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.

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.

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.

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.

Cost-effectiveness of conservative versus surgical treatment strategies of lumbar spinal stenosis in the Swiss setting: analysis of the prospective multicenter Lumbar Stenosis Outcome Study (LSOS).

PURPOSE: To evaluate the cost-effectiveness of conservative versus surgical treatment strategies for lumbar spinal stenosis (LSS). METHODS: Patients prospectively enrolled in the multicenter Lumbar Stenosis Outcome Study (LSOS) with a minimum follow-up of 12 months were included. Quality adjusted life years (QALY) were calculated based on EQ-5D data. Cost data were retrieved retrospectively. Cost-effectiveness was calculated via decision tree analysis. RESULTS: A total of 434 patients were included, treated surgically (n = 170) or conservatively (n = 264) for LSS. The majority of surgically treated patients underwent decompression (n = 141, 82.9%), and 17.1% (n = 29) additionally underwent fusion. A reoperation was required in 13 (7.6%) surgically treated patients. In 27 (10.2%) conservatively treated patients, a single infiltration was successful, with no further infiltration or surgery within the follow-up. However, 46 patients (17.4%) required multiple infiltrations, and in 191 (72.4%) initially conservatively treated patients a subsequent surgery was needed. The area under the curve was 0.776 QALY in the surgical arm (0.776 and 0.790, decompression or additional fusion, respectively), compared to 0.778 in the conservative arm. Treatment costs were estimated at CHF 12,958 and 13,637 (USD 13,465 and 14,169) in surgically and initially conservatively treated patients, respectively [base-case incremental cost-effectiveness ratio (ICER): CHF 392,145, USD 407,831], per QALY gained. Probabilistic sensitivity analysis identified surgery as the preferred strategy in 67.1%. CONCLUSIONS: Both the surgical and the conservative treatment approach resulted in a comparable health-related quality of life within the first year after study inclusion. Due to slightly higher costs, mostly because the majority of initially conservatively treated patients underwent multiple infiltrations or a subsequent surgery, decompressive surgery was identified as the most cost-effective approach for LSS in this setting.

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.

Influence of gender on patient-oriented outcomes in spine surgery.

PURPOSE: Few studies have examined gender differences in patient-oriented health-related quality of life before and after spine surgery. This study examined the influence of gender on baseline status and 1-year postoperative outcomes in a large series of patients undergoing surgery for different degenerative spinal disorders. METHODS: The study included 1518 patients [812 men and 706 women; mean (SD) age 61.4 ± 16.2 years], with three different pathologies (disc herniation, degenerative spondylolisthesis, or spinal stenosis), treated with specified surgical approaches. Preoperatively and 12 months postoperatively, patients completed the multidimensional Core Outcome Measures Index (COMI). Medical history, surgical details and perioperative complications were documented with the Eurospine "Spine Tango" Surgery 2006 form. RESULTS: Preoperatively and for all three pathologies, women had significantly (p < 0.05) worse COMI-scores than men, especially for the sub-domains "leg/buttock pain", "dominant pain intensity", and "general quality of life"; the change in the COMI sum score 12 months postoperatively showed no significant gender differences for any pathology (p > 0.05). 71.3 % males and 72.9 % females achieved the minimal clinically important change score (MCIC; 2.2 point reduction) for the COMI. Controlling for potential cofounders (preoperative COMI, ASA, complications, pathology), gender showed no significant association with the failure to achieve MCIC. CONCLUSIONS: This results show that women do not differ significantly from men regarding their postoperative outcome, even though they present with a worse preoperative status. The management of a patient's condition should not differ depending on their gender, since both men and women are able to improve to a similar extent.

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.

Surgery in lumbar degenerative spondylolisthesis: indications, outcomes and complications. A systematic review.

PURPOSE: This systematic review summarises the literature on patient selection, decision-making, effectiveness and outcomes in the surgical treatment of lumbar degenerative spondylolisthesis (LDS). INTRODUCTION: In daily practice, decision-making in the treatment of LDS is challenging. There is little consensus on either the precise indications or prognostic factors for any specific therapy (operative or non-operative). METHODS: We searched for LDS trials published between 01.01.1990 and 16.11.2011 in Medline, Embase, Cochrane Library and Cinahl. Two independent reviewers selected studies according to the inclusion criteria. Data were then extracted by two of the authors. Quality assessment was performed using the Downs and Black list for the clinical trials/studies and AMSTAR for the reviews. DATA SYNTHESIS: 21 papers met the inclusion criteria (2 studies comprising both a RCT and a concurrent observational analysis, 1 RCT, 6 prospective studies, 8 retrospective studies, 3 reviews, 1 review guideline). The quality of the clinical studies was on average "fair" [mean score 15.6 points (range 10-19) out of 24 points (Downs and Black)]. The quality of the reviews ranged from 1 to 7 out of 11 points with an average of 5 points (AMSTAR). The study outcomes could not be subject to meta-analysis due to heterogeneity of study design and variable measure used. CONCLUSIONS: Despite there being many articles describing and/or comparing different surgical options for LDS, there was insufficient evidence to draw conclusions concerning clear indications for specific types of surgical treatment, predictors of outcome or complication rates. There remains a need to establish a decision-making tool to facilitate daily clinical practice and to assure appropriate treatment for patients with LDS.

The influence of comorbidity on the risks and benefits of spine surgery for degenerative lumbar disorders.

PURPOSE: The ageing of the population will see a growing number of patients presenting for spine surgery with appropriate indications but numerous medical comorbidities. This complicates decision-making, requiring that the likely benefit of surgery (outcome) be carefully weighed up against the potential risk (complications). We assessed the influence of comorbidity on the risks and benefits of spine surgery. METHODS: 3,549/4,053 patients with degenerative lumbar disorders, undergoing surgery with the goal of pain relief, completed the multidimensional Core Outcome Measures Index (COMI; scored 0-10) before and 12 months after surgery. At 12 months postoperatively, they also rated the global treatment outcome and their satisfaction with care. Using the Eurospine Spine Tango Registry, surgeons documented surgical details, American Society of Anesthesiologists comorbidity (ASA) grades and perioperative surgical and general complications. RESULTS: 29.0% patients were rated as ASA1 (normal healthy), 45.7% as ASA2 (mild/moderate systemic disease), 24.9% as ASA3 (severe), and just 0.4% as ASA4 (life-threatening). In going from ASA1 to ASA3 (ASA4 group too small), surgical complications increased significantly from 5.0 to 14.5% and general complications increased from 2.9 to 15.7%; 12-month outcomes showed a corresponding decline, with a good global outcome being reported by 79% ASA1 patients, 76% ASA2, and 68% ASA3. Satisfaction with treatment was 87, 85, and 79%, respectively, and reduction in COMI was 4.2 ± 2.9, 3.7 ± 3.0, and 3.4 ± 3.0 points, respectively. Multiple regression analysis revealed a significant (p < 0.0001) independent effect of ASA grade on both complications and outcome. CONCLUSION: The negative impact of comorbidity on the outcome of spine surgery has not been well investigated/quantified to date. The ASA grade may be helpful in producing algorithms for decision-making and preoperative counselling regarding the corresponding risks and benefits of surgery.

Validity of a single-item measure to assess leg or back pain as the predominant symptom in patients with degenerative disorders of the lumbar spine.

PURPOSE: Recent studies suggest that the location of predominant pain (back or leg) can be a significant predictor of the outcome of surgery for degenerative spinal disorders. However, others challenge the notion that the predominant symptom can be reliably identified. This study examined the validity of a single item used to determine the most troublesome symptom. METHODS: A total of 2,778 patients with degenerative disorders of the lumbar spine scheduled for surgery with the goal of pain relief completed a questionnaire enquiring as to their most troublesome symptom ["main symptom"; back pain (BACK) or leg/buttock pain (LEG)]. They also completed separate 0-10 graphic rating scales for back pain (LBP) and leg/buttock pain (LP) intensity. Receiver operating characteristics (ROC) analysis was used to determine the accuracy with which the "LP minus LBP" score was able to classify patients into their declared "main symptom" group. Sub-studies evaluated the test-retest reliability of the patients' self-rated pain scores (N = 45) and the agreement between the main symptom declared by the patient in the questionnaire and that documented by the surgeon after the clinical consultation (N = 118). RESULTS: Test-retest reliability of the back and leg pain scores was good (ICC2,1 of 0.8 for each), as was patient-surgeon agreement regarding the main symptom (BACK or LEG) (κ value 0.79). In the BACK group, the mean values for pain intensity were 7.3 ± 2.0 (LBP) and 5.2 ± 2.9 (LP); in the LEG group, they were 4.3 ± 2.9 (LBP) and 7.5 ± 1.9 (LP). The area under the curve for the ROC was 0.95 (95 % CI 0.94-0.95), indicating excellent discrimination between the BACK and LEG groups based on the "LP minus LBP" scores. A cutoff score >0.0 for "LP minus LBP" score gave optimal sensitivity and specificity for indicating membership of the LEG group (sensitivity 79.1%, specificity 95.7%). CONCLUSIONS: The responses on the single item for the "main symptom" were in good agreement with the differential ratings on the 0-10 pain scales for LBP and LP intensity. The cutoff >0 for "LP minus LBP" for classifying patients as LEG pain predominant seemed appropriate and suggests good concurrent validity for the single-item measure. The single item may be of use in sub-grouping patients with the same disorder (e.g. spondylolisthesis) or as an indication in surgical decision-making.

The bothersomeness of patient self-rated "complications" reported 1 year after spine surgery.

PURPOSE: The last few decades have witnessed a paradigm shift in the assessment of outcome in spine surgery, with patient-centred questionnaires superseding traditional surgeon-based assessments. The assessment of complications after surgery and their impact on the patient has not enjoyed this same enlightened approach. This study sought to quantify the incidence and bothersomeness of patient-rated complications 1 year after surgery. METHODS: Patients with lumbar degenerative disorders, operated with the goal of pain relief between October 2006 and September 2010, completed a questionnaire 1 year postoperatively enquiring about complications arising as a consequence of their operation. They rated the bothersomeness of any such complications on a 5-point scale. Global outcome of surgery and satisfaction at the 12-month follow-up were also rated on 5-point Likert scales. The multidimensional Core Outcome Measures Index (COMI) was completed preoperatively and at the 12-month follow-up. RESULTS: Of 2,282 patients completing the questionnaire (92% completion rate), 687 (30.1%) reported complications, most commonly sensory disturbances (36% of those with complications) or ongoing/new pain (26%), followed by motor problems (8%), pain plus neurological disturbances (11%), and problems with wound healing (6%). The corresponding "bothersomeness" ratings for these were: 1% not at all, 23% slightly, 27% moderately, 31% very, and 18% extremely bothersome. The greater the bothersomeness, the worse the global outcome (Rho = 0.51, p < 0.0001), patient satisfaction (Rho = 0.44, p < 0.0001) and change in COMI score (Rho = 0.52, p < 0.0001). CONCLUSION: Most complications reported by the patient are perceived to be at least moderately bothersome and hence are not inconsequential. Complications and their severity should be assessed from both the patient's and the surgeon's perspectives--not least to better understand the reasons for poor outcome and dissatisfaction with treatment.

To fuse or not to fuse in lumbar degenerative spondylolisthesis: do baseline symptoms help provide the answer?

INTRODUCTION: Clinical symptoms in lumbar degenerative spondylolisthesis (LDS) vary from predominantly radiating pain to severe mechanical low back pain. We examined whether the outcome of surgery for LDS varied depending on the predominant baseline symptom and the treatment administered [decompression with fusion (D&F) or decompression alone (D)]. METHODS: 213 consecutive patients (69 ± 9 years; 155f, 58 m) participated. Inclusion criteria were LDS, maximum three affected levels, no previous surgery at the affected level, and D (N = 56) or D&F (N = 157) as the operative procedure. Pre-op and at 12 months' follow-up (FU), patients completed the multidimensional Core Outcome Measures Index (COMI) including 0-10 leg-pain (LP) and LBP scales. At 12 months' FU, patients rated global outcome which was then dichotomised into "good" and "poor". RESULTS: Pre-operatively, LBP and COMI scores were significantly worse (p < 0.05) in the D&F group than in the D group. The improvement in COMI at 12 months' FU was significantly greater for D&F than for D (p < 0.001) and was not influenced by the patient's declared "main problem" at baseline (back pain, leg pain, or neurological disturbances) (p > 0.05). There was a higher proportion (p = 0.01) of "good" outcomes at 12 months' FU in D&F (86%) than in D (70%). Multiple regression analysis, controlling for possible confounders, revealed treatment group to be the only significant predictor of outcome (adding fusion = better outcome). DISCUSSION: Our study indicated that LDS patients showed better patient-based outcome with instrumented fusion and decompression than with decompression alone, regardless of baseline symptoms. This may be due to the fact that the underlying slippage as the cause of the stenosis is better addressed with fusion.

The outcome of decompression surgery for lumbar herniated disc is influenced by the level of concomitant preoperative low back pain.

Decompression surgery is a common and generally successful treatment for lumbar disc herniation (LDH). However, clinical practice raises some concern that the presence of concomitant low back pain (LBP) may have a negative influence on the overall outcome of treatment. This prospective study sought to examine on how the relative severity of LBP influences the outcome of decompression surgery for LDH. The SSE Spine Tango System was used to acquire the data from 308 patients. Inclusion criteria were LDH, first-time surgery, maximum 1 affected level, and decompression as the only procedure. Before and 12 months after surgery, patients completed the multidimensional Core Outcome Measures Index (COMI; includes 0-10 leg/buttock pain (LP) and LBP scales); at 12 months, global outcome was rated on a Likert scale and dichotomised into "good" and "poor" groups. In the "good" outcome group, mean baseline LP was 2.8 (SD 3.1) points higher than LBP; in the "poor" group, the corresponding value was 1.1 (SD 2.9) (p < 0.001 between groups). Significantly fewer patients with back pain as their "main problem" had a good outcome (69% good) when compared with those who reported leg/buttock pain (84% good) as the main problem (p = 0.04). In multivariate regression analyses (controlling for age, gender, co-morbidity), baseline LBP intensity was a significant predictor of the 12-month COMI score, and of the global outcome (each p < 0.05) (higher LBP, worse outcome). In conclusion, patients with more back pain showed significantly worse outcomes after decompression surgery for LDH. This finding fits with general clinical experience, but has rarely been quantified in the many predictor studies conducted to date. Consideration of the severity of concomitant LBP in LDH may assist in establishing realistic patient expectations before the surgery.

Microdiscectomy compared with standard discectomy: an old problem revisited with new outcome measures within the framework of a spine surgical registry.

Studies comparing the relative merits of microdiscectomy and standard discectomy report conflicting results, depending on the outcome measure of interest. Most trials are small, and few have employed validated, multidimensional patient-orientated outcome measures, considered essential in outcomes research. In the present study, data were collected prospectively from six surgeons participating in a surgical registry. Inclusion criteria were: lumbar/lumbosacral degenerative disease; discectomy/sequestrectomy without additional fusion/stabilisation; German or English-speaking. Before and 3 and 12 months after surgery, patients completed the Core Outcome Measures Index comprising questions on leg/buttock pain, back pain, back-related function, symptom-specific well-being, general quality-of-life, and social and work disability. At follow-up, they rated overall satisfaction, global outcome, and perceived complications. Compliance with the registry documentation was excellent: 87% for surgeons (surgery forms), 91% for patients (for 12 months follow-up). 261 patients satisfied the inclusion criteria (225 microdiscectomy, 36 standard discectomy). The standard discectomy group had significantly greater blood-loss than the microdiscectomy (P < 0.05). There were no group differences in the proportion of surgical complications or duration of hospital stay (P > 0.05). The groups did not differ in relation to any of the patient-orientated outcomes or individual outcome domains (P > 0.05). Though not equivalent to an RCT, the study included every single eligible patient in our Spine Center and allowed surgeons to use their regular procedure; it hence had extremely high external validity (relevance/generalisability). There was no clinically relevant difference in outcome after lumbar disc excision dependent on the use of the microscope. The decision to use the microscope should rest with the surgeon.

The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice.

The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument, with excellent psychometric properties, that has been recommended for use in monitoring the outcome of spinal surgery from the patient's perspective. This study examined the feasibility of implementation of COMI and its performance in clinical practice within a large Spine Centre. Beginning in March 2004, all patients undergoing spine surgery in our Spine Centre (1,000-1,200 patients/year) were asked to complete the COMI before and 3, 12 and 24 months after surgery. The COMI has one question each on back (neck) pain intensity, leg/buttock (arm/shoulder) pain intensity, function, symptom-specific well being, general quality of life, work disability and social disability, scored as a 0-10 index. At follow-up, patients also rated the global effectiveness of surgery, and their satisfaction with their treatment in the hospital, on a five-point Likert scale. After some fine-tuning of the method of administration, completion rates for the pre-op COMI improved from 78% in the first year of operation to 92% in subsequent years (non-response was mainly due to emergencies or language or age issues). Effective completion rates at 3, 12 and 24-month follow-up were 94, 92 and 88%, respectively. The 12-month global outcomes (from N = 3,056 patients) were operation helped a lot, 1,417 (46.4%); helped, 860 (28.1%); helped only little, 454 (14.9%); did not help, 272 (8.9%); made things worse, 53 (1.7%). The mean reductions in COMI score for each of these categories were 5.4 (SD2.5); 3.1 (SD2.2); 1.3 (SD1.7); 0.5 (SD2.2) and -0.7 (SD2.2), respectively, yielding respective standardised response mean values ("effect sizes") for each outcome category of 2.2, 1.4, 0.8, 0.2 and 0.3, respectively. The questionnaire was feasible to implement on a prospective basis in routine practice, and was as responsive as many longer spine outcome questionnaires. The shortness of the COMI and its multidimensional nature make it an attractive option to comprehensively assess all patients within a given Spine Centre and hence avoid selection bias in reporting outcomes.

The quality of spine surgery from the patient's perspective: part 2. Minimal clinically important difference for improvement and deterioration as measured with the Core Outcome Measures Index.

The Core Outcome Measures Index (COMI) is a reliable and valid instrument for assessing multidimensional outcome in spine surgery. The minimal clinically important score-difference (MCID) for improvement (MCID(imp)) was determined in one of the original research studies validating the instrument, but has never been confirmed in routine clinical practice. Further, the MCID for deterioration (MCID(det)) has never been investigated; indeed, this needs very large sample sizes to obtain sufficient cases with worsening. This study examined the MCIDs of the COMI in routine clinical practice. All patients undergoing surgery in our Spine Center since February 2004 were asked to complete the COMI before and 12 months after surgery. The COMI has one question each on back (neck) pain intensity, leg/buttock (arm/shoulder) pain intensity, function, symptom-specific well-being, general quality of life, work disability, and social disability, scored as a 0-10 index. At follow-up, patients also rated the global effectiveness of surgery, on a 5-point Likert scale. This was used as the external criterion ("anchor") in receiver operating characteristics (ROC) analyses to derive cut-off scores for individual improvement and deterioration. Twelve-month follow-up questionnaires were returned by 3,056 (92%) patients. The group mean COMI score change for patients declaring that the "operation helped" was a reduction of 3.1 points; the corresponding value for those whom it "did not help" was a reduction of 0.5 points. The group MCID(imp) was hence 2.6 points reduction; the corresponding group MCID(det) was 1.2 points increase (0.5 minus -0.7). The area under the ROC curve was 0.88 for MCID(imp) and 0.89 for MCID(det) (both P < 0.0001), indicating that the COMI had good discriminative ability. The cut-offs for individual improvement and deterioration, respectively, were > or =2.2 points decrease (sensitivity 81%, specificity 83%) and > or =0.3 points increase (sensitivity 83%, specificity 88%). The MCID(imp) score of 2.2 points was similar to that reported in the original study (2-3 points, depending on external criterion used). The MCID(det) suggested that the COMI is less responsive to deterioration than to improvement, a phenomenon also reported for other spine outcome instruments. This needs further investigation in even larger patient groups. The MCIDs provide essential information for both the planning (sample size) and interpretation of the results (clinical relevance) of future clinical studies using the COMI.

Multimodal intraoperative monitoring (MIOM) during surgical decompression of thoracic spinal stenosis in 36 patients.

A prospective study of 36 patients who received multimodal intraoperative monitoring (MIOM) during decompression of thoracic spinal stenosis between March 2000 and December 2005 was chosen as the study design. The objective was to determine the sensitivity and specificity of MIOM techniques used for monitoring spinal cord during surgical thoracic decompression. The background data revealed that the surgical decompression for thoracic spinal stenosis is less frequent than in other regions of the spine. However, due to the relative narrow spinal canal, neurological complications could be severe. The combination of monitoring ascending and descending pathways may provide an early alert to the surgeon in order to alter the surgical procedure, and avoid neurological complications. The methods involved evaluation of intraoperative somatosensory spinal and cerebral evoked potentials and motor evoked potentials of the spinal cord and muscles that were compared with post operative clinical neurological changes. 36 consecutive patients with thoracic spinal stenosis of different aetiologies were monitored by the means of MIOM during the surgical procedure. 31 patients had true negative while one patient had false positive findings. Three patients had true positive and one patient had false negative findings. This indicates a sensitivity of 75% and a specificity of 97%. The one case of false negative findings recovered completely within 3 months. In conclusion, the MIOM is an effective method of monitoring the spinal cord during surgical decompression of the thoracic spine.