How well can the clinician appraise the patient's perception of the severity and impact of their back problem?

PURPOSE: A main concern of patients with back problems is pain and its impact on function and quality of life. These are subjective phenomena, and should be probed during the clinical consultation so that the physician can ascertain the extent of the problem. This study evaluated the agreement between clinicians' and patients' independent ratings of patient status on the Core Outcome Measures Index (COMI). METHODS: This was an analysis of the data from 5 spine specialists and 108 patients, in two centres. Prior to the consultation, the patient completed the COMI. After the consultation, the clinician (blind to the patient's version) also completed a COMI. Concordance was assessed by % agreement, Kappa values, Bland-Altman plots, Spearman rank, Intraclass Correlation Coefficients and comparisons of mean values, as appropriate. RESULTS: Agreement regarding the "main problem" (back pain, leg/buttock pain, sensory disturbances, other) was 83%, Kappa = 0.70 (95%CI 0.58-0.81). Moderate/strong correlations were found between the doctors' and patients' COMI-item ratings (0.48-0.74; p < 0.0001), although compared with the patients' ratings the doctors systematically underestimated absolute values for leg pain (p = 0.002) and dissatisfaction with symptom state (p = 0.002), and overestimated how much the patient's function was impaired (p = 0.029). CONCLUSION: The doctors were able to ascertain the location of the main problem and the multidimensional outcome score with good accuracy, but some individual domains were systematically underestimated (pain, symptom-specific well-being) or overestimated (impairment of function). More detailed/direct questioning on these domains during the consultation might deliver a better appreciation of the impact of the back problem on the patient's daily life.

Development of a mapping function ("crosswalk") for the conversion of scores between the Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI).

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.

Development of a machine-learning based model for predicting multidimensional outcome after surgery for degenerative disorders of the spine.

BACKGROUND: It is clear that individual outcomes of spine surgery can be quite heterogeneous. When consenting a patient for surgery, it is important to be able to offer an individualized prediction regarding the likely outcome. This study used a comprehensive set of data collected over 12 years in an in-house registry to develop a parsimonious model to predict the multidimensional outcome of patients undergoing surgery for degenerative pathologies of the thoracic, lumbar or cervical spine. METHODS: Data from 8374 patients (mean age 63.9 (14.9-96.3) y, 53.4% female) were used to develop a model to predict the 12-month scores for the Core Outcome Measures Index (COMI) and its subdomain scores. The data were split 80:20 into a training and test set. The top predictors were selected by applying recursive feature elimination based on LASSO cross validation models. Based on the 111 top predictors (contained within 20 variables), Ridge cross validation models were trained, validated, and tested for each of 9 outcome domains, for patients with either "Back" (thoracic/lumbar spine) or "Neck" (cervical spine) problems (total 18 models). RESULTS: Among the strongest outcome predictors in most models were: preoperative scores for almost all COMI items (especially axial pain (back or neck) and peripheral pain (leg/buttock or arm/shoulder)), catastrophizing, fear avoidance beliefs, comorbidity, age, BMI, nationality, previous spine surgery, type and spinal level of intervention, number of affected levels, and surgeon seniority. The R2 of the models on the validation/test sets averaged 0.16/0.13. A preliminary online tool was programmed to present the predicted outcomes for individual patients, based on their presenting characteristics. https://linkup.kws.ch/prognostictool . CONCLUSION: The models provided estimates to enable a bespoke prediction of the outcome of surgery for individual patients with varying degenerative pathologies and baseline characteristics. The models form the basis of a simple, freely-available online prognostic tool developed to improve access to and usability of prognostic information in clinical practice. It is hoped that, following confirmation of its validity and practical utility, the tool will ultimately serve to facilitate decision-making and the management of patients' expectations.

Shorter and sweeter: the 16-item version of the SRS questionnaire shows better structural validity than the 20-item version in young patients with spinal deformity.

PURPOSE: In patients with adult spinal deformity, it was previously shown that 16 of the non-management items of the SRS-instrument showed a better fit to the theoretical four-factor model (pain, function, self-image, mental health) than did all 20 items. Whether the same phenomenon is observed in data from younger (< 20y) patients, for whom the questionnaire was originally designed, is not currently known. METHODS: Confirmatory factor analysis was used to evaluate the factor structure of the 20 non-management items of the SRS-instrument completed by 3618 young patients with spinal deformity (75.5% female; mean age, 15.0 ± 2.0 years) and of its equivalence across language versions (2713 English-speaking, 270 Spanish, 264 German, 223 Italian, and 148 French). The root mean square error of approximation (RMSEA) and comparative fit index (CFI) indicated model fit. RESULTS: Compared with the 20-item version, the 16-item solution significantly increased the fit (p < 0.001) across all language versions, to achieve good model fit (CFI = 0.96, RMSEA = 0.06). For both 16-item and 20-item models, equivalence across languages was not reached, with some items showing weaker item-loading for some languages, in particular German and French. CONCLUSION: In patients with adolescent idiopathic scoliosis, the shorter 16-item version showed a better fit to the intended 4-factor structure of the SRS-instrument. The wording of some of the items, and/or their equivalence across language versions, may need to be addressed. Questionnaire completion can be a burden for patients; if a shorter, more structurally valid version is available, its use should be encouraged.

Patient-rated outcome after atlantoaxial (C1-C2) fusion: more than a decade of evaluation of 2-year outcomes in 126 patients.

INTRODUCTION: Various surgical techniques have been introduced for atlantoaxial (C1-C2) fusion, the most common being Magerl's (transarticular) or the Harms/Goel screw fixation. Common indications include degenerative osteoarthritis (OA), trauma or rheumatoid arthritis (RA). Only few, small studies have evaluated patient-reported outcomes after C1-C2 fusion. We investigated 2-year outcomes in a large series of consecutive patients undergoing isolated C1-C2 fusion. METHODS: We analysed prospectively collected data (2005-2016) from our Spine outcomes database, collected within the framework of EUROSPINE's Spine Tango Registry. It included 126 patients (34 (27%) men, 92 (73%) women; mean (SD) age 67 ± 19 y) who had undergone first-time isolated C1-C2 fusion (61% Magerl, 39% Harms(-Goel)) at least 2 years ago for OA (83 (66%)), RA (20 (16%)), fracture (15 (12%)) or other (8 (6%)). Patients completed the multidimensional Core Outcome Measures Index (COMI; 0-10) and various single item outcomes. RESULTS: Questionnaires were returned by 118/126 (94%) patients, 2 years post-operative. Mean COMI scores showed a significant reduction from baseline: 6.9 ± 2.4 to 2.7 ± 2.5 (p < 0.0001). Overall, 75% patients achieved the MCIC of ≥ 2.2 points reduction in COMI and 88% reported a good global outcome. 91% patients were satisfied/very satisfied with their care. Self-reported complications were declared by 16% patients and further surgery at the same segment, by 2.5%. CONCLUSION: In this large series with almost complete follow-up, C1-C2 fusion showed extremely good results. Despite the complexity of the intervention, outcomes surpassed those typically reported for simple procedures such as ACDF and lumbar discectomy, suggesting reservations about the procedure should perhaps be reviewed.

Can the Charlson Comorbidity Index be used to predict the ASA grade in patients undergoing spine surgery?

BACKGROUND: The American Society of Anaesthesiologists' Physical Status Score (ASA) is a key variable in predictor models of surgical outcome and "appropriate use criteria". However, at the time when such tools are being used in decision-making, the ASA rating is typically unknown. We evaluated whether the ASA class could be predicted statistically from Charlson Comorbidy Index (CCI) scores and simple demographic variables. METHODS: Using established algorithms, the CCI was calculated from the ICD-10 comorbidity codes of 11'523 spine surgery patients (62.3 ± 14.6y) who also had anaesthetist-assigned ASA scores. These were randomly split into training (N = 8078) and test (N = 3445) samples. A logistic regression model was built based on the training sample and used to predict ASA scores for the test sample and for temporal (N = 341) and external validation (N = 171) samples. RESULTS: In a simple model with just CCI predicting ASA, receiver operating characteristics (ROC) analysis revealed a cut-off of CCI ≥ 1 discriminated best between being ASA ≥ 3 versus < 3 (area under the curve (AUC), 0.70 ± 0.01, 95%CI,0.82-0.84). Multiple logistic regression analyses including age, sex, smoking, and BMI in addition to CCI gave better predictions of ASA (Nagelkerke's pseudo-R2 for predicting ASA class 1 to 4, 46.6%; for predicting ASA ≥ 3 vs. < 3, 37.5%). AUCs for discriminating ASA ≥ 3 versus < 3 from multiple logistic regression were 0.83 ± 0.01 (95%CI, 0.82-0.84) for the training sample and 0.82 ± 0.01 (95%CI, 0.81-0.84), 0.85 ± 0.02 (95%CI, 0.80-0.89), and 0.77 ± 0.04 (95%CI,0.69-0.84) for the test, temporal and external validation samples, respectively. Calibration was adequate in all validation samples. CONCLUSIONS: It was possible to predict ASA from CCI. In a simple model, CCI ≥ 1 best distinguished between ASA ≥ 3 and < 3. For a more precise prediction, regression algorithms were created based on CCI and simple demographic variables obtainable from patient interview. The availability of such algorithms may widen the utility of decision aids that rely on the ASA, where the latter is not readily available.

What level of symptoms are patients with adult spinal deformity prepared to live with? A cross-sectional analysis of the 12-month follow-up data from 1043 patients.

INTRODUCTION: Previous studies suggest that a meaningful and easily understood measure of treatment outcome may be the proportion of patients who are in a "patient acceptable symptom state" (PASS). We sought to quantify the score equivalent to PASS for different outcome instruments, in patients with adult spinal deformity (ASD). METHODS: We analysed the following 12-month questionnaire data from the European Spine Study Group (ESSG): Oswestry Disability Index (ODI; 0-100); Numeric Rating Scales (NRS; 0-10) for back/leg pain; Scoliosis Research Society (SRS) questionnaire; and an item "if you had to spend the rest of your life with the symptoms you have now, how would you feel about it?" (5-point scale, dichotomised with top 2 responses "somewhat satisfied/very satisfied" being considered PASS+, everything else PASS-). Receiver operating characteristics (ROC) analyses indicated the cut-off scores equivalent to PASS+. RESULTS: Out of 1043 patients (599 operative, 444 non-operative; 51 ± 19 years; 84% women), 42% reported being PASS+ at 12 months' follow-up. The ROC areas under the curve were 0.71-0.84 (highest for SRS subscore), suggesting the questionnaire scores discriminated well between PASS+ and PASS-. The scores corresponding to PASS+ were > 3.5 for the SRS subscore (> 3.3-3.8 for SRS subdomains); ≤ 18 for ODI; and ≤ 3 for NRS pain. There were slight differences in cut-offs for subgroups of age, treatment type, aetiology, baseline symptoms, and sex. CONCLUSION: Most interventions for ASD improve patients' complaints but do not totally eliminate them. Reporting the percentage achieving a score equivalent to an "acceptable state" may represent a more stringent and discerning target for denoting treatment success in ASD. These slides can be retrieved under Electronic Supplementary Material.

Does neck pain as chief complaint influence the outcome of cervical total disc replacement?

PURPOSE: We investigated whether outcomes after cervical total disc replacement (cTDR) are influenced by preoperative neck pain as the chief complaint. METHODS: This was a retrospective study using data in our local spine surgery outcomes database, linked to EUROSPINE Spine Tango Registry. Patients completed questionnaires at baseline enquiring about the "chief complaint" [neck pain (NP), arm/shoulder pain (AP) or neurological deficits (ND)] and including the Core Outcome Measures Index (COMI); these were completed again at 24 months postoperatively, along with a rating of "global treatment outcome" (on a five-point scale, later dichotomized as "good" or "poor"). Differences in outcomes between the groups were examined using ANOVA. Multivariable regression analysis examined the effect of the chief pain location on 24-month outcomes, controlling for age, gender, comorbidity, baseline pain and COMI scores. RESULTS: One hundred and fifty-nine consecutive patients were included, with a chief complaint of NP in 31%, AP in 38% and ND in 31%. The chief complaint groups did not differ in relation to their baseline COMI scores or their reductions in score from before surgery to 24 months after surgery (reduction: NP group, 4.4 ± 2.9 points; AP group, 4.7 ± 2.7; ND group, 4.3 ± 2.9; p = 0.78). Similarly, the percentage of patients reporting a "good global treatment outcome" at 24 months postoperatively did not differ between the groups (NP, 79%; AP, 77%; ND, 85%; p = 0.64). The findings were consistent when controlling for possible confounders in multiple regression. CONCLUSIONS: Having neck pain as opposed to arm pain or neurological deficits as preoperative chief complaint had no significant impact on clinical outcome after cTDR. These slides can be retrieved under Electronic Supplementary Material.

Non-medical factors significantly influence the length of hospital stay after surgery for degenerative spine disorders.

BACKGROUND: Unnecessarily long hospital stays are costly and inefficient. Studies have shown that the length of hospital stay (LOS) for spine surgical procedures is influenced by various disease-related or medical factors, but few have examined the role of socio-demographic/socio-economic (SDE) factors. METHODS: This was a retrospective analysis of data from 10,770 patients (5056 men, 5714 women; 62 ± 15 years) with degenerative spinal disorders, collected prospectively in an in-house database within the framework of EUROSPINE's Spine Tango Registry. Surgeons completed the Tango surgery form (clinical history, demographics, surgical measures, complications), and patients, a baseline Core Outcome Measures Index. Stepwise linear regression analyses examined SDE predictors of LOS, controlling for potential medical/biological factors. RESULTS: The mean LOS was 7.9 ± 5.2 days. The final model accounted for 42% of variance in LOS, with SDE variables explaining 13% variance and medical/surgical predictors, 29%. In the final model, the SDE factors age and being female were significant independent predictors of LOS, whereas others were either non-significant (insurance status, being of Swiss nationality, being a smoker) or reached only borderline significance (p < 0.1) (BMI). Controlling for all other SDE and medical/surgical confounders, being female was associated with 1.11-day longer LOS (95% CI 0.96-1.27; p < 0.0001). CONCLUSIONS: Patients of advanced age and female gender are at increased risk of longer hospital stay after surgery for degenerative spinal disorders. Further studies should seek to understand the reasoning behind the gender disparity, in order to minimise potentially unnecessary costs of prolonged LOS. Targeted preoperative discharge planning may improve the utilisation of hospital resources. These slides can be retrieved under Electronic Supplementary Material.

Factors associated with having an indication for surgery in adult spinal deformity: an international european multicentre study.

PURPOSE: The aim of this study was to evaluate factors that distinguish between patients with adult spinal deformity (ASD) with and without an indication for surgery, irrespective of their final treatment. METHODS: Baseline variables (demographics, medical history, outcome measures, coronal, sagittal and neurologic parameters) were evaluated in a multicentre, prospective cohort of patients with ASD. Multivariable analyses were carried out for idiopathic and degenerative patients separately with the dependent variable being "indication for surgery" and baseline parameters as independent variables. RESULTS: In total, 342 patients with degenerative ASD and 624 patients with idiopathic ASD were included in the multivariable models. In patients with degenerative ASD, the parameters associated with having an indication for surgery were greater self-rated disability on the Oswestry Disability Index [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.02-1.07] and a lower thoracic kyphosis (OR 0.97 95% CI 0.95-0.99), whereas in patients with idiopathic ASD, it was lower (worse) SRS self-image scores (OR 0.45 95% CI 0.32-0.64), a higher value for the major Cobb angle (OR 1.03 95% CI 1.01-1.05), lower age (OR 0.96 95% CI 0.95-0.98), prior decompression (OR 3.76 95% CI 1.00-14.08), prior infiltration (OR 2.23 95% CI 1.12-4.43), and the presence of rotatory subluxation (OR 1.98 95% CI 1.11-3.54) and sagittal subluxation (OR 4.38 95% CI 1.61-11.95). CONCLUSION: Specific sets of variables were found to be associated with an indication for surgery in patients with ASD. These should be investigated in relation to patient outcomes for their potential to guide the future development of decision aids in the treatment of ASD. These slides can be retrieved under Electronic Supplementary Material.

Factor analysis of the SRS-22 outcome assessment instrument in patients with adult spinal deformity.

PURPOSE: Designed for patients with adolescent idiopathic scoliosis, the SRS-22 is now widely used as an outcome instrument in patients with adult spinal deformity (ASD). No studies have confirmed the four-factor structure (pain, function, self-image, mental health) of the SRS-22 in ASD and under different contexts. Factorial invariance of an instrument over time and in different languages is essential to allow for precise interpretations of treatment success and comparisons across studies. This study sought to evaluate the invariance of the SRS-22 structure across different languages and sub-groups of ASD patients. METHODS: Confirmatory factor analysis was performed on the 20 non-management items of the SRS-22 with data from 245 American English-, 428 Spanish-, 229 Turkish-, 95 French-, and 195 German-speaking patients. Item loading invariance was compared across languages, age groups, etiologies, treatment groups, and assessment times. A separate sample of SRS-22 data from 772 American surgical patients with ASD was used for cross-validation. RESULTS: The factor structure fitted significantly better to the proposed four-factor solution than to a unifactorial solution. However, items 14 (personal relationships), 15 (financial difficulties), and 17 (days off work) consistently showed weak item loading within their factors across all language versions and in both baseline and follow-up datasets. A trimmed SRS (16 non-management items) that used the four least problematic items in each of the four domains yielded better-fitting models across all languages, but equivalence was still not reached. With this shorter version there was equivalence of item loading with respect to treatment (surgery vs conservative), time of assessment (baseline vs 12 months follow-up), and etiology (degenerative vs idiopathic), but not age (< vs ≥50 years). All findings were confirmed in the cross-validation sample. CONCLUSION: We recommend removal of the worst-fitting items from each of the four domains of the SRS-instrument (items 3, 14, 15, 17), together with adaptation and standardization of other items across language versions, to provide an improved version of the instrument with just 16 non-management items.

How does patient-rated outcome change over time following the surgical treatment of degenerative disorders of the thoracolumbar spine?

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.

Dural sac cross-sectional area and morphological grade show significant associations with patient-rated outcome of surgery for lumbar central spinal stenosis.

PURPOSE: Lumbar central spinal stenosis (LSS) is one of the most common reasons for spine surgery in the elderly patient. Magnetic resonance imaging (MRI) represents the gold standard for the assessment of LSS and can be used to obtain quantitative measures of the dural sac cross-sectional area (DCSA) or qualitative measures (morphological grades A-D) of the rootlet/cerebrospinal fluid ratio. This study investigated the intercorrelation between these two MRI evaluation methods and explored their respective relationships with the patient baseline clinical status and outcome 12 months after surgery. METHODS: This was a retrospective analysis of prospectively collected data from 157 patients (88 male, 69 female; age 72 ± 7 years) who were undergoing first-time surgery for LSS. Patients with foraminal or isolated lateral stenosis were excluded. The Core Outcome Measures Index (COMI) was completed before and 12 months after surgery. Preoperative T2 axial MRIs were blinded and independently evaluated for DCSA and morphological grade. Spearman rank correlation coefficients described the relationship between the two MRI measures of stenosis severity and between each of these and the COMI baseline and change-scores (pre to 12 months' postop). Multiple logistic regression analysis (controlling for baseline COMI, age, gender, number of operated levels, health insurance status) was used to analyse the influence of stenosis severity on the achievement of the minimum clinically important change (MCIC) score for COMI and on global treatment outcome (GTO). RESULTS: There was a correlation of ρ = -0.69 (p < 0.001) between DCSA and morphological grade. There was no significant correlation between COMI baseline scores and either DCSA or morphological grades (p > 0.85). However, logistic regression revealed significant (p < 0.05) associations between stenosis ratings and 12-month outcome, whereby patients with more severe stenosis (as measured using either of the methods) benefited more from the surgery. Patients with a DCSA <75 mm2 or morphological grade D had a 4-13-fold greater odds of achieving the MCIC for COMI or a "good" GTO, compared with patients in the least severe categories of stenosis. CONCLUSIONS: Postoperative outcome was clearly related to the degree of preoperative radiological LSS. The two MRI methods appeared to deliver similar information, as given by the relatively strong correlation between them and their comparable performance in relation to baseline and 12-month outcomes. However, the qualitative morphological grading can be performed in an instant, without measurement tools, and does not deliver less clinically useful information than the more complex and time-consuming measures; as such, it may represent the preferred method in the clinical routine for assessing the extent of radiological stenosis and the likelihood of a positive outcome after decompression.

A novel use of the Spine Tango registry to evaluate selection bias in patient recruitment into clinical studies: an analysis of patients participating in the Lumbar Spinal Stenosis Outcome Study (LSOS).

PURPOSE: Patients enrolled in clinical studies typically represent a sub-set of all who are eligible, and selection bias may compromise the generalizability of the findings. Using Registry data, we evaluated whether surgical patients recruited by one of the referring centres into the Lumbar Spinal Stenosis Outcome Study (LSOS; a large-scale, multicentre prospective observational study to determine the probability of clinical benefit after surgery) differed in any significant way from those who were eligible but not enrolled. METHODS: Data were extracted for all patients with lumbar spinal stenosis registered in our in-house database (interfaced to Eurospine's Spine Tango Registry) from 2011 to 2013. Patient records and imaging were evaluated in relation to the admission criteria for LSOS to identify those who would have been eligible for participation but were not enrolled (non-LSOS). The Tango surgery data and Core Outcome Measures Index (COMI) data at baseline and 3 and 12 months after surgery were analysed to evaluate the factors associated with LSOS enrolment or not. RESULTS: 514 potentially eligible patients were identified, of which 94 (18%) were enrolled into LSOS (range 2-48% for the 6 spine surgeons involved in recruiting patients) and 420 (82%) were not; the vast majority of the latter were due to non-referral to the study by the surgeon, with only 5% actually refusing participation. There was no significant difference in gender, age, BMI, smoking status, or ASA score between the two groups (p ≥ 0.18). Baseline COMI was significantly (p = 0.002) worse in the non-LSOS group (7.4 ± 1.9) than the LSOS group (6.7 ± 1.9). There were no significant group differences in any Tango surgery parameters (additional spine patholothegies, operation time, blood loss, complications, etc.) although significantly more patients in the non-LSOS group had a fusion procedure (38 vs 18% in LSOS; p = 0.0004). Postoperatively, neither the COMI nor its subdomain scores differed significantly between the groups (p > 0.05). Multiple logistic regression revealed that worse baseline COMI (p = 0.021), surgeon (p = 0.003), and having fusion (p = 0.014) predicted non-enrolment in LSOS. CONCLUSION: A high proportion of eligible patients were not enrolled in the study. Non-enrolment was explained in part by the specific surgeon, worse baseline COMI status, and having a fusion. The findings may reflect a tendency of the referring surgeon not to overburden more disabled patients and those undergoing more extensive surgery with the commitments of a study. Beyond these factors, non-enrolment appeared to be somewhat arbitrary, and was likely related to surgeon forgetfulness, time constraints, and administrative errors. Researchers should be aware of potential selection bias in their clinical studies, measure it (where possible) and discuss its implications for the interpretation of the study's findings.

The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity.

INTRODUCTION: The Core Outcome Measures Index for the back (COMI-back) is a very brief instrument for assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability). However, it might be expected to be less responsive than a disease-specific instrument when evaluating specific pathologies. In patients with adult spinal deformity, we compared the performance of COMI-back with the widely accepted SRS-22 questionnaire. METHODS: At baseline and 12 months after non-operative (N = 121) and surgical (N = 83) treatment, patients (175 F, 29 M) completed the following: COMI-back, SRS-22, Oswestry Disability Index (ODI) and SF-36 PCS. At 12 months' follow-up, patients also indicated on a 15-point Global Rating of Change Scale (GRCS) how their back problem had changed relative to 1 year ago. Construct validity for the COMI-back was assessed by the correlation between its scores and those of the comparator instruments; responsiveness was assessed with receiver operating characteristics (ROC) analysis of COMI-back change scores versus the criterion 'treatment success' (dichotomized GRCS). RESULTS: Baseline values for the COMI-back showed significant (p < 0.0001) correlations with SRS-22 (r = -0.85), ODI (r = 0.83), and SF-36 PCS (r = -0.82) scores; significantly worse scores for all measures were recorded in the surgical group. The correlation between the change scores (baseline to 12 months) for COMI and SRS-22 was 0.74, and between each of these change scores and the external criterion of treatment success were: COMI-back, r = 0.58; SRS-22, r = -0.58 (each p < 0.0001). The ROC areas under the curve for the COMI-back and SRS-22 change scores were 0.79 and 0.82, respectively. CONCLUSION: Both baseline and change scores for the COMI-back correlated strongly with those of the SRS-22, and differed significantly in surgical and non-operative patients, suggesting good construct validity. With the "change in the back problem" serving as external criterion, COMI-back showed similar external responsiveness to SRS-22. The COMI-back was well able to detect important change. Coupled with its brevity, which minimizes patient burden, these favourable psychometric properties suggest the COMI-back is a suitable instrument for use in registries and can serve as a valid instrument in clinical studies emerging from such data pools.

Adult degenerative scoliosis: comparison of patient-rated outcome after three different surgical treatments.

PURPOSE: Few studies have examined the effectiveness of surgical treatment for adult degenerative scoliosis (ADS) using validated patient-orientated outcome instruments. This study reports patient outcomes in a large, consecutive series of patients being treated for ADS by simple decompression (D), short fusion (SF), or long fusion (LF). METHODS: Our local spine surgery database (part of the Eurospine Spine Tango Registry) was used to acquire the data from patients with ADS undergoing D, SF or LF. Preoperatively and at 12 and 24 months follow-up (FU), patients completed the multidimensional Core Outcome Measures Index (COMI; 0-10); at FU, satisfaction and global outcome were rated on a five-point Likert scale and dichotomised as "good" and "poor", and patient-rated complications were recorded. RESULTS: 173 patients took part (81 D, 53 SF, 39 LF). Compared with the two fusion groups, the D group was significantly older, had more comorbidity, and had more leg pain than back pain (each p < 0.05). There were significant differences among the groups for operation duration, blood loss and general complications (each p < 0.05), in each case with the LF group showing the greatest values and the D group the lowest values. However, patient-rated complications were not significantly different between the groups (p > 0.89). Further surgery within the 2-year follow-up was required in 7 % of the D group, 15 % in SF and 28 % in LF. All groups benefited significantly from surgery with no significant differences (p > 0.05) between them: improvement in COMI after 24 months was 2.9 ± 2.8 points for D, 3.1 ± 3.3 points for SF and 3.2 ± 3.1 points for LF; a "good global outcome" was recorded for 69, 74 and 76 % patients, respectively. CONCLUSIONS: Despite the complexity of the disease, patient-orientated outcomes after surgery for ADS were similar to those previously reported using the same outcome instruments in patients with lumbar stenosis and degenerative spondylolisthesis. The use of D, SF and LF for ADS yielded similarly good results from the patient's perspective. This most likely reflects careful and appropriate patient selection. Further analyses are warranted to identify baseline variables predicting the 26-31 % cases in each group with a poor outcome.

Impact on health related quality of life of adult spinal deformity (ASD) compared with other chronic conditions.

PURPOSE: Medical and health policy providers should be aware of the impact of adult spinal deformity (ASD) on health-related quality of life (HRQL). The purpose of this study was to compare the relative burden of four chronic conditions with that of ASD. METHODS: The International Quality of Life Assessment project gathered data from 24,936 people and published the SF-36 scores of patients with self-reported arthritis, chronic lung disease, diabetes and congestive heart failure from 8 industrialized countries (3 continents) Alonso et al. (Qual Life Res Int J Qual Life Asp Treat Care Rehabil 13:283-298, 2004). We compared these with the SF-36 baseline data of consecutive patients with ASD enrolled in a prospective multicentre international database with the following inclusion criteria: age >18 years and scoliosis >20°, sagittal vertical axis >5 cm, pelvic tilt >25° or thoracic kyphosis >60°. Four ASD groups were considered: all ASD patients, surgical candidates (preop HRQL scores), and non-surgical candidates with and without previous surgery. Adjusted estimates of the impact of chronic disease were calculated using separate multivariate linear regression models. Individuals without chronic conditions were used as the reference group. Coefficients for each chronic condition and ASD represent the difference compared with this healthy group. RESULTS: 766 patients (mean age 45.8 years) met the inclusion criteria for ASD. The scores on all SF-36 domains were lower in ASD patients than in any other chronic condition. Differences between ASD and the other chronic conditions were always greater than the reported minimal clinically important differences. When compared with individuals reporting no medical conditions, SF-36 scores from the population with self-reported chronic conditions ranged from -2.5 to -14.1. Comparable scores for patients with ASD ranged from -10.9 to -45.0. Physical function, role physical and pain domains showed the worst scores. Surgical candidates with ASD displayed the worst HRQL scores (-17.4 to -45.0) and patients previously operated the best (-10.9 to -33.3); however, even the latter remained worse than any scores for the other self-reported chronic conditions. CONCLUSIONS: The global burden of ASD was huge compared with other self-reported chronic conditions in the general population of eight industrialized countries. The impact of ASD on HRQL warrants the same research and health policy attention as other important chronic diseases.

Development of appropriateness criteria for the surgical treatment of symptomatic lumbar degenerative spondylolisthesis (LDS).

PURPOSE: Spine surgery rates are increasing worldwide. Treatment failures are often attributed to poor patient selection and inappropriate treatment, but for many spinal disorders there is little consensus on the precise indications for surgery. With an aging population, more patients with lumbar degenerative spondylolisthesis (LDS) will present for surgery. The aim of this study was to develop criteria for the appropriateness of surgery in symptomatic LDS. METHODS: A systematic review was carried out to summarize the current level of evidence for the treatment of LDS. Clinical scenarios were generated comprising combinations of signs and symptoms in LDS and other relevant variables. Based on the systematic review and their own clinical experience, twelve multidisciplinary international experts rated each scenario on a 9-point scale (1 highly inappropriate, 9 highly appropriate) with respect to performing decompression only, fusion, and instrumented fusion. Surgery for each theoretical scenario was classified as appropriate, inappropriate, or uncertain based on the median ratings and disagreement in the ratings. RESULTS: 744 hypothetical scenarios were generated; overall, surgery (of some type) was rated appropriate in 27%, uncertain in 41% and inappropriate in 31%. Frank panel disagreement was low (7% scenarios). Face validity was shown by the logical relationship between each variable's subcategories and the appropriateness ratings, e.g., no/mild disability had a mean appropriateness rating of 2.3 ± 1.5, whereas the rating for moderate disability was 5.0 ± 1.6 and for severe disability, 6.6 ± 1.6. Similarly, the average rating for no/minimal neurological abnormality was 2.3 ± 1.5, increasing to 4.3 ± 2.4 for moderate and 5.9 ± 1.7 for severe abnormality. The three variables most likely (p < 0.0001) to be components of scenarios rated "appropriate" were: severe disability, no yellow flags, and severe neurological deficit. CONCLUSION: This is the first study to report criteria for determining candidacy for surgery in LDS developed by a multidisciplinary international panel using a validated method (RAM). The panel ratings followed logical clinical rationale, indicating good face validity. The work refines clinical classification and the phenotype of degenerative spondylolisthesis. The predictive validity of the criteria should be evaluated prospectively to examine whether patients treated "appropriately" have better clinical outcomes.