scores among patients aged 75 or over undergoing lumbar spine surgery.

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 ≥ 75years undergoing lumbar spine surgery. We retrospectively reviewed patients aged ≥ 75years 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 < 75years 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. A total of 247 patients aged ≥ 75years and 398 patients aged < 75years were included for analysis. Of patients aged ≥ 75years, 83.4% showed at least "somewhat improved" outcomes, while 91.0% of patients aged < 75years reported this outcome. PCS change score was not adequately correlated to health transition in patients aged ≥ 75years. 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 ≥ 75years, and 12.7 for ODI, 0.19 for EQ-5D, and 2.3 for COMI in patients aged < 75years. In patients aged ≥ 75years, 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 ≥ 75years, compared with those in patients aged < 75years.

Association between the appropriateness of surgery, according to appropriate use criteria, and patient-rated outcomes after surgery for lumbar degenerative spondylolisthesis.

Treatment failures in spine surgery are often attributable to poor patient selection and the application of inappropriate treatment. We used published appropriate use criteria (AUC) to evaluate the appropriateness of surgery in a large group of patients operated for lumbar degenerative spondylolisthesis (LDS) and to evaluate its association with outcome. This was a retrospective analysis of prospectively collected outcome data from patients operated in our Spine Centre, 2005-2012. Appropriateness of surgery was judged based on the AUC. Patients had completed the multidimensional Core Outcome Measures Index (COMI) before surgery and at 3 months' and 1, 2 and 5years' follow-up (FU). In total, 448 patients (69.8 ± 9.6years; 323 (72%) women) were eligible for inclusion and the AUC could be applied in 393 (88%) of these. Surgery was considered appropriate (A) in 234 (59%) of the patients, uncertain/equivocal (U) in 90 (23%) and inappropriate (I) in 69 (18%). A/U patients had significantly (p < 0.05) greater improvements in COMI than I patients at each FU time point. The minimal clinically important change (MCIC) score for COMI was reached by 82% A, 76% U and 54% I patients at 1-year FU (p < 0.001, I vs A and U); the odds of achieving MCIC were 3-4 times greater in A/U patients than in I patients. The results suggest a relationship between appropriateness of surgery for LDS and the improvements in COMI score after surgery. The findings require confirmation in prospective studies that also include a control group of non-operated patients.

Does Instrumentation of the Fractured Level in Thoracolumbar Fixation Affect the Functional and Radiological Outcome?

Retrospective comparative study. To compare radiological and functional outcomes of patients with fixation constructs utilizing pedicle screw stabilization at the fracture level (FL group) versus patients with non-fracture level (NFL group) fixation in single level fractures of the thoracolumbar junction (T11-L1). 53 patients of whom fracture level screw was used in 34 (FL group) were compared to 19 patients in NFL group. Radiological parameters analyzed were sagittal index, bi-segmental kyphosis (Cobb) angle and degree of vertebral height restoration. Prospectively collected patient reported functional outcomes and post-operative complications were also studied. Stepwise regression analysis adjusted by age, gender and functional scores was performed to account for the small numbers and unequal sizes of the groups. Back pain score was significantly lower in the FL group (P < 0.025). Core Outcome Measures Index scores and leg pain scores, though low in the FL group, were not statistically significant. The regression analysis showed that the inclusion of the fracture-level screw was independently associated with a greater change in sagittal index and vertebral height restoration post-operatively. Sagittal index was maintained through to final follow up as well. The bi-segmental Cobb's angle correction was not associated with fracture-level screw construct. There was no significant difference between the groups for revision surgery, deep infection, implant failure or length of hospital stay. The inclusion of the fracture-level pedicle screws in the fixation construct significantly improves the immediate and final measured radiological parameters, with improved functional scores in single level unstable vertebral fractures of the thoracolumbar junction.

Concomitant back and leg pain as predictors for trajectories of poor outcome after single level lumbar micro-decompression alone and with micro-discectomy: a study of 3,308 patients.

Lumbar decompression is the commonest spinal intervention. One in four patients have suboptimal outcome postoperatively, however no large studies identified clear poor outcome predictors. The aim of this study was to study low back pain (LBP) as a predictor of poor outcome following lumbar micro-decompression. Prospectively collected spinal registry data was analysed for patients who underwent primary, single-level, decompression with or without discectomy at single spinal centre (2011-2017). Based on the response to the Likert global outcome question, we had two outcome groups (good & poor). Percentage of achievement of minimum clinically relevant change (MCRC) for Core Outcome Measures Index (COMI) score, LBP and leg pain (LP) was examined. A two-step approach was adopted. First, COMI score, LBP and LP visual analogue scales (VAS) trajectories were modelled using a discrete mixture model. Second, multinomial logistic regression was used to determine the association between variables and trajectories. We included 3,308 patients with mean follow up (1.4 y). MCRC was achieved in COMI score in 63% of cases, 42% in LBP and 62% in LP. A three-group trajectory model was identified: large-improvement (LI) (n=980), moderate-improvement (MI) (n=1,364) and no-improvement (NI) (n=966) with 99.5%, 84.5% and 31.5% of patients presenting good outcome, respectively. Higher pre-operative LBP and COMI score and smoking were strongly associated with MI and NI. In addition, higher LP, post-operative surgical complications, previous surgery at same level, conservative treatment >6 months and anxiety/depression were associated with NI. This is the first large-scale study reporting preoperative LBP severity, spinal stenosis and smoking as predictors for poor functional outcomes post lumbar decompression with or without discectomy. This is very useful while counselling patients for surgery to meet realistic expectations.

Vertebral body cemented stents combined with posterior stabilization in the surgical treatment of metastatic spinal cord compression of the thoracolumbar spine.

Background: Extensile interventions to provide anterior spinal column support in metastatic spinal cord compression (MSCC) surgery incur added morbidity in this surgically frail group of patients. We present our preliminary results of posterior spinal decompression and stabilization coupled with vertebral body cemented stents for anterior column support in MSCC.Methods: Fourteen patients underwent posterior spinal decompression and pedicle screw construct along with vertebral body stenting (VBS) technique for reconstruction and augmentation of the vertebral body. The primary in all except one was solid organ malignancy and 10 patients (71%) were treatment naïve. The mean revised Tokuhashi score was 10.7 ± 2.7 and the mean spinal instability neoplastic score was 9.6 ± 1.9. All vertebral body lesions were purely lytic and were associated with a cortical defect in the posterior wall.Results: A mean 5.3 ± 2.7 ml low-viscosity polymethyl methacrylate bone cement was injected within the stent at each compression level. No cement extrusion posteriorly was noted in any case from intraoperative fluoroscopy or postoperative radiographs. Five patients died at a mean 6.8 months (range 1–15 months), while the remaining patients have a mean survival of 18 months. Neither further revision surgical intervention nor any neurological deterioration was noted in any patient, who all continued to be ambulatory. The mean postoperative Core Outcome Measures Index score for 11 patients was 4.03 (standard deviation 3.11, 95% confidence interval (1.93–6.12).Conclusion: In lytic vertebral body lesions with posterior wall erosions, cemented VBS technique adds to the surgical armamentarium in MSCC surgery showing promising early results without added complications.

Cross-cultural adaptation and validation of the Slovenian version of the Core outcome measures index for low back pain

BackgroundTo 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.MethodsThe 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.ResultsThe 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).ConclusionsThe 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.

Validity of the Japanese Core Outcome Measures Index (COMI)-Back for thoracic and lumbar spine surgery: a prospective cohort study.

To investigate the psychometric properties of the Japanese version of the Core Outcome Measures Index-Back (COMI-Back), only recently published according to the established linguistic and cultural conversion guidelines, in patients undergoing spine surgery. We recruited 145 patients who underwent thoracic or lumbar spine surgery in one of the five specific tertiary care institutions. They were asked to complete a booklet questionnaire (the COMI-Back, the Numerical Rating Scale for pain, the Short Form-12, Euro-QOL-5 dimensions, and Oswestry Disability Index) at baseline and 12months postoperatively to investigate floor/ceiling effect, construct validity, and postoperative responsiveness. The patients were also asked to answer an anchor question (Global Treatment Outcome) to analyze the minimum clinically important difference (MCID) by receiver operating characteristics curves. Of the 145 patients, 112 completed the study. Another group of 59 volunteers with chronic symptoms completed the questionnaire twice within a 7-14-day interval for the test-retest reproducibility. The COMI summary score displayed no notable floor or ceiling effects. Except for symptom-specific well-being, the individual COMI domains and the COMI summary score correlated as expected with the scores of the chosen reference measures (ρ = 0.4-0.8). A similar trend was observed between the pre-/postoperative changes in the COMI score and those in the reference measures. The MCID for the COMI summary score was 2.5. The intraclass correlation coefficient and minimum detectable change (MDC95%) were 0.93 and 1.26, respectively. The Japanese COMI-Back was a reliable and responsive questionnaire in our Japanese patients undergoing thoracic/lumbar spine surgery. These slides can be retrieved under Electronic Supplementary Material.

Recovering the capability to work among patients with chronic low Back pain after a four-week, multidisciplinary biopsychosocial rehabilitation program: 18-month follow-up study

BackgroundChronic low back pain (LBP) is a leading cause of disability worldwide. Biopsychosocial rehabilitation programs have been advocated for its management, especially since the widespread acceptance of the biopsychosocial model of chronic pain. Despite extensive evidence of its short-term benefits, few studies have reported on its long-term effect and more specifically on indirect outcomes such as return to work and quality of life (QoL). The present study evaluated the long-term effect of a multidisciplinary biopsychosocial rehabilitation (MBR) program for patients with chronic LBP, for which short- and intermediate-term efficacy had been established, with an emphasis on recovering work capability.MethodsThis prospective cohort study enrolled 201 patients on a four-week MBR program incorporating physical and occupational therapies and psychological counselling. Assessments occurred at program admission and discharge and at 6 and 18 months. Work capability, Oswestry Disability Index, Tampa Scale for Kinesiophobia, Core Outcome Measures Index (COMI), and Hospital Anxiety and Depression Scale were assessed. Multiple mixed models were used to detect changes in each outcome. Logistic regressions were calculated to identify predictors of recovery of work capability.ResultsOf the 201 patients who fulfilled the eligibility criteria, 160 (79.8%) attended the discharge assessment, 127 (63.2%) attended the 6-month follow-up, and 107 (53.3%) continued to the 18-month follow-up. Initially, 128 patients (71.5%) had been on sick leave. At 6 and 18 months, 72 (56.7%) and 84 (78.5%) participants had recovered their work capability, respectively. There were significant improvements in pain, disability, kinesiophobia, and anxiety and depression scores over time. Patients who recovered work capability showed significantly greater improvements in their total COMI score, general QoL, and disability, which were the best three predictors of recovering work capability.ConclusionsThis study extends previous results confirming the program’s contribution to recovering work capability among chronic LBP patients.

226. The high vs limited screw density group in posterior fusions for adolescent idiopathic scoliosis: use of the Spine Tango registry to supplement the evidence from randomized control trials

BACKGROUND CONTEXT Several randomized controlled trials (RCTs) have compared patient outcomes of The high screw density group(HSD) with those of limited screw density group(LSD). Because RCTs have known limitations with regard to their external validity, the comparative effectiveness of the two therapies in everyday practice remains unknown. PURPOSE This study was designed to compare patient-reported outcomes after HSD vs LSD based on data from an international spine registry. STUDY DESIGN/SETTING A retrospective analysis of registry data was performed. PATIENT SAMPLE Inclusion criteria were adolescent idiopathic scoliosis HSD or LSD, no previous surgery, and a Core Outcome Measures Index (COMI) completed at baseline and at least 3 months' follow-up. Overall, 877 patients were identified. OUTCOME MEASURES Construct characteristics and radiographic measurements were compared preoperatively and at last follow-up. Operative time and estimated costs were also evaluated. COMI score improvement were the outcome measures. METHODS Three separate analyses were performed to compare HSD and LSD surgical outcomes: (1) mimicking an RCT setting, with admission criteria typical of those in published RCTs, a 1:1 matched analysis was carried out in 797 patients; (2) an analysis was performed on 371 patients outside the classic RCT spectrum, that is, with one or more typical RCT exclusion criteria; (3) a subgroup analysis of all patients with additional follow-up longer than 2 years (n=279). RESULTS Matching resulted in 217 pairs with an average follow-up of 20 months that had no significant residual differences for any patient characteristics. Small but statistically significant differences in outcome were found in favor of HSD, which are potentially clinically relevant. Subgroup analyses of typical patients and of patients with longer-term follow-up showed no significant differences in outcome between the treatments. CONCLUSIONS The results of this observational study were in accordance with those of the published RCTs. Excellent curve correction, stability, and balance can be achieved using fewer screws than commonly used in posterior pedicle screw fusions for AIS. Operative time is reduced, and risk and cost are decreased with the use of limited screw density constructs.. Analysis of typical patients suggested that, in patients outside the spectrum of clinical trials, both surgical interventions appeared to work to a similar extent to that shown for the cohort in the matched study. Also, in the longer-term perspective, both therapies resulted in comparable benefits to the patients. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. Several randomized controlled trials (RCTs) have compared patient outcomes of The high screw density group(HSD) with those of limited screw density group(LSD). Because RCTs have known limitations with regard to their external validity, the comparative effectiveness of the two therapies in everyday practice remains unknown. This study was designed to compare patient-reported outcomes after HSD vs LSD based on data from an international spine registry. A retrospective analysis of registry data was performed. Inclusion criteria were adolescent idiopathic scoliosis HSD or LSD, no previous surgery, and a Core Outcome Measures Index (COMI) completed at baseline and at least 3 months' follow-up. Overall, 877 patients were identified. Construct characteristics and radiographic measurements were compared preoperatively and at last follow-up. Operative time and estimated costs were also evaluated. COMI score improvement were the outcome measures. Three separate analyses were performed to compare HSD and LSD surgical outcomes: (1) mimicking an RCT setting, with admission criteria typical of those in published RCTs, a 1:1 matched analysis was carried out in 797 patients; (2) an analysis was performed on 371 patients outside the classic RCT spectrum, that is, with one or more typical RCT exclusion criteria; (3) a subgroup analysis of all patients with additional follow-up longer than 2 years (n=279). Matching resulted in 217 pairs with an average follow-up of 20 months that had no significant residual differences for any patient characteristics. Small but statistically significant differences in outcome were found in favor of HSD, which are potentially clinically relevant. Subgroup analyses of typical patients and of patients with longer-term follow-up showed no significant differences in outcome between the treatments. The results of this observational study were in accordance with those of the published RCTs. Excellent curve correction, stability, and balance can be achieved using fewer screws than commonly used in posterior pedicle screw fusions for AIS. Operative time is reduced, and risk and cost are decreased with the use of limited screw density constructs.. Analysis of typical patients suggested that, in patients outside the spectrum of clinical trials, both surgical interventions appeared to work to a similar extent to that shown for the cohort in the matched study. Also, in the longer-term perspective, both therapies resulted in comparable benefits to the patients.